GENERIC NAME OF THE MEDICINAL PRODUCT:

Mannitol with Glycerin Injection (10mg+10mg/ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Mannitol with Glycerin Injection (10mg+10mg/ml)
Composition:
Each 100 ml contains:
Mannitol ……………………………10g
Glycerin …………………………… 10g
Water for Injection …………… q.s.
Calculated Osmolarity:
Approx. 549mOs/L

THERAPEUTIC INDICATIONS:

Mannitol + Glycerin Infusion is indicated in use as an osmotic diuretic in the promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established.

DIRECTION OF USE:

To be administered aseptically.
No preservative added.
For I.V. use only.

CAUTION & WARNING:

CAUTION: Even Invisible damage to bottle caused during storage or transit may result in contamination. Do not use if bottle is damaged or leaking or contents not clear or contains visible solid particles. Return the bottle for replacement.
Discard any unused solution.
WARNING: Do not use if the solution contains visible solid particles, even on warming.

STORAGE & DOSAGE:

Storage: Store at a temperature between 20°C & 30°C.
Exposure to lower temperature may cause the deposition of crystals, which should be dissolved by warming before use.
Do not freeze.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Dosage: As directed by the Physician.

Mannitol with Glycerin Injection (10mg+10mg/ml) Technical Specification:

Product Name:Mannitol with Glycerin Injection (10mg+10mg/ml)
Brand Name:Generics
Strength:10mg+10mg/ml
Dosage Form:I.V. Infusion Bottle (LVP)
Packing:100mL IV Bottle
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:Diuretic
Indication: Mannitol + Glycerin Infusion is indicated in use as an osmotic diuretic in the promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established.
Storage:Store at a temperature between 20°C & 30°C. Exposure to lower temperature may cause the deposition of crystals, which should be dissolved by warming before use.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Mannitol with Glycerin Injection (10mg+10mg/ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Mannitol with Glycerin Injection (10mg+10mg/ml)
    Composition:
    Each 100 ml contains:
    Mannitol ……………………………10g
    Glycerin …………………………… 10g
    Water for Injection …………… q.s.
    Calculated Osmolarity:
    Approx. 549mOs/L

THERAPEUTIC INDICATIONS:

Mannitol + Glycerin Infusion is indicated in use as an osmotic diuretic in the promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established.

DIRECTION OF USE:

To be administered aseptically.
No preservative added.
For I.V. use only.

CAUTION & WARNING:

CAUTION: Even Invisible damage to bottle caused during storage or transit may result in contamination. Do not use if bottle is damaged or leaking or contents not clear or contains visible solid particles. Return the bottle for replacement.

Discard any unused solution.

WARNING: Do not use if the solution contains visible solid particles, even on warming.

STORAGE & DOSAGE:

Storage: Store at a temperature between 20°C & 30°C. Exposure to lower temperature may cause the deposition of crystals, which should be dissolved by warming before use. Do not freeze.

STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.

Keep medicine out of reach of children.
FOR HUMAN USE ONLY

Dosage: As directed by the Physician.