natgillin/translations-raw huggingface dataset:
Quintanrix kan også anvendes til at forstærke tidligere vaccinationer mod difteri, stivkrampe og kighoste, mod hepatitis B eller mod Hib, når den gives mindst seks måneder efter det første mi
Quintanrix can also be used to boost previous vaccinations against diphtheria, tetanus and na
vaccinationsprograms sidste dosis.
pertussis, against hepatitis B or against Hib, when it should be given at least six months after the last dose of the first vaccination course.
Quintanrix kan gives til børn, der fik en hepatitis B- vaccine, da de blev født. ge
Quintanrix can be given to children who received a hepatitis B vaccine at birth. i dic
Vacciner fungerer ved at lære kroppens naturlige forsvar, også kaldet Læ
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against diseases.
immunsystemet, hvordan det forsvarer sig mod sygdomme.
Me
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
• toxoids from the bacteria that cause diphtheria and tetanus; • killed whole B. pertussis; • polysaccharides extracted from the ‘ capsules’ that surround the bacterium Hib - the polysaccharides are chemically attached (conjugated) to tetanus toxoid as a carrier protein because this improves the response to the vaccine; 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. • polysakkarider, der er udskilt fra den kapsel, der omgiver Hib- bakterien.
Reproduction is authorised provided the source is acknowledged. • ‘ surface antigen’ (proteins from the surface) of the hepatitis B virus.
Polysakkariderne er kemisk bundet til stivkrampetoksoidet som et bærerprotein, da dette forbedrer responset på vaccinen, • overfladeantigen, dvs. proteiner fra overfladen, fra hepatitis B- virussen.
When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘ foreign’ and makes antibodies against them.
Når et spædbarn bliver vaccineret, opfatter immunsystemet delene fra bakterierne og viraene som fremmede og danner antistoffer mod dem.
The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the bacteria or viruses.
Det vil sige, at de aktive stoffer er bundet til aluminiumsforbindelser for at
This means that the active substances are fixed on aluminium compounds,
s fremkalde et bedre immunrespons.
ed to stimulate a better immune response.
De fremstilles af en gærart, der har modtaget et
The surface antigens of the hepatitis B virus are produced by a method known as ‘ recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
til gen (DNA), som gør den i stand til at producere proteinerne.
ris The active substances in Quintanrix have been available in the European Union (EU) for a number of years in other vaccines: diphtheria, tetanus, pertussis and hepatitis B, has been available in Tritanrix HepB since 1996.
De aktive stoffer i Quintanrix har været på markedet i Den Europæiske Union (EU) i en årrække i
The
Hib - komponenten har også været tilgængelig i andre vacciner.
tho Hib component has also been available in other vaccines.
ise Hvordan blev Quintanrix undersøgt?
How has Quintanrix been studied?
Virkningerne af Quintanrix blev undersøgt i fem hovedundersøgelser, hvor mere end 2 000 spædbørn
au The effects of Quintanrix have been studied in five main studies involving over 2,000 infants.
tor deltog.
r of age.
I to af disse undersøgelser deltog i
The fourth study compared the effects of Quintarix given at six, 10 and 14 weeks of age in 318
I den fjerde undersøgelse, hvor 318 spædbørn deltog, sammenlignede forskerne virkningerne af Quintanrix, når den blev givet ved seks -, 10 - og 14- ugers- alderen til disse børn, hvoraf nogle havde fået en hepatitis ere B- vaccine, da de blev født.
ge infants who either had or had not received a hepatitis B vaccine at birth.
I alle undersøgelserne var det primære mål for virkning udviklingen af beskyttende niveauer af antistoffer ng
In all of the studies, the main measure of effectiveness was the production of protective levels of antibodies after lon the final vaccination.
Samlet set havde mellem 95 og 100% af spædbørnene beskyttende antistofniveauer mod difteri, stivkrampe, kighoste, hepatitis B og Hib en måned efter det første vaccinationsprogram. ke
Overall, between 95 and 100% of the infants had protective levels of antibodies to diphtheria, tetanus, no
En tidligere hepatitis B- vaccination påvirkede ikke virkningen af Quintanrix.
pertussis, hepatitis B and Hib, one month after the first vaccination course.
Undersøgelsen af booster- vaccinationen viste, at Quintanrix var lige så effektiv som de to særskilte ik
There was no impact of prior hepatitis B vaccination on the effectiveness of Quintanrix.
vacciner, idet mellem 92 og 100% af spædbørnene havde beskyttende antistofniveauer 42 dage efter booster- vaccinationen. er
The study of booster vaccination also showed Quintanrix was as effective as the two separate vaccines, with between 92 and 100% of the infants having protective levels of antibodies 42 days after t uc
Hvilken risiko er der forbundet med Quintanrix?
What is the risk associated with Quintanrix? rod
De hyppigste bivirkninger ved Quintanrix (som ses ved mere end 1 ud af 10 doser vaccine) er t
The most common side effects with Quintanrix (seen in more than 1 in 10 doses of the vaccine) are irritability, drowsiness, loss of appetite, pain, redness and swelling, and fever.
irritabilitet, døsighed, appetitløshed, smerte, rødme og hævelse samt feber.
For the full list of side effects reported with Quintanrix, see the Package Leaflet.
Den fuldstændige liste over dle
Quintanrix should not be used in people who may be hypersensitive (allergic) to any of the active lP
alle de indberettede bivirkninger ved Quintanrix fremgår af indlægssedlen.
substances or any of the other ingredients.
Quintanrix bør ikke anvendes til personer, der kan være overfølsomme over for et eller flere af de aktive stoffer eller et eller flere af de andre indholdsstoffer.
It should not be given if the child has had encephalopathy (a brain disease) of unknown cause within seven days of a previous vaccination with a vaccine containing pertussis.
Den bør ikke gives, hvis barnet har haft mi
Quintanrix should be postponed in people with a severe sudden fever. na
hjernelidelsen encefalopati af ukendte årsager inden for syv dage efter en tidligere vaccination med en vaccine, der indeholder kighostebakterie.
As for all vaccines, if Quintanrix is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Vaccination med Quintanrix skal udskydes hos personer ge
Their breathing should be monitored for up to three days after vaccination. i dic
med pludseligt opstået, alvorlig feber.
Why has Quintanrix been approved?
Deres vejrtrækning bør Læ
The Committee for Medicinal Products for Human Use (CHMP) decided that Quintanrix’ s benefits are greater than its risks for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Hib and for booster Me
overvåges i op til tre dage efter vaccinationen.
The Committee recommended that Quintanrix be given marketing authorisation.
Hvorfor blev Quintanrix godkendt?
Other information about Quintanrix:
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Quintanrix er større end risiciene ved Quintanrix ved primær immunisering af spædbørn i løbet af deres første leveår mod difteri, stivkrampe, kighoste, hepatitis B og invasive sygdomme fremkaldt af Hib og som booster -
The European Commission granted a marketing authorisation valid throughout the EU for Quintanrix to GlaxoSmithKline Biologicals s. a. on 21 October 2004.
2/ 3 immunisering af små børn i løbet af deres andet leveår.
2/ 3 The full EPAR for Quintanrix can be found here.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Quintanrix.
This summary was last updated in 04-2008.
Andre oplysninger om Quintanrix:
ed ris tho aur ge lon
a lg Den fuldstændige EPAR for Quintanrix findes her.
lP
s Dette sammendrag blev sidst ajourført i 04- 2008.
rod
til ret ise tor au ere ng læ
uc
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EU number
Særnavn
Invented namStrength Pharmaceutical
Pakningsstørrelse
is ed Package size
s
1
EU/ 1/ 4/ 301/ 001
EU/ 1/ 4/ 301/ 001
-- 1
1 vial + 1 vial
Pulver og væske til Intramuskulær
suspension for
Pulver:
(glass);
0, 5 ml
au
1 hætteglas + 1
1
suspension til injektion
suspension for injection
hætteglas; suspension:
suspension: vial (glass)
ris 1 EU/ 1/ 4/ 301/ 002
r EU/ 1/ 4/ 301/ 002
Pulver og væske til suspension til
Powder and
100 hætteglas + 100 hætteglas
100 vials + 100
to
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suspension for suspension for
suspension:
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injection
a EU/ 1/ 4/ 301/ 003
lo EU/ 1/ 4/ 301/ 003
Pulver og væske til Intramuskulær
Powder and suspension for
Pulver:
powder: vial (glass);
1 hætteglas + 1
1 vial + 1 vial
suspension til
suspension for
hætteglas
suspension: vial
suspension: hætteglas
(glass)
ng EU/ 1/ 4/ 301/ 004
EU/ 1/ 4/ 301/ 004
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suspension for suspension for
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use
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injection
kk EU/ 1/ 4/ 301/ 005
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Pulver og væske til Intramuskulær
Intramuscular
Pulver:
powder: vial
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lP
suspension til injektion
suspension for suspension for
hætteglas; suspension:
(glass); suspension: vial
hætteglas
injection
te hætteglas
(glass)
-- 1 id 1 dosis (0, 5 ml) indeholder: le m Difteri toxoid *
--1 ic in 1 dose (0.5 ml) contains:
≥ 30 IU
≥ 30 IU ≥ 60 IU
ge Stivkrampe toxoid * Inaktiveret stamme af Bordetella pertussis **
M Inactivated Bordetella pertussis strain**
≥ 60 IU ≥ 4 IU
≥ 4 IU
Læ Hepatitis B virus overflade antigen rekombinant ** (S protein) *** Haemophilus influenzae type b polysaccharid
Hepatitis B virus surface antigen recombinant** (S protein)***
(polyribosylribitolfosfat) 2
1/ 2 ed Haemophilus influenzae type b polysaccharide
1/ 2 alg konjugeret til stivkrampe toxoid som bærestof
is (polyribosylribitol phosphate) 2
5- 10 mikrogram
2.5 micrograms
s *
or conjugated to tetanus toxoid as a carrier
adsorberet til aluminiumhydroxidhydrat
5-10 micrograms
Total:
* adsorbed on aluminium hydroxide hydrated Total:
0, 26 milligram Al3+
0.26 milligrams Al3+
Total:
th ** adsorbed on aluminium phosphate Total:
0, 40 milligram Al3+
0.40 milligrams Al3+
t *** fremstillet i Saccharomyces cerevisae celler vha. rekombinant DNA teknologi
au *** produced in Saccharomyces cerevisiae cells by recombinant DNA technology
er 2/ 2
r n ge o lo tn uc r od a lP ic in M ed 2/ 2
Læ ge mi dle
ed ris tho r au ANNEX Ige lon SUMMARY OF PRODUCT CHARACTERISTICS t no uc rod lP nai dic Me
læ
1 1.
a lg 2.
ed 2.
s Efter rekonstituering indeholder 1 dosis (0. 5 ml):
ris After reconstitution, 1 dose (0.5 ml) contains:
til Difteri toxoid1 Stivkrampe toxoid1
tho Diphtheria toxoid1 Tetanus toxoid1 Inactivated Bordetella pertussis 2 Hepatitis B surface antigen (rDNA) 2, 3
mindst 30 International Units mindst 60 International Units
not less than 30 International Units not less than 60 International Units not less than 4 International Units 10 micrograms
ret Inaktiveret Bordetella kighoste 2 Hepatitis B overflade antigen (rDNA) 2, 3 Haemophilus influenzae type b polysakkarid
au Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 2
mindst 4 International Units 10 microgram
2.5 micrograms
ise (polyribosylribitolfosfat) 2
conjugated to tetanus toxoid as a carrier
2. 5 microgram
5-10 micrograms
konjugeret til stivkrampe toxoid som bærestof
r 1 Total:
5- 10 microgram
0.26 milligrams Al3+
adsorberet til aluminiumhydroxidhydrat
ge adsorbed on aluminium hydroxide, hydrated 2 3
adsorberet til aluminiumfosfat
adsorbed on aluminium phosphate
0. 40 milligram Al3+
0.40 milligrams Al3+
Fremstillet i Saccharomyces cerevisae celler vha. rekombinant DNA teknologi.
produced in Saccharomyces cerevisae cells by recombinant DNA technology lon For excipients, see section 6.1.
LÆGEMIDDELFORM
PHARMACEUTICAL FORM no
Den flydende difteri, stivkrampe, kighoste (hel celle), hepatitis B (DTPw HBV) komponent er en uklar læ
Powder and suspension for suspension for injection The liquid diphtheria, tetanus, pertussis (whole cell), hepatitis B (DTPw-HBV) component is a turbid white suspension. t
Den frysetørrede Haemophilus influenzae type b (HIB) komponent er et hvidt pulver. ke
The lyophilised Haemophilus influenzae type b (HIB) component is a white powder. uc rod
KLINISKE OPLYSNINGER ik
CLINICAL PARTICULARS
4. 1 Terapeutiske indikationer
4.1 Therapeutic indications lP
stivkrampe, kighoste, hepatitis B og angribende sygdom forårsaget af Haemophilus influenzae type b, og til booster immunisering af småbørn under 2. leveår. t dle
Quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Haemophilus influenzae type b and for booster immunisation of young children during the second year of life. na
4. 2 Dosering og indgivelsesmåde mi
4.2 Posology and method of administration i dic
Dosering ge
Posology
Det primære vaccinationsprogram består af tre doser af 0, 5 ml som skal administreres med intervaller på mindst 4 uger, inden for de første 6 levemåneder i overensstemmelse med lokale officielle anbefalinger.
The primary vaccination schedule consists of three doses of 0.5 ml to be administered at intervals of at least 4 weeks within the first six months of life in accordance with local official recommendations.
Følgende programmer er blevet undersøgt i kliniske studier:
The following schedules have been studied in clinical trials:
2 4 6 måneder, 3 4 5 måneder og 6 10 14 uger.
2-4-6 months, 3-4-5 months and 6-10-14 weeks.
Quintanrix kan gives til børn som har modtaget hepatitis B vaccine ved fødslen.
2 Quintanrix can be given to children who have received hepatitis B vaccine at birth.
2 De immunoprofylaktiske målinger for hepatitis B skal ikke modificeres til børn født af hepatitis B virus bærende mødre.
The immunoprophylactic measures for hepatitis B should not be modified for children born to hepatitis B virus carrying mothers.
Booster vaccination:
ed Booster vaccination:
a lg Efter afslutningen af de primære vaccinationer, skal en booster gives og helst før slutningen af 2. leveår.
After the completion of the primary series, a booster should be administered preferably before the
til komposition er i overensstemmelse med officielle anbefalinger for boosting.
tho Quintanrix may be used to boost responses to DTP, HBV and HIB antigens if its composition is in accordance with official recommendations for boosting.
ret Indgivelsesmåde
au Method of administration
ise Quintanrix er til dyb intramuskulær injektion, anterolateralt på låret.
Quintanrix is for deep intramuscular injection, preferably in the anterolateral thigh.
4. 3 Kontraindikationer
r ge 4.3 Contraindications
tor Overfølsomhed over for de aktive substanser eller over for et eller flere af hjælpestofferne.
Hypersensitivity to the active substances or to any of the excipients. lon Quintanrix is contra-indicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
Quintanrix er kontraindiceret hvis barnet har haft encephalopati med ukendt ætiologi, der er opstået au inden for 7 dage efter vaccination.
In these circumstances the vaccination course should be continued with diphtheria, tetanus, hepatitis B and HIB vaccines. no
Under disse omstændigheder skal vaccinationsprogrammet fortsættes med difteri, stivkrampe, hepatitis B og HIB vacciner. ere Som med andre vacciner, skal administration af Quintanrix udsættes hos individer med akut alvorlig febril sygdom.
As with other vaccines, the administration of Quintanrix should be postponed in subjects suffering from acute severe febrile illness.
Tilstedeværelsen af en mindre infektion, som forkølelse, er ikke en kontraindikation for vaccination. ng
The presence of a minor infection, such as a cold, is not a contraindication for vaccination. t uc
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen læ
4.4 Special warnings and special precautions for use rod
Inden vaccination skal der skal være overblik over anamnesen (specielt med hensyn til tidligere vaccination og mulig forekomst af bivirkninger). ke
Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events).
Som for alle injicerbare vacciner skal passende medicinsk behandling og tilsyn altid være umiddelbart til rådighed i tilfælde af en sjælden anafylaktisk reaktion efter administration af ik
As with all injectable vaccines, appropriate medical treatment and supervision should always be lP
vaccinen.
readily available in case of a rare anaphylactic event following the administration of the vaccine.
Af denne årsag skal den vaccinerede person forblive under medicinsk tilsyn i mindst 30 minutter. er
For this reason, the vaccinee should remain under medical supervision for at least 30 minutes.
Hvis nogle af de følgende forhold opstår i tidsmæssig relation til modtagelsen af Quintanrix, skal beslutningen, om at give efterfølgende doser af en vaccine indeholdende kighoste komponenten, t
If any of the following events occur in temporal relation to receipt of Quintanrix, the decision to give na
• Temperatur på ≥ 40. 0 °C inden for 48 timer, som ikke skyldes en anden infektion. • Kollaps eller shock- lignende tilstand (hypotonisk- hyporesponsiv episode) inden for 48 timer. • Vedholdende gråd der varer ≥ 3 timer, og opstår inden for 48 timer. mi
subsequent doses of a vaccine containing the pertussis component should be carefully considered: • Temperature of ≥ 40.0 °C within 48 hours, not due to another identifiable cause. • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours. i dic
• Kramper med eller uden feber, der opstår inden for 3 dage.
• Persistent crying lasting ≥ 3 hours, occurring within 48 hours. • Convulsions with or without fever, occurring within 3 days.
Der kan være omstændigheder, såsom en høj hyppighed af kighoste, hvor de potentielle fordele vejer ge
Me
blødningslidelse, da blødning kan opstå efter en intramuskulær administration hos disse personer.
Quintanrix should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
3 Vaccinen vil ikke forebygge infektion forårsaget af andre patogener der vides at inficere leveren såsom hepatitis A, hepatitis C og hepatitis E virus.
3 The vaccine will not prevent infection caused by other pathogens known to infect the liver such as hepatitis A, hepatitis C and hepatitis E virus.
a lg En anamnese med feberkramper, en familieanamnese med kramper eller Sudden Infant Death Syndrome (SIDS) er ikke en kontraindikation for brug af Quintanrix.
ed A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Quintanrix.
Vaccinerede personer med en anamnese med feberkramper skal følges tæt da sådanne bivirkninger muligvis opstår indenfor 2 til 3
Vaccinees with a history of
s dage efter vaccination.
ris febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days post vaccination.
til HIV infektion betragtes ikke som en kontraindikation.
tho HIV infection is not considered as a contraindication.
ret Da kapsel polysakkarid antigenet udskilles i urinen kan der observeres en positiv urin antigen test inden for 1- 2 uger efter vaccination.
Since the capsular polysaccharide antigen is excreted in the urine a positive urine antigen test can be
ise periode.
au observed within 1-2 weeks following vaccination.
tor Den potentielle risiko for apnø og behov for respiratorisk overvågning i 48- 72 timer bør overvejes ved primære immuniseringprogrammer til meget tidligt fødte børn (fødsel ≤ uge 28 af svangerskabet) og specielt for tidligere respiratorisk immature børn. au Da fordelene ved vaccination er stor for denne gruppe børn, bør vaccination ikke udelades eller ere forsinkes
r ge The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. lon As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed. no
4. 5 Interaktion med andre lægemidler og andre former for interaktion ng
4.5 Interaction with other medicinal products and other forms of interaction
I pædiatri vaccination er det normal praksis, at co- administrere forskellige injicerbare vacciner på separate injektionssteder, under samme konsultation. læ
In paediatric vaccination it is often practice to co-administer different injectable vaccines at separate injection sites, during the same session. t uc
Selvom der ikke er tilgængelige data på immumresponset overfor Bacille ke
Although no data are available on the immune response to the Bacille-Calmette- rod
Calmette Guérin (BCG) antigenet, forventes der ingen interferens. ik
Guérin (BCG) antigen, no interference is expected.
Som med andre vacciner kan det forventes at et tilstrækkeligt respons måske ikke opnås hos patienter der modtager immunosuppressiv behandling eller patienter med nedsat immunforsvar. er
As with other vaccines it may be expected that an adequate response may not be achieved in patients receiving immunosuppressive therapy or patients with immunodeficiency. lP
4. 6 Graviditet og amning t
4.6 Pregnancy and lactation
Da Quintanrix ikke er tilsigtet brug for voksne, er information om sikkerhed af vaccinen, ved brug dle
As Quintanrix is not intended for use in adults, information on the safety of the vaccine when used na
under graviditet eller amning, ikke tilgængelig.
during pregnancy or lactation is not available.
4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner mi
4.7 Effects on ability to drive and use machines i dic
Ikke relevant. ge
Not relevant.
4. 8 Bivirkninger Læ
4.8 Undesirable effects Me
Quintanrix blev administreret til cirka 1, 340 raske spædbørn fra 6 ugers alderen som et primært vaccinationsprogram i adskillelige kliniske studier.
Quintanrix was administered to approximately 1,340 healthy infants from 6 weeks of age as a primary vaccination course in several clinical trials.
50% af den administrerede dosis.
In these trials, the most common reactions occurring after vaccine administration were pain at the site of injection, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) and irritability, which were associated with about 50% of the doses administered.
4 Bivirkninger er opstillet herunder.
4 Adverse reactions are listed below.
(> 1/ 100, < 1/ 10) (> 1/ 1, 000, < 1/ 100)
(> 1/ 10) (> 1/ 100, < 1/ 10)
a lg Sjælden:
ed Uncommon:
(> 1/ 10, 000, < 1/ 1, 000) (< 1/ 10, 000) inklusiv enkeltstående rapporteringer.
(> 1/ 1,000 ,< 1/100) (> 1/10 ,000, < 1/1,000) (< 1/ 10,000) including isolated reports
s Psykiske lidelser: meget almindelig: irritabilitet
ris Psychiatric disorders: very common: irritability
ret Meget almindelig: døsighed Sjælden: kollaps eller shock lignende tilstand (hypotonisk- hyporesponsiv episode), kramper
tho Nervous system disorders: very common: drowsiness rare: collapse or shock-like state (hypotonic-hyporesponsiveness episode), convulsions
ise Sygdomme i åndedrætsorganer, brysthule og mediastinum Sjælden: bronchitis, hoste
au Respiratory, thoracic and mediastinal disorders rare: bronchitis, coughing
Meget almindelig: smerte, rødme og hævelse, feber (axillær ≥ 37. 5 °C; rektalt ≥ 38 °C) ere Almindelig: induration, feber (axillær > 39 °C; rektalt > 39. 5 °C)
r ge Gastrointestinal disorders: very common: loss of appetite rare: vomiting lon General disorders and administration site conditions: very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: induration, fever (axillary > 39°C; rectal > 39.5°C) no