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Hemangiol is a brand name for Propranolol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's EMA label. Tap a section to expand.
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. 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.
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.
3 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.
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).
5%). Globally, the adverse reactions reported in the compassionate use program and in literature concerned hypoglycemia (and related event like hypoglycaemic seizure) and aggravated respiratory tract infections with respiratory distress.
Tabulated list of adverse reactions The following table gives the adverse reactions, reported whatever dose and treatment duration, in three clinical studies, including 435 patients treated by HEMANGIOL at 1 mg/kg/day or 3 mg/kg/day for a maximum treatment duration of 6 months.
Their frequency is defined using the following conventions: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Due to the clinical trial database size rare and very rare categories are not represented. Within each system organ class, adverse reactions are presented in order of decreasing seriousness. Very common Common Uncommon Not known Infections and infestations Bronchitis Bronchiolitis Metabolism and nutrition disorders Decreased appetite Psychiatric disorders Sleep disorder Agitation Nightmares Irritability Nervous system disorders Somnolence Hypoglycemic seizure Cardiac disorders AV block Bradycardia Vascular disorders Peripheral coldness Hypotension Vasoconstriction Raynaud’s phenomenon Respiratory, thoracic and mediastinal disorders Bronchospasm Gastrointestinal disorders Diarrhea Vomiting Constipation Abdominal pain Skin and subcutaneous tissue disorders Erythema Dermatitis diaper Urticaria Alopecia Dermatitis psoriasiform Investigations Decreased blood pressure Decreased blood glucose Decreased heart rate Neutropenia Agranulocytosis Hyperkaliemia 9 Description of selected adverse reactions Concerning the lower respiratory tract infections like bronchitis or bronchiolitis, an aggravation of symptoms (including bronchospasm) has been observed in patients treated with HEMANGIOL due to the bronchoconstrictive effect of propranolol.
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 must be performed including heart rate, cardiac and pulmonary auscultation.
In case of suspected cardiac abnormality, a specialist advice must be sought before treatment initiation to determine any subjacent contra-indication. In case of acute broncho-pulmonary abnormality, the initiation of the treatment should be postponed.
Hypoglycaemia Propranolol prevents the response of endogenous catecholamines to correct hypoglycaemia. It masks the adrenergic warning signs of hypoglycaemia, particularly tachycardia, shakiness, anxiety and hunger. g. poor oral food intake, infection, vomiting), when glucose demands are increased (cold, stress, infections), or in case of overdose.
Hypoglycaemic episodes associated with the taking of propranolol may present exceptionally in the form of seizures and/or coma. If clinical signs of hypoglycaemia occur, it is necessary to make the child drink a sugary liquid solution and to temporarily stop the treatment.
Appropriate monitoring of the child is required until symptoms disappear. Prescribers should inform carers/parents on the risk of serious hypoglycaemia that remains equally prominent throughout the whole treatment period. 2). Carers should be provided guidance on how to recognise the clinical signs of hypoglycaemia in order to : • immediately treat the hypoglycaemic condition to prevent life-threatening situations, • contact a doctor or to go straight to hospital, • discontinue the treatment.
In children with diabetes, blood glucose monitoring should be more frequent and followed by the endocrinologist. Respiratory disorders In the event of lower respiratory tract infection associated with dyspnoea and wheezing, treatment should be temporarily discontinued.
1 • Asthma or history of bronchospasm • Second- or third-degree atrioventricular blocks • Disease of the sinus node (including sinoatrial block) • Bradycardia below the following limits: Age 0-3 months 3-6 months 6-12 months Heart rate (beats/min) 100 90 80 4 • Low blood pressure below the following limits: Age 0-3 months 3-6 months 6-12 months Blood pressure (mmHg) 65/45 70/50 80/55 • Cardiogenic shock • Heart failure not controlled by treatment • Prinzmetal’s angina • Severe peripheral arterial circulatory disturbances (Raynaud’s phenomenon) • Infants prone to hypoglycaemia • Phaeochromocytoma
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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.
4). Sleep disorders corresponded to insomnia, poor quality of sleep and hypersomnia. Other Central Nervous System disorders were principally observed during the early periods of treatment. Diarrhea was frequently reported and was not always associated with an infectious gastrointestinal disease.
The occurrence of diarrhea seems to be dose-dependent between 1 and 3 mg/kg/day. None of cases was of severe intensity and led to treatment discontinuation. Cardiovascular events reported during clinical studies were asymptomatic. In the context of the 4 hours cardiovascular monitoring during the titration days, it was observed a decrease of heart rate (about 7 bpm) and of systolic blood pressure (less than 3 mmHg) following drug administration.
One case of second degree atrioventricular heart block in a patient with underlying conduction disorder led to definitive treatment discontinuation. Isolated cases of symptomatic bradycardia and hypotension have been reported in literature.
Blood sugar decreases observed during clinical studies were asymptomatic. 4). 5). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
The administration of beta2 agonists and inhaled corticosteroids is possible. The readministration of propranolol may be considered when the child has fully recovered; in case of reoccurrence, treatment should be permanently discontinued.
In the event of isolated bronchospasm, treatment must be permanently discontinued. 5 Cardiovascular disorders Propranolol, due to its pharmacological action, may cause or worsen bradycardia or blood pressure abnormalities. Bradycardia should be diagnosed if the heart rate declines by more than 30 bpm from baseline.
Bradycardia is defined below the following limits:
Age 0-3 months 3-6 months 6-12 months Heart rate (beats/min) 100 90 80 After the first intake and each dose increase, a clinical monitoring including blood pressure and heart rate must be performed at least hourly for at least 2 hours.
In case of symptomatic bradycardia or bradycardia under 80 bpm, immediate specialist advice must be sought. In case of severe and/or symptomatic bradycardia or hypotension occurring at any time during treatment, treatment must be discontinued and a specialist advice should be sought.
Cardiac failure:
Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta blockade may precipitate more severe failure. In children with cardiac failure, the treatment should be managed by the cardiologist.
PHACE syndrome Very limited safety data of propranolol in PHACE syndrome patients are available. Propranolol may increase the risk of stroke in PHACE syndrome patients with severe cerebrovascular anomalies by dropping blood pressure and attenuating flow through occluded, narrow, or stenotic vessels.
Infants with large facial infantile hemangioma should be thoroughly investigated for potential arteriopathy associated with PHACE syndrome, with magnetic resonance angiography of the head and neck and cardiac imaging to include the aortic arch, prior to considering propranolol therapy.
Specialised advice should be sought.
Breast-feeding:
Propranolol passes through breast milk, mothers being treated with propranolol who breastfeed their infant should inform their health care professional. Liver or kidney failure Propranolol is metabolised in the liver and excreted by the kidneys.
2). Hypersensitivity In patients likely to experience severe anaphylactic reaction, regardless of origin, particularly with iodinated contrast agents, beta-blocker treatment may lead to worsening of the reaction and resistance to its treatment with adrenaline at normal doses.
In children who are at risk of anaphylaxis, the benefit risk of the medicinal product should be evaluated. General anaesthesia Beta-blockers will result in an attenuation of reflex tachycardia and an increased risk of hypotension. It is necessary to alert the anaesthetist to the fact that the patient is being treated with beta-blockers.
When a patient is scheduled for surgery, beta-blocker therapy should be discontinued at least 48 hours prior to the procedure. Hyperkaliemia Hyperkaliemia cases have been reported in patients with large ulcerated hemangioma. A monitoring of electrolyte should be performed in these patients.
Psoriasis Worsening of disease has been reported with beta-blockers in patients suffering from psoriasis. Therefore the need for treatment should be carefully weighed up. e. essentially ‘sodium- free’. 08 mg of propylene glycol/kg/day.
Caution should be taken into account in babies less than 4 weeks old, in particular if the baby is given other medicines that contain propylene glycol or alcohol. Co-administration with any […]