SUFENTA Solution for injection / infusion (2021)

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Περιεχόμενα

1. Name of the medicinal product

SUFENTA 2 mL solution for injection or infusion. SUFENTA 10 mL solution for injection or infusion.

2. Qualitative and quantitative composition

Each mL contains 0,005 mg (5 µg) sufentanil as sufentanil citrate. Sugar free. For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for injection or infusion. (For IV or epidural use.) A clear colourless solution. Free from visible foreign material.

4.1. Therapeutic indications

SUFENTA administered intravenously in adults is indicated: as an analgesic adjunct during induction and maintenance of balanced general anaesthesia as an anaesthetic agent for induction and maintenance ...

4.2. Posology and method of administration

SUFENTA injection should be administered only by persons specifically trained in the use of intravenous anaesthetics and management of the respiratory effects of potent opioids. Ensure that an opioid antagonist, ...

4.3. Contraindications

SUFENTA is contraindicated in patients with a known intolerance to sufentanil or to other opioids. Intravenous use in labour or before clamping of the cord during caesarean section is contraindicated due ...

4.4. Special warnings and precautions for use

Respiratory depression is dose related and can be reversed by specific opioid antagonists, e.g. naloxone, but a repeated dose of the antagonist may be necessary because the duration of respiratory depression ...

4.5. Interaction with other medicinal products and other forms of interaction

Effect of other medicines on SUFENTA Central nervous system (CNS) depressants Barbiturates, benzodiazepines or related medicines, neuroleptics, general anaesthetics and other non-selective CNS depressants ...

4.6. Pregnancy and lactation

Pregnancy Safety in pregnancy and lactation has not been established, although studies in animals have not demonstrated any teratogenic effects. SUFENTA added to epidural bupivacaine in total doses up ...

4.7. Effects on ability to drive and use machines

Patients should not drive, operate a machine or make legally binding decisions at least until 24 hours after administration of SUFENTA, nor should alcohol be consumed during that time period.

4.8. Undesirable effects

Clinical trial data The safety of SUFENTA was evaluated in 650 sufentanil-treated subjects who participated in 6 clinical trials. Of these, 78 subjects participated in 2 trials of sufentanil administered ...

4.9. Overdose

Signs and symptoms An overdose of SUFENTA manifests itself as an extension of its pharmacological actions. Depending on the individual sensitivity, the clinical picture is determined primarily by the degree ...

5.1. Pharmacodynamic properties

Category and class A. 2.9 Central nervous system depressants. Narcotic analgesics. Pharmacotherapeutic group: opioid anaesthetics ATC code: N01AH03 SUFENTA injection is an opioid analgesic ...

5.2. Pharmacokinetic properties

Sufentanil is a synthetic opioid with µ-agonist pharmacological effects. The pharmacokinetics of intravenous SUFENTA can be described as a three-compartment model with an average distribution time of 0,72 ...

5.3. Preclinical safety data

Preclinical effects were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to clinical use.

6.1. List of excipients

Hydrochloric acid solution (for pH adjustment) Sodium hydroxide solution (for pH adjustment) Sodium chloride Water for injection

6.2. Incompatibilities

SUFENTA solution must not be mixed with other products. If desired, SUFENTA may be mixed with sodium chloride or glucose intravenous infusions. Such dilutions are compatible with plastic infusion sets. ...

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store at or below 25°C. Protect from light.

6.5. Nature and contents of container

Cartons containing: 5 2 mL and 5 10 mL ampoules.

6.6. Special precautions for disposal and other handling

Wear gloves while opening the ampoule. 1. Hold the ampoule between the thumb and index finger, leaving the tip of the ampoule free. 2. With the other hand, hold the tip of the ampoule by putting the ...

7. Marketing authorization holder

Piramal Critical Care (Pty) Ltd, Office 2, Ground Floor, Kiepersol House, Stonemill Office Park, 300 Acacia Road, Darrenwood 2194

8. Marketing authorization number(s)

SUFENTA 2 mL: T/2.9/240 SUFENTA 10 mL: T/2.9/241

9. Date of first authorization / renewal of the authorization

22 February 1988

10. Date of revision of the text

15 July 2021

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