Leaflet MIDAZOLAM SUN 1mg / ml injection / infusion solution in pre-filled syringe


Indicated for: sedation

Route of administration: injectable / infusion

Substance: midazolam (benzodiazepine)

ATC: N05CD08 (Nervous system | Hypnotics and sedatives | Benzodiazepine derivatives)

Midazolam is a medication used for sedation, anxiety reduction, sleep induction, and seizure control. It belongs to the benzodiazepine class and works by enhancing the effect of gamma-aminobutyric acid (GABA), a neurotransmitter that decreases brain activity, inducing relaxation and drowsiness.

Midazolam is commonly used in medical or surgical procedures to induce conscious sedation or general anesthesia. It is also used to treat acute seizures, including status epilepticus, and to calm agitated patients in intensive care units.

It can be administered intravenously, intramuscularly, orally, or intranasally, depending on the indication. Its effects are rapid, but its duration is relatively short, making it ideal for use in acute situations.

Common side effects include drowsiness, dizziness, confusion, low blood pressure, and respiratory depression. In high doses or when combined with other central nervous system depressants (such as alcohol or opioids), it can cause severe respiratory depression or even respiratory arrest.

Midazolam must be used under strict medical supervision, and the dosage should be adjusted based on the patient's age, weight, and overall condition. It is contraindicated in individuals with benzodiazepine allergies or severe respiratory insufficiency.

General data about MIDAZOLAM SUN 1mg / ml

  • Substance: midazolam
  • Date of last drug list: 01-05-2026
  • Commercial code: W66102001
  • Concentration: 1mg / ml
  • Pharmaceutical form: injection / infusion solution in pre-filled syringe
  • Packing volume: 50ml
  • Product type: generic
  • Price: 105.83 RON
  • Prescription restrictions: TAB3 - Medicines that are issued with a special prescription (psychotropic) in green color.

Marketing authorisation

  • Manufacturer: SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V. - TARILE DE JOS
  • Holder: SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V. - TARILE DE JOS
  • Number: 15316/2024/01
  • Shelf life: 2 years

Concentrations available for midazolam

  • 10mg
  • 10mg/2ml
  • 1mg/ml
  • 2.5mg
  • 2.5mg/0.5ml
  • 2mg/ml
  • 5mg
  • 5mg/1ml
  • 5mg/ml
  • 7.5mg
  • 72.5mg/1.5ml

Compensation lists for MIDAZOLAM SUN 1mg / ml Sun Pharmaceutical Industries

C3 - Sublist C - section C3 (children, pregnant women and postpartum women) with 100% discount from the reference price

Price

Copayment

Patient

105.83 RON

33.71 RON

72.12 RON