Nicardipine Hydrochloride Injection USP 10mg/10ml (1mg/ml) Technical Specification:
| Product Name: | Nicardipine Hydrochloride Injection USP |
| Brand Name: | (GENERICS) |
| Strength: | 10mg/10ml (1mg/ml), 25mg/10ml (2.5mg/ml) |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 10ml Ampoules, Vial (single-dose) |
| Route of Administration: | For Intravenous Infusion |
| 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-angina, Anti-hypertensive, Calcium channel blocker. |
| Indication: | Nicardipine is used alone or together with other medicines to treat severe chest pain (angina) or high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. |
| Storage: | Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Nicardipine Hydrochloride Injection USP 10mg/10ml (1mg/ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Nicardipine Hydrochloride Injection USP 10mg/10ml (1mg/ml)
Each ml contains:
Nicardipine Hydrochloride USP………..1mg
Benzoic acid USP ………….3.05mg
Sodium chloride USP………75mg
Water for Injection USP…………q.s.
THERAPEUTIC INDICATION:
Nicardipine is used alone or together with other medicines to treat severe chest pain (angina) or high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.
CAUTION & WARNING:
CAUTION: Do not use it if the solution is not clear or has suspended matter.
Must be diluted before infusion.
KEEP OUT OF REACH OF CHILDREN.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature.
Discard the unused portion after use.
Dosage: As directed by the Physician.
GENERIC NAME OF MEDICINAL PRODUCT:
(A) Nicardipine Hydrochloride Injection USP 10mg/10ml (1mg/ml)
(B) Nicardipine Hydrochloride Injection USP 25mg/10ml (2.5mg/ml)
(B) Nicardipine Hydrochloride Injection USP 25mg/10ml (2.5mg/ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Nicardipine Hydrochloride Injection USP 10mg/10ml (1mg/ml)
Each ml contains:
Nicardipine Hydrochloride USP………..1mg
Benzoic acid USP ………….3.05mg
Sodium chloride USP………75mg
Water for Injection USP…………q.s.
B) Nicardipine Hydrochloride Injection USP 25mg/10ml (2.5mg/ml)
Each ml contains:
Nicardipine Hydrochloride USP………..2.5mg
Benzoic acid USP ………….3.05mg
Sodium chloride USP………75mg
Water for Injection USP…………q.s.
Each ml contains:
Nicardipine Hydrochloride USP………..1mg
Benzoic acid USP ………….3.05mg
Sodium chloride USP………75mg
Water for Injection USP…………q.s.
B) Nicardipine Hydrochloride Injection USP 25mg/10ml (2.5mg/ml)
Each ml contains:
Nicardipine Hydrochloride USP………..2.5mg
Benzoic acid USP ………….3.05mg
Sodium chloride USP………75mg
Water for Injection USP…………q.s.
THERAPEUTIC INDICATION:
Nicardipine is used alone or together with other medicines to treat severe chest pain (angina) or high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.
CAUTION & WARNING:
CAUTION: Do not use if solution is not clear or has suspended matter.
Must be diluted before infusion.
KEEP OUT OF REACH OF CHILDREN.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
Must be diluted before infusion.
KEEP OUT OF REACH OF CHILDREN.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77°). See USP controlled room temperature.
Discard the unused portion after use.
Dosage: As directed by Physician.
Discard the unused portion after use.
Dosage: As directed by Physician.
