Hypnovel

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

MIDAZOLAM HYDROCHLORIDE

Commercializzato da:

Roche Products (Ireland) Ltd

Codice ATC:

N05CD; N05CD08

INN (Nome Internazionale):

MIDAZOLAM HYDROCHLORIDE

Dosaggio:

10 mg/5ml

Forma farmaceutica:

Solution for injection

Tipo di ricetta:

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

Area terapeutica:

Benzodiazepine derivatives; midazolam

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1985-03-27

Scheda tecnica

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