GEMCITABINE 38 MG/ML POWDER FOR SOLUTION FOR INFUSION

Active substance: GEMCITABINE HYDROCHLORIDE

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Gemcitabine 38 mg/ml Package Insert - UK (Bordon)
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.

2. BEFORE YOU ARE GIVEN GEMCITABINE
You should not be given Gemcitabine:

Read all of this leaflet carefully before you start receiving this medicine.
- Keep this leaflet. You may need to read it again.

- if you are allergic (hypersensitive) to gemcitabine or any of the other
ingredients of Gemcitabine.

If you have further questions on the use of this product ask your doctor or
pharmacist.

Pregnancy and breast-feeding

4. POSSIBLE SIDE EFFECTS

Very common side effects

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

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)

Frequencies of the observed side effects are defined as:

If you are breast-feeding, tell your doctor.

• very common: affects more than 1 user in 10

- If you have further questions, please ask your doctor, nurse or pharmacist.

- if you are breast-feeding.

You must discontinue breast-feeding during Gemcitabine treatment.

Take special care with Gemcitabine:

Driving and using machines

• uncommon: affects 1 to 10 users in 1,000

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.

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.

• very rare: affects less than 1 user in 10,000

In this leaflet:
1. What Gemcitabine is and what it is used for
3. How Gemcitabine is given

Periodically you will have samples of your blood taken to evaluate your kidney
and liver function.

4. Possible side effects

Please tell your doctor if:

5. How to store Gemcitabine

• you have, or have previously had liver disease, heart disease or vascular
disease.

2. Before you are given Gemcitabine

6. Further information

• you have recently had, or are going to have radiotherapy.

1. WHAT GEMCITABINE IS AND WHAT IT IS USED FOR

• you have been vaccinated recently

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

• you develop breathing difficulties or feel very weak and are very pale (may
be a sign of kidney failure).

Gemcitabine may be given alone or in combination with other anti-cancer
medicines, depending on the type of cancer.

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.

Gemcitabine is used in the treatment of the following types of cancer:
• non-small cell lung cancer (NSCLC), alone or together with cisplatin.

Side effects with Gemcitabine may include:

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.

- 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.

• 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)

• common: affects 1 to 10 users in 100
• rare: affects 1 to 10 users in 10,000

Important information about some of the ingredients of Gemcitabine

• not known: frequency can't be estimated from the available data

Gemcitabine contains 3.5 mg (< 1 mmol) of sodium in each 200 mg vial, and
17.5 mg (< 1 mmol) sodium in each 1000 mg vial and 35 mg (1.5 mmol)
sodium in each 2000 mg vial. To be taken into consideration by patients on a
controlled sodium diet.

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

3. HOW GEMCITABINE IS GIVEN

• Irregular heart rate (arrhythmia) (frequency not known).

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.

• 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).

How frequently you receive your Gemcitabine infusion depends on the type of
cancer that you are being treated 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).

A hospital pharmacist or doctor will have dissolved the Gemcitabine powder
before it is given to you.

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Date: 23 September 2013

Version: 04

Font: Arial - 8 Pt.

Reason for the Artwork* : Change in Text (Storage condition)

Dimension

Artwork No.

Supersedes No. : 7220131163 / 220270

Prepared By
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Form No.: SOP/PDD/003-03 Rev. 05
D:\Europe\Gemita\2013\UK\Sept 2013\Gemcitabine PIL - GBR.cdr

: 592 x 132 mm

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* Attached separate sheet if required

Common side effects
Fever accompanied by low white blood cell count (febrile neutropaenia)
Anorexia (poor appetite)
Headache
Insomnia
Sleepiness
Cough
Runny nose
Constipation
Diarrhoea

V001/UK

• ovarian cancer, together with carboplatin.
• bladder cancer, together with cisplatin.

You will always receive Gemcitabine by infusion into one of your veins. The
infusion will last approximately 30 minutes.

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Gemcitabine 38 mg/ml powder for solution for infusion
Gemcitabine

• pancreatic cancer.
• breast cancer, together with paclitaxel.

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PACKAGE LEAFLET: INFORMATION FOR THE
USER

Circulation No. 2
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 the 200 mg vials with 5 ml of 9 mg/ml
(0.9 %) sterile sodium chloride solution for injection,
without preservative, the 1000 mg vial with 25 ml sterile
sodium chloride solution for injection, without
preservative and the 2000 mg vial with 50 ml sterile
sodium chloride solution for injection, without
preservative. Shake to dissolve. The total volume after
reconstitution is 5.26 ml (200 mg vial), 26.3 ml (1000 mg
vial) or 52.6 ml (2000 mg 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 strawcoloured.
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. From a microbiological point of view,
the product should be used immediately. If not used
immediately, in-use storage times and conditions prior

Gemcitabine 38 mg/ml Package Insert - UK (Bordon)

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 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

This medicine is for single use only; any unused solution should be discarded
under the local requirements.
6. FURTHER INFORMATION
What Gemcitabine contains
The active substance is gemcitabine. Each vial contains 200, 1000 or
2000 mg of gemcitabine (as gemcitabine hydrochloride).
The other ingredients are mannitol (E421), sodium acetate trihydrate,
hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH
adjustment).
What Gemcitabine looks like and contents of the pack
Gemcitabine is a white to off-white powder, for solution for infusion in a vial.
Each vial contains 200, 1000 or 2000 mg of gemcitabine. Each pack of
Gemcitabine contains 1 vial.
Marketing Authorisation Holder and Manufacturer
Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon
Hampshire, GU35 0NF, United Kingdom

5. HOW TO STORE GEMCITABINE
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 carton and label after .
The expiry date refers to the last day of that month
Store below 25°C.
Reconstituted solution: The product should be used immediately. When
prepared as directed, chemical and physical in-use stability of reconstituted
solutions of gemcitabine were demonstrated for 24 hours at 25°C. Further
dilution by a healthcare provider may be done. Solutions of reconstituted
gemcitabine should not be refrigerated, as crystallisation may occur.
Diluted solution: The chemical and physical in-use stability of diluted solutions
of gemcitabine was demonstrated for 30 days at 25°C.
Do not use Gemcitabine powder for solution for infusion if you notice any
particulate matter and / or discolouration.

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This medicinal product is authorised in the Member States of the EEA
under the following names:
Belgium:
Gemcitabine Fresenius Kabi 38 mg/ml poeder voor
oplossing voor infusie
Cyprus:
γεμσιταβίνης Kabi 38 mg/ml κόνις για διάλυμα προς έγχυση
Spain:
Gemcitabina Kabi 200 mg polvo para solución para
perfusion EFG
Gemcitabina Kabi 1000 mg polvo para solución para
perfusion EFG
Gemcitabina Kabi 2000 mg polvo para solución para
perfusion

Finland:

Gemcitabin Fresenius Kabi 200 mg infuusiokuiva-aine,
liuosta varten
Gemcitabin Fresenius Kabi 1000 mg infuusiokuiva-aine,
liuosta varten
Gemcitabin Fresenius Kabi 2000 mg infuusiokuiva-aine,
liuosta varten
France:
Gemcitabine Kabi 38 mg/ml, poudre pour solution pour
perfusion
Hungary:
Gemcitabin Kabi 38 mg/ml por oldatos infúzióhoz
Ireland:
Gemcitabine 200 mg powder for solution for infusion
Gemcitabine 1 g powder for solution for infusion
Gemcitabine 2 g powder for solution for infusion
Italy:
Gemcitabina Kabi 38 mg/ml polvere per soluzione per
infusione
Luxemburg:
Gemcitabin Kabi 38 mg/ml Pulver zur Herstellung einer
Infusionslösung
Sweden:
Gemcitabin Fresenius Kabi 200 mg pulver till
infusionsvätska, lösning
Gemcitabin Fresenius Kabi 1000 mg pulver till
infusionsvätska, lösning
Gemcitabin Fresenius Kabi 2000 mg pulver till
infusionsvätska, lösning
Slovenia:
Gemcitabin Kabi 38 mg/ml prašek za raztopino za
infundiranje
United Kingdom: Gemcitabine 38 mg/ml powder for solution for infusion
This leaflet was last approved in Sep 2013.

Date: 23 September 2013

Version: 04

Font: Arial - 8 Pt.

Reason for the Artwork* : Change in Text (Storage condition)

Dimension

Artwork No.

Supersedes No. : 7220131163 / 220270

Prepared By
PDD

: 7220131914 / 220666
Checked By
PDD

Production

QA

Approved
Online

Form No.: SOP/PDD/003-03 Rev. 05
D:\Europe\Gemita\2013\UK\Sept 2013\Gemcitabine PIL - GBR.cdr

: 592 x 132 mm

Approved By
PDD

V001/UK

Uncommon side effects
Interstitial pneumonitis (scarring of the air sacs of the lung)
Spasm of the airways (wheeze)
Abnormal chest X ray/scan (scarring of 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 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.

7220131914

Pain, redness, swelling or sores in the mouth
Itching
Sweating
Muscle pain
Back pain
Fever
Weakness
Chills

220666

to use are the responsibility of the user and would
normally not be longer than 24 hours at room
temperature, unless reconstitution has taken place in
controlled and validated aseptic conditions.
6. Chemical and physical in-use stability for the diluted
injection has been demonstrated for 30 days at 25°C.
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 room temperature, unless
dilution has taken place in controlled and validated
aseptic conditions.
7. 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.

Circulation No. 2

CONFIDENTIAL

I&D RA

QM

Country RA

NA

* Attached separate sheet if required

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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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