Posology : מינונים

4.2 Posology and method of administration
Treatment with Hemangiol should be initiated by physicians who have expertise in the diagnosis, treatment and management of infantile haemangioma, in a controlled clinical setting where adequate facilities for handling of adverse reactions, including those requiring urgent measures, are available.

Posology
The posology is expressed in propranolol base.
The recommended starting dose is 1 mg/kg/day which is divided into two separate doses of 0.5 mg/kg. It is recommended to increase the dose up to the therapeutic dose under medical supervision as follows: 1 mg/kg/day for 1 week, then 2 mg/kg/day for 1 week and then 3 mg/kg/day as a maintenance dose.
The therapeutic dose is 3 mg/kg/day, which is to be administered into 2 separate doses of 1.5 mg/kg, one in the morning and one in late afternoon, with a time interval of at least 9 hours between two intakes. Hemangiol is to be given during or right after a feed to avoid the risk of hypoglycaemia.
If the child is not eating enough or is vomiting it is recommended to skip the dose.
In case the child spits up a dose or does not take all of the medicinal product, no other dose should be given before the next scheduled dose.

During the titration phase, each dose increase must be managed and monitored by a physician in the same conditions as the administration of the initial dose. After the titration phase, the dose will be readjusted by the physician according to the changes in the child’s weight.

Clinical monitoring of the child condition, and dose readjustment, need to be performed at least monthly.

Duration of treatment:
Hemangiol should be administered for a 6-month period.
Discontinuation of treatment does not require a progressive decrease in the dose.
In the minority of patients showing a relapse of symptoms after treatment discontinuation, treatment may be re-initiated under the same conditions with a satisfactory response.

Paediatric populations
In the absence of clinical efficacy and safety data, Hemangiol should not be used in infants aged below 5 weeks.
There is no clinical efficacy and safety data in the clinical studies carried out with Hemangiol to recommend its initiation in infants and children aged above 5 months.

Infants with hepatic or renal impairment
In the absence of data, administration of the medicinal product is not recommended to infants with hepatic or renal impairment (see section 4.4).

Method of administration
Oral use.
Hemangiol should be administered directly into the child's mouth using the graduated oral syringe, calibrated in mg of propranolol base, supplied with the oral solution bottle (see instructions for use in section 3 of the patient information leaflet).
The bottle should not be shaken before use.
If necessary, the medicinal product may be diluted in a small quantity of baby-milk or age- adapted apple and/or orange fruit juice. The medicine should not be put in the full filled bottle.
The mixing may be done with one teaspoonful (approximately 5 mL) of milk for children weighing up to 5 kg, or with a tablespoonful (approximately 15 mL) of milk or fruit juice for children weighing more than 5 kg, delivered in a baby’s bottle. The mixing should be used within 2 hours.
Hemangiol and the feed must be given by the same person in order to avoid the risk of hypoglycaemia. If different people are involved, good communication is essential in order to ensure the safety of the child.