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Gemzar (Gemcitabine)

Gemzar 200 mg powder for solution for infusion

Gemzar 1000 mg powder for solution for infusion

Gemcitabine

Gemzar (Gemcitabine)1. WHAT GEMZAR IS AND WHAT IT IS USED FOR

Gemzar belongs to a group of medicines called “cytotoxics”. These medicines kill dividing cells, including cancer cells.

Gemzar may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer.

Gemzar is used in the treatment of the following types of cancer:

•     non-small cell lung cancer (NSCLC), alone or together with cisplatin.

•     pancreatic cancer.

•     breast cancer, together with paclitaxel.

•     ovarian cancer, together with carboplatin.

•     bladder cancer, together with cisplatin.

2. BEFORE YOU ARE GIVEN GEMZAR

You should not be given Gemzar:

if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of Gemzar if you are breast-feeding

Take special care with Gemzar:

Before the first infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function. Before each infusion you will have samples of your blood taken to evaluate if you have enough blood cells to receive Gemzar. Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low. Periodically you will have samples of your blood taken to evaluate your kidney and liver function.

Please tell your doctor if:

•     you have, or have previously had liver disease, heart disease or vascular disease.

•     you have recently had, or are going to have radiotherapy,

•     you have been vaccinated recently,

•     you develop breathing difficulties or feel very weak and are very pale (may be a sign of kidney failure).

Men are advised not to father a child during and up to 6 months following treatment with Gemzar. If you would like to father a child during the treatment or in the 6 months following treatment, seek advice from your doctor or pharmacist. You may want to seek counselling on sperm storage before starting your therapy.

  • Taking other medicines

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

  • Pregnancy and breast-feeding

If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of Gemzar should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Gemzar during pregnancy.

If you are breast-feeding, tell your doctor.

You must discontinue breast-feeding during Gemzar treatment.

  • Driving and using machines

Gemzar may make you feel sleepy, particularly if you have consumed any alcohol. Do not drive a car or use machinery until you are sure that Gemzar treatment has not made you feel sleepy.

Important information about some of the ingredients of Gemzar

Gemzar contains 3.5 mg (< 1 mmol) of sodium in each 200 mg vial and 17.5 mg (< 1 mmol) sodium in each 1000 mg vial. To be taken into consideration by patients on a controlled sodium diet.

Gemzar (Gemcitabine)3. HOW GEMZAR IS GIVEN

The usual dose of Gemzar is 1000-1250 mg for every square metre of your body’s surface area. Your height and weight are measured to work out the surface area of your body. Your doctor will use this body surface area to work out the right dose for you. This dosage may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition.

How frequently you receive your Gemzar infusion depends on the type of cancer that you are being treated for.

A hospital pharmacist or doctor will have dissolved the Gemzar powder before it is given to you.

You will always receive Gemzar by infusion into one of your veins. The infusion will last approximately 30 minutes.

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

4. POSSIBLE SIDE EFFECTS

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

Frequencies of the observed side effects are defined as:

•     very common: affects more than 1 user in 10

•     common: affects 1 to 10 users in 100

•     uncommon: affects 1 to 10 users in 1,000

•     rare: affects 1 to 10 users in 10,000

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

•    not known: frequency can’t be estimated from the available data

You must contact your doctor immediately if you notice any of the following:

  • Fever or infection (common): if you have a temperature of 38°C or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common).
  • Irregular heart rate (arrhythmia) (frequency not known).
  • Pain, redness, swelling or sores in your mouth (common).
  • Allergic reactions: if you develop skin rash (very common) / itching (common), or fever (very common).
  • Tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).
  • Bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common).
  • Difficulty breathing (it is very common to have mild breathing difficulty soon after the Gemzar infusion which soon passes, however uncommonly or rarely there can be more severe lung problems).

Side effects with Gemzar may include:

Very common side effects

  • Low haemoglobin level (anaemia)
  • Low white blood cells
  • Low platelet count
  • Difficulty breathing
  • Vomiting
  • Nausea
  • Skin rash- allergic skin rash, frequently itchy
  • Hair loss
  • Liver problems: found through abnormal blood test results
  • Blood in urine
  • Abnormal urine tests: protein in urine
  • Flu like symptoms including fever
  • Oedema (swelling of ankles, fingers, feet, face)

Common side effects

  • Fever accompanied by low white blood cell count (febrile neutropenia)
  • Anorexia (poor appetite)
  • Headache
  • Insomnia
  • Sleepiness
  • Cough
  • Runny nose
  • Constipation
  • Diarrhoea
  • Pain, redness, swelling or sores in the mouth
  • Itching
  • Sweating
  • Muscle pain
  • Back pain
  • Fever
  • Weakness
  • Chills

Uncommon side effects

  • Interstitial pneumonitis (scarring of the air sacs of the lung)
  • Spasm of the airways (wheeze)
  • Abnormal chest X ray/scan (scarring of the lungs)

Rare side effects

  • Heart attack (myocardial infarction) Low blood pressure
  • Skin scaling, ulceration or blister formation Injection site reactions

Very rare side effects

Increased platelet count

  • Anaphylactic reaction (severe hypersensitivity/ allergic reaction)
  • Sloughing of skin and severe skin blistering
  • Side effects with frequency not known
  • Irregular heart beat (arrhythmia)
  • Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure)
  • Radiation recall-(a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy.
  • Fluid in the lungs
  • Radiation toxicity- scarring of the air sacs of the lung associated with radiation therapy
  • Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced blood supply)
  • Heart failure
  • Kidney failure
  • Gangrene of fingers or toes
  • Serious liver damage, including liver failure
  • Stroke

You might have any of these symptoms and/or conditions. You must tell your doctor as soon as possible when you start experiencing any of these side effects.

If you are concerned about any side effects, talk to your doctor.

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

5. HOW TO STORE GEMZAR

Keep out of the reach and sight of children.

Do not use after the expiry date (EXP) which is stated on the carton.

Unopened vial: Store below 30°C.

Reconstituted solution: The product should be used immediately. When prepared as directed, chemical and physical in-use stability of reconstituted solutions of gemcitabine were demonstrated for 24 hours at 30°C. Further dilution by a healthcare provider may be done. Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation may occur.

This medicine is for single use only; any unused solution should be discarded under the local requirements.

6. FURTHER INFORMATION

  • What Gemzar contains

The active substance is gemcitabine. Each vial contains 200 or 1000 mg of gemcitabine (as gemcitabine hydrochloride).

The other ingredients are mannitol (E421), sodium acetate, hydrochloric acid and sodium hydroxide.

  • What Gemzar looks like and contents of the pack

Gemzar is a white to off-white powder, for solution for infusion in a vial. Each vial contains 200 or 1000 mg of gemcitabine. Each pack of Gemzar contains 1 vial.

Marketing Authorisation Holder and Manufacturer

[See Annex I – To be completed nationally]

The following information is intended for medical or healthcare professionals only: Instructions for use, handling and disposal.

1. Use aseptic techniques during the reconstitution and any further dilution of gemcitabine for intravenous infusion administration.

2. Calculate the dose and the number of Gemzar vials needed.

3. Reconstitute 200 mg vials with 5 ml of 9 mg/ml (0.9 %) sterile sodium chloride solution for injection, without preservative, or 25 ml sterile sodium chloride solution for injection, without preservative to the 1000 mg vial. Shake to dissolve. The total volume after reconstitution is 5.26 ml (200 mg vial) or 26.3 ml (1000 mg vial) respectively. This dilution yields a gemcitabine concentration of 38 mg/ml, which includes accounting for the displacement volume of the lyophilised powder. Further dilution with sterile sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative may be done. The resulting solution is clear and ranges in colour from colourless to light straw-coloured.

4. Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.

5. Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation may occur. Chemical and physical in-use stability has been demonstrated for 24 hours at 30°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 room temperature, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

6. Gemcitabine solutions are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

Preparation and administration precautions

The normal safety precautions for cytostatic agents must be observed when preparing and disposing of the infusion solution. Handling of the solution for infusion should be done in a safety box and protective coats and gloves should be used. If no safety box is available, the equipment should be supplemented with a mask and protective glasses.

If the preparation comes into contact with the eyes, this may cause serious irritation. The eyes should be rinsed immediately and thoroughly with water. If there is lasting irritation, a doctor should be consulted. If the solution is spilled on the skin, rinse thoroughly with water.

Disposal

Any unused product should be disposed of in accordance with local requirements.

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