| Product Name: | Apomorphine Hydrochloride Sublingual Tablets |
| Brand Name: | Generic |
| Strength: | 2mg, 3mg |
| Dosage Form: | Tablets (Sublingual) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-Parkinson, Central Nervous System |
| Indication: | Apomorphine is a morphine derivative D2 dopamine agonist used to treat hypomobile “off” episodes of advanced Parkinson’s disease. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Apomorphine Hydrochloride Sublingual Tablets 2mg
B) Apomorphine Hydrochloride Sublingual Tablets 3mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Apomorphine Hydrochloride Sublingual Tablets 2mg
Each Sublingual tablet contains:
Apomorphine Hydrochloride ………2mg
Excipients……………………………………..q.s.
Colours: Quinizarine green ss
B) Apomorphine Hydrochloride Sublingual Tablets 3mg
Each Sublingual tablet contains:
Apomorphine Hydrochloride ………3mg
Excipients……………………………………..q.s.
Colours: Quinizarine green ss
THERAPEUTIC INDICATIONS:
Apomorphine belongs to a class of drugs called dopamine agonists. It is used to treat a progressive nervous system disorder that affects movement called Parkinson’s disease.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature.
Dispense in tight container.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.