Tacrolimus Capsules USP 0.5mg
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Tacrolimus Capsules USP 0.5mg Technical Specification:

Product Name:Tacrolimus Capsules USP  0.5mg
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:

  • Tacrolimus Capsules USP 0.5mg

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.

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

Attach dispensing label as per end county.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Tacrolimus Capsules USP 0.5mg
B) Tacrolimus Capsules USP 1mg
C) Tacrolimus Capsules USP 2mg
D) Tacrolimus Capsules USP 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) 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.

B) 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.

C) 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.

D) 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
Attach dispensing label as per end county.