HYPNOVEL AMPOULES 10 mg/2ml Solution for Injection

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

MIDAZOLAM HYDROCHLORIDE

Доступна з:

Roche Products Limited

Код атс:

N05CD08

ІПН (Міжнародна Ім'я):

MIDAZOLAM HYDROCHLORIDE

Дозування:

10 mg/2ml

Фармацевтична форма:

Solution for Injection

Тип рецепту:

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

Терапевтична области:

Benzodiazepine derivatives

Статус Авторизація:

Authorised

Дата Авторизація:

1983-04-18

інформаційний буклет

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

Характеристики продукта

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