GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Risperidone Dry Powder for Injection (Lyophilized) 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Risperidone Dry Powder for Injection (Lyophilized) 50mg
Each vial contains:
Risperidone ……………………………..50mg
Powder for suspension for injection
Polyglactin
Diluent
Carmellose sodium 40 mPa.s
Anhydrous citric acid
Dibasic sodium phosphate dihydrate
Polysorbate 20
Sodium chloride
Sodium hydroxide
Water for injection

THERAPEUTIC INDICATIONS:

for the treatment of schizophrenia and other psychotic disorders. These include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted effect, emotional and social withdrawal, poverty of speech) are prominent.

CAUTION & SCHEDULE:

CAUTION: Before reconstitution, the entire dose pack should be stored in the refrigerator (2-8°C) and protected from light. It should not be exposed to temperatures above 25°C. Administer dose as soon as possible after reconstitution to avoid settling.
SCHEDULE: Not to be sold by retail without the prescription of registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Before reconstitution, the entire dose pack should be stored in the refrigerator (2-8°C) and protected from light. It should not be exposed to temperatures above 25°C.If refrigeration is unavailable, can be stored at temperatures not exceeding 25°C for no more than 7 days prior to administration. Do not expose unrefrigerated product to temperatures above 25°C.After reconstitution, the product should be used immediately. The maximum allowable storage time at room temperature is 6 hours. If the product is not used right away it should be shaken vigorously to re-suspend. Do not refrigerate or refreeze.
Dosage: See package insert for dosage information.
As directed by Physician

Risperidone Dry Powder for Injection (Lyophilized) 50mg Technical Specification:

Product Name:Risperidone Dry Powder for Injection (Lyophilized)
Brand Name:Generics
Strength:50mg
Dosage Form:Dry Powder Injection (Sterile)
Packing:LYOPHILIZED Powder
Route of Administration:FOR IV USE Only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Antipsychotics
Indication: For the treatment of schizophrenia and other psychotic disorders.These include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted effect, emotional and social withdrawal, poverty of speech) are prominent.
Storage:Store Protected from moisture at a temperature not exceeding 30°C

GENERIC NAME OF MEDICINAL PRODUCT:

  • Risperidone Dry Powder for Injection (Lyophilized) 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Risperidone Dry Powder for Injection (Lyophilized) 50mg
Each vial contains:
Risperidone ……………………………..50mg
Powder for suspension for injection
Polyglactin
Diluent
Carmellose sodium 40 mPa.s
Anhydrous citric acid
Dibasic sodium phosphate dihydrate
Polysorbate 20
Sodium chloride
Sodium hydroxide
Water for injection

THERAPEUTIC INDICATION:

For the treatment of schizophrenia and other psychotic disorders. These include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted effect, emotional and social withdrawal, poverty of speech) are prominent.

CAUTION & SCHEDULE:

CAUTION:Before reconstitution, the entire dose pack should be stored in the refrigerator (2-8°C) and protected from light. It should not be exposed to temperatures above 25°C.
Administer dose as soon as possible after reconstitution to avoid settling.
SCHEDULE:Not to be sold by retail without the prescription of registered Medical Practitioner.

STORAGE & DOSAGE:

Storage:Before reconstitution, the entire dose pack should be stored in the refrigerator (2-8°C) and protected from light.
It should not be exposed to temperatures above 25°C.
If refrigeration is unavailable, can be stored at temperatures not exceeding 25°C for no more than 7 days prior to administration.
Do not expose unrefrigerated product to temperatures above 25°C.
After reconstitution, the product should be used immediately.
The maximum allowable storage time at room temperature is 6 hours. If the product is not used right away it should be shaken vigorously to re-suspend. Do not refrigerate or refreeze.
Dosage:See package insert for dosage information.
As directed by Physician