Difterivaccine "SSI"

Primær information

  • Handelsnavn:
  • Difterivaccine "SSI" 2 IE/dosis injektionsvæske, suspension, enkeltdosisbeholder
  • Dosering:
  • 2 IE/dosis
  • Lægemiddelform:
  • injektionsvæske, suspension, enkeltdosisbeholder
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Difterivaccine "SSI" 2 IE/dosis injektionsvæske, suspension, enkeltdosisbeholder
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Ikke markedsført
  • Autorisationsnummer:
  • 14830
  • Sidste ændring:
  • 02-02-2018

Indlægsseddel

Difterivaccine ”SSI”

Injektionsvæske, suspension,

enkeltdosisbeholder.

Difteritoksoid

Til REVACCINATION.

Læs denne indlægsseddel grundigt,

inden du/dit barn får vaccinen.

Gem indlægssedlen. Du kan få

brug for at læse den igen.

Spørg lægen, apotekspersonalet

eller sundhedspersonalet, hvis der

er mere, du vil vide.

Kontakt lægen, apotekspersonalet

eller sundhedspersonalet hvis en

bivirkning bliver værre, eller du

får bivirkninger, som ikke er

nævnt her. Se punkt 4.

S T A T E N S

S E R U M

I

N S T I

T U T

Oversigt over indlægssedlen:

1. Virkningen af Difterivaccine ”SSI” og hvad du får den

2. Det skal du vide, før du bliver vaccineret med

Difterivaccine ”SSI”

3. Sådan får du Difterivaccine ”SSI”

4. Bivirkninger

5. Opbevaring

6. Pakningsstørrelser og yderligere oplysninger

1. Virkningen af Difterivaccine ”SSI” og hvad du

får den for

Difterivaccine ”SSI” er en vaccine, som beskytter mod

difteri.

Difterivaccine ”SSI” virker ved at stimulere kroppen til at

danne antistoffer mod difteribakterier.

2. Det skal du vide, før du bliver vaccineret med

Difterivaccine ”SSI”

Du må ikke blive vaccineret med Difterivaccine ”SSI”

hvis:

du har haft alvorlige bivirkninger ved tidligere

vaccination med Difterivaccine ”SSI” eller en tilsvarende

vaccine.

du er allergisk over for difteritoksoid eller et af de øvrige

indholdsstoffer i Difterivaccine ”SSI” angivet i punkt 6.

Artillerivej 5

2300 København S

Danmark

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

Lægen eller sygeplejersken vil være ekstra forsigtig med

at vaccinere dig med Difterivaccine ”SSI”

hvis du:

er syg og har feber. Hvis du har feber kan det være, at

lægen udsætter vaccinationen.

har nedsat immunforsvar eller får medicin, som påvirker

immunforsvaret. Det er ikke sikkert, du danner nok

antistoffer til at beskytte dig mod difteri. Tal med lægen.

er overfølsom over for formaldehyd, skal du fortælle det

til lægen, inden du får vaccinen, da Difterivaccine ”SSI”

kan indeholde meget små mængder af formaldehyd.

Brug af anden medicin

Fortæl det altid til lægen, hvis du bruger anden medicin eller

har brugt det for nylig.

Du kan få andre vacciner samtidig, uden at det ændrer

virkningen af Difterivaccine ”SSI”.

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 bliver vaccineret

med Difterivaccine ”SSI”

Trafik- og arbejdssikkerhed

Difterivaccine ”SSI” påvirker ikke arbejdssikkerheden eller

evnen til at færdes sikkert i trafikken.

Vigtig information om nogle af de øvrige indholdsstoffer

i Difterivaccine ”SSI”

Difterivaccine ”SSI” indeholder mindre end 1 mmol

(23 mg) natrium pr. dosis, dvs. den er i det væsentlige

natriumfri.

3. Sådan får du Difterivaccine ”SSI”

Du vil normalt få Difterivaccine ”SSI” af en læge eller

sygeplejerske.

Du vil få indsprøjtningen i en muskel.

Dosis er 0,5 ml til børn og voksne.

Hvis du tidligere er blevet vaccineret med Difterivaccine

”SSI” får du kun 1 vaccination. Er du i tvivl, så spørg lægen

eller sygeplejersken.

Hvis du mangler at få en vaccination

Spørg lægen eller sygeplejersken, hvis du tror, at du

mangler at få en vaccination.

4. Bivirkninger

Difterivaccine ”SSI” kan som al anden medicin give bivirk-

ninger, men ikke alle får bivirkninger.

Følgende oplysninger er tiltænkt læger og

sundhedspersonale

Indikation

Revaccination af børn og voksne mod difteri.

Dosering

Dosis er 0,5 ml som gives intramuskulært.

Den samme vaccine anvendes til børn og voksne.

revaccination

gives 1 injektion til børn og voksne af

1 dosis (0,5 ml) sv.t. 6,25 Lf difteritoksoid.

Det nødvendige beredskab for behandling af alvorlige

allergiske reaktioner bør altid være til stede ved

vaccinationen.

Instruktioner vedrørende håndtering

Vaccinen omrystes kraftig før brug. Vaccinen skal efter

grundig omrystning være en farveløs eller lysegul

suspension af hvide eller grå partikler.

Alvorlige bivirkninger

Sjældne bivirkninger

(det sker hos mellem 1 og 10 ud af

10.000 vaccinerede)

Pludselige overfølsomhedsreaktioner (inden for minutter

til timer), f.eks. hududslæt, åndedrætsbesvær og besvimelse

(anafylaktisk reaktion). Kan være livsfarligt. Ring 112.

Ikke alvorlige bivirkninger

Almindelige bivirkninger

(det sker hos mellem 1 og 10 ud

af 100 vaccinerede)

Rødme, hævelse og ømhed, hvor du er blevet vaccineret.

Hovedpine, generel utilpashed og feber (38 °C eller

derover).

Tal med lægen eller sundhedspersonalet, hvis en bivirkning

bliver værre eller du får bivirkninger, som ikke er nævnt i

her.

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 indberetningsskema.

Ved at indrapportere bivirkninger kan du hjælpe med at

fremskaffe mere information om sikkerheden af dette

lægemiddel.

5. Opbevaring

Opbevar Difterivaccine ”SSI” utilgængeligt for børn.

Opbevar Difterivaccine ”SSI” i køleskab (2 °C – 8 °C).

Frys ikke Difterivaccine ”SSI”, og brug ikke

Difterivaccine ”SSI”, hvis den har været udsat for frost.

Brug ikke Difterivaccine ”SSI” efter den udløbsdato,

der står på pakningen efter EXP. Udløbsdatoen er den

sidste dag i den nævnte måned.

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

Difterivaccine ”SSI” indeholder

Aktivt indholdsstof:

Difteritoksoid 6,25 Lf/dosis.

Adsorberet til aluminiumhydroxidhydrat svarende til 0,5 mg

aluminium pr. dosis.

Øvrige indholdsstoffer:

Natriumchlorid, natriumhydroxid og vand til

injektionsvæsker.

Udseende og pakningsstørrelse

Vaccinen skal efter grundig omrystning være en farveløs

eller lysegul uklar væske med hvide eller grå partikler.

Difterivaccine ”SSI” leveres i hætteglas.

1 x 0,5 ml.

Indehaveren af markedsføringstilladelsen og fremstiller

Statens Serum Institut, Artillerivej 5, 2300 København S,

Danmark

Tlf.: +45 3268 3268

Fax: +45 3268 3973

E-mail: serum@ssi.dk

Denne indlægsseddel blev senest revideret 12/2014.

13-441-01

02/2015

Difterivaccine ”SSI” kan gives samtidig med andre

vacciner, men som en separat injektion.

Vaccinerester skal bortskaffes som klinisk risikoaffald i

henhold til det gældende kommunale affaldsdirektiv.

Opbevaring og holdbarhed

Opbevares i køleskab (2 °C – 8 °C). Må ikke fryses, eller

udsættes for frost. Vaccinen må ikke anvendes hvis den har

været frossen.

Anvend ikke vaccinen efter udløbsdatoen. Udløbsdatoen er

den sidste dag i den nævnte måned.

13-441-01

02/2015

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EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Active substance: Icatibant acetate) - Transfer of orphan designation - Commission Decision (2018)6432 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/054/02/T/01

Europe -DG Health and Food Safety

1-10-2018

Gefitinib Mylan (Mylan S.A.S.)

Gefitinib Mylan (Mylan S.A.S.)

Gefitinib Mylan (Active substance: gefitinib) - Centralised - Authorisation - Commission Decision (2018)6406 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4826

Europe -DG Health and Food Safety

30-9-2018

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Active substance: edoxaban) - PSUSA - Modification - Commission Decision (2018)5089 of Sun, 30 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10387/201710

Europe -DG Health and Food Safety

26-9-2018

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Active substance: pimobendan / benazepril) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6321 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2804/T/11

Europe -DG Health and Food Safety

26-9-2018

Comfortis (Elanco GmbH)

Comfortis (Elanco GmbH)

Comfortis (Active substance: Spinosad) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6323 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2233/T/18

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

25-9-2018

Udenyca (ERA Consulting GmbH)

Udenyca (ERA Consulting GmbH)

Udenyca (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6290 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004413/0000

Europe -DG Health and Food Safety

25-9-2018

Voriconazole Hikma (Hikma FarmacEutica (Portugal), S.A.)

Voriconazole Hikma (Hikma FarmacEutica (Portugal), S.A.)

Voriconazole Hikma (Active substance: voriconazole) - Centralised - Yearly update - Commission Decision (2018)6286 of Tue, 25 Sep 2018

Europe -DG Health and Food Safety

25-9-2018

Inovelon (Eisai GmbH)

Inovelon (Eisai GmbH)

Inovelon (Active substance: Rufinamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6283 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/660/T/48

Europe -DG Health and Food Safety

25-9-2018

Zonegran (Eisai GmbH)

Zonegran (Eisai GmbH)

Zonegran (Active substance: zonisamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6285 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/577/T/90

Europe -DG Health and Food Safety

25-9-2018

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (Active substance: melatonin) - Centralised - Authorisation - Commission Decision (2018)6223 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425

Europe -DG Health and Food Safety

25-9-2018

Brilique (AstraZeneca AB)

Brilique (AstraZeneca AB)

Brilique (Active substance: ticagrelor) - PSUSA - Modification - Commission Decision (2018)6282 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1241/PSUSA/2948/201712

Europe -DG Health and Food Safety

25-9-2018

Fycompa (Eisai GmbH)

Fycompa (Eisai GmbH)

Fycompa (Active substance: Perampanel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6280 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002434/T/0040

Europe -DG Health and Food Safety

25-9-2018

Opsumit (Janssen-Cilag International NV)

Opsumit (Janssen-Cilag International NV)

Opsumit (Active substance: macitentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6279 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002697/T/0028

Europe -DG Health and Food Safety

25-9-2018

Imfinzi (AstraZeneca AB)

Imfinzi (AstraZeneca AB)

Imfinzi (Active substance: durvalumab) - Centralised - Authorisation - Commission Decision (2018)6289 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004771/0000

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Kanuma (Alexion Europe SAS)

Kanuma (Alexion Europe SAS)

Kanuma (Active substance: sebelipase alfa) - Centralised - Yearly update - Commission Decision (2018)6245 of Mon, 24 Sep 2018

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

Renvela (Genzyme Europe B.V.)

Renvela (Genzyme Europe B.V.)

Renvela (Active substance: sevelamer (carbonate)) - Centralised - Variation - Commission Decision (2018)6225 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/993/X/39

Europe -DG Health and Food Safety

24-9-2018

Deferiprone Lipomed (Lipomed GmbH)

Deferiprone Lipomed (Lipomed GmbH)

Deferiprone Lipomed (Active substance: Deferiprone) - Centralised - Authorisation - Commission Decision (2018)6233 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4710

Europe -DG Health and Food Safety

24-9-2018

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6228 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

24-9-2018

Sevelamer carbonate Zentiva (Genzyme Europe B.V.)

Sevelamer carbonate Zentiva (Genzyme Europe B.V.)

Sevelamer carbonate Zentiva (Active substance: Sevelamer carbonate) - Centralised - Variation - Commission Decision (2018)6214 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3971/X/11

Europe -DG Health and Food Safety

24-9-2018

Rixathon (Sandoz GmbH)

Rixathon (Sandoz GmbH)

Rixathon (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6230 of Mon, 24 Sep 2018

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

Cinqaero (Teva B.V.)

Cinqaero (Teva B.V.)

Cinqaero (Active substance: reslizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6218 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3912T/18

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