Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
nimodipine, Quantity: 30 mg
Bayer Australia Ltd
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; povidone; maize starch; crospovidone; magnesium stearate; hypromellose; macrogol 4000; iron oxide yellow; titanium dioxide
Oral
100 tablets
(S4) Prescription Only Medicine
Prophylaxis and treatment of ischaemic neurological deficits caused by cerebral vasospasm after subarachnoid haemorrhage following ruptured intracranial aneurysm, in patients who are in good neurological condition post-ictus (eg Hunt and Hess Grades I-III).
Visual Identification: Round, convex, yellow film-coated tablets embossed "SK" on top and the Bayer Cross on the bottom.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
1993-06-09
NIMOTOP ® CMI 1 NIMOTOP ® (NEE·MOE·TOP) _nimodipine_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Nimotop. This leaflet 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 Nimotop against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again WHAT NIMOTOP IS USED FOR Nimotop tablets and infusion solution are used to prevent or to treat a lack of blood supply in the brain caused by narrowing of the blood vessels after a haemorrhage (burst blood vessel in the brain). This medicine belongs to a group of drugs called calcium channel blockers. Nimotop works by relaxing the smooth muscle of the small blood vessels in the brain. This allows narrowed vessels to open up, thereby increasing blood flow, reducing blood pressure, and improving circulation. YOUR DOCTOR MAY PRESCRIBE THIS MEDICINE FOR ANOTHER USE. IF YOU WANT MORE INFORMATION, ASK YOUR DOCTOR. If you have any further questions on your Nimotop treatment, or are unsure of the information, please see your doctor, nurse or dispensing pharmacist, who will be able to assist you. BEFORE YOU TAKE NIMOTOP _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE NIMOTOP TABLETS OR INFUSION SOLUTION IF YOU HAVE AN ALLERGY TO: • nimodipine, the active ingredient in Nimotop • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE BROKEN OR DISCOLOURED TABLETS, OR CLOUDY OR DISCOLOURED INFUSION SOLUTIONS. DO NOT TAKE NIMOTOP TABLETS IF YOU ARE TAKING ANOTHER MEDICINE CONTAINING: • phenobarbito Les hele dokumentet
Nimotop PI VX3.0; CCDS 5 1 AUSTRALIAN PRODUCT INFORMATION – NIMOTOP® (NIMODIPINE) 1 NAME OF THE MEDICINE Nimodipine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nimodipine is a yellow crystalline substance, practically insoluble in water. Nimodipine is light sensitive but to a much lesser degree than nifedipine. Nimotop is available as tablets containing 30 mg nimodipine or a 0.2 mg/mL concentrated intravenous infusion solution. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM NIMOTOP CONCENTRATED INTRAVENOUS INFUSION SOLUTION Clear slightly yellowish solution containing 10 mg nimodipine/50 mL and 10 g alcohol/ 50 mL. NIMOTOP TABLETS Round convex, yellow film-coated tablets containing 30 mg nimodipine marked "SK" on top and the Bayer cross on the bottom. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Prophylaxis and treatment of ischaemic neurological deficits caused by cerebral vasospasm after subarachnoid haemorrhage following ruptured intracranial aneurysm, in patients who are in good neurological condition post-ictus, e.g., Hunt and Hess Grades I-III (see Section 5 Pharmacological properties). 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE: NIMOTOP CONCENTRATED INTRAVENOUS INFUSION SOLUTION For single use in one patient only. Discard any residue. _Continuous intravenous infusion: _ Nimotop concentrated intravenous infusion solution must be administered by co-infusion via a three- way stopcock to the central catheter. The initial dosage is 5 mL Nimotop concentrated intravenous solution (= 1 mg nimodipine) per hour infused continuously for the first 2 hours (approximately 15 µg/kg body weight/hr). Co-infusion solution must be administered at a rate of 20 mL per hour with this initial dosage. If this dosage is tolerated, particularly if there is no severe reduction in blood pressure, the dosage should then be increased to 10 mL Nimotop concentrated intravenous infusion Nimotop PI VX3.0; CCDS 5 2 solution per hour (= 2 mg nimodipine/h) (approximately 30 µg/kg body Les hele dokumentet