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:
  • 48808
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Indlægsseddel: Information til patienten

Heparin LEO 5000 IE/ml

injektionsvæske, opløsning

Heparinnatrium

Læs denne indlægsseddel grundigt, inden

du begynder at få dette lægemiddel, da den

indeholder vigtige oplysninger.

– Gem indlægssedlen. Du kan få brug for at læse

den igen.

– Spørg lægen eller sundhedspersonalet, hvis der er

mere, du vil vide.

– Kontakt lægen eller sundhedspersonalet, hvis du

får bivirkninger, herunder bivirkninger, som ikke er

nævnt her. Se afsnit 4.

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. Pakningsstørrelser og

yderligere oplysninger

1. Virkning og anvendelse

Heparin LEO 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.

Du skal have Heparin LEO som

en indsprøjtning. Det vil normalt

være en læge eller sygeplejerske,

der giver dig indsprøjtningen.

2. Det skal du vide om

Heparin LEO

Lægen kan have foreskrevet

anden anvendelse end angivet

i denne information. Følg altid

lægens anvisning.

Du må ikke få Heparin LEO,

hvis du

– er allergisk over for

heparinnatrium eller et af

de øvrige indholdsstoffer

i Heparin LEO (angivet i

afsnit 6).

– har eller har haft for få

blodplader i blodet efter

behandling med heparin.

– har aktuel blødning eller

risiko for større blødning.

– har betændelse i hjertet

(septisk endocarditis).

– hvis du skal have lokal

bedøvelse.

Advarsler og

forsigtighedsregler

Lægen eller sundhedspersonalet

vil være ekstra forsigtig med at

behandle dig med Heparin LEO,

hvis du

– har risiko for blødning.

– har diabetes.

– har for meget kalium

i blodet eller tager

kaliumbesparende,

vanddrivende medicin.

– tager eller skal tage

blodfortyndende medicin

og anden medicin mod

blodpropper.

– nedsat nyrefunktion.

– tidligere har haft for meget

syre i blodet (metabolisk

acidose).

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.

06-2017

P047413-3

Så længe du er i behandling

med Heparin LEO vil din læge

rutinemæssigt tage blodprøver.

Børn

For tidligt fødte eller nyfødte

må ikke få Heparin LEO, da det

indeholder benzylalkohol.

Brug af anden medicin

sammen med Heparin LEO

Fortæl det altid til lægen eller

sundhedspersonalet, hvis du

tager anden medicin eller har

gjort det for nylig.

Tal med din læge, 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).

– medicin mod depression

(SSRI).

Graviditet og amning

Hvis du er gravid eller ammer,

har mistanke om, at du er

gravid, eller planlægger at blive

gravid, skal du spørge din læge

eller sundhedspersonalet til råds,

før du får dette lægemiddel.

Graviditet

Hvis du er gravid, må du kun få

Heparin LEO efter aftale med

lægen.

Amning

Du kan få Heparin LEO, selvom

du ammer.

Trafik- og arbejdssikkerhed

Heparin LEO påvirker ikke

eller kun i ubetydelig grad

arbejdssikkerheden eller evnen

til at færdes sikkert i trafikken.

Heparin LEO indeholder

methylparahydroxybenzoat,

propylparahydroxybenzoat,

benzylalkohol og natriumclorid

Heparin LEO indeholder

methylparahydroxybenzoat

(E 218) og

propylparahydroxybenzoat

(E 216), der kan give allergiske

reaktioner (kan optræde efter

behandlingen) og i sjældne

tilfælde åndedrætsbesvær

(bronkospasme).

Heparin LEO indeholder 10 mg

benzylalkohol pr. ml. For tidligt

fødte og nyfødte må ikke få

benzylalkohol. Benzylalkohol

kan give forgiftningsreaktioner

og allergiske reaktioner hos

spædbørn og børn op til 3 år.

Denne medicin indeholder

mindre end 1 mmol (23 mg)

natrium pr. 5 ml hætteglas,

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.

Se den nyeste indlægsseddel på www.indlaegsseddel.dk

En læge eller sygeplejerske

vil normalt give dig

indsprøjtningen.

Du vil få indsprøjtet Heparin LEO

i en blodåre.

Hvis du har mistanke om, at

du har fået for meget Heparin

LEO

Kontakt lægen eller

sundhedspersonalet, hvis du

har mistanke om, at du har

fået for meget Heparin LEO (og

du føler dig utilpas).

Du kan få blødninger, f.eks.

fra slimhinder, sår på huden,

fra mavetarmkanalen og

underlivet, hvis du får for

meget Heparin LEO.

Hvis en dosis af Heparin LEO

er glemt

Da du vil få dette lægemiddel

under tæt medicinsk

overvågning, er det ikke

sandsynligt, at en dosis vil blive

glemt.

Hvis behandlingen med

Heparin LEO bliver stoppet

Spørg lægen eller

sundhedspersonalet, hvis der er

noget, du er i tvivl om.

4. Bivirkninger

Dette lægemiddel kan som al

anden medicin give bivirkninger,

men ikke alle får bivirkninger.

Hvis du får alvorlige bivirkninger,

skal du straks kontakte lægen

eller sundhedspersonalet.

Almindelige bivirkninger:

(det sker hos mellem 1 og 10 ud

af 100 behandlede).

• Blodansamling ved stedet for

indsprøjtning.

• Blødninger (kan påvirke alle

organer).

• Rødme af huden (erythem).

Ikke almindelige bivirkninger:

(det sker hos mellem 1 og 10 ud

af 1.000 behandlede):

• Forskellige former for

hududslæt.

• Nældefeber (urticaria).

• Kløe (pruritus).

• Øget risiko for knoglebrud

pga. knogleskørhed

(osteoporose) ved

længerevarende behandling.

Kan udvikle sig til en alvorlig

bivirkning. Kontakt lægen,

hvis du får pludselige smerter

i ryggen.

• Blødning fra hud og slimhin-

der pga. forandringer i blodet

(for få blodplader). Kontakt

læge eller skadestue.

• Forandringer i huden med sår

og vævsdød (hudnekrose).

• Pludseligt hududslæt, ånde-

drætsbesvær og besvimelse

(inden for minutter til timer)

pga. overfølsomhed

(anafylaktisk reaktion). Kan

være livsfarligt. Ring 112.

• Overfølsomhedsreaktioner.

• Irritation og smerter ved

stedet for indsprøjtning.

• Muskelsvaghed, forvirring

og talebesvær pga. for højt

kalium i blodet.

• Vedvarende, smertefuld

rejsning af penis (priapisme).

Kontakt læge eller skadestue.

Sjældne bivirkninger: (det sker

hos mellem 1 og 10.000 ud af

1000 behandlede).

• 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 bevidsthedssvækkelse

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.

Heparin LEO kan herudover

give bivirkninger, som du

normalt ikke mærker noget til.

Det drejer sig om ændringer

i visse laboratorieprøver,

f.eks. blodprøver herunder

leverfunktion, som igen bliver

normale, når behandlingen

ophører.

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 via

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

Ved at indrapportere bivirkninger

kan du hjælpe med at

fremskaffe mere information om

sikkerheden af dette lægemiddel.

5. Opbevaring

Opbevar Heparin LEO

utilgængeligt for børn.

Heparin LEO må ikke opbevares

over 25 °C.

Brug ikke Heparin LEO efter

den udløbsdato, der står på

pakningen efter EXP.

Udløbsdatoen er den sidste dag i

den nævnte måned.

Brug ikke Heparin LEO, hvis

der er uklarheder eller synlige

partikler i hætteglasset.

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

Heparin LEO indeholder:

– Aktivt stof: Heparinnatrium.

1 ml injektionsvæske,

opløsning indeholder 5000 IE

heparinnatrium.

– Øvrige indholdsstoffer:

Natriumchlorid,

natriumcitrat, benzylalkohol,

methylparahydroxybenzoat

(E218),

propylparahydroxybenzoat

(E 216), fortyndet saltsyre og

vand til injektionsvæsker.

Udseende og

pakningsstørrelser

Udseende

Heparin LEO er en klar, farveløs

eller gul væske, fri for uklarhed

og synlige partikler, i hætteglas

med 5 ml.

Pakningsstørrelser

Heparin LEO er i pakninger med

5 hætteglas med 5 ml.

Indehaver af

markedsføringstilladelsen og

fremstiller:

2care4

Tømrervej 9

6710 Esbjerg V

Denne indlægsseddel blev

senest ændret juni 2017.

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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