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GEMCITABINE 40MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): GEMCITABINE / GEMCITABINE HYDROCHLORIDE

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you are suffering from alcoholism, as this medicinal product contains ethanol
(alcohol)
you are suffering from epilepsy, as this medicinal product contains ethanol
(alcohol)

A hospital pharmacist or doctor will have diluted the Gemcitabine concentrate before
it is given to you.

Men are advised not to father a child during and up to 6 months following treatment
with Gemciatbine. 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.

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

Other medicines and Gemcitabine:

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




The amount of alcohol in this medicinal product may alter the effects of other
medicines.
Pregnancy, breast-feeding and fertility:
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.

up to 21.1 g of ethanol per 50 ml vial, equivalent to 421 ml of beer, 175 ml of wine.

Side effects with Gemcitabine may include:

Gemcitabine belongs to a group of medicines called “cytotoxics”. These medicines
kill dividing cells, including cancer cells.
This medicine may be given alone or in combination with other anti-cancer medicines,
depending on the type of cancer.
This medicine 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
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 amount of alcohol in this medicinal product may impair your ability to drive or
use machines.
Gemcitabine contains ethanol and sodium:
This medicinal product contains 42.1% ethanol (alcohol) which corresponds to 421
mg ethanol per ml of concentrate, i.e. up to 2.1 g of ethanol per 5 ml vial, equivalent
to 42 ml of beer, 18 ml of wine,

2. What you need to know before you use Gemcitabine
Do not use 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:

Harmful for those suffering from alcoholism.
To be taken into account in pregnant or breast-feeding women, children and high-risk
groups such as patients with liver disease or epilepsy.
The amounts of alcohol in this medicinal product may alter the effects of other
medicines.

This medicine contains 3.40 mg/ml to 3.70 mg/ ml (0.15 mmol/ml to 0.16 mmol/ml)
sodium. This should be taken into consideration by patients on a controlled sodium diet.
3. How to use Gemcitabine

Any unused product or waste material
should be disposed of in accordance with
local requirements.

1. Use aseptic technique during dilution

of gemcitabine for intravenous
infusion administration.
2. The total quantity of the
gemcitabine 40 mg/ml concentrate
for solution for infusion required
for an individual patient should
be diluted into at least 500 ml
of sterile sodium chloride 9 mg/
ml (0.9%) solution for injection
(without preservative) and infused
over 30 min. Further dilution
with the same diluent can be done.
Diluted solution is a clear colourless
or light straw-coloured solution.
3. Parenteral medicinal products should
be inspected visually for particulate
matter and discolouration prior to
administration. If particulate matter
is observed, do not administer.

How frequently you receive your Gemcitabine infusion depends on the type of cancer
that you are being treated for.

The only approved diluent for dilution of
Gemcitabine 40 mg/ml concentrate for
solution for infusion is sodium chloride
9  mg/ml (0.9%) solution for injection
(without preservative).

Instructions for dilution should be
strictly followed in order to avoid
adverse events.

Instructions for dilution

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.

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.

The normal safety precautions for
cytostatic agents must be observed when
preparing and disposing of the infusion
solution. Pregnant personnel should
not handle the product. 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.

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).

Handling

The amount of alcohol in this medicinal product may impair your ability to drive or
use machines.

The following information is intended
for healthcare professionals only:
Instruction for use
Cytotoxic

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.

Very common: may affect more than 1 in 10 people
- 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
- Kidney 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)

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You must discontinue breast-feeding during gemcitabine treatment.

V001/BO

up to 10.5 g of ethanol per 25 ml vial, equivalent to 210 ml of beer, 88 ml of wine,

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) ( uncommon).
- 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).

If you are breast-feeding, tell your doctor.

1. What Gemcitabine is and what it is used for

Frequencies of the observed side effects are defined as:
- Very common: may affect more than 1 in 10 people
- Common: may affect up to 1 in 10 people
- Uncommon: may affect 1 in 100 people
- Rare: may affect 1 in 1,000 people
- Very rare: may affect up to 1 in 10,000 people

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What is in this leaflet:
1. What Gemcitabine is and what it is used for
2. What you need to know before you use Gemcitabine
3. How to use Gemcitabine
4. Possible side effects
5. How to store Gemcitabine
6. Contents of the pack and other information

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.

4. Possible side effects

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

Read all of this leaflet carefully before you start using 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, nurse or pharmacist.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet.

Chemical and physical in-use stability
after dilution in 0.9 % sodium chloride
solution has been demonstrated for 3
days at 2°C to 8°C or at 30°C.

Gemcitabine

You will always receive this medicine only after dilution by infusion into one of your
veins. The infusion will last approximately 30 minutes.

Shelf life after dilution:

Gemcitabine 40 mg/ml
concentrate for solution for infusion

Storage conditions

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
5. How to store Gemcitabine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label
after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage condition.
Shelf life after dilution(Solution for Infusion):
Chemical and physical in-use stability after dilution in 0.9 % w/v sodium chloride
solution has been demonstrated for 3 days at 2°C to 8°C or at 30°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 2°C to
8°C, unless dilution has taken place in controlled and validated aseptic conditions.
This medicine is for single use only. Discard any unused contents.
If the solution appears discoloured or contains visible particles, it should be discarded.

This medicinal product is authorised in the Member States of the EEA under the
following names:
Austria
Belgium
Bulgaria
Cyprus
Czech Republic
Germany
Denmark
Estonia
Greece
Spain
Finland
France
Hungary

Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help
protect the environment.

Ireland
Iceland
Italy

6. Contents of the pack and other information

Latvia

What Gemcitabine contains

Rare: 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
- 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
- Gangrene of fingers or toes
- Clinical signs of peripheral vasculitis (inflammation of the blood vessels)
- Sloughing of skin and severe skin blistering

The active substance is gemcitabine (as hydrochloride). Each ml of concentrate for
solution for infusion contains 40 mg gemcitabine as gemcitabine hydrochloride.

Very rare: may affect up to 1 in 10,000 people
- Increased platelet count
- Anaphylactic reaction (severe hypersensitivity/ allergic reaction)
- Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced
blood supply)

Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon
Hampshire, GU350NF
United Kingdom

Each 5 ml vial contains 200 mg gemcitabine (as hydrochloride)
Each 25 ml vial contains 1000 mg gemcitabine (as hydrochloride)
Each 50 ml vial contains 2000 mg gemcitabine (as hydrochloride).
The other ingredients are: Ethanol (96%), sodium hydroxide (E524) (for pH
adjustment), hydrochloric acid (E507) (for pH adjustment) and water for injections
What Gemcitabine looks like and contents of the pack
This medicinal product is a concentrate for solution for infusion.
Gemcitabine is a concentrate for solution for infusion and a clear, colourless to slightly
yellow solution.
Each pack contains 1 vial of 5 ml, 25 ml or 50 ml of solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

Lithuania
Luxembourg
Malta
The Netherlands
Norway
Poland
Portugal
Romania
Sweden
Slovenia
Slovak Republic
United Kingdom

Gemcitabin Kabi 40 mg/ml Konzentrat zur Herstellung
einer Infusionslösung
Gemcitabine Fresenius Kabi 40 mg/ml concentraat voor
oplossing voor infusie
Gemcitabine Kabi 40 mg/ml концентрат за инфузионен
разтвор
Gemcitabine Kabi 40 mg/ml πυκνό διάλυμα για παρασκευή
διαλύματος προς έγχυση
Gemcitabine Kabi 40 mg/ml koncentrát pro infuzní roztok
Gemcitabin Kabi 40 mg/ml Konzentrat zur Herstellung
einer Infusionslösung
Gemkabi
Gemcitabine Kabi 40 mg/ml
Gemcitabine Kabi 40 mg/ml πυκνό διάλυμα για παρασκευή
διαλύματος προς έγχυση
Gemcitabina Kabi 40 mg/ml concentrado para solución para
perfusión EFG
Gemcitabin Fresenius Kabi 40mg/ml infuusiokonsentraatti,
liuosta varten
Gemcitabine Kabi 40 mg/ml solution à diluer pour perfusion
Gemcitabin Kabi 40 mg/ml koncentrátum oldatos
infúzióhoz
Gemcitabine 40 mg/ml concentrate for solution for infusion
Gemcitabine Fresenius Kabi
Gemcitabina Fresenius 40 mg/ml concentrato per soluzione
per infusione
Gemcitabine Kabi 40 mg/ml koncentrāts infūziju šķīduma
pagatavošanai
Gemcitabine Kabi 40 mg/ml koncentratas infuziniam
tirpalui
Gemcitabin Kabi 40 mg/ml Konzentrat zur Herstellung
einer Infusionslösung
Gemcitabine 40 mg/ml concentrate for solution for infusion
Gemcitabinee Fresenius Kabi 40mg/ml concentraat voor
oplossing voor infusie
Gemkabi 40 mg/ml konsentrat til infusjonsvæske
Gemcitabine Kabi
Gemcitabina Kabi
Gemcitabina Kabi 40 mg/ml concentrat pentru soluţie
perfuzabilă
Gemcitabin Fresenius Kabi 40 mg/ml koncentrat till
infusionsvätska, lösning
Gemcitabin Kabi 40 mg/ml koncentrat za raztopino za
infundiranje
Gemcitabine Kabi 40 mg/ml, infúzny koncentrát
Gemcitabine 40 mg/ml concentrate for solution for infusion

This leaflet was last revised in 10/2012

V001/BO

Potentially life-threatening cutaneous reactions with widespread purpuric
macules and epidermal detachment (Toxic epidermal necrolysis, Stevens-Johnson
Syndrome).

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Uncommon: 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
- Kidney failure
- Serious liver damage, including liver failure
- Stroke
- Haemolytic uraemic syndrome (a disease characterized by haemolytic anaemia,
acute renal failure and a low platelet count)

-

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Common: may affect up to 1 in 10 people
- 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

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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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