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GEMCITABINE 1000MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): GEMCITABINE HYDROCHLORIDE

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PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
Gemcitabine 200 mg and 1 g powder for solution for infusion
Gemcitabine
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, 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:

Other medicines and Gemcitabine

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

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.

1. WHAT GEMCITABINE IS AND WHAT IT IS USED
FOR

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.

Pregnancy, breast-feeding and fertility
Pregnancy

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.

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. 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
GEMCITABINE

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.

Do not use Gemcitabine:

Gemcitabine contains sodium

Warnings and Precautions:
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.

If you have, or have previously had liver disease, heart
disease, vascular disease or problems with your kidneys talk
to your doctor or hospital pharmacist as you may not be able
to receive Gemcitabine.
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.
If you have been vaccinated recently, please tell your doctor
as this can possibly cause bad effects with Gemcitabine.
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 generalized 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

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
misplacement 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.

2. Calculate the dose and the number of Gemcitabine vials needed.

1. Use aseptic techniques during the reconstitution and any further dilution of
gemcitabine for intravenous infusion administration.

Instructions for use, handling and disposal.

The following information is intended for medical or healthcare
professionals only:

There is no relevant use of Gemcitabine in the paediatric
population.

Other medicines and Gemcitabine

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 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, this medicine can cause side effects,
although not everybody gets them.
Frequencies of the observed side effects are defined as:






4. Parenteral medicinal products should be inspected visually for particulate matter
and discolouration prior to administration. If particulate matter is observed, do
not administer.

Talk to your doctor, nurse or hospital pharmacist before using
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 i.e. essentially sodium free.

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

6. Gemcitabine solutions are for single use only. Any unused product or waste
material should be disposed of in accordance with local requirements.



if you are allergic to gemcitabine or any of the other
ingredients of this medicine (listed in section 6).
if you are breast-feeding.

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 room temperature. 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 room temperature, unless
reconstitution/dilution has taken place in controlled and validated aseptic
conditions.



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).
Contact your doctor if you get a severe rash or itching or
blistering (Stevens-Johnson syndrome or Toxic
epidermal necrolysis).
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 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).
Generalised swelling, shortness of breath or weight gain,
as you might have fluid leakage from small blood vessels
into the tissues (very rare).

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 or sores in the mouth
Itching
Sweating
Muscle pain
Back pain
Fever
Weakness
Chills

Uncommon side effects









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





Very rare side effects
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)
 Capillary leak syndrome (fluids from your small blood
vessels leak out into the tissue)
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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at: http://yellowcard.mhra.gov.uk/. By reporting side
effects you can help provide more information on the safety of
this medicine..

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 carton and the vial.
Unopened vial: Store below 30°C.
Reconstituted solution: The product should be used
immediately. When prepared as directed, chemical and
physical in-use stability of reconstituted solutions of
gemcitabine were demonstrated for 24 hours at room
temperature. Further dilution by a healthcare provider may be
done. 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.

CONTENTS OF THE PACK AND OTHER
INFORMATION

The active substance is gemcitabine. Each vial contains 200
or 1000 mg of gemcitabine (as
gemcitabine hydrochloride).
The other ingredients are mannitol (E421), sodium acetate,
hydrochloric acid and sodium hydroxide.
What Gemcitabine looks like and contents of the pack
Gemcitabine is a white to off-white powder, for solution for
infusion in a vial. Each vial contains 200 or 1000 mg of
gemcitabine. Each pack of Gemcitabine contains 1 vial.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, East Yorkshire, HU17 0LD, United Kingdom.
This leaflet was last revised in 07/2014

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.

Heart attack (myocardial infarction)



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

Disposal









Any unused product should be disposed of in accordance with local requirements.

Rare side effects

Rare side effects

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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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