Aripiprazole Tablets 5mg Technical Specification:
| Product Name: | Aripiprazole Tablets 5mg |
| Brand Name: | Aripiprazole |
| Strength: | 2mg, 5mg, 10mg, 15mg, 30mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 100s, 500s, 1000s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antipsychotic (SGA) or atypical antipsychotic, Central nervous system |
| Indication: | Aripiprazole is a medication that works in the brain to treat schizophrenia. used to treat certain mental/mood disorders (such as bipolar disorder, schizophrenia, Tourette’s syndrome, and irritability associated with autistic disorder). |
| Storage: | Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Aripiprazole Tablets 5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Aripiprazole Tablets 5mg
Each film coated tablet contains:
Aripiprazole………………5mg
Excipients…………………. q.s.
Colour: Quinoline Yellow Lake
THERAPEUTIC INDICATIONS:
Aripiprazole is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
keep medicine out of reach of children.
swallow whole does not chew or crush
ANY UNUSED MEDICINAL PRODUCT OR WASTE MATERIAL SHOULD BE DISPOSED OF IN ACCORDANCE WITH LOCAL REQUIREMENTS
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
| Attach dispensing label as per end country. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Aripiprazole Tablets 2mg
B. Aripiprazole Tablets 5mg
C. Aripiprazole Tablets 10mg
D. Aripiprazole Tablets 15mg
E. Aripiprazole Tablets 30mg
B. Aripiprazole Tablets 5mg
C. Aripiprazole Tablets 10mg
D. Aripiprazole Tablets 15mg
E. Aripiprazole Tablets 30mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Aripiprazole Tablets 2mg
Each film coated tablet contains:
Aripiprazole………………2mg
Excipients…………………. q.s.
Colour: Yellow Oxide of Iron
B. Aripiprazole Tablets 5mg
Each film coated tablet contains:
Aripiprazole………………5mg
Excipients……………………q.s.
Colour: Quinoline Yellow Lake
C. Aripiprazole Tablets 10mg
Each film coated tablet contains:
Aripiprazole….………….10mg
Excipients…………………...q.s.
Colour: D&C Orange 4
D. Aripiprazole Tablets 15mg
Each film coated tablet contains:
Aripiprazole……………...15mg
Excipients…………………………q.s.
Colour: Carmoisine Lake
E. Aripiprazole Tablets 30mg
Each film coated tablet contains:
Aripiprazole……………….30mg
Excipients…………………………q.s.
Colour: Quinoline Yellow
Each film coated tablet contains:
Aripiprazole………………2mg
Excipients…………………. q.s.
Colour: Yellow Oxide of Iron
B. Aripiprazole Tablets 5mg
Each film coated tablet contains:
Aripiprazole………………5mg
Excipients……………………q.s.
Colour: Quinoline Yellow Lake
C. Aripiprazole Tablets 10mg
Each film coated tablet contains:
Aripiprazole….………….10mg
Excipients…………………...q.s.
Colour: D&C Orange 4
D. Aripiprazole Tablets 15mg
Each film coated tablet contains:
Aripiprazole……………...15mg
Excipients…………………………q.s.
Colour: Carmoisine Lake
E. Aripiprazole Tablets 30mg
Each film coated tablet contains:
Aripiprazole……………….30mg
Excipients…………………………q.s.
Colour: Quinoline Yellow
THERAPEUTIC INDICATIONS:
Aripiprazole is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
keep medicine out of reach of children.
swallow whole does not chew or crush
ANY UNUSED MEDICINAL PRODUCT OR WASTE MATERIAL SHOULD BE DISPOSED OF IN ACCORDANCE WITH LOCAL REQUIREMENTS WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
keep medicine out of reach of children.
swallow whole does not chew or crush
ANY UNUSED MEDICINAL PRODUCT OR WASTE MATERIAL SHOULD BE DISPOSED OF IN ACCORDANCE WITH LOCAL REQUIREMENTS WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
