METOCLOPRAMIDE S.A.L.F 10 MG2 ML

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

METOCLOPRAMIDE HYDROCHLORIDE

Tillgänglig från:

RAZ PHARMACEUTICS LTD, ISRAEL

ATC-kod:

A03FA01

Läkemedelsform:

SOLUTION FOR INJECTION

Sammansättning:

METOCLOPRAMIDE HYDROCHLORIDE 5 MG/ML

Administreringssätt:

I.M, I.V

Receptbelagda typ:

Required

Tillverkad av:

S.A.L.F. S.P.A. LABORATORIO FARMACOLOGICO, ITALY

Terapiområde:

METOCLOPRAMIDE

Terapeutiska indikationer:

METOCLOPRAMIDE S.A.L.F 10 MG/2 ML is indicated in adults for: - Prevention of postoperative nausea and vomiting (PONV) - Prevention of delayed nausea and vomiting caused by chemotherapy (delayed CINV) - Prevention of nausea and vomiting caused by radiation therapy - Symptomatic treatment of nausea and vomiting, including nausea and vomiting caused by migraine attack. In migraine attacks, metoclopramide can be used concomitantly with oral analgesics to improve their absorption. - Diabetic gastroparesis - To faciliate diagnostic procedures (ie, to faciliate small bowel intubation and as an aid in radiological examinations) Pediatric population. METOCLOPRAMIDE S.A.L.F 10 MG/2 ML is indicated in children aged 1 to 18 years for: - Second line-therapy: Treatment of established postoperative nausea and vomiting (PONV) - Second-line therapy: Prevention of delayed nausea and vomiting caused by chemotherapy (delayed CINV) - To facilitate diagnostic procedures (ie, to faciliate small bowel intubation and as an aid in radiological examinations).

Tillstånd datum:

2022-04-30

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
METOCLOPRAMIDE S.A.L.F 10mg/2ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml solution contains:
Metoclopramide hydrochloride monohydrate 5.25 mg
(equivalent to 5 mg of Metoclopramide hydrochloride
anhydrous).
Each ampoule of 2ml contains:
Metoclopramide hydrochloride monohydrate 10.5 mg
(equivalent to 10 mg of Metoclopramide
hydrochloride anhydrous).
Excipients with known effect:
Each ampoule of 2ml contains 2.96 mg of sodium
metabisulphite.
Each ampoule of 2ml contains 1.29 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for I.V or I.M injection.
Clear colorless solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Metoclopramide is an antiemetic and stimulates GI
motility.
Adult population
METOCLOPRAMIDE S.A.L.F 10mg/2ml is indicated in
adults for:
-
Prevention of postoperative nausea and vomiting
(PONV).
-
Prevention of delayed nausea and vomiting caused
by chemotherapy (delayed CINV).
-
Prevention of nausea and vomiting caused by
radiation therapy.
-
Symptomatic treatment of nausea and vomiting,
including nausea and vomiting caused by migraine
attack. In migraine attacks, metoclopramide can be
used concomitantly with oral analgesics to improve
their absorption.
-
Diabetic gastroparesis.
-
To facilitate diagnostic procedures (i.e., to facilitate
small bowel intubation and as an aid in radiological
examinations).
Pediatric population
METOCLOPRAMIDE S.A.L.F 10mg/2ml is indicated in
children aged 1 to 18 years for:
-
Second line-therapy: Treatment of established
postoperative nausea and vomiting (PONV).
-
Second-line therapy: Prevention of delayed nausea
and vomiting caused by chemotherapy (delayed
CINV).
-
To facilitate diagnostic procedures (i.e., to facilitate
small bowel intubation and as an aid in radiological
examinations).
4.2
Posology and method of administration
Posology
Adult patients
For all adult indications except diabetic gastroparesis
and facilitation of diagnostic pro