Hypnovel

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

MIDAZOLAM HYDROCHLORIDE

Disponibil de la:

Roche Products (Ireland) Ltd

Codul ATC:

N05CD; N05CD08

INN (nume internaţional):

MIDAZOLAM HYDROCHLORIDE

Dozare:

10 mg/5ml

Forma farmaceutică:

Solution for injection

Tip de prescriptie medicala:

Product subject to prescription which may not be renewed (A)

Zonă Terapeutică:

Benzodiazepine derivatives; midazolam

Statutul autorizaţiei:

Marketed

Data de autorizare:

1985-03-27

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hypnovel 10mg/5ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2 mg midazolam (as midazolam hydrochloride).
One ampoule of 5ml contains 10mg midazolam.
Excipient(s) with known effect: Sodium 3.48mg/ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypnovel is a short-acting sleep-inducing drug that is indicated:
IN ADULTS
CONSCIOUS SEDATION before and during diagnostic or therapeutic
procedures with or without local
anaesthesia.
ANAESTHESIA
Premedication before induction of anaesthesia
Induction of anaesthesia
As a sedative component in combined anaesthesia.
SEDATION IN INTENSIVE CARE UNITS
IN CHILDREN
CONSCIOUS SEDATION before and during diagnostic or therapeutic
procedures with or without local
anaesthesia.
ANAESTHESIA
Premedication before induction of anaesthesia.
SEDATION IN INTENSIVE CARE UNITS
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4.2 POSOLOGY AND METHOD OF ADMINISTRATION
STANDARD DOSAGE
Midazolam is a potent sedative agent that requires titration and slow
administration. Titration is strongly recommended
to safely obtain the desired level of sedation according to the
clinical need, physical status, ag