MIDAZOLEX – Exir Pharmaceutical Company

MIDAZOLEX 5, 15

Ampoule Midazolam 5, 15mg/ml ( 1, 3ml )

Generic Name of Product	Brand Name	Dosage Form	Strength	Pharmacologic Group	Therapeutic Group	Unit Per Pack
Midazolam	Midazolex®	Ampoule	5 mg/ml (1ml) - 5 mg/ml (3ml)	Benzodiazepines	General anaesthesia	10

Indications And Usage

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 infusion in patients in intensive care.

Administration

Intravenous injection or by intravenous infusion

For the administration of Midazolam Injection, the patient should be placed in a supine position and remain there throughout the procedure. Resuscitation facilities should always be available and a second person fully trained in the use of such equipment should always be present.

Contraindications

Hypersensitivity to the active substance, benzodiazepines

Use of this drug for conscious sedation in patients with severe respiratory failure, or acute respiratory depression.

Precautions

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 in the recognition and management of expected adverse events including respiratory and cardiac resuscitation.

Special caution is required for the indication of conscious sedation in patients with impaired respiratory function

Adverse Reactions

Sedation, amnesia, impaired attention and impaired muscular function may adversely affect the ability to drive or use machines.

Pregnancy and lactation

Midazolam should not be used during pregnancy unless clearly necessary. It is preferable to avoid using it for caesarean.

Midazolam passes in low quantities into breast milk. Nursing mothers should be advised to discontinue breast-feeding for 24 hours following administration of midazolam.

Renal and liver Impairment

There is no specific data in patients with severe renal impairment (creatinine clearance below 30 ml/min) receiving midazolam for induction of anaesthesia.

Laboratory Tests

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