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GEMCITABINE 38MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): GEMCITABINE

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

Package leaflet:
Information for the user

Pregnancy, breast-feeding and fertility
Pregnancy

Gemcitabine 38 mg/ml Concentrate for Solution for Infusion
Gemcitabine

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.

Breast-feeding

Read all of this leaflet carefully, before you start receiving this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please 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. See section 4.
What is in this leaflet:
1. What Gemcitabine Concentrate for Solution for Infusion is and what it is used for
2. What you need to know 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. Contents of the pack and other information

1. What Gemcitabine Concentrate for Solution for Infusion is and what it is used for
Gemcitabine Concentrate for Solution for Infusion (Gemcitabine) belongs to a group of
medicines called ‘cytotoxics’. These medicines kill dividing cells, including cancer cells.
Gemcitabine may be given on its own or in combination with other anti-cancer medicines
(e.g. cisplatin, paclitaxel, carboplatin), depending on the type of cancer you have.
Gemcitabine is used in the treatment of the following types of cancer:
• Non-small cell lung cancer (NSCLC), when given alone or together with cisplatin
• Pancreatic cancer
• Breast cancer, when given together with paclitaxel
• Ovarian cancer, when given together with carboplatin
• Bladder cancer, when given together with cisplatin

2. What you need to know before you are given Gemcitabine Concentrate for Solution
for Infusion
You should not be given Gemcitabine if:
• you are allergic to gemcitabine or any of the other ingredients of this medicine (listed in
section 6).
• you are breast-feeding

If you are breast-feeding, tell your doctor.
You must discontinue breast-feeding during gemcitabine treatment.

Fertility
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.

Driving and using machines
Gemcitabine may make you feel sleepy, particularly if you have consumed any alcohol. Do not
drive a car or operate machinery until you are sure that Gemcitabine treatment has not made
you feel sleepy.

Gemcitabine Concentrate for Solution for Infusion contains sodium
Gemcitabine Concentrate for Solution for Infusion contains up to 2.4 mg sodium (< 1 mmol) in
each 200 mg vial, up to 12.1 mg sodium (< 1 mmol) in each 1 g vial and up to 24.2 mg sodium
in each 2 g vial. To be taken into consideration by patients on a sodium controlled diet.

3. How Gemcitabine Concentrate for Solution for Infusion is given
Your initial dose of Gemcitabine will be calculated by your doctor and will depend on the type
of cancer you have and the surface area of your body in square meters (m2).
Your height and weight are measured to work out the surface area of your body. Your doctor
will use this information to work out the right dose for you. The usual dose of Gemcitabine is
between 1 g/m2 and 1.25 g/m2.
This dosage may be adjusted, or treatment may be delayed depending on your blood cell
counts, your general health and any side effects you experience.
How frequently you receive your gemcitabine infusion will depend on what type of cancer you
are being treated for.
You will always receive Gemcitabine as an infusion (a slow injection via a drip) into one of
your veins. The infusion will last approximately 30 minutes.
As Gemcitabine will be given to you under the supervision of a doctor, it is unlikely that you
will receive the wrong dose. However, if you have any concerns about the dose you receive
or if you have any further questions about the use of this medicine, please talk to your doctor,
nurse or pharmacist.

4. Possible side effects

Warnings and precautions

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

Before your first infusion, you will have samples of your blood taken to check how well your
kidneys and liver are working. Before each infusion, you will also have blood tests to check if
you have enough blood cells to receive Gemcitabine.

You must contact your doctor immediately if you notice any of the following:

Your doctor may decide to change your dose or delay treating you, based on your general
health or if your blood cell counts are too low.
Periodically, you will have samples of your blood taken to evaluate 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 recently been vaccinated
you develop breathing difficulties, or feel very weak and look very pale (this may be a sign
of kidney failure).

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.

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

Gemcitabine 38 mg/ml Concentrate for Solution for Infusion
Instructions for use, handling and disposal
Use
• Refer to the SPC to calculate the dose and the number of vials required.
• Dilution of the solution is required: An approved diluent for Gemcitabine Concentrate
for Solution for Infusion is sodium chloride 9 mg/ml (0.9%) solution for injection (without
preservative). Use the aseptic technique during any further dilution of the Gemcitabine
concentrate, prior to administration.
• Parenteral products should be visually inspected for particulate matter and discolouration prior
to administration. If particulate matter is observed, do not administer.
• After dilution, chemical and physical in-use stability has been demonstrated for:

• 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 38°C 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).

Diluent

Target Concentration

Storage Conditions

Time period

0.9% sodium
chloride solution for
infusion

0.1 mg/ml and 26 mg/ml

2-8°C in the absence
of light in non-PVC
(polyolefin) infusion
bags

84 days

0.9% sodium
chloride solution for
infusion

0.1 mg/ml and 26 mg/ml

2-8°C in the absence
of light in PVC
infusion bags

24 hours

0.9% sodium
chloride solution for
infusion

0.1 mg/ml and 26 mg/ml

25°C under normal
lighting conditions in
PVC infusion bags

24 hours

5% glucose solution
for infusion

0.1 mg/ml and 26 mg/ml

25°C under normal
lighting conditions in
PVC infusion bags

24 hours

Q77950
434471

Component Specification

Requester

Item number:

Q77950

Request number:

AS4501

Country:

United Kingdom /
Ireland / Malta

OI template:
Amalia version:
Mulgrave version:

88S120
5
4

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q77025 / 434347

Dimensions:
Container(s):
Supplier:
Stock:

300 x 378 mm
Glass Vial
Howden Printing
Primapharm 40gsm /
Teropaque Thin Medical 40gsm
Folded dimensions: 31.5 x 150 mm
Printed both sides: Yes
Perforated:
No
Pharma code:
Pharma code length:
Mulgrave 4 series no.:

Colours
Black:

71 (112111)
9 mm
434471

Signed:
Date:

Version 1
Technician: BE
Date: 21/Jul/14

Version 2
Technician: BE
Date: 21/Jul/14

Version 3
Technician: LB
Date: 25/Jul/14

Version 4
Technician: LB
Date: 23/Oct/14

Version 5
Technician: LB
Date: 23/Oct/14

Version 6
Technician: EM
Date: 23/Oct/14

Version 7
Technician: JH
Date: 24/Oct/14

Version 8
Technician: JH
Date: 08/Jan/16

Version 9
Technician: JH
Date: 11/Feb/16

Version 10
Technician: XX
Date: dd/mmm/yy

• 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).

• Low haemoglobin level (anaemia), low white blood cells and low platelet count will be
detected by a blood test.

Other side effects with Gemcitabine may include:

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

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)

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 or nurse. This includes any possible side effects
not mentioned in this leaflet. You can also report side effects directly via

Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

Common side effects (may affect up to 1 in 10 people)
• Poor appetite (anorexia)
• Headache
• Insomnia
• Sleepiness
• Cough
• Runny nose
• Constipation
• Diarrhoea
• Itching
• Sweating
• Muscle pain
• Back pain
• Fever
• Weakness
• Chills

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Gemcitabine Concentrate for Solution for Infusion
Gemcitabine will be stored and administered by healthcare professionals, who will follow this
guidance:
• 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.
• Store in a refrigerator (2°C-8°C).
• This medicine is for single use only; any unused solution should be discarded according to
local procedures.

6. Contents of the pack and other information
What Gemcitabine Concentrate for Solution for Infusion contains

Uncommon side effects (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

• The active ingredient in Gemcitabine Concentrate for Solution for Infusion is gemcitabine
(in the form of gemcitabine hydrochloride). The concentrated solution has a strength of
38 mg/ml, which means that every millilitre of the concentrate contains 38 milligrams of
gemcitabine (in the form of gemcitabine hydrochloride).
• The other ingredients in this medicine are Water for Injections, hydrochloric acid (for pH
adjustment) and sodium hydroxide (for pH adjustment).

What Gemcitabine Concentrate for Solution for Infusion looks like and contents of the
pack

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)

• Gemcitabine Concentrate for Solution for Infusion is a clear, colourless or light
straw-coloured solution
• Gemcitabine Concentrate for Solution for Infusion is packaged in glass vials
• Three sizes of glass vial are available, containing either
• 200 mg gemcitabine (as hydrochloride) in 5.3 ml solution
• 1 g gemcitabine (as hydrochloride) in 26.3 ml solution
• 2 g gemcitabine (as hydrochloride) in 52.6 ml solution
• Each vial is packed into a single outer carton

Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is Hospira UK Limited, Horizon, Honey Lane, Hurley,
Maidenhead, SL6 6RJ UK.
The manufacturer is Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead,
SL6 6RJ UK.
This leaflet was last revised in 03/2016.

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 to 8°C, unless dilution has taken place in
controlled and validated aseptic conditions.

Handling
• The normal safety precautions for cytostatic agents must be observed when preparing and
disposing of the infusion solution. Handling of the concentrate 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
• Gemcitabine Concentrate for Solution for Infusion is for single use only. Any unused product or
waste material should be disposed of in accordance with local requirements.
Q77950
434471

Component Specification

Requester

Item number:

Q77950

Request number:

AS4501

Country:

United Kingdom /
Ireland / Malta

OI template:
Amalia version:
Mulgrave version:

88S120
5
4

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q77025 / 434347

Dimensions:
Container(s):
Supplier:
Stock:

300 x 378 mm
Glass Vial
Howden Printing
Primapharm 40gsm /
Teropaque Thin Medical 40gsm
Folded dimensions: 31.5 x 150 mm
Printed both sides: Yes
Perforated:
No
Pharma code:
Pharma code length:
Mulgrave 4 series no.:

Colours
Black:

71 (112111)
9 mm
434471

Signed:
Date:

Version 1
Technician: BE
Date: 21/Jul/14

Version 2
Technician: BE
Date: 21/Jul/14

Version 3
Technician: LB
Date: 25/Jul/14

Version 4
Technician: LB
Date: 23/Oct/14

Version 5
Technician: LB
Date: 23/Oct/14

Version 6
Technician: EM
Date: 23/Oct/14

Version 7
Technician: JH
Date: 24/Oct/14

Version 8
Technician: JH
Date: 08/Jan/16

Version 9
Technician: JH
Date: 11/Feb/16

Version 10
Technician: XX
Date: dd/mmm/yy

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.

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