HEMANGIOL

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

PROPRANOLOL AS HYDROCHLORIDE

Verfügbar ab:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC-Code:

C07AA05

Darreichungsform:

SOLUTION

Zusammensetzung:

PROPRANOLOL AS HYDROCHLORIDE 3.75 MG / 1 ML

Verabreichungsweg:

PER OS

Verschreibungstyp:

Required

Hergestellt von:

PIERRE FABRE MEDICAMENT, FRANCE

Therapiebereich:

PROPRANOLOL

Anwendungsgebiete:

For 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

Berechtigungsdatum:

2022-11-30

Gebrauchsinformation

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Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hemangiol, 3.75 mg/mL oral solution
CAREGIVER GUIDE
The marketing of Hemangiol is subject to a risk management plan (RMP)
including a ‘caregiver
guide' for the patient’s parents. The ‘caregiver guide’,
emphasizes important safety information
that the patient’s parent
s should be aware of before and during treatment. Please explain to
the
patient's parents the need to read the 'caregiver guide' before
starting treatment.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 4.28 mg of propranolol hydrochloride
equivalent to 3.75 mg of
propranolol base.
Excipients with known effect:
1 ml of solution contains 2.60 mg Propylene glycol.
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