Gemcitabine Pfizer 38 mg/ml, poeder voor oplossing voor infusie

Gemcitabine Pfizer contains the active substance gemcitabine.

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

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

Gemcitabine Pfizer 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.

You must not be given Gemcitabine Pfizer if:

• you are allergic to gemcitabine or any of the other ingredients of this medicine (listed in section 6).
• You are breast-feeding (see section “pregnancy, breast-feeding and fertility”).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Gemcitabine Pfizer.

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 Pfizer. 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 Gemcitabine Pfizer. 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.

Children and adolescents

Gemcitabine Pfizer is not recommended for use in children under 18 years of age because it is not known if it safe or if it works.

Other medicines and Gemcitabine Pfizer

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of Gemcitabine Pfizer should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Gemcitabine Pfizer during pregnancy.

If you are breast-feeding, tell your doctor.

You must discontinue breast-feeding during Gemcitabine Pfizer treatment.

Men being treated with Gemcitabine Pfizer are advised not to father a child during and up to 6 months after treatment and to seek further advice (see section “warnings and precautions”).

Driving and using machines

Gemcitabine Pfizer 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 Pfizer treatment has not made you feel sleepy.

Gemcitabine Pfizer contains sodium

Gemcitabine Pfizer contains 3.5 mg (< 1 mmol) of sodium in each 200 mg vial, 17.5 mg (< 1 mmol) of sodium in each 1000 mg vial and 35 mg (1.5 mmol) of sodium in each 2000 mg vial. To be taken into consideration by patients on a controlled sodium diet.

The recommended dose of Gemcitabine Pfizer 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 Gemcitabine Pfizer infusion depends on the type of cancer that you are being treated for.

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

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

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

As Gemcitabine Pfizer will be given to you under the supervision of a doctor, it is unlikely that you will receive the wrong dose. However, if you have any concerns about the dose you receive or if you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine 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 38ºC 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) (uncommon).
• 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 Pfizer infusion which soon passes, however uncommonly or rarely there can be more severe lung problems).

Other side effects with Gemcitabine Pfizer may include:

Very common side effects (may affect more than 1 in 10 people):

• Low red blood cells level (anaemia)
• Low white blood cells
• Low platelet count
• Difficulty breathing
• Vomiting (being sick)
• Nausea (feeling sick)
• 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
• Swelling of ankles, fingers, feet, face (oedema).

Common side effects (may affect up to 1 in 10 people):

• Fever accompanied by low white blood cell count (febrile neutropenia)
• Poor appetite (anorexia)
• Headache
• Difficulty sleeping (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 (may affect up to 1 in 100 people):

• Scarring of the air sacs of the lung (interstitial pneumonitis)
• Wheezing (spasm of the airways)
• Abnormal chest X ray/scan (scarring of the lungs).
• Irregular heart beat (arrhythmia)
• Heart failure
• Kidney failure
• Serious liver damage, including liver failure

• Stroke
• A disease characterised by haemolytic anaemia, acute renal failure and a low platelet count (haemolytic uraemic syndrome).

Rare side effects (may affect up to 1 in 1,000 people):

• Heart attack (myocardial infarction)
• Inflammation of the blood vessels (peripheral vasculitis)
• Low blood pressure
• Skin scaling, ulceration or blister formation
• Sloughing of skin and severe skin blistering
• Injection site reactions
• Severe lung inflammation causing respiratory failure (Adult Respiratory Distress Syndrome)
• A skin rash like severe sunburn (radiation recall) which can occur on skin that has previously been exposed to radiotherapy
• Fluid in the lungs
• Scarring of the air sacs of the lung associated with radiation therapy (radiation toxicity)
• Gangrene of fingers or toes.

Very rare side effects (may affect up to 1 in 10,000 people):

• Increased platelet count
• Severe hypersensitivity/allergic reaction (anaphylactic reaction)
• Inflammation of the lining of the large bowel, caused by reduced blood supply (Ischaemic colitis)
• Potentially life-threatening cutaneous reactions with widespread purpuric macules and epidermal detachment (toxic epidermal necrolysis, Stevens-Johnson Syndrome).

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 you get any of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.

Unopened vials: This medicinal product does not require any special storage condition.

Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.

From a microbiological point to 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 25°C.

Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation may occur.

Do not use Gemcitabine Pfizer if you notice any particulate matter and / or discolouration.

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

What Gemcitabine Pfizer contains

• The active substance is gemcitabine. Each vial contains 200 mg, 1000 mg or 2000 mg of gemcitabine (as gemcitabine hydrochloride).
• The other ingredients are mannitol (E421), sodium acetate (E262), hydrochloric acid (E507) (for pH adjustment) and sodium hydroxide (E524) (for pH adjustment).

What Gemcitabine Pfizer looks like and contents of the pack

Gemcitabine Pfizer is a white powder or plug, for solution for infusion in a type I tubular flint glass vial, with a dark grey bromobutyl rubber stopper and sealed with a light yellow flip off aluminium seal.

Each vial contains 200 mg, 1000 mg or 2000 mg of gemcitabine. Each carton pack of Gemcitabine Pfizer contains 1 vial.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Pfizer BV

Rivium Westlaan 142

2909 LD Capelle aan den IJssel

Manufacturer

Pfizer Service Company BVBA

Hoge Wei 10, B-1930, Zaventem

Belgium

RVG: 111543

This medicinal product is authorized in the Member States of the EEA under following names:

This leaflet was last revised in {MM/YYYY}.

The following information is intended for 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 Pfizer 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 or 50 ml sterile sodium chloride solution for injection, without preservative to the 2000 mg vial. Shake to dissolve. The total volume after reconstitution is 5.26 ml (200 mg vial), 26.3 ml (1000 mg vial), or 52.6 ml (2000 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 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions of the reconstituted solution 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.

Remnants of the medicinal product as well as all materials that have been used for reconstitution, for dilution and administration must be destroyed according to hospital standard procedures applicable to cytotoxic agents with due regard to current laws related to the disposal of hazardous waste.