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GEMCITABINE GP-PHARM 200 MG POWDER FOR SOLUTION FOR INFUSION

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PATIENT INFORMATION LEAFLET
Gemcitabine 200 mg powder for
solution for infusion
Gemcitabine
 9LHKHSSVM[OPZSLHÅL[JHYLM\SS`ILMVYL`V\Z[HY[\ZPUN
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.

blood taken to 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.

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Taking other medicines

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

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

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.

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.

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.”

Driving and using machines

2. BEFORE YOU ARE GIVEN Gemcitabine

Gemcitabine contains 3.5 mg (< 1 mmol) sodium in each
vial. To be taken into consideration by patients on a controlled sodium diet.

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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

The following information is intended for medical or
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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

3. HOW GEMCITABINE IS GIVEN
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

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

3. Reconstitute each 200 mg vial with 5 ml solution for injection
in sterile sodium chloride, 9 mg / ml (0.9%) without preservatives. Shake to dissolve. The total volume after reconstitution
is 5.26 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
200 mg powder for solution for infusion.

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

Instructions for use, handling and disposal

Conforme

Fecha
Edición:

Producto:

Prospecto Gemcitabina Europa 200 mg

Material:

Ófset blanco 50 g

Color:

23.12.11

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
Like all medicines, Gemcitabine can cause side effects,
although not everybody gets them.
Frequencies of the observed side effects are defined as:
sVERYCOMMON4HESEMAYAFFECTMORETHANINPEOPLE
sCOMMON4HESEMAYAFFECTUPTOINPEOPLE
sUNCOMMON4HESEMAYAFFECTUPTOINPEOPLE
sRARE4HESEMAYAFFECTUPTOIN PEOPLE
sVERYRARE4HESEMAYAFFECTUPTOIN PEOPLE
sNOTKNOWNFREQUENCYCANNOTBEESTIMATEDFROMTHEAVAIlable data
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HU`VM[OLMVSSV^PUN!
s&EVERORINFECTIONCOMMON IFYOUHAVEATEMPERATUREOF
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).
s4IREDNESS FEELINGFAINT BECOMINGEASILYBREATHLESSORIF
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

ation. 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 reconsti-

CÓDIGOS
GP-Pharm: PR-GEMCI601-GB-01

Reflex Blue

Tamaño:

200x260

Registro:
Plegado a:

25x130 mm

cara

G. Maculart:

01
266P061-A

- 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)

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.

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

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.

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

If you are concerned about any side effects, talk to your
doctor.

5. HOW TO STORE GEMCITABINE
Keep out of the 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.
This medicine is for single use only; any unused solution
should be discarded under the local requirements.

This medicinal product is authorized in the Member States
of the EEA under the following names:
Spain: Gemcitabina GP-Pharm 200 mg polvo para solución para
perfusión EFG
Italy: Gemcitabina GP-Pharm 200 mg polvere per soluzione per
infusione
Portugal: Gemcitabina GP-Pharm 200 mg pó para solução para
perfusão
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ȑȖȤȣıȘ
United Kingdom: Gemcitabine GP-Pharm 200 mg powder for
solution for infusion
Germany: Gemcitabine GP-Pharm 200 mg Pulver zur Herstellung einer Infusionslösung
%XOJDULD *HPFLWDELQH &6&  PJ ɩɪɚɯ ɡɚ ɢɧɮɭɡɢɨɧɟɧ
ɪɚɡɬɜɨɪ
3RODQG *HPFLWDELQH &6&  PJ SURV]HN GR VSRU]ąG]DQLD
roztworu do infuzji
Lithuania: Gemcitabine CSC 200 mg milteliai infuziniam tirpalui
/DWYLD *HPFLWDELQH &6&  PJ SXOYHULV LQIX]LMX ãƷƯGXPD
pagatavošanai
Estonia: Gemcitabine CSC 200 mg pulber infusioonilahuse valmistamiseks
Czeck Republic: Gemcitabine CSC Pharmaceuticals 200 mg
SUiãHNSURSĜtSUDYXLQIX]QtKRUR]WRNX
5RPDQLD *HPFLWDELQă &6&  PJ SXOEHUH SHQWUX VROXĠLH
SHUIX]DELOă
Slovakia: Gemcitabine CSC 200 mg prášok na infúzny roztok
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6. ADDITIONAL INFORMATION
What Gemcitabine contains

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

The active substance is gemcitabine. Each vial contains 200
mg of gemcitabine (as gemcitabine hydrochloride).
The other ingredients are mannitol (E421), sodium acetate
trihydrate, 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)

What Gemcitabine looks like and contents of the pack
Gemcitabine is a white or off white powder, for solution for
infusion in a vial packaging. Each vial contains 200 mg of
gemcitabine. Each pack of Gemcitabine contains 1 vial.

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
PR-GEMCI601-GB-01

tution / dilution is carried out under aseptic conditions
controlled and validated.
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

Conforme

Fecha
Edición:

Producto:

Prospecto Gemcitabina Europa 200 mg

Material:

Ófset blanco 50 g

Color:

23.12.11

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.

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

CÓDIGOS
GP-Pharm: PR-GEMCI601-GB-01

Reflex Blue

Tamaño:

200x260

Registro:
Plegado a:

25x130 mm

dors

G. Maculart:

01
266P061-A

Expand Transcript

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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