(A) Imipenem and Cilastatin Injection USP 1gm
(B) Imipenem and Cilastatin Injection USP 2gm
(C) Imipenem and Cilastatin Injection USP 500mg
GENERIC NAME OF MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Imipenem and Cilastatin Injection USP 1gm
a) Each vial contains:
(Sterile) Imipenem IP
Eq. to Anhydrous Imipenem…………… 500mg
(Sterile) Cilastatin sodium IP
Eq. to Cilastatin ……………………….…….500mg
(Sterile) Sodium Bicarbonate IP
Added as a Buffer
b) Sterile Water for Injection IP…………10ml
2. Imipenem and Cilastatin Injection USP 2gm
a) Each vial contains:
(Sterile) Imipenem IP
Eq. to Anhydrous Imipenem…………… 1gm
(Sterile) Cilastatin sodium IP
Eq. to Cilastatin ……………………….…….1gm
(Sterile) Sodium Bicarbonate IP
Added as a Buffer
b) Sterile Water for Injection IP…………20ml
3. Imipenem and Cilastatin Injection USP 500mg
a) Each vial contains:
(Sterile) Imipenem IP
Eq. to Anhydrous Imipenem…………… 250mg
(Sterile) Cilastatin sodium IP
Eq. to Cilastatin ……………………….…….250mg
(Sterile) Sodium Bicarbonate IP
Added as a Buffer
b) Sterile Water for Injection IP…………10ml
a) Each vial contains:
(Sterile) Imipenem IP
Eq. to Anhydrous Imipenem…………… 500mg
(Sterile) Cilastatin sodium IP
Eq. to Cilastatin ……………………….…….500mg
(Sterile) Sodium Bicarbonate IP
Added as a Buffer
b) Sterile Water for Injection IP…………10ml
2. Imipenem and Cilastatin Injection USP 2gm
a) Each vial contains:
(Sterile) Imipenem IP
Eq. to Anhydrous Imipenem…………… 1gm
(Sterile) Cilastatin sodium IP
Eq. to Cilastatin ……………………….…….1gm
(Sterile) Sodium Bicarbonate IP
Added as a Buffer
b) Sterile Water for Injection IP…………20ml
3. Imipenem and Cilastatin Injection USP 500mg
a) Each vial contains:
(Sterile) Imipenem IP
Eq. to Anhydrous Imipenem…………… 250mg
(Sterile) Cilastatin sodium IP
Eq. to Cilastatin ……………………….…….250mg
(Sterile) Sodium Bicarbonate IP
Added as a Buffer
b) Sterile Water for Injection IP…………10ml
THERAPEUTIC INDICATION:
Imipenem and cilastatin injection are used to treat certain serious infections that are caused by bacteria, including endocarditis and respiratory tract, urinary tract, abdominal, gynecological, blood, skin, bone, and joint infections.
DIRECTION OF USE:
Reconstitute with 10ml sterile water for Injection IP. Reconstituted should be used immediately after the preparation.
Read the enclosed leaflet before reconstitution & use.
Read the enclosed leaflet before reconstitution & use.
CAUTION & SCHEDULE:
CAUTION: If any particle is visible in the vial after dissolving the contents, please do not use the solution & return the vial for replacement.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
SCHEDULE: SCHEDULE H1 PRESCRIPTION DRUG: It is dangerous to take this preparation except in accordance with the medical advice.
Not to be sold by retail without the prescription of a Registered Medical Practitioner.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
SCHEDULE: SCHEDULE H1 PRESCRIPTION DRUG: It is dangerous to take this preparation except in accordance with the medical advice.
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.
Reconstituted solution should be use immediately after preparation.
Any unused reconstitution portion must be discarded.
KEEP OUT OF REACH OF CHILDREN.
DOSAGE: As directed by Physician.
Reconstituted solution should be use immediately after preparation.
Any unused reconstitution portion must be discarded.
KEEP OUT OF REACH OF CHILDREN.
DOSAGE: As directed by Physician.
Imipenem & Cilastatin Injection USP 1gm Technical Specification:
| Product Name: | Imipenem & Cilastatin Injection USP 1gm |
| Brand Name: | (PIPRANEM) |
| Strength: | 1gm, 2gm, 500mg |
| Dosage Form: | Dry Powder Injection (Sterile) |
| Packing: | Vial + WFI in Tray |
| Route of Administration: | For I.V. use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Product Permission, Stability Studies, GMP |
| Therapeutic use: | β-lactam Antibiotic, Anti-bacterial & Carbapenem. |
| Indication: | Endocarditis, respiratory tract, urinary tract, abdominal, gynecological, blood, skin, bone, and joint infections |
| Storage: | Store below 25°C. Protect from light & moisture. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Imipenem & Cilastatin Injection USP 1gm (PIPRANEM)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Imipenem & Cilastatin Injection USP 1gm
Each vial contains:
(Sterile) Imipenem IP
Eq. to Anhydrous Imipenem…………… 500mg
(Sterile) Cilastatin sodium IP
Eq. to Cilastatin ……………………….…….500mg
(Sterile) Sodium Bicarbonate IP
Added as a Buffer
Sterile Water for Injection IP…………10ml
THERAPEUTIC INDICATION:
Imipenem and cilastatin injections are used to treat certain serious infections that are caused by bacteria, including endocarditis and respiratory tract, urinary tract, abdominal, gynecological, blood, skin, bone, and joint infections.
DIRECTION OF USE:
Reconstitute with 10ml sterile water for Injection IP. Reconstituted should be used immediately after the preparation. Read the enclosed leaflet before reconstitution & use.
CAUTION & SCHEDULE:
CAUTION: If any particle is visible in the vial after dissolving the contents, please do not use the solution & return the vial for replacement.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
SCHEDULE H1 PRESCRIPTION DRUG: It is dangerous to take this preparation except in accordance with medical advice.
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.
The reconstituted solution should be used immediately after preparation.
Any unused reconstitution portion must be discarded.
KEEP OUT OF REACH OF CHILDREN.
DOSAGE: As directed by the Physician.
