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GEMCITABINE MEDAC 38 MG/ML POWDER FOR SOLUTION FOR INFUSION

Active substance(s): GEMCITABINE HYDROCHLORIDE

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Gemcitabine 38 mg/ml · 90700-VPGB · CB · 11.14 · Pharma-Code: 748
Format: 592 x 132 mm · HKS 44 · Corrective action: KV01_osc_28.11.14 / KV02_osc_28.11.14 / KV03_osc_01.12.14

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. 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. No sufficient data are available about the safety
and efficacy of gemcitabine in children.
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. 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.
• if you are breast-feeding.
Take special care with Gemcitabine:
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.

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. 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.
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.
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, 17.5 mg (< 1 mmol) sodium in
each 1000 mg vial and 26.3 mg (> 1 mmol) sodium
in each 1500 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 ºC 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).

The following information is intended for medical or
healthcare professionals only:
Special precautions for disposal and other handling
Reconstitution:
For single use only.
This medicinal product has only been shown to be
compatible with sodium chloride 9 mg/ml (0.9 %) solution
for injection. Accordingly, only this diluent should be
used for reconstitution. Compatibility with other active
substances has not been studied. Therefore, it is not
recommended to mix this medicinal product with other
active substances when reconstituted.
Reconstitution at concentrations greater than 38 mg/ml
may result in incomplete dissolution, and should be
avoided.
To reconstitute, slowly add the appropriate volume of
sodium chloride 9 mg/ml (0.9 %) solution for injection
(as stated in the table below) and shake to dissolve.
Presentation
volume of sodium
Final
chloride 9 mg/ml Reconstituted
Presentation
volume
concentration
(0.9 %) solution
for injection to be
added
200 mg

5 ml

5.26 ml

38 mg/ml

1,000 mg

25 ml

26.3 ml

38 mg/ml

1,500 mg

37.5 ml

39.5 ml

38 mg/ml

The appropriate amount of medicinal product may be
further diluted with sodium chloride 9 mg/ml (0.9 %)
solution for injection.
Parenteral medicinal products should be inspected
visually for particulate matter and discolouration, prior to
administration, whenever solution and container permit.
Any unused solution should be discarded as described
below.
Guidelines for the Safe Handling of Cytotoxic
Medicinal Products:
Local guidelines on safe preparation and handling
of cytotoxic medicinal products must be adhered to.
Cytotoxic preparations should not be handled by pregnant
staff. The preparation of injectable solutions of cytotoxic
agents must be carried out by trained specialist personnel
with knowledge of the medicines used. This should be
performed in a designated area. The work surface should
be covered with disposable plastic-backed absorbent
paper.
Suitable eye protection, disposable gloves, face mask and
disposable apron should be worn. Precautions should be
taken to avoid the medicinal product accidentally coming
into contact with the eyes. If accidental contamination
occurs, the eye should be washed with water thoroughly
and immediately.
Syringes and infusion sets should be assembled
carefully to avoid leakage (use of Luer lock fittings is
recommended). Large bore needles are recommended to
minimise pressure and the possible formation of aerosols.
The latter may also be reduced by the use of a venting
needle.

Gemcitabine 38 mg/ml · 90700-VPGB · CB · 11.14 · Pharma-Code: 748
Format: 592 x 132 mm · HKS 44 · Corrective action: KV01_osc_28.11.14 / KV02_osc_28.11.14 / KV03_osc_01.12.14

Actual spillage or leakage should be mopped up wearing
protective gloves. Excreta and vomit must be handled with
care.

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)
• Sweating
• Sleeping difficulties

Disposal:
Adequate care and precaution should be taken in the
disposal of items used to reconstitute this medicinal
product. Any unused dry product or contaminated
materials should be placed in a high-risk waste bag.
Sharp objects (needles, syringes, vials, etc) should be
placed in a suitable rigid container. Personnel concerned
with the collection and disposal of this waste should be
aware of the hazard involved. Waste material should be
destroyed by incineration. Any unused product or waste
material should be disposed of in accordance with local
requirements.

90700-VPGB
CB

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
• 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
• Stroke
• Serious liver damage, including liver failure
• Kidney failure
• Haemolytic uraemic syndrome (low red blood
cell count with renal insufficiency)
Rare side effects
• Heart attack (myocardial infarction)
• Low blood pressure
• Skin scaling, ulceration or blister formation
• Injection site reactions
• Gangrene of fingers or toes
• Fluid in the lungs
• 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.
• Radiation toxicity – scarring of the air sacs of the lung
associated with radiation therapy

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)
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 nurse.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via
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

as directed, chemical and physical in-use stability of
reconstituted solutions of gemcitabine were demonstrated
for 35 days at 25 °C. 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. FURTHER INFORMATION
What Gemcitabine contains
The active substance is gemcitabine.
Each vial contains 200, 1000 or 1500 mg of gemcitabine
(as gemcitabine hydrochloride).
The other ingredients are mannitol (E421), sodium acetate,
hydrochloric acid and sodium hydroxide.

This medicinal product is authorised in the Member
States of the EEA under the following names:
Czech Republic Gemcitabine medac 38 mg/ml
prášek pro přípravu infuzního roztoku
Germany
Gemedac 38 mg/ml
Pulver zur Herstellung einer
Infusionslösung
Lithuania
Gemcitabine medac 38 mg/ml
milteliai infuziniam tirpalui
Poland
Gemcitabine medac
Slovak Republic Gemcitabine medac 38 mg/ml
prášok na infúzny roztok
United Kingdom Gemcitabine 38 mg/ml
powder for solution for infusion
This leaflet was last revised in 11/2014.

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, 1000 or 1500 mg
of gemcitabine. Each pack of Gemcitabine contains 1 vial.

Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the
carton after EXP.
This medicinal product does not require any special storage
conditions.
Reconstituted solution:
The product should be used immediately. When prepared

Marketing Authorisation Holder and Manufacturer:
medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Phone: +49 4103 8006-0
Fax:
+49 4103 8006-100

90700-VPGB
CB

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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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