Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
quetiapine fumarate, Quantity: 345.39 mg (Equivalent: quetiapine, Qty 300 mg)
Sandoz Pty Ltd
Quetiapine fumarate
Tablet, film coated
Excipient Ingredients: sodium starch glycollate type A; povidone; calcium hydrogen phosphate dihydrate; magnesium stearate; lactose monohydrate; microcrystalline cellulose; silicon dioxide; titanium dioxide; hypromellose; macrogol 4000
Oral
60 film-coated tablets
(S4) Prescription Only Medicine
Quetiapine Sandoz is indicated for:,Bipolar disorder Adults ? Maintenance treatment of bipolar I disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes ? Treatment of depressive episodes associated with bipolar disorder (see Dose and method of administration) ? Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate,Children/adolescents aged 10 to 17 years ? Monotherapy treatment of acute mania associated with bipolar I disorder,Schizophrenia (adults and adolescents aged 13 to 17 years) ? Treatment of schizophrenia
Visual Identification: QUETIAPINE SANDOZ 300mg is presented as a white coloured, capsoid in shape, scored on both sides, film-coated tablet; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2011-04-28
_Product Information _ _ _ _Quetiapine Sandoz 25/100/200/300mg film-coated tablets _ _1 _ _09/2017 _ _ _ _ _ _ _ _ _ _Sandoz Pty Ltd _ _ _ _Version 02 _ PRODUCT INFORMATION QUETIAPINE SANDOZ ® 25/100/200/300 MG FILM-COATED TABLETS NAME OF THE MEDICINE Quetiapine fumarate Chemical Name: Bis[2-(2-[4-(dibenzo[b,f][1,4]-thiazepin-11-yl)piperazin-1-yl] ethoxy) ethanol] fumarate. Quetiapine fumarate has no chiral centres and only one morphological entity has been detected throughout development. Structural Formula: CAS Number: 111974-72-2 Empirical formula: C 42 H 50 N 6 O 4 S 2 ∙ C 4 H 4 O 4 MW: 883.11 DESCRIPTION Quetiapine fumarate is a weak acid (pKa 3.3, 6.8) which exhibits moderate pH dependent solubility (94.3mg/mL to 2.37mg/mL at pH values from 1 to 9) and lypophilicity characteristics (Log P) which vary with pH (0.45 in water, 1.37 at pH 5, 2.65 at pH 7 and 2.59 at pH 9). Quetiapine fumarate displays good solid state stability, has an aqueous solubility of 3.29mg/mL at 25°C and exhibits suitable tableting properties when combined with appropriate excipients. Quetiapine Sandoz 25mg, 100mg, and 200mg are round, film-coated tablets. Quetiapine Sandoz 300mg is capsoid, film-coated tablets. Quetiapine Sandoz 25mg, 100mg, 200mg and 300mg tablets contain quetiapine fumarate equivalent to 25mg, 100mg, 200mg and 300mg quetiapine free base respectively. The inactive ingredients are: povidone, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, lactose monohydrate, sodium starch glycollate A, _Product Information _ _ _ _Quetiapine Sandoz 25/100/200/300mg film-coated tablets _ _2 _ _09/2017 _ _ _ _ _ _ _ _ _ _Sandoz Pty Ltd _ _ _ _Version 02 _ colloidal silica, magnesium stearate, hypromellose, macrogol 4000, titanium dioxide, iron oxide yellow C177492 (25mg and 100mg) and iron oxide red C177491 (25mg). PHARMACOLOGY PHARMACODYNAMICS _ _ Quetiapine is an atypical antipsychotic agent. Quetiapine and the human plasma metabolite, norquetiapine, interact with a broad range of neurotransmitter receptors. Queti Izlasiet visu dokumentu