HYPNOVEL Solution for injection (2022)

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Περιεχόμενα

1. Name of the medicinal product

Hypnovel 10mg/2ml solution for injection.

2. Qualitative and quantitative composition

Active ingredient: midazolam as hydrochloride. Ampoules 10mg/2ml; for i.v., i.m. and rectal administration. For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for injection.

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 ...

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 ...

4.3. Contraindications

Hypersensitivity to the active substance, benzodiazepines or to any of the excipients listed in section 6.1. Conscious sedation in patients with severe respiratory failure or acute respiratory depression. ...

4.4. Special warnings and precautions for use

Midazolam should be administered only by experienced physicians in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained ...

4.5. Interaction with other medicinal products and other forms of interaction

Pharmacokinetic Interactions Midazolam is metabolised by CYP3A4. Inhibitors and inducers of CYP3A have the potential to respectively increase and decrease the plasma concentrations, and subsequently the ...

4.6. Pregnancy and lactation

Pregnancy Insufficient data are available on midazolam to assess its safety during pregnancy. Animal studies do not indicate a teratogenic effect, but foetotoxicity was observed as with other benzodiazepines. ...

4.7. Effects on ability to drive and use machines

Midazolam has a major influence on the ability to drive and use machines. Sedation, amnesia, impaired attention and impaired muscular function may adversely affect the ability to drive or use machines. ...

4.8. Undesirable effects

Table 4 summarises the undesirable effects which have been reported (frequency not known, cannot be estimated from the available data) to occur when midazolam is injected. Tabulated list of adverse reactions ...

4.9. Overdose

Symptoms Like other benzodiazepines, midazolam commonly causes drowsiness, ataxia, dysarthria and nystagmus. Overdose of midazolam is seldom life-threatening if the drug is taken alone, but may lead to ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Hypnotics and sedatives (benzodiazepine derivatives) ATC code: N05CD08 Mechanism of action The central actions of benzodiazepines are mediated through an enhancement ...

5.2. Pharmacokinetic properties

Absorption Absorption after i.m. injection Absorption of midazolam from the muscle tissue is rapid and complete. Maximum plasma concentrations are reached within 30 minutes. The absolute bioavailability ...

5.3. Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6.1. List of excipients

Sodium chloride Hydrochloric acid Sodium hydroxide Water for injection

6.2. Incompatibilities

Admixture with Hartmanns solution is not recommended, as the potency of midazolam decreases.

6.3. Shelf life

60 months.

6.4. Special precautions for storage

Keep ampoules in the outer carton.

6.5. Nature and contents of container

Clear glass 2ml ampoules.

6.6. Special precautions for disposal and other handling

Hypnovel ampoule solution is stable, both physically and chemically, for up to 24 hours at room temperature when mixed with 500ml infusion fluids containing Dextrose 4% with Sodium Chloride 0.18%, Dextrose ...

7. Marketing authorization holder

Neon Healthcare Ltd., 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom

8. Marketing authorization number(s)

PL 45043/0037

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 8 December 1982 Date of latest renewal: 22 April 1998

10. Date of revision of the text

31/01/2022

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