Skip to Content

UK Edition. Click here for US version.

GEMCITABINE 2G POWDER FOR SOLUTION FOR INFUSION

Active substance(s): GEMCITABINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PRINTED AT 90%

PRINTED AT 90%
01036-A

93.130.XXX-X

PREPARATION GUIDE FOR USE WITH
GEMCITABINE 200 mg, 1 g
AND 2 g POWDER FOR
SOLUTION FOR INFUSION
Please note this is a Prescriber Information Leaflet NOT the SPC.
For full details regarding this product please refer to the SPC.
The following information is intended for medical or healthcare
professionals only:
Instructions for use, handling and disposal.
1. Use aseptic techniques during the reconstitution and any
further dilution of gemcitabine for intravenous infusion
administration.
2. Calculate the dose and the number of Gemcitabine vials
needed.
3. Reconstitute 200 mg vials with 5 ml of 9 mg/ml (0.9 %)
sterile sodium chloride solution for injection, without
preservative, or 25 ml sterile sodium chloride solution for
injection, without preservative to the 1 g vial or 50 ml
sterile sodium chloride solution for injection, without
preservative to the 2 g vial. Shake to dissolve. The total
volume after reconstitution is 5.26 ml (200 mg vial), 26.3 ml
(1 g vial) or 52.6 ml (2 g vial) respectively. This dilution
yields a gemcitabine concentration of 38 mg/ml, which
includes accounting for the displacement volume of the
lyophilised powder. Further dilution with sterile sodium
chloride 9 mg/ml (0.9%) solution for injection, without
preservative may be done. The resulting solution is clear
and ranges in colour from colourless to light straw-coloured.
4. Parenteral medicinal products should be inspected visually for
particulate matter and discolouration prior to administration.
If particulate matter is observed, do not administer.
5. Solutions of reconstituted gemcitabine should not be
refrigerated, as crystallisation may occur. Chemical and
physical in-use stability has been demonstrated for 24 hours
at 25°C for the reconstituted product with a concentration of
38 mg/ml. Chemical and physical in-use stability has been
demonstrated for ambient conditions (15-25°C, ambient
light) or in a refrigerator (2-8°C) for at most 72 hours (3 days)
for the diluted solution at concentrations between
0.1 mg/mL and 30 mg/mL in 0.9% sodium chloride for
injection. From a microbiological point of view, the
reconstituted and diluted 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 room
temperature, unless reconstitution (and further dilution, if
applicable) has taken place in controlled and validated aseptic
conditions.
6. Gemcitabine solutions are for single use only. Any unused
product or waste material should be disposed of in
accordance with local requirements.
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.
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.
Disposal
Any unused product should be disposed of in accordance with
local requirements.

PACKAGE LEAFLET: INFORMATION
FOR THE USER

GEMCITABINE 200 mg, 1 g AND
2 g POWDER FOR SOLUTION
FOR INFUSION
Read all of this leaflet carefully before you start
receiving 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 Powder for Solution for Infusion
is and what it is used for
2. Before you are given Gemcitabine Powder for
Solution for Infusion
3. How Gemcitabine Powder for Solution for Infusion
is given
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 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.
Gemcitabine 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 POWDER FOR SOLUTION
FOR INFUSION

You should not be given Gemcitabine:
• if you are allergic (hypersensitive) to gemcitabine
or any of the other ingredients of Gemcitabine.
• if you are breast-feeding.
Take special care with Gemcitabine:
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.
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).
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.

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.
Pregnancy and breast-feeding
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.
If you are breast-feeding, tell your doctor.
You must discontinue breast-feeding during
Gemcitabine treatment.
Ask your doctor, nurse or pharmacist for advice
before taking any medicine.
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.
Important information about some of the ingredients
of Gemcitabine
Gemcitabine contains 3.5 mg (< 1 mmol) of sodium
in each 200 mg vial, 17.5 mg (< 1 mmol) sodium in
each 1 g vial and 35 mg (1.5 mmol) sodium in each
2 g vial. To 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 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 dissolved
the Gemcitabine powder 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.
If you have further questions on the use of this
product ask your doctor or hospital pharmacist.

4 POSSIBLE SIDE EFFECTS
Like all medicines, Gemcitabine 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 not be estimated from
the available data.
You must contact your doctor immediately if you
notice any of the following:
• Fever or infection (common): if you have a
temperature of 38ºC 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).
Side effects with Gemcitabine may include:
Very common side effects:
• 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 side effects:
• 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
• Fever
• Weakness
• Chills
• Back pain.
Uncommon side effects:
• Interstitial pneumonitis (scarring of the air sacs of
the lung)
• Spasm of the airways (wheezing)
• Abnormal chest X ray/scan (scarring of the lungs).
Rare side effects:
• Heart attack (myocardial infarction)
• Low blood pressure
• Skin scaling, ulceration or blister formation
• Injection site reactions.
Very rare side effects:
• Increased platelet count
• Anaphylactic reaction (severe
hypersensitivity/allergic reaction)
• Sloughing of the skin and severe skin blistering.
Side effects with frequency not known:
• 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.

93.130.XXX-X

5 HOW TO STORE GEMCITABINE
POWDER 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.
Unopened vial:
No special storage conditions are required.

Reconstituted solution:
The product should be used immediately. When
prepared as directed, chemical and physical in-use
stability of gemcitabine has been demonstrated for
24 hours at 25°C for the reconstituted product with
a concentration of 38 mg/ml. Further dilution by a
healthcare provider may be done. Solutions of
reconstituted gemcitabine should not be refrigerated,
as crystallisation may occur.
From a microbiological point of view, the
reconstituted and diluted 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 room temperature, unless
reconstitution (and further dilution, if applicable) has
taken place in controlled and validated aseptic
conditions.
For single use only. Discard any unused solution.
Do not use Gemcitabine if you notice any particles or
visible signs of deterioration.
Medicines should not be disposed of via wastewater
or household waste. Your doctor should dispose of
medicines that are no longer required. These
measures will help to protect the environment

6 FURTHER INFORMATION
What Gemcitabine Powder For Solution For Infusion
contains
The active substance is gemcitabine. Each vial
contains 200 mg, 1 g or 2 g of gemcitabine (as
gemcitabine hydrochloride).
The other ingredients are mannitol (E421), sodium
acetate (E262), hydrochloric acid and sodium
hydroxide.
What Gemcitabine Powder For Solution For Infusion
looks like and contents of the pack
Each vial of Gemcitabine contains a white to
off-white powder supplied in a glass vial closed with
a rubber stopper and aluminium cap with a plastic
cover.
Gemcitabine 200 mg Powder for solution for
infusion are available in packs containing 1, 5 and 10
vials.
Gemcitabine 1 g Powder for solution for infusion are
available in packs containing 1, 5 and 10 vials.
Gemcitabine 2 g Powder for solution for infusion are
available in packs containing 1, 5 and 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder is TEVA UK Limited,
Eastbourne, BN22 9AG.
Manufacturer is: Pharmachemie B.V,
2031 GA Haarlem, The Netherlands.
This leaflet was last revised in January 2010.
PL 00289/1299-1301

01036-A

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 any of the side effects gets serious, or if you notice
any side effects not mentioned in this leaflet, please
tell your doctor.
01036-A
93.130.XXX.X

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