Skip to Content

GEMCITABINE 1000MG POWDER FOR INFUSION

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

X

784193 Reg
148 594
148
Pantone 533 C
993

d37spg9e.indd 1

297

27.01.2011 08:46:38

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gemcitabine 200 mg powder for solution for infusion
Gemcitabine 1000 mg 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 powder for solution for infusion is and what it is used for
2. Before you are given Gemcitabine powder for solution for infusion
3. How Gemcitabine powder for solution for infusion is given
4. Possible side effects
5. How to store Gemcitabine powder for solution for infusion
6. Further information
1. WHAT GEMCITABINE POWDER FOR SOLUTION FOR INFUSION IS AND WHAT IT IS USED
FOR
Gemcitabine powder for solution for infusion belongs to a group of medicines called “cytotoxics”.
These medicines kill dividing cells, including cancer cells.
Gemcitabine powder for solution for infusion may be given alone or in combination with other
anti-cancer medicines, depending on the type of cancer.
Gemcitabine powder for solution for infusion 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 POWDER FOR SOLUTION FOR INFUSION
You should not be given Gemcitabine powder for solution for infusion:
- f you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of Gemcitabine
i
powder for solution for infusion.
- f you are breast-feeding
i
Take special care with Gemcitabine powder for solution for infusion:
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 powder for solution for
infusion. 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.

Men are advised not to father a child during and up to 6 months following treatment with
Gemcitabine powder for solution for infusion. 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.

SSSSAAASA

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).

Pregnancy and breast-feeding
If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of
Gemcitabine powder for solution for infusion should be avoided during pregnancy. Your doctor
will discuss with you the potential risk of taking Gemcitabine powder for solution for infusion
during pregnancy.
If you are breast‑feeding, tell your doctor.
You must discontinue breast‑feeding during Gemcitabine powder for solution for infusion
treatment.
Driving and using machines
Gemcitabine powder for solution for infusion 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
powder for solution for infusion treatment has not made you feel sleepy.
Important information about some of the ingredients of Gemcitabine powder for solution
for infusion
Gemcitabine powder for solution for infusion contains 3.9 mg (< 1 mmol) of sodium in each
200 mg vial and 19.6 mg (< 1 mmol) sodium in each 1000 mg vial. To be taken into consideration
by patients on a controlled sodium diet.
3. HOW GEMCITABINE POWDER FOR SOLUTION FOR INFUSION IS GIVEN
The usual dose of Gemcitabine powder for solution for infusion 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 powder for solution for infusion 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 powder for solution for infusion can cause side effects, although
not everybody gets them.

SSSSAAASA

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°C 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) (frequency not known).
• 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)
Side effects with Gemcitabine powder for solution for infusion 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 neutropaenia)
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)
784193–Reg

d37spg9e.indd 2

27.01.2011 08:46:39

SSSSAAASA

Rare side effects
Heart attack (myocardial infarction)
Low blood pressure
Skin scaling, ulceration or blister formation
Injection site reactions
Very rare side effects
Increased platelet count
Anaphylactic reaction (severe hypersensitivity/ allergic reaction)
Sloughing of skin and severe skin blistering
Side effects with frequency not known
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 previously
been 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
Stroke
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.
5. HOW TO STORE GEMCITABINE POWDER FOR SOLUTION FOR INFUSION
Keep out of the reach and sight of children.
Do not refrigerate or freeze.
Do not use after the expiry date (EXP) which is stated on the carton and the vial.
The expiry date refers to the last day of that month.
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 25°C. Further dilution by a healthcare provider may be done.
Solutions of reconstituted gemcitabine should not be refrigerated or frozen, 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 powder for solution for infusion contains
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 and sodium hydroxide.
What Gemcitabine powder for solution for infusion looks like and contents of the pack
Gemcitabine powder for solution for infusion 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
powder for solution for infusion contains 1 or 5 vial(s). Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
EBEWE Pharma Ges.m.b.H. Nfg. KG
Mondseestrasse 11
4866 Unterach
Austria
Manufacturer:
Actavis Italy S.p.A.
Nerviano Plant
Viale Pasteur 10
20014 Nerviano
Italy
This medicinal product is authorised in the Member States of the EEA under the following
names:
BE

Gemcitabine Sandoz 200 mg/1000 mg poeder voor oplossing voor infusie

BG

Gemcitabin “Ebewe” 200 mg/1000 mg powder for solution for infusion

CY

Gemcitabin “Ebewe” 200 mg/1000 mg powder for solution for infusion

CZ

Gemcitabin Ebewe 200 mg/1000 mg prášek pro prípravu infuzního roztoku

DE

Gemcitabin HEXAL 200 mg/1000mg Pulver zur Herstellung einer Infusionslösung

DK

Gemcitabin Ebewe

EE

Gemcitabine Ebewe 200 mg/1000 mg

EL

Gemcitabine Ebewe 200 mg/1000 mg κόνις γιa dιάλυµa pρος έγχυsη

ES

Gemcitabina Ebewe 200 mg/1000 mg polvo para solución para perfusión

FI

Gemcitabin “Ebewe” 200mg/1000mg infuusiokuiva-aine, liuosta varten

HU

Gemcitabin Ebewe 200 mg/1000 mg powder for solution for infusion

IE

Gemcitabine “Ebewe” 200 mg/1000 mg powder for solution for infusion

IT

Gemcitabina Ebewe 200 mg/1000 mg polvere per soluzione per infusione

LT

Gemcitabin Ebewe 200 mg/1000 mg powder for solution for infusion

LU

Gemcitabine Sandoz 200mg/1000mg, poudre pour solution pour perfusion

LV

Gemcitabin “Ebewe” 200 mg/1000 mg powder for solution for infusion

MT

Gemcitabin “Ebewe” 200 mg/1000 mg powder for solution for infusion

NL

Gemcitabine “Ebewe”, 200 mg/1000 mg poeder voor oplossing voor infusie

NO

Gemcitabin “Ebewe” 200mg/1000mg pulver til infusjonsvæske, oppløsning

PL

Gemcitabin-Ebewe

PT

Gemcitabina Ebewe Pó para solução para perfusão

RO

Gemcitabină Ebewe 200 mg/1000 mg pulbere pentru soluţie perfuzabilă

SE

Gemcitabin Ebewe, 200 mg/1000 mg pulver till infusionsvätska, lösning

SI

Gemcitabin “Ebewe” 200 mg/1000 mg prašek za raztopino za infundiranje

SK

Gemcitabin Ebewe 200 mg/1000 mg prášok na infúzny roztok

UK

Gemcitabine 200 mg/1000 mg powder for solution for infusion

This leaflet was last approved in 08/2010. .
The following information is intended for medical or healthcare professionals only:
Instructions for use, handling and disposal.
1. Use aseptic techniques during the reconstitution and any further dilution of gemcitabine for
intravenous infusion administration.
2. Calculate the dose and the number of Gemcitabine powder for solution for infusion vials
needed.
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 displacement 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.
4. Parenteral medicinal products should be inspected visually for particulate matter and
discolouration prior to administration. If particulate matter is observed, do not administer.
5. Solutions of reconstituted gemcitabine should not be refrigerated or frozen, as crystallisation
may occur. Chemical and physical in-use stability has been demonstrated for 24 hours at
25°C. 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.
6. Gemcitabine solutions are for single use only. Any unused product or waste material should be
disposed of in accordance with local requirements.
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.
Disposal
Any unused product should be disposed of in accordance with local requirements.

d37spg9e.indd 3

27.01.2011 08:46:39

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.

Hide