Medicinal Products

ANZEMET 12,5mg / 0,625ml

Generic drug of the therapeutic class: Gastro-Entero-Hepatology
active ingredients: Dolasétron mesilate
laboratory: Sanofi-Aventis France

Injectable solution
Box of 1 ampoule of 0.625 ml
All forms

Indication

Treatment of postoperative nausea and vomiting in adults.

Dosage ANZEMET 12, 5mg / 0, 625ml Solution for injection Box of 1 ampoule of 0, 625 ml

Reserved for adults over 15 years of age: 12.5 mg as a single dose when nausea or vomiting occurs.

No dosage adjustment is recommended in the elderly or renal or hepatic impairment.

The dolasetron injectable solution can be administered intravenously directly in 30 seconds (approximately) or infused within 15 minutes after dilution in a compatible intravenous solution. It is recommended to avoid faster injections.

Compatibility with infusion fluids:

In line with good pharmaceutical practice, infusion solutions should be prepared extemporaneously. The injectable solution of dolasetron may be diluted in the following infusion liquids:

· Sodium Chloride at 0.9%

· Glucose solute at 5%

· 10% Mannitol solution

· Sodium lactate infusion solution

· 0.18% sodium chloride solution + 4% glucose solution

The dolasetron solution administered in polypropylene syringes is stable.

Note: The preparation must be made under appropriate aseptic conditions.

Compatibility with other products:

When administering a drug during the dolasetron infusion, the tubing and Y-fitting should be thoroughly rinsed with a compatible infusion fluid for administration of the two drug dolasetron has incompatibilities with a number of drugs, including dexamethasone.

Against indications

Hypersensitivity to dolasetron or any of the components of the drug.

Side effects Anzemet

Have been reported in clinical studies:

· Headache, dizziness,

· Transient elevation of transaminases,

· Poor extension of the PR, QRS, QTc intervals.

· In clinical trials, hypotension was observed in 1.9% of dolasetron patients; the incidence of this event was similar in placebo patients.
In very rare cases, severe hypotension with bradycardia and possible loss of consciousness may occur during or immediately following an intravenous bolus injection of dolasetron mesilate.

· Pain or burning sensation during intravenous administration.

With the intravenous form, very rare cases of tachycardia or ventricular fibrillation or even cardiac arrest have been reported.

As with other 5HT3 receptor antagonists, hypersensitivity reactions such as rash, pruritus, urticaria, bronchospasm, and very rare cases of angioedema and anaphylaxis have been reported.

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