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Gamot sa breast cancer ni-recall

Ludy Bermudo - Pilipino Star Ngayon

MANILA, Philippines - Nagbabala ang Food and Drug Administration (FDA) sa publiko laban sa isang batch ng gamot para sa breast cancer na sinasabing boluntaryo namang ini-recall ng manufacturer.

Sinabi ni FDA head Kenneth Hartigan-Go, na mismong ang Fresenius Kabi Philippines Inc. ang bumawi sa batch ng Paclitaxel 30mg/1.5mL Solution for Nanoparticle Injection (Nanoxel) matapos maobserbahang ang Concentrate of Excipients nito ay naging dilaw na likido, na taliwas sa registered specification nito na dapat ay clear colorless, bago pa man ang aprubadong shelf-life nito.

Sakop ng recall ang lahat ng gamot na may batch numbers na 873TF00103 (nanoxel injection) at 873RX001 (accompanying concentrate of excipients), na ginawa noong Enero 2013 at may expiry date na Disyembre 2014.

Kaugnay nito, pinayuhan ni Hartigan-Go ang mga distributors, retailers, ospital, pharmacies, at mga klinika na may natitira pang stock ng apektadong batch ng Paclitaxel 30mg/mL Solution for Nanoparticle Injection (Nanoxel) at kasamang Concentrate of Excipients, na itigil na ang paggamit at distribus­yon ng naturang gamot.

“Any report about es­tablishment(s) dealing illegally with sale or offer for sale of unre­gistered health products should be reported immediately to FDA at [email protected],” ani Hartigan-Go.

Nabatid na ang pro­dukto ay ginagamit na panlunas sa breast cancer matapos ang bigong kumbinasyon ng chemotherapy para sa metastatic disease o relapse sa loob ng anim na buwang adjuvant chemotherapy.

vuukle comment

CONCENTRATE OF EXCIPIENTS

DISYEMBRE

DRUG ADMINISTRATION

FRESENIUS KABI PHILIPPINES INC

HARTIGAN-GO

KENNETH HARTIGAN-GO

NANOPARTICLE INJECTION

NANOXEL

PACLITAXEL

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