JINARC TABLET 60MG30MG

Country: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

(30mg Tablet) Tolvaptan; (60mg Tablet) Tolvaptan

Fáanlegur frá:

OTSUKA PHARMACEUTICALS (SINGAPORE) PTE. LTD.

ATC númer:

C03XA01

Lyfjaform:

TABLET

Samsetning:

(30mg Tablet) Tolvaptan 30.000mg; (60mg Tablet) Tolvaptan 60.000mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

Prescription Only

Framleitt af:

Otsuka Pharmaceutical Co., Ltd. - Tokushima Factory (DP intermediate)

Leyfisstaða:

ACTIVE

Leyfisdagur:

2022-09-23

Vara einkenni

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This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
JINARC 15 mg tablets
JINARC 30 mg tablets
JINARC 45 mg tablets
JINARC 60 mg tablets
JINARC 90 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
JINARC 15 mg tablets
Each tablet contains 15 mg of tolvaptan.
_Excipient(s) with known effect _
Each 15 mg tablet contains approximately 35 mg lactose (as
monohydrate).
JINARC 30 mg tablets
Each tablet contains 30 mg of tolvaptan.
_Excipient(s) with known effect _
Each 30 mg tablet contains approximately 70 mg lactose (as
monohydrate).
JINARC 45 mg tablets
Each tablet contains 45 mg of tolvaptan.
_Excipient(s) with known effect _
Each 45 mg tablet contains approximately 12 mg lactose (as
monohydrate).
JINARC 60 mg tablets
Each tablet contains 60 mg of tolvaptan.
_Excipient(s) with known effect _
Each 60 mg tablet contains approximately 16 mg lactose (as
monohydrate).
JINARC 90 mg tablets
Each tablet contains 90 mg of tolvaptan.
_Excipient(s) with known effect _
Each 90 mg tablet contains approximately 24 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
JINARC 15 mg tablets
Blue, triangular, debossed with “OTSUKA” and “15” on one side.
JINARC 30 mg tablets
Blue, round, debossed with “OTSUKA” and “30” on one side.
JINARC 45 mg tablets
Blue, square, debossed with “OTSUKA” and “45” on one side.
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JINARC 60 mg tablets
Blue, modified rectangular, debossed with “OTSUKA” and “60” on
one side.
JINARC 90 mg tablets
Blue, pentagonal, debossed with “OTSUKA” and “90” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
JINARC is indicated to slow the progression of cyst development and
renal insufficiency of autosomal
dominant polycystic kidney disease (ADPKD) in