Rocuronium bromide

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Rocuronium bromide 10 mg/mL;  

Disponible depuis:

Max Health Limited

DCI (Dénomination commune internationale):

Rocuronium bromide 10 mg/mL

Dosage:

10 mg/mL

forme pharmaceutique:

Solution for injection

Composition:

Active: Rocuronium bromide 10 mg/mL   Excipient: Glacial acetic acid Sodium acetate trihydrate Sodium chloride Water for injection

Type d'ordonnance:

Prescription

Fabriqué par:

Sicor de Mexico SA de CV

indications thérapeutiques:

Rocuronium is indicated as an adjunct to general anaesthesia to facilitate endotracheal intubation during routine induction, to provide muscle relaxation and to facilitate mechanical ventilation in adults, and paediatric patients from term newborn infants to adolescents. In adults, rocuronium is also indicated as an adjunct to general anaesthesia to facilitate endotracheal intubation during rapid sequence induction when suxamethonium is contraindicated. In adults, rocuronium is also indicated as an adjunct in the intensive care unit (ICU) to facilitate mechanical ventilation.

Descriptif du produit:

Package - Contents - Shelf Life: Ampoule, glass, Type 1, 5 mL - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 weeks not refrigerated stored at or below 30°C. Do not refrigerate. Do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type 1, 10mL - 5 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 weeks not refrigerated stored at or below 30°C. Do not refrigerate. Do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type 1, 5mL - 5 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 weeks not refrigerated stored at or below 30°C. Do not refrigerate. Do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type 1, 2.5mL - 5 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 weeks not refrigerated stored at or below 30°C. Do not refrigerate. Do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type 1, 10mL - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 weeks not refrigerated stored at or below 30°C. Do not refrigerate. Do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type 1, 5mL - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 weeks not refrigerated stored at or below 30°C. Do not refrigerate. Do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type 1, 2.5mL - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 weeks not refrigerated stored at or below 30°C. Do not refrigerate. Do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze)

Date de l'autorisation:

2014-08-05

Résumé des caractéristiques du produit

Page 1 of 14
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
Rocuronium bromide, 10mg/mL solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection / infusion contains 10 mg rocuronium
bromide.
Each vial filled with 2.5 mL solution contains 25 mg rocuronium
bromide.
Each ampoule or vial filled with 5 mL solution contains 50 mg
rocuronium bromide.
Each vial filled with 10 mL solution contains 100 mg rocuronium
bromide.
Excipient with known effect:
This medicinal product contains less than 1 mmoL sodium (23 mg) per
dose, that is to say
essentially 'sodium- free'.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale brownish-yellow solution
pH of the solution: 3.8 to 4.2
Osmolality: 270 – 310 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rocuronium is indicated as an adjunct to general anaesthesia to
facilitate endotracheal
intubation during routine induction, to provide muscle relaxation and
to facilitate mechanical
ventilation in adults, and paediatric patients from term newborn
infants to adolescents.
In adults, rocuronium is also indicated as an adjunct to general
anaesthesia to facilitate
endotracheal
intubation
during
rapid
sequence
induction
when
suxamethonium
is
contraindicated.
In adults, rocuronium is also indicated as an adjunct in the intensive
care unit (ICU) to facilitate
mechanical ventilation.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage
Like other neuromuscular blocking agents, rocuronium should only be
administered by, or under
supervision of, experienced clinicians who are familiar with the
action and use of these agents.
The dosage of rocuronium should be individualized in each patient. The
method of anaesthesia
and the expected duration of surgery, the method of sedation and the
expected duration of
mechanical ventilation, the possible interaction with other medicines
that are administered
concomitantly and the condition of the patient should be taken into
account when det