advagraf tacrolimus sustained release capsules 0

Description

Indication & Scope

Tacrolimus Capsules inhibits calcineurin, blocks T lymphocyte activation and reduces inflammatory cytokine release. It suppresses immune response to prevent transplant organ rejection.

Mechanism
Calcineurin inhibitor / Potent immunosuppressant
Drug class
Oral systemic immunosuppressant / Transplant anti-rejection capsules
Clinical use
Potent calcineurin inhibitor immunosuppressant; suppresses lymphocyte activation, core medication for solid organ transplant anti-rejection therapy.

Specification

Generic Name	Tacrolimus Capsules
Brand Name	SaiFuKai®; Advagraf®
Ingredient	Tacrolimus
Dosage Form	Oral Hard Capsules; Sustained-release Capsules
Package	0.5mg*50 capsules/box
Conditions Treated	Prophylaxis of graft rejection after liver or kidney transplantation; treat refractory graft rejection uncontrolled by other immunosuppressants post liver and kidney transplantation.
Taboos	Patients hypersensitive to tacrolimus or other macrolides are forbidden.
Place of origin	China; Ireland
Priscription Type	Prescription Drug
Storage Conditions	Sealed, store below 30°C, protected from light
Manufacturer	Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.; Astellas Ireland Co. Limited
Registration Authority	National Medical Products Administration (NMPA)
Approval number	H20094027; HJ20150029
Approval Date	May 31, 2023; July 10, 2024
Shelf Life	24 months

How to use ?

Recommended Dose:Oral administration, swallow whole with water.

Time: Administered twice daily, morning and evening, preferably on an empty stomach.

Instructions for use: Regular monitoring of tacrolimus blood trough level, renal function and blood pressure is essential. Grapefruit juice must be avoided. Reliable contraception is required during treatment.

Interaction: Drugs affecting CYP3A4 will alter tacrolimus blood concentration; regular trough concentration monitoring is required. Combined nephrotoxic agents increase renal damage risk.

Side effects: Tremor, hypertension, renal function impairment, hyperglycemia, insomnia.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support