देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
Diazepam 4 mg/mL
Teva Pharma (New Zealand) Limited
Diazepam 4 mg/mL
10mg/2.5mL
Enema
Active: Diazepam 4 mg/mL Excipient: Benzoic acid Benzyl alcohol Ethanol Propylene glycol Purified water Sodium benzoate
Tube, plastic, 2.5mL, 5 dose units
Class C5 Controlled Drug
Class C5 Controlled Drug
F.I.S. Fabbrica Italiana Sintetici SpA
For the treatment of febrile and childhood convulsions, where rapid onset of anticonvulsant therapy is imperative.
Package - Contents - Shelf Life: Tube, plastic, 2.5mL - 5 dose units - 30 months from date of manufacture stored at or below 25°C protect from light
1981-08-10
NEW ZEALAND CONSUMER MEDICINE INFORMATION STESOLID ® DIAZEPAM _(pronounced die-az-e-pam)_ _RECTAL TUBES CONTAINING 5MG OR 10MG DIAZEPAM _ WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about Stesolid ® . 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 your taking Stesolid ® 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 STESOLID ® IS USED FOR Stesolid ® rectal tubes contain a medicine called diazepam (die-az-e-pam) and are used for the treatment of fits or seizures caused by fever (called febrile convulsions). Your doctor may have prescribed Stesolid ® for another reason. Ask your doctor or pharmacist if you have any questions about why Stesolid ® has been prescribed for you. BEFORE YOU USE STESOLID ® _WHEN YOU MUST NOT USE IT _ • If you are sensitive (allergic) to diazepam (or the group of medicines to which it belongs, called benzodiazepines) or any of the ingredients of Stesolid ® (listed at the end of this leaflet). • If you have severe breathing problems or have difficulty breathing. • If you have a condition called myasthenia gravis which causes muscle weakness. • If you have a condition called sleep apnoea where you stop breathing temporarily whilst asleep. • If you are breast feeding. • If you have severe liver problems. • If the packaging is torn or shows signs of tampering. _BEFORE YOU START TO USE IT _ Tell your doctor or pharmacist if: • you are pregnant or plan on becoming pregnant. Your doctor will discuss the risks and benefits of using Stesolid ® with you. • you suffer from anxiety or depression • you are using any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. MANY MED पूरा दस्तावेज़ पढ़ें
Version 1.0 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Stesolid® Rectal Tubes 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tube contains 5 mg diazepam in 2.5 mL or 10 mg diazepam in 2.5 mL solution. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Stesolid ® is a clear colourless-to-slightly-yellowish aqueous liquid, in a yellow polyethylene tube. Stesolid ® is available in a 5mg/2.5mL tube or 10mg/2.5mL tube, for rectal administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of febrile and childhood convulsions, where rapid onset of anticonvulsant activity is imperative. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE AGE GROUP DOSAGE IN MG NUMBER OF 5MG/2.5ML TUBES OR NUMBER OF 10MG/2.5ML TUBES Adults 10 to 20 mg 2 to 4 1 to 2 Children (7-12 years) 10 mg 2 1 Children (1-6 years) 5 mg 1 Not applicable If necessary, these doses may be repeated once only, after five minutes A maximum dose of 30 mg is recommended, unless adequate medical supervision and monitoring are available. METHOD OF ADMINISTRATION For rectal administration only. 1. Position the patient with the buttocks raised. If a child, place the child across your knee. 2. Remove the tube cap and coat the opening of the nozzle with a little Vaseline. 3. Insert the ENTIRE length of the nozzle (about 5cm) into the anus. In children less than three years of age, insert the nozzle HALFWAY only. 4. IMPORTANT: In order to empty the tube, the nozzle must point downwards. 5. When the tube feels empty, keep squeezing it, while simultaneously withdrawing the nozzle. 6. Keep the patient in the same position and press the buttocks together for a few minutes, to avoid seepage. 4.3 CONTRAINDICATIONS Hypersensitivity to diazepam or to benzodiazepines, or to any of the excipients listed in this data sheet (see Section 6.1 List of excipients). Version 1.0 2 Myasthenia gravis, severe respiratory insufficiency, sleep apnoea syndrome, severe hepatic insufficiency. Not for IV, IM or oral administration. 4.4 SPECIAL WARNINGS पूरा दस्तावेज़ पढ़ें