PRODUCT DETAIL

Scopolamine butylbromide Kalceks 20 mg/ml injekčný roztok

Code

3594D

MA number

73/0031/20-S

Product Form:

sol inj 10x1 ml (amp.skl.)

MA Status:

R - Valid Marketing Authorisation

Type of procedure:

Decentralised

Therapeutic Class:

73 - SPASMOLYTICA

ATC:

A	ALIMENTARY TRACT AND METABOLISM
A03	DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
A03B	BELLADONNA AND DERIVATIVES, PLAIN
A03BB	Belladonna alkaloids, semisynthetic, quaternary amines
A03BB01	Butylscopolamine

Shelf life:

Container:

glass ampoule

Route of admin.:

Subcutaneous, intramuscular and intravenous use

Prescription Status:	Medicinal product subject to medical prescription.
Legal basis:	Article 10(1) generic application
MA issued:	05.03.2020
Validity:	05.03.2025
MA renewed:	Renewal application submitted
Pediatric indication:	Yes
Pediatric posology:	Yes
PIL:	PIL_Scopolamine butylbromide Kalceks 20 mg_ml injekčný roztok_12_2022.pdf
SPC:	SPC_Scopolamine butylbromide Kalceks 20 mg_ml injekčný roztok_12_2022.pdf
Safety feature	Yes
Data update:	08.12.2020