Expiration date: 10/2025

The composition and form of issue:

Lyophilisate for preparation of intravenous solution. 1 vial contains:

Pipecuronium bromide 4 mg

excipients: 

lyophilisate — mannitol 

solvent sodium chloride, water for injections 

in vials together with the solvent (sodium chloride solution 0.9%) in 2 ml ampoules in a carton 25 sets.

Description pharmaceutical form:

Lyophilisate: white or almost white lyophilisate.

The solvent: colorless and transparent solution.

Pharmacological action:

Does n-holinoretseptora skeletal muscles, prevents their contact with the mediator (acetylcholine) slows down the depolarization of the endplate and disrupts neuromuscular transmission.

Indications:

Relaxation of the striated muscles during surgeries and diagnostic procedures in conditions of artificial lung ventilation.

Contraindications:

Hypersensitivity, myasthenia gravis.

Side effects:

Bradycardia, hypotension, rarely — anaphylactic reactions.

Drug interactions:

Effects Ardoin enhance and/or prolong inhalation (halothane, diethyl ether) and non-inhalation (ketamine, fentanyl, propanidid, barbiturates) drugs for anesthesia, antibiotics (aminoglycosides, tetracyclines, polypeptides, metronidazole), diuretics, beta-adrenergic blockers, thiamine, MAO inhibitors, Protamine, phenytoin, alpha-adrenergic blockers, calcium channel blockers, lidocaine (with on/in the introduction) reduce — glucocorticoids, neostigmine, norepinephrine, theophylline, calcium chloride, sodium chloride.

Method of application and dose:

Immediately before administration of 4 mg dry matter throw made solvent.

With a balanced anesthetic ED50 and ED90 of Arduan are 0.03 and 0.05 mg/kg of body weight respectively. The minimum time required for the onset of effect is observed at doses of 0.07–0.08 mg/kg.

The dose selected for each patient individually, taking into account the type of anesthesia, estimated duration of the surgical intervention, possible interactions with other drugs used before or during anesthesia, concomitant diseases and condition of the patient. For the control of neuromuscular block is recommended to use the stimulator of the peripheral nerves.

The drug should be used under the supervision of an experienced Clinician who is familiar with the operation and use of such drugs.

Recommended dose:

- initial dose for intubation and subsequent surgery — 0,08–0,1 mg/kg provides good to excellent conditions for intubation within 150-180 C, the duration of muscle relaxation is 60-90 min.

- initial dose for muscle relaxation during surgical intervention after intubation with succinylcholine — 0.05 mg/kg provides 30 to 60-minute muscle relaxation

- supporting dose of 0,01–0,02 mg/kg provides 30 to 60-minute muscle relaxation.

In chronic renal insufficiency dose depends on creatinine clearance: Cl >100 ml/min to 100 micrograms/kg, when Cl is 100 ml/min, 85 mcg/kg, when Cl 80 ml/min, 70 µg/kg, when Cl 60 ml/min — 55 µg/kg, when Cl <40 50="" p="">

Dose in children under 3 months not determined: 3 to 12 months — 40 mg/kg (which provides muscle relaxation with duration from 10 to 44 min), from 1 year to 14 years — 57 µg/kg (muscle relaxation — from 18 up to 52 min).

Effect of termination: at the time of 80-85% blockade, measured using a stimulator of peripheral nerve fibers, or when partial blockade, defined by clinical signs, application of atropine (0,5–1,25 mg) in combination with neostigmine (1-3 mg) or galantamine (10-30 mg) stops the neuromuscular action of Arduan.