Skip to Content

UK Edition. Click here for US version.

GEMCITABINE 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): GEMCITABINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Gemcitabine RTU

Market

UK

Language

English

Size

300 x 300 mm PIL

Min. Font Size

9

Version No.

4 (Page 1 of 2)

Date

07/05/14 (Gemcitabine RTU (ACC-UK)VAR-PIL)

Prepared By
Regulatory Affairs

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gemcitabine 100 mg/ml
Concentrate 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 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 Concentrate for solution for infusion is
and what it is used for
2. Before you are given Gemcitabine Concentrate for solution
for infusion
3. How Gemcitabine Concentrate for solution for infusion is given
4. Possible side effects
5. How to store Gemcitabine Concentrate for solution for infusion
6. Further information

1. What Gemcitabine Concentrate for solution
for infusion is and what it is used for

Checked By
Regulatory Affairs

- if you are allergic (hypersensitive) to Gemcitabine or any of
the other ingredients of Gemcitabine Concentrate for
solution for infusion.
- if you are breast-feeding.
Take Special care with Gemcitabine Concentrate 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 have samples of your
blood taken to evaluate if you have enough blood cells to
receive Gemcitabine Concentrate 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 evaluate 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 (may be a sign of kidney failure).
• you are suffering from alcoholism, as this medicinal product
contains ethanol (alcohol)
• you are suffering from epilepsy, as this medicinal product
contains ethanol (alcohol).
Men are advised not to father a child during and up to 6
months following treatment with Gemcitabine Concentrate 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
counselling on sperm storage before starting your therapy.

The name of your medicine is ‘Gemcitabine 100 mg/ml
Concentrate for Solution for Infusion’ but in the rest of the
leaflet it will be called ‘Gemcitabine concentrate for solution
for infusion’.

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.

Gemcitabine Concentrate for solution for infusion belongs to a
group of medicines called “cytotoxics”. These medicines kill
dividing cells, including cancer cells.

Pregnancy and breast-feeding
If you are pregnant, or thinking about becoming pregnant, tell
your doctor. The use of Gemcitabine Concentrate for solution
for infusion should be avoided during pregnancy. Your doctor
will discuss with you the potential risk of taking Gemcitabine
Concentrate for solution for infusion during pregnancy.

Gemcitabine Concentrate for solution for infusion may be
given alone or in combination with other anti-cancer
medicines, depending on the type of cancer.
Gemcitabine Concentrate 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
Concentrate for solution for infusion
You should not be given Gemcitabine Concentrate for
solution for infusion

The following information is intended for medical or
healthcare professionals only
Instructions for use, handling and disposal.
1) Use aseptic techniques during preparation of gemcitabine
for intravenous infusion administration.
2) Calculate the dose and the number of Gemcitabine vials
needed.
Gemcitabine concentrate for solution for infusion is a clear
colourless to slightly yellow solution with a concentration of 100
mg/ml gemcitabine. The concentrate should be diluted with
sterile sodium chloride 9 mg/ml (0.9%) solution for injection,
without preservative to a final concentration of 0.1 to 10 mg/ml.

If you are breast-feeding, tell your doctor.
You must discontinue breast-feeding during Gemcitabine
Concentrate for solution for infusion treatment.
Fertility
Men are advised not to father a child during and up to 6
months following treatment with Gemzar. 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.
Driving and using machines
Gemcitabine Concentrate for solution for infusion may make
you feel sleepy, particularly if you have consumed any alcohol.
The amount of alcohol in this medicinal product may impair

The total quantity of the Gemcitabine concentrate for
solution for infusion required for an individual patient should
be diluted into at least 250 ml of diluent. Further dilution
with the same diluent can be done. Diluted solution is a
clear colourless to slightly yellow solution.
3) After opening before dilution:
Each vial is for single use and should be used immediately
after opening. If not used immediately, in-use storage times
and conditions are the responsibility of the user.
After dilution:
Chemical and physical in-use stability after dilution in 0.9 %
sodium chloride solution has been demonstrated for 3 days at
25°C and 2 °C to 8 °C.

Approved By
Quality Assurance

your ability to drive or use machines. Do not drive a car or use
machinery until you are sure that treatment with Gemcitabine
has not made you feel sleepy.
Important information about some of the ingredients of
Gemcitabine
This medicine contains ethanol anhydrous 44 % w/v, i.e. up to
9.9 g per maximum daily dose (2250 mg), equivalent to 250
ml beer or 100 ml wine per dose.
• 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 amount of alcohol in this medicinal product may alter the
effects of other medicines.
• The amount of alcohol in this medicinal product may impair
your ability to drive or use machines.
This medicine contains 199.6 mg (8.68 mmol) of sodium per
maximum daily dose (2250 mg). To be taken into
consideration by patients on a controlled sodium diet.

3. How Gemcitabine Concentrate for solution
for infusion is given
The usual dose of Gemcitabine Concentrate 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 Gemcitabine Concentrate for
solution for 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 Gemcitabine by infusion into one of
your veins. The infusion will last approximately 30 minutes.
This medicinal product is not recommended for use in children
under 18 years of age.
If you have further questions on the use of this product ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, Gemcitabine Concentrate 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: frequency can't be estimated from the available
data

From a microbiological point of view, the solution for infusion
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 condition.
Preparation of the infusion solution
Gemcitabine concentrate for solution for infusion should
be diluted prior to administration.
If the vials are stored under refrigeration, allow the required
number of boxes of Gemcitabine concentrate for solution for

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Gemcitabine RTU

Market

UK

Language

English

Size

300 x 300 mm PIL

Min. Font Size

9

Version No.

4 (Page 2 of 2)

Date

07/05/14 (Gemcitabine RTU (ACC-UK)VAR-PIL)

Prepared By
Regulatory Affairs

You must contact your doctor immediately if you notice any of
the following:
- Fever or infection (common): if you have a temperature of
380C 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).
Very common (affects more than 1 user in 10)
- 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
- Blood in urine
- Abnormal urine tests: protein in urine
- Flu-like symptoms including fever
- Oedema (swelling of ankles, fingers, feet, face)
Common (affects 1 to 10 users in 100)
- Fever accompanied by low white blood cell count (febrile
neutropenia)
- 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
Uncommon (affects 1 to 10 users in 1,000)
- 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
- Stroke

infusion to stand below 25°C for 5 minutes before use. More than
one vial of Gemcitabine concentrate for solution for infusion may
be necessary to obtain the required dose for the patient.
Aseptically withdraw the required amount of Gemcitabine
concentrate for solution for infusion using a calibrated syringe.
The required volume of Gemcitabine concentrate for solution
for infusion must be injected into at least 250 ml infusion bag
containing sodium chloride 9 mg/ml (0.9%) solution for
infusion.
Mix the infusion bag manually using a rocking motion. Further
dilution with the same diluent can be done.

Checked By
Regulatory Affairs

- Serious liver damage, including liver failure
- Kidney failure
- Haemolytic uraemic syndrome (a disease characterized by
haemolytic anaemia, acute renal failure and a low platelet
count)
Rare (affects 1 to 10 users in 10,000)
- Heart attack (myocardial infarction)
- Low blood pressure
- Skin scaling, ulceration or blister formation
- Injection site reactions
- Gangrene of fingers or toes
- Fluid in the lungs
- 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.
- Radiation toxicity: scarring of the air sacs of the lung
associated with radiation therapy
- Inflammation of the blood vessels
- Sloughing of skin and severe skin blistering
Very rare (affects less than 1 user in 10,000)
- Increased platelet count
- Anaphylactic reaction (severe hypersensitivity/ allergic
reaction)
- Ischaemic colitis (inflammation of the lining of the large
bowel, caused by reduced blood supply)
- Potentially life-threatening cutaneous reactions with
widespread purpuric macules and epidermal detachment
(Toxic epidermal necrolysis, Stevens-Johnson Syndrome)
- Capillary leak syndrome (CLS) is when fluids from your small
blood vessels leak out into the tissue. Symptoms can
include very low blood pressure (hypotension), a decrease of
the fluid content of the blood with increased concentration of
formed elements (hemoconcentration) and low levels of
albumin in the blood (hypoalbuminemia)
- Posterior reversible encephalopathy syndrome (PRES) which
can include symptoms of headache, nausea, vomiting, altered
mental status, stupor, confusion, seizures and visual loss)
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.

Approved By
Quality Assurance

After opening before dilution:
Each vial is for single use and should be used immediately
after opening. If not used immediately, in-use storage times
and conditions are the responsibility of the user.
After dilution:
Chemical and physical in-use stability after dilution in 0.9 %
sodium chloride solution has been demonstrated for 3 days at
25°C and 2 °C to 8 °C.
From a microbiological point of view, the solution for infusion
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 condition.
This medicine will be prepared and administered to you by
healthcare staff. Any unused medicine must be disposed of by
the healthcare staff.

6. Further information
What Gemcitabine Concentrate for solution for infusion
contains:
Gemcitabine concentrate for solution for infusion contains the
active ingredient Gemcitabine.
Each ml of the concentrate for solution for infusion contains
100 mg gemcitabine (as gemcitabine hydrochloride).
Each vial contains either 200 mg, 1000 mg, 1500 mg or 2000
mg gemcitabine (as gemcitabine hydrochloride).
The other ingredients are Macrogol 300, Propylene Glycol,
Sodium Hydroxide and Ethanol anhydrous.
What Gemcitabine Concentrate for solution for infusion
looks like and contents of the pack
This medicine is a concentrate for solution for infusion.
The concentrate is a clear, colourless to slightly yellow
solution. It is filled in clear glass vials sealed with rubber
stoppers and aluminium flip-off seals.
Pack sizes:
Each vial of 2 ml contains 200 mg gemcitabine.
Each vial of 10 ml contains 1000 mg gemcitabine.
Each vial of 15 ml contains 1500 mg gemcitabine.
Each vial of 20 ml contains 2000 mg gemcitabine
Not all pack sizes may be marketed.

If you are concerned about any side effects, talk to your doctor.

Marketing Authorisation Holder:

If any of the side effects gets serious, or if you notice any side
effects not mentioned in this leaflet, please tell your doctor.

Accord Healthcare Limited.
Sage House, 319 Pinner Road, North Harrow,
Middlesex, HA1 4HF
United Kingdom

5. How to store Gemcitabine Concentrate for
solution for infusion
Keep out of the reach and sight of children.
Do not use after the expiry date (EXP) which is stated on the
carton and vial. The expiry date refers to the last day of that
month.

Manufacturer:
Accord Healthcare Limited.
Sage House, 319 Pinner Road, North Harrow,
Middlesex, HA1 4HF
United Kingdom

This medicinal product does not require any special storage
conditions.

This leaflet was last approved in 02/2014.

The infusion bag solution should be used within 24 hours
when stored at 2°-8° C. As with all parenteral medicinal
products, Gemcitabine infusion solution should be inspected
visually for particulate matter and discolouration prior to
administration. If particulate matter is observed, do not
administer.

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.

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.

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

Expand view ⇕

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.

Hide