A) Tacrolimus Capsules USP 0.5mg
B) Tacrolimus Capsules USP 1mg
C) Tacrolimus Capsules USP 2mg
D) Tacrolimus Capsules USP 5mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
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.
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.
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 country.
Protect from light and moisture.
Dosage: As directed by the Nephrologist.
Attach dispensing label as per end country.
Tacrolimus Capsules USP 1mg Technical Specification:
| 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:
- Tacrolimus Capsules USP 0.5mg
- Tacrolimus Capsules USP 1mg
- Tacrolimus Capsules USP 2mg
- Tacrolimus Capsules USP 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. - 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.
Attach dispensing label as per end country.
