Medicinal Products

PERFANE 100 mg / 20 mL

Generic drug of the therapeutic class: Cardiology and angiology
Active ingredients: Enoximone
laboratory: Carinopharm Gmbh

IV injectable solution
Box of 10 ampoules of 20 ml
All forms

Indication

Short-term treatment of congestive heart failure.

Dosage PERFANE 100 mg / 20 mL Injectable solution for injection IV Box of 10 ampoules of 20 ml

Dosage

a) Initial treatment:

Treatment may be initiated at a dose of 0.5 - 1.0 mg / kg administered at a rate not exceeding 12.5 mg / min; repeated doses of 0.5 mg / kg may be administered every 30 minutes until a satisfactory hemodynamic response is obtained or until a total cumulative dose of 3.0 mg / kg is reached. The treatment can also be started using a perfusion rate of 90 μg / kg / min administered over 10 to 30 minutes and until the desired hemodynamic response is obtained.

b) Maintenance treatment:

Maintaining the hemodynamic response can be achieved by repeated injection of diluted PERFAN solution (4 to 8 times per 24 hours) at a dose up to the effective initial dose (maximum 3.0 mg / kg).

Treatment may also be maintained with continuous or intermittent infusion at a dose of 5 to 20 μg / kg / min for up to 48 hours.

Use in children :

This medication should not be used in children due to the lack of data on safety and efficacy.

Administration mode

The pH of the solution being approximately 12:

· This solution MUST BE DILUTED before injection,

· Its use is strictly intravenous.

The specialty must be diluted in 0.9% sodium chloride solution or in water for injection. Do not use other solutes and especially do not use glucose solution because of a risk of crystallization.

If dilution is not used immediately, it can be stored at room temperature for up to 24 hours.

ONLY PLASTIC BOTTLES should be used to prepare dilutions, in order to avoid the risk of crystallisation which occurs within one hour if the solution is left in vials or glass syringes. DO NOT REFRIGERATE the dilutions due to the risk of crystallisation.

NO OTHER PRODUCT OR LIQUID SHOULD BE MIXED in the same vial or syringe as the solution or even administered at the same time in the same infusion line.

The following procedure is recommended:

Dilute the product volume to volume with either 0.9% sodium chloride solution or water for injection.

Against indications

This medicine should not be prescribed in the following cases;

· Severe obstructive heart disease and valvulopathies,

· Uncompensated severe hypovolemia,

Supraventricular tachyarrhythmias, ventricular aneurysm,

· Known hypersensitivity reactions to enoximone or other constituents.

Due to the presence of alcohol, this drug is not recommended in combination with drugs that provoke an antabuse reaction (heat, redness, vomiting, palpitations) with alcohol (disulfiram, certain antibacterials, some antifungals), CNS depressants ( antidepressants, antihistamines, anxiolytics, neuroleptics, opioids, certain antihypertensives), drugs intended for the treatment of diabetes (chlorpropamide, glibenclamide, glipizide, insulin, metformin, sulphonylureas).

Perfane side effects

Hypotension and arrhythmias may occur with enoximone therapy.

The following side effects have been reported. Their frequency is indeterminate.

Heart conditions

Hypotension, extrasystoles, supraventricular arrhythmias and ventricular tachyarrhythmias. These arrhythmias may require stopping treatment (see section 5.1 Pharmacodynamic properties).

Nervous system disorders

Headache, Insomnia

Gastrointestinal disorders

Nausea and / or vomiting, diarrhea may lead to a reduction in dosage

General disorders and administration site abnormalities

Chills, fever, extremity pains

Blood and lymphatic system disorders

Moderate thrombocytopenia without associated bleeding or purpura or petechiae

Renal and urinary disorders

Oliguria, urinary retention

Hepatobiliary disorders

Increased reversible liver enzymes upon discontinuation of treatment

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