Controloc powder for solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

pantoprazole (pantoprazole sodium sesquihydrate)

Available from:

Takeda GmbH

ATC code:

A02BC02

INN (International Name):

pantoprazole (pantoprazole sodium sesquihydrate)

Dosage:

40mg

Pharmaceutical form:

powder for solution for injection

Units in package:

glass vial

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-10-29

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Controloc 40 mg powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate).
Excipients with known effect:
Each vial contains 1 mg disodium edetate and 0.24 mg sodium hydroxide.
This medicinal product contains less than 1 mmol sodium (23 mg) per
vial, i.e. is essentially
„sodium-free‟.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Reflux oesophagitis.
-
Gastric and duodenal ulcer.
-
Zollinger-Ellison-Syndrome and other pathological hypersecretory
conditions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicine should be administered by a healthcare professional and
under appropriate medical
supervision.
Intravenous administration of Controloc is recommended only if oral
administration is not appropriate.
Data are available on intravenous use for up to 7 days. Therefore, as
soon as oral therapy is possible,
treatment with Controloc i.v. should be discontinued and 40 mg
pantoprazole p.o. should be administered
instead.
Posology
Gastric and duodenal ulcer, reflux oesophagitis
The recommended intravenous dose is one vial of {Controloc} (40 mg
pantoprazole) per day.
Zollinger-Ellison-Syndrome and other pathological hypersecretory
conditions
For the long-term management of Zollinger-Ellison-Syndrome and other
pathological hypersecretory
conditions patients should start their treatment with a daily dose of
80 mg Controloc. Thereafter, the dose
can be titrated up or down as needed using measurements of gastric
acid secretion to guide. With doses
above 80 mg daily, the dose should be divided and given twice daily. A
temporary increase of the dose
above 160 mg pantoprazole is possible but should not be applied longer
than required for adequate acid
control.
3
In case a rapid acid control is required, a starting dose of 2