Vocinti 10 mg Film-Coated Tablet

Země: Filipíny

Jazyk: angličtina

Zdroj: FDA (Food And Drug Administration)

Aktivní složka:

Vonoprazan (as fumarate)

Dostupné s:

Japan; Importer: N/A; Distributor: Takeda Healthcare Philippines, Inc.

INN (Mezinárodní Name):

Vonoprazan (as fumarate)

Dávkování:

10 mg

Léková forma:

Film-Coated Tablet

Jednotky v balení:

PVC/Aluminum Blister Pack x 10's (Box of 30's), PVC/Aluminum blister by 10’s (Box of 30's)

Výrobce:

Takeda Pharmaceutical Company Limited (Hikari Plant)

Datum autorizace:

2023-03-23

Charakteristika produktu

PRODUCT DESCRIPTION:
10 mg tablets: pale yellow, oval, biconvex, film-coated tablets with "
B217" printed on one side
(
: Takeda logo)
20 mg tablets: pale red, oval, biconvex, film-coated tablets with
score on both sides and "
B218"
printed on one side (
: Takeda logo)
FORMULATION
Each tablet contains 10mg or 20mg Vonoprazan (as fumarate).
INDICATION
●

Gastric ulcer, duodenal ulcer, reflux esophagitis, prevention of
recurrence of gastric ulcer or
duodenal ulcer during low-dose aspirin administration, or prevention
of recurrence of gastric ulcer
or duodenal ulcer during NSAIDs administration
●

Adjunct to _Helicobacter pylori_ eradication in the followings
Gastric ulcer, duodenal ulcer, gastric MALT lymphoma, idiopathic
thrombocytopenic purpura, the
stomach after endoscopic resection of early stage gastric cancer, or
Helicobacter pylori gastritis
PRECAUTIONS FOR INDICATIONS
_Prevention of recurrence of gastric ulcer or duodenal ulcer during
low-dose aspirin administration_
This drug should be administered to the patients who are under
continuous administration of low-
dose aspirin for prevention of blood clots and emboli formation.
History of gastric ulcer or duodenal
ulcer should be confirmed before starting administration.
_Prevention of recurrence of gastric ulcer or duodenal ulcer during
NSAIDs administration_
This drug should be administered to the patients who are under
continuous administration of NSAIDs
for purpose such as pain management of rheumatoid arthritis or
osteoarthritis, etc. History of gastric
ulcer or duodenal ulcer should be confirmed before starting
administration.
ADJUNCT TO _HELICOBACTER PYLORI_ ERADICATION
(1)
The efficacy of _Helicobacter pylori_ eradication in the advanced
stage of gastric MALT lymphoma has
not been established.
(2)
_Helicobacter pylori_ eradication should be conducted in the
idiopathic thrombocytopenic purpura
patients only if _Helicobacter pylori_ eradication is considered
appropriate with referring to the
guidelines etc.
(3) The efficacy on the prevention o