DYNABAC

Genel Bilgiler

  • Ticaret Unvanı:
  • DYNABAC 10 ENTERIK KAPLI TABLET
  • Reçete türü:
  • Normal
  • İçin kullanmak:
  • İnsanlar
  • İlaç türü:
  • allopatik ilaç

Belgeler

Yerelleştirme

  • Bulunduğu ülkeler::
  • DYNABAC 10 ENTERIK KAPLI TABLET
    Türkiye
  • Dil:
  • Türkçe

Terapötik bilgiler

  • Terapötik alanı:
  • dirithromycin

Diğer bilgiler

Durum

  • Kaynak:
  • TİTCK - TÜRKİYE İLAÇ VE TIBBİ CİHAZ KURUMU - Türkiye
  • Yetkilendirme durumu:
  • Aktif
  • Yetkilendirme numarası:
  • 8699514042723
  • Yetkilendirme tarihi:
  • 29-01-2013
  • Son Güncelleme:
  • 25-05-2018

Hasta Bilgi broşürü: Ürün Özellikleri Özeti - kompozisyon, endikasyonlar, yan etkiler, dozaj, etkileşimleri, advers reaksiyonlar, gebelik, laktasyon

KULLANMA TALİMATI

DYNABAC250 mgenterikkaplıtablet

Ağızdanalınır.

Etkin madde:Her birenterik kaplıtablette 250mg diritromisiniçerir.

Yardımcımaddeler:Magnezyumkarbonat, mikrokristalinselüloz, sodyumnişasta glikolat,

hidroksipropil selüloz,kroskarmelozsodyum, magnezyumstearat,metil hidroksipropil

selüloz, polietilen glikol,propilenglikol,metaakrilik asitkopolimeri, renkkarışımıbeyaz

T3166-WE, trietilasetat

Bu ilacıkullanmayabaşlamadanönce buKULLANMA TALİMATINI dikkatlice

okuyunuz,çünkü sizin içinönemlibilgiler içermektedir.

Bu kullanmatalimatınısaklayınız.Dahasonra tekrarokumayaihtiyaçduyabilirsiniz.

Eğer ilavesorularınızolursa, lütfen doktorunuzaveyaeczacınızadanışınız.

Builaç kişisel olaraksizin içinreçete edilmiştir, başkalarınavermeyiniz.

Bu ilacın kullanımısırasında,doktoraveyahastaneyegittiğinizde doktorunuza builacı

kullandığınızısöyleyiniz.

Bu talimattayazılanlara aynen uyunuz.İlaç hakkındasize önerilendozundışında

yüksekveyadüşükdoz kullanmayınız.

Bu Kullanma Talimatında :

1. DYNABAC nedir ve neiçinkullanılır ?

2. DYNABAC'ıkullanmadan öncedikkat edilmesigerekenler

3.DYNABAC nasıl kullanılır ?

4.Olasıyan etkiler nelerdir?

5.DYNABAC'ın saklanması

Başlıklarıyeralmaktadır.

1.DYNABACnedir ve neiçinkullanılır ?

DYNABAC,10ve14enterikkaplıtabletiçerenblisterambalajlardasunulanmakrolid grububir

antibiyotiktir.

DYNABACetkin madde olarakdiritromisiniçerir.

Diritromisin,birçokbakteriüzerindeetkili,genişspektrumlubirantibiyotiktir.

DYNABAC’ınmikroorganizmalar üzerindekietkisinin,duyarlıbakterilerin proteinsentezini

baskılamak yoluylaolduğu düşünülmektedir.

Diritromisin,Staphylococcusaureus,Streptococcus pneumoniae, Streptococcuspyogenes,

Haemophilus influenzae, Legionellapneumophila,Moraxellacatarrhalis,Mycoplasma

pneumoniaegibimikroorganizmalar üzerine antibakteriyel etkinlikgösterir.

DYNABACyukarıdabelirtilenbakteriler tarafından meydanagetirilen,aşağıdakienfeksiyonların

tedavisindeendikedir.

Alt veüst solunumyollarıenfeksiyonları

-Kronikbronşitinakutalevlenmeleri

-Akutbronşittebağlıolarak gelişensekonderbakteriyel enfeksiyonlar

-Toplumdaedinilmişpnömoniler

-Yutakve bademcik iltihapolgularında

Derive yumuşakdokuenfeksiyonları

2.DYNABAC’ıkullanmadanöncedikkatedilmesi gerekenler

DYNABAC'ıaşağıdakidurumlardaKULLANMAYINIZ

Diritromisin, eritromisinveyadiğermakrolidantibiyotiklerekarşıalerjisiolankişilerde,

Ergot alkaloidleriyleveözellikle ergotaminvedihidroergotaminle(migren tedavisinde

kullanılanbirilaç grubu)birlikte kullanımda,

Sisaprid(midedenyemek borusunamideiçeriğininkaçması(reflü)tedavisindekullanılan

birilaç) ile birliktekullanımda.

DYNABAC'ıaşağıdakidurumlarda DİKKATLİKULLANINIZ

Hamileliğinizin ilk3ayında doktorunuza danışmadankullanmayınız.

Psödomembranözkolit adıverilen ve kanlı-mukuslu ishal ilekendini belliedenhastalık, geniş

spektrumlubütün antibiyotiklerin(makrolidler,penisilinlervesefalosporinlerdahil)kullanımına

eşlikedebilir. Bu nedenleuzunsüredirantibiyotik kullanıyorsanız veishalinizvarsa,

psödomembranözkolitgelişme olasılığınıunutmayınız. Hafif psödomembranözkolitvakaları

genellikle,ilacın bırakılmasıile düzelirken,orta-ileriderecedeşiddetli vakalardagerekliönlemler

alınmalıdır.

Aşırıçoğalabilecek dirençliorganizmaların ortayaçıkmaolasılığıakıldatutulmalıdır. Tedaviniz

sırasında hastalığınşiddetlenmesi gelişebilir.

DYNABACkullanırken doğrudanuzunsüregüneşışığınamaruzkalmayın.ZiraDYNABAC

derinizingüneşışığına karşıduyarlılığınıarttırabilir.Gerekirse korunmatedbirleriniarttırınız.

Buuyarılar geçmişteki herhangibirdönemdedahiolsasiziniçingeçerliyse lütfendoktorunuza

danışınız.

DYNABAC'ın yiyecek veiçecek ilekullanılması

DYNABAC,yemeklerleveyayemeklerden sonraki 1saat içindealınmalıdır.Günde2-3L suve

içecektüketilmelidir.

Hamilelik

İlacıkullanmadanöncedoktorunuzaveyaeczacınızadanışınız.

Gerekli olduğudurumlardadoktorunuzunkontrolüaltındakullanınız.

Tedavinizsırasındahamileolduğunuzufark edersenizhemendoktorunuzaveya eczacınıza

danışınız.

Emzirme

İlacıkullanmadanöncedoktorunuza veyaeczacınızadanışınız.

DYNABAC’ın annesütünegeçipgeçmediği bilinmediğinden,tedavinindevamıkonusunda

doktorunuzadanışınız.

Araç vemakinekullanımı

Araçvemakinekullanmaya bilinenbiretkisiyoktur.

DYNABAC’ın içeriğindebulunan bazıyardımcımaddelerhakkındaönemlibilgiler

Kroskarmelloz sodyumiçermektedir.Dozunedeniyleherhangibir uyarıgerektirmemektedir..

Diğerilaçlar ile birliktekullanımı

Ergot alkaloidleri (migrentedavisindekullanılanbir ilaçgrubu), sisaprid(midedenyemek

borusunamideiçeriğinin kaçması(reflü) tedavisinde kullanılanbir ilaç)vepimozid (şizofreni

tedavisindekullanılan birilaç)ile birlikte kullanmayınız.

Bromokriptin(parkinsontedavisindekullanılır), dofetilid(Kalpritmbozukluğundakullanılır),

siklosporin (bağışıklık sistemini baskılayan ilaç), fentanil ( merkezietkiliağrıkesici),digoksin

(kalp ritmbozukluklarıvekalpyetmezliğindekullanılır) ile birlikteDynabac’ın kullanılması

önerilmez.

Ağızdanalınan pıhtılaşmayıönleyenilaçlarilebirliktekullanımda dikkatliolunuz.

Eğer reçeteliyadareçetesiz herhangi birilacışu andakullanıyorsanız veyasonzamanlarda

kullandınız iselütfendoktorunuzaveyaeczacınızabunlar hakkındabilgiveriniz.

3.DYNABACnasıl kullanılır?

Uygun kullanım ve doz/uygulamasıklığıiçintalimatlar:

Hekimtarafındanbaşka türlüönerilmediği takdirde;erişkinlerdetümendikasyonlardagünde

1defa 500mg(250mg’lık 2 tablet)şeklinde kullanılır.

Çeşitli enfeksiyonlardakullanım dozu,sıklığıvekullanımsüresi aşağıdatablo halindeverilmiştir.

EnfeksiyonDoz VerilişsıklığıVerilişsüresi

Kronikbronşitin akut

alevlenmeleri 500mg Günde 1kez 5-7gün

Akut bronşitte sekonder

enfeksiyon 500mg Günde1 kez 7 gün

Toplumda edinilmişpnömoni 500mg Günde 1kez 14 gün

Yutak vebademcikiltihabı 500mg Günde1 kez 10gün

Deriveyumuşakdoku

enfeksiyonları 500mg Günde 1kez 5-7gün

Uygulama yoluvemetodu:

DYNABACsadece ağızdankullanım içindir.

DYNABAC,yemeklerleveya yemeklerden sonraki 1saatiçindealınmalıdır. Tabletler

kırılmadanveçiğnenmedenbirbütün olarakyutulmalıdır.

2 tabletaynıanda,1 bardaksuile alınır.

Değişik yaşgrupları:

Çocuklardakullanımı:

12 yaşındanbüyük çocuklardakullanılır.

Doz günde1kez alınan 2tabletşeklindedir.

Yaşlılarda kullanımı:

YaşlıhastalardaDYNABACdozununayarlanmasına gerek yoktur.

Özelkullanım durumları:

Böbrek/Karaciğer yetmezliği:

Hafif-ortaderecedeki böbrekyadakaraciğeryetmezliğidurumlarında dozayarlamasına

gerekyoktur.

Eğer DYNABAC’ınetkisininçok güçlüveyazayıf olduğunadairbir izleniminizvar ise

doktorunuz veyaeczacınız ilekonuşunuz.

Kullanmanızgerekenden dahafazlaDYNABACkullandıysanız

DYNABAC’tankullanmanız gerekenden fazlasınıkullanmışsanız bir doktor veyaeczacıile

konuşunuz.

DYNABAC’ıkullanmayıunutursanız

Unutulandozlarıdengelemekiçinçiftdozalmayınız.

DYNABACiletedavi sonlandırıldığında oluşabileceketkiler

Bulunmamaktadır.

4.Olasıyan etkiler nelerdir?

Tümilaçlar gibi, DYNABAC’ıniçeriğindebulunanmaddelereduyarlıolankişilerde yanetkiler

olabilir.

Aşağıdakilerde biriolursa, DYNABAC’ıkullanmayıdurdurunuzve DERHAL

doktorunuza bildirinizveya sizeenyakın hastaneninacilbölümünebaşvurunuz:

Aşırıduyarlılık reaksiyonları(Solukalmadazorluk,yüz,dudak,dil veyaboğazdaşişme,

ani kan basıncıdüşmesi,yaygın veşiddetli kızarıklık, kaşıntı, kurdeşen)

Bunlarınhepsi çok ciddiyan etkilerdir.

Eğerbunlardanbiri sizdemevcut ise,sizin DYNABAC’akarşıciddi alerjinizvar demektir.Acil

tıbbimüdahaleyeveyahastaneyeyatırılmanıza gerekolabilir.’

Buçok ciddiyanetkilerin hepsi oldukçaseyrekgörülür.

Aşağıdakilerdenherhangibirini farkedersenizhemendoktorunuzabildirinizveyasizeen

yakın hastanenin acilbölümünebaşvurunuz:

Kanlı-mukusluishal

Deride genişbiralanayayılandöküntüler

Vajinadamantarenfeksiyonu

Derivegözlerdesararma,bulantı, karın ağrısı, aşırıyorgunlukgibikaraciğer hasar

belirtileri

Bunların hepsiciddiyan etkilerdir.Aciltıbbi müdahalegerekebilir.

Ciddi yanetkiler çokseyrekgörülür.

Aşağıdakilerdenherhangibirini farkederseniz,doktorunuzasöyleyiniz:

Karın ağrısı

İshal

Bulantı-Kusma

Hazımsızlık

Gazşikayetleri

İştahsızlık

Yorgunluk

Deridehafifdöküntüve kaşıntı

Başağrısı

Başdönmesi

Uykusuzluk

BunlarDYNABAC’ın hafifyan etkileridir.

Buyanetkiler dozazaltıldığındaveyatedavikesildiğindekaybolur.

Eğer bukullanmatalimatındabahsigeçmeyenherhangibiryan etkiylekarşılaşırsanız

doktorunuzuveyaeczacınızıbilgilendiriniz.

5.DYNABAC’ın saklanması

DYNABAC’ıçocukların göremeyeceği, erişemeyeceği yerlerdeveambalajında saklayınız.

25ºC’nin altındaki oda sıcaklığında saklanmalıdır.

Son kullanma tarihiyle uyumluolarakkullanınız.

Etiketin veyaambalajın üzerinde belirtilensonkullanma tarihinden sonra DYNABAC’ı

kullanmayınız.

Eğerüründeve/veya ambalajında bozukluklarfarkederseniz DYNABAC’ıkullanmayınız.

Ruhsat Sahibi:

AbdiİbrahimİlaçSan. ve Tic.A.Ş.

Reşitpaşa Mah.Eski Büyükdere Cad.No:434467

Maslak/Sarıyer/İstanbul

Üretim yeri:

AbdiİbrahimİlaçSan.ve Tic.A.Ş.

Sanayi Mah.Tunç Cad.No:3

Esenyurt/İstanbul

Bu kullanmatalimatı06.06.2016tarihindeonaylanmıştır.

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19-7-2018

Food additive re-evaluation: EFSA workshop in November focuses on foods for infants below 16 weeks of age

Food additive re-evaluation: EFSA workshop in November focuses on foods for infants below 16 weeks of age

Food additive re-evaluation: EFSA workshop in November focuses on foods for infants below 16 weeks of age

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

28-6-2018

FDA Releases Guidance to Help Animal Drug Sponsors with Antimicrobial Animal Drug Sales and Distribution Reporting Requirements

FDA Releases Guidance to Help Animal Drug Sponsors with Antimicrobial Animal Drug Sales and Distribution Reporting Requirements

FDA is releasing Guidance for Industry #252. This small entity compliance guide is intended to help small businesses comply with the Antimicrobial Animal Drug Sales and Distribution final rule.

FDA - U.S. Food and Drug Administration

12-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections

The increase in serious antimicrobial drug resistant infections is a critical public health concern and a growing threat to patients. FDA is taking steps to combat antibiotic-resistant bacteria.

FDA - U.S. Food and Drug Administration

18-5-2018

FDA approves novel preventive treatment for migraine

FDA approves novel preventive treatment for migraine

FDA approves Aimovig for the preventive treatment of migraine. Aimovig works by blocking the activity of a molecule that is involved in migraine attacks.

FDA - U.S. Food and Drug Administration

14-4-2018

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

AMA Wholesale Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. Tadalafil is an active ingredient in a FDA-approved prescription drug that is used for erectile dysfunction.

FDA - U.S. Food and Drug Administration

5-1-2017

Re-examination of the CVMP's decision to phase out zinc oxide for young pigs

Re-examination of the CVMP's decision to phase out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) will re-examine the decision to phase out medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs.

Danish Medicines Agency

13-1-2016

Access to results in EudraCT from 13 January

Access to results in EudraCT from 13 January

When a clinical trial of medicinal products has ended, the trial results must be entered in the EudraCT database. The system has been unavailable for a period of time during which data could not be entered in the EudraCT database. The EMA now re-opens the database and results can be entered in EudraCT again.

Danish Medicines Agency

11-8-2015

New organisation structure of DHMA

New organisation structure of DHMA

The Danish Medicines Agency to be re-established as an independent agency.

Danish Medicines Agency

27-2-2014

Paracetamol use during pregnancy

Paracetamol use during pregnancy

A new Danish study suggests a possible connection between mothers' use of paracetamol painkillers during pregnancy and the risk of developing disorders like ADHD (attention deficit hyperactivity disorder) in children.

Danish Medicines Agency

25-4-2013

Danish Pharmacovigilance Update, 21 February 2013

Danish Pharmacovigilance Update, 21 February 2013

In this issue of Danish Pharmacovigilance Update: Cardiovascular monitoring when initiating and re-initiating treatment with fingolimod (Gilenya®).

Danish Medicines Agency

26-11-2018

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

These examples help illustrate why we believe that newer devices should be compared to the benefits and risks of more modern technologies and why we’re looking at ways to promote the use of more recent predicates

These examples help illustrate why we believe that newer devices should be compared to the benefits and risks of more modern technologies and why we’re looking at ways to promote the use of more recent predicates

These examples help illustrate why we believe that newer devices should be compared to the benefits and risks of more modern technologies and why we’re looking at ways to promote the use of more recent predicates

FDA - U.S. Food and Drug Administration

20-11-2018

#FDA has set important new goal when it comes to device safety: ensuring that we’re consistently first in the world to identify and act upon device safety signals to protect patients.  https://go.usa.gov/xPAf7 pic.twitter.com/IATHeEUgHe

#FDA has set important new goal when it comes to device safety: ensuring that we’re consistently first in the world to identify and act upon device safety signals to protect patients. https://go.usa.gov/xPAf7 pic.twitter.com/IATHeEUgHe

#FDA has set important new goal when it comes to device safety: ensuring that we’re consistently first in the world to identify and act upon device safety signals to protect patients. https://go.usa.gov/xPAf7  pic.twitter.com/IATHeEUgHe

FDA - U.S. Food and Drug Administration

8-11-2018

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. pic.twitter.com/WkDNnXqmbw

FDA - U.S. Food and Drug Administration

21-10-2018

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting  ht

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting ht

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting https://go.usa.gov/xPnyd .

FDA - U.S. Food and Drug Administration

21-10-2018

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding  ht

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding ht

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding https://go.usa.gov/xPnda . pic.twitter.com/nktV9BDAC3

FDA - U.S. Food and Drug Administration

17-10-2018

Save the date & Join the @US_FDA’s  Patient Engagement Advisory Committee on Nov 15th to discuss  patient-generated health data from sources like social media, activity  trackers, and patient-driven registries. Learn more:  https://go.usa.gov/xPRau  #Digi

Save the date & Join the @US_FDA’s Patient Engagement Advisory Committee on Nov 15th to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. Learn more: https://go.usa.gov/xPRau  #Digi

Save the date & Join the @US_FDA’s Patient Engagement Advisory Committee on Nov 15th to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. Learn more: https://go.usa.gov/xPRau  #DigitalHealth #PEAC2018 pic.twitter.com/NU61Snpxxw

FDA - U.S. Food and Drug Administration

21-9-2018

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like  activity trackers, social media, and patient registries to better  understand their needs.  Click the link for more information about the upcoming meeting:  https:/

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like activity trackers, social media, and patient registries to better understand their needs. Click the link for more information about the upcoming meeting: https:/

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like activity trackers, social media, and patient registries to better understand their needs. Click the link for more information about the upcoming meeting: https://bit.ly/2MUNqhU 

FDA - U.S. Food and Drug Administration

21-9-2018

Regulatory and procedural guideline:  Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1, draft: consultation open

Regulatory and procedural guideline: Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1, draft: consultation open

The guideline, which was developed to encourage optimal use and to minimise selection of antimicrobial resistance (AMR), was revised in order to improve consistency of the summary of product characteristics (SPCs) for antimicrobial products in the EU Member States.

Europe - EMA - European Medicines Agency

21-9-2018

Scientific guideline:  Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Europe - EMA - European Medicines Agency

11-9-2018

 Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

The Antimicrobials Working Party of the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) is holding a focus group meeting with stakeholders to discuss the revision of the antimicrobial veterinary medicinal product risk assessment guideline, following a public consultation on the draft revised guideline ending on 31 October 2018. The meeting will focus on topics identified during this public consultation. This guideline aims to provide guidance to marketing authorisat...

Europe - EMA - European Medicines Agency

5-9-2018

Patients may not have access to an #FDA approved or cleared device in the absence of adequate coverage. That’s why we’re expanding our work with private payors to help narrow the time it takes for payors to make a coverage determination on new medical dev

Patients may not have access to an #FDA approved or cleared device in the absence of adequate coverage. That’s why we’re expanding our work with private payors to help narrow the time it takes for payors to make a coverage determination on new medical dev

Patients may not have access to an #FDA approved or cleared device in the absence of adequate coverage. That’s why we’re expanding our work with private payors to help narrow the time it takes for payors to make a coverage determination on new medical devices

FDA - U.S. Food and Drug Administration

6-8-2018

A reminder about the safe and correct use of condoms

A reminder about the safe and correct use of condoms

A reminder on the safe use of condoms, including making sure you’re aware of the expiry date

Therapeutic Goods Administration - Australia

27-7-2018

Scientific guideline:  Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Scientific guideline: Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Established veterinary antibiotics are not always used at the authorised dose, and the dose may need to be reviewed in order to maintain their effectiveness whilst limiting the risks of antimicrobial resistance. Before a new dose is introduced, the company would typically have to conduct new studies to ensure it does not negatively affect the safety of the target animal, the consumer of animal produce, or the environment. This may reduce product availability, which could have a negative impact on antimic...

Europe - EMA - European Medicines Agency

22-7-2018

Medical device safety is a key #FDA priority. We’re committed to protecting U.S. patients by minimizing avoidable risks, assuring they have timely information to make well-informed decisions, and advancing devices that are safer, more effective, and addre

Medical device safety is a key #FDA priority. We’re committed to protecting U.S. patients by minimizing avoidable risks, assuring they have timely information to make well-informed decisions, and advancing devices that are safer, more effective, and addre

Medical device safety is a key #FDA priority. We’re committed to protecting U.S. patients by minimizing avoidable risks, assuring they have timely information to make well-informed decisions, and advancing devices that are safer, more effective, and address unmet medical need. pic.twitter.com/Dm73SQ213p

FDA - U.S. Food and Drug Administration

22-7-2018

Some devices come to market after #FDA determines that they're substantially equivalent to another legally marketed device called the predicate – this is the 510(k) pathway typically used for moderate risk devices.

Some devices come to market after #FDA determines that they're substantially equivalent to another legally marketed device called the predicate – this is the 510(k) pathway typically used for moderate risk devices.

Some devices come to market after #FDA determines that they're substantially equivalent to another legally marketed device called the predicate – this is the 510(k) pathway typically used for moderate risk devices.

FDA - U.S. Food and Drug Administration

22-7-2018

We’re exploring ways to use umbrella regulation or seek authority to address new risks faster. We're pursuing ways to spur innovation in safer devices; creating a Breakthrough Devices-like path  https://bit.ly/2O43EqH  and providing streamlined paths for

We’re exploring ways to use umbrella regulation or seek authority to address new risks faster. We're pursuing ways to spur innovation in safer devices; creating a Breakthrough Devices-like path https://bit.ly/2O43EqH  and providing streamlined paths for

We’re exploring ways to use umbrella regulation or seek authority to address new risks faster. We're pursuing ways to spur innovation in safer devices; creating a Breakthrough Devices-like path https://bit.ly/2O43EqH  and providing streamlined paths for comparative safety claims pic.twitter.com/30wLydOAec

FDA - U.S. Food and Drug Administration

18-7-2018

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity:  https://hea

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity: https://hea

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity: https://healthsectorcouncil.org/health-sector-mobilizes-against-cyber-threats/ …

FDA - U.S. Food and Drug Administration

30-4-2018

Regulatory and procedural guideline:  Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances, draft: consultation open

Regulatory and procedural guideline: Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances, draft: consultation open

The guideline, which was developed to encourage optimal use and to minimise selection of antimicrobial resistance (AMR), was revised in order to improve consistency of the summary of product characteristics (SPCs) for antimicrobial products in the EU Member States.

Europe - EMA - European Medicines Agency