GENERIC NAME OF MEDICINAL PRODUCT:
A) Amobarbital Sodium for Injection, USP (0.5g)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Amobarbital Sodium for Injection, USP (0.5g)
Composition:
Each vial contains:
Amobarbital sodium..............500mg
(As lyophilized powder)
Sterile Water for Injection USP………5ml
Composition:
Each vial contains:
Amobarbital sodium..............500mg
(As lyophilized powder)
Sterile Water for Injection USP………5ml
THERAPEUTIC INDICATIONS:
Amobarbital sodium for Injection is a sedative used for short-term treatment of insomnia.
DIRECTION OF USE:
To prepare a 10% solution, dissolve contents of vials in 5ml Sterile Water for Injection USP.
See accompanying package insert for uses & method of administration.
See accompanying package insert for uses & method of administration.
CAUTION & WARNING:
CAUTION: If used intravenously the rate of injection should not exceed 50mg per minute.
Under no circumstances should any solution be injected which is not absolutely clear.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
Under no circumstances should any solution be injected which is not absolutely clear.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 15° to 30°C.
Keep all medicines out of reach of children.
Dosage: As directed by Physician.
Keep all medicines out of reach of children.
Dosage: As directed by Physician.
Amobarbital Sodium for Injection, USP 0.5g Technical Specification:
| Product Name: | Amobarbital Sodium for Injection, USP |
| Brand Name: | Generic |
| Strength: | 0.5g |
| Dosage Form: | Lyophilized Dry Powder Injection (Sterile) *Preservative Free |
| Packing: | 1 Vial + 1 Ampoule |
| Route of Administration: | For IM/IV 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: | Sedative (Barbiturate) |
| Indication: | Amobarbital sodium for Injection is a sedative used for the short-term treatment of insomnia. |
| Storage: | Store at 15° to 30°C. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Amobarbital Sodium for Injection, USP (0.5g)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Amobarbital Sodium for Injection, USP (0.5g)
Composition:
Each vial contains:
Amobarbital sodium…………..500mg
(as lyophilized powder)
Sterile Water for Injection USP………5ml
THERAPEUTIC INDICATIONS:
Amobarbital sodium for Injection is a sedative used for the short-term treatment of insomnia.
DIRECTION OF USE:
To prepare a 10% solution, dissolve the contents of vials in 5ml Sterile Water for Injection USP.
See the accompanying package insert for uses & methods of administration.
CAUTION & WARNING:
CAUTION: If used intravenously the rate of injection should not exceed 50mg per minute.
Under no circumstances should any solution be injected which is not absolutely clear.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 15° to 30°C.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
