Budesonide "Teva Pharma"

Primær information

  • Handelsnavn:
  • Budesonide "Teva Pharma" 0,5 mg/ml inhalationsvæske til nebulisator, suspension
  • Dosering:
  • 0,5 mg/ml
  • Lægemiddelform:
  • inhalationsvæske til nebulisator, suspension
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Budesonide "Teva Pharma" 0,5 mg/ml inhalationsvæske til nebulisator, suspension
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 51428
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel: sammensætning, indikationer, bivirkninger, dosering, interaktioner, bivirkninger, graviditet, amning

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

Budesonide Teva Pharma inhalationsvæske til nebulisator,

suspension 0,125 mg/ml, 0,25 mg/ml og 0,5 mg/ml

budesonid

Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den

indeholder vigtige oplysninger.

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

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

Lægen har ordineret dette lægemiddel til dig personligt. Lad derfor være med at give medicinen

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

Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger,

som ikke er nævnt her. Se punkt 4.

Den nyeste udgave af indlægssedlen til dette lægemiddel kan findes på www.indlaegsseddel.dk.

Oversigt over indlægssedlen

Virkning og anvendelse

Det skal du vide, før du begynder at tage Budesonide Teva Pharma

Sådan skal du tage Budesonide Teva Pharma

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

VIRKNING OG ANVENDELSE

Budesonid tilhører en gruppe lægemidler, der hedder glukokortikosteroider (binyrebarkhormon), der

kan bruges til at lindre eller forebygge betændelsestilstande (inflammation) i lungerne.

Dette lægemiddel kan bruges af voksne, unge, børn og spædbørn over 6 måneder.

Din medicin skal bruges til behandling af astma. Medicinen bruges til patienter, hvor andre typer af

inhalatorer, såsom inhalationsspray eller pulverinhalatorer har en utilfredsstillende eller utilstrækkelig

virkning.

Budesonide Teva Pharma kan også bruges til behandling af meget alvorlig falsk strubehoste (laryngitis

subglottica) hos spædbørn og børn, der er indlagt på hospitalet.

Lægen kan have foreskrevet anden anvendelse eller dosering end angivet i denne information. Følg

altid lægens anvisning og oplysningerne på doseringsetiketten.

2.

DET SKAL DU VIDE, FØR

DU BEGYNDER AT TAGE BUDESONIDE TEVA

PHARMA

Tag ikke Budesonide Teva Pharma:

hvis du er allergisk over for budesonid eller et af de øvrige indholdsstoffer i Budesonide Teva

Pharma (angivet i punkt 6).

Advarsler og forsigtighedsregler

Kontakt lægen eller apotekspersonalet, før du tager Budesonide Teva Pharma:

hvis du har eller har haft tuberkulose

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hvis du har eller har haft en leversygdom eller problemer med din lever

hvis du har en svampeinfektion, virusinfektion eller en anden infektion i luftvejene, fx forkølelse

eller en infektion i lungerne.

Budesonid er et steroid. Du skal være opmærksom på, at du kan blive testet positiv i en dopingtest,

hvis du bruger dette lægemiddel. Du bør tale med din læge, hvis du er i tvivl om noget.

Børn og unge

I sjældne tilfælde kan langtidsbehandling med budesonid nedsætte væksten hos børn og unge. Hvis dit

barn bruger lægemidlet over en længere periode, vil lægen normalt kontrollere dit barns højde

regelmæssigt.

Brug af anden medicin sammen med Budesonide Teva Pharma

Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for

nyligt. Det gælder også medicin som ikke er købt på recept.

Nogen lægemidler kan øge virkningen af budesonid, og din læge vil overvåge dig omhyggeligt, hvis

du tager sådanne lægemidler (inklusive visse former for hiv-medicin: ritonavir, cobicistat):

medicin til behandling af svampeinfektioner såsom ketoconazol eller itraconazol.

Antibiotika, erythromycin og clarithromycin.

anden medicin mod besværet åndedræt.

østrogener og p-piller, der indeholder steroider.

Graviditet, amning og fertilitet

Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal

du spørge din læge eller apotekspersonalet til råds, før du tager Budesonide Teva Pharma. Hvis du

bliver gravid, mens du er i behandling med dette lægemiddel, skal du kontakte din læge, så snart du

finder ud af, at du er gravid.

Trafik- og arbejdssikkerhed

Det er ikke sandsynligt, at Budesonide Teva Pharma påvirker din evne til at føre motorkøretøj eller

betjene maskiner.

3.

SÅDAN SKAL DU TAGE BUDESONIDE TEVA PHARMA

Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning. Er du i tvivl, så spørg

lægen eller på apoteket.

Din læge vil fortælle dig, hvilken dosis du skal tage. Din dosis afhænger af graden af din astma.

Du vil måske opleve, at din astma forbedres inden for 3 dage, men det kan tage mellem 2-4 uger at

opnå den ønskede effekt. Det er vigtigt, at du bliver ved med at tage din medicin efter lægens

anvisninger, også selvom du har fået det bedre.

Den anbefalede dosis er:

Astma

Voksne (herunder ældre) og unge (12 år og derover)

Den sædvanlige dosis er 0,5-2,0 mg budesonid dagligt. Denne dosis vil normalt skulle tages på 2

forskellige tidspunkter på dagen, men hvis din astma er stabil og ikke alvorlig, kan din læge råde dig

til kun at tage lægemidlet 1 gang dagligt. Din læge vil fortælle dig, hvordan og hvornår du skal tage

din medicin, og du skal altid følge lægens anvisninger.

Spædbørn og børn (fra 6 måneder til 11 år)

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Den sædvanlige dosis er 0,25-1,0 mg budesonid dagligt. Lægen vil fortælle dig, hvordan dit barn skal

tage sin medicin. Medicinen skal normalt tages på 2 forskellige tidspunkter på dagen. Men hvis dit

barns astma er stabil og ikke alvorlig, kan din læge råde dig kun at give dit barn medicinen 1 gang

dagligt.

Falsk strubehoste

Den sædvanlige dosis til spædbørn og børn er 2 mg dagligt. Det kan gives som en enkelt behandling (2

ampuller af 1 mg/2 ml) eller som to behandlinger med 1 mg givet med 30 minutters mellemrum.

Denne behandling kan gentages hver 12. time i maksimalt 36 timer, eller indtil forbedring ses.

Brugsanvisning

Din medicin skal bruges sammen med en jet-nebulisator. Den ”forstøvning”, som produceres skal

inhaleres gennem et mundstykke eller en maske. Ultralydsnebulisatorer kan ikke anvendes sammen

med dette lægemiddel.

Du skal følge nedenstående anvisninger, når du skal tage din medicin:

Fjern en af de sterile plastikbeholdere (ampullen) fra den mærkede strip ved at dreje og hive

(Diagram A).

Ryst forsigtigt ampullen i cirkelbevægelser i ca. 10 sekunder, indtil der ikke længere er synligt

bundfald.

Hold ampullen lodret, og vrid toppen af (Diagram B).

Pres indholdet fra ampullen ned i kammeret på nebulisatoren (Diagram C). Sæt toppen af

kammeret på nebulisatoren, og kassér omhyggeligt den tomme ampul.

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Slut den ene ende af kammeret til mundstykket eller masken og den anden ende til luftindtaget.

Omryst forsigtigt kammeret igen, og tænd for nebulisatoren. Indånd ”forstøvningen” roligt og dybt

gennem mundstykket eller masken.

Når der ikke kommer mere ”forstøvning” ud af mundstykket eller masken, er din behandling

færdig.

Skyl munden med vand. Spyt vandet ud, og lad være med at synke det. Hvis du har brugt en

maske, skal du også vaske dit ansigt. Det er vigtigt, at du vasker ansigtet og/eller munden for at

undgå nogle af de bivirkninger, der er forbundet med brug af dette lægemiddel.

Du skal rengøre din nebulisator efter hver brug. Vask nebulisatorkammeret og mundstykket eller

masken i varmt vand tilsat et mildt rengøringsmiddel i henhold til producentens instruktioner.

Nebulisatoren skal derefter skylles grundigt og tørres ved at forbinde nebulisatorkammeret med

luftindtaget.

Det er vigtigt, at du følger producentens instruktioner, som følger med nebulisatoren. Hvis du er i tvivl

om, hvordan du skal bruge nebulisatoren, skal du kontakte apotekspersonalet.

Din læge kan også have foreskrevet følgende:

Din læge kan overveje at give dig steroidtabletter sammen med denne behandling i perioder, hvor

du er mere udsat (fx hvis du har en infektion), eller hvis du har taget høje doser inhalerede

steroider gennem en længere periode eller før en operation.

Hvis du har taget steroider i tabletform til behandling af din astma, kan din læge reducere antallet

af tabletter, når du starter din behandling med Budesonide Teva Pharma. Du kan få nogle

symptomer som et resultat heraf, herunder tilstoppet eller løbende næse, mangel på energi,

depression, eksem (en slags udslæt), og led- og/eller muskelsmerter. Hvis nogle af disse

symptomer bekymrer dig eller varer ved, skal du kontakte din læge.

Din læge kan bede dig om at kombinere dette lægemiddel med 0,9 % saltvandsopløsning, eller

opløsninger der indeholder andre aktive stoffer, der virker på luftvejene såsom salbutamol,

terbutalin, natriumkromglycat og ipratropriumbromid. Hvis dette er tilfældet, skal du følge lægens

anvisninger nøje. Tilsætningen skal anvendes inden for 30 minutter. Du må ikke kombinere dette

lægemiddel med andre lægemidler, medmindre din læge specifikt har bedt dig om at gøre det.

Hvis du har taget for meget Budesonide Teva Pharma

Kontakt lægen, skadestuen eller apoteket, hvis du har taget mere Budesonide Teva Pharma, end der

står her, eller mere end lægen har foreskrevet, og du føler dig utilpas. Tag pakningen og eventuelle

resterende ampuller med. Det er vigtigt, at du tager den dosis, som er angivet på etiketten, eller som

lægen har foreskrevet. Du må ikke øge eller nedsætte din dosis uden at have talt med lægen.

Hvis du har glemt at tage Budesonide Teva Pharma

Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis. Tag den næste dosis som

planlagt.

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

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4.

BIVIRKNINGER

Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.

Alle lægemidler kan forårsage allergiske reaktioner, selvom alvorlige allergiske reaktioner er meget

sjældne. Fortæl det straks til din læge, hvis dit åndedræt pludselig bliver hvæsende, hvis du får

åndedrætsbesvær, hævede øjenlåg, ansigt eller læber, udslæt eller kløe (især hvis det påvirker hele

kroppen).

Lægemidler til inhalation, såsom budesonid, forårsager sjældent akut hvæsende åndedræt og/eller

kortåndethed. Hvis du oplever dette, skal du straks stoppe behandlingen og kontakte lægen.

Følgende bivirkninger er blevet rapporteret:

Almindelige bivirkninger

(forekommer hos mellem 1 og 10 ud af 100 patienter)

Ømhed og/eller irritation i munden (herunder trøske i munden), irritation i halsen, synkebesvær og

hoste.

Ikke alminelige bivirkninger

(forekommer hos mellem 1 og 10 ud af 1.000 patienter)

Angst

Depression

Tremor

Sløring af linsen i øjet (grå stær)

Muskelspasmer

Sjældne bivirkninger

(forekommer hos mellem 1 og 10 ud af 10.000 patienter)

Hudreaktioner, herunder kløe, udslæt, blå mærker, betændelsestilstande, rødmen af huden og/eller

hududslæt, hævelse, langsom vækst hos børn og unge, overfølsomhed (en allergisk reaktion over

for medicinen) og kortåndethed (sammentrækning af musklerne i luftvejene, som resulterer i

hvæsende åndedræt).

Påvirkning af binyren (en lille kirtel ved siden af nyrerne) kan også opstå. De væsentligste

symptomer på påvirkning af binyren er hovedpine, træthed, kvalme og opkastning, vægttab,

mavesmerter og appetitmangel.

Følelse af rastløshed, nervøs og irritabel (særligt hos børn).

Hæshed, ændringer af stemmen.

Meget sjældne bivirkninger

(forekommer hos færre end 1 ud af 10.000 patienter)

Fald i knoglemineraltætheden (svind af knoglemasse).

Ikke kendt

(kan ikke estimeres ud fra forhåndenværende data)

Grøn stær (øget tryk på øjet), aggression, søvnproblemer og nervøsitet.

Indberetning af bivirkninger

Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket. Dette gælder

også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel. Du eller dine pårørende kan

også indberette bivirkninger direkte til Lægemiddelstyrelsen påwww.meldenbivirkning.dk, eller ved at

kontakte Lægemiddelstyrelsen via mail på dkma@dkma.dk eller med almindeligt brev til

Lægemiddelstyrelsen, Axel Heides Gade 1, 2300 København S. Ved at indrapportere bivirkninger kan

du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.

5.

OPBEVARING

Opbevar lægemidlet utilgængeligt for børn.

Version 1408-01

Brug ikke lægemidlet efter den udløbsdato, der står på den ydre karton, posen og ampullen efter Exp.

Udløbsdatoen er den sidste dag i den nævnte måned.

Må ikke nedfryses.

Opbevares lodret.

Når posen er åbnet, skal ampullerne indeni bruges inden for 3 måneder (det er en god idé at skrive

datoen for første åbning på foliepakningen). Opbevar ampullen i den åbnede pose. Den åbnede pose

skal opbevares i den ydre karton for at beskytte mod lys, og de må ikke nedfryses.

Hver ampul er til engangsbrug.

Åben ampul: Anvendes straks. Ikke-anvendt suspension kasseres.

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

medicinrester i afløbet, toilettet eller skraldespanden.

6.

PAKNINGSSTØRRELSER OG YDERLIGERE OPLYSNINGER

Budesonide Teva Pharma indeholder:

Aktivt stof: budesonid.

Budesonide Teva Pharma inhalationsvæske til nebulisator, suspension 0,125 mg/ml indeholder 0,25

mg budesonid som aktivt stof i hver enkeltdosis 2 ml ampul.

Budesonide Teva Pharma inhalationsvæske til nebulisator, suspension 0,25 mg/ml indeholder 0,5 mg

budesonid som aktivt stof i hver enkeltdosis 2 ml ampul.

Budesonide Teva Pharma inhalationsvæske til nebulisator, suspension 0,5 mg/ml indeholder 1 mg

budesonid som aktivt stof i hver enkeltdosis 2 ml ampul.

Øvrige indholdsstoffer (hjælpestoffer): Dinatriumedetat, natriumchlorid, polysorbat 80 E433,

citronsyremonohydrat E330, natriumcitrat E331 og vand til injektionsvæsker.

Udseende og pakningsstørrelser

Budesonide Teva Pharma indeholder plasticampuller til engangsbrug indeholdende 2 ml hvid til

råhvid steril suspension til brug for nebulisering (bliver til en fin forstøvning til inhalation).

Strips med 5 ampuller er pakket i folieposer, som er pakket i kartoner. Der er 5, 10, 15, 20, 25, 30, 40,

50 eller 60 ampuller i hver karton.

Indehaver af markedsføringstilladelsen og fremstiller

Indehaver af markedsføringstilladelsen

Teva Pharma B.V.

Swensweg 5

2031 GA Haarlem

Holland

Repræsentant i Danmark

Teva Denmark A/S

Parallelvej 10-12

2800 Kgs. Lyngby

Fremstiller:

Norton Healthcare Limited t/a IVAX Pharmaceuticals UK

Version 1408-01

Runcorn

Cheshire

WA7 3FA

Storbritannien

Dette lægemiddel er godkendt i EEA’s medlemslande under følgende navne:

Belgien

Budesonide Teva 0.125 mg/ml, 0.25 mg/ml and 0,5 mg/ml vernevelsuspensie

Cypern

Budesonide/Teva 0,25 mg, 0,5 mg and 1 mg Εναιώρημα για εισπνοή με εκνεφωτή

Danmark

Budesonide Teva Pharma

Finland

Budesonide Teva 0,125 mg/ml, 0,5 mg/ml sumutinsuspensio

Buderatio 0,25 mg/ml sumutinsuspensio

Grækenland

Budesonide/Teva 0,25 mg, 0,5 mg and 1 mg Εναιώρημα για εισπνοή με εκνεφωτή

Holland

Budesonide Teva Steri-Neb® 0.25 mg/2 ml, 0.5 mg/2 ml and 1 mg/2 ml,

vernevelsuspensie

Island

Budesonide Teva 0,125 mg/ml, 0,25 mg/ml and 0,5 mg/ml dreifa fyrir eimgjafa

Irland

Budesonide Teva Pharma 0.25 mg/2 ml, 0.5 mg/2 ml and 1 mg/2 ml Nebuliser

Suspension

Malta

Budesonide Teva Pharma 0.25 mg/2 ml, 0.5 mg/2 ml and 1 mg/2 ml Nebuliser

Suspension

Polen

Nebbud

Budesonide Teva

Budesonide Teva

Sverige

Budesonide Teva Pharma

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22-10-2018

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials, to the patient consumer level. The product has been found to have unidentified small particulate floating in the solution.

FDA - U.S. Food and Drug Administration

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

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

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

28-8-2018

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.

Danish Medicines Agency

15-2-2019


Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019

Europe - EMA - European Medicines Agency

4-2-2019

Reyataz (Bristol-Myers Squibb Pharma EEIG)

Reyataz (Bristol-Myers Squibb Pharma EEIG)

Reyataz (Active substance: atazanavir sulphate) - Centralised - Yearly update - Commission Decision (2019)843 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

4-2-2019

Taxotere (Aventis Pharma S.A.)

Taxotere (Aventis Pharma S.A.)

Taxotere (Active substance: Docetaxel) - Centralised - Yearly update - Commission Decision (2019)861 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

18-1-2019


Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019

Europe - EMA - European Medicines Agency

16-1-2019

EU/3/12/1062 (EUSA Pharma (Netherlands) B.V.)

EU/3/12/1062 (EUSA Pharma (Netherlands) B.V.)

EU/3/12/1062 (Active substance: Chimeric monoclonal antibody against GD2) - Transfer of orphan designation - Commission Decision (2019)238 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003198

Europe -DG Health and Food Safety

16-1-2019

EU/3/14/1309 (Pharma Gateway AB)

EU/3/14/1309 (Pharma Gateway AB)

EU/3/14/1309 (Active substance: 17a,21-dihydroxy-16a-methyl-pregna-1,4,9(11)-triene-3,20-dione) - Transfer of orphan designation - Commission Decision (2019)232 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002736

Europe -DG Health and Food Safety

15-1-2019

EU/3/16/1680 (Chugai Pharma France)

EU/3/16/1680 (Chugai Pharma France)

EU/3/16/1680 (Active substance: Humanised anti-IL-6 receptor monoclonal antibody) - Transfer of orphan designation - Commission Decision (2019)229 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003065

Europe -DG Health and Food Safety

20-12-2018

Ravicti (Horizon Pharma Ireland Limited)

Ravicti (Horizon Pharma Ireland Limited)

Ravicti (Active substance: Glycerol phenylbutyrate) - Centralised - 2-Monthly update - Commission Decision (2018)9126 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3822/II/19

Europe -DG Health and Food Safety

19-12-2018

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (Active substance: pegaptanib sodium) - Withdrawal - Commission Decision (2018)9064 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

19-12-2018

EU/3/18/2120 (Takeda Pharma A/S)

EU/3/18/2120 (Takeda Pharma A/S)

EU/3/18/2120 (Active substance: Pevonedistat) - Orphan designation - Commission Decision (2018)9035 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/164/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2108 (Pharma Gateway AB)

EU/3/18/2108 (Pharma Gateway AB)

EU/3/18/2108 (Active substance: Adeno-associated viral vector expressing human 21-hydroxylase) - Orphan designation - Commission Decision (2018)9023 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2106 (AudioCure Pharma GmbH)

EU/3/18/2106 (AudioCure Pharma GmbH)

EU/3/18/2106 (Active substance: 6-fluoro-9-methyl-9H-pyrido[3,4-b]-indole) - Orphan designation - Commission Decision (2018)9021 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/170/18

Europe -DG Health and Food Safety

17-12-2018

OCALIVA (Intercept Pharma Ltd)

OCALIVA (Intercept Pharma Ltd)

OCALIVA (Active substance: obeticholic acid) - Centralised - Annual renewal - Commission Decision (2018)8909 of Mon, 17 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4093/R/9

Europe -DG Health and Food Safety

13-12-2018


Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

Europe - EMA - European Medicines Agency

12-12-2018

Daklinza (Bristol-Myers Squibb Pharma EEIG)

Daklinza (Bristol-Myers Squibb Pharma EEIG)

Daklinza (Active substance: daclatasvir) - Centralised - Yearly update - Commission Decision (2018)8758 of Wed, 12 Dec 2018

Europe -DG Health and Food Safety

12-12-2018

EVOTAZ (Bristol-Myers Squibb Pharma EEIG)

EVOTAZ (Bristol-Myers Squibb Pharma EEIG)

EVOTAZ (Active substance: atazanavir / cobicistat) - Centralised - Yearly update - Commission Decision (2018)8679 of Wed, 12 Dec 2018

Europe -DG Health and Food Safety

11-12-2018

Xermelo (Ipsen Pharma)

Xermelo (Ipsen Pharma)

Xermelo (Active substance: telotristat) - Centralised - Yearly update - Commission Decision (2018)8684 of Tue, 11 Dec 2018

Europe -DG Health and Food Safety

30-11-2018

Keppra (UCB Pharma S.A.)

Keppra (UCB Pharma S.A.)

Keppra (Active substance: levetiracetam) - Centralised - Yearly update - Commission Decision (2018)8160 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

30-11-2018

Pioglitazone Teva Pharma (Teva B.V.)

Pioglitazone Teva Pharma (Teva B.V.)

Pioglitazone Teva Pharma (Active substance: pioglitazone) - Centralised - Yearly update - Commission Decision (2018)8158 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

26-11-2018

Alunbrig (Takeda Pharma A/S)

Alunbrig (Takeda Pharma A/S)

Alunbrig (Active substance: brigatinib) - Centralised - Authorisation - Commission Decision (2018)7976 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4248/

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Active substance: 3-(3-(3,5-dimethyl-1H-pyrazol-4-yl)propoxy)-4-fluorobenzoic acid) - Orphan designation - Commission Decision (2018)7790 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/096/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2101 (TMC Pharma Services Ltd)

EU/3/18/2101 (TMC Pharma Services Ltd)

EU/3/18/2101 (Active substance: Setmelanotide) - Orphan designation - Commission Decision (2018)7811 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/143/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2091 (Pharma Gateway AB)

EU/3/18/2091 (Pharma Gateway AB)

EU/3/18/2091 (Active substance: Glucagon) - Orphan designation - Commission Decision (2018)7801 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/108/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2083 (MaaT PHARMA)

EU/3/18/2083 (MaaT PHARMA)

EU/3/18/2083 (Active substance: Allogeneic faecal microbiota, pooled) - Orphan designation - Commission Decision (2018)7792 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/123/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

12-11-2018

Neupro (UCB Pharma S.A.)

Neupro (UCB Pharma S.A.)

Neupro (Active substance: Rotigotine) - Centralised - Yearly update - Commission Decision (2018)7551 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

1-11-2018

Protopic (Leo Pharma A/S)

Protopic (Leo Pharma A/S)

Protopic (Active substance: Tacrolimus) - Centralised - Yearly update - Commission Decision (2018)7343 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

29-10-2018

Sustiva (Bristol-Myers Squibb Pharma EEIG)

Sustiva (Bristol-Myers Squibb Pharma EEIG)

Sustiva (Active substance: efavirenz) - Centralised - 2-Monthly update - Commission Decision (2018)7252 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/249/II/145/G

Europe -DG Health and Food Safety

25-10-2018

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Active substance: enzalutamide) - Centralised - 2-Monthly update - Commission Decision (2018)7132 of Thu, 25 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2639/II/39G

Europe -DG Health and Food Safety

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

16-10-2018

Dexxience (Portola Pharma UK Limited)

Dexxience (Portola Pharma UK Limited)

Dexxience (Active substance: betrixaban) - Refusal of authorisation - Commission Decision (2018)6226 of Tue, 16 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4309

Europe -DG Health and Food Safety

2-10-2018

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Active substance: Lamivudine) - Centralised - Yearly update - Commission Decision (2018)6476 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

24-9-2018

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Active substance: Botulinum Toxin Type B) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6221 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000301/T/0101

Europe -DG Health and Food Safety

24-9-2018

Rasilez (Noden Pharma DAC)

Rasilez (Noden Pharma DAC)

Rasilez (Active substance: aliskiren) - Centralised - Yearly update - Commission Decision (2018)6229 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (Active substance: vigabatrin) - Centralised - Authorisation - Commission Decision (2018)6224 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4534

Europe -DG Health and Food Safety

24-9-2018

INCRELEX (Ipsen Pharma)

INCRELEX (Ipsen Pharma)

INCRELEX (Active substance: Mecasermin) - Centralised - Yearly update - Commission Decision (2018)6240 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 6097 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3962/T/08

Europe -DG Health and Food Safety

19-9-2018

Agenda:  Agenda – 12th Pharmacovigilance stakeholder forum

Agenda: Agenda – 12th Pharmacovigilance stakeholder forum

Europe - EMA - European Medicines Agency

19-9-2018

 12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety

29-8-2018

Cometriq (Ipsen Pharma)

Cometriq (Ipsen Pharma)

Cometriq (Active substance: cabozantinib) - PSUSA - Modification - Commission Decision (2018)5761 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10180/201711

Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety