Hypnovel

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

MIDAZOLAM HYDROCHLORIDE

Tilgængelig fra:

Roche Products (Ireland) Ltd

ATC-kode:

N05CD; N05CD08

INN (International Name):

MIDAZOLAM HYDROCHLORIDE

Dosering:

10 mg/5ml

Lægemiddelform:

Solution for injection

Recept type:

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

Terapeutisk område:

Benzodiazepine derivatives; midazolam

Autorisation status:

Marketed

Autorisation dato:

1985-03-27

Produktets egenskaber

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
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_2_
_1_
_/_
_0_
_8_
_/_
_2_
_0_
_1_
_8_
_C_
_R_
_N_
_ _
_2_
_2_
_0_
_8_
_2_
_8_
_6_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
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