GEMCITABINE 38 MG/ML POWDER FOR SOLUTION FOR INFUSION

Active substance: GEMCITABINE HYDROCHLORIDE

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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 38 mg/mL Powder for Solution for Infusion is and what it is
used for
2. Before you are given Gemcitabine 38 mg/mL Powder for Solution for Infusion
3. How Gemcitabine 38 mg/mL Powder for Solution for Infusion is given
4. Possible side effects
5. How to store Gemcitabine 38 mg/mL Powder for Solution for Infusion
6. Further information
1. WHAT GEMCITABINE 38 mg/mL POWDER FOR SOLUTION FOR
INFUSION IS AND WHAT IT IS USED FOR
Gemcitabine 38 mg/mL Powder for Solution for Infusion belongs to a group of
medicines called “cytotoxics”. These medicines kill dividing cells, including cancer
cells.
Gemcitabine 38 mg/mL Powder for Solution for Infusion may be given alone or in
combination with other anti-cancer medicines, depending on the type of cancer.
Gemcitabine 38 mg/mL 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 38 mg/mL POWDER FOR
SOLUTION FOR INFUSION
You should not be given Gemcitabine 38 mg/mL Powder for Solution for
Infusion if you:

-

are allergic (hypersensitive) to gemcitabine or any of the other ingredients of
Gemcitabine 38 mg/mL Powder for Solution for Infusion.
are breast-feeding.

Take special care with Gemcitabine 38 mg/mL Powder for Solution for Infusion:
Before the first infusion you will have samples of your blood taken to check if your
kidneys and liver are working properly . Before each infusion you will have samples
of your blood taken to checkif you have enough blood cells to receive Gemcitabine 38
mg/mL 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 check if your kidneys and
liver are working properly.
Please tell your doctor if you:
 have, or have previously had liver disease, heart disease or vascular disease.
 have recently had, or are going to have radiotherapy.
 have been vaccinated recently
 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 38 mg/mL 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
councelling 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 38 mg/mL Powder for Solution for Infusion should be avoided during
pregnancy. Your doctor will discuss with you the potential risk of taking Gemcitabine
38 mg/mL Powder for Solution for Infusion during pregnancy.
If you are breast-feeding, tell your doctor.
You must discontinue breast-feeding during Gemcitabine 38 mg/mL Powder for
Solution for Infusion treatment.
Ask your doctor for advice before using any medicine.
Driving and using machines
Gemcitabine 38 mg/mL 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 38 mg/mL Powder for Solution for Infusion
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 and 17.5 mg
(< 1 mmol) sodium in each 1000 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 38ºC 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 may include:
Very common side effects
Low red blood cells level (anaemia)
Low white blood cells
Low platelet count
Difficulty breathing
Being sick (vomiting)
Feeling sick (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
Swelling of ankles, fingers, feet, face (Oedema)
Common side effects
Fever accompanied by low white blood cell count (febrile neutropaenia)
Poor appetite (anorexia)
Headache
Difficuly sleeping (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
Scarring of the air sacs of the lung (Interstitial pneumonitis)
Wheezing (Spasm of the airways)
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

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)
A skin rash like severe sunburn (radiation recall) 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
Inflammation of the lining of the large bowel, caused by reduced blood supply
(Ischaemic colitis)
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
Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the carton and label after .
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage condition
Reconstituted solution : Chemical and physical in-use stability has been demonstrated
for 24 hours at 25°C. From a microbiological point to 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 25°C.
Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation
may occur.
Do not use Gemcitabine if you notice any particulate matter and / or discolouration.

This medicine is for single use only; any unused solution should be discarded under
the local requirements.
Remnants of the medicinal product as well as all materials that have been used for
reconstitution, for dilution and administration must be destroyed according to hospital
standard procedures applicable to cytotoxic agents with due regard to current laws
related to the disposal of hazardous waste.
6. FURTHER INFORMATION
What Gemcitabine contains
The active substance is gemcitabine. Each vial contains 200 mg or 1000 mg of
gemcitabine (as gemcitabine hydrochloride).
The other ingredients are mannitol (E421), sodium acetate, hydrochloric acid (for pH
adjustment) and sodium hydroxide (for pH adjustment).
What Gemcitabine looks like and contents of the pack
Gemcitabine is a white powder or plug, for solution for infusion in a tubular glass
vial, with a dark grey rubber stopper and sealed with a light yellow flip off aluminium
seal.
Each vial contains 200 mg or 1000 mg of gemcitabine. Each carton pack of
Gemcitabine contains 1 vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK
Manufacturer
Strides Arcolab Polska Sp.z.o.o.
10, Daniszewska Str
03-230 Warsaw
Poland
This medicinal product is authorized in the Member States of the EEA under
following names:
Name Member State

Name of the medicinal product

The Netherlands (RMS)

Gemcitabine Strides 38 mg/ml poeder voor oplossing voor infusie

Austria

Gemcitabin Strides 38 mg/ml Pulver zur Herstellung einer
Infusionslösung

Belgium

Gemcitabine Strides 38 mg/ml poeder voor oplossing voor infusie

Bulgaria

Gemcitabine Strides 38 mg/ml Прах за инфузионен разтвор

Cyprus

Gemcitabin Strides 38 mg/ml κόνις για διάλυμα προς έγχυση

Czech Republic

Gemcitabin Strides 38 mg/ml prášek pro přípravu infuzního roztoku

Germany

Gemcitabin Strides 38 mg/ml Pulver zur Herstellung einer
Infusionslösung

Denmark

Gemcitabin Strides 38 mg/ml pulver til infusionsvæske, opløsning

Estonia

Gemcitabin Strides

Greece

Gemcitabin Strides 38 mg/ml kόνις για διάλυμα προς έγχυση

Finland

Gemcitabin Strides 38 mg/ml infuusiokuiva-aine, liuosta varten

France

Gemcitabine Strides Arcolab International 38 mg/ml poudre pour
solution pour perfusion

Hungary

Gemcitabin Strides 38 mg/ml por oldatos infúzióhoz

Ireland

Gemcitabine Strides 38 mg/ml powder for solution for infusion

Iceland

Gemcitabin Strides 38 mg/ml innrennslisstofn, lausn

Italy

Gemcitabina Strides

Latvia

Gemcitabine Strides 38 mg/ml pulveris infuziju šķīduma
pagatavošanai

Lithuania

Gemcitabine Strides 38 mg/ml milteliai infuziniam tirpalui

Luxemburg

Gemcitabine Strides 38 mg/ml poudre pour solution pour perfusion

Malta

Gemcitabin Strides 38 mg/ml trab għal soluzzjoni għall-infużjoni

Norway

Gemcitabin Strides 38 mg/ml pulver til infusjonsvæske, oppløsning

Poland

Gemcitabine Strides

Portugal

Gemcitabina Strides

Romania

Gemcitabina Strides Arcolab International 38 mg/ml pulbere pentru
soluţie perfuzabilă

Spain

Gemcitabina Strides 38 mg/ml polvo para solución para perfusion

Sweden

Gemcitabin Strides 38 mg/ml pulver till infusionsvätska, lösning

Slovak Republic

Gemcitabin Strides 38 mg/ml prášok na infúzny roztok

Slovenia

Gemcitabin Strides Arcolab 38 mg/ml prašek za raztopino za
infundiranje

UK

Gemcitabine 38 mg/ml powder for solution for infusion

This leaflet was last approved in10/2014.

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 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, as
crystallisation may occur.
Chemical and physical in-use stability has been demonstrated for 24 hours at
25°C. From a biological standpoint, the product should be used immediately. If
not used immediately, in-use storage times and conditions of the reconstituted
solution 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.

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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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