Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
quetiapine fumarate, Quantity: 115.122 mg (Equivalent: quetiapine, Qty 100 mg)
Arrotex Pharmaceuticals Pty Ltd
Quetiapine fumarate
Tablet, film coated
Excipient Ingredients: calcium hydrogen phosphate dihydrate; purified talc; colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type A; povidone; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400
Oral
100
(S4) Prescription Only Medicine
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 Dosage and 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: Yellow, round, biconvex, film-coated tablets imprinted with 'E 53' on one side and plain on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2011-10-18
AURO-QUETIAPINE CONSUMER MEDICINE INFORMATION Ver 1.2 Page 1 of 5 AURO-QUETIAPINE 25, 100, 150, 200 & 300 Quetiapine (as fumarate) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about AURO-QUETIAPINE. 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 will have weighed the risks of you taking it against the benefits they expect it will 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 AURO-QUETIAPINE IS USED FOR AURO-QUETIAPINE helps to correct chemical imbalances in the brain. It is used to treat conditions such as: • Schizophrenia, an illness with disturbances in thinking, feelings and behaviour • Bipolar disorder, an illness in which there are sustained mood swings either up (mania) or down (depression). During mania, patients experience episodes of overactivity, elation or irritability. During depression, patients may feel depressed or guilty, lack energy, lose their appetite and have trouble sleeping. AURO-QUETIAPINE belongs to a group of medicines called antipsychotics. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Your doctor may prescribe this medicine for another reason. It is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE AURO-QUETIAPINE WHEN YOU MUST NOT TAKE AURO-QUETIAPINE DO NOT TAKE AURO-QUETIAPINE IF YOU HAVE AN ALLERGY TO • quetiapine, the active ingredient in the medicine • any of the other 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 or you may feel faint. DO NOT GIVE AURO-QUETIAPINE TO CHILDRE Lees het volledige document
Product Information: AURO-QUETIAPINE (Quetiapine Tablets 25, 100, 150, 200 & 300 mg) Ver 1.3 Page 1 of 35 PRODUCT INFORMATION AURO-QUETIAPINE 25 (25 MG QUETIAPINE AS FUMARATE) AURO-QUETIAPINE 100 (100 MG QUETIAPINE AS FUMARATE) AURO-QUETIAPINE 150 (150 MG QUETIAPINE AS FUMARATE) AURO-QUETIAPINE 200 (200 MG QUETIAPINE AS FUMARATE) AURO-QUETIAPINE 300 (300 MG QUETIAPINE AS FUMARATE) NAME OF THE MEDICINE The name of the medicine is Quetiapine as Quetiapine fumarate CHEMICAL NAME: Bis[2-[2-(4-dibenzo[b,f] [1,4]thiazepin-11-yl)piperazin-1-yl] ethoxy)ethanol] fumarate. MOLECULAR FORMULA: (C 21 H 25 N 3 O 2 S) 2 .C 4 H 4 O 4 MOLECULAR WEIGHT: 883.10 CAS REGISTRY NUMBER: _[111974-72-2]_ DESCRIPTION Quetiapine fumarate is a weak acid (pKa 3.3, 6.8) which exhibits moderate pH dependent solubility (94.3 mg/mL to 2.37 mg/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 is a white to off white powder. It is freely soluble in glacial acetic acid, soluble in N,N-dimethylformamide, sparingly soluble in methanol. Inactive: Calcium hydrogen phosphate, lactose, cellulose-microcrystalline (Avicel PH-101 & PH- 102), sodium starch glycollate type A, povidone, silica-colloidal anhydrous, talc-purified & magnesium stearate. The 25 mg tablet also contains opadry film coating pink 03B84904 (PI-ARTG No. 106472). The 100 mg tablet also contains opadry film coating yellow 03B82923 (PI-ARTG No. 106480). The 150 mg tablet also contains opadry film coating yellow 03B82924 (PI-ARTG No. 106483). The 200 mg tablet also contains hypromellose, macrogol 400 & titanium dioxide. The 300 mg tablet also contains hypromellose, macrogol 400 & titanium dioxide. Product Information: AURO-QUETIAPINE (Quetiapine Tablets 25, 100, 150, 200 & 300 mg) Ver 1.3 Page 2 of 35 The 100mg, 150mg, 200mg & 300mg tablets also contains Opacode Black S-1-17823 (PI-ARTG No. 12108) as imprinting ink. PHARMACOLOGY MECHANISM OF ACTION Quetiapine is an atypica Lees het volledige document