Labetalol Hydrochloride Injection USP 200mg/40ml Technical Specification:
| Product Name: | Labetalol Hydrochloride Injection USP |
| Brand Name: | Generic |
| Strength: | 5mg/1ml, 20mg/4ml, 100mg/20ml, 200mg/40ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 5mg/1ml (Single Dose Vial/Ampoule) 20mg/4ml (Single Dose Vial/Ampoule) 100mg/20ml (Multi Dose Vial) 200mg/40ml (Multi Dose Vial) |
| Route of Administration: | For I.V. use only |
| 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-Hypertensive |
| Indication: | Labetalol Hydrochloride Injection is indicated for control of blood pressure in severe hypertension. |
| Storage: | Store at 20°C to 25°C (68°F to 77°F). Store in a cool and dry place. Improper storage may be deteriorate the product. Protect from freezing and light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Labetalol Hydrochloride Injection USP 200mg/40ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Labetalol Hydrochloride Injection USP 200mg/40ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP………….45mg
Edetate disodium USP………………0.10mg
Methylparaben USP………………….0.80mg
Propylparaben USP…………………..0.10mg
Water for Injection USP………………q.s
THERAPEUTIC INDICATIONS:
Labetalol Hydrochloride Injection is indicated for control of blood pressure in severe hypertension.
DIRECTION OF USE:
For Intravenous use only.
See package insert for usual dosage.
CAUTION & Warning:
CAUTION: This injection should not be used if it contains visible particulate matter.
Retain in carton until time of use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
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°F to 77°F).
Store in a cool and dry place.
Improper storage may be deteriorate the product.
Protect from freezing and light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Labetalol Hydrochloride Injection USP 5mg/1ml
B. Labetalol Hydrochloride Injection USP 20mg/4ml
C. Labetalol Hydrochloride Injection USP 100mg/20ml
D. Labetalol Hydrochloride Injection USP 200mg/40ml
B. Labetalol Hydrochloride Injection USP 20mg/4ml
C. Labetalol Hydrochloride Injection USP 100mg/20ml
D. Labetalol Hydrochloride Injection USP 200mg/40ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Labetalol Hydrochloride Injection USP 5mg/1ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP………....45mg
Edetate disodium USP………………0.10mg
Methylparaben USP………………….0.80mg
Propylparaben USP…………………..0.10mg
Water for Injection USP…………...q.s
B. Labetalol Hydrochloride Injection USP 20mg/4ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP……..…..45mg
Edetate disodium USP…………….…0.10mg
Methylparaben USP…………………..0.80mg
Propylparaben USP………………......0.10mg
Water for Injection USP……………..q.s
C. Labetalol Hydrochloride Injection USP 100mg/20ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP……..…..45mg
Edetate disodium USP………………0.10mg
Methylparaben USP………………...0.80mg
Propylparaben USP………………....0.10mg
Water for Injection USP……….….q.s
D. Labetalol Hydrochloride Injection USP 200mg/40ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP……..…..45mg
Edetate disodium USP………………0.10mg
Methylparaben USP…………….…..0.80mg
Propylparaben USP………………....0.10mg
Water for Injection USP…………..q.s
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP………....45mg
Edetate disodium USP………………0.10mg
Methylparaben USP………………….0.80mg
Propylparaben USP…………………..0.10mg
Water for Injection USP…………...q.s
B. Labetalol Hydrochloride Injection USP 20mg/4ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP……..…..45mg
Edetate disodium USP…………….…0.10mg
Methylparaben USP…………………..0.80mg
Propylparaben USP………………......0.10mg
Water for Injection USP……………..q.s
C. Labetalol Hydrochloride Injection USP 100mg/20ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP……..…..45mg
Edetate disodium USP………………0.10mg
Methylparaben USP………………...0.80mg
Propylparaben USP………………....0.10mg
Water for Injection USP……….….q.s
D. Labetalol Hydrochloride Injection USP 200mg/40ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP……..…..45mg
Edetate disodium USP………………0.10mg
Methylparaben USP…………….…..0.80mg
Propylparaben USP………………....0.10mg
Water for Injection USP…………..q.s
THERAPEUTIC INDICATIONS:
Labetalol Hydrochloride Injection is indicated for control of blood pressure in severe hypertension.
DIRECTION OF USE:
For Intravenous use only.
See package insert for usual dosage.
See package insert for usual dosage.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter.
Retain in carton until time of use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Retain in carton until time of use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
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°F to 77°F).
Store in a cool and dry place.
Improper storage may be deteriorate the product.
Protect from freezing and light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Store in a cool and dry place.
Improper storage may be deteriorate the product.
Protect from freezing and light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
