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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

HEMANGIOL Oral solution (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

HEMANGIOL 3.75 mg/mL oral solution.

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 Propylene glycol 2.60 mg. For the full ...

Pharmaceutical form

Oral solution. Clear, colourless to slightly yellow oral solution, with a fruity odour.

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 ...

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 ...

Contraindications

Premature infants, for whom the corrected age of 5 weeks has not been reached (the corrected age being calculated by subtracting the number of weeks of prematurity from the actual age) Breastfed infants, ...

Special warnings and precautions for use

Initiation of treatment Prior to initiating propranolol therapy, screening for risks associated with propranolol use must be performed. An analysis of the medical history and a full clinical examination ...

Interaction with other medicinal products and other forms of interaction

In the absence of specific studies in children, the drug interactions with propranolol are those known in adults. Combinations should consider the 2 following situations (not mutually exclusive): Infants ...

Fertility, pregnancy and lactation

Pregnancy Not relevant. Breast-feeding Breastfeeding mothers: see section 4.4 and section 4.5. Fertility Although some reversible effects on male and female fertilities were reported in adult rats receiving ...

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

Summary of the safety profile In clinical trials for proliferating infantile haemangioma, the most frequently reported adverse reactions in infant treated with HEMANGIOL were sleep disorders (16.7%), aggravated ...

Overdose

The toxicity of beta-blockers is an extension of their therapeutic effects: Cardiac symptoms of mild to moderate poisoning are decreased heart rate and hypotension. Atrioventricular blocks, intraventricular ...

Pharmacodynamic properties

Pharmacotherapeutic group: Beta-Blocking agent, non-selective ATC code: C07AA05 Mechanism of action Potential mechanisms of action of propranolol in proliferating infantile haemangioma described in the ...

Pharmacokinetic properties

Adults Absorption and distribution Propranolol is almost completely absorbed after oral administration. However, it undergoes an extensive first-pass metabolism by the liver and on average only about 25% ...

Preclinical safety data

In animals, after an acute dosing, propranolol is considered as a moderately toxic drug with an oral LD<sub>50</sub> of about 600 mg/kg. The main effects reported after repeated administration of propranolol ...

List of excipients

Hydroxyethylcellulose Sodium saccharin Strawberry flavour (contains propylene glycol) Vanilla flavour (contains propylene glycol) Citric acid monohydrate Purified water

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Before opening: 3 years. After first opening: 2 months.

Special precautions for storage

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.

Nature and contents of container

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 ...

Special precautions for disposal and other handling

No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

PIERRE FABRE DERMATOLOGIE, 45 place Abel Gance, F-92100 Boulogne

Marketing authorization number(s)

EU/1/14/919/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 23 April 2014

Πηγαίο έγγραφο

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