Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
phenobarbital sodium, Quantity: 219 mg/mL
Aspen Pharmacare Australia Pty Ltd
phenobarbital (phenobarbitone) sodium
Injection, solution
Excipient Ingredients: propylene glycol; ethanol; water for injections
Intramuscular, Intravenous
1mL x 5
(S4) Prescription Only Medicine
Treatment of grand mal and psychomotor epilepsy; sedation
Visual Identification: A clear, colourless solution.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-11-04
Phenobarbitone Injection- Consumer Medicine Information Page 1 of 4 PHENOBARBITONE INJECTION _phenobarbital (phenobarbitone) sodium _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Phenobarbitone Injection. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using it against the benefits they expect it will have. IF YOU HAVE ANY CONCERNS ABOUT THE USE OF THIS MEDICINE ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PHENOBARBITONE INJECTION IS USED FOR The active ingredient is called phenobarbital (phenobarbitone) sodium_. _ It belongs to a group of medicines called barbiturates, which act by inducing sleep and stopping convulsions. Phenobarbitone Injection is used for treatment of grand mal and psychomotor epilepsy and sedation. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PHENOBARBITONE INJECTION HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. Phenobarbitone Injection is available only with a doctor’s prescription. The use of barbiturates may lead to dependence on this medicine. BEFORE IT IS GIVEN _WHEN IT MUST NOT BE USED _ PHENOBARBITONE INJECTION SHOULD NOT BE USED IF YOU ARE ALLERGIC TO: phenobarbital (phenobarbitone) sodium any of the other ingredients listed at the end of this leaflet any other barbiturate. Some of the symptoms of an allergic reaction may include red, itchy skin rashes; difficulty breathing; hay fever; swelling of the face or throat or faintness. DO NOT USE IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: porphyria (a rare blood pigment disorder) severe anaemia (a disease of the blood with reduced number of red blood cells) if it is due to folate deficiency uncontrolled severe asthma severe respiratory depression uncontrolled diabetes Prečítajte si celý dokument
PHENOBARBITONE INJECTION - PI Page 1 of 19 AUSTRALIAN PRODUCT INFORMATION PHENOBARBITONE INJECTION PHENOBARBITAL (PHENOBARBITONE) SODIUM 1. NAME OF THE MEDICINE phenobarbital (phenobarbitone) sodium. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PHENOBARBITONE INJECTION contains phenobarbital (phenobarbitone) sodium 219 mg (equivalent to phenobarbitone 200 mg) per 1 mL ampoule. Excipients include ethanol. For the full list of excipients, see section 6.1: List of excipients. 3. PHARMACEUTICAL FORM PHENOBARBITONE INJECTION is a clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of grand mal and psychomotor epilepsy; sedation. 4.2 DOSE AND METHOD OF ADMINISTRATION PHENOBARBITONE INJECTION is for single use in one patient only. Discard any residue. PHENOBARBITONE INJECTION has been administered by intramuscular (IM) or slow intravenous (IV) injection. Intravenous administration requires a delivery of a diluted (1/10) solution in water for injections at a rate not exceeding 60 mg/minute to reduce the risk of significant respiratory depression and circulatory collapse. Extravasation of solution, especially if concentrated, may cause tissue damage. Adequate provisions for supporting respiration and circulation should be present if the intravenous route is contemplated. The subcutaneous route should be avoided as it may cause tissue necrosis. Phenobarbitone dosage reduction is recommended in the elderly and in patients with decreased renal or hepatic function. The solution should be inspected for discolouration or the presence of particulate matter. The sponsor recommends that PHENOBARBITONE INJECTION be given by the intramuscular (IM) route. PHENOBARBITONE INJECTION - PI Page 2 of 19 The following dosage regimen is a guide only. ANTICONVULSANT _Adults _ Intramuscular, 100 to 300 mg, repeated if necessary up to a total dose of 600 mg during a 24 hour period. _Paediatric _ Initial – Intramuscular 10 to 20 mg per kg body weight as a single loading dose. Maintenance – Intramuscular 1 Prečítajte si celý dokument