Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Sertraline hydrochloride 55.95mg equivalent to 50 mg Sertraline;
Teva Pharma (New Zealand) Limited
Sertraline hydrochloride 55.95 mg (equiv to 50 mg Sertraline)
50 mg
Film coated tablet
Active: Sertraline hydrochloride 55.95mg equivalent to 50 mg Sertraline Excipient: Calcium hydrogen phosphate Hyprolose Hypromellose Macrogol 400 Magnesium stearate Microcrystalline cellulose Polysorbate 80 Sodium starch glycolate Titanium dioxide
Prescription
Mylan Laboratories Limited
Sertraline Actavis is indicated for the treatment of symptoms of depression, including depression accompanied by symptoms of anxiety, in patients with or without a history of mania. Following satisfactory response, continuation with sertraline therapy is effective in preventing relapse of the initial episode of depression or recurrence of further depressive episodes.
Package - Contents - Shelf Life: Blister pack, PVC/Aluminium - 30 tablets - 48 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/Aluminium - 90 tablets - 48 months from date of manufacture stored at or below 25°C protect from light
2014-08-27
NEW ZEALAND CONSUMER MEDICINE INFORMATION SERTRALINE ACTAVIS Sertraline hydrochloride WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SERTRALINE ACTAVIS. 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 SERTRALINE ACTAVIS against the benefits it is expected to 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 SERTRALINE ACTAVIS IS USED FOR SERTRALINE ACTAVIS is used to treat depression and conditions called obsessive compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), social phobia (social anxiety disorder) and premenstrual dysphoric disorder (PMDD). PMDD affects some women in the days before their period. PMDD is different from premenstrual syndrome (PMS). The mood symptoms (anger, sadness, tension, etc) in PMDD are more severe than in PMS and affect the woman’s daily activities and relationships with others. SERTRALINE ACTAVIS belongs to a group of medicines called _ selective _ _serotonin reuptake inhibitors _(_SSRIs)_. They are thought to work by blocking the uptake of a chemical called serotonin into nerve cells in the brain. Serotonin and other chemicals called amines are involved in controlling mood. Your doctor, however, may prescribe SERTRALINE ACTAVIS for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SERTRALINE ACTAVIS HAS BEEN PRESCRIBED FOR YOU. SERTRALINE ACTAVIS should not be used in children and adolescents under the age of 18 years for the treatment of any medical condition other than obsessive compulsive disorder (OCD). The safety and efficacy of SERTRALINE ACTAVIS for the treatment of medical conditions (other than OCD) in this age group has not been satisfactorily established. For the treatment of OCD, SERTRALINE ACTAVIS is not recommended for Perskaitykite visą dokumentą
NEW ZEALAND DATA SHEET SERTRALINE ACTAVIS Sertraline hydrochloride Tablets 50mg & 100mg PRESENTATION _Sertraline Actavis Tablets 50mg:_ White to off white, capsule shaped, biconvex, film-coated tablets with “50” and “BL” embossed on either side of the breakline. _Sertraline Actavis Tablets 100mg:_ White to off- white, capsule shaped, biconvex, film coated tablets with “100” and “BL” embossed on one side. _Sertraline Actavis tablets include the following inert ingredients:_ Calcium hydrogen phosphate anhydrous, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate, hypromellose, macrogol 400, titanium dioxide, polysorbate – 80. “Do not halve the Sertraline Actavis 100mg tablet. Dose equivalence when the tablet is divided has not been established.” USES _ACTIONS _ Sertraline is a potent and selective inhibitor of neuronal serotonin (5-HT) uptake in vitro, which results in the potentiation of the effects of 5-HT in animals. It has only very weak effects on noradrenaline and dopamine neuronal reuptake. At clinical doses, sertraline blocks the uptake of serotonin into human platelets. It is devoid of stimulant, sedative or anticholinergic activity, or cardiotoxicity in animals. In controlled studies in normal volunteers, sertraline did not cause sedation and did not interfere with psychomotor performance. In accord with its selective inhibition of 5-HT uptake, sertraline does not enhance catecholaminergic activity. Sertraline has no affinity for muscarinic (cholinergic), serotonergic, dopaminergic, adrenergic, histaminergic, GABA or benzodiazepine receptors. The chronic administration of sertraline in animals was associated with downregulation of brain noradrenaline receptors as observed with other clinically effective antidepressants and antiobsessional drugs. Sertraline has not demonstrated potential for abuse. In a placebo-controlled, double blind, randomised study of the comparative abuse liability of sertraline, alprazolam and d-amphetamine in human Perskaitykite visą dokumentą