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Package leaflet: Information for the user

Gemcitabine 38 mg/ml Concentrate for Solution for Infusion

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 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.

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

Warnings and precautions

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.

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).

--------------------------

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:

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

Pregnancy, breast-feeding and fertility

The use of Gemcitabine should be avoided during pregnancy.

If you are a woman of child-bearing age, you should take steps to avoid becoming pregnant during treatment and for some time after treatment has stopped. If you become pregnant during treatment, you must inform your doctor immediately. You should also advise your doctor if you fall pregnant shortly after your treatment has stopped.

If you are already pregnant, or are thinking about becoming pregnant, you must tell your doctor, who will discuss with you the possible risks of taking gemcitabine during pregnancy.

You must not breast-feed during treatment with Gemcitabine. If you are currently breast-feeding, you must tell your doctor.

If you are a man, you should avoid fathering a child during, and up to 6 months after treatment with Gemcitabine. If you would like to father a child during this time, you should seek advice from your doctor or nurse. There is a risk that treatment with gemcitabine can lead to male infertility and you may wish to seek advice about sperm storage before the treatment starts.

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

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

Frequencies of the observed side effects are defined as:

•    very common:    affects more than 1 patient in 10

•    common:    affects    1    to    10 patients in    100

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

•    rare:    affects    1    to    10 patients in    10,000

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

•    not known:    the frequency of side-effects cannot

be estimated from the data available

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, or experience sweating or other signs of infection (since it is very common to have less white blood cells than normal).

•    Irregular heart rate (arrhythmia) (uncommon).

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.

Q770S5

434347

Component Specification

Item number:		Q77025
Request number:		AS3987
Country:		United Kingdom / Ireland
OI template:		88S120
Amalia version:		5
Mulgrave version:		4
Dimensions:	300 x 378 mm
Container(s):	Glass Vial
Supplier:	Howden Printing
Stock:	Primapharm 40gsm / Teropaque Thin Medical 40gsm
Folded dimensions:	31.5 x 150 mm
Printed both sides:	Yes
Perforated:	No
Pharma code:		194 (2111122)
Pharma code length		12.5 mm
Mulgrave 4 series no.:		434347
Colours
Black:		■

ft

Hospira

Requester

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 / 433732
Latest QP Release Date:
Signed:
Date:
Version 1 Technician: Date:	LB 25/Feb/14	Version 2 Technician: Date:	LB 28/Feb/14
Version 3 Technician: Date:	LB 08/May/14	Version 4 Technician: Date:	LB 12/May/14
Version 5 Technician: Date:	NC 19/May/14	Version 6 Technician: Date:	XX dd/mmm/yy
Version 7 Technician: Date:	XX dd/mmm/yy	Version 8 Technician: Date:	XX dd/mmm/yy
Version 9 Technician: Date:	XX dd/mmm/yy	Version 10 Technician: Date:	XX dd/mmm/yy

•    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 it is very common to have less haemoglobin than normal).

•    Bleeding from the gums, nose or mouth or any bleeding that will not stop, reddish or pinkish urine, unexpected bruising (since it is very common to have less platelets than normal).

•    Difficulty breathing. It is very common to have mild breathing difficulties, which quickly pass, soon after the gemcitabine infusion is given. However, uncommonly or rarely, there can be more severe lung problems.

•    Tiredness, looking pale, bruising easily and kidney problems which your doctor will do blood tests to investigate (uncommon).

•    Worsening skin rash with sloughing of skin rash and severe skin blistering together with mouth sores (very rare).

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 neutropaenia)

•    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 side effects

•    Stroke

•    Irregular heart beat (arrhythmia)

•    Heart failure

•    Interstitial pneumonitis (scarring of the air sacs of the lung).

•    Abnormal chest X-ray or scan (scarring of the lung)

•    Spasm of the airways (wheeze)

•    Serious liver damage, including liver failure

•    Kidney failure

Rare side effects

•    Heart attack (myocardial infarction)

•    Gangrene of fingers or toes

•    Low blood pressure

•    Fluid in the lungs

•    Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure)

•    Skin scaling, ulceration or blister formation

•    Injection site reactions

•    Radiation toxicity (scarring of the air sacs of the lung associated with radiation therapy)

•    Radiation recall (a skin rash like severe sunburn which can occur on skin that has previously been exposed to radiotherapy)

Very rare side effects

•    Increased platelet count

•    Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced blood supply)

•    Anaphylactic reaction (severe hypersensitivity/ allergic reaction)

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not mentioned in this leaflet.

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

•    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

•    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, Queensway,

Royal Leamington Spa, Warwickshire, CV31 3RW, UK.

The manufacturer is Hospira UK Limited, Queensway, Royal Leamington Spa,

Warwickshire, CV31 3RW, UK.

This leaflet was last revised in 05/2014

-3*--------------------------

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.

Q770S5

434347

Component Specification

Item number:		Q77025
Request number:		AS3987
Country:		United Kingdom / Ireland
OI template:		88S120
Amalia version:		5
Mulgrave version:		4
Dimensions:	300 x 378 mm
Container(s):	Glass Vial
Supplier:	Howden Printing
Stock:	Primapharm 40gsm / Teropaque Thin Medical 40gsm
Folded dimensions:	31.5 x 150 mm
Printed both sides:	Yes
Perforated:	No
Pharma code:		194 (2111122)
Pharma code length		12.5 mm
Mulgrave 4 series no.:		434347
Colours
Black:		■

ft

Hospira

Requester

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 / 433732
Latest QP Release Date:
Signed:
Date:
Version 1 Technician: Date:	LB 25/Feb/14	Version 2 Technician: Date:	LB 28/Feb/14
Version 3 Technician: Date:	LB 08/May/14	Version 4 Technician: Date:	LB 12/May/14
Version 5 Technician: Date:	NC 19/May/14	Version 6 Technician: Date:	XX dd/mmm/yy
Version 7 Technician: Date:	XX dd/mmm/yy	Version 8 Technician: Date:	XX dd/mmm/yy
Version 9 Technician: Date:	XX dd/mmm/yy	Version 10 Technician: Date:	XX dd/mmm/yy