Heparin "LEO"

Primær information

  • Handelsnavn:
  • Heparin "LEO" 5.000 IE/ml injektionsvæske, opløsning
  • Dosering:
  • 5.000 IE/ml
  • Lægemiddelform:
  • injektionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Heparin "LEO" 5.000 IE/ml injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 51060
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

Heparin LEO 5.000 IE/ml, injektionsvæske, opløsning

Heparinnatrium

Læs denne indlægsseddel

grundigt, inden du begynder at

tage medicinen.

Gem indlægssedlen. Du kan få

brug for at læse den igen.

Spørg lægen eller

sundhedspersonalet, hvis der er

mere, du vil vide.

Tal med lægen eller sundheds-

personalet, hvis en bivirkning bliver

værre, eller hvis du får bivirkninger,

som ikke er nævnt her.

Oversigt over indlægssedlen

1. Virkning og anvendelse

2. Det skal du vide om Heparin LEO

3. Sådan bliver du behandlet med

Heparin LEO

4. Bivirkninger

5. Opbevaring

6. Yderligere oplysninger

1. VIRKNING OG ANVENDELSE

Heparin forhindrer, at der dannes

blodpropper i pulsårer og blodårer

(vener) ved at nedsætte blodets evne

til at størkne. Heparin LEO kan også

opløse nogle former for blodpropper.

Blodpropper opstår især i forbindelse

med operationer og længere tids

sengeleje.

Du kan få Heparin LEO til

forebyggelse og behandling af

blodpropper.

Lægen kan give dig Heparin LEO for

noget andet. Spørg lægen.

2. DET SKAL DU VIDE OM

HEPARIN LEO

Du må ikke få Heparin LEO, hvis du

er overfølsom over for

heparinnatrium eller et af de øvrige

indholdsstoffer

har eller har haft for få blodplader i

blodet efter behandling med

heparin

er gravid og skal have rygmarvs-

bedøvelse (epidural) under fødslen

har stor risiko for blødning. Det kan

være, hvis du

har mavesår

har hjerneblødning

har betændelse i

hjerteklapperne

er gravid og har stor risiko for

abort

har forstyrrelser i blodets evne til

at størkne

skal opereres i øjne, ører eller

centralnervesystemet

har meget forhøjet blodtryk

har meget dårlig lever

Fortæl lægen at du er i behandling

med Heparin LEO, hvis du skal have

en lokalbedøvelse.

For tidligt fødte eller nyfødte må ikke

få Heparin LEO, da det indeholder

benzylalkohol.

Lægen eller sundhedspersonalet

vil være ekstra forsigtig med at

behandle dig med Heparin LEO

Tal med lægen, inden du får Heparin

LEO, hvis du

har forhøjet blodtryk

har dårlig lever eller nyrer

har for få blodplader i blodet

har diabetes

har haft tilfælde af for meget syre i

blodet (metabolisk acidose)

har for meget kalium i blodet eller

tager kaliumbesparende,

vanddrivende medicin

tager eller skal tage

blodfortyndende medicin og anden

medicin mod blodpropper

Kontakt straks læge eller

sundhedspersonale, hvis du har fået

rygmarvsbedøvelse og får rygsmerter

eller følelsesløshed, stivhed eller

svaghed i benene og får problemer

med tarm- og blærefunktion.

Oplys altid ved blodprøvekontrol og

urinprøvekontrol, at du er i behandling

med Heparin LEO. Det kan påvirke

prøveresultaterne.

Så længe du er i behandling med

Heparin LEO vil din læge

rutinemæssigt tage blodprøver.

Brug af anden medicin

Fortæl altid lægen eller sundheds-

personalet, hvis du bruger anden

medicin eller har brugt det for nyligt.

Det gælder også medicin, som ikke er

købt på recept, medicin købt i

udlandet, naturlægemidler, stærke

vitaminer og mineraler samt

kosttilskud.

Tal med lægen, hvis du tager:

Medicin mod gigt eller smerter

(f.eks. acetylsalicylsyre, NSAID).

Blodfortyndende medicin (f.eks.

warfarin).

Anden medicin til forebyggelse og

behandling af blodpropper.

Medicin mod alvorlig blodforgiftning

(aktiveret protein C).

Graviditet og amning

Spørg din læge eller apoteket til råds,

før du tager nogen form for medicin.

Graviditet

Du må ikke få Heparin LEO, hvis du

er gravid. Det indeholder

benzylalkohol, der kan skade fostret.

Husk at informere lægen.

Amning

Du kan få Heparin LEO, selvom du

ammer.

Trafik- og arbejdssikkerhed

Heparin LEO påvirker ikke arbejds-

sikkerheden eller evnen til at færdes

sikkert i trafikken.

Vigtig information om nogle af de

øvrige indholdsstoffer i Heparin

LEO

Indeholder 10 mg benzylalkohol pr.

ml. For tidligt fødte og nyfødte må

ikke få benzylalkohol. Benzyl-

alkohol kan give forgiftnings-

reaktioner og allergiske reaktioner

hos spædbørn og børn op til 3 år.

Indeholder methylparahydroxy-

benzoat (E218) og propylpara-

hydroxybenzoat (E216), der kan

give allergiske reaktioner (kan

optræde efter behandlingen) og i

sjældne tilfælde åndedrætsbesvær.

Denne medicin indeholder mindre

end 1 mmol (22 mg) natrium pr.

dosis, dvs. den er i det væsentlige

natriumfri.

3. SÅDAN BLIVER DU BEHANDLET

MED HEPARIN LEO

Lægen kan fortælle dig, hvilken dosis

du får og hvor tit, du skal have den.

Er du i tvivl, så spørg lægen eller

sundhedspersonalet. Det er kun

lægen, der kan ændre dosis.

En læge eller sygeplejerske vil

normalt give dig indsprøjtningen.

Du vil få indsprøjtet Heparin LEO i en

blodåre.

Heparin LEO må aldrig sprøjtes ind i

en muskel.

Hvis du har fået for meget Heparin

LEO

Kontakt læge eller sundheds-

personalet, hvis du tror du har fået for

meget Heparin LEO.

Du kan få blødninger, f.eks. fra

slimhinder, sår på huden, fra

mavetarmkanalen og underlivet, hvis

du får for meget Heparin LEO.

Heparin LEO, 1. udgave

Senest revideret marts 2013

Hvis en dosis er glemt

Spørg lægen eller sundheds-

personalet, hvis du tror, at du mangler

at få en dosis.

Hvis behandlingen bliver stoppet

Spørg lægen eller sundheds-

personalet, hvis der er noget du er i

tvivl om.

4. BIVIRKNINGER

Heparin LEO kan, som al anden

medicin, give bivirkninger, men ikke

alle får bivirkninger.

Alvorlige bivirkninger

Almindelige bivirkninger (forekommer

hos mellem 1 og 10 ud af 100

patienter):

Blødning fra hud og slimhinder og

blå mærker pga. forandringer i

blodet (for få blodplader). Kontakt

læge eller skadestue.

Blødninger i indre organer, hjerne,

øjne, ører. Kontakt straks læge

eller skadestue. Ring evt. 112.

Sjældne bivirkninger (forekommer

hos mellem 1 og 10 ud af 10.000

patienter):

Blødning fra hud og slimhinder og

blå mærker pga. forandringer i

blodet (for få blodplader), evt.

blodpropper. Kontakt læge eller

skadestue. Ring evt. 112.

Mangel på hormonet aldosteron.

Symptomerne er:

Hovedpine, træthed, kvalme og

opkastninger pga. for meget

syre i blodet (specielt hvis du har

diabetes eller dårlige nyrer). I

alvorlige tilfælde bevidstheds-

svækkelse med dyb og hurtig

vejrtrækning. Kontakt straks

læge eller skadestue. Ring evt.

112.

Muskelsvaghed, forvirring,

talebesvær pga. for meget

kalium i blodet. For meget

kalium i blodet kan i meget

sjældne tilfælde blive alvorlig

med lammelser og forstyrrelser i

hjertets rytme (risiko for

hjertestop). Tal med lægen.

Meget sjældne bivirkninger

(forekommer hos færre end 1 ud af

10.000 patienter):

Rygsmerter, lammelser og

føleforstyrrelser i benene samt

vandladningsbesvær pga.

blodansamling i rygraden eller

omkring rygmarven ved samtidig

brug af rygmarvsbedøvelse.

Kontakt læge eller skadestue.

Pludseligt hududslæt,

åndedrætsbesvær og besvimelse

(inden for minutter til timer) pga.

overfølsomhed (anafylaktisk

reaktion/shock). Kan være

livsfarligt. Ring 112.

Vedvarende, smertefuld rejsning af

penis. Kontakt læge eller

skadestue.

Ikke alvorlige bivirkninger

Almindelige bivirkninger (forekommer

hos mellem 1 og 10 ud af 100

patienter):

Irritation, smerter og blodansamling

ved stedet for indsprøjtning.

Ikke Almindelige bivirkninger

(forekommer hos mellem 1 og 10 ud

af 1.000 patienter):

Hududslæt, nældefeber og kløe.

Efter langvarig behandling kan der

opstå øget risiko for knoglebrud

pga. knogleskørhed. Kan udvikle

sig til en alvorlig bivirkning. Kontakt

lægen, hvis du får pludselige

smerter i ryggen.

Sjældne bivirkninger (forekommer

hos mellem 1 og 10 ud af 10.000

patienter):

Forandringer i huden med sår og

vævsdød.

Overfølsomhedsreaktioner.

Meget sjældne bivirkninger

(forekommer hos færre end 1 ud af

10.000 patienter):

Feber, udslæt i ansigt og på arme

og ben.

Bivirkninger, hvor hyppigheden ikke

er kendt:

Forbigående hårtab ved langtids-

behandling med Heparin LEO.

Heparin LEO kan herudover give

bivirkninger, som du normalt ikke

mærker noget til. Det drejer sig om

ændringer i visse laboratorieprøver,

f.eks. blodprøver, urinprøver etc.

herunder leverfunktion, som igen

bliver normale, når behandlingen

ophører.

Indberetning af bivirkninger til

sundhedsstyrelsen

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

sundhedsstyrelsen på

www.meldenbivirkning.dk, eller ved at

kontakte sundhedsstyrelsen via mail,

med almindeligt brev eller telefonisk

for at rekvirere et indberetnings-

skema.

Ved at indrapportere bivirkninger kan

du hjælpe med at fremskaffe mere

information om sikkerheden af dette

lægemiddel.

5. OPBEVARING

Heparin LEO skal opbevares

utilgængeligt for børn.

Opbevar ikke Heparin LEO ved

temperaturer over 25 °C.

Brug ikke Heparin LEO efter den

udløbsdato, der står på pakningen.

Brug ikke Heparin LEO, hvis der er

uklarheder eller synlige partikler i

hætteglasset.

Aflever altid medicinrester på

apoteket. Af hensyn til miljøet må du

ikke smide medicinrester i afløbet,

toilettet eller skraldespanden.

6. YDERLIGERE OPLYSNINGER

Heparin LEO 5.000 IE/ml,

injektionsvæske, opløsning

indeholder:

Aktivt stof: Heparinnatrium.

Øvrige indholdsstoffer:

Natriumchlorid, natriumcitratdihydrat,

benzylalkohol, methylparahydroxy-

benzoat (E218), propylparahydroxy-

benzoat (E216), fortyndet saltsyre og

vand til injektionsvæsker.

Udseende og pakningsstørrelser

Heparin LEO er en klar, farveløs eller

gul væske, fri for uklarhed og synlige

partikler, i hætteglas med 5 ml.

Heparin LEO er i pakninger med 5

hætteglas med 5 ml.

Indehaver af markedsførings-

tilladelsen

EuroPharmaDK

Oddesundvej 39

6715 Esbjerg N.

Ompakket og frigivet af

EuroPharmaDK

Oddesundvej 39

6715 Esbjerg N.

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Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Active substance: Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)3394 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/18

Europe -DG Health and Food Safety

29-5-2018

EU/3/15/1453 (Roche Registration GmbH)

EU/3/15/1453 (Roche Registration GmbH)

EU/3/15/1453 (Active substance: Chimeric 2'-O-(2-methoxyethyl) modified oligonucleotide targeted to huntingtin RNA) - Transfer of orphan designation - Commission Decision (2018)3401 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/256/14/T/01

Europe -DG Health and Food Safety

29-5-2018

EU/3/11/857 (Alnylam Netherlands B.V.)

EU/3/11/857 (Alnylam Netherlands B.V.)

EU/3/11/857 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against transthyretin mRNA) - Transfer of orphan designation - Commission Decision (2018)3398 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/142/10/T/02

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3148 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/041/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3147 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/039/14/T/01

Europe -DG Health and Food Safety

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Active substance: Volanesorsen sodium) - Transfer of orphan designation - Commission Decision (2018)1822 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/082/16/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1671 (IQVIA RDS Ireland Limited)

EU/3/16/1671 (IQVIA RDS Ireland Limited)

EU/3/16/1671 (Active substance: 2'-O-(2-methoxyethyl)phosphorothioate antisense oligonucleotide targeting the growth hormone receptor) - Transfer of orphan designation - Commission Decision (2018)1821 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/023/16/T/01

Europe -DG Health and Food Safety