Tinidazole Intravenous Infusion 400mg/100ml

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Tinidazole Intravenous Infusion (4mg/ml or 400mg/100ml)
B. Tinidazole Intravenous Infusion (2mg/ml or 200mg/100ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Tinidazole Intravenous Infusion (4mg/ml or 400mg/100ml)
Composition:
Each 100ml contains: Tinidazole ……………………………400mg
Sodium Chloride ……………………790mg
Water for Injection ………………… q.s.

B. Tinidazole Intravenous Infusion (2mg/ml or 200mg/100ml)
Composition:
Each 100ml contains:
Tinidazole ……………………………200mg
Sodium Chloride ……………………790mg
Water for Injection ………………… q.s.

THERAPEUTIC INDICATIONS:

Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as Hemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in non-pregnant women.

DIRECTION OF USE:

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

CAUTION & WARNING:

CAUTION: Examine the bottle before use & do not use if solution is found leaking or having particulate matter/fungal contamination which may occur due to even invisible damage to bottles in transit or storage.
Discard any unused solution.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at a temperature not exceeding 30°C. Store protected from light & moisture.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
ISOTONIC SOLUTION
Read enclosed leaflet before use.
Dosage: As directed by the Physician.

Tinidazole Intravenous Infusion 400mg/100ml Technical Specification:

Product Name:Tinidazole Intravenous Infusion 400mg/100ml
Brand Name:Generics
Strength:(4mg/ml or 400mg/100ml), (2mg/ml or 200mg/100ml)
Dosage Form:I.V. Infusion Bottle (LVP)
Packing:100mL, 200mL, 400mL 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:Anti-protozoal
Indication: Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as Hemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in non-pregnant women.
Storage:Store at a temperature not exceeding 30°C. Store protected from light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Tinidazole Intravenous Infusion (4mg/ml or 400mg/100ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Tinidazole Intravenous Infusion (4mg/ml or 400mg/100ml)
    Composition:
    Each 100ml contains:
    Tinidazole ……………………………400mg
    Sodium Chloride ……………………790mg
    Water for Injection ………………… q.s.

THERAPEUTIC INDICATIONS:

Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as Hemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in non-pregnant women.

DIRECTION OF USE:

To be administered aseptically.

For I.V. use only.

No preservative added.

CAUTION & WARNING:

CAUTION: Examine the bottle before use & do not use if solution is found leaking or having particulate matter/fungal contamination which may occur due to even invisible damage to bottles in transit or storage.

Discard any unused solution.

WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at a temperature not exceeding 30°C. Store protected from light & moisture.

STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.

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

ISOTONIC SOLUTION
Read enclosed leaflet before use.

Dosage: As directed by the Physician.