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Gemcitabine 38 Mg/Ml Powder For Solution For Infusion

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Gemcitabine 38 mg/mL Powder for Solution for Infusion

Gemcitabine

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

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

-    If you have further questions, please 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

2. BEFORE YOU ARE GIVEN GEMCITABINE You 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 check if your kidneys and liver are working properly. Before each infusion you will have samples of your blood taken to check 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 check if your kidneys and liver are working properly.

Please tell your doctor if you:

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

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

•    have been vaccinated recently

•    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. 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 counseling 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 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.

Ask your doctor for advice before using any medicine.

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 (< 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.

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 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 infusion depends on the type of cancer that you are being treated for.

A hospital pharmacist or doctor will have dissolved the Gemcitabine powder 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.

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

Side effects with Gemcitabine may include:

Very common side effects

Low red blood cells level (anaemia)

Low white blood cells Low platelet count Difficulty breathing Being sick (vomiting)

Feeling sick (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 Swelling of ankles, fingers, feet, face (Oedema)

Common side effects

Fever accompanied by low white blood cell count (febrile neutropaenia)

Poor appetite (anorexia)

Headache

Difficuly sleeping (insomnia)

Sleepiness Cough Runny nose Constipation Diarrhoea



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 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 25°C. From a biological standpoint, the product should be used immediately. If not used immediately, inuse storage times and


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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.




Pain, redness, swelling or sores in the mouth

Itching

Sweating

Muscle pain

Back pain

Fever

Weakness

Chills

Uncommon side effects

Scarring of the air sacs of the lung (Interstitial pneumonitis) Wheezing (Spasm of the airways)

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)

A skin rash like severe sunburn (radiation recall) 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

Inflammation of the lining of the large bowel, caused by reduced blood supply (Ischaemic colitis)

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 GEMCITABINE

Keep out of the reach and sight of children.

Do not use 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.

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 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.

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.

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 (E421), sodium acetate, hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).

What Gemcitabine looks like and contents of the pack

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

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Strides Arcolab International Limited Unit 4, Metro Centre,

Tolpits Lane,

Watford, Hertfordshire,

WD18 9SS UNITED KINGDOM Manufacturer

Strides Arcolab Polska Sp.z.o.o.

10, Daniszewska Str 03-230 Warsaw Poland

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

Name Member State

Name of the medicinal product

The Netherlands (RMS)

Gemcitabine Strides 38 mg/ml poeder voor oplossing voor infusie

Austria

Gemcitabin Strides 38 mg/ml Pulver zur Herstellung einer Infusionslosung

Belgium

Gemcitabine Strides 38 mg/ml poeder voor oplossing voor infusie

Bulgaria

Gemcitabine Strides 38 mg/ml npax 3a HH$y3HOHeH parraop

Cyprus

Gemcitabin Strides 38 mg/ml Kovig yia Siakuga npog sytuoti

Czech Republic

Gemcitabin Strides 38 mg/ml prasek pro pripravu infuzniho roztoku

Germany

Gemcitabin Strides 38 mg/ml Pulver zur Herstellung einer Infusionslosung

Denmark

Gemcitabin Strides 38 mg/ml pulver til infusionsvsske, oplosning

Estonia

Gemcitabin Strides

Greece

Gemcitabin Strides 38 mg/ml kovig Y1a Siakuga npog syxuoti

Finland

Gemcitabin Strides 38 mg/ml infuusiokuiva-aine, liuosta varten


France

Gemcitabine Strides Arcolab International 38 mg/ml poudre pour solution pour perfusion

Hungary

Gemcitabin Strides 38 mg/ml por oldatos infuziohoz

Ireland

Gemcitabine Strides 38 mg/ml powder for solution for infusion

Iceland

Gemcitabin Strides 38 mg/ml innrennslisstofn, lausn

Italy

Gemcitabina Strides

Latvia

Gemcitabine Strides 38 mg/ml pulveris infuziju sklduma pagatavosanai

Lithuania

Gemcitabine Strides 38 mg/ml milteliai infuziniam tirpalui

Luxemburg

Gemcitabine Strides 38 mg/ml poudre pour solution pour perfusion

Malta

Gemcitabin Strides 38 mg/ml trab ghal soluzzjoni ghall-infuzjoni

Norway

Gemcitabin Strides 38 mg/ml pulver til infusjonsvsske, opplosning

Poland

Gemcitabine Strides

Portugal

Gemcitabina Strides

Romania

Gemcitabina Strides Arcolab International 38 mg/ml pulbere pentru solutie perfuzabila

Spain

Gemcitabina Strides 38 mg/ml polvo para solucion para perfusion

Sweden

Gemcitabin Strides 38 mg/ml pulver till infusionsvatska, losning

Slovak Republic

Gemcitabin Strides 38 mg/ml prasok na infuzny roztok

Slovenia

Gemcitabin Strides Arcolab 38 mg/ml prasek za raztopino za infundiranje

UK

Gemcitabine 38 mg/ml powder for solution for infusion

This leaflet was last approved in 09/2011.



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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.