MIDAZOLAM Solution for injection or infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Midazolam 5mg/ml Solution for Injection/Infusion.
Qualitative and quantitative composition
Each 1ml solution contains 5mg midazolam presented in 2ml and 10ml ampoules. Excipient(s) with known effect: Each 1ml contains 1.97 mg of Sodium. For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for Injection / Infusion.
Therapeutic indications
As intravenous sedative cover before and during minor medical, dental and surgical procedures such as gastroscopy, endoscopy, cystoscopy, bronchoscopy and cardiac catheterisation. For sedation by continuous ...
Posology and method of administration
Posology Intravenous sedation One or more intravenous administrations over a single operating session. In most circumstances, the 2mg/ml formulation is more convenient for titration purposes. Adults An ...
Contraindications
Hypersensitivity to the active substance, benzodiazepines or to any excipient listed in section 6.1. Use of this drug for conscious sedation in patients with severe respiratory failure, or acute respiratory ...
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 ...
Interaction with other medicinal products and other forms of interaction
Pharmacokinetic Interactions Midazolam is metabolised by CYP3A4. Inhibitors and inducers of CYP3A4 have the potential to respectively increase and decrease the plasma concentrations and, subsequently, ...
Pregnancy and lactation
Pregnancy Midazolam should not be used during pregnancy unless clearly necessary. It is preferable to avoid using it for caesarean. Insufficient data are available on midazolam to assess its safety during ...
Effects on ability to drive and use machines
Sedation, amnesia, impaired attention and impaired muscular function may adversely affect the ability to drive or use machines. Prior to receiving midazolam, the patient should be warned not to drive a ...
Undesirable effects
The following undesirable effects have been reported to occur when midazolam is injected: Frequency categories are as follows: Very common: ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1,000 to <1/100 Rare ...
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Hypnotics and sedatives (benzodiazepine derivatives) ATC code: N05CD08 Midazolam is a derivative of the imidazobenzodiazepine group. The free base is a lipophilic substance ...
Pharmacokinetic properties
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 after i.m. ...
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.
List of excipients
Sodium chloride Hydrochloric acid Sodium hydroxide Water for injections
Incompatibilities
Midazolam Injection is stable, both physically and chemically, for up to 1 hour at room temperature when mixed in the same syringe with Atropine Sulphate Injection BP or Hyoscine Hydrobromide Injection ...
Shelf life
Unopened: 3 years. After reconstitution: not applicable. After first opening: not applicable.
Special precautions for storage
Protect from light. Store below 25°C.
Nature and contents of container
Clear One Point Cut (OPC) 2ml & 10ml glass ampoules, glass type I, Ph. Eur. Pack sizes: 5 2ml ampoules; 10 2ml ampoules. 5 10ml ampoules; 10 10ml ampoules Not all pack sizes may be marketed.
Special precautions for disposal and other handling
If only part used, discard the remaining solution. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK
Marketing authorization number(s)
PL 12762/0591
Date of first authorization / renewal of the authorization
20/12/2005
Date of revision of the text
February 2019
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