GEMCITABINE 2 G POWDER FOR SOLUTION FOR INFUSION

Active substance: GEMCITABINE HYDROCHLORIDE

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Pregnancy, breast-feeding and fertility

Package leaflet:
Information for the user
GEMCITABINE 200 mg POWDER FOR SOLUTION FOR INFUSION
GEMCITABINE 1 g POWDER FOR SOLUTION FOR INFUSION
GEMCITABINE 2 g POWDER FOR SOLUTION FOR INFUSION
Gemcitabine
Read all of this leaflet carefully before you start using this medicine.
• 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, or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Gemcitabine Powder for Solution for Infusion is and what it is used for
2. What you need to know before you use Gemcitabine Powder for Solution for Infusion
3. How to use Gemcitabine Powder for Solution for Infusion
4. Possible side effects
5. How to store Gemcitabine Powder for Solution for Infusion
6. Contents of the pack and other 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 may be given alone or in combination with other anti-cancer medicines,
depending on the type of cancer you have.
Gemcitabine Powder for Solution for Infusion is used in the treatment of a number of types of
cancer including:
• 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. What you need to know before you use Gemcitabine Powder for Solution for Infusion
You should not be given Gemcitabine Powder for Solution for Infusion
• If you are allergic to gemcitabine or any of the other ingredients of this medicine (listed in
section 6).
• If you are breast-feeding.
Tell the doctor if you think any of the above applies to you.

Warnings and precautions
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 also have samples of your
blood taken to check if you have enough blood cells to receive Gemcitabine. Your doctor may
decide to change your 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 your kidney and liver function.

Talk to your doctor or nurse before using Gemcitabine 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 (this may be a sign of
lung problems or kidney failure).

Other medicines and Gemcitabine Powder for Solution for Infusion

If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of
Gemcitabine Powder for Solution for Infusion should be avoided if pregnant. 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
treatment with Gemcitabine Powder for Solution for Infusion.
Men are advised not to father a child during, and up to 6 months after treatment with
gemcitabine. If you would like to father a child during the treatment or in the 6 months
following treatment, please seek advice from your doctor or pharmacist. You may want to seek
counselling on sperm storage before starting your therapy.

Driving and using machines
Gemcitabine treatment can make you feel drowsy. Alcohol can make this worse. Do not drive
or operate machinery until you are sure that Gemcitabine Powder for Solution for Infusion has
not made you feel sleepy.

Gemcitabine Powder for Solution for Infusion contains sodium
This medicinal product contains 35 mg (1.5 mmol) of sodium per 2 g dose. This should be
taken into consideration by patients on a controlled sodium diet.

3. How to use Gemcitabine Powder for Solution for Infusion
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 infusion will depend on the type of cancer you are being
treated for.
A hospital pharmacist or doctor will have dissolved the Gemcitabine Powder for Solution for
Infusion 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, this medicine 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: the frequency cannot be estimated from the available data

If any of the following happen, tell your doctor immediately:
• 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 receiving
a gemcitabine infusion but which soon passes; however uncommonly or rarely there can be
more severe lung problems).
• Tiredness, looking pale, bruising easily and kidney problems which your doctor will do
blood tests to investigate (uncommon).
• Worsening skin rash with sloughing of skin rash and sever skin blistering together with
mouth sores (very rare).

Tell your doctor if you are taking, have recently taken or might take any other medicines,
including vaccinations.

The following information is intended for healthcare professionals only:

Presentation

Reconstitution:
For single use only
This medicinal product has only been shown to be compatible with sodium chloride 9 mg/ml
(0.9%) solution for injection. Accordingly, only this diluent should be used for reconstitution.
Compatibility with other active substances has not been studied. Therefore, it is not
recommended to mix this medicinal product with other active substances when reconstituted.
Reconstitution at concentrations greater than 38 mg/ml may result in incomplete dissolution, and
should be avoided.
To reconstitute, slowly add the appropriate volume of sodium chloride 9 mg/ml (0.9%) solution for
injection (as stated in the table below) and shake to dissolve.

Volume of sodium chloride
9 mg/ml (0.9%) solution for
injection to be added

Displacement volume

Final concentration

200 mg

5 ml

0.26 ml

38 mg/ml

1g

25 ml

1.3 ml

38 mg/ml

2g

50 ml

2.6 ml

38 mg/ml

The appropriate amount of drug may be further diluted with sodium chloride 9 mg/ml (0.9%)
solution for injection.
Chemical and physical in-use stability has been demonstrated for 35 days at 25°C.
From a microbiological point of view, the product should be used immediately.
Solutions should not be refrigerated, as crystallisation may occur.
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Side effects that you might experience when taking Gemcitabine Powder for Solution
for Infusion include:

Very rare (affects less than 1 user in 10,000 less than 1 in 10,000 patients):
• Increased platelet count
• Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced blood
supply)
• Anaphylactic reaction (severe hypersensitivity/allergic reaction)
• Sloughing of skin and severe skin blistering

Very common side effects (affecting more than 1 user in 10):














Low haemoglobin levels (anaemia)
Low white blood cells
Low platelet count
Difficulty breathing
Vomiting
Nausea
Skin rash (an allergic skin rash which is frequently itchy)
Hair loss
Liver problems: found through abnormal blood test results
Blood in the urine
Abnormal urine tests: protein in urine
Flu like symptoms (including fever)
Oedema (swelling of ankles, fingers, feet and face)

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects
not listed in this leaflet.

5. How to store Gemcitabine Powder for Solution for Infusion
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 vial and carton after EXP.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
After reconstitution:
This medicine may be stored for 35 days at 25°C. From a microbiological point of view
however, it is advised that the product is used immediately.

Common side effects (affecting 1 to 10 users in 100):

















Fever, accompanied by a low white blood cell count (febrile neutropaenia)
Anorexia (poor appetite)
Headache
Drowsiness
Difficulty sleeping (insomnia)
Cough
Runny nose or nasal congestion
Diarrhoea
Constipation
Pain, redness, swelling or sores in the mouth
Itching
Sweating
Muscle pain
Back pain
Weakness
Chills

The reconstituted solution should not be refrigerated.
The prepared solution for infusion should not be used if it contains particles or if it is strongly
coloured.
This medicine will be prepared and administered to you by healthcare staff. Any unused
medicine will be disposed of by healthcare staff, according to local procedures.

6. Contents of the pack and other information
What Gemcitabine Powder for Solution for Infusion contains
• The active substance is gemcitabine (as hydrochloride)
• Vials contain either 200 mg, 1 g or 2 g gemcitabine (as hydrochloride)
• The other ingredients are mannitol, sodium acetate trihydrate, hydrochloric acid (for pH
adjustment) and sodium hydroxide (for pH adjustment)
• One ml of the reconstituted solution for infusion contains 38 mg gemcitabine (as
hydrochloride)

What Gemcitabine Powder for Solution for Infusion looks like and contents of the pack
This medicinal product is a powder for solution for infusion (a powder which is dissolved
before being injected slowly via a drip into a vein). It can also be referred to as a ‘powder for
infusion’.

Uncommon side effects (affecting 1 to 10 users in 1,000):









Stroke
Irregular heart beat (arrhythmia)
Heart failure
Interstitial pneumonitis (scarring of the air sacs of the lung)
Spasm of the airways (wheezing)
Abnormal chest X ray/scan (which show scarring of the lungs)
Serious liver damage, including liver failure
Kidney failure

The powder is white to off-white and when dissolved ready for infusion, it produces a
colourless or slightly yellow solution.
The 200 mg, 1 g and 2 g vials are sold separately as single packs or packs of 5. Not all pack
sizes may be marketed. Vials may be sheathed in protective ONCO-TAIN® sleeves.

Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder and manufacturer is Hospira UK Limited, Queensway,
Royal Leamington Spa, Warwickshire, CV31 3RW, United Kingdom.

Rare side effects (affecting 1 to 10 users in 10,000):












This leaflet was last revised in 12/2012 (024)

Heart attack (myocardial infarction)
Gangrene of fingers or toes
Low blood pressure
Fluid in the lungs
Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure)
Skin shedding
Skin blisters
Skin sores (ulcers)
Soreness at the injection site after the injection
Radiation toxicity (scarring of the air sacs of the lung associated with radiation therapy)
Radiation recall (a skin rash like severe sunburn which can occur on skin that has
previously been exposed to radiotherapy)

Parenteral drugs should be inspected visually for particulate matter and discolouration prior to
administration, whenever solution and container permit.
Any unused solution should be discarded as described below.
Guidelines for the Safe Handling of Cytotoxic Medicinal Products:
Local guidelines on safe preparation and handling of cytotoxic medicinal products must be
adhered to. Cytotoxic preparations should not be handled by pregnant staff. The preparation of
injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with
knowledge of the medicines used. This should be performed in a designated area. The work
surface should be covered with disposable plastic-backed absorbent paper.
Suitable eye protection, disposable gloves, face mask and disposable apron should be worn.
Precautions should be taken to avoid the drug accidentally coming into contact with the eyes.
If accidental contamination occurs, the eye should be washed with water thoroughly and
immediately.

Syringes and infusion sets should be assembled carefully to avoid leakage (use of Luer lock
fittings is recommended). Large bore needles are recommended to minimise pressure and the
possible formation of aerosols. The latter may also be reduced by the use of a venting needle.
Actual spillage or leakage should be mopped up wearing protective gloves. Excreta and vomit
must be handled with care.
Disposal:
Adequate care and precaution should be taken in the disposal of items used to reconstitute this
medicinal product. Any unused dry product or contaminated materials should be placed in a
high-risk waste bag. Sharp objects (needles, syringes, vials, etc) should be placed in a suitable
rigid container. Personnel concerned with the collection and disposal of this waste should be
aware of the hazard involved. Waste material should be destroyed by incineration. Any unused
product or waste material 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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