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GEMCITABINE 38 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): GEMCITABINE HYDROCHLORIDE

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Gemcitabin 38 mg/ml · 90730-VBGB · AA · 02.16 · Pharma-Code: 276 (Dummy)
Format: 592 x 132 mm · HKS 44 · Corrective action: KV01_jem_28.01.16 / KV02_jem_28.01.16 / KV03_jte_03.02.16 / KV04_jem_03.02.16

Package leaflet: Information for the user

Gemcitabine 38 mg/ml
concentrate for solution for infusion
gemcitabine
Read all of this leaflet carefully before you start
receiving 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. What Gemcitabine is and what it is used for
2. What you need to know before you are given
Gemcitabine
3. How Gemcitabine is given
4. Possible side effects
5. How to store Gemcitabine
6. Contents of the pack and other 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.
Therapeutic indications
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 are given
Gemcitabine
Gemcitabine may only be administered if strictly
indicated, and by doctors experienced in this type of
therapy.
You should not be given 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.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are
given Gemcitabine.
Please tell your doctor if:
• you have, or have previously had liver disease,
heart disease, renal 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).
• during treatment with this medicine, you get symptoms
such as headache with confusion, seizures (fits) or
changes in vision. This could be a very rare nervous
system side effect named posterior reversible
encephalopathy syndrome.
• you develop generalised swelling, shortness of breath or
weight gain, as this may be a sign of fluid leaking from
your small blood vessels into the tissue.
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.
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
Tell your doctor if you are taking, have recently taken or
might take any other medicines.
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 you are given this
medicine.

Pregnancy
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 being treated with Gemcitabine are advised not to
father a child during and up to 6 months after treatment
and to seek further advice regarding cryoconservation
of sperm prior to treatment because of the possibility of
infertility due to therapy with gemcitabine.

3. How Gemcitabine is given
The recommended dose of Gemcitabine is
1,000 – 1,250 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.
You will always receive Gemcitabine by infusion into one of
your veins. The infusion will last approximately 30 minutes.

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.

If you have further questions on the use of this medicine,
ask your doctor or pharmacist.

Gemcitabine contains sodium
Each 200 mg vial gemcitabine contains
460 mg (20 mmol) sodium.
Each 1,000 mg vial gemcitabine contains
2,300 mg (100 mmol) sodium.
Each 2,000 mg vial gemcitabine contains
4,600 mg (200 mmol) sodium.
To be taken into consideration by patients on a
controlled sodium diet.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

4. Possible side effects

Tell your doctor immediately if you notice any of the
following:
• Temperature of 38 ºC 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).
• Irregular heart rate (arrhythmia) (uncommon).
• Pain, redness, swelling or sores in your mouth
(stomatitis) (common).

• Mild to moderate skin rash (very common) / itching
(common), or fever (very common) (allergic reactions).
• 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 blood
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).
• 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).
• 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).

The following information is intended for healthcare
professionals only:
Dilution:
This medicinal product has only been shown to be
compatible with sodium chloride 9 mg/ml (0.9 %) solution
or with glucose 50 mg/ml (5.0 %) solution. Accordingly,
only these diluents should be used for dilution.
The in-use stability of further dilutions with 9 mg/ml (0.9 %)
sodium chloride solution and 50 mg/ml (5 %) glucose
solution, respectively, were tested for two concentrations,
10.0 mg/ml and 1.0 mg/ml gemcitabine.
Compatibility with other active substances has not been
studied. Therefore, it is not recommended to mix this
medicinal product with other active substances.
Parenteral medicinal products should be inspected
visually for particulate matter and discolouration, prior to
administration, whenever solution and container permit.
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.

Gemcitabin 38 mg/ml · 90730-VBGB · AA · 02.16 · Pharma-Code: 276 (Dummy)
Format: 592 x 132 mm · HKS 44 · Corrective action: KV01_jem_28.01.16 / KV02_jem_28.01.16 / KV03_jte_03.02.16 / KV04_jem_03.02.16

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.
Actual spillage or leakage should be mopped up wearing
protective gloves. Excreta and vomit must be handled with
care.
Disposal:
Adequate care and precaution should be taken in the
disposal of items used to prepare this medicinal product.
Any unused 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.

90730-VBGB
AA

Side effects with Gemcitabine may include:
Very common side effects
(may affect more than 1 in 10 people):
• Low haemoglobin level (anaemia)
• Low white blood cells
• Low blood 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
Common side effects
(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







Muscle pain
Back pain
Fever
Weakness
Chills

Uncommon side effects
(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
• Stroke
• Serious liver damage, including liver failure
• Kidney failure
• Haemolytic uraemic syndrome (low red blood cell count
with renal insufficiency)
Rare side effects
(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
• 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
(may affect up to 1 in 10,000 people):
• Increased blood platelet count
• Anaphylactic reaction (severe hypersensitivity / allergic
reaction)
• Sloughing of skin and severe skin blistering (StevensJohnson syndrome, toxic epidermal necrolysis)
• Ischaemic colitis (inflammation of the lining of the large
bowel, caused by reduced blood supply)
• Generalised swelling, shortness of breath or weight gain
(capillary leak syndrome)
• Headache with confusion, seizures (fits) or changes in
vision (posterior reversible encephalopathy syndrome)
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

Do not use this medicine after the expiry date which is
stated on the carton after EXP. The expiry date refers to
the last day of that month.
This medicinal product does not require any special
storage conditions.
After dilution:
When diluted with glucose 50 mg/ml (5 %) solution
the chemical and physical in-use stability has been
demonstrated for 15 days at 20 °C ± 5 °C protected
from light.
When diluted with sodium chloride 9 mg/ml (0.9 %)
solution the chemical and physical in-use stability has
been demonstrated for 98 days at 20 °C ± 5 °C protected
from light.

6. Contents of the pack and other information
What Gemcitabine contains
• The active substance is gemcitabine (as hydrochloride).
Each vial contains 200, 1,000 or 2,000 mg of gemcitabine.
• The other ingredients are disodium phosphate dihydrate,
sodium dihydrogen phosphate dihydrate, sodium
hydroxide (for pH-adjustment), hydrochloric acid (for
pH-adjustment), polyethylene glycol 400, water for
injections.
What Gemcitabine looks like and contents of the pack
Gemcitabine is a clear, colourless to light yellow
concentrate for solution for infusion in a vial.
Each vial contains 200, 1000 or 2,000 mg of gemcitabine.

Dilutions with 9 mg/ml (0.9 %) sodium chloride
solution and 50 mg/ml (5 %) glucose solution,
respectively, were tested for two concentrations,
10.0 mg/ml and 1.0 mg/ml gemcitabine.

Each carton of Gemcitabine contains 1 vial.

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 – 8 °C, unless dilution has taken place in controlled and
validated aseptic conditions.

medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Tel.: +49 4103 8006-0
Fax: +49 4103 8006-100

This medicine is for single use only; any unused solution
should be discarded under the local requirements.

Marketing Authorisation Holder and Manufacturer

This medicinal product is authorised in the Member
States of the EEA under the following names:
Czech Republic Gemcitabine medac 38 mg/ml
koncentrát pro infuzní roztok
Denmark
Gemcitabin medac
Estonia
Gemcitabine medac
Finland
Gemcitabine medac 38 mg/ml
infuusiokonsentraatti, liuosta varten
France
Gemcitabine medac 38 mg/mL solution
à diluer pour perfusion
Germany
Gemedac 38 mg/ml Konzentrat zur
Herstellung einer Infusionslösung
Italy
Gemcitabina medac
Latvia
Gemcitabine medac 38 mg/ml
koncentrāts infūziju šķīduma
pagatavošanai
Lithuania
Gemcitabine medac 38 mg/ml
koncentratas infuziniam tirpalui
Norway
Gemcitabine medac 38 mg/ml konsentrat
til infusjonsvæske, oppløsning
Poland
Gemcitabine medac
Portugal
Gemcitabina medac
Slovakia
Gemcitabine medac 38 mg/ml infúzny
koncentrát
Sweden
Gemcitabine medac 38 mg/ml
koncentrat till infusionsvätska, lösning
United Kingdom Gemcitabine 38 mg/ml concentrate for
solution for infusion
This leaflet was last revised in February 2016.

Keep this medicine out of the sight and reach of children.
90730-VBGB
AA

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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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