Leaflet DEXMEDETOMIDINA KALCEKS 100mcg / ml concentrate for solution for infusion

Indicated for: sedation

Route of administration: infusion

Substance: dexmedetomidine (sedative-hypnotic)

ATC: N05CM18 (Nervous system | Hypnotics and sedatives | Other hypnotics and sedatives)

Precautions:
Driving impairment
Driving impairment

This medicine may affect your ability to drive or use machines.

Dizziness / vertigo
Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Dependence / abuse
Dependence / abuse

This medicine may cause dependence or be misused.

Respiratory depression
Respiratory depression

May slow breathing, especially with alcohol or sedatives.

Avoid alcohol
Avoid alcohol

Avoid alcohol during treatment.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Elderly warning
Elderly warning

Older people may have an increased risk of side effects.

Withdrawal / do not stop abruptly
Withdrawal / do not stop abruptly

Do not stop treatment abruptly without medical advice.

Drowsiness / sedation
Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

Dexmedetomidine is a medication used for sedation in intensive care units or during certain medical procedures. It is a selective alpha-2 adrenergic receptor agonist that induces sedation, analgesia, and anxiolysis.

The medication is administered intravenously under the strict supervision of a doctor, and the dosage is adjusted based on the patient's response. Dexmedetomidine is preferred in certain situations due to its minimal effects on respiratory function.

Side effects may include low blood pressure, bradycardia, nausea, or dry mouth. In rare cases, severe adverse effects such as cardiac arrhythmias may occur.

Patients should be closely monitored during treatment, and pregnant or breastfeeding women should consult a specialist before use.

General data about DEXMEDETOMIDINA KALCEKS 100mcg / ml

  • Substance: dexmedetomidine
  • Date of latest medicines list: 01-06-2026
  • Product code: W66498002
  • Concentration: 100mcg / ml
  • Pharmaceutical form: concentrate for solution for infusion
  • Packing volume: 2ml
  • Product type: Generic medicine
  • Price: 2558.96 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: AS KALCEKS - LETONIA
  • Holder: AS KALCEKS - LETONIA
  • Number: 12626/2019/02
  • Shelf life: 3 years