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1. Oxaliplatin Hospira 5 Mg/Ml Powder For Solution For Infusion
2. Oxaliplatin Hospira 5 Mg/Ml Powder For Solution For Infusion

PACKAGE LEAFLET: INFORMATION FOR THE USER

Oxaliplatin Hospira 5 mg/ml powder for solution for infusion

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor.

•    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 or pharmacist.

In this leaflet:

1.    What Oxaliplatin Hospira is and what it is used for

2.    Before you use Oxaliplatin Hospira

3.    How to use Oxaliplatin Hospira

4.    Possible side effects

5.    How to store Oxaliplatin Hospira

6.    Further information

1. WHAT OXALIPLATIN HOSPIRA IS AND WHAT IT IS USED FOR

Oxaliplatin is an anti-cancer drug and is used to treat metastatic (advanced) cancer of the colon (large bowel) or rectum (back passage), or as additional treatment following surgery to remove a tumour (growth) in the colon.

It is used in combination with another anti-cancer medicine called 5-fluorouracil (5-FU) and folinic acid (FA).

2. BEFORE YOU USE OXALIPLATIN HOSPIRA

Do not use Oxaliplatin Hospira:

•    if you are hypersensitive (allergic) to oxaliplatin or any of the other ingredients of Oxaliplatin Hospira, lactose monohydrate,

•    if you are breast-feeding,

•    if you already have a reduced number of blood cells,

•    if you already have tingling and numbness in the fingers and/or toes, and have difficulty performing delicate tasks, such as buttoning clothes,

•    if you have a severe kidney problem.

Take special care with Oxaliplatin Hospira:

•    if you have mild or moderate kidney problems,

•    if you have ever suffered an allergic reaction to other platinum-containing medicines such as carboplatin or cisplatin.

Taking other medicines

Please tell your doctor if you are taking or have recently taken, any other medicines, including medicines obtained without a prescription.

Pregnancy

Ask your doctor or pharmacist for advice before taking any medicine.

You must not become pregnant during treatment with oxaliplatin and must use an effective method of contraception. If pregnancy occurs during your treatment, you must immediately inform your doctor. You should take appropriate contraceptive measures during and after cessation of therapy during 4 months for women and 6 months for men.

Oxaliplatin may have an anti-fertility effect, which could be irreversible.

Male patients are therefore advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment.

Breast-feeding

Do not use Oxaliplatin Hospira whilst breast-feeding.

Driving and using machines

Since oxaliplatin treatment may result in an increase risk of dizziness, nausea and vomiting, and other neurological symptoms that affect gait and balance, it may lead to a minor or moderate influence on your ability to drive and use machines. This medicine may cause temporary loss of vision. You should not drive or operate machinery if you suffer from this side effect.

3. HOW OXALIPLATIN HOSPIRA IS USED

For adults only.

Oxaliplatin Hospira will be prescribed by a specialist in cancer treatment. The dose depends on your body surface area (calculated by m²) and your state of health. It also depends on other medicines that are used in your cancer treatment. The duration of your treatment will be determined by your doctor.

Oxaliplatin Hospira is given by injection into a vein (an intravenous infusion) over a 2-6 hour period.

The usual dose for adults, including the elderly, is 85 mg/m² of body surface area once every 2 weeks, before the infusion of the other anti-cancer medicines.

The dose you receive and duration of administration will depend on results of blood tests and whether you have previously experienced side effects with oxaliplatin. Your next dose may need to be postponed dependant on your blood cell levels or the severity of any mouth soreness. Your doctor will test your nervous system prior to each administration and at certain times afterwards.

If you are given more Oxaliplatin Hospira than you should:

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, oxaliplatin can cause side effects, although not

everybody gets them. If you experience any side effect it is important that

you inform your doctor before your next treatment.

Tell your doctor immediately if you notice any of the following:

•    Abnormal bruising, bleeding or signs of infection such as a sore throat and high temperature

•    Persistent or severe diarrhoea or vomiting

•    Stomatitis/mucositis (sore lips or mouth ulcers)

•    Unexplained respiratory symptoms such as a non-productive cough, difficulty in breathing or crackles

•    Symptoms of angioedema - swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing)

•    A group of symptoms such as seizures, headache, high blood pressure, confusion and loss of vision. These symptoms could be caused by reversible posterior leukoencephalopathy syndrome (a rare disorder of the nervous system).

The most common side effects (in more than 10% of patients) are:

•    A disorder of the nerves which can cause weakness, tingling or numbness in the fingers, toes, around the mouth or in the throat that may sometimes occur in association with cramps. This is often triggered by exposure to cold e.g. opening a refrigerator or holding a cold drink. You may also have difficulty in performing delicate tasks, such as buttoning clothes. Although in the majority of cases these symptoms resolve completely there is a possibility of persistent symptoms after the end of the treatment

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

INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL

As with other potentially toxic compounds, caution should be exercised when handling and preparing oxaliplatin solutions.

Instructions for Handling

Special precautions for administration

•    DO NOT use injection equipment containing aluminium

•    DO NOT administer undiluted

•    Only glucose 5% (50 mg/ml) infusion solution is to be used as a diluent. DO NOT reconstitute or dilute for infusion with saline sodium chloride or chloride containing solutions

•    DO NOT mix with any other medicinal products in the same infusion bag or administer simultaneously by the same infusion line

•    DO NOT mix with alkaline medicinal products or solutions, in particular

5 fluorouracil, folinic acid preparations containing trometamol as an excipient and trometamol salts of other active substances. Alkaline medicinal products or solutions will adversely affect the stability of oxaliplatin Instruction for use with folinic acid (FA) (as calcium folinate or disodium folinate)

Oxaliplatin 85 mg/m² intravenous infusion in 250 to 500 ml of glucose 5%

(50 mg/ml) solution is given at the same time as folinic acid (FA) intravenous infusion in glucose 5% (50 mg/ml) solution, over 2 to 6 hours, using a Y-line placed immediately before the site of infusion. These two medicinal products should not be combined in the same infusion bag. Folinic acid (FA) must not contain trometamol as an excipient and must only be diluted using isotonic glucose 5% (50 mg/ml) solution, never in alkaline solutions or sodium chloride or chloride containing solutions.

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•    Some people have experienced a tingling shock-like sensation passing down the arms or trunk when the neck is flexed

•    Oxaliplatin can sometimes cause an unpleasant sensation in the throat, in particular when swallowing, and give the sensation of shortness of breath. This sensation, if it happens, usually occurs during or within hours of the infusion and may be triggered by exposure to the cold. Although unpleasant, it will not last long and goes away without the need for any treatment. Your doctor may decide to alter your treatment as a result

•    Signs of infection such as a sore throat and high temperature

•    Reduction in the number of white blood cells, which make infections more likely

• Reduction in blood platelets, which increases risk of bleeding or bruising

• Reduction in red blood cells, which can make the skin pale and cause weakness or breathlessness. Your doctor will take blood to check that you have sufficient blood cells before you start treatment and before each subsequent course

•    Allergic reactions - 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) and you may feel you are going to faint

•    Loss or lack of appetite

•    Too high levels of glucose (sugar) in your blood which may cause a great thirst, dry mouth or a need to urinate more often

•    Low blood levels of potassium which can cause abnormal heart rhythm

•    High blood levels of sodium which can cause tiredness, weakness, irritability, fits or coma

•    Taste disorder

•    Headache

•    Nosebleeds

•    Shortness of breath

•    Coughing

•    Nausea (feeling sick), vomiting (being sick) - medication to prevent sickness is usually given to you by your doctor before treatment and may be continued after treatment

•    Diarrhoea, if you suffer from persistent or severe diarrhoea or vomiting contact your doctor immediately for advice

•    Sore mouth or lips, mouth ulcers

•    Stomach pain, constipation

•    Skin disorder

•    Hair loss

•    Back pain

•    Tiredness, loss of strength/weakness, body pain

•    Pain or redness close to or at the injection site during the infusion

•    Fever

•    Blood tests which show changes in the way the liver is working

•    Weight increase

Common side effects (in 1 to 10% of patients) are:

•    Runny nose

•    Chest infection

•    Dehydration

•    Excessive excitability or irritability

•    Dizziness

•    Swelling of the nerves to your muscles

•    Neck stiffness, intolerance/dislike of bright light and headache

•    Conjunctivitis, visual problems

•    Abnormal bleeding, blood in the urine and stools

•    Blood clot, usually in a leg, which causes pain swelling or redness

•    Blood clot in the lungs which causes chest pain and breathlessness

•    Flushing

•    High blood pressure

•    Chest pain, hiccups

•    Indigestion and heartburn

•    Flaking skin, skin rash, increased sweating and nail disorder

•    Joint pain and bone pain

•    Pain on passing urine or a change in frequency when passing urine

•    Blood tests which show changes in the way the kidney is working

•    Loss of weight

•    Depression

•    Difficulty sleeping

Uncommon side effects (in 0.1% to 1% of patients) are:

•    Hearing problems

•    Blockage or swelling of the bowel

•    Feeling anxious or nervous

•    Blood tests which show an increase in acidity

Rare side effects (in 0.01% to 0.1% of patients) are:

•    Slurred speech

•    Deafness

•    Unexplained respiratory symptoms, difficulties in breathing, scarring of the lungs which causes shortness of breath. This can sometimes be fatal

•    Inflammation which causes abdominal pain or diarrhoea

•    Reversible and temporary vision loss

•    Severe abdominal pain, feeling sick or being sick (pancreatitis)

Very rare effects (less than 1 in 10,000 patients) are:

•    Liver disease that your doctor will monitor you for

•    Changes in kidney function

Frequency unknown

• Convulsion

If any of the side effects get serious or, if you notice any side effects not mentioned in this leaflet, please inform your doctor.

5. HOW TO STORE OXALIPLATIN HOSPIRA

Keep out of the reach and sight of children. No special precautions for storage for the unopened vial. Do not use after the expiry date, the last day of the month, which is stated on the carton and label.

The reconstituted solution should be diluted immediately in glucose 5%

(50 mg/ml) solution to give a concentration between not less than 0.2 mg/ml and 0.7 mg/ml. Once diluted the infusion preparation should be used immediately. Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 8°C. If not used immediately, in-use storage times and conditions are the responsibility of the user and would not normally be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6. FURTHER INFORMATION

What Oxaliplatin Hospira contains

•    The active substance is oxaliplatin

•    The other ingredient is lactose monohydrate

Oxaliplatin Hospira is in the form of a powder for solution for infusion. The medicine comes in glass containers called vials containing 50 mg or 100 mg of oxaliplatin. One ml of reconstituted solution contains oxaliplatin 5 mg. The vials are wrapped in a protective plastic to reduce the risk of spillage if the vials break - these are referred to as ONCO-TAIN®. The vials are available in single packs.

A solution is made by mixing the powder with water for injections or 5% glucose. This solution is then diluted further in 5% glucose and can be given as an infusion via a drip.

The Marketing Authorisation Holder and company responsible for batch release in the EU is Hospira UK Limited, Warwickshire, CV31 3RW, UK.

This package leaflet has been approved in

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Instruction for use with 5 fluorouracil (5 FU)

Oxaliplatin should always be administered before fluoropyrimidines - i.e.

5 fluorouracil (5 FU).

After oxaliplatin administration, flush the line and then administer 5 fluorouracil (5 FU).

For additional information on medicinal products combined with oxaliplatin, see the corresponding manufacturer's summary of product characteristics.

•    USE ONLY the recommended solvents (see below).

•    Any reconstituted solution that shows evidence of precipitation should not be used and should be destroyed with due regard to legal requirements for disposal of hazardous waste (see below).

Reconstitution of the solution

•    Water for Injections or 5% glucose solution should be used to reconstitute the solution.

•    For a vial of 50 mg: add 10 ml of solvent to obtain a concentration of 5 mg oxaliplatin/ml.

•    For a vial of 100 mg: add 20 ml of solvent to obtain a concentration of 5 mg oxaliplatin/ml.

From a microbiological and chemical point of view, the reconstituted solution should be diluted immediately with 5% glucose solution.

Inspect visually prior to use. Only clear solutions without particles should be used.

The medicinal product is for single use only. Any unused infusion solution should be discarded.

Dilution for intravenous infusion

Withdraw the required amount of reconstituted solution from the vial(s) and then dilute with 250 ml to 500 ml of a 5% glucose solution to give an oxaliplatin concentration between not less than 0.2 mg/ml and 0.7 mg/ml. The concentration range over which the physico-chemical stability of oxaliplatin has been demonstrated is 0.2 mg/ml to 1.3 mg/ml.

Administer by IV infusion.

Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 8°C.

From a microbiological point of view, this infusion preparation 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°C to 8°C unless dilution has taken place in controlled and validated aseptic conditions.

Inspect visually prior to use. Only clear solutions without particles should be used.

The medicinal product is for single use only. Any unused infusion solution should be discarded.

NEVER use sodium chloride or chloride containing solutions for either reconstitution or dilution.

Infusion

The administration of oxaliplatin does not require prehydration.

Oxaliplatin diluted in 250 to 500 ml of a 5% glucose solution to give a concentration not less than 0.2 mg/ml must be infused either by peripheral vein or central venous line over 2 to 6 hours. When oxaliplatin is administered with 5-fluorouracil, the oxaliplatin infusion must precede the administration of 5-fluorouracil.

Disposal

Remnants of the medicinal product as well as all materials that have been used for reconstitution, for dilution and administration must be destroyed according to hospital standard procedures applicable to cytotoxic agents in accordance with local requirements related to the disposal of hazardous waste.    Q71949

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