Carohet 40 mg/2 ml/100 mg/5 ml/300 mg/15 ml

CAROHET belongs to a group of medicines called cytostatics (anti-cancer medicines). CAROHET may be used alone or in combination with a number of other medicines used to treat cancer. These combinations may be used to treat cancers of the colon and rectum.

CAROHET should not be administered to you:

• If you are hypersensitive (allergic) to irinotecan hydrochloride trihydrate (active ingredient) or any of the other ingredients of CAROHET.
• If you are pregnant or breastfeeding.
• If you have severe bone marrow failure.
• If your WHO performance status > 2 (i.e., if your general health status does not allow you to carry out general activities of daily living).
• If you have a disease involving frequent inflammation of the intestine (chronic inflammatory bowel disease) or blockage of the intestine (ileus).
• If your bilirubin (breakdown product of red blood cells) level is high.
• If you are a child.
• If you are taking azole antifungal medication (used to treat fungal infections) or St John’s Wort (a herbal supplement).

Warnings and precautions

Tell your doctor or health care provider before being given the injection: Special care should be taken with CAROHET:

• If you have impaired liver function you are at greater risk of developing severe decrease in white blood cells or fever.
• If you experience nausea and vomiting. If you experience vomiting together with delayed diarrhoea, you should be hospitalised for treatment.
• If you experience early diarrhoea together with a group of symptoms such as sweating, abdominal cramping, watery eyes and salivation. If this occurs, inform your doctor as a specific medication is required in order for these symptoms to disappear.
• If you are an elderly patient, the dose may have to be adjusted accordingly.

Contraceptive measures must be taken during and for at least 3 months after stopping therapy. Avoid vaccination with live vaccines.

CAROHET is an injection. You will not be expected to give yourself CAROHET. It will be given to you by a person who is qualified to do so. CAROHET will be given as an infusion into your veins over a period of 30 to 90 minutes. The amount of CAROHET you are given will depend on your age, size and general medical condition. It will also depend on any other treatment you may have received for your cancer. Your doctor will calculate your body surface area in square meters (m2). Your doctor will tell you how long your treatment with CAROHET will last.

If you have the impression that CAROHET is too strong or too weak, tell your doctor or pharmacist.

If you receive more CAROHET than you should Since a healthcare professional will administer CAROHET, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to use CAROHET Since a healthcare professional will administer CAROHET, it is unlikely that the dose will be missed.

CAROHET can have side effects. Not all side effects reported for CAROHET are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving CAROHET, please consult your health care provider for advice.

If any of the following happens, stop treatment with CAROHET and tell your doctor immediately:

• allergic skin reactions
• inflammation at the injection site
• inflammation of the lining of the mouth
• swelling of feet and hands, headache, increased sweating, flushing

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to CAROHET. You may need urgent medical attention or hospitalisation.

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

• Diarrhoea. CAROHET may cause you to have diarrhoea. There are two types of diarrhoea, which can be distinguished by when they start. “Early” diarrhoea starts less than 24 hours after the infusion and “delayed” diarrhoea starts more than 24 hours after the infusion. If you have ANY DIARRHOEA it is IMPORTANT that you tell your doctor or health care professional immediately.

Patients with an increased risk of diarrhoea are those who had a previous abdominal/pelvic radiotherapy and initial raised white blood cells.

Early diarrhoea (Frequent) if your diarrhoea starts less than 24 hours after the infusion (“early diarrhoea”) you should contact your doctor IMMEDIATELY. This “early diarrhoea” may be accompanied by a group of other symptoms listed below. This is known as acute cholinergic syndrome occurring during or within the first 24 hours after the infusion of CAROHET. The symptoms may be:

• Frequent: abdominal pain/cramping
• Less frequent: chills, lacrimation (watery eyes), rhinitis (irritation and inflammation inside the nose which may result in stuffy nose, runny nose and/or post-nasal drip)

Dizziness, hypotension (low blood pressure), malaise (lack of well-being), increased salivation (mouth-watering), myosis (constriction to the pupil of the eyes)

Frequency unknown: sweating, visual disturbances, conjunctivitis (inflammation of the eye), vasodilation (widening of blood vessels)

Delayed diarrhoea (Frequent) if your diarrhoea starts more than 24 hours after the infusion (“delayed diarrhoea”) you should IMMEDIATELY contact your doctor. You must tell your doctor if: you have nausea and vomiting as well as diarrhoea you have any fever as well as the diarrhoea you still have diarrhoea 48 hours after starting the diarrhoea treatment.

Store at or below 25 °C and store in original package, protect from light and moisture as well as do not freeze. KEEP OUT OF REACH OF CHILDREN.

In-use storage conditions CAROHET are subjected to 0.9% NaCl (0.12 mg/ml Concentration), 0.9% NaCl (2.8 mg/ml Concentration), 5% Glucose (0.12mg/ml concentration), 5% Glucose (2.8 mg/ml Concentration) for 24 Hrs at 2-8 °C, 3 days at 25 °C and 28 days at 5 °C.