Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
pregabalin, Quantity: 300 mg
AdiraMedica Pty Ltd
Capsule, hard
Excipient Ingredients: mannitol; pregelatinised starch; purified talc; Gelatin; titanium dioxide; brilliant blue FCF; sodium lauryl sulfate; iron oxide yellow; iron oxide red
Oral
60 capsules, 56 capsules, 20 capsules, 14 capsules
(S4) Prescription Only Medicine
Pregabalin is indicated for the treatment of neuropathic pain in adults.,Pregabalin is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Visual Identification: Green Opaque Cap and Green Opaque Body of Size '0' hard gelatin capsules containing wihite coloured granular powder; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2022-03-28
Version: 01 Page 1 of 22 WARNINGS MISUSE, ABUSE POTENTIAL OR DEPENDENCE ADIRAMEDICA PREGABALIN is a potential drug of misuse, abuse, and dependence. ADIRAMEDICA PREGABALIN poses risks of misuse, abuse and dependence which can lead to overdose and death especially when used concomitantly with opioids and other CNS depressants. Assess the patient’s risk of misuse, abuse or dependence before prescribing and monitor the patient regularly during treatment, particularly amongst patients with current or past misuse, abuse or dependence of opioids and/or benzodiazepines (see Section 4.4 - Special warnings and precautions for use). AUSTRALIAN PRODUCT INFORMATION - ADIRAMEDICA PREGABALIN (PREGABALIN) CAPSULES 1. NAME OF THE MEDICINE Pregabalin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ADIRAMEDICA PREGABALIN capsules contain 25 mg, 75 mg, 150 mg and 300 mg pregabalin. EXCIPIENT(S) WITH KNOWN EFFECT: Contains mannitol. For the full list of excipients, see Section 6.1 – List of excipients. 3. PHARMACEUTICAL FORM ADIRAMEDICA PREGABALIN 25 mg capsules: Brown Opaque Cap and White Opaque Body of Size‘1’ hard gelatin capsules containing white coloured granular powder. ADIRAMEDICA PREGABALIN 75 mg capsules: Yellow Opaque Cap and Yellow Opaque body of Size ‘1’ hard gelatin capsules containing white coloured granular powder. ADIRAMEDICA PREGABALIN 150 mg capsules: Blue Opaque Cap and White Opaque body of Size ‘1’ hard gelatin capsules containing white coloured granular powder. ADIRAMEDICA PREGABALIN 300 mg capsules: Green Opaque Cap and Green Opaque body of Size ‘0’ hard gelatin capsules containing white coloured granular powder. Version: 01 Page 2 of 22 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pregabalin is indicated for the treatment of neuropathic pain in adults. Pregabalin is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE The dose range is 150 to 600 mg per day given in two divided doses. ADIRAM Izlasiet visu dokumentu