Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
propranolol hydrochloride
Pierre Fabre Australia Pty Ltd
Propranolol hydrochloride
Registered
CONSUMER MEDICINE INFORMATION Version: A03-090818 1 Supercedes: A02-1216 HEMANGIOL ® 3.75 MG/ML ORAL SOLUTION _Propranolol _ _ _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Hemangiol ® . It does not contain all the information that is known about Hemangiol ® . It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of giving your child Hemangiol ® against the benefits this medicine is expected to have. If you have any concerns about this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. WHAT HEMANGIOL ® IS USED FOR Hemangiol ® is used to treat a condition in infants called hemangioma. A hemangioma is a collection of extra blood vessels that have formed a lump in or under the skin. A hemangioma can be superficial or deep. It is sometimes called a ‘strawberry mark’ because the surface of a hemangioma looks a bit like a strawberry. Hemangiol ® contains the medicine, propranolol which belongs to a group of medicines known as beta-blockers. Beta- blockers are used to treat a variety of heart and blood vessel conditions. Your doctor may have prescribed Hemangiol ® for another reason. Ask your doctor if you have any questions about why Hemangiol ® has been prescribed for your child. This medicine is only available with a doctor’s prescription. BEFORE HEMANGIOL ® IS GIVEN TO YOUR CHILD _WHEN IT MUST NOT BE _ _GIVEN TO YOUR CHILD _ DO NOT GIVE HEMANGIOL ® if your child: • is born prematurely and has not reached the corrected age of 5 weeks. (The corrected age is worked out by subtracting the number of weeks your child was premature from your child’s actual age, i.e. the age of your child minus the number of weeks premature); • has an allergy to propranolol or any of the ingredients listed at the end of this leaflet. An allergic reaction can include a rash, itching, hives, shortness of breath, wheezing, or difficulty breathing Läs hela dokumentet
Version: A02-090818 Page 1 of 21 Supercedes: A01-0615 PRODUCT INFORMATION HEMANGIOL ® 3.75 MG/ML ORAL SOLUTION NAME OF THE MEDICINE propranolol hydrochloride CAS Registry Number: 318-98-9 DESCRIPTION Propranolol hydrochloride is a white to off-white powder with the molecular formula C 16 H 21 NO 2 . HCI and a molecular weight of 295.8. It is soluble in water and ethanol, slightly soluble in chloroform and practically insoluble in ether. It is non-hygroscopic with a pKa of 9.5. Propranolol hydrochloride has a chiral centre; its synthesis produces a racemic mixture. Hemangiol ® drug product is presented as a colourless to slightly yellow, clear, oral solution with a fruity odour. One mL of Hemangiol ® oral solution contains 3.75 mg of propranolol base (as propranolol hydrochloride 4.28 mg). Hemangiol ® also contains the excipients: hydroxyethylcellulose, saccharin sodium, citric acid monohydrate, purified water and strawberry (proprietary ingredient number: 109091) and vanilla (proprietary ingredient number: 109044) flavours. Attention is drawn to the difference in the labelling of the content of propranolol in Hemangiol ® compared to other propranolol dosage forms: Hemangiol ® solution is labelled in terms of the amount of _propranolol base_ per mL whereas propranolol tablets are labelled in terms of the amount of _propranolol hydrochloride_ per tablet. Propylene glycol is the major component of the strawberry and vanilla flavours. Propylene glycol exposure is up to 2.08 mg/kg/day which does not present a significant safety concern for the pediatric patient population, no risk for health of treated children is expected_._ Version: A02-090818 Page 2 of 21 Supercedes: A01-0615 _ _ PHARMACOLOGY PHARMACODYNAMICS Propranolol is a non-selective beta-blocker that is characterised by three pharmacological properties: • The absence of cardioselective beta-1 beta-blocking activity; • An antiarrhythmic effect; • Lack of partial agonist activity (or intrinsic sympathomimetic activity). The pathogenesis of infantil Läs hela dokumentet