País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
phenytoin sodium, Quantity: 250 mg
Juno Pharmaceuticals Pty Ltd
Phenytoin sodium
Injection, solution
Excipient Ingredients: sodium hydroxide; water for injections; ethanol; propylene glycol
Intravenous
10 x 5mL, 5 x 5mL, 1 x 5mL
Medicine Registered
(S4) Prescription Only Medicine
Control of status epilepticus, tonic-clonic (grand mal), psychomotor seizures and the prevention of seizures occuring during or following neurosurgery. Phenytoin will prevent or effectively decrease the incidence and severity of convulvsive seizures in a high percentage of cases, with patients exhibiting little tendency to become resistant to its action. Besides its effectiveness in controlling seizures, phenytoin frequently improves the mental condition and outlook of epileptic patients. It has also been used in the treatment of certain cardiac arrhythmias, particularly in those patients who do not respond to convential antiarrhythmic agents or to cardioversion. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see dosage and administation).
Visual Identification: Clear , colourless solution; Container Type: Ampoule; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2006-12-22
Phenytoin Sandoz® 1 PHENYTOIN SANDOZ ® INJECTION _Phenytoin sodium Injection _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Phenytoin Sandoz. It does not contain all 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 this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PHENYTOIN SANDOZ IS USED FOR Phenytoin Sandoz is used to control epilepsy. Epilepsy is a condition where you have repeated seizures (fits). There are many types of seizures, ranging from mild to severe. Phenytoin Sandoz contains the active ingredient, phenytoin. Phenytoin belongs to a group of medicines known as anticonvulsants. These drugs are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. Phenytoin Sandoz is also used to help prevent seizures during or after brain surgery. It may also be used to treat a rapid or irregular heartbeat. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. There is no evidence that Phenytoin Sandoz is addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN PHENYTOIN SANDOZ _WHEN YOU MUST NOT BE GIVEN _ _IT _ YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU HAVE AN ALLERGY TO: Phenytoin sodium or phenytoin, the active ingredients, or any other ingredients listed at the end of this leaflet under Product Description a group of medicines called hydantoins or other similar medicines such as methylphenobarbitone or any other barbiturate medicines, succinimides, oxazolidinediones and other related compounds other medicines used to treat fits and convulsions. Symptoms of Leia o documento completo
Australian Product Information Product Information v3.0 Page | 1 AUSTRALIAN PRODUCT INFORMATION _PHENYTOIN JUNO (PHENYTOIN SODIUM) _ 1 NAME OF THE MEDICINE Phenytoin sodium. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Phenytoin Juno 100mg/2mL and 250mg/5mL - Ready mixed ampoules. Each mL of solution contains 50 mg of phenytoin sodium as an active ingredient. EXCIPIENTS WITH KNOWN EFFECT: Contains alcohol (ethanol) 10% v/v For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Solution for injection. Clear colourless solution, free from visible particulates. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Control of status epilepticus, tonic-clonic (grand mal), psychomotor seizures and the prevention of seizures occurring during or following neurosurgery. Phenytoin will prevent or effectively decrease the incidence and severity of convulsive seizures in a high percentage of cases, with patients exhibiting little tendency to become resistant to its action. Besides its effectiveness in controlling seizures, phenytoin frequently improves the mental condition and outlook of epileptic patients. It has also been used in the treatment of certain cardiac arrhythmias, particularly in those patients who do not respond to conventional antiarrhythmic agents or to cardioversion. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION). 4.2 DOSE AND METHOD OF ADMINISTRATION Phenytoin Juno must be administered slowly. Intravenous administration should not exceed 50mg/minute in adults. In neonates and children, the drug should be administered at a rate not exceeding 1 to 3mg/kg/minute, maximum of 50mg/minute. Dilution of Phenytoin Juno into intravenous infusion is not recommended due to lack of solubility and resultant precipitation. The solution is suitable for use as long as it remains free of haziness and precipitate. A precipitate might form if the product has been kept in a refrigerator or freezer. This prec Leia o documento completo