Posts Tagged ‘Possible Side Effects’
Fluorouracil Injection
Fluorouracil 25 mg/ml Injection
For Intravenous or Intraarterial Use
Incompatibilities
Fluorouracil is incompatible with carboplatin, cisplatin, cytarabine, diazepam, doxorubicin, other anthracyclines and possibly methotrexate.
Formulated solutions are alkaline and it is recommended that admixture with acidic drugs or preparations should be avoided.
Preparation Instructions
Fluorouracil Injection may be diluted with Glucose 5% Injection or Sodium Chloride 0.9% Injection BP or Water for Injections BP immediately before parenteral use.
Dosage and Administration
Adult Dose
Selection of an appropriate dose and treatment regime will depend upon the condition of the patient, the type of carcinoma being treated and whether fluorouracil is to be administered alone or in combination with other therapy. Initial treatment should be given in hospital and the total daily dose should not exceed 0.8-1 gram. It is customary to calculate the dose in accordance with the patient’s actual bodyweight unless there is obesity, oedema or some form of abnormal fluid retention such as ascites. Ideal weight is used as the basis for calculation in such cases.
The initial dose should be reduced by one-third to one half in patients with any of the following:
1. Cachexia.
2. Major surgery within preceding 30 days.
3. Reduced bone marrow function.
4. Impaired hepatic or renal function.
Single Agent
The following regimens have been recommended for use as a single agent:-
Initial Treatment
This may be in the form of an infusion or an injection, the former usually being preferred because of lesser toxicity.
Intravenous Intusion
15 mg/kg bodyweight but not more than 1 g per infusion, diluted in 300 – 500 ml of 5% glucose or 0.9% NaCI injection and given by intravenous infusion over 4 hours.
Alternatively the daily dose may be infused over 30 – 60 minutes or may be given as a continuous infusion over 24 hours. The infusion may be repeated daily until there is evidence of toxicity or a total dose of 12 – 15 g has been reached.
Intravenous Injection
12 mg/kg bodyweight may be given daily for 3 days and then, if there is no evidence of toxicity, 6 mg/kg on alternate days for a further 3 doses.
An alternative regimen is 15 mg/kg as a single intravenous injection once a week throughout the course.
Intraarterial Intusion
5 – 7.5 mg/kg bodyweight daily may be given by 24 hour continuous intra-arterial infusion.
Maintenance Therapy
An initial intensive course may be followed by maintenance therapy providing there are no significant toxic effects. In all instances, toxic side effects must disappear before maintenance therapy is started.
The initial course of fluorouracil can be repeated after an interval of 4 to 6 weeks from the last dose or, alternatively, treatment can be continued with intravenous injections of 5-15 mg/kg bodyweight at weekly intervals. This sequence constitutes a course of therapy. Some patients have received up to 30 g at a maximum rate of 1 g daily.
1. What Fluorouracil Injection is and what it is used tor
Fluorouracil Injection is an anti-cancer medicine, in the form of a solution for injection. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.
The medicine is presented in glass containers called vials. Each ml (millilitre) of solution contains 25 mg (milligrams) of fluorouracil. The 10 ml vial contains 250 mg fluorouracil, the 20 ml vial contains 500 mg fluorouracil and the 100 ml vial contains 2.5 g fluorouracil. It is available in packs containing 5×10 ml, 10 x 20 ml or 1 x 100 ml. Not all presentations may be marketed.
Fluorouracil Injection is used to treat many common cancers, particularly cancers of the Gl tract, pancreas, large bowel, ovary, prostate and breast. It may be used in combination with other anti-cancer medicines or radiotherapy.
2. Before Fluorouracil Injection is used
Fluorouracil Injection should not be used:
• if you have shown signs of hypersensitivity (severe allergy) to fluorouracil or any of the ingredients of this medicine on previous occasions
• if you have been very much weakened by long illness
• If your bone marrow has been damaged by other treatments (including radiotherapy)
• if you are pregnant or trying for a baby
• if you are breastfeeding
• if your cancer is non-malignant
Special care will be taken:
• if the number of cells in your blood become too low (you will have blood tests to check this)
• if you have any problems with your kidneys
• if you have any problems with your liver including jaundice (yellowing of the skin)
• if you have suffered from angina or have a history of heart disease. Tell your doctor if you experience any chest pain during treatment.
• if you have reduced activity/deficiency of the enzyme DPD (dihydropyrimidine dehydrogenase).
• if you are taking certain other medicines, such as:
• methotrexate (an anti-cancer medicine)
• metronidazole (an antibiotic)
• calcium leucovorin (also called calcium folinate – used to reduce the harmful effects of anti-cancer medicines)
• allopurinol (used to treat gout)
• cimetidine (used to treat stomach ulcers)
• warfarin (used to treat blood clots)
• sorivudine (an antiviral)
Please tell your doctor if you are taking, or have recently taken, any other medicines, including ones that are not prescribed for you.
A more recent alternative method is to give 15 mg/kg intravenously once a week throughout the course of treatment. This obviates the need for an initial period of daily administration.
In Combination with Irradiation
Irradiation combined with fluorouracil has been found to be useful in the treatment of certain types of metastatic lesions in the lungs and for the relief of pain caused by recurrent, inoperable growth. The standard dose of fluorouracil should be used.
- Children
No recommendations are made regarding the use of fluorouracil in children.
- Elderly
Fluorouracil should be used in the elderly with similar considerations as in younger adults, I notwithstanding that incidence of concomitant medical illness is higher in the former I group.
- Warnings
It is recommended that Fluorouracil be given only by, or under the strict supervision of, a qualified physician who is conversant with the use of potent antimetabolites.
All patients should be admitted to hospital for initial treatment.
Adequate treatment with Fluorouracil is usually followed by leucopenia, the lowest white blood cell (W.B.C) count commonly being observed between the 7th and 14th day of the first course, but occasionally being delayed for as long as 20 days. The count usually returns to normal by the 30th day.
Daily monitoring of platelet and W.B.C count is recommended and treatment should be stopped if platelets fall below 100,000 per mm3 or the W.B.C. count falls below 3,500 per mm3. If the total count is less than 2000 mm3, and especially if there is granulocytopenia, it is recommended that the patient be placed in protective isolation in the hospital and treated with appropriate measures to prevent systemic infection.
Treatment should be stopped at the first sign of oral ulceration or if there is evidence of gastrointestinal side effects such as stomatitis, diarrhoea, bleeding from the G.I. tract or haemorrhage at any site. The ratio between effective and toxic dose is small and therapeutic response is unlikely without some degree of toxicity. Care must be taken therefore, in the selection of patients and adjustment of dosage.
Flourouracil should be used with caution in patients with reduced renal or liver function or jaundice. Isolated cases of angina, ECG abnormalities and rarely, myocardial infarction have been reported following administration of Fluorouracil. Care should therefore be exercised in treating patients who experience chest pain during courses of treatment, or patients with a history of heart disease.
- Overdose
The symptoms of overdose are qualitatively similar to the undesirable effects: diarrhoea, nausea and vomiting (an anti-emetic may be given for nausea and vomiting), chest pain, tachycardia, breathlessness, ECG changes and confusional state. Palmer-Plantar Erythrodysesthesia Syndrome has been reported as an unusual complication of high dose bolus or protracted continuous therapy with fluorouracil.
- Storage
Do not store above 25°C. Do not refrigerate or freeze. Keep container in the outer carton.
Chemical and physical stability has been demonstrated for 5 days at 20 – 21 °C.
From a microbiological point of view, the product should be used immediately. 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 – 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
The pH of fluorouracil injection is 8.9 and the drug has maximal stability over the pH range 8.6 to 9.0.
If a precipitate has formed as a result of exposure to low temperatures, redissolve by heating to 60°C accompanied by vigorous shaking. Allow to cool to body temperature prior to use.
The product should be discarded if it appears brown or dark yellow in solution.
Do not drive or use machines:
• if you experience any effect which may impair your ability to drive or use machines.
3. How Fluorouracil Injection is used
The dose of medicine given to you will depend on your medical condition, your body weight, if you have had recent surgery and how well your liver and kidneys are working. It will also depend on the results of your blood tests. The dose should not be more than 800 mg – 1 g per day. Your first course of treatment may be given daily or at weekly intervals. Further courses may be given according to your response to treatment. You may also receive treatment in combination with radiotherapy.
The medicine may be diluted with glucose solution, sodium chloride solution or Water for Injections before it is given to you. It will be given either into a vein or an artery. If it is given into a vein, it can either be given as a normal injection or a slow injection via a drip (infusion). If it is given into an artery, it will be given as an infusion.
As this medicine will usually be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however, tell your doctor or pharmacist if you have any concerns.
You will need to have blood tests during and after treatment with fluorouracil to check the levels of cells in your blood. Treatment may have to be stopped if the level of white blood cells drops too low.
4. Possible Side Effects
Like all medicines, fluorouracil can have side effects.
If any of the following happen, tell your doctor immediately:
• chest pains
• your bowel motions are bloodstained or black
• your mouth becomes sore or develops ulcers
• severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint
• symptoms of leucoencephalopathy (disease of brain) – weakness, coordination problems in arms and legs; thinking/speech difficulties; vision/memory problems; seizures; headaches
These are very serious side effects. You may need urgent medical attention.
All of these very serious side effects are rare.
If you experience any of the following tell your doctor as soon as possible:
• diarrhoea
• feeling or being sick
• hair loss (especially in women)
• skin problems
• changes in your nails
• unsteady on your feet
• fever
• quickening of your heart rate and breathlessness
• painful and/or watering eyes, changes in vision or sensitivity to light
• feeling confused
• reddening of the palms of the hands and/or the soles of the feet
• the vein where fluorouracil is administered may become painful or discoloured
If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
5. Storing Fluorouracil Injection
Keep out of the reach of children.
The vials should not be stored above 25°C. They should not be put in the fridge or frozen.
The vials should be kept in the outer carton in order to protect from light.
This medicine should not be used after the expiry date printed on the vial label.
Doxorubicin Hydrochloride
Doxorubicin Hydrochloride 10 mg and 50 mg Powder for Injection
1. What Doxorubicin Hydrochloride Powder for Injection is and what it is used for
Doxorubicin Hydrochloride Powder for Injection is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.
Doxorubicin is used in the treatment of certain types of cancer, for example, cancers of the blood (leukaemia), breast, soft tissue, bone, lung and bladder. It is also used in the treatment of some cancers in children. Doxorubicin is often given with other anti-cancer medicines.
2. Before you use Doxorubicin Hydrochloride Powder for Injection
Do not use Doxorubicin Hydrochloride Powder for Injection
• if you have shown signs of hypersensitivity (severe allergy) to doxorubicin or any of the other ingredients mentioned in section 6, in the past
• if your bone marrow is not making enough blood cells (your doctor will check for this using blood tests)
• if after your last dose you had a burning sensation in your mouth or mouth ulcers
Tell your doctor if any of the above applies to you before this medicine is used.
Take special care with Doxorubicin Hydrochloride Powder for Injection
• if you have any heart problems
• if you have liver problems
• if the levels of cells in your blood become low (your doctor will check this)
• if you have received or are going to have radiation therapy
Tell your doctor if any of the above applies to you before this medicine is used.
Taking/using other medicines
Special care is needed if you are taking/using other medicines as some could interact with doxorubicin; for example:
• the toxicity of other anti-cancer medicines may be increased by the use of doxorubicin e.g. blood in the urine with cyclophosphamide and liver damage with 6-mercaptopurine
• the combination of ciclosporin (a medicine used to reduce the activity of the body’s immune system) and doxorubicin may increase the risk of nervous system side effects
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
- Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will decide if you should receive this medicine.
Due to the risk of birth defects, women of childbearing potential should use appropriate contraception methods during treatment with doxorubicin.
Ask your doctor or pharmacist for advice before taking any medicine.
- Driving and using machines
Do not drive or use machines if you experience any side effect (e.g. drowsiness) which may lessen your ability to do so.
3. How to Use Doxorubicin Hydrochloride Powder for Inject
This medicine is given by injection into a vein, by infusion (drip) into an artery or by instillation (using a catheter) into the bladder.
- Dose
Your doctor will work out the correct dose of Doxorubicin Hydrochloride Powder for Injection for you and how often it must be given.
The dose of medicine given to you will depend upon your medical condition, your age, size, blood cell levels, how well your liver is working and whether you are receiving any other anti-cancer medicines. Your doctor will check your blood cell levels and tell how well your liver is working using blood tests.
If you are to be given an instillation of this medicine directly into the bladder, you may be told by your doctor not to drink any fluids for 12 hours before treatment. After the installation you may be asked to change your position frequently to ensure that the medicine comes into contact with all areas of the bladder.
If you are given too much or too little Doxorubidn Hydrochloride Powder for Injection
This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.
4. Possible Side Effects
Like all medicines, Doxorubicin Hydrochloride Powder for Injection can have side effects, although not everybody gets them.
If any of the following happen, tell your doctor immediately:
• severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint
• chest pain
• pain at the injection site during or immediately after the injection
These are serious side effects. You may need urgent medical attention.
If any of the following happen, tell your doctor as soon as possible:
The following side effects are more common:
• unexpected bruises or bleeding, or symptoms of an infection e.g. fever, chills or achiness (these problems may occur up to 3 weeks after your last treatment)
• painful burning sensation in the mouth, throat or oesophagus (food-pipe). It often develops 5 to 10 days after treatment. The vagina and back passage may also be affected. Ulcers may form which can become infected. It normally gets better after 10 days. It is often worse if you have had radiation treatment to these areas before.
• abnormally fast heart beat
• skin problems (possibly a skin infection affecting the face, neck or legs; the affected area may be hot, tender and red)
• pain or redness of the blood vessels
• inflammation of a vein or red streaking along a vein near the injection site
• reddening of the face (if the injection has been given too quickly)
• hair loss
• dehydration (feeling thirsty)
• feeling or being sick
• diarrhoea
• red coloured urine
The following side effects are less common:
• itchy skin rash (hives)
• paleness due to anaemia
• conjunctivitis (red, sore and itchy eyes)
• drowsiness
• loss of appetite
• unusual colouration of the nail beds and skin creases (seen in children)
As doxorubicin may affect your heart, your doctor may do tests to monitor your heart function before starting treatment and during or after treatment. Problems with your heart may occur even years after stopping doxorubicin treatment.
Doxorubicin may lead to changes in your blood cells. Your doctor will take blood samples to monitor for these and also to check how well your liver and kidneys are working. Leukaemia (abnormalities of the white blood cells) has been reported when doxorubicin has been given together with some other cancer treatments.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
- Effects on fertility
Men and women taking this medicine may become infertile. In women, ovulation and menstruation (periods) should return once treatment is stopped. If you have any questions about the effects of this medicine on the chances of you having a baby, ask your doctor.
5. How to store Doxorubicin Hydrochloride Powder for Injection
Keep out of the reach and sight of children
- Expiry
This medicine must not be used after the expiry date which is stated on the vial label and carton after ‘EXP’. Where only a month and year is stated, the expiry date refers to the last day of that month.
- Storage
Keep the vial in the outer carton, in order to protect from light, and store at or below 25°C.
Unused portions of opened vials must not be stored for later use.
Prepared infusions should be used immediately, however, if this is not possible they can be stored for up to 21 days provided they have been prepared in a way to exclude microbial contamination.
6. Further Information
What Doxorubicin Hydrochloride Powder for Injection contains
The active ingredient is doxorubicin hydrochloride. After reconstitution, each millilitre (ml) of solution contains 2 milligrams (mg) of doxorubicin hydrochloride.
The other ingredient is lactose monohydrate.
What Doxorubicin Hydrochloride Powder for Injection looks like and contents of the pack
Doxorubicin Hydrochloride Powder for Injection is an orange-red powder for solution for injection (a powder which is made into a solution before being injected). It comes in glass containers called vials.
It may be supplied in packs containing:
• 1 x 10 mg vial
• 1 x 50 mg vial
Doxorubicin Hydrochloride 10 mg and 50 mg Powder for Injection
The following information is intended for medical or healthcare professionals only
Further to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here.
Incompatibilities
Doxorubicin should not be mixed with heparin since it has been reported that these drugs are incompatible to the extent that a precipitate may form. Until specific compatibility data are available, it is not recommended that doxorubicin be mixed with other drugs.
Reconst’rrution and dilution
Single use only
Discard any unused contents
The contents of the vial should be reconstituted with Water for Injection, sodium chloride 0.9%, or dextrose 5% to a solution concentration of 2 mg doxorubicin hydrochloride per ml.
Chemical and physical in-use stability following reconstitution in either sodium chloride 0.9% or Water for Injections in glass or polypropylene containers has been demonstrated for up to 21 days at 2-8°C. From a microbiological point of view, however, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours when stored at 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Cytotoxic Handling Guidelines
Doxorubicin is a potent cytotoxic agent which should only be prescribed, prepared and administered by professionals who have been trained in the safe use of the preparation. The following guidelines should be followed when handling, preparing and disposing of doxorubicin.
Preparation: Reconstitution of powder, transfer to syringes or infusion bags should be carried out in designated areas, preferably a laminar flow station.
Personnel must be adequately protected with suitable clothing, gloves, mask and eye shield.
Pregnant women should be excluded from handling cytotoxic agents.
Contamination: In the event of contact with the skin or eyes, the affected area should be washed with copious amounts of water or normal saline. A bland cream may be used to treat transient stinging of skin. Medical advice should be sought if the eyes are affected.
In the event of spillage treat with 1% sodium hypochlorite solution using a cloth/sponge kept in the designate area. Rinse twice with water. Put all cloths into a plastic bag and seal for incineration.
Disposal: All items used during preparation or administration including syringes, containers, absorbent materials, residual solutions should all be placed in a thick plastic bag and incinerated at 700°C.
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Cisplatin Sterile Concentrate
Cisplatin 1 mg/ml Sterile Concentrate
1. What Cisplatin Sterile Concentrate is and what it is used for
Cisplatin Sterile Concentrate is an anti-cancer medicine in the form of a concentrate for solution for infusion (a concentrated solution which is diluted to make a solution which can be given as a slow injection via a drip). Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.
Each millilitre (ml) of solution contains 1 milligram (mg) of cisplatin. This medicine is presented in glass containers called vials. The 10 ml vial contains 10 mg of cisplatin, the 50 ml vial contains 50 mg of cisplatin and the 100 ml vial contains 100 mg of cisplatin. It is available in packs containing a single vial and 10 vials (not all the presentations and pack sizes mentioned may be marketed)
Cisplatin is used in the treatment of certain types of cancer, for example ovarian cancer, testicular cancer, bladder cancer and head and neck cancer. Cisplatin may be used in combination with other anti-cancer medicines.
2. Before Cisplatin Sterile Concentrate is used
Cisplatin Sterile Concentrate should not be used:
- if you have shown signs of hypersensitivity (severe allergy) to cisplatin or similar medicines on previous occasions
- if you have severe kidney disease
- if you have hearing difficulties
- if you have fewer blood cells than normal (your doctor will check this)
- if you are pregnant or trying for a baby
- if you are breastfeeding
Special care will be taken:
if you are taking certain other medicines, such as:
- other medicines that may affect your kidneys or hearing e.g. furosemide (water tablet), gentamicin (antibiotic)
- other anti-cancer medicines e.g. bleomycin, methotrexate
- phenytoin (medicine often used to treat epilepsy)
Please tell your doctor if you are taking, or have recently taken, any other medicines, including ones that are not prescribed for you.
Do not drive or use machines:
- if you feel drowsy
- if you experience any other effect which may impair your ability to drive or use machines
Male and female patients should take contraceptive measures during and for at least three months after therapy. As in the case with all anticancer drugs, in men this drug may cause temporary or permanent sterility.
3. How Cisplatin Sterile Concentrate is used
The dose of medicine given to you will depend on your health, how well your kidneys are working and any other medicines you may be taking. Cisplatin is given as a single dose every 3 to 4 weeks or as a daily dose for 5 days every 3 to 4 weeks.
The medicine will be diluted in 0.9% sodium chloride (salt water) before it is given to you. It will be given slowly, usually via a drip into a vein over a period of 1 to 2 hours, but it may also be given over 6 to 8 hours. Before and after treatment you will normally be given an infusion of fluids to increase the amount of urine you produce. You should drink plenty of fluids for 24 hours after treatment.
Before treatment is started your doctor will carry out blood tests to check the levels of cells (red blood cells, white blood cells and platelets) in your blood, and also to check how well your kidneys are working. Further tests may also be done during and after treatment. You may also have a hearing test before and regularly during treatment.
As this medicine will be given to you whilst you are in hospital is unlikely that you will be given too little or too much, however, tell your doctor or pharmacist if you have any concerns.
4. Possible Side Effects
Like all medicines, cisplatin can have side effects.
If any of the following happen, tell your doctor immediately:
severe allergic reaction — you may experience swelling of the face, wheezing, increased heart rate, a sudden itchy rash and you may feel you are going to faint.
• heart and circulatory problems such as chest pain or stroke.
These are very serious side-effects. You may need urgent medical attention. These very serious side-effects are rare.
If you experience any of the following tell your doctor as soon as possible: feeling or being sick loss of appetite, anorexia temporary loss or changes to your eyesight ringing in the ears or changes in your hearing changes in the number of red cells, white cells and platelets in your blood may occur and there may be alterations in your kidney function so that changes in your blood chemistry may occur. Your doctor will monitor for these by blood tests, spasms tingling or tremor in your hands and feet taste loss seizures
- the blood flow to your fingers and toes may be affected, which could mean that they become pale in colour and can be sensitive fast or irregular heart beats, chest pain
- swelling or soreness where the injection was given
If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
5.Storing Cisplatin Sterile Concentrate
Keep out of the reach of children.
The vials should not be stored above 25 °C. They should not be kept in the refrigerator or frozen. Vials should be kept in the outer carton to protect from light.
This medicine should not be used after the expiry date printed on the vial label and carton.
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Carboplatin Intravenous Infusion
Carboplatin 10mg/ml Intravenous Infusion
1. What Carboplatin Intravenous Infusion is and what it is used for
Carboplatin Intravenous Infusion is an anti-cancer medicine in the form of a solution for infusion (a solution which can be given as a slow injection via a drip). Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.
Each millilitre (ml) of solution contains 10 milligrams (mg) of carboplatin. This medicine is presented in glass containers called vials (standard vials and Onco-Vials). The 5ml vial contains 50mg of carboplatin, the 15ml vial contains 150mg carboplatin, the 45ml vial contains 450mg of carboplatin and the 60ml vial contains 600mg of carboplatin. The standard vials are available in single packs of 5ml, 15ml, 45ml or 60ml. The Onco-Vials are available in single packs of either 5 ml, 15ml or 45ml. Not all pack sizes may be marketed. Onco-Vials are only available in the UK.
Carboplatin is used in the treatment of certain types of lung cancer and ovarian cancer.
2. Before Carboplatin Intravenous Infusion is used
Carboplatin Intravenous Infusion should not be used:
• if you have shown signs of hypersensitivity (severe allergy) to carboplatin or similar medicines on previous occasions
• if you have severe kidney disease
• if you have fewer blood cells than normal (your doctor will check this)
• if you are pregnant, trying to become pregnant or breast-feeding
Special care will be taken:
• to ensure the number of cells in your blood does not drop too low. Your doctor will regularly check this
• if you have mild renal disease
• if you are being given other anti-cancer medicines
• if you are being given other medicines that may affect your kidneys or hearing
Please tell your doctor if you are taking, or have recently taken, any other medicines, including ones that are not prescribed for you.
3. How Carboplatin Intravenous Infusion is used
The dose of medicine given to you will depend on your age, your health, how well your kidneys are working and any other medicines you may be taking. This medicine is not normally given to children.
The medicine may be diluted with glucose (sugar solution) or sodium chloride (salt water) before it is given to you. It will be given slowly, usually via a drip into a vein over 15-60 minutes. You may be given another dose of this medicine in 4 weeks.
While you are receiving carboplatin, your doctor will take regular blood tests. This is to measure the effect the drug is having and whether further doses of carboplatin are necessary.
As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much; however, tell your doctor or pharmacist if you have any concerns.
4. Possible Side-Effects
Like all medicines, carboplatin can have side-effects.
If any of the following happen, tell your doctor immediately:
• you have difficulty in breathing
• you develop raised, coloured blotches that may also be itchy
• swelling and/or flushing (redness) of the face
• abnormal heart beat (faster, slower or irregular) or chest pains
These are very serious side-effects which may occur more frequently after previous exposure to platinum therapy. You may need urgent medical attention.
If you experience any of the following tell your doctor as soon as possible:
• feeling or being sick
• feeling faint, dizzy or about to collapse
• feeling weak or tired
• stomach pains, diarrhoea or constipation
• tingling in your hands, feet, arms or legs
• ringing in the ears or changes in your hearing
• temporary loss or changes to your eyesight
• taste alteration or loss of appetite
• loss of hair
• rash and/or itchy skin
• unexplained bruising or bleeding
• fever
• flu-like symptoms
• redness, pain or swelling at the injection site.
Carboplatin may also affect your kidney and liver function and the number of cells in your blood. Your doctor will monitor such effects with regular blood tests.
Carboplatin may have an adverse effect on sperm and egg formation that may lead to possible risks to the foetus.
If you notice any side-effects not mentioned in this leaflet, please tell your doctor or pharmacist.
5. Storing Carboplatin Intravenous Infusion
Keep out of the reach and sight of children.
The standard vials should not be stored above 25°C. The Onco-Vials should be stored at 2-8C (in the refrigerator).
All vials should be kept in the outer carton to protect from light.
Do not use after the expiry date printed on the vial label and carton.
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