Hypnovel 10 mg/2 ml Solution for Injection

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Midazolam hydrochloride

Tillgänglig från:

CHEPLAPHARM Arzneimittel GmbH

ATC-kod:

N05CD; N05CD08

INN (International namn):

Midazolam hydrochloride

Dos:

10 mg/2ml

Läkemedelsform:

Solution for injection

Terapiområde:

Benzodiazepine derivatives; midazolam

Bemyndigande status:

Marketed

Tillstånd datum:

1983-04-18

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HYPNOVEL
® 10 MG/2 ML SOLUTION FOR INJECTION
HYPNOVEL
® 10 MG/5 ML SOLUTION FOR INJECTION
Midazolam (as midazolam hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or nurse.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Hypnovel is and what it is used for
2.
What you need to know before you are given Hypnovel
3.
How Hypnovel is given
4.
Possible side effects
5.
How to store Hypnovel
6.
Contents of the pack and other information
1.
WHAT HYPNOVEL IS AND WHAT IT IS USED FOR
Hypnovel contains the active substance midazolam, which belongs to a
group of medicines known as
benzodiazepines. It is a short-acting medicine that is used to induce
sedation (a very relaxed state of
calm, drowsiness or sleep) and relieves anxiety and muscle tension.
This medicine is used for:
•
Conscious sedation (an awake but very relaxed state of calm or
drowsiness during a medical test
or procedure) in adults and children.
•
Sedation of adults and children, in intensive care units.
•
Anaesthesia in adults, used alone or with other medicines.
•
Premedication (medicine used to cause relaxation, calm and drowsiness
before an anaesthetic) in
adults and children.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HYPNOVEL
YOU MUST NOT BE GIVEN HYPNOVEL IF:
•
You are allergic (hypersensitive) to midazolam or any of the other
ingredients of the medicine
(listed in section 6).
•
You are allergic to other benzodiazepine medicines, such as diazepam
or nitrazepam.
•
You have severe breathing problems and you are going to have Hyp

Produktens egenskaper

Health Products Regulatory Authority
21 September 2023
CRN00DRX2
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hypnovel 10 mg/2 ml 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
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
STANDARD DOSAGE
Health Products Regulatory Authority
21 September 2023
CRN00DRX2
Page 2 of 16
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 and concomitant medication. In
adults over 60 years, debilitated or chronically ill patients and
paediatric patients, dose should be determined with caution and
risk factors related to each patient should be taken into account.
Standard dosages are provided in the table below. Additional
details are provided in the text following the table.
Indication
Adults < 60 y
Adults ≥ 60 y /
debilitated or
chronically ill
Children
Conscious
sedation
_I.V._
Initial dose: 2 -
2.5mg
Titration doses:
1mg
Total dose: 3.5
- 7.5mg
_I.V._
Initial