Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: PIERRE FABRE DERMATOLOGIE, 45 place Abel Gance, F-92100 Boulogne
HEMANGIOL is indicated in the treatment of proliferating infantile haemangioma requiring systemic therapy:
It is to be initiated in infants aged 5 weeks to 5 months (see section 4.2).
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.
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 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.
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.
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.
In the absence of data, administration of the medicinal product is not recommended to infants with hepatic or renal impairment (see section 4.4).
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.
The toxicity of beta-blockers is an extension of their therapeutic effects:
Propranolol is highly lipid-soluble and may cross the blood brain barrier and cause seizures.
The patient should be placed on a cardiac monitor, monitor vital signs, mental status and blood glucose. Intravenous fluids for hypotension and atropine for bradycardia should be given. Glucagon then catecholamines should be considered if the patient does not respond appropriately to intravenous fluid. Isoproterenol and aminophylline may be used for bronchospasm.
Before opening: 3 years.
After first opening: 2 months.
Keep the bottle in the outer carton in order to protect from light.
Do not freeze.
Store the bottle and the oral syringe in the outer carton between each use.
120 mL solution, in a type III amber-glass bottle fitted with a low density polyethylene insert and a child resistant polypropylene screw cap, provided with a polypropylene oral syringe graduated in mg of propranolol base.
Pack size: carton containing 1 bottle and 1 oral syringe.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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