Typhim VI
Primær information
- Handelsnavn:
- Typhim VI injektionsvæske, opløsning
- Aktiv bestanddel:
- Salmonella typhi Ty2 Vi kapselpolysaccharid
- Tilgængelig fra:
- Sanofi Pasteur Europe
- ATC-kode:
- J07AP03
- INN (International Name):
- Salmonella typhi Ty2 We capsule polysaccharide
- Lægemiddelform:
- injektionsvæske, opløsning
- Brugt til:
- Mennesker
- Medicin typen:
- Allopatiske stof
Dokumenter
- for den brede offentlighed:
- Indlægsseddel
-
- for sundhedspersonale:
- Produktresumé
-
Lokation
- Fås i:
-
Danmark
- Sprog:
- dansk
Andre oplysninger
Status
- Kilde:
- Lægemiddelstyrelsen - Danish Medicines Agency
- Autorisation status:
- Markedsført
- Autorisationsnummer:
- 14739
- Sidste ændring:
- 24-02-2018
Indlægsseddel
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
Typhim Vi, 25 mikrogram/dosis, injektionsvæske, opløsning
Tyfoid polysaccharid vaccine
Læs denne indlægsseddel grundigt, inden du begynder at bruge denne vaccine, da den
indeholder vigtige oplysninger.
Gem indlægssedlen. Du kan få brug for at læse den igen.
Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
Lægen har ordineret Typhim Vi til dig personligt. Lad derfor være med at give Typhim Vi til
andre. Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har.
Kontakt lægen, apotekspersonalet eller sundhedspersonalet , hvis en bivirkning bliver værre,
eller du får bivirkninger, som ikke er nævnt her. Se punkt 4.
Oversigt over indlægssedlen:
Virkning og anvendelse
Det skal du vide, før du begynder at bruge Typhim Vi
Sådan skal du bruge Typhim Vi
Bivirkninger
Opbevaring
Pakningsstørrelser og yderligere oplysninger
1
VIRKNING OG ANVENDELSE
Typhim Vi er en vaccine. Vacciner bruges til at beskytte mod infektionssygdomme.
Typhim Vi hjælper med at beskytte dig eller dit barn, der er 2 år eller ældre mod tyfoid feber.
Vigtigt
Typhim Vi vil kun hjælpe til forebyggelse af denne sygdom, hvis den er forårsaget af den samme
bakterie, som er anvendt til produktionen af vaccinen. Du, eller dit barn, kan stadig få
infektionssygdomme, hvis de er forårsaget af andre bakterier.
2
DET SKAL DU VIDE, FØR DU BEGYNDER AT BRUGE TYPHIM VI
Brug ikke Typhim Vi hvis du, eller dit barn:
er overfølsom (allergisk) over for:
det aktive stof, eller et af de øvrige indholdsstoffer (se afsnit 6)
andre vacciner, der indeholder nogle af de stoffer, som er vist i afsnit 6
har høj feber eller en akut sygdom. Vaccination med Typhim Vi skal udsættes, til du eller dit
barn er blevet rask.
Vær ekstra forsigtig med at bruge Typhim Vi
Fortæl det til lægen, før vaccination, hvis:
Du eller dit barn er overfølsom (allergisk) over for formaldehyd. Dette skyldes, at dette stof er
anvendt under produktionen af Typhim Vi, og der stadig kan være upåviselige spor af dette stof
i vaccinen;
Du eller dit barn har problemer med immunsystemet, eller du eller dit barn modtager
immunundertrykkende behandling. Det anbefales at udsætte vaccinationen indtil ophør af en
sådan sygdom eller behandling. Indgivelse af Typhim Vi til personer, der har kroniske
problemer med deres immunsystem (herunder HIV-infektion) anbefales, men immunitet mod
infektioner efter modtagelse af vaccinen, er muligvis ikke så god som hos personer med god
immunitet over for infektioner;
Du eller dit barn har thrombocytopeni (mangel på blodplader) eller en blødningsforstyrrelse
(såsom hæmofili), fordi du eller dit barn kan bløde ved injektionsstedet.
Besvimelse kan opstå (hovedsageligt hos helt unge) efter, eller endda før, en injektion med en kanyle.
Fortæl det derfor til din læge eller sygeplejerske, hvis du eller dit barn besvimede i forbindelse med
en tidligere injektion.
Brug af anden medicin
Typhim Vi kan gives samtidig med andre almindelige vacciner: gul feber, difteri, stivkrampe, polio,
rabies fremstillet på Vero-celler, meningitis A+C, Hepatitis A og Hepatitis B.
Din læge eller sygeplejerske vil give de to injektioner på forskellige injektionssteder, og vil anvende
separate injektionssprøjter til hver injektion.
Fortæl det altid til lægen, sygeplejersken eller apoteket, hvis du eller dit barn bruger anden medicin
eller har brugt det for nylig. Dette gælder også medicin, som ikke er købt på recept.
Spørg din læge/sygeplejerske eller apoteket, hvis der er noget du ikke forstår.
Graviditet og amning
Typhim Vi må kun anvendes til gravide kvinder hvis det er absolut nødvendigt, og efter en vurdering
af risikoen for fosteret over for fordelene for moderen.
Da det ikke vides, om vaccinen udskilles i modermælken, skal der udvises forsigtighed ved
vaccination af ammende mødre med Typhim Vi.
Trafik- og arbejdssikkerhed
Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene
maskiner.
Vigtig information om nogle af de øvrige indholdsstoffer i Typhim Vi
Typhim Vi indeholder mindre end 1 mmol (22 mg) natrium pr. dosis, dvs. den er i det væsentlige
natriumfri.
Typhim Vi kan indeholde små mængder formaldehyd. Hvis De er overfølsom over for formaldehyd,
skal De fortælle det til lægen, inden De får vaccinen.
3
SÅDAN SKAL DU BRUGE TYPHIM VI
Dosering
Voksne og børn fra 2 år modtager én 0,5 ml dosis.
Børn under 2 år: som med andre polysakkaride vacciner, kan antistofresponset være mangelfuldt hos
børn under 2 år.
Hvis personen stadig er risikoudsat, bør revaccination udføres med et maksimalt interval på 3 år.
Vaccination bør udføres mindst 2 uger før en mulig udsættelse for infektion med
Salmonella typhi
Indgivelsesmåde og -vej
Typhim Vi indgives som en injektion i musklen eller dybt under huden.
4
BIVIRKNINGER
Typhim Vi kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
I kliniske undersøgelser var de hyppigst indberettede bivirkninger efter vaccination med TYPHIM Vi
milde reaktioner på injektionsstedet (smerte ved injektionsstedet, forhærdning eller rødme ved
injektionsstedet, eller feber). Disse blev normalt set inden for 48 timer efter vaccination, og ophørte
efter 2 dage.
Data efter markedsføring
Følgende yderligere bivirkninger er indberettet, baseret på spontane indberetninger, under kommerciel
anvendelse af TYPHIM Vi. Disse hændelser blev indberettet meget sjældent. Den præcise hyppighed
for forekomsten kan dog ikke beregnes.
Immunsystemet
Anafylaktiske reaktioner, serumsyge, anafylaktisk shock
Nervesystemet
Hovedpine
Besvimelse som reaksjon på injeksjon
Luftveje, thorax og mediastinum
Astma.
Mave-tarmkanalen
Kvalme, opkastning, diarré, mavesmerter.
Hud og subkutane væv
Allergiske reaktioner såsom kløe, udslæt, nældefeber.
Knogler, led, muskler og bindevæv
Arthralgi, myalgi.
Almene symptomer og reaktioner på administrationsstedet
Træthed, utilpashed
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 Sundhedsstyrelsen via
Sundhedsstyrelsen
Axel Heides Gade 1
DK-2300 København S
Websted: www.meldenbivirkning.dk
E-mail: sst@sst.dk
Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden
af dette lægemiddel.
5
OPBEVARING
Opbevar Typhim Vi utilgængeligt for børn.
Opbevar Typhim Vi i køleskab (2
C). Må ikke nedfryses. Opbevar Typhim Vi i original
emballage, da det er følsomt for lys.
Brug ikke Typhim Vi efter den udløbsdato, der står på pakningen efter ”EXP”. Udløbsdatoen er den
sidste dag i den nævnte måned.
Spørg på apoteket, hvordan du skal aflevere medicinrester. Af hensyn til miljøet må du ikke smide
medicinrester i afløbet, toilettet eller skraldespanden.
6
PAKNINGSSTØRRELSER OG YDERLIGERE OPLYSNINGER
Typhim Vi, indeholder:
Aktivt stof:
Renset Vi kapsel-polysaccharid fra
Salmonella typhi
Ty2 stamme
) – 0,025 mg per 0,5 ml dosis.
Øvrige indholdsstoffer:
Phenol, natriumchlorid, dinatriumphosphat, mononatriumphosphat og vand til injektion.
Typhim Vis udseende og pakningstørrelser
Pakningsstørrelser
Hætteglas med prop.
Injektionssprøjte med påsat kanyle.
Injektionssprøjte uden kanyle.
Injektionssprøjte med en eller to separate kanyler (til hver sprøjte).
Pakninger med 1 eller 10 stk.
Ikke alle pakningsstørrelser er nødvendigvis markedsført.
Indehaveren af markedsføringstilladelsen og fremstiller
Indehaveren af markedsføringstilladelsen
Sanofi Pasteur MSD
Airport Plaza
Building Montreal
Leonardo da Vincilaan 19
B-1831 Diegem
Belgien
Fremstiller
Sanofi Pasteur,
58 Avenue Leclerc,
F-69006 Lyon,
Frankrig
Denne indlægsseddel blev sidst revideret 25/06/2015
Følgende oplysninger er kun til læger og sundhedspersonale:
Som ved enhver vaccine skal relevant medicinsk behandling og overvågning være umiddelbart
tilgængelig i tilfælde af sjældne anafylaktiske reaktioner eller alvorlige allergiske reaktioner efter
injektion af vaccinen. Som en sikkerhedsmæssig forholdsregel, skal epinephrininjektion (1:1000)
være umiddelbart tilgængelig i tilfælde af uventede anafylaktiske eller alvorlige allergiske reaktioner.
Før injektion af et biologisk produkt, skal den person, der er ansvarlig for injektionen tage alle
forholdsregler til forebyggelse af allergiske eller andre former for reaktioner.
Må ikke indgives som intravaskulær injektion: sørg for at kanylen ikke gennemtrænger et blodkar.
Som ved enhver injektionsvaccine skal vaccinen gives med forsigtighed til personer med
trombocytopeni eller blødningsforstyrrelser, da der kan forekomme blødning efter intramuskulær
injektion hos sådanne personer.
Vaccinen skal bringes til stuetemperatur før anvendelse.
I tilfælde af injektionssprøjter uden kanyle skal kanylen påsættes på enden af den fyldte
injektionssprøjte og derefter drejes 90 grader.
Omrystes umiddelbart før injektion.
Vaccinen må ikke blandes med andre lægemiddelpræparater i samme injektionssprøjte.
Se også afsnit 3. SÅDAN SKAL DU BRUGE Typhim Vi
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Raws For Paws Recalls Turkey Pet Food Because of Possible Salmonella Health Risk
Raws for Paws of Minneapolis, MN is recalling approximately 4,000 pounds of its 5 lb. and 1 lb. chubs of Ground Turkey Pet Food because they have the potential to be contaminated with Salmonella. Salmonella can affect animals eating the product and there is risk to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
FDA - U.S. Food and Drug Administration
8-2-2018

Smokehouse Pet Products Inc Recalls Limited Lots of “Beefy Munchies” Sold Regionally Because of Possible Salmonella Contamination
Smokehouse Pet Products, Inc. of Sun Valley, CA is recalling 4-oz bags of dog treats labeled as “Beefy Munchies,” because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
FDA - U.S. Food and Drug Administration
24-1-2018

"Zero For Him" Dietary Supplement by Break Ventures/California Basics: Recall - Possible Salmonella Contamination
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
FDA - U.S. Food and Drug Administration
24-1-2018

Arthri-D 120ct Dietary Supplement by Arthri-D: Recall - Possible Salmonella Contamination
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
FDA - U.S. Food and Drug Administration
21-1-2018

Break Ventures/California Basics Recalls "Zero For Him" 150ct Lot#1710-638 Because of Possible Health Risk
Break Ventures/California Basics is recalling its Dietary Supplement "Zero for Him 150ct" Lot#1710-638(the "Product") because it may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
FDA - U.S. Food and Drug Administration
21-1-2018

Arthri-D, LLC Recalls Arthri-D Lot#1701-092 Because of Possible Health Risk
Arthri-D, LLC is recalling its Dietary Supplement "Arthri-D 120ct" Lot#1701-092 (the "Product") because it may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
FDA - U.S. Food and Drug Administration
4-1-2018

Evershing International Trading Company Recalls Frozen Shredded Coconut Because of Possible Health Risk
Evershing International Trading Company is recalling 16 ounces Coconut Tree Brand Frozen Shredded Coconut because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune system. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella c...
FDA - U.S. Food and Drug Administration
25-10-2017

Relish Foods, Inc. Recalls Frozen Tuna Loins Because of Possible Health Risk
On October 13, 2017, Relish Foods, Inc. of Culver City, Calif., voluntarily initiated the recall of frozen Newport brand 5 to 8 lb. tuna loins. The recall has since expanded to include: 3 to 5 lb. tuna loins, 6 oz. tuna steaks, and 4 oz. tuna steaks. The recall is the result of sampling by the FDA which revealed that the product has potential to contain the bacteria Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with w...
FDA - U.S. Food and Drug Administration
17-10-2017

Orphan designation: Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2, for the: Treatment of glioma
Europe - EMA - European Medicines Agency
12-9-2017

Bravo Produce Inc. Retira Maradol Papaya de Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre SPR de RL y empacadas por Frutas Selectas de Tijuana, S. de R.L. de C.V. Por posible riesgo a la salud
Bravo Produce Inc de San Ysidro, está retirando Maradol Papaya, cultivadas por Productores y Exportadores de Carica Papaya de Tecoman y Costa Alegre SPR de RL y empacadas por Frutas Selectas de Tijuana, S. de R.L. de C.V., como manera preventiva, debido a que dicho producto ha probado positivo para Salmonella, es de suma importancia mencionar que dicha bacteria puede afectar a niños, ancianos y personas con sistemas inmunológicos débiles. Los síntomas a experimentar son fiebre, diarrea, náusea, vóm...
FDA - U.S. Food and Drug Administration
7-8-2017

Freshtex Produce Recalls “Valery” Brand Maradol Papayas Due to Possible Health Risk
Freshtex Produce of Alamo, TX is voluntarily recalling “Valery” brand Maradol Papayas grown and packed by Carica de Campeche, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection...
FDA - U.S. Food and Drug Administration
2-8-2017

Grande Produce emite retiro voulantrio del mercado de una cantidad limitada de Papaya "Caribeña" por un potencial de riesgo contra la salud.”
Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.
FDA - U.S. Food and Drug Administration
17-4-2018

Company Recalls More Than 200 Million Eggs Due to Salmonella Scare
Title: Company Recalls More Than 200 Million Eggs Due to Salmonella ScareCategory: Health NewsCreated: 4/15/2018 12:00:00 AMLast Editorial Review: 4/16/2018 12:00:00 AM
US - MedicineNet
10-4-2018

Kratom-Linked Salmonella Outbreak Widens: CDC
Title: Kratom-Linked Salmonella Outbreak Widens: CDCCategory: Health NewsCreated: 4/6/2018 12:00:00 AMLast Editorial Review: 4/9/2018 12:00:00 AM
US - MedicineNet
5-4-2018

FDA Recalls Kratom Products Due to Salmonella Threat
Title: FDA Recalls Kratom Products Due to Salmonella ThreatCategory: Health NewsCreated: 4/3/2018 12:00:00 AMLast Editorial Review: 4/4/2018 12:00:00 AM
US - MedicineNet
17-3-2018

Kratom-Linked Salmonella Outbreak Expands: CDC
Title: Kratom-Linked Salmonella Outbreak Expands: CDCCategory: Health NewsCreated: 3/16/2018 12:00:00 AMLast Editorial Review: 3/16/2018 12:00:00 AM
US - MedicineNet
13-3-2018

Salmonella Cases Linked to Chicken Salad Now Total 170
Title: Salmonella Cases Linked to Chicken Salad Now Total 170Category: Health NewsCreated: 3/9/2018 12:00:00 AMLast Editorial Review: 3/12/2018 12:00:00 AM
US - MedicineNet
9-3-2018
![RIZE 2 THE OCCASION Capsule [We Care Distributor Inc.]](/web/assets/global/img/flags/us.png)
RIZE 2 THE OCCASION Capsule [We Care Distributor Inc.]
Updated Date: Mar 9, 2018 EST
US - DailyMed
8-3-2018

Pet Guinea Pigs Likely Cause of Multistate Salmonella Outbreak: CDC
Title: Pet Guinea Pigs Likely Cause of Multistate Salmonella Outbreak: CDCCategory: Health NewsCreated: 3/7/2018 12:00:00 AMLast Editorial Review: 3/7/2018 12:00:00 AM
US - MedicineNet
8-3-2018
![TIANNA RED (Tianna) Capsule [We Care Distributor Inc.]](/web/assets/global/img/flags/us.png)
TIANNA RED (Tianna) Capsule [We Care Distributor Inc.]
Updated Date: Mar 8, 2018 EST
US - DailyMed
7-3-2018

NEUROTOX (Agaricus Muscarius, Coccus Cacti, Conium Maculatum, Lycopodium Clavatum, Phosphorus, Epstein-Barr Virus Nosode, Gelsemium Sempervirens, Latrodectus Mactans, Morbillinum, Poliomyetilis Virus, Rhus Tox, Tarentula Cubensis, Salmonella Typhi, Lantha
Updated Date: Mar 7, 2018 EST
US - DailyMed
6-3-2018

Kratom-Linked Salmonella Outbreak: CDC
Title: Kratom-Linked Salmonella Outbreak: CDCCategory: Health NewsCreated: 3/5/2018 12:00:00 AMLast Editorial Review: 3/5/2018 12:00:00 AM
US - MedicineNet
24-2-2018

Chicken Salad Sold at Fareway Stores Linked to Salmonella Outbreak
Title: Chicken Salad Sold at Fareway Stores Linked to Salmonella OutbreakCategory: Health NewsCreated: 2/23/2018 12:00:00 AMLast Editorial Review: 2/23/2018 12:00:00 AM
US - MedicineNet
22-2-2018

Herbal Drug Kratom Linked to Salmonella Illnesses, CDC Says
Title: Herbal Drug Kratom Linked to Salmonella Illnesses, CDC SaysCategory: Health NewsCreated: 2/20/2018 12:00:00 AMLast Editorial Review: 2/21/2018 12:00:00 AM
US - MedicineNet
24-1-2018

Salmonella Outbreak Linked to Raw Sprouts: CDC
Title: Salmonella Outbreak Linked to Raw Sprouts: CDCCategory: Health NewsCreated: 1/22/2018 12:00:00 AMLast Editorial Review: 1/23/2018 12:00:00 AM
US - MedicineNet
18-1-2018

Salmonella Outbreak Linked to Coconut Tree Brand Frozen Shredded Coconut
Title: Salmonella Outbreak Linked to Coconut Tree Brand Frozen Shredded CoconutCategory: Health NewsCreated: 1/17/2018 12:00:00 AMLast Editorial Review: 1/17/2018 12:00:00 AM
US - MedicineNet
27-12-2017
![COBRA 74000 (Green Cobra) Capsule [We Care Distributor Inc.]](/web/assets/global/img/flags/us.png)
COBRA 74000 (Green Cobra) Capsule [We Care Distributor Inc.]
Updated Date: Dec 27, 2017 EST
US - DailyMed
21-12-2017

Salmonella Infection Linked to Rattlesnake Pills: CDC
Title: Salmonella Infection Linked to Rattlesnake Pills: CDCCategory: Health NewsCreated: 12/19/2017 12:00:00 AMLast Editorial Review: 12/20/2017 12:00:00 AM
US - MedicineNet
12-12-2017
![TYPHIM VI (Salmonella Typhi Ty2 Vi Polysaccharide Antigen) Injection, Solution [A-S Medication Solutions]](/web/assets/global/img/flags/us.png)
TYPHIM VI (Salmonella Typhi Ty2 Vi Polysaccharide Antigen) Injection, Solution [A-S Medication Solutions]
Updated Date: Dec 12, 2017 EST
US - DailyMed
20-11-2017

Human Cases of Salmonella Rise to 66
Title: Human Cases of Salmonella Rise to 66Category: Health NewsCreated: 11/17/2017 12:00:00 AMLast Editorial Review: 11/20/2017 12:00:00 AM
US - MedicineNet
20-10-2017
![COBRA 79000 (Gold Cobra) Capsule [We Care Distributor Inc.]](/web/assets/global/img/flags/us.png)
COBRA 79000 (Gold Cobra) Capsule [We Care Distributor Inc.]
Updated Date: Oct 20, 2017 EST
US - DailyMed
25-8-2017

EU/3/17/1909 (Vaximm GmbH)
EU/3/17/1909 (Active substance: Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2) - Orphan designation - Commission Decision (2017)5918 of Fri, 25 Aug 2017 European Medicines Agency (EMA) procedure number: EMA/OD/069/17
Europe -DG Health and Food Safety