nge, 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. Don’t put the medicine in the full 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.
4.3 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, if the mother is treated with medicines contraindicated with propranolol
· Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
· 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
· 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 medication
· Prinzmetal’s angina
· Severe peripheral arterial circulatory disturbances (Raynaud’s phenomenon)
· Infants prone to hypoglycaemia
· Phaeochromocytoma
4.4 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 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.
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 |
