Furosemide-Baxter

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Furosemide 10mg

Disponible depuis:

Baxter Healthcare Ltd

DCI (Dénomination commune internationale):

Furosemide 10 mg

Dosage:

10 mg/mL

forme pharmaceutique:

Solution for injection

Composition:

Active: Furosemide 10mg Excipient: Hydrochloric acid Sodium hydroxide pH adjustment Sodium chloride Sodium hydroxide Water for injection

Unités en paquet:

Ampoule, glass, Type I amber glass ampoule, 5 mL, 5 dose units

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Ipca Laboratories Limited

indications thérapeutiques:

Furosemide-Baxter Injection is indicated in adults, infants and children for the treatment of oedema associated with congestive heart failure, cirrhosis of the liver and renal disease including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential than that of those commonly employed is desired. Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations.

Descriptif du produit:

Package - Contents - Shelf Life: Ampoule, glass, Type I amber glass ampoule, 5 mL - 5 dose units - 3 years from date of manufacture stored at or below 25°C - Ampoule, glass, Type I amber glass ampoule,2 mL - 5 dose units - 3 years from date of manufacture stored at or below 25°C - Ampoule, glass, Type I amber glass ampoule, 5mL - 25 dose units - 3 years from date of manufacture stored at or below 25°C - Ampoule, glass, Type I amber glass ampoule, 2 mL - 25 dose units - 3 years from date of manufacture stored at or below 25°C

Date de l'autorisation:

2009-05-04

Résumé des caractéristiques du produit

NEW ZEALAND DATA SHEET
Furosemide‐Baxter Data Sheet 15 October 2019
Page 1 of 14
Baxter Healthcare Ltd
1 FUROSEMIDE‐BAXTER (10mg/mL solution for injection)
FUROSEMIDE‐BAXTER 10mg/mL solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
FUROSEMIDE‐BAXTER solution for injection contains 10mg frusemide per
mL.
FUROSEMIDE‐BAXTER is available in 2mL and 5mL ampoules which contain
20mg/2mL and 50mg/5mL
respectively.
_Excipients with known effect _
Sodium chloride and sodium hydroxide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
_Appearance _
FUROSEMIDE‐BAXTER solution for injection is a clear colourless
solution for injection.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
_OEDEMA _
FUROSEMIDE‐BAXTER solution for injection is indicated in adults,
infants and children for the
treatment of oedema associated with congestive heart failure,
cirrhosis of the liver and renal disease
including the nephrotic syndrome.
Frusemide is particularly useful when an agent with greater diuretic
potential than that of those
commonly employed is desired. Parenteral therapy should be reserved
for patients unable to take
oral medication or for patients in emergency clinical situations.
FUROSEMIDE‐BAXTER solution for injection is also indicated as
adjunctive therapy in acute pulmonary
oedema and cerebral oedema where intense and rapid onset of diuresis
is desired. If
gastrointestinal absorption is impaired or oral medication is not
practical for any reason, frusemide
is indicated by the intravenous route. Parenteral use should be
replaced with oral frusemide as soon
as practical.
4.2
Dose and method of administration
_Adults _
Parenteral therapy with FUROSEMIDE‐BAXTER solution for injection
should be used only in patients
unable to take oral medication or in emergency situations and should
be replaced with oral therapy
as soon as practical.
_Oedema_
The usual initial dose of FUROSEMIDE‐BAXTER is 20 to 40mg given as a
single dose, injected
intramuscularly