Hypnovel

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

MIDAZOLAM HYDROCHLORIDE

Fáanlegur frá:

Roche Products (Ireland) Ltd

ATC númer:

N05CD; N05CD08

INN (Alþjóðlegt nafn):

MIDAZOLAM HYDROCHLORIDE

Skammtar:

10 mg/2ml

Lyfjaform:

Solution for injection

Gerð lyfseðils:

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

Lækningarsvæði:

Benzodiazepine derivatives; midazolam

Leyfisstaða:

Marketed

Leyfisdagur:

1983-04-18

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hypnovel 10mg/2ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 5mg midazolam (as midazolam hydrochloride).
One ampoule of 2 ml contains 10mg midazolam.
Excipient(s) with known effect: Sodium 2.2mg/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, age