HYPNOVEL AMPOULES 10 MG/5ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MIDAZOLAM HYDROCHLORIDE

Available from:

Roche Products Limited

ATC code:

N05CD08

INN (International Name):

MIDAZOLAM HYDROCHLORIDE

Dosage:

10 MG/5ml

Pharmaceutical form:

Solution for Injection

Prescription type:

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

Therapeutic area:

Benzodiazepine derivatives

Authorization status:

Authorised

Authorization date:

1985-03-27

Patient Information leaflet

1
ie-pil-hypnovel-clean-170629-10mg-2ml&5ml-Inj
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HYPNOVEL
® 10MG/2ML SOLUTION FOR INJECTION
ROCHE
HYPNOVEL
® 10MG/5ML 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

Summary of Product characteristics

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