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1. WHAT OXALIPLATIN IS AND WHAT IT IS USED FOR

Oxaliplatin is an anticancer drug and contains

platinum.

Oxaliplatin is used

• after complete surgical removal of the bowel tumour, to treat cancer of the large bowel (colon) that has spread beyond the bowel wall to nearby lymph glands but not to other tissues

• to treat cancer of the colon and rectum (back passage) that has spread beyond the bowel to other body tissues, such as the liver or lungs

Oxaliplatin is used in combination with other anticancer medicinal products called 5-fluorouracil and folinic acid, with or without prior surgery to remove the cancer.

2. BEFORE YOU ARE GIVEN OXALIPLATIN

You should not be given Oxaliplatin if you:

•    are allergic (hypersensitive) to oxaliplatin or any of the other ingredients of Oxaliplatin

•    are breast-feeding

•    already have a reduced number of blood cells

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

•    have severe kidney problems

Take special care with Oxaliplatin:

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

•    if you have moderate kidney problems

•    if you have any liver problems

•    if blood cell counts are too low after previous oxaliplatin treatment. Your doctor will perform tests to check that you have sufficient blood cells before treatment.

•    if you have symptoms of nerve damage such as weakness, numbness, disturbances of feeling or taste after previous oxaliplatin treatment. These effects are often triggered by exposure to cold.

If you notice such symptoms tell your doctor, especially if they are troublesome and/or last longer than 7 days. Your doctor will carry out neurological examinations, before and regularly during treatment, especially if you are given other drugs which may cause nerve damage. Symptoms of nerve damage can persist after the end of the treatment.

• if you also receive 5-fluorouracil, because the risk of diarrhoea, vomiting, sore mouth and blood abnormalities is increased.

Before and/or during treatment with oxaliplatin you may be given special medicines to prevent and/or treat nausea and vomiting.

You should take appropriate contraceptive measures during and after cessation of therapy continuing for 4 months after treatment for women and for 6 months after treatment 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 (please refer to ‘pregnancy and breast-feeding’).

Taking other medicines

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

Pregnancy and breast-feeding

It is not recommended that you become pregnant during treatment with oxaliplatin.

You should use appropriate contraception during treatment, and also for 4 months after treatment for women and also for 6 months after treatment for men.

If you get pregnant during your treatment, you must immediately inform your doctor.

You must not breast-feed while you are treated with oxaliplatin.

Oxaliplatin may have an anti-fertility effect, which could be irreversible. Male patients are therefore advised to seek advice on conservation of sperm prior to treatment.

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

Driving and using machines

It is unknown whether treatment with Oxaliplatin affects the ability to drive and use machines.

If you feel sleepy and/or dizzy following oxaliplatin infusion do not drive, operate potentially dangerous machinery, or engage in other activities that may be hazardous because of decreased alertness.

If you have vision problems following oxaliplatin infusion do not drive or operate potentially dangerous machinery.

3. HOW OXALIPLATIN IS GIVEN

Oxaliplatin should only be used in specialised departments of cancer treatment and should be administered under the supervision of an experienced specialist in cancer treatment.

Oxaliplatin is given by injection into a vein (an intravenous infusion) over a 2 to 6 hour period. The injection is first made by mixing the powder with a small amount of water or glucose solution. This is then diluted further in approximately 250 to 500 ml of glucose solution.

The needle must remain in the vein while the drug is being given. If the needle comes out or becomes loose, or the solution is going into the tissue outside the vein (you may feel discomfort or pain) -tell the doctor or nurse immediately.

Oxaliplatin will be made up in a special area before the doctor or nurse gives it to you.

The dose of Oxaliplatin is based on your body

surface area. This is calculated from your height and weight.

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 anticancer medicines.

The dose you receive will also depend on results of blood tests and whether you have previously experienced side effects with Oxaliplatin.

The duration of treatment will be determined by your doctor. Treatment for 6 months is recommended when oxaliplatin is used after surgery to remove your cancer.

Oxaliplatin is only to be given to adults.

If you use more Oxaliplatin than you should

Your doctor will ensure that the correct dose for your condition is given. In case of an overdose, you may experience increased side effects. Your doctor will monitor your blood counts carefully and will treat your symptoms.

If you forget to use Oxaliplatin

Oxaliplatin needs to be given on a fixed schedule. Be sure to keep all appointments. If you miss a dose, you should discuss this with your doctor. Your doctor will decide when you should be given your next dose of Oxaliplatin.

If you stop treatment with Oxaliplatin

Stopping your treatment with Oxaliplatin 5 mg/ml may stop the effect on tumour growth. Do not stop treatment with Oxaliplatin unless you have discussed this with your doctor.

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

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:

•    persistent or severe diarrhoea or vomiting

•    stomatitis/mucositis (sore lips or mouth ulcers)

•    swelling of the face, lips, mouth or throat

•    unexplained respiratory symptoms such as dry cough, difficulty in breathing or crackles

•    difficulty in swallowing

•    numbness or tingling in your fingers or toes

•    extreme tiredness

•    abnormal bruising or bleeding

•    signs of infection, such as sore throat and high temperature

•    sensation of discomfort close to or at the injection site during the infusion.

Very common side effects (in more than or equal 1 in 10 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.

•    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 usually subsides without the need for any treatment. Jaw spasm, muscle spasms and twitching, abnormal coordination and gait, balance disorders and a feeling of chest pressure have also been reported.

In addition, eye disorders such as drooping of upper eye lid (ptosis) or double vision (diplopia), voice loss (aphonia), impairment of voice (dysphonia), roughness of voice (hoarseness), abnormal tongue sensation or speech disturbance (dysarthria) as well as facial pain and eye pain have been observed.

Your doctor may decide to alter your treatment as a result.

•    Taste disorder

•    Headache

•    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 red blood cells, which can make the skin pale and cause weakness or breathlessness.

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

Your doctor will take blood to check that you have

sufficient blood cells before you start treatment and

before each subsequent course.

•    Nosebleeds

•    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.

•    Shortness of breath, coughing

•    Loss or lack of appetite

•    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

•    Weight gain

•    abnormal levels of glucose (sugar) in your blood

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

•    Abnormal levels of sodium blood levels e.g. low sodium levels which can cause tiredness and confusion, muscle twitching, fits or coma.

•    Abnormal blood tests which show changes of liver function (increase of alkaline phosphatase, bilirubin, LDH and hepatic enzymes).

Common side effects (in less than 1 in 10 but

more than or equal 1 in 100 patients) are:

•    Fever and/or infection due to a reduction in the number of white blood cells

•    Dehydration

•    Depression

•    Difficulty sleeping

•    Dizziness

•    Inflammation of nerves leading to muscle spasms, cramps, loss of certain reflexes

•    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

•    Runny nose

•    Nose and throat infection

•    Flushing

•    Chest pain, hiccups

•    Indigestion and heartburn

•    Loss of weight

•    Peeling 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

•    Abnormal blood tests which show changes of kidney function (e.g. increase of creatinine)

•    High blood pressure

Uncommon side effects (in less than 1 in 100 but

more than or equal 1 in 1,000 patients) are:

•    Nervousness

•    Hearing problems

•    Impaired or blocked bowel passage

•    Disturbance in the body‘s acid-base balance

Rare side effects (in less than 1 in 1,000 but

more than or equal 1 in 10,000 patients) are:

•    Reduction in blood platelets due to an allergic reaction

•    Reduction in red blood cells caused by cell destruction

•    Slurred speech

•    Reversible posterior leukoencephalopathy syndrome (a syndrome characterised by headache, dizziness, seizures, high blood pressure and visual disturbances)

•    Temporary deterioration in eyesight

•    Inflammation of the optic nerve

•    Deafness

•    Unexplained respiratory symptoms, difficulties in breathing, scarring of the lungs which causes shortness of breath

•    Bowel inflammation causing abdominal pain or diarrhoea, including severe bacterial infection (Clostridium difficile)

•    Inflammation of the pancreas, which causes severe pain in the abdomen and back

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

•    Liver disease

•    Kidney inflammation and kidney failure

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

•    Convulsions

•    Haemolytic uraemic syndrome

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.

Oxaliplatin should not come into contact with the eyes or skin. If there is any accidental spillage, tell the doctor or nurse immediately.

5. HOW TO STORE OXALIPLATIN

Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not freeze.

The reconstituted concentrated solution in the vial should be diluted immediately before use in glucose 5 % solution. The solution for infusion should then 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.

6. FURTHER INFORMATION

What Oxaliplatin contains

The active substance is oxaliplatin.

50 mg vial: Each vial contains 50 mg oxaliplatin for reconstitution in 10 ml of solvent.

100 mg vial: Each vial contains 100 mg oxaliplatin for reconstitution in 20 ml of solvent.

150 mg vial: Each vial contains 150 mg oxaliplatin for reconstitution in 30 ml of solvent.

One ml of the reconstituted concentrate solution contains 5 mg oxaliplatin.

The other ingredient is lactose monohydrate.

What Oxaliplatin looks like and contents of the pack

Each vial contains a white powder for solution for infusion containing 50 mg, 100 mg or 150 mg oxaliplatin with lactose monohydrate. The vials are supplied in cartons of one (1).

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder:

medac

Gesellschaft fur klinische Spezialpraparate mbH Fehlandtstr. 3

D-20354 Hamburg, Germany Tel.: +49 / 4103 / 8006-0 Fax: +49 / 4103 / 8006-100

Manufacturer:

medac

Gesellschaft fur klinische Spezialpraparate mbH Fehlandtstr. 3

D-20354 Hamburg, Germany Production Site:

Theaterstr. 6

D-22880 Wedel, Germany

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

Germany    Oxaliplan 5mg/ml Pulver zur

Herstellung einer Infusionslosung United Kingdom Oxaliplatin 5 mg/ml, powder for solution for infusion

This leaflet was last approved on 2012-02-22.

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

Instructions for use and handling

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

Instructions for Handling

The handling of this cytotoxic agent by nursing or medical personnel requires every precaution to guarantee the protection of the handler and his surroundings.

The preparation 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 integrity of the product, the protection of the environment and in particular the protection of the personnel handling the medicines, in accordance with the hospital policy. 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, containers and collection bags for waste.

Excreta and vomit must be handled with care.

Pregnant women must be warned to avoid handling cytotoxic agents.

Any broken container must be treated with the same precautions and considered as contaminated waste. Contaminated waste should be incinerated in suitably labelled rigid containers. See below section “Disposal”.

If oxaliplatin powder, reconstituted solution or infusion solution, should come into contact with skin, wash immediately and thoroughly with water.

If oxaliplatin powder, reconstituted solution or infusion solution, should come into contact with mucous membranes, wash immediately and thoroughly with water.

Special precautions for administration

-    DO NOT use injection material containing aluminium.

-    DO NOT administer undiluted.

-    Only glucose 5% infusion solution (50 mg/ml) is to be used as a diluent.

-    DO NOT reconstitute or dilute for infusion with sodium chloride or chloride containing solutions.

-    DO NOT mix with any other medication in the same infusion bag or administer simultaneously by the same infusion line.

-    DO NOT mix with alkaline drugs or solutions, in particular 5-fluorouracil, folinic acid preparations containing trometamol as an excipient and trometamol salts of other drugs. Alkaline drugs or solutions will adversely affect the stability of oxaliplatin.

Instruction for use with folinic acid (as calcium folinate or disodium folinate)

Oxaliplatin 85mg/m² IV infusion in 250 to 500 ml of 5% glucose solution (50 mg/ml) is given at the same time as folinic acid IV infusion in 5% glucose solution, over 2 to 6 hours, using a Y-line placed immediately before the site of infusion.

These two drugs should not be combined in the same infusion bag. Folinic acid must not contain trometamol as an excipient and must only be diluted using isotonic 5% glucose solution, never in alkaline solutions or sodium chloride or chloride containing solutions.

Instruction for use with 5-fluorouracil

Oxaliplatin should always be administered before fluoropyrimidines - i.e. 5-fluorouracil.

After oxaliplatin administration, flush the line and then administer 5-fluorouracil.

For additional information on drugs combined with oxaliplatin, see the corresponding manufacturer‘s summary of product characteristics.

Reconstitution of the powder

-    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.

-    For a vial of 150 mg: add 30 ml of solvent to obtain a concentration of 5 mg oxaliplatin/ml.

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

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

Dilution before infusion

Withdraw the required amount of reconstituted concentrate 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, concentration range for which the physico-chemical stability of oxaliplatin has been demonstrated.

Administer by IV infusion.

After dilution in 5% glucose, chemical and physical in-use stability has been demonstrated for 24 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 solution should be discarded.

NEVER use sodium chloride solution for either reconstitution or dilution.

The compatibility of oxaliplatin solution for infusion has been tested with representative, PVC-based, administration sets.

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 should precede that 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 with due regard to current laws related to the disposal of hazardous waste.

90400-VPGB

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