Leaflet SOFENTIL 50mcg / ml solution for injection / infusion


Indicated for: analgesia; anesthesia

Route of administration: injectable / infusion

Substance: sufentanil citrate (opioid analgesic)

ATC: N01AH03 (Nervous system | Anesthetics, general | Opioid anesthetics)

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.

Sufentanil citrate is a potent opioid analgesic used in anesthesia and for the management of severe pain. It works by binding to opioid receptors in the central nervous system, reducing the perception of pain.

The medication is administered intravenously or as sublingual tablets, as directed by a doctor. It is important for administration to be performed under strict medical supervision to prevent overdose.

Patients should be aware of potential side effects, such as drowsiness, nausea, or respiratory depression. It is important to inform the doctor of any unusual symptoms.

Common side effects include drowsiness, nausea, vomiting, and constipation. In rare cases, severe reactions such as respiratory depression or dependency may occur. Patients should be informed of these risks before starting treatment.

General data about SOFENTIL 50mcg / ml

  • Substance: sufentanil citrate
  • Date of last drug list: 01-06-2026
  • Commercial code: W65848002
  • Concentration: 50mcg / ml
  • Pharmaceutical form: solution for injection / infusion
  • Packing volume: 5 ml
  • Product type: generic
  • Price: 242.48 RON
  • Prescription restrictions: TAB2 - Medicines that are issued with a special prescription (narcotics) in yellow color.

Marketing authorisation

  • Manufacturer: MEDOCHEMIE LTD. - CIPRU
  • Holder: MEDOCHEMIE LTD. - CIPRU
  • Number: 11504/2019/02
  • Shelf life: Dupa ambalare pentru comercializare-30 months; Dupa prima deschidere a fiolei-it is used immediately

Pharmaceutical forms available for sufentanil citrate

Concentrations available for sufentanil citrate

  • 50mcg/ml
  • 5mcg/ml