Vinorelbine Pfizer 10 mg/ml, Concentraat voor oplossing voor infusie

Vinorelbine Pfizer is used in the treatment of cancer and belongs to a group of medicines known as Vinca alkaloids.

Vinorelbine Pfizer is used to treat certain types of lung cancer and breast cancer.

Do not use Vinorelbine Pfizer if:

• you are allergic (hypersensitive) to vinorelbine, other vinca alkaloids or any of the other ingredients of this medicine (listed in section 6).
• you have or recently had a serious infection or severe decrease in white blood cells (neutropenia).
• you have severe decrease in blood platelets (thrombocytopenia).
• you are pregnant.
• you are breast-feeding (breast-feeding should be discontinued during treatment with vinorelbine).
• you are a woman of child-bearing potential not using an effective contraception.
• in combination with yellow fever vaccine.

This medicine is strictly for intravenous use only and should not be injected into the spine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Vinorelbine Pfizer.

• if you have had a heart disease involving lack of blood supply to the heart (ischaemic heart disease, angina).
• if you are having radiotherapy and the treatment field includes the liver
• if you present signs and symptoms suggestive of an infection (such as fever, chills, sore throat), let your doctor know immediately, so that he/she can carry out tests which may be needed
• if you have impaired liver function

VINO Gx 001 PIL 18MAR2013 EN.doc

1

• if you have had a vaccination or need a vaccination. Special care must be taken with live attenuated vaccines such as measles, mumps, rubella, polio. Varicella and tuberculosis (BCG).
• if you receive a cancer medicine named mitomycin C
• if you receive phenytoin, itraconazole, or any other medicine mentioned in the section “Other medicines and Vinorelbine Pfizer”.

Vinorelbine Pfizer must not get into contact with the eye as there is a risk of severe irritation and even corneal ulceration. If this occurs, immediately rinse the eye with normal saline solution and contact an ophthalmologist.

Men and women who are treated with Vinorelbine Pfizer should use an effective contraception during treatment and after treatment. Men and women should BOTH read the information below under the section

“pregnancy, breast-feeding and fertility”.

Before each administration of Vinorelbine Pfizer, a blood sample will be taken for analysis of its components. If the results of this analysis are not satisfactory, your treatment may be delayed and further checks made until these values return to normal.

Other medicines and Vinorelbine Pfizer

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription. This is especially important if you are using any of the following medicines:

• other medicines which can affect the bone marrow e.g. anti-cancer medicines.
• carbamazepine, phenytoin and phenobarbital (medicines for the treatment of epilepsy)
• antibiotics such as rifampicin, erythromycin, clarithromycin, telithromycin.
• St John’s Wort (Hypericum perforatum).
• ketoconazole and itraconazole (medicines for the treatment of fungal infections).
• anti-viral medicines to treat HIV-infections e.g. ritonavir (HIV protease inhibitors).
• nefazodone (medicine for the treatment of depression).
• ciclosporine and tacrolimus (medicines which decrease the activity of the immune system).
• verapamil, quinidine (medicines for the treatment of heart diseases).
• other medicines for the treatment of cancer e.g. mitomycin C, cisplatin. There is an increased risk of difficulty breathing if Vinorelbine Pfizer is used with mitomycin C.
• blood thinning medicines e.g. warfarin.
• vaccines (see “Warnings and precautions”).

Vinorelbine Pfizer with food, drink and alcohol

There are no known interactions with food and drink when using Vinorelbine Pfizer. However you should check with your doctor before consuming alcohol.

Pregnancy, breast-feeding and fertility

Vinorelbine Pfizer should not be given to pregnant women, because it can cause serious birth defects.

If you are a woman of child-bearing age, you must use an effective method of contraception during treatment and for up to 3 months after the end of treatment. If pregnancy occurs during treatment, you must immediately inform your doctor. If you are or become pregnant during treatment with Vinorelbine Pfizer, genetic counselling is recommended.

If you are a man, you should avoid fathering a child druing treatment with Vinorelbine Pfizer and for 6 months after treatment has stopped. There is also a risk that treatment with Vinorelbine Pfizer will lead to male infertility and you may wish to seek advice about sperm storage before treatment starts.

You must discontinue breast-feeding before treatment with Vinorelbine Pfizer starts as it is not known whether it might pass into breast milk thereby affecting the baby.

VINO Gx 001 PIL 18MAR2013 EN.doc

2

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No studies on the effects on the ability to drive have been performed but no negative influence is expected. However, caution is necessary in patient treated with vinorelbine considering some adverse effects of the drug. Do not drive or use machines if you feel drowsy, or if you experience any other effect which may impair your ability to drive or use machines.

Vinorelbine Pfizer will be givento you under the supervision of a doctor specialised in this type of treatment.

Dosage

Before and during treatment with Vinorelbine Pfizer, your doctor will check your blood cell count. The results of your blood test will decide when you receive your treatment. The dosage depends on the condition you are being treated for, your response to the therapy and other medications you are being given. The dose will depend on your height and weight and your general condition. Your doctor will calculate your body surface area and will determined the dose you should receive.

Your general condition and your response to the treatment will be closely observed before, during and after the vinorelbine treatment.

The usual dosage of vinorelbine is 25 – 30 mg/m2 of body surface area.

Dosage may be reduced if you have severe liver problems.

Frequency of administration

Vinorelbine Pfizer is scheduled once a week. The frequency will be determined by your doctor.

Duration of treatment

The duration of your treatment is decided by your doctor.

Method and route of administration

Vinorelbine Pfizer should be diluted before use with a solution of sodium chloride or glucose.

Vinorelbine Pfizer is given into a vein as an injection over 6 – 10 minutes or by infusion (drip) over 20 – 30 minutes.

Following your treatment, a solution of sodium chloride will be used to flush the vein.

Use in children and adolescents

The safety and efficacy in children has not been determined.

If you use more Vinorelbine Pfizer than you should

As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much, however, tell your doctor or pharmacist if you have any concerns.

If you stop using Vinorelbine Pfizer

Your doctor will decide when you should stop your treatment. However if you want to stop your treatment earlier, you should discuss other options with your doctor.

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

VINO Gx 001 PIL 18MAR2013 EN.doc

3

Whilst taking Vinorelbine Pfizer, if you develop any of the following symptoms you should contact your doctor immediately:

• chest pain (common, may affect up to 1 in 10 people)
• narrowing of the airways (bronchospasm), shortness of breath (uncommon, may affect up to 1 in 100 people)
• pain in the chest radiating into the neck and arm (angina pectoris), heart attack, lung disease (rare, may affect up to 1 in 1,000 people)
• blood poisoning (septicaemia) (very rare, may affect up to 1 in 10,000 people)
• acute systemic allergic reaction (anaphylaxis, anaphylatic shock) (not known, frequency cannot be estimated from the available data).

These are very serious side effects. You may need immediate medical attention.

If any of the following side effects occur, contact your doctor as soon as possible:

Very common (may affect more than 1 in 10 people):

• Low count of white blood cells, which may increase the risk of infection.
• Low count of red blood cells (anaemia), which may make you feel tired.
• Inflammation of the mouth.
• Nausea and vomiting.
• Constipation.
• Hair loss.
• Oedema, tenderness, pain and/or rash on the injection site.
• Abnormal results of liver function tests.
• Loss of deep tendon reflexes.
• Weakness of lower extremities.

Common (may affect up to 1 in 10 people):

• Joint, muscle and jaw pain.
• Increased creatinine values (change in renal function).
• Symptoms of infection e.g. fever, pain.
• Low count of blood platelets (risk of bleeding).
• Fatigue, fever, weakness.
• Pain at different locations including pain at the tumour site.
• Inflammation of the gullet.
• Diarrhoea.

Uncommon (may affect up to 1 in 100 people):

• Severe sepsis (blood infection).
• Numbness (paraesthesia).
• High blood pressure, low blood pressure, flushing and peripheral coldness.
• Difficulty in breathing

Rare (may affect up to 1 in 1,000 people):

• Inflammation of the pancreas.
• Paralytic intestinal blockage (ileus).
• Low levels of sodium in the blood.
• Injection site necrosis & other skin reactions.
• Collapse due to low blood pressure.
• Inflammation of the lungs

Very rare (may affect up to 1 in 10,000 people):

VINO Gx 001 PIL 18MAR2013 EN.doc

4

• Heart rhythm disorders.

Not known (frequency cannot be estimated from the available data):

• A reduction in a special type of white blood cells, which can result in fever (febrile neutropenia).
• Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH syndrome). Symptoms of this include increased weight, nausea (feeling sick), vomiting, muscle cramps, confusion and seizures (fits).
• Anorexia (decreased appetite).
• Skin reactions.
• Generalised infections in combination with a drop in white blood cells count (neutropenic sepsis)

As changes in the blood may occur, your doctor may order blood samples to be taken to control this (low count of white blood cells, anaemia and/or low count of blood platelets, influence on the liver or kidney function and the electrolyte balance in your body).

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

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 label and carton after EXP. The expiry date refers to the last day of that month.

Unopened vial: Store in a refrigerator (2 – 8oC). Keep the vial in the outer carton in order to protect from light.

After first opening: The content of the vial should be used immediately after the first opening of the vial.

After dilution: Following dilution with physiological sodium chloride solution or 50 mg/ml (5%) glucose solution, the chemical and physical stability of the reconstituted solution has been confirmed for 24 hours at 2 – 8oC and not above 25oC at concentrations from 0.5 mg/ml to 3.0 mg/ml.

From a microbiological point of view the product should be used immediately.

If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 – 8oC.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Vinorelbine Pfizer contains

• The active substance is vinorelbine (as tartrate).
• The other ingredient is water for injections.

1 ml concentrate for solution for infusion contains 10 mg of vinorelbine equivalent to 13.85 mg of vinorelbine tartrate.

Each 1 ml vial contains 10 mg of vinorelbine (as tartrate). Each 5 ml vial contains 50 mg of vinorelbine (as tartrate).

VINO Gx 001 PIL 18MAR2013 EN.doc

5

What Vinorelbine Pfizer looks like and contents of the pack

Vinorelbine Pfizer 10 mg/ml Concentrate for solution for infusion is a clear, colourless to slightly yellow solution.

1 ml vial: Colourless glass vial (type I) with a grey bromobutyl rubber stopper and sealed with a light blue flip-off aluminium seal.

5 ml vial: Colourless glass vial (type I) with a grey bromobutyl rubber stopper and sealed with a light blue flip-off aluminium seal.

Pack Sizes: 1 x 1 ml vial 1 x 5 ml vial

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Pfizer bv

Rivium Westlaan 142

2909 LD Capelle aan den IJssel Nederland

Manufacturer

Pfizer Service Company BVBA

Hoge Wei 10

1930 Zaventem

België

In het register ingeschreven onder

RVG 111711

This medicinal product is authorised in the Member States of the EEA under the following names:

Member State	Name of medicinal product
Netherlands	Vinorelbine Pfizer 10 mg/ml, Concentraat voor oplossing voor infusie
Belgium	Vinorelbine Pfizer 10 mg/ml Solution à diluer pour perfusion/Concentraat voor
	oplossing voor infusie/Konzentrat zur Herstellung einer Infusionslösung
Germany	Vinorelbin Pfizer 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Denmark	Vinorelbin Pfizer
Greece	Vinorelbine/Pfizer
France	VINORELBINE PFIZER 10 mg/ml, solution à diluer pour perfusion
Italy	VINORELBINA PFIZER
Luxembourg	Vinorelbine Pfizer 10 mg/ml Solution à diluer pour perfusion
Norway	Vinorelbin Pfizer
Portugal	Vinorrelbina Pfizer
United Kingdom	Vinorelbine 10 mg/ml Concentrate for Solution for Infusion

This leaflet was last revised in April 2013.

VINO Gx 001 PIL 18MAR2013 EN.doc

6

The following information is intended for healthcare professionals only:

Below is a summary of information to assist in the preparation, administration and handling of Vinorelbine Pfizer 10 mg/ml, Concentraat voor oplossing voor infusie

ANTINEOPLASTIC AGENT

Please refer to the Summary of Product Characteristics for detailed information regarding this product.

Vinorelbine Pfizer 10 mg/ml Concentrate for Solution for Infusion (Vinorelbine as tartrate).

Read this guide prior to the preparation and administration of Vinorelbine Pfizer.

Vinorelbine Pfizer is a concentration for solution for infusion. It is a clear, colourless to slightly yellow solution with a pH of 3.3 to 3.8 in clear glass vials containing 10 mg per 1 ml and 50 mg per 5 ml of vinorelbine (as tartrate). These are supplied in boxes containing a single vial only.

The preparation and administration of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medicines used, in conditions that guarantee the protection of the environment and, in particular, the protection of the personnel handling the medicines. It requires a preparation area reserved for this purpose. It is forbidden to smoke, eat or drink in this area.

Personnel must be provided with appropriate handling materials, notably long sleeved gowns, protection masks, caps, protective goggles, sterile single-use gloves, protective covers for the work area and collection bags for waste.

Syringes and infusion sets should be assembled carefully to avoid leakage (use of Luer lock fittings is recommended).

Spills and leakages must be wiped up, wearing protective gloves.

Precautions should be taken to avoid exposing staff during pregnancy.

All contact with eyes must be strictly avoided. Immediate washing of the eye with normal saline solution should be undertaken if any contact occurs. In case of irritation contact an ophthalmologist.

In case of skin contact, thoroughly wash the affected area with water.

On completion, any exposed surface should be thoroughly cleaned and hands and face washed.

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

For single use only, discard any unused contents.

There is no incompatibility between Vinorelbine Pfizer and glass vials, PVC bag, vinyl acetate bag or polypropylene syringe.

VINO Gx 001 PIL 18MAR2013 EN.doc

7

In case of poly-chemotherapy, Vinorelbine Pfizer should not be mixed with other agents.

The intra-thecal route is contraindicated.

Vinorelbine Pfizer must only be administered by the intravenous route as an infusion.

Vinorelbine Pfizer may be administered by slow bolus (6-10 minutes) after dilution in 20-50ml of normal saline or glucose 50mg/ml (5%) solution or by a short infusion (20-30 minutes) after dilution in 125ml of normal saline or glucose 50mg/ml (5%) solution. Administration should always be followed with at least 250 ml of an isotonic solution infusion to flush the vein.

Vinorelbine should only be given intravenously. It is very important to make sure that the cannula is accurately placed in the vein before the injection is commenced. If vinorelbine infiltrates the surrounding tissue during intravenous administration, a substantial irritation may occur. In this case, the injection should be stopped, the vein flushed with saline solution and the rest of the dose should be administered in another vein. In the event of extravasation, glucocorticoids could be given intravenously to reduce the risk of phlebitis.

Excreta and vomit must be handled with care.

Unopened vial: Store in a refrigerator (2 – 8oC). Keep the vial in the outer carton in order to protect from light. Do not use Vinorelbine Pfizer after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

After first opening: The content of the vial should be used immediately after the first opening of vial.

After dilution: Following dilution with physiological sodium chloride solution or 50 mg/ml (5%) glucose solution, the chemical and physical stability of the reconstituted solution has been confirmed for 24 hours at 2 – 8oC and not above 25oC at concentrations from 0.5 mg/ml to 3.0 mg/ml.

From a microbiological point of view the product should be used immediately.

If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 – 8oC.

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

VINO Gx 001 PIL 18MAR2013 EN.doc

8