GENERIC NAME OF MEDICINAL PRODUCT:
(A) Promethazine HCl Injection USP 25mg/ml
(B) Promethazine HCl Injection USP 50mg/ml
(B) Promethazine HCl Injection USP 50mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
(A) Promethazine HCl Injection USP 25mg/ml
Each ml contains:
Promethazine Hydrocholride USP……….25mg
Excipients………………………q.s.
Water for Injection USP………….q.s.
(B) Promethazine HCl Injection USP 50mg/ml
Each ml contains:
Promethazine Hydrocholride USP……….50mg
Excipients………………………q.s.
Water for Injection USP………….q.s.
Each ml contains:
Promethazine Hydrocholride USP……….25mg
Excipients………………………q.s.
Water for Injection USP………….q.s.
(B) Promethazine HCl Injection USP 50mg/ml
Each ml contains:
Promethazine Hydrocholride USP……….50mg
Excipients………………………q.s.
Water for Injection USP………….q.s.
THERAPEUTIC INDICATION:
Promethazine injection is used to relieve or prevent some types of allergy or allergic reactions. It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes.
CAUTION & WARNING:
• CAUTION: Discolored solution or solution with any visible suspended material should not be used.
• Do not use if any particle, leakage or breakage is found.
• DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
• KEEP OUT OF REACH AND SIGHT OF CHILDREN.
• WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
• Do not use if any particle, leakage or breakage is found.
• DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
• KEEP OUT OF REACH AND SIGHT 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.
Dosage: As directed by Physician.
Dosage: As directed by Physician.
Promethazine HCl Injection USP 50mg/ml Technical Specification:
| Product Name: | Promethazine HCl Injection USP |
| Brand Name: | (GENERICS) |
| Strength: | 25mg/ml, 50mg/ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 1ml Ampoule & 1ml vial |
| Route of Administration: | For I.M and slow I.V. injection |
| 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-Allergic, Anti-histamine |
| Indication: | Promethazine injection is used to relieve or prevent some types of allergies or allergic reactions. It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. |
| Storage: | Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Promethazine HCl Injection USP 50mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Promethazine HCl Injection USP 50mg/ml
Each ml contains:
Promethazine Hydrochloride USP……….50mg
Excipients………………………q.s.
Water for Injection USP………….q.s.
THERAPEUTIC INDICATION:
Promethazine injection is used to relieve or prevent some types of allergies or allergic reactions. It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes.
CAUTION & WARNING:
- CAUTION: Discolored solution or solution with any visible suspended material should not be used.
- Do not use if any particle, leakage, or breakage is found.
- DO NOT ACCEPT IF THE VIAL SEAL IS BROKEN.
- KEEP OUT OF REACH AND SIGHT 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.
Dosage: As directed by the Physician.
