GENERIC NAME OF MEDICINAL PRODUCT:
(A) Aztreonam for Injection USP 1gm
(B) Aztreonam for Injection USP 2gm
(C) Aztreonam for Injection USP 500mg
(D) Aztreonam for Injection USP 250mg
(B) Aztreonam for Injection USP 2gm
(C) Aztreonam for Injection USP 500mg
(D) Aztreonam for Injection USP 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Aztreonam for Injection USP 1gm
A. Each vial contains:
(Sterile) Aztreonam USP
Eq. to Anhydrous Aztreonam …………1000mg
L-Arginine as a Buffer……………….780mg
B. Sterile water for Injection BP ….…………… 10ml
2. Aztreonam for Injection 2gm
A. Each vial contains:
(Sterile) Aztreonam USP
Eq. to Anhydrous Aztreonam …………2000mg
L-Arginine as a Buffer…….1.560gm
B. Sterile water for Injection BP ….…………… 20ml
3. Aztreonam for Injection USP 500mg
A. Each vial contains:
(Sterile) Aztreonam USP
Eq. to Anhydrous Aztreonam …………500mg
L-Arginine as a Buffer………….390mg
B. Sterile water for Injection BP ………….… 10ml
4. Aztreonam for Injection USP 250mg
A. Each vial contains:
(Sterile) Aztreonam USP
Eq. to Anhydrous Aztreonam …………250mg
L-Arginine as a Buffer…….195mg
B. Sterile water for Injection BP ………….… 5ml
A. Each vial contains:
(Sterile) Aztreonam USP
Eq. to Anhydrous Aztreonam …………1000mg
L-Arginine as a Buffer……………….780mg
B. Sterile water for Injection BP ….…………… 10ml
2. Aztreonam for Injection 2gm
A. Each vial contains:
(Sterile) Aztreonam USP
Eq. to Anhydrous Aztreonam …………2000mg
L-Arginine as a Buffer…….1.560gm
B. Sterile water for Injection BP ….…………… 20ml
3. Aztreonam for Injection USP 500mg
A. Each vial contains:
(Sterile) Aztreonam USP
Eq. to Anhydrous Aztreonam …………500mg
L-Arginine as a Buffer………….390mg
B. Sterile water for Injection BP ………….… 10ml
4. Aztreonam for Injection USP 250mg
A. Each vial contains:
(Sterile) Aztreonam USP
Eq. to Anhydrous Aztreonam …………250mg
L-Arginine as a Buffer…….195mg
B. Sterile water for Injection BP ………….… 5ml
THERAPEUTIC INDICATION:
Aztreonam injection is used to treat certain infections that are caused by bacteria, including respiratory tract (including pneumonia and bronchitis), urinary tract, blood, skin, gynecological, and abdominal (stomach area) infections, that are caused by bacteria.
DIRECTION OF USE:
The powder to be reconstituted with 5ml of Sterile Water for Injections BP.
The reconstituted solution should be use immediately after preparation. The prepared solution should be used only, if it is clear.
The reconstituted solution should be use immediately after preparation. The prepared solution should be used only, if it is clear.
CAUTION & WARNING:
CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution & ask for replacement.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner
STORAGE AND DOSAGE:
STORAGE: Store Below 25°C.Protect from light & moisture.
Keep medicine out of reach of children.
Reconstituted solution should be use immediately after preparation.
Any unused reconstitution portion must be discarded.
Read enclosed leaflet before use.
DOSAGE: As directed by Physician.
Keep medicine out of reach of children.
Reconstituted solution should be use immediately after preparation.
Any unused reconstitution portion must be discarded.
Read enclosed leaflet before use.
DOSAGE: As directed by Physician.
Aztreonam for Injection USP 250mg Technical Specification:
| Product Name: | Aztreonam for Injection USP 250mg |
| Brand Name: | Generics |
| Strength: | 1gm, 2gm, 500mg, 250mg |
| Dosage Form: | Dry Powder Injection (Sterile) |
| Packing: | Vial + WFI in Tray |
| Route of Administration: | For I.M./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: | β-lactam Antibiotic, Anti-bacterial & Carbapenem |
| Indication: | Aztreonam injection is used to treat certain infections that are caused by bacteria, including respiratory tract, urinary tract, blood, skin, gynecological, and abdominal infections, that are caused by bacteria. |
| Storage: | Store Below 25°C.Protect from light & moisture. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Aztreonam for Injection USP 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Aztreonam for Injection USP 250mg
Each vial contains:
(Sterile) Aztreonam USP
Eq. to Anhydrous Aztreonam …………250mg
L-Arginine as a Buffer………………………195mg
Sterile water for Injection BP ……….……… 5ml
THERAPEUTIC INDICATION:
Aztreonam injection is used to treat certain infections that are caused by bacteria, including respiratory tract (including pneumonia and bronchitis), urinary tract, blood, skin, gynecological, and abdominal (stomach area) infections, that are caused by bacteria.
DIRECTION OF USE:
The powder is to be reconstituted with 5ml of Sterile Water for Injections BP.
The reconstituted solution should be used immediately after preparation. The prepared solution should be used only if it is clear.
CAUTION & WARNING:
CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution & ask for a replacement.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE AND DOSAGE:
STORAGE: Store Below 25°C.Protect from light & moisture.
Keep the medicine out of reach of children.
The reconstituted solution should be used immediately after preparation.
Any unused reconstitution portion must be discarded.
Read the enclosed leaflet before use.
DOSAGE: As directed by the Physician.
