Montelukast "Accord"

Primær information

  • Handelsnavn:
  • Montelukast "Accord" 5 mg tyggetabletter
  • Dosering:
  • 5 mg
  • Lægemiddelform:
  • tyggetabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Montelukast "Accord" 5 mg tyggetabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 46197
  • Sidste ændring:
  • 17-07-2018

Indlægsseddel

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

Montelukast Accord 5 mg tyggetabletter

Til børn i alderen 6 til 14 år

Montelukast

Læs denne indlægsseddel grundigt, inden du/dit barn begynder at tage medicinen

Gem indlægssedlen. Du kan få brug for at læse den igen.

Spørg lægen eller på apoteket, hvis der er mere, du vil vide.

Lægen har ordineret Montelukast Accord 5 mg til dig eller dit barn personligt. Lad derfor være med at give det

til andre. Det kan være skadeligt for andre, selvom de har de samme symptomer, som du eller dit barn har.

Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du eller dit barn får bivirkninger, som ikke

er nævnt her.

Oversigt over indlægssedlen:

Virkning og anvendelse

Det skal du vide, før du eller dit barn begynder at tage Montelukast Accord 5 mg

Sådan skal du eller dit barn tage Montelukast Accord 5 mg

Bivirkninger

Opbevaring

yderligere oplysninger

1. VIRKNING OG ANVENDELSE

Din eller dit barns læge har ordineret Montelukast Accord 5 mg til behandling af din eller dit barns astma og til at

forhindre astmasymptomer om dagen og natten.

• Montelukast Accord 5 mg anvendes til behandling af patienter, som har brug for yderligere behandling end den

medicin, de allerede får.

• Montelukast Accord 5 mg kan også anvendes som et alternativ til inhalerede kortikosteroider til patienter i alderen

6 til 14 år, der ikke for nylig har taget kortikosteroidtabletter mod deres astma, og som har vist, at de ikke kan

anvende inhalerede kortikosteroider.

• Montelukast Accord 5 mg hjælper også med at forebygge forsnævring af luftvejene udløst af fysisk aktivitet hos

patienter i alderen 6 år og ældre.

Lægen vil beslutte, hvordan Montelukast Accord 5 mg skal anvendes, afhængigt af symptomerne og af, hvor alvorlig

din eller dit barns astma er.

Montelukast Accord 5 mg er en såkaldt leukotrienreceptor-antagonist, som blokerer for nogle stoffer, der kaldes

leukotriener. Leukotriener forårsager forsnævring og hævelse af luftvejene i lungerne. Ved at blokere for leukotrienerne,

kan Montelukast Accord 5 mg mindske astmasymptomer og hjælpe med at kontrollere astmaen.

Hvad er astma?

Astma er en kronisk sygdom.

Astma omfatter:

• vejrtrækningsbesvær forårsaget af forsnævring af luftvejene. Denne forsnævring forværres eller bedres som

reaktion på forskellige forhold.

• følsomme luftveje, der reagerer på mange ting, såsom cigaretrøg, pollen, kold luft eller fysisk aktivitet.

• hævelse (betændelse) i slimhinderne i luftvejene.

Symptomer på astma er bl.a.: hoste, hvæsende vejrtrækning og trykken for brystet.

2. DET SKAL DU VIDE, FØR DU ELLER DIT BARN BEGYNDER AT TAGE MONTELUKAST ACCORD 5

mg

Fortæl lægen om alle helbredsproblemer eller allergier, som du eller dit barn har nu eller har haft.

Tag ikke/giv ikke dit barn Montelukast Accord 5 mg

hvis du eller dit barn er allergisk (overfølsom) over for montelukast eller et af de øvrige indholdsstoffer i

Montelukast Accord 5 mg (se pkt. 6: Yderligere oplysninger).

Vær ekstra forsigtig med at tage/give dit barn Montelukast Accord 5 mg

Fortæl det straks til lægen, hvis din eller dit barns astma eller vejrtrækningsproblemer forværres.

Montelukast Accord 5 mg er ikke beregnet til behandling af akutte astmaanfald. Hvis du eller dit barn får et

astmaanfald, skal du følge de instruktioner, du har fået af lægen. Du skal altid have din/dit barns nødmedicin til

astmaanfald med dig.

Det er vigtigt, at du/dit barn tager al den astmamedicin, som lægen har ordineret. Montelukast Accord 5 mg må

ikke tages som erstatning for anden astmamedicin, som lægen har udskrevet til dig/dit barn.

Hvis du/dit barn tager medicin mod astma, skal du kontakte lægen, hvis du/barnet udvikler en kombination af

influenzalignende

symptomer,

stikkende

prikkende

fornemmelser

eller

følelsesløshed

arme

eller

ben,

forværring af lungesymptomer og/eller udslæt.

Du/dit barn bør ikke tage acetylsalicylsyre (aspirin) eller medicin mod betændelse (såkaldt nonsteroid anti-

inflammatorisk medicin eller NSAID), hvis din/dit barns astma forværres af dette.

Brug til børn

Montekulast tyggetabletter 5 mg fås til børn i alderen 6 til 14 år.

Montekulast tyggetabletter 4 mg fås til børn i alderen 2 til 5 år. Brug af Montekulast tyggetabletter 4 mg til børn under 2

år anbefales ikke.

Brug af anden medicin

Andre lægemidler kan påvirke virkningen af Montelukast Accord 5 mg , og Montelukast Accord 5 mg kan påvirke

andre lægemidlers virkning.

Fortæl det altid til lægen eller på apoteket, hvis du/dit barn bruger anden medicin eller har brugt det for nylig. Det

gælder også medicin, som ikke er købt på recept.

Fortæl det til lægen, hvis du/dit barn tager følgende medicin, før du begynder at tage Montelukast Accord 5 mg /give

dit barn Montelukast Accord 5 mg :

phenobarbital (bruges til behandling af epilepsi)

phenytoin (bruges til behandling af epilepsi)

rifampicin (bruges til behandling af tuberkulose og visse andre infektioner)

Brug af Montelukast Accord 5 mg sammen med mad og drikke

Montelukast Accord 5 mg må ikke indtages samtidig med mad, men skal tages mindst 1 time før eller to timer efter et

måltid.

Graviditet og amning

Graviditet

Gravide kvinder eller kvinder, der planlægger at blive gravide, bør kontakte deres læge, før de tager Montelukast

Accord 5 mg . Lægen vil vurdere, om de kan tage Montelukast Accord 5 mg .

Amning

Det vides ikke, om Montelukast udskilles i modermælk. Du skal kontakte din læge, før du tager Montelukast Accord 5

mg , hvis du ammer eller planlægger at amme.

Trafik- og arbejdssikkerhed

Det er ikke sandsynligt, at Montelukast Accord 5 mg vil påvirke din evne til at køre bil eller betjene maskiner. Dog er

det forskelligt, hvordan man reagerer på medicin. Visse bivirkninger (såsom svimmelhed og døsighed), som i meget

sjældne tilfælde er set i forbindelse med brug af Montelukast Accord 5 mg , kan påvirke evnen til at køre bil eller

betjene maskiner.

Vigtig information om nogle af de øvrige indholdsstoffer i Montelukast Accord 5 mg

Montelukast Accord 5 mg indeholder aspartam, en kilde til fenylalanin.

Kan være skadelige for børn med fenylketonuri (en sjælden, arvelig stofskiftelidelse). Hvis du/dit barn lider af

fenylketonuri, skal du tage i betragtning, at hver Montelukast tyggetablet indeholder fenylalanin (svarende til 0,842 mg

fenylalanin per 5 mg tyggetablet).

3. SÅDAN SKAL DU/DIT BARN TAGE MONTELUKAST ACCORD 5 mg

• Denne medicin skal tages under opsyn af en voksen.

• Du eller dit barn må kun tage én Montelukast tyggetablet dagligt som foreskrevet af lægen.

• Tabletterne skal også tages, selvom du/dit barn ikke har symptomer, eller hvis du/dit barn har et akut astmaanfald.

• Du/dit barnet skal altid tage tabletten nøjagtigt efter lægens anvisning. Er du i tvivl, så spørg lægen eller på

apoteket.

• Tabletten tages gennem munden.

Én Montelukast tyggetablet dagligt tages om aftenen. Montelukast Accord 5 mg tyggetablet bør ikke indtages samtidig

med mad. De bør tages mindst 1 time før eller 2 timer efter et måltid.

Hvis du/dit barn tager Montelukast Accord 5 mg , skal du sikre dig, at du/dit barn ikke også tager anden medicin, som

indeholder det samme aktive indholdsstof, montelukast.

Hvis du/dit barn har taget for mange Montelukast Accord 5 mg

Kontakt straks lægen.

I de fleste tilfælde med overdosering er der ikke rapporteret om bivirkninger. De mest almindelige symptomer, der er set

i forbindelse med overdosering hos voksne og børn, er mavesmerter, søvnighed, tørst, hovedpine, opkastning og

hyperaktivitet.

Hvis du har glemt at give Montelukast Accord 5 mg til dit barn

Giv Montelukast tabletter som foreskrevet af lægen. Hvis du har glemt at tage/har glemt at give dit barn en dosis, skal

du genoptage behandlingen og fortsætte med én tablet én gang dagligt.

Giv ikke en dobbelt dosis som erstatning for en glemt dosis.

Hvis du/dit barn holder op med at tage Montelukast Accord 5 mg

Montelukast Accord 5 mg kan kun behandle din/dit barns astma, hvis du/dit barn fortsætter med at tage dem. Det er

vigtigt at fortsætte med at tage Montelukast Accord 5 mg , så længe lægen foreskriver det. Det vil hjælpe med at

kontrollere din/dit barns astma.

Spørg lægen eller på apoteket hvis der er noget, du er i tvivl om.

4. BIVIRKNINGER

Montelukast Accord 5 mg kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.

De følgende betegnelser bruges til at angive, hvor ofte bivirkninger forekommer:

Meget almindelig: forekommer hos flere end 1 patient ud af 10

Almindelig: forekommer hos 1 til 10 patienter ud af 100

Ikke almindelig: forekommer hos 1 til 10 patienter ud af 1.000

Sjælden: forekommer hos 1 til 10 patienter ud af 10.000

Meget sjælden: forekommer hos færre end 1 patient ud af 10.000

Ikke kendt: Hyppigheden kan ikke anslås ud fra de foreliggende data

I kliniske undersøgelser med Montelukast Accord 5 mg har de mest almindeligt rapporterede bivirkninger, som menes

at være forbundet med Montelukast Accord 5 mg , været:

5 mg:

• hovedpine

Disse bivirkninger var som regel milde og forekom mere hyppigt hos patienter, der blev behandlet med Montelukast,

end hos patienter, der fik placebopiller (piller, der ikke indeholder medicin).

Desuden er de følgende bivirkninger blevet indberettet, mens lægemidlet har været på markedet:

• betændelse i de øvre luftveje

• øget tendens til blødning

• allergiske reaktioner, herunder udslæt, hævelse af ansigt, læber, tunge og/eller svælg, der kan give vejrtræknings-

eller synkebesvær

• ændringer i opførsel eller sindsstemning [abnorme drømme - herunder mareridt - hallucinationer, irritabilitet,

ængstelse,

rastløshed,

ophidselse

aggressiv

adfærd

eller

fjendtlighed,

rysten,

depression,

søvnbesvær,

søvngængeri, selvmordstanker og selvmordshandlinger (i meget sjældne tilfælde)]

• svimmelhed, døsighed, stikkende og prikkende fornemmelser/følelsesløshed, krampeanfald

• hjertebanken

• næseblod

• diarré, tør mund, fordøjelsesbesvær, kvalme, opkastning

• leverbetændelse

• blå mærker, kløe, nældefeber, ømme røde knuder under huden, oftest på skinnebenene (erythema nodosum)

• smerter i led eller muskler, muskelkramper

• træthed, utilpashed, hævelser, feber

Hos astmatiske patienter, der er blevet behandlet med montelukast, er der i meget sjældne tilfælde rapporteret om en

kombination af symptomer med influenzalignende sygdom, stikkende og prikkende fornemmelse eller følelsesløshed i

arme og ben, forværring af lungesymptomer og/eller udslæt (Churg-Strauss’ syndrom). Kontakt straks lægen, hvis du/dit

barn får et eller flere af disse symptomer.

Spørg din/dit barns læge eller på apoteket om mere information om bivirkninger. Tal med lægen eller apoteket, hvis en

bivirkning er generende eller bliver værre, eller du/dit barn får bivirkninger, som ikke er nævnt her.

Bivirkningerne kan dermed blive indberettet til Lægemiddelstyrelsen, og viden om bivirkninger kan blive bedre.

Patienter eller pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen.

Du finder skema og vejledning under Bivirkninger på Lægemiddelstyrelsens netsted.

5. OPBEVARING

Opbevares utilgængeligt for børn.

Brug ikke Montelukast Accord 5 mg efter den udløbsdato, der står på pakningen. Udløbsdatoen (Exp) er den

sidste dag i den nævnte måned.

Må ikke opbevares ved temperaturer over 30 °C. Opbevares i den originale pakning for at beskytte mod fugt og

lys.

Spørg på apoteket, hvordan du skal aflevere medicinrester. Af hensyn til miljøet må du ikke smide medicinrester i

afløbet, toilettet eller skraldespanden.

6. YDERLIGERE OPLYSNINGER

Montelukast Accord 5 mg indeholder:

• Det aktive stof er montelukast. Hver tyggetablet indeholder montelukastnatrium svarende til 5 mg montelukast.

• De øvrige indholdsstoffer er: mannitol(E421) (SD 200), mikrokrystallinsk cellulose (PH 112),

croscarmellosenatrium, kirsebæraroma (501027 AP0551), rød jernoxid (E172), aspartam (E951),

magnesiumstearat.

Udseende og pakningsstørrelser:

Lyserøde, spættede, ovale, bikonvekse tabletter præget “M5” på den ene side, flade på den anden.

Pakket i OPA-al-PVC/al-blisterpakninger.

Pakningsstørrelser: 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140 og 200 tabletter.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen

Accord Healthcare AB,

Erik Dahlbergsgatan 11B, 411 26 Göteborg,

Sweden

Fremstiller

Accord Healthcare Limited,

Sage House, 319, Pinner Road,

North Harrow, Middlesex,

HA1 4HF,

Storbritannien

eller

Cemelog BRS Limited,

2040 Budaörs, Vasút u. 13.,

Ungarn

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Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

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

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by 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

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

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

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

FDA - U.S. Food and Drug Administration

29-8-2018

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

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

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 24 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

Accofil (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5428 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety