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Gemcitabine 200 Mg Powder For Solution For Infusion

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Gemcitabine 200 mg Powder for Solution for Infusion Gemcitabine 1000 mg Powder for Solution for Infusion

Gemcitabine

Read all of this leaflet carefully before you start taking this medicine.

- Keep this leaflet. You may need to read it again.

- If you have any further questions, ask your doctor, nurse or pharmacist.

- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

In this leaflet:

1. What Gemcitabine is and what it is used for

2. Before you are given Gemcitabine

3. How Gemcitabine is given

4. Possible side effects

5. How to store Gemcitabine

6. Further information.

1. WHAT GEMCITABINE IS AND WHAT IT IS USED FOR

Gemcitabine belongs to a group of medicines called "cytotoxics". These medicines kill dividing cells, including cancer cells.

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

Gemcitabine 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 GEMCITABINE Yon should not be given Gemcitabine if you

• are allergic (hypersensitive) to gemcitabine or any of the other ingredients of Gemcitabine

• are breast-feeding.

Take special care with Gemcitabine

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 Gemcitabine. 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 previously 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 sign of kidney failure).

Men are advised not to father a child during and up to 6 months following treatment with Gemcitabine. 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 breath-feeding

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

If you are-breast-feeding, tell your doctor.

You must discontinue breast-feeding during Gemcitabine treatment.

Driving and using machines

Gemcitabine 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 Gemcitabine treatment has not made you feel sleepy.

Important information about some of the ingredients of Gemcitabine

Gemcitabine contains 3.5 mg of sodium in each 200 mg vial and 17.5 mg sodium in each 1000 mg vial. To be taken into consideration by patients on a controlled sodium diet.

3 HOW GEMCITABINE IS GIVEN

The usual dose of Gemcitabine is 1000-1250 mg for every square metre of your body's surface area. Your height and weight are determined 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 Gemcitabine infusion depends on the type of cancer that you are being treated for.

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

You will always receive Gemcitabine 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, Gemcitabine can cause side effects, although not everybody gets them.

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 Gemcitabine infusion which soon passes, however uncommonly or rarely there can be more severe lung problems).

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 cannot be estimated from the available data

Side effects with Gemcitabine 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 of sores in the mouth

• Itching

• Sweating

• Muscle pain

• Back pain

• Fever

• Weakness

• Chills.

Uncommon side effects

• Interstitial pneumonitis (scaring 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 that might cause 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 (decay of body tissues) 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 get serious, or if you notice any side effects not mentioned this leaflet, please tell your doctor.

HOW TO STORE GEMCITABINE

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: Do not store above 25°C. Keep the vial tightly closed in order to protect from moisture.

Reconstituted solution: The product should be used immediately. If prepared as described the chemical and physical stability of reconstituted gemcitabine solution has been demonstrated for 48 hours at 25°C.

The solution can be further diluted by the medicinal health care professional.

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 Gemcitabine contains

The active substance is gemcitabine.

Each vial contains 200 mg or 1000 mg of gemcitabine (as gemcitabine hydrochloride).

The other ingredients are mannitol, sodium acetate (as sodium acetate trihydrate), hydrochloric acid, and sodium hydroxide for pH regulation.

What Gemcitabine looks like and content of the pack

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

Marketing Authorisation Holder and Manufacturer

Pharma Resources DR SCHLUTTIG GmbH

HefeHof 8, 31785 Hameln

Germany

This medicinal product is authorised in the Member States of the EEA under the following names:
Bulgaria	Gemcitabine Pharma Resources 200 mg Gemcitabine Pharma Resources 1000 mg
Cyprus	Gemcitabine Pharma Resources 200 mg Gemcitabine Pharma Resources 1000 mg
Germany	Gemcitabine Pharma Resources 200 mg Gemcitabine Pharma Resources 1000 mg

Romania Gemcitabina Pharma Resources 200 mg pulbere pentru solutie perfuzabila

Gemcitabina Pharma Resources 1000 mg pulbere pentru solutie perfuzabila

Slovakia Gemcitabine Pharma Resources 200 mg prasok na infuzny roztok

Gemcitabine Pharma Resources 1 000 mg prasok na infuzny roztok

United Kingdom Gemcitabine 200 mg powder for solution for infusion

Gemcitabine 1000 mg powder for solution for infusion

This leaflet was last revised in 02/2012.

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 Gemcitabine 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 via1. Shake to dissolve. The total volume after reconstitution is 5.26 ml (200 mg vial) or 26.3 ml (l000 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 discoloration 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 48 hours at 25°C. From a microbiological point of view, the reconstituted solution 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. Thy eyes should be rinsed immediately and thoroughly with water. If there is a 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.