Otrivin Comp

Primær information

  • Handelsnavn:
  • Otrivin Comp 0,5+0,6 mg/ml næsespray, opløsning
  • Dosering:
  • 0,5+0,6 mg/ml
  • Lægemiddelform:
  • næsespray, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

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Lokation

  • Fås i:
  • Otrivin Comp 0,5+0,6 mg/ml næsespray, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 43140
  • Sidste ændring:
  • 01-02-2018

Produktresumé

4. juli 2017

PRODUKTRESUMÉ

for

Otrivin Comp, næsespray, opløsning

0.

D.SP.NR.

25910

1.

LÆGEMIDLETS NAVN

Otrivin Comp

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

1 ml indeholder 0,5 mg xylometazolinhydrochlorid og 0,6 mg ipratropiumbromid.

1 pust (ca. 140 mikroliter) indeholder 70 mikrogram xylometazolinhydrochlorid og 84

mikrogram ipratropiumbromid.

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Næsespray, opløsning.

Klar, farveløs opløsning.

4.

KLINISKE OPLYSNINGER

4.1

Terapeutiske indikationer

Symptomatisk behandling af nasal kongestion (hævede slimhinder i næsen) og rhinorrhea

(næseflåd) i forbindelse med forkølelse.

4.2

Dosering og indgivelsesmåde

Dosering

Voksne:1 pust i hvert næsebor op til 3 gange dagligt. Der skal gå mindst 6 timer mellem 2

doseringer. 3 anvendelser dagligt i hvert næsebor må ikke overskrides.

Behandlingsvarigheden bør ikke overstige 7 dage (se pkt. 4.4).

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1 af 7

For at mindske risikoen for bivirkninger (se pkt. 4.8) anbefales det at ophøre med

behandlingen, når symptomerne er aftaget, også før den maksimale behandlingsvarighed

på 7 dage.

Pædiatrisk population

Otrivin Comp bør ikke anvendes til børn og unge under 18 år pga. utilstrækkelig

dokumentation.

Ældre

Der er kun begrænset erfaring med anvendelse til patienter over 70 år.

Administration

Før første anvendelse skal der trykkes 4 gange på udløseren for at klargøre pumpen.

Herefter er pumpen klar til anvendelse i behandlingstiden. Hvis pumpen ikke afgiver

sprayen, når der trykkes på den, eller hvis lægemidlet ikke er blevet anvendt i mere end 6

dage, skal pumpen klargøres igen ved at trykke 4 gange ligesom ved første anvendelse.

4.3

Kontraindikationer

Otrivin Comp bør ikke anvendes til børn og unge under 18 år pga. utilstrækkelig

dokumentation.

Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne

anført i punkt 6.1.

Kendt overfølsomhed over for atropin eller lignende stoffer som f.eks. hyoscyamin eller

skopolamin.

Efter operationer, hvor dura mater kan være penetreret, f.eks. ved transsphenoidal

hypofysektomi eller anden transnasal operation.

Til patienter med glaukom.

Til patienter med rhinitis sicca.

4.4

Særlige advarsler og forsigtighedsregler vedrørende brugen

Otrivin Comp skal administreres med forsigtighed til patienter med:

Hypertension, kardiovaskulære sygdomme

Hyperthyreoidisme, diabetes mellitus

Prostatahypertrofi, blærehalsobstruktion

Fæokromocytom

Der skal udvises forsigtighed hos patienter, der er prædisponerede for:

Snævervinklet glaukom

Epistaxis (f. eks. hos ældre)

Paralytisk ileus

Cystisk fibrose

Umiddelbar overfølsomhed omfattende urticaria, angioødem, udslæt, bronkospasme,

pharynxødem og anafylaksi kan forekomme.

Lægemidlet skal bruges med forsigtighed af patienter, der er følsomme over for adrenerge

substanser, som kan give symptomer såsom søvnforstyrrelser, svimmelhed, tremor,

hjertearytmier eller forhøjet blodtryk.

43140_spc.doc

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2 af 7

Behandlingsvarigheden bør ikke overstige 7 dage, da kronisk behandling med

xylometazolinhydrochlorid kan medføre hævelse af næseslimhinden og hypersekretion på

grund af øget sensibilitet i cellerne, "rebound-effekt" (rhinitis medicamentosa).

Patienter bør instrueres i at undgå at spraye Otrivin Comp i eller rundt om øjnene. Hvis

Otrivin Comp kommer i kontakt med øjnene, kan det medføre følgende: Forbigående sløret

syn, irritation, smerte, røde øjne. Forværring af snævervinklet glaukom kan også

forekomme. Patienten skal instrueres i at skylle øjnene med koldt vand, hvis Otrivin Comp

kommer i direkte kontakt med øjnene, og kontakte en læge, hvis de oplever øjensmerter

eller sløret syn.

4.5

Interaktion med andre lægemidler og andre former for interaktion

Monoaminooxidasehæmmere (MAO hæmmere)

Samtidig brug, eller anvendelse indenfor de seneste 2 uger, af sympatomimetiske

lægemidler kan forårsage svært forhøjet blodtryk og anbefales derfor ikke.

Sympatomimetiske lægemidler frigiver catecholamin, hvilket resulterer i frigivelse af en

stor mængde noradrenalin. Noradrenalin har en vasokonstriktorisk virkning, der udløser en

blodtryksstigning. Ved kritiske tilfælde af forhøjet blodtryk bør behandlingen med Otrivin

Comp afbrydes og det forhøjede blodtryk behandles.

Tri- og tetracykliske antidepressiva

Samtidig brug, eller anvendelse indenfor de seneste 2 uger, af tricykliske antidepressiva og

sympatomimetika kan resultere i øget sympatomimetisk virkning af xylometazolin og

anbefales derfor ikke.

Samtidig brug af andre antikolinerge lægemidler kan forstærke den antikolinerge virkning.

Ovenstående interaktioner er studeret individuelt for begge de aktive substanser i Otrivin

Comp, men ikke for kombinationen.

Der er ikke udført interaktionsstudier med andre stoffer.

4.6

Fertilitet, graviditet og amning

Graviditet

Der foreligger ikke tilstrækkelige data om brugen af Otrivin Comp hos gravide kvinder. De

udførte dyreforsøg er utilstrækkelige med hensyn til dokumentation for påvirkning af

graviditet, embryoets/fostrets udvikling, fødsel og postnatal udvikling. Den potentielle

risiko for mennesker er ukendt.

Otrivin Comp bør ikke anvendes under graviditet, med mindre det er påkrævet/yderst

nødvendigt.

Amning

Det vides ikke om ipratropiumbromid og xylometazolinhydrochlorid udskilles i human

mælk. Den systemiske påvirkning af ipratropiumbromid og xylometazolin hydrochlorid er

lav. Det er derfor ikke sandsynligt at det ammede barn påvirkes. Før anvendelse til

ammende bør en afvejning mellem fordelene ved amning og moderens behov for

behandling og mulig risiko for barnet finde sted.

4.7

Virkning på evnen til at føre motorkøretøj og betjene maskiner

Ikke mærkning

43140_spc.doc

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3 af 7

Synsforstyrrelser (herunder sløret syn og mydriasis), svimmelhed og træthed er blevet

rapporteret med Otrivin Comp. Patienter bør instrueres i, at hvis de er påvirkede, må de

ikke føre motorkøretøj, betjene maskiner eller deltage i aktiviteter, hvor disse symptomer

kan udsætte dem selv eller andre for fare.

4.8

Bivirkninger

Resumé af sikkerhedsprofilen

De almindeligst rapporterede bivirkninger er epistaxis, der forekommer hos 14,8% og

næsetørhed, der forekommer hos 11,3% af patienterne.

Mange af de rapporterede bivirkninger er også symptomer på almindelig forkølelse.

Oversigt over bivirkninger opstillet i tabelform

Følgende bivirkninger blev rapporteret i to randomiserede kliniske studier og i et ikke-

interventions-studie med produktet efter markedsføring samt overvågning efter

markedsføring.

Bivirkningerne er opført nedenfor efter systemorganklasse og hyppighed. Hyppighederne

er defineret som:

Meget almindelig (≥1/10)

Almindelig (≥1/100 til <1/10)

Ikke almindelig (

1/1.000 til <1/100)

Sjælden (

1/10.000 til <1/1.000)

Meget sjælden (

<

1/10.000)

Ikke kendt (kan ikke estimeres fra tilgængelige data).

Hyppighed

System-

organklasse

Meget

almindelig

Almindelig

Ikke

almindelig

Sjælden

Ikke kendt

Immunsystem

Overfølsomh

Psykiske

forstyrrelser

Insomni

Nervesystemet

Dysgeusi, hovedpine

Parosmi,

svimmelhed,

tremor

Øjne

Øjen-

irritation,

tørre øjne

Akkomo-

dations-

forstyrrelse,

forværring af

snæver-

vinklet

glaukom,

øjen-smerter,

fotopsi,

øget

intraokulært

tryk, sløret

43140_spc.doc

Side

4 af 7

Hyppighed

System-

organklasse

Meget

almindelig

Almindelig

Ikke

almindelig

Sjælden

Ikke kendt

syn,

mydriasis,

halovision

Hjerte

Palpitationer,

takykardi

Atrieflimren

Luftveje,

thorax og

mediastinum

Epistaxis,

tørhed i

næsen

Ubehag i næsen,

tilstoppet næse,

tørhed i svælget,

irritation i svælget,

smerter i næsen

Sår i næsen,

nysen,

orofarynge

smerter,

hoste,

dysfoni

Næseflo

Paranasalt

sinus-

ubehag.

larynxspasm

pharynxøde

Mave-tarm-

kanalen

Mundtørhed

Dyspepsi,

kvalme

Dysfagi

Hud og

subkutane væv

Pruritus,

udslæt,

urticaria

Nyrer og

urinveje

Urin-

retention

Almene

symptomer og

reaktioner på

admini-

strations-

stedet

Ubehag,

træthed

Ubehag i

brystet, tørst,

Beskrivelse af udvalgte bivirkninger

Adskillige af de bivirkninger, der er opført under ”Ikke kendt”, er kun blevet rapporteret én

gang for produktet i kliniske studier eller er kun rapporteret fra overvågning efter

markedsføring.Der kan derfor ikke gives en hyppighedsvurdering baseret på det aktuelle

antal af patienter, som er behandlet med Otrivin Comp.

Indberetning af formodede bivirkninger

Når lægemidlet er godkendt, er indberetning af formodede bivirkninger vigtig. Det

muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet. Læger og

sundhedspersonale anmodes om at indberette alle formodede bivirkninger til:

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

4.9

Overdosering

43140_spc.doc

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5 af 7

Overdosering efter oral eller overdreven topikal anvendelse af xylometazolinhydrochlorid

kan medføre svær svimmelhed, svedudbrud, svært nedsat legemstemperatur, hovedpine,

bradykardi, hypertension, respirationsdepression, koma og kramper. Hypertension kan

afløses af hypotension. Små børn er mere udsatte over for forgiftning end voksne.

Da absorptionen efter nasal eller oral administration er meget begrænset, er akut

overdosering efter intranasal anvendelse af ipratropiumbromid ikke sandsynlig, men hvis

der skulle forekomme en overdosering, er symptomerne mundtørhed,

akkomodationsbesvær og takykardi. Behandlingen er symptomatisk.

Ved en betragtelig overdosis kan patienten få antikolinerge CNS-symptomer såsom

hallucinationer. Disse skal behandles med cholinestereasehæmmere.

Der skal initieres passende understøttende forholdsregler hos alle personer, hvor der er

mistanke om en overdosering, og hvis påkrævet, er en hurtig symptomatisk behandling

under lægelig opsyn indiceret. Dette bør omfatte observation af personen i mindst 6 timer.

I tilfælde af en alvorlig overdosering med hjertestop, skal genoplivning fortsættes i mindst

1 time.

4.10

Udlevering

5.

FARMAKOLOGISKE EGENSKABER

5.1

Farmakodynamiske egenskaber

Farmakoterapeutisk klassifikation: Sympatomimetika, kombinationsprodukter uden

kortikosteroider.

ATC-kode: R 01 AB 06.

Xylometazolinhydrochlorid er et sympatomimetika, som virker på α-adrenerge receptorer.

Xylometazolin har vasokonstriktorisk virkning. Virkningen indtræder efter 5-10 minutter

og varer 6-8 timer.

Ipratropiumbromid er en kvartær ammoniumforbindelse med antikolinerg virkning. Ved

nasal administration reduceres den nasale sekretion ved kompetitiv hæmning af de

kolinerge receptorer lokaliseret i næsens epithel. Virkningen indtræder sædvanligvis inden

for 15 minutter og varer gennemsnitligt i 6 timer.

5.2

Farmakokinetiske egenskaber

Efter administration af et pust pr. næsebor af 140 µg xylometazolin og 84 µg

ipratropiumbromid hos 24 raske forsøgspersoner, opnåedes gennemsnitlige koncentrationer

på 0,085 ng/ml og 0,13 ng/ml 1 og 2 timer efter administration for henholdsvis

ipratropiumbromid og xylometazolin. Blodniveauerne er meget lave. Dog forventes det på

baggrund af eksisterende data, at ipratropiumbromid og især xylometazolin vil

akkumuleres ved den foreslåede administration 3 gange dagligt.

5.3

Prækliniske sikkerhedsdata studier

43140_spc.doc

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6 af 7

Både ipratropium og xylometazolin er blevet testet i prækliniske studier. Data herfra viser

ingen relevante kliniske risici med den aktuelle dosis af Otrivin Comp.

Daglig, intranasal anvendelse af Otrivin Comp til hunde i 28 dage i doser op til 4 gange

den påtænkte dosis viste ingen lokal eller systemisk virkning.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Dinatriumedetat

Glycerol 85 %

Saltsyre (til justering af pH)

Natriumhydroxid (til justering af pH)

Renset vand

6.2

Uforligeligheder

Ikke relevant.

6.3

Opbevaringstid

3 år.

Efter åbning kan næsesprayen anvendes til slutningen af holdbarhed.

6.4

Særlige opbevaringsforhold

Må ikke opbevares over 25°C.

6.5

Emballagetype og pakningsstørrelser

10 ml multidosisbeholder (ca. 70 pust) HDPE-flaske med en PP spraypumpe med

beskyttende hætte, der giver afmålt dosis (materiale der er i kontakt med opløsningen:

LDPE, HDPE, PE/butyl, rustfrit stål).

6.6

Regler for bortskaffelse og anden håndtering

Ikke anvendt lægemiddel samt affald heraf bør bortskaffes i henhold til lokale

retningslinjer.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

GlaxoSmithKline Consumer Healthcare A/S

Nykær 68

2605 Brøndby

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

43140

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF

TILLADELSEN

26. november 2008

10.

DATO FOR ÆNDRING AF TEKSTEN

4. juli 2017

43140_spc.doc

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7 af 7

  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

    Anmode informationsbrochure for offentligheden.



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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

6-6-2018

National Network for the Monitoring and Prevention of Occupational Diseases: new data published on cancers of occupational origin

National Network for the Monitoring and Prevention of Occupational Diseases: new data published on cancers of occupational origin

At the 35th French occupational medicine and health congress (CNMST) held in Marseille from 5 to 8 June 2018, ANSES presented for the very first time data on cancers of occupational origin collected by the National Network for Monitoring and Prevention of Occupational Diseases (RNV3P) coordinated by the Agency. These data are used to build up a comprehensive picture of the cancers associated with occupational exposure situations, in order toidentify the industry sectors and situations most at risk, with ...

France - Agence Nationale du Médicament Vétérinaire

5-6-2018

FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

FDA announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.

FDA - U.S. Food and Drug Administration

22-5-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens

The FDA is announcing three new efforts as part of a comprehensive set of actions to advance the FDA’s framework for sun protection products ahead of this coming summer

FDA - U.S. Food and Drug Administration

27-4-2018

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

Today, the Agency is publishing an inventory of alternatives to antibiotics aimed at reducing their use in animal husbandry and based on an original method for evaluating the diverse scientific publications in the field. In its report, ANSES identifies numerous products and substances including compounds, plants, plant extracts and micro-organisms, which are used as alternatives to antibiotics. However, it emphasises the diversity of the data available to assess their safety and efficacy, and their abili...

France - Agence Nationale du Médicament Vétérinaire

17-4-2018

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

FDA - U.S. Food and Drug Administration

26-2-2016

New comprehensive list of euphoriant substances regulated in Denmark

New comprehensive list of euphoriant substances regulated in Denmark

You can now find a comprehensive list of euphoriant substances that are subject to control in Denmark via the executive order on euphoriant substances.

Danish Medicines Agency

8-9-2009

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

On 3 september 2009, the Danish Medicines Agency decided on the future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds).

Danish Medicines Agency

11-9-2018

Agenda:  Agenda - COMP agenda of the 11-13 September 2018 meeting

Agenda: Agenda - COMP agenda of the 11-13 September 2018 meeting

Europe - EMA - European Medicines Agency

17-8-2018

 Minutes of the COMP meeting of 22-24 May 2018

Minutes of the COMP meeting of 22-24 May 2018

Europe - EMA - European Medicines Agency

17-8-2018

 Minutes of the COMP meeting of 19-21 June 2018

Minutes of the COMP meeting of 19-21 June 2018

Europe - EMA - European Medicines Agency

19-7-2018

Regulatory and procedural guideline:  Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018

Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018

The opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the European Medicines Agency (EMA).

Europe - EMA - European Medicines Agency

17-7-2018

Agenda:  Agenda - COMP agenda of the 17-19 July 2018 meeting

Agenda: Agenda - COMP agenda of the 17-19 July 2018 meeting

Draft agenda for the meeting on 17-19 July 2018

Europe - EMA - European Medicines Agency

16-7-2018

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments:

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments:

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments: https://go.usa.gov/xQ7Jb  pic.twitter.com/hQxiKdMZBK

FDA - U.S. Food and Drug Administration

28-6-2018

 Minutes of the COMP meeting of 17-19 April 2018

Minutes of the COMP meeting of 17-19 April 2018

Europe - EMA - European Medicines Agency

18-6-2018

Agenda:  Agenda - COMP agenda of the 19-21 June 2018 meeting

Agenda: Agenda - COMP agenda of the 19-21 June 2018 meeting

Committee for Orphan Medicinal Products (COMP) draft agenda for the meeting on 19-21 June 2018

Europe - EMA - European Medicines Agency

28-5-2018

 Minutes of the COMP meeting of 13-15 March 2018

Minutes of the COMP meeting of 13-15 March 2018

Europe - EMA - European Medicines Agency

22-5-2018

Agenda:  Agenda - COMP agenda of the 22-24 May 2018 meeting

Agenda: Agenda - COMP agenda of the 22-24 May 2018 meeting

Europe - EMA - European Medicines Agency

15-5-2018

 Minutes of the COMP meeting of 13-15 February 2018

Minutes of the COMP meeting of 13-15 February 2018

Europe - EMA - European Medicines Agency