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GEMCITABINE 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): GEMCITABINE HYDROCHLORIDE

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Package leaflet: Information for the user
Gemcitabine 10 mg/ml Concentrate for Solution for Infusion
gemcitabine
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

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

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

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Gemcitabine is and what it is used for
What you need to know before you use Gemcitabine
How to use Gemcitabine
Possible side effects
How to store Gemcitabine
Contents of the pack and other information

1.

What Gemcitabine is and what it is used for

Gemcitabine contains the active substance gemcitabine. 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. What you need to know before you use Gemcitabine
Do not use Gemcitabine:


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

Warnings and precautions
Before the first infusion, your doctor or nurse will take samples of your blood to evaluate if you
have sufficient kidney and liver function. Before each infusion your doctor or nurse will take
samples of your blood 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 your doctor or nurse will take samples of
your blood to evaluate your kidney and liver function.
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 (these may be signs of
kidney failure).
Children and adolescents
Gemcitabine 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
Tell your doctor or pharmacist if you are using, have recently used or might use 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 using this medicine.
The use of Gemcitabine should be avoided during pregnancy. Your doctor will discuss with you
the potential risk of using this medicine during pregnancy.
If you are breast-feeding, tell your doctor.
You must discontinue breast-feeding during treatment with Gemcitabine.
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.
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.
Gemcitabine contains sodium
Gemcitabine contains 1.1 mg (0.05 mmol) sodium per ml concentrate.

Gemcitabine contains 23 mg (1 mmol) of sodium in each 20 ml vial. To be taken into
consideration by patients on a controlled sodium (salt) diet.
Gemcitabine contains 113 mg (4.92 mmol) of sodium in each 100 ml vial. To be taken into
consideration by patients on a controlled sodium (salt) diet.

3. How to use Gemcitabine
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 determine 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.
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 medicine, ask your doctor or pharmacist.
4. Possible side effects
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 infusion, which soon passes, however uncommonly or rarely there can be
more severe lung problems)
Side effects with Gemcitabine may include:

Very common (may affect more than 1 in 10 people)
 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 (may affect up to 1 in 10 people)
 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 (may affect up to 1 in 100 people)
 Interstitial pneumonitis (scarring of the air sacs of the lung)
 Spasm of the airways (wheeze)
 Abnormal chest X ray/scan (scarring of the lungs)
 Irregular heart beat (arrhythmia)
 Heart failure
 Kidney failure
 Serious liver damage, including liver failure
 Stroke
Rare (may affect up to 1 in 1,000 people)











Heart attack (myocardial infarction)
Low blood pressure
Skin scaling, ulceration or blister formation
Injection site reactions
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
Gangrene of fingers or toes

Very rare (may affect up to 1 in 10,000 people)
 Increased platelet count
 Anaphylactic reaction (severe hypersensitivity/ allergic reaction)
 Sloughing of skin and severe skin blistering
 Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced blood
supply)

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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via (see detail below).
By reporting side effects you can help provide more information on the safety of this medicine.
[To be completed nationally]
5. How to store Gemcitabine
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 vial and carton after
EXP. The expiry date refers to the last day of that month.
Unopened vial: Store below 25°C. Do not refrigerate or freeze.
This medicinal product should be used immediately after opening. Discard any unused solution.
Diluted solution:
Chemical and physical in-use stability has been demonstrated for 48 hours at 25°C and 2-8°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°C – 8°C, unless dilution has taken place in
controlled and validated aseptic conditions.
This medicine is for single use only.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Gemcitabine contains




The active substance is gemcitabine.
1 ml contains gemcitabine hydrochloride equivalent to 10 mg of gemcitabine.
Each 20 ml vial contains 200 mg gemcitabine (as hydrochloride).
Each 100 ml vial contains 1000 mg gemcitabine (as hydrochloride).
The other ingredients are anhydrous sodium acetate, hydrochloric acid, sodium hydroxide
and water for injections

What Gemcitabine looks like and contents of the pack
Gemcitabine is a clear, colourless solution free from visible particles.
It is supplied in 20 ml and 100 ml glass vials. Both sizes are available in cartons containing 1
vial, 5 vials or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK
Manufacturer
Agila specialties polska Sp. z o.o
10, Daniszewska Str, 03-230 Warsaw
Poland

The leaflet was last revised in 10/2014
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The following information is intended for healthcare professionals only.
Handling
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.
In cases of skin contact with the diluted solution, the affected area should be immediately and
carefully washed with soap and water. In case of contact of mucous membranes with
concentrated or diluted solution, the mucous should be washed with water thoroughly and
immediately. 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.
Pregnant women should not prepare or handle the solution.
Instructions for dilution
This medicinal product must be diluted before use.
The only approved diluent for Gemcitabine solution is sodium chloride 9 mg/ml (0.9% w/v)
solution for injection (without preservative).
1. Use the aseptic technique during any dilution of Gemcitabine for intravenous infusion
administration.
2. The total quantity of Gemcitabine required for an individual patient should be diluted with
sterile sodium chloride 9 mg/ml (0.9% w/v) solution for injection (without preservative) and
infused over 30 minutes. The diluted solution is a clear, colourless solution
3. Parenteral medicinal products should be inspected visually for particulate matter and
discolouration prior to administration. If particulate matter is observed, do not administer.
This medicine is for single use only. Any unused medicinal product or waste material should be
disposed of in accordance with local requirements.
Method of administration
Gemcitabine is tolerated well during infusion and may be administered ambulant. If
extravasation occurs, generally the infusion must be stopped immediately and started again in
another blood vessel. The patient should be monitored carefully after the administration.
Shelf life after first opening: This medicinal product should be used immediately after opening.
Discard any unused solution
Shelf life after dilution:
Chemical and physical in-use stability has been demonstrated for 48 hours at 25°C and 2-8°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°C – 8°C, unless dilution has taken place in
controlled and validated aseptic conditions.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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