Informations for option: Oxaliplatin Medac 5 Mg/Ml Concentrate For Solution For Infusion, show other option

Select option:

1. Oxaliplatin Medac 5 Mg/Ml Concentrate For Solution For Infusion
2. Oxaliplatin Medac 5 Mg/Ml Concentrate For Solution For Infusion

Package leaflet: Information for the user

Oxaliplatin is an antineoplastic or anticancer medicine and contains platinum.

2. What you need to know before you use Oxaliplatin

Do not use Oxaliplatin

•    if you are allergic to oxaliplatin or any of the other ingredients of this medicine (listed in section 6).

•    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 severe kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before using Oxaliplatin.

Take special care with Oxaliplatin

•    if you have moderate or mild kidney problems.

•    if you have ever suffered an allergic reaction to platinum-containing medicines (e.g. carboplatin or cisplatin). Allergic reactions can occur during any oxaliplatin infusion.

•    if you have any liver problems.

•    if you are pregnant or planning a pregnancy.

It is very important that you discuss this with your doctor before you receive any treatment.

Oxaliplatin can cause infertility, which may be irreversible. Male patients are therefore advised not to father children during and up to 6 months after the treatment and to seek advice on conservation of sperm prior to treatment. Male patients should take appropriate contraceptive measures during and after therapy continuing for 6 months.

Other medicines and Oxaliplatin

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

Pregnancy, breast-feeding and fertility

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.

It is not recommended that you become pregnant during treatment with oxaliplatin and you must use an effective method of contraception. Female patients should take appropriate contraceptive measures during and after therapy continuing for 4 months.

If you are pregnant or planning a pregnancy it is very important that you discuss this with your doctor before you receive any treatment.

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

You must not breast-feed while on treatment with Oxaliplatin.

Driving and using machines

Treatment with Oxaliplatin involves an increased risk of dizziness, nausea and vomiting, and other neurological symptoms that affect walking and balance.

If this happens you should not drive or operate machinery. If you have vision problems while taking this medicine, do not drive, operate machinery or engage in potentially dangerous activities.

3. How to use Oxaliplatin

Oxaliplatin may only be administered to adults. For single use only.

Dose

The dose depends on the body surface area (calculated in m^{1 2}), which is determined from your height and weight.

In addition the dose depends on the results of blood tests and whether you have previously experienced side effects with oxaliplatin.

The usual dose for adults, including elderly patients, is 85 mg/m2 body area.

Route of administration

Oxaliplatin will be prescribed to you by a doctor with experience in the treatment of cancer.

You will be treated by a healthcare professional, who will have made up the required dose of Oxaliplatin.

Oxaliplatin is given by slow injection into a vein (intravenous infusion) over a 2 to 6 hour period.

Oxaliplatin will be given to you at the same time as folinic acid and before the infusion of 5-fluorouracil.

You should usually receive your infusion once every 2 weeks.

Duration of use

The duration of therapy will be decided by your doctor. Your treatment will last a maximum of 6 months when used after complete removal of your tumour.

If you use more Oxaliplatin than you should

As this medicine is administered by a healthcare professional, it is highly unlikely that you have received too much or too little. However, do inform your doctor if you have any concerns.

In case of overdose, you may experience increased side effects. Your doctor will give you appropriate treatment for these side effects.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects,

although not everybody gets them.

Please inform your doctor immediately if you notice

any of the following side effects:

•    Abnormal occurrence of bruises, bleeding, or signs of infection such as a sore throat or a high body temperature.

•    Persistent or severe diarrhoea or vomiting.

•    Presence of blood or dark brown coffee-coloured particles in your vomit.

•    Sore lips or mouth ulcers (stomatitis/mucositis).

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

•    Swelling of the hands, feet, ankles, face, lips, mouth or the pharynx (which may give rise to difficulties in swallowing or breathing) - symptoms of angiooedema.

•    A group of symptoms such as headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder).

Very common side effects

(may affect more than 1 in 10 people)

•    Oxaliplatin can affect the nerves (peripheral neuropathy). You may feel a tingling and/or numbness in the fingers, toes, around the mouth, or in the throat, which may sometimes occur in association with cramps. These symptoms are often provoked by exposure to cold,

for example by opening the refrigerator or holding a cold drink. You may also experience difficulties with the performance of fine motor movements such as buttoning up clothing. Even though in the majority of cases these symptoms disappear completely, there is a possibility that they will persist 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 may sometimes cause an unpleasant sensation in the throat, which is especially noticeable on swallowing and which gives an impression of shortness of breath. If this occurs, it usually does so during or within a few hours after the end of the infusion, and

is triggered by exposure to cold. This unpleasant phenomenon does not last long and regresses without needing any treatment. Your doctor will decide on any adjustment of treatment.

•    Signs of infection, such as sore throat and high body temperature.

•    Oxaliplatin causes temporary reduction in the number of blood cells. The reduction of red cells may cause anaemia (a reduction of red cells), abnormal bleeding or bruising (due to a reduction in platelets). The reduction in white blood cells may make you prone to infections. Your doctor will take blood to check that you have sufficient blood cells before you start treatment and before each subsequent course.

•    An increased risk of bleeding and occurrence of extravasation (leaking of fluid into the surrounding tissue).

•    Skin pallor, weakness, and breathlessness.

•    Allergic reactions - red itching rash, swelling of the hands, feet, ankles, face, lips, mouth, and the throat (which can lead to difficulties in breathing and swallowing), which may produce a sensation of incipient loss of consciousness.

•    Complete or partial loss of appetite.

•    High levels of blood glucose (blood sugar), which can cause a strong thirst, a dry mouth, or an increased frequency of passing urine.

•    Irregular heartbeat (caused by a low level of potassium in blood).

•    Tiredness, disorientation, muscle twitching, cramp attacks, and profound coma (caused by a low level of sodium in blood).

•    Disturbances of the sense of taste.

•    Headaches.

•    Nosebleeds.

•    Shortness of breath.

•    Cough.

•    Nausea and vomiting - to avoid these effects you will usually be given medication by your doctor before, and if necessary, also after the treatment.

•    Diarrhoea. Contact you doctor without delay if the diarrhoea or vomiting is persistent or severe.

•    Swelling of the nerves to your muscles, neck stiffness, abnormal tongue sensation possibly altering speech, stomatitis/mucositis (sore lips or mouth ulcers).

•    Abdominal pains, constipation.

•    Skin disorders.

•    Loss of hair.

•    Backache.

•    Tiredness, loss of strength, sensation of weakness, pains in the whole body.

•    Pain or skin reddening both around and directly at the injection site during the infusion.

•    Fever, rigors (tremors).

•    Alteration in blood tests including those relating to abnormalities in liver function.

•    Weight gain.

Common side effects (may affect up to 1 in 10 people)

•    Infection due to a reduction in white blood cells.

•    Inflammation of nasal mucous membranes.

•    Respiratory tract infection.

•    Loss of fluid with tissue dehydration.

•    Pronounced excitability and irritability.

•    Dizziness.

•    Swelling of muscle-supplying nerves.

•    Stiff neck, light intolerance, aversion to dazzling light, headaches.

•    Conjunctivitis, visual disturbances.

•    Abnormal bleeding, blood in urine or stool.

•    Blood clot formation, usually in a leg, with painful swelling and reddening.

•    Blood clot in the lung, causing chest pains and breathlessness.

•    Attacks of skin reddening.

•    Pains in the chest, hiccups.

•    Digestive disturbances, heartburn.

•    Peeling skin, rash, increased sweating and nail disorders.

•    Pains in the joints and bones.

•    Pains when passing urine or a change in urination frequency.

•    Blood tests showing a change in kidney function.

•    Loss of weight.

•    Depression.

•    Sleep disturbances.

Uncommon side effects (may affect up to 1 in 100 people)

•    Hearing disturbances.

•    Intestinal obstruction, intestinal swelling.

•    Anxiety or nervousness.

•    Higher acidity of the blood.

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

•    Indistinct speech.

•    Deafness.

•    Scarring and thickening in the lungs with difficulties in breathing, sometimes fatal (interstitial lung disease).

•    Inflammations causing abdominal pains and diarrhoea.

•    Reversible short-term loss of vision.

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

•    Liver disorders, for which your doctor will be watching out.

•    Changes in kidney function.

•    Presence of blood or dark brown coffee-coloured particles in your vomit.

.28.04.14 / KV03_osc_20.05.14

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

• Convulsion.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

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.

6. Contents of the pack and other information What Oxaliplatin contains

The active substance is oxaliplatin. 1 ml of the concentrate for solution for infusion contains 5 mg oxaliplatin.

Each vial of 10 ml of concentrate contains 50 mg oxaliplatin.

Each vial of 20 ml of concentrate contains 100 mg oxaliplatin.

Each vial of 40 ml of concentrate contains 200 mg oxaliplatin.

The other ingredient is water for injections.

What Oxaliplatin looks like and contents of the pack

Oxaliplatin is a clear, colourless concentrate for solution for infusion.

Pack sizes

Packs with 1 vial containing 10 ml, 20 ml or 40 ml of concentrate.

Marketing authorisation holder and manufacturer:

Marketing authorisation holder:

medac Gesellschaft fur Spezialpraparate mbH Theaterstr. 6 22880 Wedel Germany

Manufacturer:

AqVida GmbH Kaiser-Wilhelm-Str. 89 20355 Hamburg Germany

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

Czech Republic, Portugal, Slovakia:

Oxaliplatina medac

Denmark, Finland, Sweden, United Kingdom:

Oxaliplatin medac

Germany: medoxa

France: OXALIPLATINE MEDAC

Poland: Oksaliplatyna medac

This leaflet was last revised in 05/2014.

The following information is intended for healthcare professionals only:

Handling instructions for safe use

Like other potentially toxic substances, oxaliplatin solutions must be prepared and handled with due care.

The handling of this cytotoxic agent by medical health care professionals requires all safety measures ensuring protection of the user and his/her environment.

Injection solutions of cytotoxic medicinal products must be prepared by specially trained personnel familiar with the medicinal product used, under conditions guaranteeing protection of the environment, and especially protection of the personnel involved in accordance with the hospital’s standard procedures. This requires the provision of a working area designated for this purpose, in which smoking, eating, and drinking are prohibited.

The personnel must be provided with suitable working equipment, and in particular with long-sleeve laboratory coats, protective masks, head coverings, protective goggles, sterile disposable gloves, protective workplace coverings, containers, and collection bags for waste. Excrement and vomit must be handled with care.

Pregnant women must be warned against handling cytotoxic substances and must avoid them.

Any broken containers must be handled with the same care and treated as contaminated waste. Contaminated waste should be placed in solid suitably labeled containers for disposal by incineration. See below chapter “Waste disposal”.

If oxaliplatin concentrate for solution for infusion should come into contact with skin, wash immediately and thoroughly with water.

If oxaliplatin concentrate for solution for infusion should come into contact with mucous membranes, wash immediately and thoroughly with water.

Preparation for the intravenous administration

Special precautions for use

•    The product MUST NOT be used with aluminum-containing injection equipment.

•    The product MUST NOT be administered undiluted.

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

•    The product MUST NOT be diluted with sodium chloride or chloride-containing solutions.

•    The product MUST NOT be mixed with any other medicinal products in the same infusion bag or administered simultaneously in the same infusion line.

•    The product MUST NOT be mixed with alkaline medicinal agents or solutions, in particular 5-fluorouracil, folinic acid preparations containing trometamol as an excipient and trometamol salts of other active ingredients. Alkaline medicinal agents or solutions will adversely affect the stability of oxaliplatin.

Instructions for use with folinic acid (e.g. with calcium folinate or disodium folinate)

250 to 500 ml of 5 % (50 mg/ml) glucose infusion solution containing 85 mg/m² oxaliplatin is infused simultaneously by the i.v. route with the folinic acid infusion solution (folinic acid in 5 % glucose) using a Y-line placed immediately before the site of infusion, over a period of 2 to 6 hours.

The two medicines must not be mixed in the same infusion bag. The folinic acid must not contain trometamol as a constituent, and only isotonic 5 % glucose solution may be used for its dilution. Never use any alkaline or sodium chloride solution, or any other solution containing chloride for dilution.

Instructions for use with 5-fluorouracil Oxaliplatin should always be administered before fluoropyrimidines, i.e. 5-fluorouracil.

After the administration of Oxaliplatin the access must be rinsed through before the administration of 5-fluorouracil.

For further information on medicinal products given in combination with oxaliplatin, see the corresponding Summary of Product Characteristics.

Reconstituted solutions showing signs of precipitation must not be used, and should be destroyed with due observation of legal regulations for disposal of hazardous waste (see below).

Use only the recommended solvents (see below).

Only clear solutions without particles should be used.

Preparation of the infusion solution Withdraw the required amount of concentrate from the vial(s) and then dilute with 250 ml to 500 ml of a glucose 5 % (50 mg/ml) solution to give an oxaliplatin concentration between 0.2 mg/ml and 0.7 mg/ml.

Over this concentration range the physicochemical stability of oxaliplatin has been demonstrated.

Administer by intravenous infusion.

After dilution in glucose 5 % (50 mg/ml) solution, chemical and physical in-use stability has been demonstrated for 48 hours at 2 °C to 8 °C and for 6 hours at +25 °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 (see chapter “Waste disposal” below).

Never use sodium chloride or chloride containing solutions for dilution.

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

Infusion of the solution

The administration of oxaliplatin does not require prehydration.

Oxaliplatin diluted in 250 to 500 ml of a glucose 5 %

(50 mg/ml) 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.

Waste disposal

Remnants of this medicinal product and all material used for dilution and administration must be destroyed in accordance with the hospital’s standard procedures for cytotoxic substances and local requirements for disposal of hazardous waste.

1

What Oxaliplatin is and what it is used for

The active ingredient of Oxaliplatin is oxaliplatin.

2

Oxaliplatin is used to treat cancer of the large bowel (treatment of stage III colon cancer after complete resection of primary tumour, metastatic cancer of colon and rectum). Oxaliplatin is used in combination with other anticancer medicines called 5-fluorouracil and folinic acid.