ANDOREX

Genel Bilgiler

  • Ticaret Unvanı:
  • ANDOREX 200 ML GARGARA
  • Reçete türü:
  • Normal
  • İçin kullanmak:
  • İnsanlar
  • İlaç türü:
  • allopatik ilaç

Belgeler

Yerelleştirme

  • Bulunduğu ülkeler::
  • ANDOREX 200 ML GARGARA
    Türkiye
  • Dil:
  • Türkçe

Terapötik bilgiler

  • Terapötik alanı:
  • çeşitli

Diğer bilgiler

Durum

  • Kaynak:
  • TİTCK - TÜRKİYE İLAÇ VE TIBBİ CİHAZ KURUMU - Türkiye
  • Yetkilendirme durumu:
  • Aktif
  • Yetkilendirme numarası:
  • 8680760640023
  • Yetkilendirme tarihi:
  • 23-02-2014
  • Son Güncelleme:
  • 23-05-2018

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

1 / 5

KULLANMA TALİMATI

ANDOREX gargara

Ağızve boğaziç yüzeyine (haricen) uygulanır.

-Etkinmadde:200 ml'lik çözelti240mg (%0.12)klorheksidin diglukonatve 300mg

(%0.15) benzidamin hidroklorür içerir.

-Yardımcımaddeler:Nane aroması,sorbitol(E420),patentmavisi V,gliserol,polisorbat

20, tartrazin(E102), etanol, safsu.

Bu Kullanma Talimatında:

1.ANDOREX nedir ve ne için kullanılır?

2.ANDOREX’i kullanmadan önce dikkat edilmesi gerekenler

3.ANDOREX nasıl kullanılır?

4.Olasıyan etkiler nelerdir?

5.ANDOREX’in saklanması

Başlıklarıyeralmaktadır.

1.ANDOREX nedirve ne için kullanılır?

·

ANDOREX ağız içibölgeseltedavisinde kullanılanbir ağız preparatıdır.

·

ANDOREXGargara, berrak, yeşilrenkli, nane kokulu bir çözeltidir.

ANDOREX Gargara200 ml'lik PETşişelerde ve 15 ml'lik ölçeğiile birlikte, karton

kutuiçerisinde bulunur.Her bir kutuda 1adet 200ml'lik gargara vardır.

·

ANDOREX

-Ağızveboğaz mukozasında enflamasyon ve ağrıyla seyreden gingivit,stomatit,

farenjit, tonsilitve aftöz lezyonlarda,

-Ağızveboğazantisepsisi,hastanınyutmafonksiyonunun rahatlatılmasıvedişeti

rahatsızlıklarındasemptomgidericiolarak,

-Peridontalgirişimlerdenönceve sonra,

-Radyoterapive kemoterapisonrasıveya diğer nedenlerebağlımukozitlerde,

-Dentalplakların önlenmesinde

Builacıkullanmayabaşlamadanönce buKULLANMATALİMATINI dikkatlice

okuyunuz, çünkü sizin için önemli bilgileriçermektedir.

Bukullanmatalimatınısaklayınız.Dahasonratekrarokumayaihtiyaç

duyabilirsiniz.

Eğer ilave sorularınız olursa, lütfendoktorunuza veya eczacınıza danışınız.

Bu ilaç kisisel olarak sizin için reçete edilmiştir, başkalarına vermeyiniz.

Builacın kullanımısırasında,doktora veya hastaneye gittiğinizde doktorunuza bu

ilacıkullandığınızısöyleyiniz.

Butalimatta yazılanlara aynen uyunuz.İlaç hakkında size önerilen dozun dışında

yüksek veya düşükdoz kullanmayınız.

2 / 5

2.ANDOREX’ikullanmadanöncedikkatedilmesigerekenler

ANDOREX’i aşağıdaki durumlarda KULLANMAYINIZ

Eğer,

· Benzidamin veklorheksidineveyaiçeriğindekidiğeryardımcımaddelere karşı

bilinen aşırıduyarlılığınızvarsa,

·

Hamile iseniz veya çocuk emziriyorsanız.

ANDOREX’i aşağıdaki durumlarda DİKKATLİKULLANINIZ

·

Sadece ağzıçalkalamak içindir,yutmayınız.

·

Klinik çalışmaların yeterli sayıda olmamasınedeniyleANDOREX 6yaşın altındaki

çocuklarda tavsiye edilmez.

·

Yalnızcaağıziçindekullanınız,gözlervekulaklariletemasettirilmesinden

kaçınınız.

· Ağıziçinde,dilvedişüzerindegeri dönüşümlürenkdeğişikliğiyapabilir.Diş

lekelenmesizararsızdırve uygulamadan öncedişfırçalamayla en azaindirilebilir.

·

ANDOREXyutulmamalıvetükürmeksuretiyleağızdanuzaklaştırılmalıdır.

Seyreltilmedenkullanılır.

·

Boğaz ağrısıbakteriyelenfeksiyonlaoluşmuşveyaenfeksiyonlabirlikte görülüyorsa

ANDOREX kullanımına ilave olarak doktorunuzantibakteriyeltedavidüşünebilir.

Buuyarılargeçmiştekiherhangibirdönemdedahi olsa siziniçingeçerliyselütfen

doktorunuza danışınız.

ANDOREX’in yiyecek ve içecekile kullanılması

Uygulamayöntemi itibari ileyiyecek veiçecekileetkileşimi yoktur.

Hamilelik

İlacıkullanmadan önce doktorunuza veya eczacınıza danışınız.

HamileisenizANDOREX’ikullanmayınız.

Tedaviniz sırasında hamileolduğunuzu farkederseniz hemen doktorunuza veya eczacınıza

danışınız.

Emzirme

İlacıkullanmadan önce doktorunuza veya eczacınıza danışınız.

Emziriyoriseniz ANDOREX’i kullanmayınız.

Araç ve makine kullanımı

Araçve makine kullanma üzerine herhangibir olumsuz etkisi söz konusu değildir.

ANDOREX’in içeriğinde bulunan bazıyardımcımaddeler hakkında önemli bilgiler

İçeriğindebulunan sorbitol nedeniyle,eğerdahaöncedendoktorunuz tarafındanbazı

şekerlerekarşıdayanıksızlığınızolduğusöylenmişseANDOREX’ialmadanönce

doktorunuzla temasa geçiniz.

ANDOREX,gliseroliçermektedir.Dozunedeniyle herhangibir uyarıgerekmemektedir.

Bu tıbbiürün az miktarda – herdozda 100 mg’dandaha az (1.5 ml) – etanol(alkol) içerir.

3 / 5

Diğerilaçlarile birlikte kullanımı

Klorheksidin;

· Klorheksidin tuzlarısabun vediğeranyonik bileşiklerlegeçimsizdir.

· Klorheksidin tuzlarıkatyonik ve noniyonik yüzeyaktifmaddelerle geçimlidir, ancak

yüksekkonsantrasyonlardaberaberkullanıldıklarındabağlanmasebebiyle

klorheksidinin etkinliğiazalabilir.

·

SetrimidvelissapolNXgibiyüzeydirenciazaltıcılarlaiseçözünürlükleri

arttırılabilir.

·

Arapzamkı,sodyumalginat,sodyumkarboksimetilselülozgibianyonik

polielektrolitlerle,nişastavekitrezamkıilegeçimsizdir,aynızamandabu

maddelerle etkileride azalır.

·

Brillant green, kloramfenikol, bakır sülfat,floresseinsodyum, formaldehit, gümüş

nitrat, çinkosülfatgibi maddelerle de geçimsizdir.

·

Sertsularla seyreltildiğinde Ca +2 veMg +2 katyonlarıile etkileştiğindençözünmeyen

tuzlar halinde çökebilir.

·

Benzoatlarla,bikarbonatlarla,karbonatlarla,boratlarla,nitratlarla,fosfatlarla,

sülfatlarlabirarayagelenklorheksidintuzlarınınçözeltileri %0.05'tendaha

derişikseçözünürlüğüdahaaztuzlaroluşturacağındançökelirler.Setrimidbu

tuzlarınçözünürlükleriniarttırdığındansetrimidilekombineedildiğindebu

çökmeler olmaz.

·

Klorheksidinglukonat,setrimidvebenzalkonyum klorürlegeçimlidir.Bunlar

bakteriöldürücüetkisinieşgüdümlüolarakarttırırlar.Setrimidsertsularla

klorheksidininçökmesiniönler.

·

Klorheksidinglukonathariç klorheksidinvetuzlarıalkoldesuyagöredahaiyi

çözünür.Klorheksidinglukonatçözeltisi alkol üzerineilaveedildiğindeçökebilir.

Formülasyondaetanol bulunmasıçözeltiyi Gramnegatifmikroorganizmalarakarşı

daha etkinkılar. Selülozikfiltrelerdensüzülürken emilebilirler.

Benzidaminleherhangi birilaç etkileşimi bildirilmemiştir.

Eğerreçeteliveyareçetesizherhangibirilacışuandakullanıyorsanızveyason

zamanlardakullandınıziselütfendoktorunuzaveyaeczacınızabunlarhakkındabilgi

veriniz.

3.ANDOREX nasıl kullanılır?

Uygun kullanım ve doz/uygulamasıklığıiçin talimatlar:

ANDOREX’in yetişkindozu 15 ml'dir.Günboyunca 1,5-3 saatlik aralıklarla uygulanır.

Uygulama yolu ve metodu:

ANDOREX ağzıçalkalamakveya gargarayapmakiçindir.

ANDOREXseyreltilmeden kullanılır.

En az 30 saniye süreyleağızda tutulur.

Kullanımdansonra ağızdanatılır.

ANDOREX’in içeriğindeyer alan klorheksidin tedavi süresince plakve dişetiiltihabında

azalmayapar.EğerANDOREXdiğerağıziçi temizlikuygulamalarınaalternatifolarak

kullanılıyorsa,ağızenaz1dakikasüreyleANDOREXileçalkalanmalıdır.

ANDOREX’dekiklorheksidininsebepolduğurenklenmeyienazaindirmekiçin

kullanmadan öncedişlerifırçalamak uygundur.

4 / 5

Değişik yaşgrupları:

Çocuklarda kullanımı

12yaşve üzeriçocuklarda,5-15ml ANDOREXile her 1,5-3 saatte bir30 saniyesüreile

gargarayapılır.

Sürekliolarak 7 günden fazla kullanılmamalıdır.

Yanma ve batma hissioluşursa gargara suile seyreltilmelidir.

Yaşlılarda kullanımı:

Yaşlılarda herhangibir doz değişikliğigerekmemektedir.

Özel kullanım durumları:

Böbrekyetmezliği/ Karaciğeryetmezliği:

Bozulmuşböbrekfonksiyonu:Emilenbenzidaminveyıkım ürünleriidrarlaatıldığıiçin

şiddetliböbrekbozukluğuolanhastalardatümvücuttaetki olasılığıgözönünde

bulundurulmalıdır.

Bozulmuşkaraciğerfonksiyonu:Emilenbenzidaminyüksekorandakaraciğerdeyıkıldığı

içinşiddetli karaciğerbozukluğu olan hastalardatüm vücutta etkiolasılığıgöz önünde

bulundurulmalıdır.

Doktorunuz ayrıbir tavsiyedebulunmadıkça,bu talimatlarıtakip ediniz.

İlacınızızamanındaalmayıunutmayınız.

Doktorunuz ANDOREXile tedavinizinne kadarsüreceğinisizebildirecektir.Tedaviyi

erken kesmeyiniz çünkü istenen sonucu alamazsınız.

Eğer ANDOREX’inetkisinin çokgüçlü veyazayıfolduğuna dair bir izleniminizvarise

doktorunuz veya eczacınız ile konuşunuz.

Kullanmanızgerekenden daha fazla ANDOREX kullandıysanız

ANDOREX’den kullanmanız gerekenden fazlasınıkullanmışsanız bir doktor veya eczacıile

konuşunuz.

ANDOREXyanlışlıklaiçilirse,belirtilereyöneliktedaviyapılmalıdır.Belirlibirpanzehiri

yoktur.

ANDOREX’i kullanmayıunutursanız

Unutulan dozlarıdengelemek için çift doz almayınız.

ANDOREX ile tedavi sonlandırıldığında oluşabilecek etkiler

Herhangi bir etkibeklenmemektedir.

4.Olasıyan etkilernelerdir?

TümilaçlargibiANDOREX’iniçeriğindebulunanmaddelereduyarlıolan kişilerdeyan

etkiler olabilir.

Yaygınyan etkiler:

*Ağıziçinde hissizlik

*Tadalmada değişiklik

*Dişlerde ve diğer ağız içiyüzeylerdelekelenme ve diştaşıoluşumunda artış

5 / 5

Seyrekyanetkiler:

*Yanma ve batma hissi

Çok seyrekyanetkiler:

*Başdönmesi

*Başağrısı

*Uyuşukluk

*Bulantı

*Kusma

*Öğürme

*Mide barsakhastalıkları

*Yerelkuruluk

*Susuzluk

*Sızlama

*Ağızda serinlik hissi

*Alerjik reaksiyonlar

*Hipersensitivite

*Anaflaksi

Yan etkilerinraporlanması

KullanmaTalimatındayeralanveyaalmayanherhangibiryanetki meydanagelmesi

durumundahekiminiz, eczacınız veya hemşireniz ile konuşunuz.Ayrıca karşılaştığınız yan

etkileriwww.titck.gov.tr sitesinde yer alan "İlaç YanEtkiBildirimi" ikonuna tıklayarakya

da 0 800 314 0008numaralıyanetkibildirim hattınıarayarak TürkiyeFarmakovijilans

Merkezi(TÜFAM)'nebildiriniz.Meydanagelenyanetkileribildirerekkullanmakta

olduğunuzilacıngüvenliliğihakkındadahafazlabilgiedinilmesinekatkısağlamış

olacaksınız.

Eğer bu kullanma talimatında bahsi geçmeyenherhangi biryan etki ilekarşılaşırsanız

doktorunuzu veya eczacınızıbilgilendiriniz.

5.ANDOREX’insaklanması

ANDOREX’i çocukların göremeyeceği,erişemeyeceği yerlerde ve ambalajındasaklayınız.

25°C'nin altındakioda sıcaklığında saklayınız.

Son kullanmatarihiyle uyumlu olarakkullanınız

Ambalajdaki son kullanmatarihinden sonra ANDOREX’i kullanmayınız.

Eğer üründe ve/veya ambalajında bozukluklarfarkederseniz ANDOREX’ikullanmayınız.

Ruhsat Sahibi : Pharmactiveİlaç San.ve Tic.A.Ş.

MahmutbeyMah. Dilmenler CaddesiNo:19/3 Bağcılar-İstanbul

Üretim Yeri : Kim-PaİlaçLaboratuvarıve Ticaret Ltd.Şti.

Atatürk Sanayi BölgesiHadımköy/İstanbul

Bu kullanma talimatı………………..tarihinde onaylanmıştır.

30-11-2018

Public Notification: MOB Candy contains hidden drug ingredients

Public Notification: MOB Candy contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use MOB Candy, a product promoted and sold for sexual enhancement on various websites and in some retail stores.

FDA - U.S. Food and Drug Administration

30-11-2018

Public Notification: Willy Go Wild contains hidden drug ingredients

Public Notification: Willy Go Wild contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Willy Go Wild, a product promoted and sold for sexual enhancement on various websites and in some retail stores.

FDA - U.S. Food and Drug Administration

29-11-2018

MPS Canada Corporation recalls various Consumer chemical products in pressurized containers

MPS Canada Corporation recalls various Consumer chemical products in pressurized containers

The recalled products were not destined for the Canadian marketplace and do not have mandatory hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Vanpak Limited recalls various Cosmetic products in pressurised containers.

Vanpak Limited recalls various Cosmetic products in pressurised containers.

The recalled products do not have mandatory hazard labelling as required by the Cosmetics Regulations under the Food and Drugs Act. Improper labelling could result in misuse of the product and lead to serious injury.

Health Canada

15-11-2018

MPS Canada Corporation recalls various Cosmetic products in pressurised containers.

MPS Canada Corporation recalls various Cosmetic products in pressurised containers.

The recalled products do not have mandatory hazard labelling as required by the Cosmetics Regulations under the Food and Drugs Act. Improper labelling could result in misuse of the product and lead to serious injury.

Health Canada

8-11-2018

Public Notification: Gold Max Blue contains hidden drug ingredient

Public Notification: Gold Max Blue contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Gold Max Blue, a product promoted and sold for sexual enhancement on various websites, including www.goldmaxblue.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

18-10-2018

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Certain ProBuilt Aluminum Posts have an issue with the screws that affix the base plate to the post which may cause the post to separate from the base plate when forces over 334 pounds are applied horizontally to the top side of the post. As a result, the posts do not fully comply with local building code requirements and may pose a fall hazard.

Health Canada

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Radagast Pet Food, Inc. recalls various Rad Cat Raw Diet Pet Food

Radagast Pet Food, Inc. recalls various Rad Cat Raw Diet Pet Food

The recalled pet food may be contaminated with Listeria monocytogenes and there is risk of cross contamination and illness after handling the pet food.

Health Canada

4-9-2018

Osmo Wood and Colour Canada Ltd. recalls Various Wood Finishing Products

Osmo Wood and Colour Canada Ltd. recalls Various Wood Finishing Products

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

27-8-2018

Several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks

Several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks

Health Canada is advising Canadians that several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks. The 11products include vitamins, dietary supplements, workout supplements and decongestants. Seized products were labelled to contain various ingredients, including prescription drugs and controlled substances.

Health Canada

14-8-2018

The Uttermost Company recalls Various Types of Mirrors, Art and Wall Décor sold with Adjustable J-Hook Hanging Hardware

The Uttermost Company recalls Various Types of Mirrors, Art and Wall Décor sold with Adjustable J-Hook Hanging Hardware

The hanging hardware can break, causing mirrors and wall décor to fall from walls, posing an injury hazard to bystanders.

Health Canada

1-8-2018

Unauthorized skin creams and lotions sold at various retailers in Quebec may pose serious health risks

Unauthorized skin creams and lotions sold at various retailers in Quebec may pose serious health risks

Health Canada seized eight unauthorized skin lotions and creams from Ayotai Canada because they are labelled to contain a prescription drug (clobetasol propionate or betamethasone dipropionate). The unauthorized lotions and creams were distributed by Ayotai and sold by various retailers in Quebec.

Health Canada

11-7-2018

MyNicNaxs, LLC Issues Voluntary Nationwide Recall of Various Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredient (API)

MyNicNaxs, LLC Issues Voluntary Nationwide Recall of Various Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredient (API)

MyNicNaxs, LLC, Deltona, FL is voluntarily recalling all lots of dietary supplements distributed nationwide to the consumer level. The products have been found to contain undeclared active pharmaceutical ingredients (API). The presence of Sildenafil, Sibutramine, Diclofenac and/or Phenolphthalein in the dietary supplements renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. These products were distributed from January 2013, to December ...

FDA - U.S. Food and Drug Administration

6-7-2018

Expanded Recall: Peg Perego Canada Inc. recalls Various Book Strollers

Expanded Recall: Peg Perego Canada Inc. recalls Various Book Strollers

Health Canada's sampling and evaluation program has determined that these strollers do not meet the Carriages and Strollers Regulations in Canada. Specifically, the strollers do not meet the latching system requirements for folding strollers as they do not have a safety device independent of the latching device to prevent folding.

Health Canada

19-6-2018

Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks

Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks

Based on new information, the Endologix AFX with Strata device is at greater risk for a Type III endoleak compared to other endovascular AAA graft systems.

FDA - U.S. Food and Drug Administration

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

1-6-2018

Important sunscreen safety tips for Canadians

Important sunscreen safety tips for Canadians

Health Canada is in the process of reviewing the safety of various sunscreen products and will share the results in the coming weeks. The Department will take immediate action and inform Canadians should a safety concern be identified with any sunscreen product sold in Canada.

Health Canada

1-6-2018

Expanded Recall: Medline Canada, Corp. recalls Various Medline Cosmetic Products

Expanded Recall: Medline Canada, Corp. recalls Various Medline Cosmetic Products

The recalled products may be contaminated with the bacteria Burkolderia cepacia. Burkolderia cepacia can pose a risk of infections to consumers, especially those with weakened immune systems. Contamination of the bacteria has only been confirmed for the Remedy Essentials Cleanser No Rinse Foam that was includedin the previous recall.

Health Canada

28-5-2018

Expanded Recall: Various Uncertified USB Chargers Recalled due to Fire and Shock Risk

Expanded Recall: Various Uncertified USB Chargers Recalled due to Fire and Shock Risk

The recalled USB chargers did not pass a standard electrical test, and may pose a risk of electrical shock and fire.

Health Canada

15-5-2018

Public Notification: Best Candy contains hidden drug ingredient

Public Notification: Best Candy contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Best Candy, a product promoted as an energy booster on various websites and possibly in some retail stores. This product was identified during an examination of imported goods.

FDA - U.S. Food and Drug Administration

20-4-2018

Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination

Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination

Expanded recall of various kratom dietary supplements to additional lot numbers due to possible Salmonella Health Risk.

FDA - U.S. Food and Drug Administration

28-3-2018

Public Notification: Black Lion Pill contains hidden drug ingredient

Public Notification: Black Lion Pill contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Black Lion Pill, a product promoted and sold for sexual enhancement on various websites, including www.rakuten.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

28-3-2018

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Rhino 69 Extreme 50000, a product promoted and sold for sexual enhancement on various websites, including www.bonanza.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

28-3-2018

Public Notification: Red Zone Xtreme 3000 contains hidden drug ingredient

Public Notification: Red Zone Xtreme 3000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Red Zone Xtreme 3000, a product promoted and sold for sexual enhancement on various websites, including www.ebay.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

8-5-2015

Annual Pharmacovigilance Report 2014

Annual Pharmacovigilance Report 2014

In our annual pharmacovigilance report 2014, you can read about the development in the number of ADR reports, learn about various focus areas and the European collaboration in the pharmacovigilance area as well as see a selection of the ADR signals we processed in 2014, and much more.

Danish Medicines Agency

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

Europe - EMA - European Medicines Agency