GEMCITABINE 38 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance: GEMCITABINE HYDROCHLORIDE

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If you develop breathing difficulties or feel very weak and are very pale, please tell your
doctor as this may be a sign of kidney failure or problems with your lungs.

Gemcitabine
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. See section 4.

If you develop generalised swelling, shortness of breath or weight gain, please tell your
doctor as this may be a sign of fluid leaking from your small blood vessels into the tissue.
Children and adolescents
This medicine is not recommended for use in children under 18 years of age due to
insufficient data on safety and efficacy.
Other medicines and Gemcitabine

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

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.

1. What Gemcitabine is and what it is used for

Breast-feeding

Pregnancy, breast-feeding and fertility
Pregnancy
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.

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.

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.

If you have, or have previously had liver disease, heart disease, vascular disease or
problems with your kidneys talk to your doctor or hospital pharmacist as you may not
be able to receive gemcitabine.
If you have recently had, or are going to have radiotherapy, please tell your doctor as
there may be an early or late radiation reaction with gemcitabine.

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.

If you have been vaccinated recently, please tell your doctor as this can possibly cause
bad effects with gemcitabine.

3. How to use Gemcitabine
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 diluted the Gemcitabine concentrate before it
is given to you.
You will always receive this medicine only after dilution 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 medicine, ask your doctor or
pharmacist.

Other side effects with Gemcitabine may include:
Very common side effects (may affect more than 1 in 10 people)
- Low white blood cells
- Difficulty breathing
- Vomiting
- Nausea
- 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 effect (may affect up to 1 in 10 people)
- Poor appetite (anorexia)
- Headache
- Insomnia
- Sleepiness
- Cough
- Runny nose

The following instructions
for dilution should be strictly
followed in order to avoid
adverse events.
1. Use aseptic technique during
dilution of gemcitabine
for intravenous infusion
administration.
2. Parenteral medicinal
products should be
inspected visually for
particulate matter and
discolouration prior to
administration. If particulate
matter is observed, do not
administer.

Talk to your doctor, nurse or hospital pharmacist before using gemcitabine.

Gemcitabine contains propylene glycol which may cause alcohol-like symptoms.

Based on the recommended dose
(1000 mg/m2 and 1250 mg/m2)
and body surface area (between
1.0 m2 to 2.0 m2) a concentration
range of 2 mg/ml to 5 mg/ml is
obtained.

Before the first infusion you will have samples of your blood taken to check if your
liver and kidneys are working well enough for you to receive this medicine. Before
each infusion you will have samples of your blood taken to check 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 check how well your
kidneys and liver are working.

This medicine contains 3.16 mg/ml to 3.74 mg/ml (0.14 mmol/ml to 0.16 mmol/ml)
sodium. This should be taken into consideration by patients on a controlled sodium diet.

Total quantity of Gemcitabine
concentrate for solution required
for an individual patient must
be diluted, before use, to at
least 500 ml of sodium chloride
9 mg/ml solution for injection
to obtain clinically relevant
concentrations.

Warnings and precautions:

Gemcitabine contains sodium:

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

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.

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.

Fertility

Driving and using machines

2. What you need to know before you use Gemcitabine

Handling

You must discontinue breast-feeding during gemcitabine treatment.
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
counselling on sperm storage before starting your therapy.

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.

The following information
is intended for healthcare
professionals only:

If you are breast-feeding, tell your doctor.

You must contact your doctor immediately if you notice any of the following:
- 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).
- Tiredness, feeling faint, becoming easily breathless or if you look pale (since you
might have less haemoglobin than normal which is very common).
- Mild to moderate skin rash (very common) / itching (common), or fever (very
common); (allergic reactions).
- Temperature of 38ºC or greater, sweating or other signs of infection (since you
might have less white blood cells than normal accompanied by fever also known as
febrile neutropenia) (common).
- Pain, redness, swelling or sores in your mouth (stomatitis) (common).
- Irregular heart rate (arrhythmia) (uncommon)
- Extreme tiredness and weakness, purpura or small areas of bleeding in the skin
(bruises), acute renal failure (low urine output /or no urine output), and signs of
infection (haemolytic uraemic syndrome). It may be fatal (uncommon).
- Difficulty breathing (it is 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)
- Severe chest pain (myocardial infarction) (rare).
- Severe hypersensitivity/allergic reaction with severe skin rash including red itchy
skin, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause
difficulty in swallowing or breathing), wheezing, fast beating heart and you may feel
you are going to faint (anaphylactic reaction) (very rare).
- Generalised swelling, shortness of breath or weight gain, as you might have fluid
leakage from small blood vessels into the tissues (capillary leak syndrome) (very
rare)
- Headache with changes in vision, confusion, seizures or fits (posterior reversible
encephalopathy syndrome) (very rare)
- Severe rash with itching, blistering or peeling of the skin (Stevens-Johnson
syndrome, toxic epidermal necrolysis) (very rare).

V001/BO

concentrate for solution for infusion

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

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Gemcitabine 38 mg/ml

4. Possible side effects

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If during treatment with this medicine, you get symptoms such as headache with
confusion, seizures (fits) or changes in vision, call your doctor right away. This could
be a very rare nervous system side effect named posterior reversible encephalopathy
syndrome.

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

Package leaflet: Information for the user

Rare side effects (may affect up to 1 in 1,000 people)
- Low blood pressure
- Skin scaling, ulceration or blister formation
- Sloughing of the skin and severe skin blistering
- Injection site reactions
- Severe lung inflammation causing respiratory failure (adult respiratory distress
syndrome)
- A skin rash like severe sunburn) which can occur on skin that has previously been
exposed to radiotherapy (radiation recall).
- Fluid in the lungs
- Scarring of the air sacs of the lung associated with radiation therapy (radiation
toxicity)
- Gangrene of fingers or toes
- Inflammation of the blood vessels (peripheral vasculitis)
Very rare side effects (may affect up to 1 in 10,000 people)
- Increased platelet count
- Inflammation of the lining of the large bowel, caused by reduced blood supply
(ischaemic colitis)
- Low haemoglobin level (anaemia), low white blood cells and low platelet count will
be detected by a blood test.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly (see
details below). By reporting side effects you can help provide more information on the
safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971

5. How to store Gemcitabine
Keep this medicine out of the sight and reach of children.

This medicinal product is authorised in the Member States of the EEA under the
following names:
Austria
Belgium

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.

Gemcitabine Fresenius Kabi 38 mg/ml concentraat voor oplossing
voor infusie (1000 mg/26.3 ml)

Store below 25°C. Do not refrigerate or freeze.
Shelf life after dilution(Solution for Infusion):
Chemical and physical in-use stability after dilution in 0.9 % w/v sodium chloride
solution at a concentration of 0.1 mg/ml and 5 mg/ml has been demonstrated for
7 days at 2°C to 8°C or 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 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.
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.
6. Contents of the pack and other information
What Gemcitabine contains
The active substance is gemcitabine.
Each ml of concentrate for solution for infusion contains gemcitabine hydrochloride,
equivalent to 38 mg gemcitabine.
Each vial contains 200 mg gemcitabine (as hydrochloride)
Each vial contains 1000 mg gemcitabine (as hydrochloride)
Each vial contains 2000 mg gemcitabine (as hydrochloride).
The other ingredients are: Propylene Glycol, Macrogol 400, Sodium hydroxide (E524)
(for pH adjustment), Hydrochloric acid, concentrated (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 light
straw colored solution, free from visible particles.
Each pack contains 1 vial of 5.26 ml, 26.3 ml or 52.6 ml of solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon
Hampshire, GU35 0NF
United Kingdom

Gemcitabin Kabi 38 mg/ml Konzentrat zur Herstellung einer
Infusionslösung
Gemcitabine Fresenius Kabi 38 mg/ml concentraat voor oplossing
voor infusie (200 mg/5.26 ml)

Cyprus
Czech
Republic
Germany
Denmark
Estonia
Greece
Spain

Gemcitabine Fresenius Kabi 38 mg/ml concentraat voor oplossing
voor infusie (2000 mg/52.6 ml)
Gemcitabine Kabi 38 mg/ml πυκνό διάλυμα για παρασκευή
διαλύματος προς έγχυση
Gemcitabine Kabi 38 mg/ml koncentrát pro infuzní roztok
Gemcitabin Kabi 38 mg/ml Konzentrat zur Herstellung einer
Infusionslösung
Gemkabi
Gemcitabine Kabi 38 mg/ml
Gemcitabine Kabi 38 mg/ml πυκνό διάλυμα για παρασκευή
διαλύματος προς έγχυση
Gemcitabina FK 200 mg concentrado para solución para perfusión,
Gemcitabina FK 1000 mg concentrado para solución para perfusión,

Finland
France
Hungary
Ireland
Iceland
Italy
Latvia
Lithuania
Luxembourg
Malta
The
Netherlands
Norway
Poland
Portugal
Romania
Sweden
Slovenia
Slovak
Republic
United
Kingdom

Gemcitabina FK 2000 mg concentrado para solución para perfusión
Gemkabi
Gemcitabine Kabi 38 mg/ml solution à diluer pour perfusion
Gemcitabin Kabi 38 mg/ml koncentrátum oldatos infúzióhoz
Gemcitabine 38 mg/ml concentrate for solution for infusion
Gemkabi
Gemcitabina Fresenius
Gemcitabine Kabi 38 mg/ml koncentrāts infūziju šķīduma
pagatavošanai
Gemcitabine Kabi 38 mg/ml koncentratas infuziniam tirpalui
Gemcitabin Kabi 38 mg/ml Konzentrat zur Herstellung einer
Infusionslösung
Gemcitabine 38 mg/ml concentrate for solution for infusion
Gemcitabine Fresenius Kabi 38 mg/ml concentraat voor oplossing
voor infusie
Gemkabi
Gemcitabine Kabi
Gemcitabina Kabi
Gemcitabina Kabi 38 mg/ml concentrat pentru soluţie perfuzabilă
Gemkabi
Gemcitabin Kabi 38 mg/ml koncentrat za raztopino za infundiranje
Gemcitabine Kabi 38 mg/ml, infúzny koncentrát
Gemcitabine 38 mg/ml concentrate for solution for infusion

This leaflet was last revised in 10/2014.

V001/BO

Uncommon side effect (may affect up to 1 in 100 people)
- Scarring of the air sacs of the lung (interstitial pneumonitis)
- Wheeze (spasm of the airways )
- Scarring of the lungs (abnormal chest X ray/scan)
- Heart failure
- Kidney failure
- Serious liver damage, including liver failure
- Stroke

Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie.

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Constipation
Diarrhoea
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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