GENERIC NAME OF MEDICINAL PRODUCT:

(A) Meropenem Injection IP 1gm
(B) Meropenem Injection IP 2gm
(C) Meropenem Injection IP 500mg
(D) Meropenem Injection IP 250mg
(E) Meropenem Injection IP 125mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Meropenem Injection IP 1gm
A. Each vial contains:
Meropenem IP (Sterile)
Eq. to Anhydrous meropenem …………1000mg
Sodium Carbonate IP (Sterile)
Eq. to Sodium (as buffer) ……………………90.2mg
(A Sterile mixture of Meropenem & Sodium Carbonate)
B. Sterile water for Injection IP ……….……… 20ml

2. Meropenem Injection IP 2gm
A. Each vial contains:
Meropenem IP (Sterile)
Eq. to Anhydrous meropenem …………2gm
Sodium Carbonate IP (Sterile)
Eq. to Sodium (as buffer) ……………………180.4mg
(A Sterile mixture of Meropenem & Sodium Carbonate)
B. Sterile water for Injection IP ……….……… 30ml

3. Meropenem Injection IP 500mg
A. Each vial contains:
Meropenem IP (Sterile)
Eq. to Anhydrous meropenem …………500 mg
Sodium Carbonate IP (Sterile)
Eq. to Sodium (as buffer) …………….…45.1mg
(A Sterile mixture of Meropenem & Sodium Carbonate)
B. Sterile water for Injection IP ……….…… 10ml


4. Meropenem Injection IP 250mg
A. Each vial contains:
Meropenem IP (Sterile)
Eq. to Anhydrous meropenem …………250mg
Sodium Carbonate IP (Sterile)
Eq. to Sodium (as buffer) …………….…22.6mg
(A Sterile mixture of Meropenem & Sodium Carbonate)
B. Sterile water for Injection IP ……….…… 10ml

5. Meropenem Injection IP 125mg
A. Each vial contains:
Meropenem IP (Sterile)
Eq. to Anhydrous meropenem …………125mg
Sodium Carbonate IP (Sterile)
Eq. to Sodium (as buffer) …………….…11.275mg
(A Sterile mixture of Meropenem & Sodium Carbonate)
B. Sterile water for Injection IP ……….…… 5ml

THERAPEUTIC 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).

DIRECTION OF USE:

The powder to be reconstituted with 20ml or 10ml or 5 ml or 2.5ml of Sterile Water for injections IP for I.V. use.
The reconstituted solution should be use immediately after preparation.
The prepared solution should be used only, if it is clear.
Discard remaining water for Injection.

CAUTION AND SCHEDULE:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Any unused reconstituted portion must be discarded.
SCHEDULE: SCHEDULE 'H1' DRUG: -It is dangerous to take this preparation except in accordance with medical advice.
-Not to be sold by retail without the prescription of Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store Below 25°C Protect from light. Do not freeze.
Reconstitute before use. Read the Package Leaflet.
KEEP OUT OF REACH OF CHILDREN.
DOSAGE: As directed by the Physician.

Meropenem Injection IP 500mg Technical Specification:

Product Name:Meropenem Injection IP 500mg
Brand Name:MEROKEM
Strength:1gm, 2gm, 500mg, 250mg, 125mg
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: 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).
Storage:Store Below 25°C.  Protect from light. Do not freeze

GENERIC NAME OF MEDICINAL PRODUCT:

  • Meropenem Injection IP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Meropenem Injection IP 500mg
    Each vial contains:
    Meropenem IP (Sterile)
    Eq. to Anhydrous meropenem …………500mg
    Sodium Carbonate IP (Sterile)
    Eq. to Sodium (as a buffer) ……………………45.1mg
    (A Sterile mixture of Meropenem & Sodium Carbonate)
    Sterile water for Injection IP ……….……… 10ml

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 IP for I.V. use.
The reconstituted solution should be used immediately after preparation.
The prepared solution should be used only, if it is clear.
Discard remaining water for Injection.

CAUTION & SCHEDULE:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Any unused reconstituted portion must be discarded.

SCHEDULE: SCHEDULE ‘H1’ 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. Do not freeze.

Reconstitute before use. Read the Package Leaflet.

KEEP OUT OF REACH OF CHILDREN.

DOSAGE:
As directed by the Physician.