Naloxone Hydrochloride Hameln

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Naloxone hydrochloride dihydrate 0.44 mg/mL equivalent to 0.40 mg naloxone hydrochloride

Disponible des:

Max Health Limited

Designació comuna internacional (DCI):

Naloxone hydrochloride dihydrate 0.44 mg/mL (equivalent to 0.40 mg naloxone hydrochloride)

Dosis:

400 mcg/mL

formulario farmacéutico:

Solution for injection

Composición:

Active: Naloxone hydrochloride dihydrate 0.44 mg/mL equivalent to 0.40 mg naloxone hydrochloride Excipient: Hydrochloric acid Sodium chloride Water for injection

tipo de receta:

Prescription

Fabricat per:

Sanofi Chimie

indicaciones terapéuticas:

Naloxone hydrochloride Injection is indicated for the complete or partial reversal of narcotic depression, including respiratory depression, induced by opioids including natural and synthetic narcotics, propoxyphene, methadone and the narcotic antagonist analgesics: nalbuphine, pentazocine and butorphanol. Naloxone hydrochloride is also indicated for the diagnosis of suspected acute opioid overdosage.

Resumen del producto:

Package - Contents - Shelf Life: Ampoule, glass, colourless neutral type I, nominal volume of 1ml - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, colourless neutral type I, nominal volume of 1ml - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light

Data d'autorització:

2015-02-24

Fitxa tècnica

NEW ZEALAND DATA SHEET
1. PRODUCT NAME
NALOXONE HYDROCHLORIDE (Hameln) 400 micrograms/mL Solution for
Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of 1 mL contains naloxone hydrochloride 400 micrograms
(0.4 mg) (as naloxone
hydrochloride dihydrate).
Excipient with known effect:
1 mL solution for injection/infusion contains 3.54 mg of sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless solution free from visible particulates.
pH: 3.1 – 4.5
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Naloxone hydrochloride Injection is indicated for the complete or
partial reversal of narcotic
depression, including respiratory depression, induced by opioids
including natural and synthetic
narcotics, propoxyphene, methadone and the narcotic antagonist
analgesics: nalbuphine, pentazocine
and butorphanol. Naloxone hydrochloride is also indicated for the
diagnosis of suspected acute opioid
overdosage.
4.2
DOSE AND METHOD OF ADMINISTRATION
Naloxone hydrochloride may be administered intravenously,
intramuscularly, or subcutaneously. The
most rapid onset of action is achieved by intravenous administration
and it is recommended in
emergency situations. Since the duration of action of some narcotics
may exceed that of naloxone
hydrochloride the patient should be kept under continued surveillance
and repeated doses of
naloxone hydrochloride should be administered, as necessary.
INTRAVENOUS INFUSION - Naloxone hydrochloride may be diluted for
intravenous infusion in normal
saline or 5% dextrose solutions. The addition of 2mg of naloxone
hydrochloride in 500 mL of either
solution provides a concentration of 0.004 mg/mL. Mixtures should be
used within 24 hours. After 24
hours, the remaining unused solution must be discarded. The rate of
administration should be titrated
in accordance with the patient's response.
Parenteral medicine products should be inspected visually for
particulate matter and discolouration
prior to administration