Zalitin 50 mg/10 ml/100 mg/20 ml Infusion

The active substance of ZALITIN is oxaliplatin. ZALITIN is an antineoplastic or anticancer medicine that contains oxaliplatin, which is a medicine which has platinum in its chemical structure. It is used to treat cancer of the large bowel (colon and rectum). ZALITIN is used in combination with other anticancer medicines called 5-fluorouracil (5-FU) and folinic acid.

ZALITIN should not be administered to you:

• If you have known allergies to ZALITIN or to any other ingredients (listed in section 6).
• If you are breastfeeding.
• If you already have a reduced number of red or white 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 (peripheral nerve damage).
• If you have severe kidney problems.

Warnings and precautions

Tell your doctor or healthcare professional before being given ZALITIN:

• If you are planning a pregnancy. It is very important that you discuss this with your doctor before you receive any treatment (see Pregnancy, breastfeeding and fertility). ZALITIN may have an anti-fertility effect, which could be irreversible. It is not recommended that you become pregnant during treatment with ZALITIN, and a barrier method of contraception (condoms) should be used. If a pregnancy occurs despite the use of contraception, please inform your doctor immediately. Barrier contraceptive measures (condoms) must be used during and after cessation of therapy (4 months for women and 6 months for men).
• If you have had a reaction to any other platinum-containing medicine. Allergic reactions can occur during any cycle.
• If you have a kidney disease or kidney problems. You may need additional monitoring and a different dose.
• If you have any liver problems.
• If you have or had heart disorders such as an abnormal electrical signal called prolongation of the QT interval, an irregular heartbeat, or a family history of heart problems.

ZALITIN will be prescribed for you by a specialist in cancer treatment. You will not be expected to give yourself ZALITIN. It will be given to you by a person qualified to do so. ZALITIN is given by infusion into a vein (this is called an intravenous infusion) over a 2- to 6-hour period. ZALITIN must be diluted before it can be injected. The injection is made by mixing the concentrated injection solution with 5 % glucose solution. About 250 mL to 500 mL of the glucose solution is usually used. The ZALITIN injection will be made up in a special area before the doctor or nurse administers it to you. The dose of ZALITIN is calculated according to your body surface area. This the doctor calculates from your height and weight. The usual dose for adults is 85 mg/m2 of body surface area once every 2 weeks. Your doctor may change the dose in some instances. Each course of treatment is called a cycle; your doctor will tell you how many cycles you will receive. The dose you receive will also depend on results of blood tests and whether you have previously experienced side effects with ZALITIN.

ZALITIN can have side effects. Not all side-effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice. Tell your doctor or nurse as soon as possible if you do not feel well while ZALITIN is being given to you. You should also tell your doctor if you do not feel well between courses of ZALITIN. It is important to understand the side effects that ZALITIN may cause, even though you may not experience them. As well as the predictable side effects of ZALITIN, there are other effects that occur. If you have any side effects or notice anything unusual, it is important to inform your doctor before your next treatment. Your doctor will decide whether such effects are because of your treatment, and what action needs to be taken. If any of the following happens, stop using ZALITIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Symptoms of an allergic or anaphylactic reaction with sudden signs such as rash, itching or hives on the skin, difficulty in swallowing, swelling of the face, lips, mouth, tongue, throat or other parts of the body, shortness of breath, wheezing or trouble breathing, extreme tiredness (you may feel you are going to faint). In the majority of cases these symptoms occurred during the infusion or immediately after but delayed allergic reactions have also been observed hours or even days after the infusion.
• These are all serious side effects. If you have them, you may have had a serious reaction to ZALITIN. You might need urgent medical attention or hospitalisation.

STORE ALL MEDICINE OUT OF REACH OF CHILDREN. Store at room temperature at or below 25 °C. Do not freeze. Protect from light (keep in outer carton until use). Infusion preparation: If not used immediately, should be stored at ≤ 25 ℃ for 12 hours and at 2 °C to 8 °C for not longer than 24 hours. 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. Do not use this medicine after the expiry date shown on the pack. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or the sewerage system (e.g. toilets).