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GEMCITABINE GP-PHARM 1000 MG POWDER FOR SOLUTION FOR INFUSION

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PATIENT INFORMATION LEAFLET
Gemcitabine 1,000 mg,
powder for solution for infusion
Gemcitabine

9LHKHSSVM[OPZSLHÅL[JHYLM\SS`ILMVYL`V\Z[HY[\Zing this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you.
- Do not pass it on to others. It may harm then, 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 or pharmacist.

0U[OPZSLHÅL[!
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

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 blood takento evaluate if you have enough
blood cells to be able 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 a 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 week 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
counseling on sperm storage before starting your
treatment.
Taking other medicines

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.
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.

The usual dose of Gemcitabine is 1,000 – 1,250 mg for
every squared meter of your body’s surface area. Your
weight and height 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 any further questions on the use of this product, ask y our doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS

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Frequencies of the observed side effects are defined as:
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available data

Ask your doctor or pharmacist for advice before taking
any medicine.
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

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If you are allergic (hypersensitive) to gemcitabine or any
of the other ingredients of Gemcitabine.
If you are breast-feeding.

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.

The following information is intended for medical or
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1. Use aseptic techniques during reconstitution and any
further dilution of gemcitabine for the administration
by intravenous infusion.

3. Reconstitute each 1,000 mg vial with 25 ml solution for injection in sterile sodium chloride, 9 mg /
ml (0.9%) without preservatives. Shake to dissolve.
The total volume after reconstitution is 26.3 ml. The
resulting concentration of gemcitabine is 38 mg / ml,
which includes considering the volume of the lyophilized powder. Again it can be diluted with a solution
of sodium chloride injection, 9 mg / ml (0.9%), with
no preservatives. The reconstituted solution is clear
colorless or pale yellow.

2. Calculate the dose and the number of vials of Gemcitabine 1,000 mg powder for solution for infusion.

4. Before the administration should be inspected visually to detect the drug particles in suspension and / or

roducto:

3. HOW GEMCITABINE IS GIVEN

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.

2. BEFORE YOU ARE GIVEN Gemcitabine

Instructions for use, handling and disposal

Important information about some of the ingredients
of Gemcitabine
Gemcitabine contains 17.5 mg (< 1 mmol) sodium in
each vial. To be taken into consideration by patients on a
controlled sodium diet.

Prospecto Gemcitabina Europa 1000 mg

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

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s&EVERORINFECTIONCOMMON IFYOUHAVEATEMPERATURE
of 38ºC or greater, sweating or other signs of infection
(since you might have less white blood cells than normal, which is very common).
s)RREGULARHEARTRATEARRHYTHMIA FREQUENCYNOTKNOWN 
s0AIN REDNESS SWELLINGORSORESINYOURMOUTHCOMmon)
s!LLERGICREACTIONSIFYOUDEVELOPSKINRASHVERYCOMmon) / itching (common) or fever (very common).

discoloration. If we observe the presence of particles,
should not be given.
5. Solutions of reconstituted gemcitabine should not be
refrigerated because crystallization can occur. It has
been shown chemical and physical stability in use for
24 hours at 25 ° C. Visa from a microbiological point
of the product should be used immediately. If not used
immediately, conditions and storage periods before
use, shall be the responsibility of the user and must
not exceed 24 hours at room temperature, unless
reconstitution / dilution is carried out under aseptic
conditions controlled and validated.

s4IREDNESS FEELINGFAINT BECOMINGEASILYBREATHLESSOR
if you look pale (since you might have less haemoglobin than normal, which is very common).
s"LEEDINGFROMTHEGUMS NOSEORMOUTHORANYBLEEDing that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets
than normal which is very common)
s $IFlCULTY 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).
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=LY`JVTTVUZPKLLMMLJ[Z
- Low hemoglobin level (anemia)
- 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 tests
results
- Blood in urine
- Abnormal urine tests: proteins 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
- Diarrhea
- 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)
Rare side effects
- Heart attack (myocardial infarction)
- Low blood pressure
- Skin scaling, ulceration or blister formation
- Injection site reactions

6. Solutions of Gemcitabine should be used only once.
You must remove any unused product or waste in accordance with local rules.
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

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- Increased platelet count
- Anaphylactic reaction (severe hypersensitivity / allergic reaction)
- Sloughing of skin and severe skin blistering

The other ingredients are mannitol (E421), sodium acetate tryhydrate, hydrochloric acid and sodium hydroxide
(as pH regulator).

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- Irregular heart beat (arrhythmia)
- 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 been previously exposed to radiotherapy
- Fluid in the lungs
- Radiation toxicity – scarring of the air sacs of the lung
associated with radiation therapy
- Ischaemic colitis (inflammation of the lining of the
large bowel, caused by reduced blood supply)
- Heart Failure
- Kidney Failure
- Gangrene of fingers or toes
- Serious liver damage, including liver failure.
- Cerebral infarction (stroke)

Gemcitabine is a white or off white powder, for solution
for infusion in a vial packaging. Each vial contains 1,000
mg of gemcitabine. Each pack of Gemcitabine contains
1 vial.

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.
If any of the side effects gets serious, or if you notice any
side effects not mentioned in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE Gemcitabine
Keep out of reach and sight of children.
Do not use Gemcitabine after the expiry date (EXP)
which is stated on the package.
Unopened vial: store below 30 º C. Do not refrigerate.
Do not use Gemcitabine after the expiry date which is
stated on the vial or outer packaging after “EXP”.
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 25ºC.
You can perform a subsequent dilution by a health professional. Solutions of reconstituted gemcitabine should
not be refrigerated because crystallization can occur.

What Gemcitabine looks like and contents of the pack

Marketing authorization holder and Manufacturer
GP-Pharm, S.A.
Polígono Industrial Els Vinyets-Els Fogars, sector 2
Carretera Comarcal C-244, km. 22
08777 Sant Quintí de Mediona (Barcelona)
SPAIN
This medicinal product is authorized in the Member
States of the EEA under the following names:
Spain: Gemcitabina GP-Pharm 1,000 mg polvo para solución para perfusión EFGItaly: Gemcitabina GP-Pharm 1,000
mg polvere per soluzione per infusione
Portugal: Gemcitabina GP-Pharm 1,000 mg pó para solução
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ȖȚĮįȚȐȜȣȝĮʌȡȠȢȑȖȤȣıȘ
United Kingdom: Gemcitabine GP-Pharm 1,000 mg powder
for solution for infusion
Germany: Gemcitabine GP-Pharm 1,000 mg Pulver zur
Herstellung einer Infusionslösung
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Poland: Gemcitabine CSC 1,000 mg proszek do
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Lithuania: Gemcitabine CSC 1,000 mg milteliai infuziniam
tirpalui
/DWYLD*HPFLWDELQH&6&PJSXOYHULVLQIX]LMXãƷƯGXPD
SDJDWDYRãDQDL
Estonia: Gemcitabine CSC 1,000 mg pulber infusioonilahuse
valmistamiseks
Czeck Republic: Gemcitabine CSC Pharmaceuticals 1,000
PJSUiãHNSURSĜtSUDYXLQIX]QtKRUR]WRNX
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roztok
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This medicine is for single use only; any unused solution
should be discarded under the local requirements.
6. ADDITIONAL INFORMATION
What Gemcitabine contains
The active substance is gemcitabine. Each vial contains
1,000 mg of gemcitabine (as gemcitabine hydrochloride).

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

Prospecto Gemcitabina Europa 1000 mg

PR-GEMCI602-GB-01

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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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