Meropenem for Injection USP 1gm Technical Specification:
Product Name: | Meropenem for Injection USP 1gm |
Brand Name: | MEROKEM |
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), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | β-lactam Antibiotic, Anti-bacterial & Anti-biotics, Carbapenem Antibiotic |
Indication: | Meropenem is used to used treat severe infections of the skin or stomach. Meropenem is also used to treat bacterial meningitis (infection that causes inflammation of the tissue that covers the brain and spinal cord). |
Storage: | Store Protected from moisture at a temperature not exceeding 30°C |
GENERIC NAME OF MEDICINAL PRODUCT:
- Meropenem for Injection USP 1gm
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Meropenem for Injection USP 1gm
Each vial contains:
Meropenem (Sterile) USP
to Anhydrous meropenem …………1000mg
Sodium Carbonate (Sterile) USP
Eq. to Sodium (as a buffer) ……………………90.2mg
Sterile water for Injection BP….…………… 20ml
THERAPEUTIC INDICATION:
Meropenem is used to used treat severe infections of the skin or stomach. Meropenem is also used to treat bacterial meningitis (an infection that causes inflammation of the tissue that covers the brain and spinal cord).
DIRECTION OF USE:
The powder is to be reconstituted with 20ml of Sterile Water for Injections BP for IV use. Any unused portion must be discarded. 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.
FOR HUMAN USE ONLY.
(ULTRA-BROAD-SPECTRAM INJECTABLE ANTIBIOTICS)
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: It is dangerous to take this preparation except in accordance with the medical advice.
Not to be sold by retail without the prescription of Registered Medical Practitioner.
Keep medicine out of reach of children.
*Not to be sold without sterile water for Injection.
STORAGE & DOSAGE:
STORAGE: Store Protected from moisture at a temperature not exceeding 30°C.
Read enclosed leaflet before use.
DOSAGE: As directed by Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
(A) Meropenem for Injection USP 1gm
(B) Meropenem for Injection USP 2gm
(C) Meropenem for Injection USP 500mg
(B) Meropenem for Injection USP 2gm
(C) Meropenem for Injection USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Meropenem for Injection USP 1g
A. Each vial contains:
Meropenem (Sterile) USP
Eq. to Anhydrous meropenem …………1000mg
Sodium Carbonate (Sterile) USP
Eq. to Sodium (as buffer) ……………………90.2mg
B. Sterile water for Injection BP….…………… 20ml
2. Meropenem for Injection USP 2gm
A. Each vial contains:
Meropenem (Sterile) USP
Eq. to Anhydrous meropenem …………2gm
Sodium Carbonate (Sterile) USP
Eq. to Sodium (as buffer) ……………………180.4mg
B. Sterile water for Injection BP….…………… 30ml
3. Meropenem for Injection USP 500mg
A. Each vial contains:
Meropenem (Sterile) USP
Eq. to Anhydrous meropenem …………500mg
Sodium Carbonate (Sterile) USP
Eq. to Sodium (as buffer) …………………45.1mg
B. Sterile water for Injection BP ………….… 10ml
A. Each vial contains:
Meropenem (Sterile) USP
Eq. to Anhydrous meropenem …………1000mg
Sodium Carbonate (Sterile) USP
Eq. to Sodium (as buffer) ……………………90.2mg
B. Sterile water for Injection BP….…………… 20ml
2. Meropenem for Injection USP 2gm
A. Each vial contains:
Meropenem (Sterile) USP
Eq. to Anhydrous meropenem …………2gm
Sodium Carbonate (Sterile) USP
Eq. to Sodium (as buffer) ……………………180.4mg
B. Sterile water for Injection BP….…………… 30ml
3. Meropenem for Injection USP 500mg
A. Each vial contains:
Meropenem (Sterile) USP
Eq. to Anhydrous meropenem …………500mg
Sodium Carbonate (Sterile) USP
Eq. to Sodium (as buffer) …………………45.1mg
B. Sterile water for Injection BP ………….… 10ml
THERAPEUTIC INDICATIONS:
Meropenem is used to used treat severe infections of the skin or stomach. Meropenem is also used to treat bacterial meningitis (infection that causes inflammation of the tissue that covers the brain and spinal cord).
DIRECTION OF USE:
The powder to be reconstituted with 20ml of Sterile Water for Injections BP for IV use.
Any unused portion must be discarded.
The reconstituted solution should be use immediately after preparation.
The prepared solution should be used only, if it is clear.
Any unused portion must be discarded.
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.
FOR HUMAN USE ONLY.
(ULTRA-BROAD-SPECTRAM INJECTABLE ANTIBIOTICS)
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: It is dangerous to take this preparation except in accordance with the medical advice.
Not to be sold by retail without the prescription of Registered Medical Practitioner.
Keep medicine out of reach of children.
*Not to be sold without sterile water for Injection.
FOR HUMAN USE ONLY.
(ULTRA-BROAD-SPECTRAM INJECTABLE ANTIBIOTICS)
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: It is dangerous to take this preparation except in accordance with the medical advice.
Not to be sold by retail without the prescription of Registered Medical Practitioner.
Keep medicine out of reach of children.
*Not to be sold without sterile water for Injection.
STORAGE & DOSAGE:
STORAGE: Store Protected from moisture at a temperature not exceeding 30°C.
Read enclosed leaflet before use.
DOSAGE: As directed by Physician.
Read enclosed leaflet before use.
DOSAGE: As directed by Physician.