GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Mannitol Injection USP (10%w/v)
B. Mannitol Injection USP (20%w/v)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Mannitol Injection USP (10%w/v)
Composition:
Each 100 ml contains:
Mannitol USP……………………………10g
Water for Injection USP…………… q.s.
Osmolarity: 1100 mOsmol/L; pH5.3 (4.5-7.0)

B. Mannitol Injection USP (20%w/v)
Composition:
Each 100 ml contains:
Mannitol USP……………………………20g
Water for Injection USP…………… q.s.
Osmolarity: 1100 mOsmol/L; pH5.3 (4.5-7.0)


THERAPEUTIC INDICATIONS:

It is used to reduce pressure and swelling around the brain and in the eyes. It is also used to prevent or treat kidney failure. This medicine is also used during some urology procedures.

PACKING:

Strength Pack size
10%w/v---- 100ml, 500ml
20%w/v---- 100ml, 500ml

DIRECTION OF USE:

Dissolve any mannitol crystals by heating (<60°C) & shaking; cool before administration. Reject container if crystals are not completely redissolved.
For I.V. use only.

CAUTION & WARNING:

CAUTION: Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility maybe impaired.
Do not use in series connection. Use only if solution is clear & container & seals are intact.
Not made with natural rubber latex, PVC or DEHP.
WARNING: Do not admix with other drugs.

STORAGE & DOSAGE:

Storage: Room temperature (25°C).
Avoid excessive heat.
Protect from freezing. See Package insert.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Dosage: As directed by the Physician.

Mannitol Injection USP 20%w/v Technical Specification:

Product Name:Mannitol Injection USP 20%w/v
Brand Name:Generics
Strength:10%w/v, 20%w/v
Dosage Form:I.V. Infusion Bottle (LVP)
Packing:100mL, 500mL 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: It is used to reduce pressure and swelling around the brain and in the eyes. It is also used to prevent or treat kidney failure.
Storage:Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package insert.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Mannitol Injection USP (20%w/v)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Mannitol Injection USP (20%w/v)
    Composition:
    Each 100 ml contains:
    Mannitol USP……………………………20g
    Water for Injection USP…………… q.s.
    Osmolarity: 1100 mOsmol/L; pH5.3 (4.5-7.0)

THERAPEUTIC INDICATIONS:

It is used to reduce pressure and swelling around the brain and in the eyes. It is also used to prevent or treat kidney failure. This medicine is also used during some urology procedures.

PACKING:

StrengthPack size
10%w/v100ml, 500ml
20%w/v100ml, 500ml

DIRECTION OF USE:

Dissolve any mannitol crystals by heating (<60°C) & shaking; cool before administration. Reject container if crystals are not completely redissolved.

For I.V. use only.

CAUTION & WARNING:

CAUTION: Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility maybe impaired.

Do not use in series connection. Use only if solution is clear & container & seals are intact.

Not made with natural rubber latex, PVC or DEHP.

WARNING: Do not admix with other drugs.

STORAGE & DOSAGE:

Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package insert.

STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.

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

Dosage: As directed by the Physician.