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Posts Tagged ‘IMMEDIATELY’

Cimzia 200mg solution for injection

Certolizumab Pegol

1. WHAT CIMZIA IS AND WHAT IT IS USED FOR

Cimzia contains the active substance certolizumab pegol, a humar antibody fragment. Antibodies are proteins that specfically recognise and bind to other proteins. Cimzia binds to a specific protein callec tumour necrosis factor a (TNFa|. Thereby this TNFa is blocked by Cimzic and this decreases inflammation in rheumatoid arthritis. Medicines that oind to TNFa are also called TNF blockers.

Cimzia is used for the treatment of moderate to severe rheumatoid arthritis in adult patients, when other medicines fail to control your symptoms. Cimzia is usually used together with another medicine called methotrexate. f your doctor determines that methotrexate is inappropriate, Cimzia car oe given alone.

2. BEFORE YOU USE CIMZIA

Do NOT use Cimzia

• If you are ALLERGIC (hypersensitive] to certolizumab pegol or any of the other ingredients of Cimzic
• If you have a severe infection, including active TUBERCULOSIS
• If you have moderate to severe HEART FAILURE. Tell your doctor if you have had or have a serious heart condition.

Take special care with Cimzia

Tell your doctor before treatment with Cimzia if any of the following applies to you:

Allergic reactions

If you experience ALLERGIC REACTIONS such as chest tightness, wheezing, dizziness, swelling or rash, stop using Cimzia and contact your doctor IMMEDIATELY.

Infections

-    If you have had RECURRENT INFECTIONS or other conditions that   increase   the   risk   of   infections   (such   as   treatment   with

immunosuppressants, which are medicines that could reduce your ability to fight infections].

-    If you have an infection or if you develop symptoms such as fever, wounds, tiredness or dental problems. You might get an infectior more easily while you are being treated with Cimzia, including serious, or in rare cases, life-threatening infections. TUBERCULOSIS (TB| cases have been reported in patients treatec with Cimzia, your doctor will check you for signs and symptoms of tuberculosis before starting Cimzia. This will include a thorough medical history, a chest X-ray and a tuberculin test. The conduct of these tests should be recorded on your Patient Alert Card, f atent (inactive] tuberculosis is diagnosed, you might be reguired to -eceive appropriate anti-tuberculosis medicines before starting Cimzia. t is very important that you tell your doctor f you have ever hac tuberculosis, or f you have been in close contact with someone who nas had tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever], or any other infection appear during or after therapy with Cimzia tell your doctor immediately.

-    If you are at risk of or are a carrier of or have active HEPATITIS B VIRUS (HBV| infection, Cimzia may increase the risk of reactivation in people who carry this virus, f this occurs, you should stop using Cimzia.

Heart failure

If you have mild HEART FAILURE and you are being treated with Cimzia, your heart failure status must be closely monitored by your doctor. It is important to tell your doctor if you have had or have serious heart condition. If you develop new or worsening symptoms of heart failure (e.g. shortness of breath or swelling of your feet], you must contact your doctor immediately. Your doctor may decide to stop treatment with Cimzia.

Cancer

-    It is uncommon, but cases of certain types of CANCER have beer -eported in patients treated with Cimzia or other TNF blockers. -eople with more severe rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting a kind of cancer that affects the lymph system, callec ymphoma. If you take Cimzia, your risk also may increase. Ir addition, uncommon cases of non-melanoma skin cancer have oeen observed in patients taking Cimzia. If new skin lesions appear during or after therapy with Cimzia or existing skin lesions change appearance, tell your doctor. Patients with chronic obstructive oulmonary disease [COPD], or who are heavy smokers, may be at increased risk for cancer with Cimzia treatment. If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.

Other disorders

-    If you have a nervous system disorder, such as multiple sclerosis, your doctor will decide whether you should use Cimzia.

-    In some patients the body may fail to produce enough of the blooc cells that help your body fight infections or help you to stop bleeding, f you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor immediately. Your doctor may decide to stop treatment with Cimzia.

-    It is uncommon, but symptoms of a disease called lupus (for example oersistent rash, fever, joint pain and tiredness] may occur, f you experience these symptoms, contact your doctor. Your doctor may decide to stop treatment with Cimzia.

Vaccinations

-    Talk to your doctor if you have had, or are due to have a vaccine. You should not receive certain (live] vaccines while using Cimzia.

Operations or dental procedures

-    Talk to your doctor if you are going to have any operations or denta orocedures. Tell your surgeon or dentist performing the procedure that you are having treatment with Cimzia by showing them your Patient Alert Card.

Taking other medicines

You should NOT take Cimzia if you are using the following medicines used to treat rheumatoid arthritis:

-    anakinre

-    abatacept

If you have guestions, please ask your doctor.

Cimzia can be taken together wth:

-    methotrexate,

-    corticosteroids, or

-    pain  medicines including  nonsteroidal anti-inflammatory medicines (also called NSAIDs).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. There is a lack of experience wth Cimzia in pregnant women. Therefore, Cimzia should NOT be used in pregnant women. Womer of childbearing potential must use adeguate contraception while using Cimzia and for at least 5 months after the last Cimzia treatment, t is not known whether Cimzia passes into breast milk. You should talk to your doctor before breast-feeding during Cimzia treatment.

Driving and using machines

Cimzia may have a minor influence on your ability to drive and use machines. Dizziness (including room spinning sensation, blurred visitor and tiredness] may occur after you take Cimzia.

Important information about some of the ingredients of Cimzia

This medicinal product contains less than 1 mmol sodium (23 mg] per 400 mg, i.e. essentially ‘sodium-free’.

3. HOW TO USE CIMZIA

Always use Cimzia exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure of how to use Cimzia.

The starting dose for adults wth rheumatoid arthritis is 400 mg given at weeks 0, 2 and 4. This is followed by a maintenance dose of 200 mg every other week starting at week 6. Methotrexate is continued while using Cimzia. If your doctor determines that methotrexate is inappropriate, Cimzia can be given alone. Cimzia will usually be given to you by a specialist doctor or healthcare professional. You will be given Cimzia as either one (200 mg dose] or two injections (400 mg dose] under the skin (subcutaneous use]. It is usually injected into the thigh or tummy.

Instructions for preparing and giving an injection of Cimzia

After suitable training, your doctor may also allow you to inject Cimzic yourself. Please read the instructions at the end of this leaflet on how to inject Cimzia.

If your doctor has allowed you to self-inject, you should follow up with your doctor before the 7th dose to have the doctor determine if Cimzia is working for you or if another treatment needs to be considered.

• If you use more Cimzia than you should

f your doctor has allowed you to self-inject and you accidentally inject Cimzia more frequently than prescribed, you should tell your doctor. Always take the Patient Alert Card and the outer carton from the Cimzia package with you, even if it is empty.

• If you forget to use Cimzia

f your doctor has allowed you to self-inject and you forget to give yourself an injection, you should inject the next dose of Cimzia as soon as you remember. Then inject the following doses every 2 weeks as originally instructed.

• If you stop using Cimzia

Do not stop using Cimzia without talking to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Cimzia can cause side effects, although not everybody gets them.

Tell your doctor IMMEDIATELY f you notice any of the following side effects:

•  severe rash, hives or other signs of allergic reaction (urticaria]

•  swollen face, hands, feet (angioedema]

•  trouble breathing, swallowing (multiple causes for these symptoms]

•  shortness of breath with exertion or upon lying down or swelling of the feet (heart failure]

•   symptoms of blood disorders such as persistent fever, bruising, deeding, paleness (pancytopaenia, anaemia, low platelet count, low white blood cell count]

Tell your doctor AS SOON AS POSSIBLE if you notice any of the following side effects:

•  signs of infection such as fever, malaise, wounds, dental problems, ourning on urinatior

•  feeling weak or tirec

•  coughing.

•  tingling

•   numbness

•  double visior

•  arm or leg weakness

•   bump or open sore that doesn’t hear

The symptoms described above can be due to some of the side effects listed below, which have been observed with Cimzia:

Side effects may occur with certain frequencies, which are defined as follows:

•  Very common: affects at least 1  user in 1 0.

•   Common: affects at least 1 user in 100 but less than 10 users in 100.

•   Uncommon: affects at least 1 user in 1 ,000 but less than 10 users in 1,000.

•   Rare: affects at least 1 user in 10,000 but less than 10 users in 10,000.

•  Very rare: affects less than 1  user in 10,000.

•   not known: frequency cannot be estimated from the available data.

Common side effects:

•   bacterial infections in any site (a collection of pus]

•  viral infections (including cold sores, shingles, and influenza]

•  fever

•   high blood pressure

•   rash or itching

•   headaches (including migraines]

•  sensory abnormalities such as numbness, tingling, burning sensation

•  feeling weak and generally unwell

•   pair

•   blood disorders

•   liver problems

•   injection site reactions

Uncommon side effects:

•  allergic conditions including allergic rhinitis and allergic reactions to the drug

•  solid organ cancers

•  skin cancers, pre-cancers

•   benign (non-cancerous] tumours and cysts (including those of the skin]

•   heart problems including weakened heart muscle, heart failure, heart attack, chest discomfort or chest pressure, abnormal heart rhythm including irregular heart beats

•  oedema (swelling in the face or legs]

•   lupus (immune/connective tissue disease] symptoms (joint pain, skin-ashes, photosensitivity and fever]

•   inflammation of the blood vessels

•   sepsis (serious infection which can result in organ failure, shock or death]

•   tuberculosis infection

•  fungal infections (occur when the ability to fight off infection is essened]

•   respiratory disorders and inflammation (including asthma, shortness of oreath, cough, blocked sinuses, pleurisy, or difficulty breathing]

•  stomach problems including abdominal fluid collection, ulcers (including oral ulcers], perforation, distension, inflammation heartburn, upset, dry mouth

•   bile problems

•   muscle problems including increased muscle enzymes

•  changes in blood levels of different salts

•  changes in cholesterol and fat levels in the blood

•   blood clots in the veins or lungs

•   bleeding or bruising

•  changed numbers of blood cells, including low red cell count (anaemia], low platelet counts, increased platelet counts

•  swollen lymph nodes

•  flu-like symptoms, chills, altered temperature perception, night sweats, flushing

•  anxiety (including restlessness], mood disorders such as depression, appetite disorders, weight change

•  vertigo (dizziness]

•  feeling faint, including loss of consciousness

•   nerve disorders in the extremities including symptoms of numbness, tingling, burning sensation, dizziness, tremor

•  skin disorders such as psoriasis, sweat gland disorders, ulcers, photosensitivity, acne, hair loss, discoloration, nail separation, dry skin and injuries

•   impaired healing

•   kidney and urinary problems including impairment of kidney function, olood in the urine and urinary disturbances

•   menstrual cycle (monthly period] disorders including lack of bleeding, or heavy or irregular bleeding

•   breast disorders

•  eye and eyelid inflammation, vision disturbances, problems with tears

•   itching

•   prolonged coagulation (clotting] test times

Rare side effects:

•   lymphoma, melanoma

•   gastrointestinal cancer

•   lung inflammation

•  stroke, blockage in blood vessels

•  enlarged spleen

•   Formation of stones in the gall bladder

•   immune disorders such as sarcoidosis (rash, joint pain, fever], serum sickness, inflammation of the fat tissue, angioneurotic oedemc (swelling of the lips, face, throat]

•   thyroid disorders (go tre, tiredness, weight loss]

•   changes in blood levels of uric acid (increased]

•   suicide attempt, mental impairment, delirium

•   inflammation of the nerve for hearing, trigeminal nerve pain, impaired coordination or balance

•   ringing in the ears

•   gastrointestinal disorders such as fistula (tract from one organ to another], increased motility

•   oral disorders including pain on swallowing

•   skin sloughing, blistering, hair texture disorder

•   sexual dysfunction

Other side effects

When Cimzia has been used to treat other diseases the following uncommon side effects have occurred:

•   Gastrointestinal stenosis (narrowing of part of the digestive system].

•   Gastrointestinal obstructions (obstructions of the digestive system].

•   General physical health deterioration.

•   Grand ma I convulsion (a seizure].

•   Spontaneous abortion.

•  Azoospermia (lack of sperm production].

When other TNF blockers have been used to treat rheumatoid arthrtis, multiple sclerosis has occurred. The risk of multiple sclerosis with Cimzic is not known.

f any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE CIMZIA

Keep out of the reach and sight of children.

Do not use Cimzia after the expiry date which is stated on the package syringe after EXP. The expiry date refers to the last day of the month. Store in a refrigerator (2°C – 8°C). Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

Medicines should not be disposed of via wastewater or householc waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Cimzia contains

-    The active substance is certolizumab pegol. Each pre-filled syringe contains 200 mg of certolizumab pegol in one ml.

-    The other ingredients  are:  sodium  acetate,   sodium  chloride anc water for injections.

What Cimzia looks like and contents of the pack

One Cimzia pack contains:

•  two pre-filled syringes of solution, and

•  two alcohol wipes (for cleansing the areas chosen for injection]. None of the components of the syringe contain latex.

Packs of 2 syringes and 2 alcohol wipes, and a multipack containing 6 (3  packs of 2] syringes and 6 (3  packs of 2] alcohol wipes are

available.

Not all pack sizes may be marketed.

INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF CIMZIA

After proper training, the injection can be self-administered or given by another person, for example a family member or friend. The following instructions explain how to inject Cimzia. Please read the instructions carefully and follow them step by step. You will be instructed by your doctor or healthcare giver on the technigue of self-injection. Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.

This injection should not be mixed in the same syringe with any other medicine.

1. Setting up

•  Wash your hands thoroughly.

•   Remove the following items from the Cimzia carton and set them up on a clean surface:

One pre-filled syringe      One alcohol pack

•   Look at the expiry date on the syringe and pack. Do not use Cimzic after the expiry date which is stated on the pack and syringe after zXP. The expiry date refers to the last day of the month shown.

•  Allow the pre-filled syringe to reach room temperature. This will take up to 30 minutes. Do not try to warm up the syringe.

2.Choosing and preparing an injection site

•   Choose a site on your thigh or tummy.

•   Each new injection should be given on a separate site from the last injection site.

Do not inject in an area where the skin is reddened, bruised, or nard.

Wipe the injection site with the enclosed alcohol pad, using circular motion moving from the inside out.

Do not touch the area again before injecting.

3. Injection

•   Do NOT shake the syringe.

•   Remove the cap from the needle, being careful not to touch the needle or let the needle touch any surface.

•   Hold the syringe with needle facing up.

•  Tap the syringe to push any air bubbles to the top.

•  Press the plunger slowly until you expel any air. Stop when a sma drop appears at the tip of the needle.

• Gently grasp the cleaned  area  of skin with  one hand  and   hole firmly.

•  With the other hand, hold syringe at a 45-degree angle to skin.

•  With one quick, short motion, push the needle all the way into the skin.

•   Push plunger to inject solution. It can take up to 10 seconds to empty the syringe.

•  When the syringe is empty, carefully remove the needle from the skir at the same angle at which it was inserted.

•   Release the skin with the first hand.

•   Using your thumb or a piece of gauze, apply pressure over the injection site for a few seconds. Do not rub the injection site. A little deeding may occur.

4. Throwing away supplies

•  You must NOT re-use the syringe or re-cap the needle.

•  After injection, immediately throw away the used syringe in a specia container as instructed by your doctor, nurse or pharmacist.

•   Keep the container out of the reach and sight of children.

 

Campto 20 mg/ml

Irinotecan Hydrochloride Trihydrate

What is in Campto?

The active ingredient in Campto is irinotecan hydrochloride trihydrate. It is available as a concentrate, which should be diluted before infusion and comes in three sizes:

• 40 mg of irinotecan hydrochloride trihydrate in 2 ml

•  100 mg of irinotecan hydrochloride trihydrate in 5 ml

• 300 mg of irinotecan hydrochloride trihydrate in 15 ml

Other ingredients include sorbitol, lactic acid, sodium hydroxide, hydrochloric acid and water for injections.

Campto 40 mg/2 ml, 100 mg/5 ml and 300mg/15 ml are available in boxes containing a single vial.

Campto belongs to a group of medicines called cytostatics (anti-cancer medicines).

Why have you been prescribed Campto?

Campto may be used alone or in combination with a number of other medicines used to treat cancer. These combinations may be used to treat cancers of the colon, rectum and where the disease is at an advanced stage in the large intestine.

Your doctor may use a combination of Campto with 5-fluorouracil/folinic acid (5FU/FA) and bevacizumab to treat your cancer of the colon and rectum.

Your doctor may use a combination of Campto with capecitabine with or without bevacizumab to treat your cancer of the colon and rectum.

Your doctor may use a combination of Campto with cetuximab to treat cancer of the large intestine (KRAS wild-type) that is of a certain type known to display cell markers referred to as epidermal growth factor receptors (EGFR) which are blocked by the monoclonal antibody.

If you need any further information on your condition, please ask your doctor.

Before starting your course of treatment

Tell your doctor or hospital pharmacist if any of the following apply to you:

•       If you have any other bowel disease or a history of bowel obstruction

•       If you have had a severe allergic reaction to Campto in the past

•       If you are pregnant or breast feeding or if you think you might be pregnant

•       If you have any liver problems

•       If you are taking any prescription medicines

•       If you are taking any non-prescription medicines that you may have bought yourself, in particular

•      St Johns’ Wort

•      If you receive Campto in combination with cetuximab, please make sure that you also read the package insert for cetuximab

•      If you receive Campto in combination with bevacizumab, please make sure that you also read the package insert for bevacizumab

•      If you receive Campto in combination with capecitabine, please make sure that you also read the package insert for capecitabine

Special warnings

If you suffer from an inherited condition called fructose intolerance, tell your doctor or hospital pharmacist before you are given Campto. Campto contains sorbitol, which is unsuitable for people who cannot tolerate fructose.

As with all anti-cancer medicines the use of Campto is associated with a number of side-effects which may be serious. These side-effects require special management to minimise the risk of complications. You will be treated by a specialist team experienced in using these kinds of treatments and managing their side-effects, which are usually temporary. However, it is essential that you read the section “Does Campto have any side-effects?” and follow the instructions carefully if you get any of the symptoms described.

Can you drive or operate machinery?

Campto may make you feel dizzy or cause visual disturbances. If this happens to you do not drive or operate machinery.

How will you be given Campto?

Campto will be given as an infusion into your veins over a period of 30 to 90 minutes. The amount of Campto you are given will depend on your age, size and general medical condition. It will also depend on any other treatment you may have received for your cancer. Your doctor will calculate your body surface area in square metres (m²).

• If you have previously been treated with 5-fluorouracil you will normally be treated with Campto alone starting with a dose of 350 mg/m² every 3 weeks.

• If you have not had previous chemotherapy you will normally receive 180 mg/m² Campto every two weeks. This will be followed by folinic acid and 5-fluorouracil.

If you receive Campto in combination with cetuximab, Campto must not be administered earlier than 1 hour after the end of the cetuximab infusion. Please follow the advice of your doctor regarding your current treatment.

These dosages may be adjusted by your doctor depending on your condition and any side-effects you may have.

Does Campto have any side-effects?

Medicines like Campto will cause unwanted side-effects.

Your doctor will discuss these side-effects with you and explain the risks and benefits of your treatment.

Some of these side-effects must be treated immediately. Please read the following instructions carefully and follow them if you have any of the side-effects listed.

Diarrhoea

Campto may cause you to have diarrhoea. There are two types of diarrhoea, which can be distinguished by when they start. “Early onset” diarrhoea starts less than 24 hours after the infusion and “delayed” diarrhoea starts more than 24 hours after the infusion. If you have ANY DIARRHOEA it is IMPORTANT that you follow these instructions carefully.

•  if your diarrhoea starts less than 24 hours after the infusion (“early diarrhoea”) you should contact your doctor or nurse immediately and they will give you a suitable treatment.

Do not use any anti-diarrhoeal treatment that your doctor has given you for “delayed diarrhoea”.

This “early diarrhoea” may be accompanied by other symptoms such as

• sweating

• abdominal cramps

• watering eyes

• visual disturbance

• dizziness

• low blood pressure

• feeling unwell

• excessive mouth watering

Tell your doctor or nurse about all your symptoms.

• if your diarrhoea starts more than 24 hours after the infusion (“delayed diarrhoea”) you should IMMEDIATELY take any anti-diarrhoeal treatment that the doctor has given you EXACTLY as   he has told you. If you are unsure of what this is, ask your doctor or nurse.

Drink large amounts of rehydration fluids, IMMEDIATELY (i.e. water, soda water, fizzy drinks, soup or oral rehydration therapy). You must tell your doctor

• if you have nausea and vomiting as well as diarrhoea

• if you have any fever as well as the diarrhoea

• if you still have diarrhoea 48 hours after starting the diarrhoea treatment

• Do not take any treatment for diarrhoea other than that given to you by your doctor or nurse and the fluids described above.

Neutropenia

Campto may cause a decrease in the number of some of your white blood cells, which play an important role in fighting infections. This is called neutropenia.

Your doctor will probably arrange for you to have regular blood tests to monitor these white blood cells.

If you have any fever this may be an indication of infection associated with this neutropenia and requires immediate treatment.

If you have any fever, and particularly if you also have diarrhoea, contact your doctor or nurse IMMEDIATELY so that they can give you any treatment necessary.

Nausea and vomiting

If you have nausea and/or vomiting contact your doctor or nurse IMMEDIATELY.

Breathing difficulties

If you have breathing difficulties contact your doctor or nurse IMMEDIATELY.

Other side-effects

Very few patients who become dehydrated as a result of diarrhoea, vomiting or infection may have kidney problems, low blood pressure or circulatory failure.

Other side-effects may occur, but you do not need to contact your doctor unless they become troublesome:

• hair loss

• fatigue

• allergic skin reactions

• stomach ache

• muscular cramps

• constipation

• inflammation at the injection site

• abdominal pain

• transient speech disorders

• inflammation of the lining of the mouth

If you receive Campto in combination with cetuximab, some of the side-effects you may experience can also be related to this combination. Such side-effects may include a acne-like rash. Therefore, please make sure that you also read the package leaflet for cetuximab.

If you receive Campto in combination with capecitabine, some of the side-effects you may experience can also be related to this combination. Such side-effects may include: very common blood clots, common allergic reactions, heart attack and fever in patients with a low white blood cell count. Therefore, please make sure that you also read the package leaflet for capecitabine.

If you receive Campto in combination with capecitabine and bevacizumab, some of the side-effects you may experience can also be related to this combination. Such side-effects include: low white blood cell count, blood clots, high blood pressure and heart attack. Therefore, please make sure that you also read the package leaflet for capecitabine and bevacizumab.

Tell your doctor or nurse immediately if you have any side-effects that are not mentioned in this leaflet.

Expiry date

Campto must not be used after the expiry date. This date can be found on the vial and on the box. In both places it is given as “EXP” followed by the month and year.

Storing your medicine

•      Store in the pack in which it is supplied and protect from light.

•      Once the concentrate has been diluted for infusion the solution can be kept for 12 hours at room temperature (below 25°C) or for 24 hours in a refrigerator (at 2 to 8°C).

•      Always keep Campto in a safe place and out of the reach and sight of children.

Campto is a trademark.

INSTRUCTIONS FOR USE / HANDLING, PREPARATION AND DISPOSAL GUIDE FOR USE WITH CAMPTO CONCENTRATE FOR SOLUTION FOR INFUSION

USE/HANDLING

As with other neoplastic agents, Campto must be prepared and handled with caution. The use of glasses, masks and gloves is required. If Campto solution or infusion solution should come in contact with the skin, wash immediately and thoroughly with soap and water. If Campto solution or infusion solution should come into contact with the mucous membranes, wash immediately with water.

PREPARATION FOR THE INTRAVENOUS SOLUTION

As with any other injectable drugs, the Campto solution must be prepared aseptically.

If any precipitate is observed in the vials or after reconstitution, the product should be discarded according to standard procedures for cytotoxic agents.

Aseptically withdraw the required amount of Campto solution from the vial with a calibrated syringe and inject into a 250 ml infusion bag or bottle containing either 0.9% (w/v) sodium chloride or 5% (w/v) glucose solution. The infusion should then be thoroughly mixed by manual rotation.

It is recommended, that in order to reduce microbiological hazard, the infusion solutions should be prepared immediately prior to use and infusion commenced as soon as practicable after preparation.   If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution / dilution (etc) has taken place in controlled and validated aseptic conditions.

Campto infusion should be infused into a peripheral or central vein.

Campto should not be delivered as an intravenous bolus or an intravenous infusion shorter than 30 minutes or longer than 90 minutes.

DISPOSAL

All materials used for dilution and administration should be disposed of according to hospital standard procedures applicable to cytotoxic agents.

 

Asacol 800mg MR Tablets

(Mesalazine)

1. WHAT ASACOL 800MG MR TABLETS ARE AND WHAT THEY ARE USED FOR

Asacol 800mg MR Tablets contain the active substance mesalazine (also known as 5-aminosalicylic acid) which is an anti-inflammatory drug used in the treatment of:

• Ulceratlve colitis – a disease of the large bowel (colon) and back passage (rectum) in which the lining of the bowel becomes inflamed (red and swollen). Symptoms can include rectal bleeding frequent diarrhoea and abdominal pain. Asacol 800mg MR Tablets act locally in the colon to reduce inflammation and can also prevent further episodes (flares) of ulcerative colitis

• Crohn’s ileo-colitis – a disease affecting the small bowel (terminal ileum) and colon in which the lining of the bowel becomes swollen and sore. This may lead to the development of ulcers abscesses and narrowing (strictures) in the bowel. Asacol 800mg MR Tablets act locally in the terminal ileum and colon to control the disease and prevent further flares of Crohn’s ileo-colitis

2. BEFORE YOU TAKE ASACOL 800MG MR TABLETS

Do not take the Asacol 800mg MR Tablets if you

• are allergic (hypersensitive) to any of the ingredients in the product

• are allergic to aspirin or any other salicylate

• had kidney problems or blood abnormalities while taking other medicines such as sulphasalazine

• have confirmed severe kidney or liver impairment

• have stomach ulcers, with or without bleeding

DO NOT give the tablets to children unless directed by a doctor

Take special care with Asacol 800mg MR Tablets

•Asacol should be used with extreme caution in patients with confirmed mild to moderate kidney impairment

•Asacol should be used with caution in the elderly, and in patients who ever had any blood disorder, especially while taking medicines such as sulphasalazines

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription

Asacol 800mg MR Tablets should NOT be taken with Lactulose (a medicine for constipation)

Use of non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, aspirin, Cox-ll inhibitors) and azathioprine in particular may increase the risk of kidney reactions

Pregnancy and breast-feeding

Women who are pregnant or breast-feeding should not take Asacol 800mg MR Tablets unless advised otherwise by their doctor

Ask your doctor or pharmacist for advice before taking any medicine

Driving and using machines

Asacol 800mg MR Tablets are not expected to affect your ability to drive or operate machinery

Important information about some of the ingredients of Asacol 800mg MR Tablets

Lactose - if you know you have an intolerance to some sugars, contact your doctor before taking this medicine

3. HOW TO TAKE ASACOL 800MG MR TABLETS

Always take Asacol 800mg MR Tablets exactly as you doctor has told you. You should check with your doctor if you are not sure

The tablets should be swallowed whole with water; do not break, crush or chew them. You can take them at any time of the day, with or without meals

The usual dose is

• Treating ulcerative colitis - up to 6 tablets each day divided throughout the day (as advised by your doctor)

• Preventing a flare of ulcerative colitis or Crohn’s ileo-colitis - up to 3 tablets each day divided throughout the day (as advised by your doctor)

DO NOT take more than 6 tablets a day

Asacol 800mg MR Tablets are not recommended for use in children.

When you start taking the tablets, your doctor may test your blood from time to time. Treatment should be stopped if there is suspicion or evidence of kidney or blood abnormalities

Keep taking the 800mg MR Tablets for as long as your doctor tells you Your symptoms may come back if you stop treatment too early Remember to get a repeat prescription at the right time so that you do not miss a day of treatment

• If you take more Asacol 800mg MR Tablets than you should

Do not exceed the recommended dose. You should only take as many tablets as your doctor has instructed on the pharmacist’s label. If you take too much medicine, tell your doctor immediately or go to your nearest Accident & Emergency Department (take the tablet pack with you if possible)

• If you forget to take Asacol 800mg MR Tablets

If you forget to take a dose at the required time, take it as soon as you remember and continue taking your tablets as before. DO NOT take two doses together; if it is almost time for your next dose, wait until then and carry on as before

If you have any further questions on the use of this product, ask your doctor or pharmacist

4. POSSIBLE SIDE EFFECTS

Like all medicines, Asacol 800mg MR Tablets can cause side effects although not everybody gets them

Allergic reactions to the tablets can occur. Tell your doctor If you get a rash (with or without Itching), any shortness of breath, palpitations (rapid heart beat) or chest pain. These effects will usually disappear when you stop taking the medicine.

Tell your doctor IMMEDIATELY if you experience any of the following symptoms

• fever, sore throat, mouth or lip ulcers, spots underneath your skin anywhere on your body, including the genital and anal regions become very pale, swollen ankles or have unusual bleeding (e.g. unexpected nosebleeds or bleeding gums)

• skin rash with flaking, boils or sore lips or mouth

• bruising more easily or suspect blood abnormalities

• problems with kidney function

Common side effects (in more than 1 in 100 people but less than 1 in 10 people):

• diarrhoea

• abdominal pain •vomiting

• nausea (feeling sick) •wind

• headache

•joint and muscular pain

• indigestion

• rectal disorder

Rare side effects (in less than 1 in 1,000 people):

• problems with heart, liver, lung or kidney function

• inflammation of the liver or kidney

• inflammation of the pancreas

• blood abnormalities

• nerve ending damage, vertigo or dizziness

• chest pain or chest infections

• sinusitis (inflammation of lining of sinuses) or rhinitis (inflammatior of lining of nose)

• skin rashes

• hair loss

• unexplained wheezing or shortness of breath

• cough

• fever

• flu like symptoms

Very rare side effects (in less than 1 in 10,000people):

• worsening of symptoms of colitis

• Erythema multiforme and Stevens-Johnson syndrome (skin and mucous membrane disease)

If any of the side effects gets serious, or if your notice any side effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE ASACOL 800MG MR TABLETS

Keep out of the reach and sight of children

Do not remove the moisture absorbing pouch from the bottle

The pouch is not part of your medicine and is marked DO NOT EAT

Keep the bottle tightly closed

Do not use Asacol 800mg MR Tablets after the expiry date which is stated on the pack after ‘Exp’. The expiry date refers to the last day of that month

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment

6. FURTHER INFORMATION

What Asacol 800mg MR Tablets contain

The active substance is mesalazine (also known as 5-aminosalicylic acid). Each tablet contains 800mg mesalazine

The other ingredients are

Core: lactose monohydrate, sodium starch glycolate, talc, povidone magnesium stearate, colloidal anhydrous silica

Coating: methacrylic acid – methyl mefhacrylate copolymer (1:2) talc, dibutylphthalate, ferric oxide red (E172), methacrylic acid -methyl methacrylate copolymer (1:1), ferric oxide yellow (E172) macrogol

Black ink containing: propylene glycol, ferric oxide black (E172) ammonium hydroxide, ethanol, shellac glaze (bleached, de-waxed)

What Asacol 800mg MR Tablets look like and contents of the pack

Asacol 800mg MR Tablets are red-brown, coated, and oblong shaped marked with WC 800. They are packed in a plastic bottle with a child-resistant closure that contains cotton/silica gel moisture absorbing pouches

Asacol 800mg MR Tablets are available in packs of 12, 36 or 180 tablets (not all pack sizes may be marketed)

Getting more advice about Inflammatory Bowel Disease

In addition to advice and information available from your doctor and pharmacist, you may wish to contact the National Association for Colitis and Crohn’s Disease which offers information, advice and local support groups:

BLEOMYCIN (blee-oh-MY-sin)

Other Names for this Medication (Brand Names)

Blenoxane, Bleo

Appearance

Injection: Clear, colourless liquid for injection into the bloodstream.

Why this Medication is Used

Bleomycin is used in combination with other medications to treat many different types of cancer, such as Hodgkin’s disease, lymphomas, head and neck cancers, or testicular cancer.

How do you take this Medication

Injection: Your chemotherapy nurse will inject the medication into your bloodstream over a few minutes. You may be given a small test dose of Bleomycin on your first treatment day, to see how your body reacts to this medication.

Precautions

• Your doctor will check your progress on a regular basis to check for unwanted effects. Chest x-rays may be done from time to time, to monitor effects on your lungs.

• It is very important to tell your doctor if you have medical problems with your kidney, liver or lung disease. Tell your doctor if you smoke.

• Tell your doctor or dentist before you have any type of surgery (including dental surgery) if you are receiving Bleomycin injections.

• Tell your doctor if you are taking the medications Phenytoin or Digoxin.

• Bleomycin may cause TEMPORARY hair loss in some people. Normal hair growth should return after treatment, although it may take several months.

• This chemotherapy should not be used if you are pregnant or breast-feeding. It is important to discuss birth control with your doctor (Note: birth control pills alone are not recommended as the only birth control method). Birth control should also be used by female partners, if you are a male taking this medication

• It is important to tell your doctor if you have chickenpox (or have recently been exposed to someone who has had chickenpox), shingles, kidney disease or liver disease. Any of these conditions could affect therapy with this medication.

• Due to increased risk of infection check with your doctor before having any vaccinations. Check with your doctor, before any surgery or dental work.

• Do not take ASA (Aspirin®, acetylsalicylic acid) without your doctor’s knowledge and consent. For headache, fever, or occasional aches and pains, use acetaminophen (Tylenol ®) instead.

> If a doctor has advised you to take ASA to prevent heart disease or stroke, please discuss this with your oncologist (cancer doctor) before starting treatment.

> Many non-prescription medications contain ASA; always ask your pharmacist’s advice when choosing a product.

For more information on this medication, please call your doctor, pharmacist or nurse.

SIDE EFFECTS	PREVENTION	WHAT YOU SHOULD DO
MORE COMMON:
• Fever and chills (often starting 2 to 6 hours after injection) • Cough, shortness of breath • Trouble breathing • Nausea, vomiting • Sores on the mouth and lips • Darkening or thickening of skin, rash, itching • Loss of appetite	• Acetaminophen 325 mg (Tylenol®) 1 or 2 tablets may be taken before each injection and every 4-6 hours after, until fever and chills are gone. (max. 12 tablets/day) • Your doctor will take X-rays and check your lungs at regular clinic visits • Use anti-nausea medications as prescribed. • Maintain good mouth hygiene. Brush teeth often with a soft toothbrush. Avoid hot, spicy and acidic foods. • Your skin will return to normal a few months after the treatment has finished	• If not reduced by Acetaminophen within 12 to 24 hours, contact your doctor IMMEDIATELY. • Contact your doctor as soon as possible. • Contact your doctor if your medication for nausea is not working. See Nausea and vomiting pamphlet. • Check with your doctor or nurse as soon as you notice sores on mouth or lips.See Mouth Care pamphlet. • Check with your doctor if these become troublesome.
LESS COMMON:
• Confusion, faintness, wheezing • Changes in fingernails • Tired, feeling of weakness • Weight loss • Hair loss (from head and body) • Sensitivity to sunlight	• Wear a high SPF sunscreen and protective clothing	• Tell your doctor IMMEDIATELY. • Tell your doctor or nurse if this bothers you. • A wig, hat, cap, scarf or hairpiece may be ,e worn.
RARE:
• Sudden severe chest pain • Sudden weakness in arms and legs • Pain at tumour site • Swelling and pain in veins		• Check with your doctor IMMEDIATELY.

ACETAMINOPHEN (a-seat-a-MIN-o- fen)

Other Names for this Medication (Brand Names)

Abenol, Abensanil, Acamol, Accu-Tap, Acephen, Aceta Elixir, Aceta Tablets, Acetagesic, Acetalgin, Actamin, Actimol, Algotropyl, Allay, Alpiny, Alpinyl, Alvedon, Amadil, Aminofen, Anacin, Anacin-3, Anaflon, Anapap, Anelix, Anhiba, Apacet, Apadon, Apamid, Apamide, Atasol, Banesin, Bayer Select, Bickie-mol, Bucet, Butapap, Calpol, Captin, Cetadol, Clixodyne, Co-Gesic, Conacetol, Dafalgan, Dapa, Dapa X-S, Darvocet, Datril, Dimindol, Dirox, Disprol, Dolene AP-65, Doliprane, Dolprone, Drixoral Plus, Dularin, Dymadon, Dypap, Elixodyne, Enelfa, Eneril, Eu-Med, Excedrin, Exdol, Febridol, Febrilix, Febrinol, Febro-Gesic, Febrolin, Fendon, Feverall, Fevor, Finimal, Gelocatil, Genapap, Genebs, Hedex, Homoolan, Hy-Phen, Injectapap, Janupap, Korum, Lestemp, Liquagesic, Liquiprin, Lonarid, Lyteca, Momentum, Multin, NAPA, Napafen, Napap, Naprinol, Nealgyl, Nebs, Neopap, Neotrend, Nobedon, Norco, Oraphen-PD, Ortensan, Pacemo, Painex, Paldesic, Panadol, Panaleve, Panasorb, Panets, Panex, Panofen, Papa-Deine, Paracet, Parapan, Paraspen, Parelan, Parmol, Pasolind, Pasolind N, Pedric, Phenaphen, Phenaphen Caplets, Phendon, Phrenilin, Phrenilin Forte, Prompt, Propacet 100, Proval #3, Pyrinazine, Redutemp, Rivalgyl, Robigesic, Rounox, SK-Apap, Salzone, Sedapap, Servigesic, Snaplets-FR, St. Joseph Fever Reducer, Suppap, Synalgos-Dc-A, Tabalgin, Talacen, Tapanol, Tapar, Tavist Allergy/Sinus/Headache, Temlo, Tempanal, Tempra, Tencon, Tibinide, Tibizide, Tisin, Tisiodrazida, Tizide, Tralgon, Triaprin, Tussapap, Tycolet, Tylenol, Ultracet, Valadol, Valgesic, Valorin, Valorin Extra, Wygesic

Appearance

Tablets/Capsules: Round white tablet (325mg, 500mg), white caplet (325mg, 500mg), red/yellow gelatin caplet (500mg), Extended Release white caplet (650 mg)

Oral Liquid: Flavoured liquid [160mg/5 ml_ (teaspoon)]

Suppositories: Rectal suppositories (120mg, 325mg, 650mg)

Why this Medication is Used

This medication may be used to relieve pain and reduce fever, but NOT to relieve stiffness or swelling.

How do you take this Medication

Oral tablets/caplets/gel caps should be taken with a full glass of water. Acetaminophen may be taken with or without food.

Rectal suppository: Unwrap the suppository. Insert into the rectum. If the suppository is too soft, chill it in the fridge for 30 minutes or run cold water over it.

Precautions

• If you are using Acetaminophen to reduce a fever, take your temperature before each dose and write the number down. If you are receiving chemotherapy and the temperature is 38° C (100° F) or higher, call your doctor immediately. If you are not receiving chemotherapy, tell your doctor if the fever lasts for 2 days.

• DO NOT take more tablets than your doctor has ordered. Too many tablets can cause serious liver damage.

• Tell your doctor if you suffer from liver disease or severe kidney disease.

• Limit alcoholic beverages if you take acetaminophen on a regular basis.

• Acetaminophen may interfere with some medical tests. For example, some blood sugar tests may show false results for diabetic patients.

• Many combination medications (e.g. cough and cold products) contain acetaminophen as one of the active ingredients. Carefully check the labels of all other medications you are using before taking acetaminophen.

• Store away from heat, direct light and moisture, and out of the reach of children.

For more information on this medication, please call your doctor, pharmacist or nurse.

SIDE EFFECTS	PREVENTION	WHAT YOU SHOULD DO
There are NO COMMON SIDE EFFECTS to Acetaminophen. Uncommon or rare side effects are usually related to overdose or worsening of conditions which existed before Acetaminophen was started.
LESS COMMON:
• Diarrhea, nausea, vomiting, loss of appetite.	•These may be signs of possible overdose. DO NOT take more than prescribed.	•Contact your doctor IMMEDIATELY.
RARE:
• Yellow eyes or skin. • Black, tarry stools. • Bloody or cloudy urine, decreased urine output. • Pain in lower back. • Skin rash, hives, trouble breathing, swelling in face, mouth or throat. • Unusual bleeding, bruising.		• STOP taking the drug. • Seek medical attention IMMEDIATELY.