Metaraminol Phebra

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Metaraminol tartrate 0.95 mg/mL equivalent to Metaraminol 0.5 mg/mL

Dostupné s:

Phebra NZ Limited

Dávkování:

3 mg/6mL

Léková forma:

Solution for injection

Složení:

Active: Metaraminol tartrate 0.95 mg/mL equivalent to Metaraminol 0.5 mg/mL Excipient: Sodium chloride Sodium hydroxide Sodium metabisulfite Tartaric acid Water for injection

Druh předpisu:

Prescription

Terapeutické indikace:

Prevention and treatment of the acute hypotensive state occurring with spinal anaesthesia; adjunctive treatment of hypotension due to haemorrhage, reactions to medications, surgical complications, and shock associated with brain damage due to tumour or trauma.

Přehled produktů:

Package - Contents - Shelf Life: Vial, glass, 7 mL clear type I with rubber stopper and aluminium seal - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light

Datum autorizace:

2017-05-18

Charakteristika produktu

DATA SHEET
Metaraminol Phebra 0.5 mg/mL Solution for Injection
Version 2.0
Page 1 of 5
1
PRODUCT NAME
Metaraminol Phebra 0.5 mg/mL solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Metaraminol Phebra solution for injection contains
metaraminol (as tartrate) 0.5 mg.
Each 6 mL vial contains 3.0 mg metaraminol (as tartrate). Each 10 mL
vial contains 5.0 mg metaraminol
(as tartrate).
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Solution for injection
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Prevention and treatment of the acute hypotensive state occurring with
spinal anaesthesia; adjunctive
treatment of hypotension due to haemorrhage, reactions to medications,
surgical complications, and
shock associated with brain damage due to tumour or trauma.
It may also be useful as an adjunct in the treatment of hypotension
due to cardiogenic shock or
septicaemia.
4.2
Dose and method of administration
Metaraminol Phebra injection is for intravenous administration only
(injection or infusion) and should
be used in one patient on one occasion only. It contains no
antimicrobial preservative. Unused solution
should be discarded.
Because the maximum effect is not immediately apparent, at least ten
minutes should elapse before
increasing the dosage. As the effect tapers off when the vasopressor
is discontinued, the patient should
be carefully observed so that therapy can be reinitiated promptly if
the blood pressure falls too rapidly.
Patients with coexistent shock and acidosis may show a poor response
to vasopressors. Established
methods of shock management, such as blood or fluid replacement when
indicated, and other
measures directed to the specific cause of the shock also should be
used.
Direct intravenous injection
In severe shock, when time is of great importance, it may be desirable
to administer Metaraminol
Phebra injection by direct intravenous injection. The suggested dose
is 0.5 to 5 mg (1 to 10 mL),
followed by an infusion of 15 to 95 mg in a diluent made up to a total
volume of 500