MYCOPHENOLATE MOFETIL injection, powder, lyophilized, for solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

MYCOPHENOLATE MOFETIL (UNII: 9242ECW6R0) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)

Mevcut itibaren:

Zydus Lifesciences Limited

INN (International Adı):

MYCOPHENOLATE MOFETIL

Kompozisyon:

MYCOPHENOLATE MOFETIL 500 mg in 20 mL

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in recipients of allogeneic kidney [see Clinical Studies (14.1)] , heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.   Allergic reactions to mycophenolate mofetil have been observed; therefore, Mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product. Mycophenolate mofetil for Injection is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN).   Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. To report a pregnancy or obtain information about the registry, visit www.mycophenolateREMS.com or call 1-800-617-8191.   Risk Summary

Ürün özeti:

Mycophenolate mofetil (MMF) has demonstrated teratogenic effects in humans [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)] . Wearing disposable gloves is recommended during reconstitution and when wiping the outer surface of the bottle/cap and the table after reconstitution. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in Mycophenolate mofetil for Injection (during or after preparation) [see Dosage and Administration (2.6)] . Follow applicable special handling and disposable procedures1 .  

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

Zydus Lifesciences Limited
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SPL MEDGUIDE
Revised: 10/2023
Document Id: e4ef4cf9-a1a6-451a-bf13-3774806fc478
34391-3
Set id: 628d1ff3-94bc-44bf-9de9-d3d535e199dc
Version: 7
Effective Time: 20231003
Zydus Lifesciences Limited

Ürün özellikleri

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
ZYDUS LIFESCIENCES LIMITED
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MYCOPHENOLATE MOFETIL FOR INJECTION, USP
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL – MYCOPHENOLATE MOFETIL 500 MG CONTAINER
LABEL
NDC 70771-1084-1
Mycophenolate Mofetil for Injection, USP
(500 mg per Vial)
FOR INTRAVENOUS INFUSION ONLY
PHARMACIST: Dispense the Medication Guide provided separately to each
patient.
SINGLE DOSE VIAL
Rx only
Zydus Pharmaceuticals
PRINCIPAL DISPLAY PANEL - MYCOPHENOLATE MOFETIL 500 MG CARTON LABEL
NDC 70771-1084-8
Mycophenolate Mofetil for Injection, USP
(500 mg per Vial)
PHARMACIST: Dispense the Medication Guide provided separately to each
patient.
FOR INTRAVENOUS INFUSION ONLY
SINGLE DOSE VIAL
4 Vials
Rx only
Zydus Pharmaceuticals
MYCOPHENOLATE MOFETIL
mycophenolate mofetil injection, powder, lyophilized, for solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1084
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
MYCOPHENOLATE MOFETIL (UNII: 9242ECW6R0) (MYCOPHENOLIC ACID -
MYCOPHENOLATE
500 mg
Zydus Lifesciences Limited
UNII:HU9DX48N0T)
MOFETIL
in 20 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1084-8
4 in 1 CARTON
09/22/2017
1
20 mL in 1 VIAL; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA204473
09/22/2017
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
918596198
ANALYSIS(70771-1084) , MANUFACTURE(70771