Negara: Selandia Baru
Bahasa: Inggris
Sumber: Medsafe (Medicines Safety Authority)
Phenytoin 6 mg/mL
Viatris Limited
Phenytoin 6 mg/mL
30 mg/5mL
Oral suspension
Active: Phenytoin 6 mg/mL Excipient: Aluminium magnesium silicate Carmellose sodium Carmoisine Citric acid monohydrate Ethanol Imitation banana flavour 510120E Glycerol Polysorbate 40 Purified water Sodium benzoate Sucrose Sunset yellow FCF Terpeneless orange oil Vanillin
Bottle, 500 mL
Prescription
Prescription
Pharmacia & Upjohn Company LLC
Package - Contents - Shelf Life: Bottle, - 500 mL - 36 months from date of manufacture stored at or below 25°C
1969-12-31
Page 1 of 6 NEW ZEALAND CONSUMER MEDICINE INFORMATION DILANTIN ® _PHENYTOIN, PHENYTOIN SODIUM _ _CAPSULES 30 MG & 100 MG, CHEWABLE TABLETS 50 MG AND PAEDIATRIC ORAL _ _SUSPENSION 30 MG/5 ML _ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking DILANTIN This leaflet answers some common questions about DILANTIN. 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 taking DILANTIN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DILANTIN IS USED FOR DILANTIN is used to control Epilepsy Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe. DILANTIN belongs to a group of medicines called anticonvulsants. These drugs are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. DILANTIN is also used to help prevent seizures occurring during or after brain surgery. DILANTIN may be used alone, or in combination with other medicines, to treat your condition. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. There is no evidence that DILANTIN is addictive. BEFORE YOU TAKE DILANTIN _WHEN YOU MUST NOT TAKE _ _IT _ DO NOT TAKE DILANTIN IF YOU HAVE AN ALLERGY TO: any medicine containing phenytoin sodium or phenytoin, the active ingredients in DILANTIN, any other hydantoin medicines any of the ingredients listed at the end of this leaflet methylphenobarbitone or any other barbiturate medicines other medicines used to treat fits and convulsions. Some of the symptoms o Baca dokumen lengkapnya
Version: ujddilaa040522 Supersedes: ujddilaa10921 Page 1 of 18 NEW ZEALAND DATA SHEET DILANTIN ® _ _ _ _ 1. PRODUCT NAME Dilantin 30 mg and 100 mg phenytoin sodium capsules Dilantin Infatabs 50 mg phenytoin chewable tablets Dilantin 30 mg/5 mL phenytoin paediatric oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 30 mg capsule contains 30 mg phenytoin sodium. Each 100 mg capsule contains 100 mg phenytoin sodium. Each 50 mg chewable infatabs contains 50 mg phenytoin. Each 5 mL of paediatric suspension contains 30 mg phenytoin. EXCIPIENTS WITH KNOWN EFFECT All formulations contain sucrose. The 30 mg capsule new formulation contains lactose monohydrate. The 100 mg capsule (both new and old formulations) contains lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules 30 mg: white, marked Parke Davis, P-D 30. Capsules 100 mg: white / orange, marked Parke Davis and P-D 100. Infatabs 50 mg: chewable tablets, spearmint-flavoured, for children, triangular, yellow, scored, marked P-D 007. The scoreline is not intended to divide the tablets into equal halves. Paediatric suspension: reddish-pink suspension. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS _ Dilantin is indicated for the control of generalised tonic-clonic (grand mal) and psychomotor seizures. Dilantin 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, Dilantin frequently improves the mental condition Version: ujddilaa040522 Supersedes: ujddilaa10921 Page 2 of 18 and outlook of epileptic patients and there is also increasing evidence that Dilantin is valuable in the prevention of seizures occurring during or after neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see section 4.2). _4.2 _ _DOSE AND METHOD OF ADMINISTRATION _ Serum concentrations shoul Baca dokumen lengkapnya