SORAVAR 200 FILM COATED TABLET 200 MG

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Toimeaine:

Sorafenib Tosylate eqv to Sorafenib

Saadav alates:

ACCORD HEALTHCARE PRIVATE LIMITED

ATC kood:

L01EX02

Ravimvorm:

TABLET, FILM COATED

Koostis:

Sorafenib Tosylate eqv to Sorafenib 200 mg

Manustamisviis:

ORAL

Retsepti tüüp:

Prescription Only

Valmistatud:

Intas Pharmaceuticals Limited

Volitamisolek:

ACTIVE

Loa andmise kuupäev:

2023-05-10

Infovoldik

PACKAGE INSERT_ _
SORAVAR 200
(
_Sorafenib Tablets 200 mg_
)
I.
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S):
Sorafenib Tosilate (274 mg) Ph. Eur. equivalent to Sorafenib; 200 mg
II.
PRODUCT DESCRIPTION:
Red, round, biconvex, bevel-edged, film coated tablets debossed with
“H1” on one side and plain
on other side.
_LIST OF EXCIPIENTS: _
Tablet core
Microcrystalline cellulose,
Croscarmellose sodium,
Hypromellose E5,
Sodium lauryl sulphate,
Magnesium stearate
Film coating (
_Opadry 03F540266 Pink_
):
Hypromellose,
Titanium dioxide,
Macrogol/PEG,
Iron oxide red.
III.
PHARMACODYNAMICS/PHARMACOKINETICS:
_PHARMACODYNAMICS PROPERTIES: _
Pharmacotherapeutic group: Protein kinase inhibitor
ATC code: L01EX02
MECHANISM OF ACTION
Sorafenib is a multikinase inhibitor that decreases tumour cell
proliferation in vitro.
Sorafenib was shown to inhibit multiple intracellular (c-CRAF, BRAF
and mutant BRAF) and cell
surface kinases (KIT, FLT- 3, RET, VEGFR-1, VEGFR- 2, VEGFR- 3, and
PDGFR- ß). Several
of these kinases are thought to be involved in tumour cell signaling,
angiogenesis and apoptosis.
Sorafenib inhibited tumour growth of the human hepatocellular
carcinoma, renal cell carcinoma,
differentiated
thyroid
carcinoma
and
several
other
human
tumour
xenografts
in
immunocompromised mice. A reduction in tumour angiogenesis were seen
in models of human
hepatocellular carcinoma and renal cell carcinoma and increases in
tumour apoptosis were seen in
models of human hepatocellular, renal cell carcinoma and
differentiated thyroid carcinoma.
Additionally, a reduction in tumour cell signaling was seen in a model
of human hepatocellular
carcinoma and differentiated thyroid carcinoma.
CLINICAL EFFICACY
The clinical safety and efficacy of Sorafenib have been studied in
patients with hepatocellular
carcinoma (HCC), in patients with advanced renal cell carcinoma
(RCC) and in patients with
Differentiated Thyroid Carcinoma (DTC).
HEPATOCELLULAR CARCINOMA
Study 3 (study 100554) was a Phase III, international, multi-centre,
randomised, double bli

Toote omadused

PACKAGE INSERT_ _
SORAVAR 200
(
_Sorafenib Tablets 200 mg_
)
I.
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S):
Sorafenib Tosilate (274 mg) Ph. Eur. equivalent to Sorafenib; 200 mg
II.
PRODUCT DESCRIPTION:
Red, round, biconvex, bevel-edged, film coated tablets debossed with
“H1” on one side and plain
on other side.
_LIST OF EXCIPIENTS: _
Tablet core
Microcrystalline cellulose,
Croscarmellose sodium,
Hypromellose E5,
Sodium lauryl sulphate,
Magnesium stearate
Film coating (
_Opadry 03F540266 Pink_
):
Hypromellose,
Titanium dioxide,
Macrogol/PEG,
Iron oxide red.
III.
PHARMACODYNAMICS/PHARMACOKINETICS:
_PHARMACODYNAMICS PROPERTIES: _
Pharmacotherapeutic group: Protein kinase inhibitor
ATC code: L01EX02
MECHANISM OF ACTION
Sorafenib is a multikinase inhibitor that decreases tumour cell
proliferation in vitro.
Sorafenib was shown to inhibit multiple intracellular (c-CRAF, BRAF
and mutant BRAF) and cell
surface kinases (KIT, FLT- 3, RET, VEGFR-1, VEGFR- 2, VEGFR- 3, and
PDGFR- ß). Several
of these kinases are thought to be involved in tumour cell signaling,
angiogenesis and apoptosis.
Sorafenib inhibited tumour growth of the human hepatocellular
carcinoma, renal cell carcinoma,
differentiated
thyroid
carcinoma
and
several
other
human
tumour
xenografts
in
immunocompromised mice. A reduction in tumour angiogenesis were seen
in models of human
hepatocellular carcinoma and renal cell carcinoma and increases in
tumour apoptosis were seen in
models of human hepatocellular, renal cell carcinoma and
differentiated thyroid carcinoma.
Additionally, a reduction in tumour cell signaling was seen in a model
of human hepatocellular
carcinoma and differentiated thyroid carcinoma.
CLINICAL EFFICACY
The clinical safety and efficacy of Sorafenib have been studied in
patients with hepatocellular
carcinoma (HCC), in patients with advanced renal cell carcinoma
(RCC) and in patients with
Differentiated Thyroid Carcinoma (DTC).
HEPATOCELLULAR CARCINOMA
Study 3 (study 100554) was a Phase III, international, multi-centre,
randomised, double bli