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GEMCITABINE 200 MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): GEMCITABINE HYDROCHLORIDE / GEMCITABINE HYDROCHLORIDE / GEMCITABINE HYDROCHLORIDE

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Package Leaflet: Information for the user
Gemcitabine 200mg 1g and 2g Powder for Solution for Infusion
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you .
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 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. See section 4.
.
What is in this leaflet:
1.
What Gemcitabine Powder for Solution for Infusion is and what it is used for
2.
What you need to know before you use Gemcitabine Teva
3.
How to use Gemcitabine Teva
4.
Possible side effects
5.
How to store Gemcitabine Teva
6.
Contents of the pack and other information
1.

What Gemcitabine Teva 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.

What you need to know before you use Gemcitabine Teva

Do not use Gemcitabine Teva:
if you are allergic to gemcitabine or any of the other ingredients of this medicine (listed in section 6).
if you are breast-feeding.
Warnings and Precautions:
Before the first infusion you will have samples of your blood taken to check if your liver and kidneys are
working well enough for you to receive this medicine. 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 check how well your kidneys and liver
are working.

Talk to your doctor, nurse or hospital pharmacist before using Gemcitabine Teva
If you have, or have previously had liver disease, heart disease or vascular disease or problems with your
kidneys talk to your doctor or hospital pharmacist as you may not be able to receive Gemcitabine Teva.
If you have recently had, or are going to have radiotherapy, please tell your doctor as there may be an early
or late radiation reaction with Gemcitabine Teva.
If you have been vaccinated recently, please tell your doctor as this can possibly cause bad effects with
Gemcitabine Teva.
If during treatment with this medicine, you get symptoms such as headache with confusion, seizures (fits) or
changes in vision, call your doctor right away. This could be a very rare nervous system side effect named
posterior reversible encephalopathy syndrome.
If you develop breathing difficulties or feel very weak and are very pale, please tell your doctor as this may
be a sign of kidney failure or problems with your lungs.
If you develop generalised swelling, shortness of breath or weight gain, please tell your doctor as this may
be a sign of fluid leaking from your small blood vessels into the tissue.
Children and adolescents
This medicine is not recommended for use in children under 18 years of age due to insufficient data on
safety and efficacy.
Other medicines and Gemcitabine Teva
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, breast-feeding and fertility
Pregnancy
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.
Breast-feeding
If you are breast-feeding, tell your doctor.
You must discontinue breast-feeding during Gemcitabine treatment.
Fertility
Men are advised not to father a child during and up to 6 months following treatment with Gemcitabine Teva.
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 Teva 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 Teva contains sodium
Gemcitabine Teva contains 3.5 mg (< 1 mmol) of sodium in each 200 mg vial, 17.5 mg (< 1 mmol) sodium
in each 1 g vial and 35 mg (1.5 mmol) sodium in each 2 g vial. To be taken into consideration by patients on
a controlled sodium diet.
3.
2

How to use Gemcitabine Teva

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 hospital 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:















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).
Tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less
haemoglobin than normal which is very common).
Mild to moderate skin rash (very common) / itching (common), or fever (very common); (allergic
reactions).
Temperature of 38ºC or greater, sweating or other signs of infection (since you might have less white
blood cells than normal accompanied by fever also known as febrile neutropenia) (common).
Pain, redness, swelling or sores in your mouth (stomatitis) (common).
Irregular heart rate (arrhythmia) (uncommon).
Extreme tiredness and weakness, purpura or small areas of bleeding in the skin (bruises), acute renal
failure (low urine output /or no urine output, and signs of infection (haemolytic uraemic syndrome). It
may be fatal (uncommon).
Difficulty breathing (it is common to have mild breathing difficulty soon after the Gemcitabine Teva
infusion which soon passes, however uncommonly or rarely there can be more severe lung problems).
Severe chest pain (myocardial infarction) (rare).
Severe hypersensitivity/allergic reaction with severe skin rash including red itchy skin, swelling of the
hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or
breathing), wheezing, fast beating heart and you may feel you are going to faint (anaphylactic
reaction) (very rare).
Generalised swelling, shortness of breath or weight gain, as you might have fluid leakage from small
blood vessels into the tissues (capillary leak syndrome) (very rare).
Headache with changes in vision, confusion, seizures or fits (posterior reversible encephalopathy
syndrome (very rare).
Severe rash with itching, blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal
necrolysis) (very rare).

Other side effects with Gemcitabine Teva may include:
Very common side effects (may affect more than 1 in 10 people)

3

Low white blood cells











Difficulty breathing
Vomiting
Nausea
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)

Poor appetite (anorexia)

Headache

Insomnia

Sleepiness

Cough

Runny nose

Constipation

Diarrhoea

Itching

Sweating

Muscle pain

Back pain

Fever

Weakness

Chills
Uncommon side effects (may affect up to 1 in 100 people)

Scarring of air sacs of the lung (interstitial pneumonitis)

Spasm of the airways (wheeze)

Wheeze (spasm of the airways)

Scarring of the lungs (abnormal chest X ray/scan)

Heart failure

Kidney failure

Serious liver damage, including liver failure

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

Low blood pressure

Skin scaling, ulceration or blister formation

Sloughing of the skin and severe skin blistering

Injection site reactions

Severe lung inflammation causing respiratory failure (adult respiratory distress syndrome)

A skin rash like severe sunburn which can occur on skin that has previously been exposed to
radiotherapy (radiation recall)

Fluid in the lungs

Scarring of the air sacs of the lung associated with radiation therapy (radiation toxicity).

Gangrene of fingers of toes
Very rare side effects (may affect up to 1 in 10,000 people)

Increased platelet count

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

4



Low haemoglobin level (anaemia), low white blood cells and low platelet count will be
detected by a blood test.

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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5.

How to store Gemcitabine Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) which is stated on the carton and vial. The expiry date
refers to the last day of that month.
Unopened vial: No special storage conditions are required.
Reconstituted solution:
The product should be used immediately. When prepared as directed, chemical and physical in-use stability
of gemcitabine has been demonstrated for 24 hours at 25 C for the reconstituted product with a
concentration of 38mg/ml. Further dilution by a healthcare provider may be done. Solutions of reconstituted
gemcitabine should not be refrigerated, as crystallisation may occur.
From a microbiological point of view, the reconstituted and diluted 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 (and further dilution,
if applicable) has taken place in controlled and validated aseptic conditions.
For single use only. Discard any unused solution.
Do not use Gemcitabine Teva if you notice any particles or visible signs of deterioration.
Do not throw away any medicines via wastewater or household waste. Your doctor should dispose of
medicines that are no longer required. These measures will help to protect the environment.
6.

Contents of the pack and other information

What Gemcitabine Teva contains
The active substance is gemcitabine. Each vial contains 200 mg, 1 g or 2 g of gemcitabine (as gemcitabine
hydrochloride).
The other ingredients are mannitol (E421), sodium acetate trihydrate (E262), hydrochloric acid (E507) and
sodium hydroxide (E524).
What Gemcitabine Powder For Solution For Infusion looks like and contents of the pack
Each vial of Gemcitabine contains a white to off-white powder supplied in a glass vial closed with a rubber
stopper and aluminium cap with a plastic cover.

5

Gemcitabine Teva 200 mg Powder for solution for infusion are available in packs containing 1, 5 and 10
vials.
Gemcitabine Teva 1g Powder for solution for infusion are available in packs containing 1, 5 and 10 vials.
Gemcitabine Teva 2g Powder for solution for infusion are available in packs containing 1, 5 and 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: and Manufacturer:
Marketing Authorisation Holder is TEVA UK Limited, Eastbourne, BN22 9AG
Manufacturer is: Pharmachemie B.V, 2031 GA Haarlem, The Netherlands
This leaflet was last revised in June 2015

The following information is intended for medical or healthcare professionals only:
Instructions for use, handling and disposal.
1.
2.
3.

4.
5.

6.

Use aseptic techniques during the reconstitution and any further dilution of gemcitabine for
intravenous infusion administration.
Calculate the dose and the number of Gemcitabine Teva vials needed.
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 1 g vial or 50 ml sterile sodium chloride solution for injection, without
preservative to the 2 g vial. Shake to dissolve. The total volume after reconstitution is 5.26 ml (200
mg vial), 26.3 ml (1 g vial) or 52.6 ml (2 g 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.
Parenteral medicinal products should be inspected visually for particulate matter and discolouration
prior to administration. If particulate matter is observed, do not administer.
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 for the
reconstituted product with a concentration of 38mg/ml. Chemical and physical in-use stability has
been demonstrated for ambient conditions (15-25C, ambient light) or in a refrigerator (2-8C) for at
most 72 hours (3 days) for the diluted solution at concentrations between 0.1 mg/mL and 30 mg/mL
in 0.9% sodium chloride for injection. From a microbiological point of view, the reconstituted and
diluted 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 (and further dilution, if applicable) has taken place
in controlled and validated aseptic conditions.
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.
6

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.

7

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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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