1 NAME OF THE MEDICINAL PRODUCT
HEMANGIOL 3.75 mg/mL oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 4.28 mg of propranolol hydrochloride equivent to 3.75 mg of propranolol base.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Clear, colourless to slightly yellow oral solution, with a fruity odour.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
HEMANGIOL is indicated in the treatment of proliferating infantile haemangioma requiring systemic therapy:
· Life- or function-threatening haemangioma,
· Ulcerated haemangioma with pain and/or lack of response to simple wound care measures,
· Haemangioma with a risk of permanent scars or disfigurement.
It is to be initiated in infants aged 5 weeks to 5 months (see section 4.2).
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. The medicinal product is to be taken during or right after a feed.
If the child is not eating 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 medicine, 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.
Specific populations
In the absence of clinical efficacy and safety data, HEMANGIOL should not be used in children 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 children aged above 5 months.
Infants with hepatic or renal impairment
In the absence of data, administration of the product is not recommended to infants with hepatic or renal impairment (see section 4.4).
Method of administration
For oral use.
HEMANGIOL is to be given during or right after a feed to avoid the risk of hypoglycaemia. It should be administered directly into the child's mouth using the graduated oral syri