GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Ziprasidone Mesylate Dry Powder for Injection (Lyophilized) 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Ziprasidone Mesylate Dry Powder for Injection (Lyophilized) 20mg
Each mL (when reconstituted) contains
ziprasidone…………………….20mg
methanesulfonic acid …….4.7mg
solubilized by 294 mg of sulfobutylether B-cyclodextrin sodium (SBECD).

THERAPEUTIC INDICATIONS:

Ziprasidone mesylate for injection intramuscular is indicated for the treatment of acute agitation in schizophrenic adult patients for whom treatment with ziprasidone is appropriate and who need intramuscular antipsychotic medication for rapid control of agitation.

CAUTION & SCHEDULE:

CAUTION: Shake vigorously until all the drug is dissolved to afford a colorless to pale pink solution. Reconstitute to 20 mg/mL with 1.2 mL of Sterile Water for Injection (only)
SCHEDULE:Not to be sold by retail without the prescription of registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (69°F to 86°F) [see USP Controlled Room Temperature) in dry form. Protected from light.
Dosage: See package insert for dosage information.
As directed by Physician

Ziprasidone Mesylate Dry Powder for Injection (Lyophilized) 20mg Technical Specification:

Product Name:Ziprasidone Mesylate Dry Powder for Injection (Lyophilized)
Brand Name:Generics
Strength:20mg
Dosage Form:Dry Powder Injection (Sterile)
Packing:Single dose vial
Route of Administration:For I.M. USE ONLY
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Anti Psychotics
Indication: Ziprasidone mesylate for injection intramuscular is indicated for the treatment of acute agitation in schizophrenic adult patients for whom treatment with ziprasidone is appropriate and who need intramuscular antipsychotic medication for rapid control of agitation.
Storage:Store between 2° to 8°C. Protected from light. Do not freeze. USE IMMEDIATELY AFTER RECONSTITUTION

GENERIC NAME OF MEDICINAL PRODUCT:

  • Ziprasidone Mesylate Dry Powder for Injection (Lyophilized) 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Ziprasidone Mesylate Dry Powder for Injection (Lyophilized) 20mg <br>
Each mL (when reconstituted) contains
ziprasidone…………………….20mg
methanesulfonic acid …….4.7mg
solubilized by 294 mg of sulfobutylether  B-cyclodextrin sodium (SBECD).

THERAPEUTIC INDICATION:

Ziprasidone mesylate for injection intramuscular is indicated for the treatment of acute agitation in schizophrenic adult patients for whom treatment with ziprasidone is appropriate and who need intramuscular antipsychotic medication for rapid control of agitation.

CAUTION & SCHEDULE:

CAUTION:Shake vigorously until all the drug is dissolved to afford a colorless to pale pink solution.
Reconstitute to 20 mg/mL with 1.2 mL of Sterile Water for Injection (only)
SCHEDULE:Not to be sold by retail without the prescription of registered Medical Practitioner.

STORAGE & DOSAGE:

Storage:Store at 25°C (77°F); excursions permitted to 15°C to 30°C (69°F to 86°F) [see USP Controlled Room Temperature) in dry form.
Protected from light.
Dosage:See package insert for dosage information.
As directed by Physician.