Tranexamsyre "Pfizer"

Primær information

  • Handelsnavn:
  • Tranexamsyre "Pfizer" 100 mg/ml injektionsvæske, opløsning, i.v.
  • Dosering:
  • 100 mg/ml
  • Lægemiddelform:
  • injektionsvæske, opløsning, i.v.
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Tranexamsyre "Pfizer" 100 mg/ml injektionsvæske, opløsning, i.v.
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 37516
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Indlægsseddel: Information til brugeren

Tranexamsyre Pfizer, 100 mg/ml injektionsvæske, opløsning, til intravenøs

anvendelse

Tranexamsyre

Læs denne indlægsseddel grundigt, inden De bliver behandlet med dette lægemiddel, da den

indeholder vigtige oplysninger.

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

Spørg lægen eller sundhedspersonalet, hvis der er mere, De vil vide.

Tal med lægen eller sundhedspersonalet, hvis en bivirkning bliver værre, eller hvis De får

bivirkninger, som ikke er nævnt her. Se afsnit 4.

Se den nyeste indlæsseddel på www.indlaegsseddel.dk

Oversigt over indlægssedlen

Virkning og anvendelse

Det skal De vide, før De får Tranexamsyre Pfizer

Sådan bliver De behandlet med Tranexamsyre Pfizer

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Tranexamsyre Pfizer indeholder tranexamsyre, som tilhører en gruppe lægemidler, der kaldes

hæmostatika med antifibrinolytisk virkning. Tranexamsyre er en aminosyre.

Tranexamsyre Pfizer anvendes til voksne og børn over 1 år til forebyggelse og behandling af blødning

forårsaget af en proces i kroppen, som kaldes fibrinolyse, og som nedsætter blodets evne til at størkne.

De specifikke indikationer omfatter:

Kraftig menstruationsblødning hos kvinder

Mave-tarmblødninger

Blødning i urinvejene efter prostataoperation eller operation i urinvejene

Øre-næse-halsoperation

Operation i hjertet eller maven eller gynækologiske operationer

Blødning efter at De er blevet behandlet med et andet lægemiddel til at opløse blodpropper.

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

Følg altid lægens anvisning.

2.

Det skal De vide, før De får Tranexamsyre Pfizer

De må ikke få Tranexamsyre Pfizer,

hvis De

er allergisk over for tranexamsyre eller et af de øvrige indholdsstoffer (angivet i punkt 6).

hvis De

for tiden lider af en sygdom, hvor De får blodpropper.

hvis De

har en tilstand, der kaldes dissemineret intravaskulær koagulation, hvor blod i hele

kroppen begynder at størkne.

hvis De

har nyreproblemer.

hvis De

tidligere har haft kramper.

På grund af risikoen for væskeansamling i hjernen og kramper anbefales intratekal og intraventrikulær

injektion og intracerebral anvendelse ikke.

Hvis De mener, at noget af ovenstående gælder for Dem, eller hvis De overhovedet er i tvivl, så rådfør

Dem med Deres læge, inden De får Tranexamsyre Pfizer.

Advarsler og forsigtighedsregler

Fortæl det til lægen, hvis noget af følgende gælder for Dem, da det vil hjælpe lægen med at afgøre, om

De skal have Tranexamsyre Pfizer:

Hvis De har haft blod i urinen. Tranexamsyre Pfizer kan forårsage tilstoppede urinveje.

Hvis De har risiko for at få blodpropper.

Hvis De har en udbredt tendens til at danne blodpropper eller til kraftig blødning i hele kroppen

(dissemineret intravaskulær koagulation) er Tranexamsyre Pfizer måske ikke den rigtige

behandling til Dem. Undtaget er tilfælde, hvor De har akut alvorlig blødning og blodprøver har

vist, at den mekanisme, der nedsætter blodets evne til at størkne (fibrinolyse), er aktiveret.

Hvis De lider af kramper, bør De ikke få Tranexamsyre Pfizer. Lægen skal give den lavest mulige

dosis for at undgå kramper i forbindelse med behandling med Tranexamsyre Pfizer.

Hvis De får langtidsbehandling med Tranexamsyre Pfizer, skal De være særligt opmærksom på

ændringer i farvesynet, og om nødvendigt skal behandlingen afbrydes. Under vedvarende

langtidsbehandling med Tranexamsyre Pfizer injektionsvæske er regelmæssige øjenundersøgelser

(herunder synsstyrke, farvesyn, fundus, synsfelt etc.) påkrævet. Hvis De får sygdomsforandringer i

øjet, især sygdomme i nethinden, skal lægen efter at have rådspurgt en specialist afgøre, om det er

nødvendigt, at De får langtidsbehandling med Tranexamsyre Pfizer injektionsvæske.

Brug af anden medicin sammen med Tranexamsyre Pfizer

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

for nylig.

De skal især fortælle det til lægen, hvis De tager:

anden medicin, der får blodet til at størkne, såkaldte antifibrinolytika

medicin, der forhindrer blodet i at størkne, såkaldte trombolytika

oral prævention (P-piller)

Graviditet og amning

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

De spørge Deres læge eller apotekspersonalet til råds, før De tager dette lægemiddel.

Tranexamsyre går over i mælken. Det frarådes at anvende Tranexamsyre Pfizer, hvis De ammer.

Trafik- og arbejdssikkerhed

Det er ikke undersøgt, om Tranexamsyre Pfizer påvirker evnen til at køre bil eller betjene maskiner.

3.

Sådan bliver De behandlet med Tranexamsyre Pfizer

Voksne

De vil få Tranexamsyre Pfizer injektionsvæske, som en langsom injektion i en blodåre.

Lægen vil bestemme Deres dosis, og hvor lang tid De skal behandles.

Brug til børn

Hvis Tranexamsyre Pfizer injektionsvæske gives til børn over 1 år, vil dosis blive udregnet efter

barnets vægt. Lægen vil bestemme den korrekte dosis, og hvor lang tid barnet skal behandles.

Ældre

Dosisnedsættelse er ikke nødvendig, medmindre der er tegn på nedsat nyrefunktion.

Nedsat nyrefunktion

Hvis De har nyreproblemer, vil dosis af tranexamsyre blive nedsat i henhold til resultatet af en

blodprøve (serumkreatinin).

Nedsat leverfunktion

Dosisnedsættelse er ikke nødvendig.

Administration

Tranexamsyre Pfizer må kun gives langsomt i en blodåre.

Tranexamsyre Pfizer må ikke indsprøjtes i en muskel.

Hvis De har fået for meget Tranexamsyre Pfizer

Hvis De har fået mere end den anbefalede dosis af Tranexamsyre Pfizer, kan De opleve forbigående

blodtryksfald. Kontakt straks læge eller sundhedspersonale.

4.

Bivirkninger

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

Følgende bivirkninger er set efter behandling med Tranexamsyre Pfizer:

Almindelige (det sker hos mellem 1 og 10 ud af 100 patienter)

Virkninger i maven og tarmene: kvalme, opkastning, diarré

Ikke almindelige (det sker hos mellem 1 og 10 ud af 1.000 patienter)

Virkninger på huden: udslæt

Ikke kendt (frekvensen kan ikke fastslås ud fra tilgængelige data)

Alment ubehag med lavt blodtryk (hypotension), især hvis injektionen bliver givet for hurtigt.

Blodpropper

Virkninger på nervesystemet: kramper

Virkninger på øjnene: synsforstyrrelser, herunder ændret farvesyn

Virkninger på immunsystemet: allergiske reaktioner

Indberetning af bivirkninger

Hvis De oplever bivirkninger, bør De tale med Deres læge eller apoteket. Dette gælder også mulige

bivirkninger, som ikke er medtaget i denne indlægsseddel. De eller Deres pårørende kan også

indberette bivirkninger direkte til Lægemiddelstyrelsen via de oplysninger, der fremgår herunder.

Lægemiddelstyrelsen

Axel Heides Gade 1

2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden

af dette lægemiddel.

5.

Opbevaring

Opbevar Tranexamsyre Pfizer utilgængeligt for børn.

Må ikke nedfryses.

Brug ikke Tranexamsyre Pfizer efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen

er den sidste dag i den nævnte måned.

Aflever altid medicinrester på apoteket. Af hensyn til miljøet må De ikke smide medicinrester i

afløbet, toilettet eller skraldespanden.

6.

Pakningsstørrelser og

yderligere oplysninger

Tranexamsyre Pfizer 100 mg/ml injektionsvæske, opløsning, til intravenøs anvendelse

indeholder:

Aktivt stof: Tranexamsyre

Øvrige indholdsstoffer: Vand til injektionsvæsker.

Udseende og pakningsstørrelser

Udseende

Type 1 glas ampul indeholdende en klar, farveløs opløsning.

Pakningsstørrelser

Pakninger med 5, 6 eller 10 ampuller (Type I glas) af 5 ml i en karton. Hver ampul indeholder 500 mg

tranexamsyre.

Pakninger med 10 ampuller (Type I glas) af 10 ml i en karton. Hver ampul indeholder 1000 mg

tranexamsyre.

Multipakning med 10 x 1 ampul (Type I glas) med 5 ml i en karton. Hver ampul indeholder 500 mg

tranexamsyre.

Multipakning med 10 x 1 ampul (Type I glas) med 10 ml i en karton, hver ampul indeholder 1000 mg

tranexamsyre.

Ikke alle pakningsstørrelser er nøvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller

Indehaveren af markedsføringstilladelsen

Pfizer ApS, Lautrupvang 8, 2750 Ballerup.

Fremstiller

Pfizer Manufacturing Belgium N.V., Rijksweg 12, 2870 Puurs, Belgien.

Dette lægemiddel er godkendt i EØS medlemslande under følgende navne:

Cyklokapron:

Belgien, Estland, Irland, Holland, Luxembourg, Tyskland, Norge, Sverige,

Storbritannien, Østrig

Tranexamsyre Pfizer:

Danmark, Island

Tranexamic acid ”Pfizer”: Storbritannien

Denne indlægsseddel blev sidst ændret april 2016.

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Inflectra (Pfizer Europe MA EEIG)

Inflectra (Pfizer Europe MA EEIG)

Inflectra (Active substance: Infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5206 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2778/T/64

Europe -DG Health and Food Safety

1-8-2018

Champix (Pfizer Europe MA EEIG)

Champix (Pfizer Europe MA EEIG)

Champix (Active substance: varenicline tartrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5197 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/699/T/71

Europe -DG Health and Food Safety

1-8-2018

Nimenrix (Pfizer Europe MA EEIG)

Nimenrix (Pfizer Europe MA EEIG)

Nimenrix (Active substance: Meningococcal group A, C, W-135 and Y conjugate vaccine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5220 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2226/T/80

Europe -DG Health and Food Safety

1-8-2018

Mylotarg (Pfizer Europe MA EEIG)

Mylotarg (Pfizer Europe MA EEIG)

Mylotarg (Active substance: gemtuzumab ozogamicin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5233 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4204/T/1

Europe -DG Health and Food Safety

1-8-2018

Pregabalin Pfizer (Pfizer Limited)

Pregabalin Pfizer (Pfizer Limited)

Pregabalin Pfizer (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5234 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3880/T/24

Europe -DG Health and Food Safety

1-8-2018

Tygacil (Pfizer Europe MA EEIG)

Tygacil (Pfizer Europe MA EEIG)

Tygacil (Active substance: Tigecycline) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5218 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/644/T/104

Europe -DG Health and Food Safety

30-7-2018

Besponsa (Pfizer Europe MA EEIG)

Besponsa (Pfizer Europe MA EEIG)

Besponsa (Active substance: inotuzumab ozogamicin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5104 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4119/T/7

Europe -DG Health and Food Safety

30-7-2018

Trazimera (Pfizer Europe MA EEIG)

Trazimera (Pfizer Europe MA EEIG)

Trazimera (Active substance: trastuzumab) - Centralised - Authorisation - Commission Decision (2018)5095 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4463

Europe -DG Health and Food Safety

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/13/1127 (Pfizer Europe MA EEIG)

EU/3/13/1127 (Pfizer Europe MA EEIG)

EU/3/13/1127 (Active substance: Inotuzumab ozogamicin) - Transfer of orphan designation - Commission Decision (2018)5046 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/194/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/06/401 (Pfizer Europe MA EEIG)

EU/3/06/401 (Pfizer Europe MA EEIG)

EU/3/06/401 (Active substance: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate) - Transfer of orphan designation - Commission Decision (2018)5038 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/06/T/03

Europe -DG Health and Food Safety

27-7-2018

EU/3/00/005 (Pfizer Europe MA EEIG)

EU/3/00/005 (Pfizer Europe MA EEIG)

EU/3/00/005 (Active substance: Gemtuzumab Ozogamicin) - Transfer of orphan designation - Commission Decision (2018)5037 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/022/00/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1066 (Pfizer Europe MA EEIG)

EU/3/12/1066 (Pfizer Europe MA EEIG)

EU/3/12/1066 (Active substance: tafamidis) - Transfer of orphan designation - Commission Decision (2018)5066 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/115/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/06/420 (Pfizer Europe MA EEIG)

EU/3/06/420 (Pfizer Europe MA EEIG)

EU/3/06/420 (Active substance: Temsirolimus) - Transfer of orphan designation - Commission Decision (2018)5065 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/058/06/T/02

Europe -DG Health and Food Safety