Metoclopramide

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Metoclopramide hydrochloride monohydrate 5 mg/mL;  

Dostupné z:

AstraZeneca Limited

INN (Medzinárodný Name):

Metoclopramide hydrochloride monohydrate 5 mg/mL

Dávkovanie:

5 mg/mL

Forma lieku:

Solution for injection

Zloženie:

Active: Metoclopramide hydrochloride monohydrate 5 mg/mL   Excipient: Hydrochloric acid Sodium chloride Water for injection

Počet v balení:

Syringe, 5mg/mL in 2mL x 50, 100 mL

Trieda:

Prescription

Typ predpisu:

Prescription

Výrobca:

Dipharma Francis Srl

Prehľad produktov:

Package - Contents - Shelf Life: Syringe, 5mg/mL in 2mL x 50 - 100 mL - 24 months from date of manufacture stored at or below 25°C

Dátum Autorizácia:

1993-12-08

Súhrn charakteristických

Page 1 of 11
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
Metoclopramide Injection Ampoule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metoclopramide
Injection
contains
metoclopramide
hydrochloride
monohydrate
10.54 mg/2 mL,
e
quivalent to m
etoclopramide hydrochloride 10 mg/2 mL.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection.
Metoclopramide Injection is a clear, colourless, sterile,
preservative-free solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS (20 YEARS AND OVER)
•
Relief of nausea and vomiting associated with migraine, cancer therapy
(chemotherapy or radiation),
malignant disease, labour, infectious disease and uraemia
•
Control of post-operative vomiting
•
Assist in small bowel intubation
Metoclopramide is of little benefit for the prevention or treatment of
motion sickness.
YOUNG ADULTS AND CHILDREN (OVER 1 YEAR OF AGE)
Metoclopramide should be restricted to the following conditions and
only used as second line therapy,
when used to treat children and young adults under 20 years of age
because of the risk of adverse effects:
•
Severe intractable vomiting of known cause
•
Vomiting associated with radiation therapy or intolerance to cytotoxic
drugs
•
Assist in small bowel intubation
4.2 DOSE AND METHOD OF ADMINISTRATION
The dosage recommendations should be strictly adhered to in order to
minimise the possibility of
dystonic side effects. Metoclopramide should only be used after
careful examination has excluded any
underlying disorder (such as cerebral irritation) that may have
induced nausea and vomiting.
Total daily doses of metoclopramide should not normally exceed 0.5
mg/kg bodyweight with a
maximum of 30 mg daily. This should be less (if possible) in children
and young adults, when given
by injection. Maximum recommended treatment duration is 5 days in all
age groups.
Page 2 of 11
Usual dosage is as follows and should be administered intramuscularly
or by slow intravenous injection
over 1 to 2 minutes.
_ADULTS _
_20 years a