Graftac 0,5 / Graftac 1 / Graftac 5 Tacrolimus Sandoz 0,5 / Tacrolimus Sandoz 1 / Tacrolimus Sandoz 5 0,5 mg, 1 mg and 5 mg, Hard gelatine capsule.
PDF Leaflet Revision Date: 11 October 2022
Clinical Summary
Quick overview from the medicine insert
Indication
Primary immunosuppression in liver and kidney allograft recipients.
Dosage (summary)
Initial oral dose: 0.10-0.20 mg/kg/day for liver; 0.15-0.40 mg/kg/day for kidney, in two divided doses.
Special Populations
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Contraindicated in pregnancy; excreted in breast milk, not recommended during lactation.
Key Drug Interactions
- CYP3A4 inhibitors
- CYP3A4 inducers
- Ciclosporin
Contraindications
- Hypersensitivity to tacrolimus
- Pregnancy
- Concomitant use with live vaccines
Common side effects
- Infections
- Hypertension
- Hyperglycemia
- Nephrotoxicity
Counselling Points
- Take on an empty stomach
- Monitor for signs of infection
- Avoid grapefruit juice
Serious warnings
- Risk of graft rejection
- QT prolongation
- Increased risk of malignancies
Important Disclaimer
The Graftac 0,5 / Graftac 1 / Graftac 5 Tacrolimus Sandoz 0,5 / Tacrolimus Sandoz 1 / Tacrolimus Sandoz 5 0,5 mg, 1 mg and 5 mg, Hard gelatine capsule. professional information leaflet below is the property of Sandoz Sa and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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