Tacrolimus Capsules 5mg (Tacrotaj)

Tacrolimus Capsules 5mg (Tacrotaj)
Product Name:Tacrolimus Capsules USP
Brand Name:Generics
Strength:0.5mg, 1mg, 2mg, 5mg
Dosage Form:Capsules(Hard gelatin)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Immunosuppressants
Indication:Tacrolimus is an immunosuppressive drug. After allogeneic organ transplant, the risk of organ rejection is moderate.
Storage:Store at 20° to 25°C (68° to 77°F). Protect from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Tacrolimus Capsules USP 0.5mg
    Each hard gelatin Capsule contains:
    Tacrolimus Monohydrate
    Equivalent to Tacrolimus USP……………0.5mg
    Excipients…………………………………………q.s.
    Approved colours used in capsule shell.
  • Tacrolimus Capsules USP 1mg
    Each hard gelatin Capsule contains:
    Tacrolimus Monohydrate
    Equivalent to Tacrolimus USP…………1mg
    Excipients……………………………………….q.s.
    Approved colours used in capsule shell.
  • Tacrolimus Capsules USP 2mg
    Each hard gelatin Capsule contains:
    Tacrolimus Monohydrate
    Equivalent to Tacrolimus USP…………2mg
    Excipients……………………………………….q.s.
    Approved colours used in capsule shell.
  • Tacrolimus Capsules USP 5mg
    Each hard gelatin Capsule contains:
    Tacrolimus Monohydrate
    Equivalent to Tacrolimus USP…………5mg
    Excipients……………………………………….q.s.
    Approved colours used in capsule shell.

THERAPEUTIC INDICATIONS:

Tacrolimus is used together with other medicines to prevent the body from rejecting a transplanted organ (eg, kidney, liver, heart, or lung). This medicine may be used with steroids, azathioprine, basiliximab, or mycophenolate mofetil. Tacrolimus belongs to a group of medicines known as immunosuppressive agents.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: To be sold by retail on the prescription of a Nephrologist.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F).
Protect from light and moisture.
Dosage: As directed by the Nephrologist.

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