QUETIAPINE SANDOZ quetiapine 100 mg (as fumarate) film-coated tablet bottle

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

quetiapine fumarate, Quantity: 115.13 mg (Equivalent: quetiapine, Qty 100 mg)

Pieejams no:

Sandoz Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

Quetiapine fumarate

Zāļu forma:

Tablet, film coated

Kompozīcija:

Excipient Ingredients: lactose monohydrate; magnesium stearate; calcium hydrogen phosphate dihydrate; silicon dioxide; microcrystalline cellulose; povidone; iron oxide yellow; sodium starch glycollate type A; titanium dioxide; hypromellose; macrogol 4000

Ievadīšanas:

Oral

Vienības iepakojumā:

90 film-coated tablets

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

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

Produktu pārskats:

Visual Identification: QUETIAPINE SANDOZ 100mg is presented as yellow coloured, round, scored on one side, film-coated tablets; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Autorizācija statuss:

Licence status A

Autorizācija datums:

2011-04-28

Produkta apraksts

_Product Information _
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_Quetiapine Sandoz 25/100/200/300mg film-coated tablets _
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_09/2017 _
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_Sandoz Pty Ltd _
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_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