GEMCITABINE 2 G POWDER FOR SOLUTION FOR INFUSION

Active substance: GEMCITABINE HYDROCHLORIDE

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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 any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or healthcare staff.
In this leaflet:
1. What Gemcitabine Powder for Solution for Infusion is and what it is used for
2. 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. 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 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. BEFORE YOU USE GEMCITABINE POWDER FOR SOLUTION FOR INFUSION
You should not be given Gemcitabine Powder for Solution for Infusion
• If you are allergic (hypersensitive) to gemcitabine or any of the other
ingredients of Gemcitabine Powder for Solution for Infusion
• If you are breast-feeding
Tell the doctor if you think any of the above applies to you.

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
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.
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 (this
may be a sign of lung problems or kidney failure).
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.

Taking and using other medicines
Please tell your doctor 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 Powder for Solution for Infusion should be avoided
if pregnant. Your doctor will discuss with you the potential risk of taking
gemcitabine during pregnancy.
If you are breast-feeding, tell your doctor. You must discontinue breast-feeding
during treatment with gemcitabine.

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
has not made you feel sleepy.

Important information about some of the ingredients of Gemcitabine
Powder for Solution for Infusion
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 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 infusion will depend on the type of cancer
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.
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) (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).

The following information is intended for medical or healthcare professionals only:
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.
Presentation

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.

• 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).

Side effects that you might experience when taking Gemcitabine
Powder for Solution for Infusion include:
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)
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
Uncommon side effects (affecting 1 to 10 users in 1,000):
• 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)
Rare side effects (affecting 1 to 10 users in 10,000):
• Heart attack (myocardial infarction)
• Low blood pressure
• Skin shedding
• Skin blisters
• Skin sores (ulcers)
• Soreness at the injection site after the injection
Very rare (affects less than 1 user in 10,000):
• Increased platelet count
• Anaphylactic reaction (severe hypersensitivity/allergic reaction)
• Sloughing of skin and severe skin blistering
Side effects with a frequency that cannot be estimated from the
available data
• 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 could develop any of these symptoms and/or conditions. You must tell
your doctor as soon as possible if you start to experience any of these side
effects. If you are concerned about any of the side effects, talk to your doctor.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or healthcare staff.

5. HOW TO STORE GEMCITABINE POWDER FOR SOLUTION FOR INFUSION
Keep out of the reach and sight of children.
Do not use Gemcitabine Powder for Solution for Infusion after the expiry date
which is stated on the vial and carton. 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.
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. FURTHER 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’.
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.
This leaflet was last approved in the UK in January 2010. This leaflet
was last approved in Ireland in March 2010 (017).

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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