PROGRAF- tacrolimus capsule, gelatin coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

anhydrous tacrolimus (UNII: Y5L2157C4J) (tacrolimus - UNII:WM0HAQ4WNM)

Доступно од:

Rebel Distributors Corp

INN (Међународно име):

anhydrous tacrolimus

Састав:

anhydrous tacrolimus 1 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Prograf is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney, or heart transplants. It is recommended that Prograf be used concomitantly with adrenal corticosteroids. Because of the risk of anaphylaxis, Prograf injection should be reserved for patients unable to take Prograf capsules orally. In heart and kidney transplant recipients, it is recommended that Prograf be used in conjunction with azathioprine or mycophenolate mofetil (MMF). The safety and efficacy of the use of Prograf with sirolimus has not been established (see CLINICAL STUDIES). Prograf is contraindicated in patients with a hypersensitivity to tacrolimus. Prograf injection is contraindicated in patients with a hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil).

Резиме производа:

1 mg (containing the equivalent of 1 mg anhydrous tacrolimus) f Made in Japan Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). (for IV infusion only) NDC 0469-3016-01 Product Code 301601 5 mg/mL (equivalent of 5 mg of anhydrous tacrolimus per mL) supplied as a sterile solution in a 1 mL ampule, in boxes of 10 ampules Made in Ireland Store between 5°C and 25°C (41°F and 77°F).   Rx only Marketed by: Astellas Pharma US, Inc. Deerfield, IL 60015-2548 Revised: August 2009 09H011PRG-CPI Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Статус ауторизације:

New Drug Application

Карактеристике производа

PROGRAF- TACROLIMUS CAPSULE, GELATIN COATED
REBEL DISTRIBUTORS CORP
----------
PROGRAF®
TACROLIMUS CAPSULES
TACROLIMUS INJECTION (FOR INTRAVENOUS INFUSION ONLY)
WARNING
Increased susceptibility to infection and the possible development of
lymphoma may result from
immunosuppression. Only physicians experienced in immunosuppressive
therapy and management
of organ transplant patients should prescribe Prograf. Patients
receiving the drug should be
managed in facilities equipped and staffed with adequate laboratory
and supportive medical
resources. The physician responsible for maintenance therapy should
have complete information
requisite for the follow-up of the patient.
DESCRIPTION
Prograf is available for oral administration as capsules (tacrolimus
capsules) containing the equivalent
of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients
include lactose, hydroxypropyl
methylcellulose, croscarmellose sodium, and magnesium stearate. The
0.5 mg capsule shell contains
gelatin, titanium dioxide and ferric oxide, the 1 mg capsule shell
contains gelatin and titanium dioxide,
and the 5 mg capsule shell contains gelatin, titanium dioxide and
ferric oxide.
Prograf is also available as a sterile solution (tacrolimus injection)
containing the equivalent of 5 mg
anhydrous tacrolimus in 1 mL for administration by intravenous
infusion only. Each mL contains
polyoxyl 60 hydrogenated castor oil (HCO-60), 200 mg, and dehydrated
alcohol, USP, 80.0% v/v.
Prograf injection must be diluted with 0.9% Sodium Chloride Injection
or 5% Dextrose Injection before
use.
Tacrolimus, previously known as FK506, is the active ingredient in
Prograf. Tacrolimus is a macrolide
immunosuppressant produced by _Streptomyces tsukubaensis_. Chemically,
tacrolimus is designated as [3_S_-
[3_R_*[_E_(1_S_*,3_S_*,4_S_*)],
4_S_*,5_R_*,8_S_*,9_E_,12_R_*,14_R_*,15_S_*,16_R_*,18_S_*,19_S_*,26a_R_*]]
-
5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-
methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10