البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
clonazepam, Quantity: 2.5 mg/mL
Pharmaco Australia Ltd
Oral Liquid, solution
Excipient Ingredients: saccharin sodium; propylene glycol; brilliant blue FCF; glacial acetic acid; Flavour
Oral
10mL
Medicine Registered
(S4) Prescription Only Medicine
Tablets. Most types of epilepsy in infants and children, especially absences (petit mal), myoclonic seizures and tonic-clonic fits, whether due to primary generalised epilepsy, or to secondary generalisation of partial epilepsy. In adults all varieties of generalised epilepsy, (including myoclonic, akinetic, tonic and tonic-clonic seizures), and in partial epilepsy (including psychomotor seizures). Injection. Intravenous use for status epilepticus only. Note. Efficacy by the intramuscular route has not need demonstrated.
Visual Identification: Clear, blue homogeneous liquid; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
1991-08-23
Rivotril ® - Consumer Medicines Information 2021-08 v1.0 1 RIVOTRIL® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING RIVOTRIL®? Rivotril® contains the active ingredient clonazepam. Rivotril® is used to treat epilepsy in infants, children and adults and it is also used to treat status epilepticus (prolonged or repeated fits or seizures without any recovery between attacks). For more information, see Section 1. Why am I using Rivotril®? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE RIVOTRIL®? Do not use if you have ever had an allergic reaction to clonazepam, other benzodiazepine medicines or any of the ingredients listed at the end of the CMI. Do not use if you have severe and chronic lung disease or severe liver disease. Do not use if you have an addiction to drugs or alcohol. This medicine may be addictive. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Rivotril®? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Rivotril® and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE RIVOTRIL®? Take Rivotril® exactly as your doctor has prescribed. Measure the prescribed dose of Rivotril® oral liquid as DROPS ONLY. More instructions can be found in Section 4. How do I use Rivotril®? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING RIVOTRIL®? THINGS YOU SHOULD DO Remind any doctor, dentist or pharmacist you visit that you are using Rivotril®. Do not take any other medicines whether they require a prescription or not without first telling your doctor. Tell your doctor if you become pregnant while taking Rivotril®. Tell your doctor if, for a اقرأ الوثيقة كاملة
2021-08 v1.0 1 AUSTRALIAN PRODUCT INFORMATION RIVOTRIL (CLONAZEPAM) 1. NAME OF THE MEDICINE Clonazepam 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Rivotril tablets contain 500 micrograms clonazepam. Rivotril oral liquid contains 2.5 mg/mL clonazepam (one drop contains 0.1 mg clonazepam). Rivotril concentrated injection solution contains 1 mg clonazepam in 1 mL and is supplied with 1 mL diluent ampoules containing 1 mL of water for injections. Excipients with known effect _Tablet _contains sugars as lactose_ _ _Injection _contains alcohol as 20% v/v ethanol_ _ _Oral liquid _contains saccharin For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM The tablet is a cylindrical, biplanar, pale orange tablet, marked "0,5" on upper face, and break bar on reverse face. The oral liquid is a clear blue homogeneous liquid. The concentrated injection solution is a clear slightly yellowish liquid. The diluent is a clear colourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TABLETS Most types of epilepsy in infants and children, especially absences (petit mal), myoclonic seizures and tonic clonic fits, whether due to primary generalised epilepsy, or to secondary generalisation of partial epilepsy. In adults all varieties of generalised epilepsy (including myoclonic, akinetic, tonic and tonic clonic seizures), and in partial epilepsy (including psychomotor seizures). INJECTION Intravenous (IV) use, for status epilepticus. Note: Efficacy by the intramuscular (IM) route has not been demonstrated. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE WARNING: RIVOTRIL ORAL LIQUID MEASURE THE PRESCRIBED DOSE OF RIVOTRIL ORAL LIQUID AS DROPS ONLY. DO NOT ADMINISTER DROPS DIRECTLY INTO THE MOUTH FROM THE BOTTLE. AFTER EACH ADMINISTRATION, ENSURE THAT THE DROPPER IS SECURE IN THE NECK OF THE BOTTLE. DROPS SHOULD BE GIVEN WITH A SPOON. AFTER EACH OPENING, MAKE SURE THE DROPPER IS SECURED WITHIN THE NECK OF THE BOTTLE. 2021-08 v1.0 2 The dosage of Rivotril must be individually adjusted accord اقرأ الوثيقة كاملة