FDA, nagpaalala sa tamang pag-iimbak ng alcohol at sanitizer upang makaiwas sa sunog

Robie de Guzman   •   October 1, 2020   •   439

MANILA, Philippines – Nagpaalala ang Food and Drug Administration (FDA) sa publiko hinggil sa wastong pag-iimbak ng rubbing alcohol, sanitizer at iba pang uri ng disinfectant dahil posible umano itong pagmulan ng sunog.

Ayon kay FDA director general Eric Domingo, flammable o madaling masunog ang mga ganitong uri ng materyal dahil sa taglay nitong mataas na antas ng alcohol at iba pang kemikal.

Maliban sa rubbing alcohol at sanitizer, kabilang din sa flammable products na kalimitang nakikita sa bahay ay ang aerosols katulad ng hairspray at anti-perspirant sprays, fabric softener, nail polish remover, cooking oil, at harina.

Ginawa ni Domingo ang paalala sa gitna ng novel coronavirus disease (COVID-19) pandemic kung kailan marami ang gumagamit ng alcohol at iba pang disinfectant upang makaiwas sa COVID-19.

Ayon sa FDA chief, dapat ilagay sa maayos na lugar ang mga bote ng disinfectants at malayo sa apoy o sa mga bagay na may matataas o maiinit na temperatura.

“Gusto natin sa temperature na mababa, hindi pwede sa mainit, wala sa direct na araw. At syempre gusto natin sa mga lugar na maaliwalas, hindi sa mga confined,” ang wika ni Domingo.

“Kapag ganito, may posibility na pwede siyang ma-ignite o masindihan at hindi lang masunog, maaring sumabog,” dagdag pa niya.

Dapat rin aniya ay may maayos na label ang mga produkto at may sapat na babala at impormasyon para sa mga gagamit nito.

“Meron tayong mga labelling requirements na nakalagay. And in fact, pag alcohol, nakalagay diyan may warning na probable o maaaring masunog at of course maaaring sumabog ang ganitong produkto,” ang wika ni Domingo.

Paalala rin ng opisyal sa publiko na sundin ang mga direksyon sa pakete hinggil sa paggamit at pag-iimbak nito upang makaiwas sa aksidente. – RRD (mula sa ulat ni Correspondent Vincent Arboleda)

India’s Bharat Biotech applies for EUA in Phl for COVID-19 vaccines

Aileen Cerrudo   •   January 21, 2021

MANILA, Philippines — Indian biotechnology company Bharat Biotech has applied for Emergency Use Authorization (EUA) in the country for its COVID-19 vaccine.

The Food and Drug Administration, in a message, has confirmed that Bharat Biotech submitted their application for Covaxin on Wednesday (January 20) and pre-evaluation is already ongoing.

“They submitted an application this morning and pre-evaluation is going on,” according to FDA Director-General Eric Domingo.

Meanwhile, in a statement, the biotech company said that Covaxin is ideal for tropical countries because storage temperature only needs to be set by two to eight degrees celsius.

Bharat Biotech also said the Philippines is among the list of priority countries that will receive Covaxin supply.

“The Philippines is among the list of priority countries that Bharat Biotech will allocate supplies of Covaxin to. It was announced earlier this week that the Indian government has issued a letter of comfort covering this,” the company said in a statement.

Other companies seeking EUA in the country include Astrazeneca, Gamaleya Research Institute, and Sinovac Biotech. -AAC (with reports from Aiko Miguel)

FDA clarifies issuance of EUA of vaccine manufacturers not delayed

Aileen Cerrudo   •   January 12, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) has clarified there is no delay in the issuance of the Emergency Use Authorization (EUA) to vaccine manufacturers.

FDA Director General Eric Domingo said the agency managed to lessen the approval process from six months to 21 days.

Domingo added the applications should still be thoroughly reviewed especially if it will be distributed to Filipinos.

Kailangan naman natin ng magandang proseso at ng pagusuri bago natin payagan na gamitin ang bakuna sa milyon-milyong Pilipino (We need a thorough process and review before we can allow the vaccine to be used to millions of Filipinos), he said.

Three pharmaceutical companies Pfizer-BioNTech, AstraZeneca, and Gamaleya already submitted their application for the EUA.

Several local government units (LGUs) also signed a deal with AstraZeneca to purchase COVID-19 vaccines.

The FDA said that while LGUs are free to sign tripartite deals with a COVID-19 vaccine manufacturer of their choosing., they can still partner with other COVID-19 vaccine makers.

Maaari rin naman sila later on magkaroon ng agreements with other vaccines and coordinated with the DOH [Department of Health] and the NTF [National Task Force]. Hindi iyon exclusive sa isang marka lamang (They can have agreements with other vaccines later on, with the coordination of the DOH and NTF. That is not exclusive to one company), he said.

Meanwhile, Domingo said the FDA is still awaiting the guidelines of the national government on the vaccination plan, which includes the distribution of vaccines to various areas in the country.

Domingo also reiterated that individuals can opt-out of receiving the vaccine if they wish to do so.

“Even the FDA requires that if any person is going to be vaccinated especially under the EUA there should be a full, written informed consent before the vaccination,” he said. AAC (with reports from Aiko Miguel)

FDA reports case of heart blockage in teen after using vape juice with Cannabis

Marje Pelayo   •   January 8, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) on Wednesday (January 6) released their findings on the life-threatening case of a 17-year-old male that had a history of vaping with cannabinol, a psychoactive cannabinoid or byproduct of Cannabis or marijuana.

According to FDA, a group of doctors from Western Visayas Medical Center (WVMC) contacted the agency in early 2020 after the patient experienced seizures and a low heart rate of 23 bpm although he had no known risk factors for heart or neurological disease.

It was later determined that the teenager had a history of using vape juice labeled ‘Gluttony Mamon’ which tested positive for the presence of cannabinol and tetrahydocannabinol, both derived from Cannabis or marijuana.

A brand sample was submitted to the Philippine Drug Enforcement Agency (PDEA) which verified the presence of the dangerous substance.

Liquid Cannabis is considered a dangerous drug under Republic Act No. 9165, otherwise known as the “Comprehensive Dangerous Drug Act of 2002”.

The FDA warns the public against the purchase and consumption of Electronic Nicotine Delivery System and Electronic Non-Nicotine Delivery System (ENDS/ENNDS) products commonly known as vapes that may pose potential health risks.

In an earlier advisory, the Agency already requested law enforcement agencies and Local Government Units (LGUs) to ensure that the said product is not sold or made available in the market or areas of their jurisdiction. —MNP / Raymund David

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