Tuberkulin PPD RT23 "SSI"

Primær information

  • Handelsnavn:
  • Tuberkulin PPD RT23 "SSI" 10 TE/dosis injektionsvæske, opløsning
  • Dosering:
  • 10 TE/dosis
  • Lægemiddelform:
  • injektionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Tuberkulin PPD RT23 "SSI" 10 TE/dosis injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 14836
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Tuberkulin PPD

RT23 ”SSI”

2 T.E./0,1 ml,

injektionsvæske,

opløsning

Tuberkulin PPD

RT23 ”SSI”

10 T.E./0,1 ml,

injektionsvæske,

opløsning

Tuberkulin PPD

RT 23

Læs denne indlægsseddel grundigt,

inden du bliver hudtestet, da den

indeholder vigtige oplysninger.

Gem indlægssedlen. Du kan få

brug for at læse den igen.

Spørg lægen eller

apotekspersonalet, hvis der er

mere, du vil vide.

Lægen har ordineret Tuberkulin

PPD RT23 ”SSI” til dig

personligt. Lad derfor være med

at give det til andre. Det kan være

skadeligt for andre, selvom de har

de samme symptomer, som du har.

Kontakt lægen eller

apotekspersonalet, hvis en

bivirkning bliver værre, eller hvis

du får bivirkninger, som ikke er

nævnt her. Se punkt 4.

Oversigt over indlægssedlen

1. Virkning og anvendelse

2. Det skal du vide, før du bliver hudtestet

3. Sådan bliver du hudtestet

4. Bivirkninger

5. Opbevaring

6. Pakningsstørrelser og yderligere oplysninger

1 VIRKNING OG ANVENDELSE

Tuberkulin PPD RT23 ”SSI” anvendes som hudtest for at

finde ud af, om du nogensinde har været smittet med en

bakterie, som giver tuberkulose.

Kun til diagnostisk brug.

2 DET SKAL DU VIDE, FØR DU BLIVER

HUDTESTET

Du må ikke lade dig hudteste

Hvis du er allergisk over for Tuberkulin PPD RT23

”SSI” eller et af de øvrige indholdsstoffer i Tuberkulin

PPD RT23 ”SSI”. Se punkt 6.

Hvis du har oplevet en kraftig lokal reaktion i forbindelse

med tuberkulinprodukter.

Brug af anden medicin sammen med Tuberkulin PPD

RT23 ”SSI”

Det er sikkert at indgive Tuberkulin PPD RT23 ”SSI”

sammen med alle vacciner. Men der kan være nedsat

reaktivitet efter vaccination mod mæslinger, fåresyge og

røde hunde (MFR-vaccine). Den nedsatte reaktivitet kan

give falsk negative reaktioner. Tidligere BCG vaccination

kan give en falsk positiv reaktion.

Fortæl det altid til lægen eller apotekspersonalet, hvis du

bruger anden medicin eller har gjort det for nylig. Dette

gælder også medicin, som ikke er købt på recept.

Graviditet, amning og fertilitet

Fortæl det til lægen, hvis du er gravid eller ammer.

Hudtesten kan udføres, mens du er gravid eller ammer.

Trafik- og arbejdssikkerhed

Tuberkulin PPD RT23 ”SSI” påvirker ikke din evne til at

køre bil eller betjene maskiner.

Tuberkulin PPD RT23 ”SSI”, indeholder kalium og

natrium

Dette lægemiddel indeholder mindre end 1 mmol kalium

(39 mg) og mindre end 1 mmol natrium (23 mg) pr. dosis,

dvs. det er stort set kalium- og natriumfrit.

3 SÅDAN BLIVER DU HUDTESTET

Lægen eller sygeplejersken indsprøjter Tuberkulin PPD

RT23 ”SSI” i det øverste hudlag i underarmen.

Dosis er 0,1 ml for børn og voksne.

Efter indsprøjtningen dannes der en lille papel på 8-10 mm

i diameter, som er synlig i omkring 10 minutter. Der kan

være rødme og hævelse på indsprøjtningsstedet. Efter 48-72

timer undersøges resultatet af hudtesten af lægen eller

sygeplejersken. Hvis der er kommet en hævelse, bør den

aftage herefter. Spørg lægen eller på apoteket, hvis der er

noget, du er i tvivl om.

Der er nærmere oplysninger om indgivelse og evaluering af

hudtesten under ”Følgende oplysninger er tiltænkt læger og

sundhedspersonale”.

4 BIVIRKNINGER

Tuberkulin PPD RT23 ”SSI” kan som al anden medicin

give bivirkninger, men ikke alle får bivirkninger.

Alvorlige allergiske reaktioner (anafylaksi) som hævelse i

læber, ansigt og svælg, vejrtrækningsbesvær og nældefeber

kan forekomme i meget sjældne tilfælde (hos færre end 1 ud

af 10.000 patienter). Kontakt straks lægen, hvis du

observerer nogen af disse reaktioner.

Andre bivirkninger:

Almindelige bivirkninger

(kan forekomme hos færre end

1 ud af 10 patienter):

Smerter, kløe og irritation på indsprøjtningsstedet.

Ikke almindelige bivirkninger

(kan forekomme hos færre

end 1 ud af 100 patienter):

Feber og forstørrelse af lymfeknuderne.

Sjældne bivirkninger

(kan forekomme hos færre end 1 ud

af 1.000 patienter):

Hudnekrose, som normalt forsvinder i løbet af få dage, samt

blæredannelse.

Artillerivej 5

DK-2300 København S

Danmark

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

Følgende oplysninger er tiltænkt læger og

sundhedspersonale

Indgivelsesmåde

Nedenfor gives en detaljeret beskrivelse af indgivelse af

Tuberkulin PPD RT23 ”SSI”:

0,1 ml indgives med en 1 ml underinddelt

injektionssprøjte med en kort kanyle med skrå kant

(25G eller 26G).

Injektionen skal gives intradermalt i den midterste

tredjedel af underarmen. Injektion nær håndleddet eller

albueleddet kan svække reaktionen.

Huden strækkes let, og kanylen holdes næsten parallelt

med hudoverfladen med den skrå kant opad. Spidsen af

nålen indføres i det øverste lag af huden.

Kanylen skal ved indføringen være synlig under

epidermis. De 0,1 ml injiceres langsomt, og der

fremkommer en lille bleg papel på 8-10 mm i diameter.

Denne papel forsvinder igen i løbet af ca. 10 minutter.

Hvis der ikke fremkommer nogen papel, er injektionen

givet for dybt, og hudtesten skal gentages på den anden

arm eller på samme arm mindst 4 cm fra det første

injektionssted.

Nationale anbefalinger vedrørende udførelse af Mantoux

tuberkulinhudtesten bør tages i betragtning.

Epidermis

Dermis

Subcutis

0,1 ml

30-027-01

02-2017

Hyppighed ikke kendt

(kan ikke estimeres ud fra

forhåndenværende data):

Hovedpine og nældefeber (urticaria).

Tal med lægen eller apoteket, hvis en bivirkning er

generende eller bliver værre, eller hvis du får bivirkninger,

som ikke er nævnt her.

Indberetning af bivirkninger til Lægemiddelstyrelsen

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 på

www.meldenbivirkning.dk, ved at kontakte

Lægemiddelstyrelsen via mail på dkma@dkma.dk eller

med almindeligt brev til Lægemiddelstyrelsen, Axel Heides

Gade 1, 2300 København S. Ved at indrapportere

bivirkninger kan du hjælpe med at fremskaffe mere

information om sikkerheden af dette lægemiddel.

5 OPBEVARING

Opbevar Tuberkulin PPD RT23 ”SSI” utilgængeligt for

børn.

Brug ikke Tuberkulin PPD RT23 ”SSI” efter den

udløbsdato, der står på pakningen efter EXP.

Udløbsdatoen (EXP) er den sidste dag i den nævnte

måned.

Opbevares i køleskab (2ºC-8ºC).

Opbevares i den originale emballage for at beskytte mod

lys.

Tuberkulin PPD RT23 ”SSI” bør anvendes straks efter

åbning. Hvis det ikke anvendes med det samme, er

holdbarhedstiden og opbevaringsbetingelserne efter

anbrud og før brug brugerens ansvar og vil normalt ikke

være længere end 24 timer ved 2°C-8°C.

Spørg på apoteket, hvordan du skal bortskaffe

medicinrester. Af hensyn til miljøet må du ikke smide

medicinrester i afløbet, toilettet eller skraldespanden.

Tuberkulin PPD RT23 ”SSI” indeholder ikke levende

materiale.

6 PAKNINGSSTØRELSER OG YDERLIGERE

OPLYSNINGER

Tuberkulin PPD RT23 ”SSI” indeholder:

Aktivt stof: Tuberkulin PPD RT 23

1 dosis (0,1 ml) Tuberkulin PPD RT23 ”SSI” 2 T.E.

indeholder 0,04 mikrogram Tuberkulin PPD RT 23.

1 dosis (0,1 ml) Tuberkulin PPD RT23 ”SSI” 10 T.E.

indeholder 0,2 mikrogram Tuberkulin PPD RT 23.

Øvrige indholdsstoffer: dinatriumphosphatdihydrat,

kaliumdihydrogenphosphat, natriumchlorid,

kaliumhydroxyquinolinsulfat, polysorbat 80 og vand til

injektionsvæsker.

Udseende og pakningsstørrelser

Tuberkulin PPD RT23 ”SSI” er en injektionsvæske,

opløsning (injektionsvæske).

Det er en klar, farveløs til svagt gul opløsning.

Tuberkulin PPD RT23 ”SSI” markedsføres i to styrker.

2 T.E. og 10 T.E.

Pakningsstørrelser:

Tuberkulin PPD RT23 ”SSI” 2 T.E. hætteglas med 1,5 ml i

pakningsstørrelser på 1 eller 10.

Tuberkulin PPD RT23 ”SSI” 10 T.E. hætteglas med 1,5 ml i

pakningsstørrelser på 1 eller 10.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller

AJ Vaccines A/S

Artillerivej 5

2300 København S

Tlf.: +45 7229 7000

Fax: +45 7229 7999

E-mail: ajvaccines@ajvaccines.com

Dette lægemiddel er godkendt i EEAs medlemslande

under følgende navne:

DK: Tuberkulin PPD RT23 ”SSI”

DE: Tuberkulin PPD RT23 SSI

Denne indlægsseddel blev senest revideret januar 2017

Den nyeste indlægsseddel kan findes på

www.indlaegsseddel.dk

Tolkning

En positiv reaktion indikerer en immunrespons af en eller

flere af følgende årsager:

Infektion med

Mycobacterium tuberculosis

kompleks,

inklusive

M. tuberculosis, M. bovis, M. africanum,

M. microtii,

eller

M. tuberculosis

subsp.

caprae

Infektion med non-tuberkuløse mykobakterier.

Tidligere BCG vaccination (BCG-vaccinerede personer

bliver normalt tuberkulin-positive efter 4-8 uger).

Det er usandsynligt, at reaktioner over 15 mm skyldes

tidligere BCG vaccination eller eksponering af

mykobakterier fra omgivelserne.

Evaluering af reaktionen

En hudtestreaktion ses som en flad, ujævn, let forhøjet

induration omgivet af et område med rødme. Indurationen

bør vurderes 48-72 timer efter injektionen og bør derefter

aftage. Kun indurationen vurderes.

Indurationens diameter måles i millimeter med en

gennemsigtig, fleksibel plastlineal på tværs af underarmens

længdeakse.

Anbefalinger vedrørende tolkning af Mantoux

tuberkulintesten er vist i Tabel 1.

Indurationens diameter i millimeter

Negativ

Positiv

Stærkt positiv

0-5 mm

6-14 mm

+15 mm

Tabel 1: Normal tolkning af hudtestresultatet.

Alternative tolkninger kan anvendes afhængigt af nationale

anbefalinger samt individuelle og epidemiologiske faktorer.

30-027-01

02-2017

6-3-2018

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Some Republicans Voice Concerns About Senate Replacement for Obamacare

Some Republicans Voice Concerns About Senate Replacement for Obamacare

Title: Some Republicans Voice Concerns About Senate Replacement for ObamacareCategory: Health NewsCreated: 6/23/2017 12:00:00 AMLast Editorial Review: 6/23/2017 12:00:00 AM

US - MedicineNet

24-6-2017

Can Smartphone Use Bring on Carpal Tunnel Syndrome?

Can Smartphone Use Bring on Carpal Tunnel Syndrome?

Title: Can Smartphone Use Bring on Carpal Tunnel Syndrome?Category: Health NewsCreated: 6/23/2017 12:00:00 AMLast Editorial Review: 6/23/2017 12:00:00 AM

US - MedicineNet

24-6-2017

Choosing the Right Sunglasses

Choosing the Right Sunglasses

Title: Choosing the Right SunglassesCategory: Health NewsCreated: 6/23/2017 12:00:00 AMLast Editorial Review: 6/23/2017 12:00:00 AM

US - MedicineNet

24-6-2017

Need Braces? Say Goodbye to 'Metal-Mouth' Taunts

Need Braces? Say Goodbye to 'Metal-Mouth' Taunts

Title: Need Braces? Say Goodbye to 'Metal-Mouth' TauntsCategory: Health NewsCreated: 6/23/2017 12:00:00 AMLast Editorial Review: 6/23/2017 12:00:00 AM

US - MedicineNet

24-6-2017

Regular Sleep Makes for Happier College Students

Regular Sleep Makes for Happier College Students

Title: Regular Sleep Makes for Happier College StudentsCategory: Health NewsCreated: 6/23/2017 12:00:00 AMLast Editorial Review: 6/23/2017 12:00:00 AM

US - MedicineNet

23-6-2017

What Is Cryptitis?

What Is Cryptitis?

Title: What Is Cryptitis?Category: Doctor's & Expert's views on SymptomsCreated: 6/23/2017 12:00:00 AMLast Editorial Review: 6/23/2017 12:00:00 AM

US - MedicineNet

23-6-2017

What Is CNS Depression?

What Is CNS Depression?

Title: What Is CNS Depression?Category: Doctor's & Expert's views on SymptomsCreated: 6/23/2017 12:00:00 AMLast Editorial Review: 6/23/2017 12:00:00 AM

US - MedicineNet

23-6-2017

Does Dairy Cause Weight Gain?

Does Dairy Cause Weight Gain?

Title: Does Dairy Cause Weight Gain?Category: Doctor's & Expert's views on SymptomsCreated: 6/23/2017 12:00:00 AMLast Editorial Review: 6/23/2017 12:00:00 AM

US - MedicineNet

26-5-2017

CBO: 23 Million Would Lose Health Insurance Under House Health Care Bill

CBO: 23 Million Would Lose Health Insurance Under House Health Care Bill

Title: CBO: 23 Million Would Lose Health Insurance Under House Health Care BillCategory: Health NewsCreated: 5/25/2017 12:00:00 AMLast Editorial Review: 5/25/2017 12:00:00 AM

US - MedicineNet

24-5-2017

Health Tip: Keep Fleas Out of Your Home

Health Tip: Keep Fleas Out of Your Home

Title: Health Tip: Keep Fleas Out of Your HomeCategory: Health NewsCreated: 5/23/2017 12:00:00 AMLast Editorial Review: 5/23/2017 12:00:00 AM

US - MedicineNet

24-5-2017

Health Tip: Don't Take Stress to Bed

Health Tip: Don't Take Stress to Bed

Title: Health Tip: Don't Take Stress to BedCategory: Health NewsCreated: 5/23/2017 12:00:00 AMLast Editorial Review: 5/23/2017 12:00:00 AM

US - MedicineNet

24-5-2017

City Life Tough on Teens' Mental Health

City Life Tough on Teens' Mental Health

Title: City Life Tough on Teens' Mental HealthCategory: Health NewsCreated: 5/23/2017 12:00:00 AMLast Editorial Review: 5/23/2017 12:00:00 AM

US - MedicineNet

24-5-2017

3 Key Lifestyle Factors Can Lower Breast Cancer Odds

3 Key Lifestyle Factors Can Lower Breast Cancer Odds

Title: 3 Key Lifestyle Factors Can Lower Breast Cancer OddsCategory: Health NewsCreated: 5/23/2017 12:00:00 AMLast Editorial Review: 5/23/2017 12:00:00 AM

US - MedicineNet

24-5-2017

Ways to Track Weight Loss Success

Ways to Track Weight Loss Success

Title: Ways to Track Weight Loss SuccessCategory: Health NewsCreated: 5/23/2017 12:00:00 AMLast Editorial Review: 5/23/2017 12:00:00 AM

US - MedicineNet

24-5-2017

Dozens of Genes Linked to Intelligence Identified by Scientists

Dozens of Genes Linked to Intelligence Identified by Scientists

Title: Dozens of Genes Linked to Intelligence Identified by ScientistsCategory: Health NewsCreated: 5/23/2017 12:00:00 AMLast Editorial Review: 5/23/2017 12:00:00 AM

US - MedicineNet