FrancophonIA/ELRC3.0 huggingface dataset:
English: • if your child has previously had any allergic reaction to Tritanrix HepB, or any ingredient contained in this vaccine.
Danish: • hvis dit barn tidligere har haft en allergisk reaktion mod Tritanrix HepB eller mod nogen af indholdsstofferne, som findes i denne vaccine.
English: Tritanrix HepB contains a hepatitis B component, to provide protection against disease caused by hepatitis B virus.
Danish: Tritanrix HepB indeholder en hepatitis B komponent for at yde beskyttelse mod sygdom forårsaget af hepatitis B virus.
English: Collapse or shock-like state (hypotonic-hyporesponsive episode).
Danish: Kollaps eller shok-lignende tilstand (hypotonic-hyporesponsive episode)
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Danish: Du kan finde yderligere information om Tritanrix HepB på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu/.
English: The muscle spasms can be strong enough to cause bone fractures of the spine.
Danish: Muskelkramperne kan være så kraftige, at de forårsager brud på rygsøjlen.
English: There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh
Danish: Der kan være omstændigheder, såsom ved en høj incidens af pertussis, hvor den potentielle fordel
English: In patients receiving immunosuppressive therapy or patients with immunodeficiency, an adequate
Danish: Hos patienter, der modtager immunsuppresiv behandling eller patienter med immundefekt kan et
English: Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation.
Danish: Generelt bliver luftvejene betændte (opsvulmede), hvilket medfører vejrtrækningsbesvær og nogle gange kvælning.
English: • if your child experienced problems of the nervous system within 7 days after previous vaccination with a vaccine against pertussis (whooping cough) disease.
Danish: • hvis du barn har haft problemer med nervesystemet indenfor 7 dage efter tidligere vaccination med en vaccine mod pertussis (kighoste).
English: • if your child has a bleeding problem or bruises easily
Danish: • hvis dit barn har problemer med blødningstendens eller let får blå mærker
English: Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Danish: Apnø hos meget tidligt fødte børn (≤ 28 uger af svangerskabet) (se pkt.
English: Tritanrix HepB can be administered simultaneously at separate sites or in any temporal relationship with other paediatric vaccines if this fits conveniently in the immunisation scheme.
Danish: Tritanrix HepB kan administreres samtidigt på adskilte indstikssteder eller i tidsmæssig sammenhæng med andre pædiatriske vacciner, hvis dette passer i immuniseringsprogrammet.
English: Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours.
Danish: Kollaps eller shock-lignende tilstand (hypotonisk-hyporesponsiv episode) indenfor 48 timer.
English: The doctor will give Tritanrix HepB as an injection into the thigh muscle.
Danish: Lægen vil give Tritanrix HepB som en injektion i lårmusklen.
English: - Keep this leaflet .
Danish: - Gem indlægssedlen.
English: • if your child has experienced any health problems after previous administration of a vaccine.
Danish: • hvis dit barn har haft problemer med helbredet efter tidligere at have fået en vaccine.
English: DTPw-HBV (combined)
Danish: Gruppe 1 DTPw-HBV (kombineret)
English: Tritanrix HepB is contraindicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
Danish: Tritanrix HepB er kontraindiceret, hvis barnet har haft en encephalopati af ukendt ætiologi forekommende indenfor 7 dage efter forudgående vaccination med vaccine indeholdende pertussis.
English: If any of the following events occur in temporal relation to receipt of Tritanrix HepB, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered.
Danish: Hvis nogle af de følgende begivenheder forekommer i tidsmæssig relation til indgiften af Tritanrix HepB, skal beslutningen om at give efterfølgende doser af vaccine indeholdende pertussis
English: 0.26 mg Al3+ 0.37 mg Al3+ 3 produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology - The other ingredients in Tritanrix HepB are: thiomersal, sodium chloride and water for injections.
Danish: ≥ 30 IU ≥ 60 IU ≥ 4 IU 10 μg 0,26 mg Al3+ 0,37 mg Al3 3Produceret på gærceller (Saccharomyces cerevisiae) ved rekombinant DNA-teknologi - Øvrige indholdsstoffer: thiomersal, natriumklorid og vand til injektion.
English: Important information about some of the ingredients of Tritanrix HepB This medicinal product contains thiomersal as a preservative and it is possible that your child may experience an allergic reaction.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Tritanrix HepB Denne vaccine indeholder thiomersal som konserveringsmiddel og det er muligt at dit barn vil opleve en overfølsomhedsreaktion.
English: In clinical studies, Tritanrix HepB has been administered simultaneously with oral polio vaccine (OPV) and Haemophilus influenzae type b (Hib) vaccine.
Danish: I kliniske studier er Tritanrix HepB blevet administreret samtidigt med oral poliovaccine (OPV) og Haemophilus influenzae type b (Hib) vaccine.
English: common: gastro-intestinal symptoms such as vomiting and diarrhoea
Danish: Almindelig: Gastro-intestinale symptomer, som opkast og diaré
English: General reactions that may occur in temporal association with Tritanrix HepB vaccination are listed below.
Danish: Generelle reaktioner, som kan forekomme i tidsmæssig association med Tritanrix HepB vaccination, er listet nedenfor:
English: A history of febrile convulsions, a family history of convulsions, a family history of SIDS (Sudden Infant Death Syndrome) and a family history of an adverse reaction following Tritanrix HepB vaccination do not constitute contra-indications.
Danish: Tidligere tilfælde af febrile konvulsioner, tilfælde af konvulsioner i familien, tilfælde af SIDS (Sudden Infant Death Syndrome) i familien og tilfælde af en bivirkning efterfølgende Tritanrix HepB vaccination udgør ikke kontraindikationer.
English: • Pertussis (Whooping cough): Pertussis is a highly infectious illness.
Danish: • Kighoste (pertussis): Kighoste er en svær smitsom sygdom.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Danish: Tegn på en allergisk reaktion kan være kløende hududslæt, kortåndethed og opsvulming af ansigtet eller tungen.
English: This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.3)
Danish: Denne vaccine indeholder thiomersal (en organisk kviksølvforbindelse) som konserveringsmiddel og der er derfor risiko for, at overfølsomhedsreaktioner kan forekomme (se pkt.
English: Group 2
Danish: Gruppe 2 (Separate)
English: • collapse or periods of unconsciousness or lack of awareness have been reported within 2 to 3 days
Danish: • kollaps eller perioder med bevidsthedstab eller mangel på koncentration er rapporteret
English: TRITANRIX HepB SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED
Danish: TRITANRIX HepB MÅ UNDER INGEN OMSTÆNDIGHEDER ADMINISTRERES
English: See section 6.5 for the number of doses per vial.
Danish: Se antal doser pr. hætteglas i afsnit 6.5
English: Tritanrix HepB can be mixed with the lyophilised Hib vaccine (Hiberix).
Danish: Tritanrix HepB kan blandes med den lyofiliserede Hib vaccine (Hiberix).
English: HIV infection is not considered as a contra-indication for diphtheria, tetanus, pertussis and HBV vaccination.
Danish: HIV infektion betragtes ikke som en kontraindikation for difteri, tetanus, pertussis og HBV vaccination.
English: What Tritanrix HepB is and what it is used for Before your child receives Tritanrix HepB
Danish: Tritanrix HepBs virkning og hvad du skal bruge det til Det skal du vide, før dit barn modtager Tritanrix HepB
English: The incidences are presented below:
Danish: Incidenserne er angivet
English: In some clinical studies, Tritanrix HepB was used to reconstitute the lyophilised Hib vaccine (Hiberix); no interference in the immune response to any of the antigens was observed as compared to the responses observed following administration of the vaccines at separate sites.
Danish: I nogle kliniske studier blev Tritanrix HepB anvendt til at rekonstituere den lyofiliserede Hib vaccine (Hiberix); der blev ikke observeret nogen interferens i immunresponset mod nogle af antigenerne i sammenligning med de responser, der blev observeret efter administration af vaccinerne på adskilte steder.
English: • in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination
Danish: • længere mellemrum mellem vejrtrækningerne hos meget tidligt fødte børn (født i uge 28 eller før af svangerskabet) kan forekomme 2-3 dage efter vaccination
English: * in a subgroup of infants not administered hepatitis B vaccine at birth, 89.9% of subjects had anti-HBs titres † cut-off accepted as indicative of protection †† vaccine response: % of subjects considered to have responded to the Bordetella pertussis antigen
Danish: * Hos en undergruppe af spædbørn, der ikke blev vaccineret med hepatitis B-vaccine ved fødslen, † Den fastsatte grænseværdi, som indikerer beskyttelse †† Vaccinerespons: Procentdel af personer, der vurderes at have responderet på Bordetella pertussis
English: Tritanrix HepB is for deep intramuscular injection, preferably in the anterolateral thigh.
Danish: Tritanrix HepB er til dyb intramuskulær injektion, fortrinsvis i det anterolaterale lår.
English: The vaccine should be well shaken in order to obtain a homogeneous turbid white suspension and be inspected visually for any foreign particulate matter and/or variation of physical aspect.
Danish: Vaccinen skal omrystes omhyggeligt for at opnå en homogen uklar hvid suspension og skal inspiceres visuelt for fremmede partikler og/eller variationer i det fysisk udseende.
English: This leaflet was last approved in
Danish: Denne indlægsseddel blev senest godkendt:
English: It causes the liver to become inflamed and swollen.
Danish: Det medfører, at leveren bliver betændt og opsvulmet.
English: POSSIBLE SIDE EFFECTS Like all medicines, Tritanrix HepB can cause side effects, although not everybody gets them.
Danish: Tritanrix HepB kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Tritanrix HepB is available in the following pack sizes:
Danish: Tritanrix HepB findes i følgende pakningsstørrelser:
English: The active substances and other ingredients in Tritanrix HepB are listed at the end of the leaflet.
Danish: De aktive substanser samt øvrige ingredienser i Tritanrix HepB er anført I slutningen af denne indlægsseddel.
English: TRITANRIX HepB SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVENOUSLY.
Danish: TRITANRIX HepB MÅ UNDER INGEN OMSTÆNDIGHEDER ADMINISTRERES INTRAVENØST.
English: The vaccine should be well shaken in order to obtain a homogeneous turbid white suspension and visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration.
Danish: Vaccinen skal omrystes omhyggeligt for at opnå en homogen uklar hvid suspension og skal inspiceres visuelt for fremmede partikler og/eller forandringer af det fysiske udseende før administration.
English: Store in the original package, in order to protect from light.
Danish: Opbevares i den original pakning for at beskytte mod lys.
English: • redness or swelling at the injection site
Danish: • Rødme eller hævelse på injektionsstedet
English: Tritanrix HepB should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Danish: Tritanrix HepB skal administreres med forsigtighed til personer med thrombocytopeni eller en blødningsforstyrrelse, da blødning kan forekomme efter intramuskulær administration hos disse personer.
English: After the marketing of Tritanrix HepB, the following additional side effects have been reported on a few
Danish: Efter markedsføring af Tritanrix HepB er følgende bivirkninger set i få tilfælde:
English: As with other vaccines, a dose of vaccine should be withdrawn under strict aseptic conditions and precautions taken to
Danish: Som med andre vacciner skal en dosis af vaccinen tages op under nøje aseptiske omstændigheder, og passende forholdsregler skal tages for at undgå kontaminering af indholdet.
English: After control of the disease the vaccine should be administered
Danish: Når sygdommen er under kontrol kan vaccinen gives.
English: • if after previously having Tritanrix HepB or another vaccine against pertussis (whooping cough) disease, your child had any problems, especially: ♦ A high temperature (over 40°C) within 48 hours of vaccination ♦ A collapse or shock-like state within 48 hours of vaccination ♦ Persistent crying lasting 3 hours or more within 48 hours of vaccination ♦ Seizures/fits with or without a high temperature within 3 days of vaccination
Danish: • hvis dit barn efter en tidligere vaccination med Tritanrix HepB eller en anden vaccine mod pertussis (kighoste) har haft problemer, specielt hvad angår: ♦ Høj temperatur (over 40°C) indenfor 48 timer efter vaccinationen.
English: The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, fits and even death.
Danish: Bakterierne frigiver et toksin (giftstof), som kan give muskelstivhed, smertefulde muskelkramper, krampeanfald og endda medføre døden.
English: Pertussis can also cause ear infections, bronchitis which may last a long time, pneumonia, fits, brain damage and even death.
Danish: Kighoste kan også give betændelse i ørene, langvarig bronkitis, lungebetændelse, krampeanfald, hjerneskade og endda medføre døden.
English: HOW TO STORE TRITANRIX HepB
Danish: SÅDAN OPBEVARER DU TRITANRIX HepB
English: • if your child has previously had an allergic reaction to any vaccine against diphtheria, tetanus, pertussis (whooping cough) or hepatitis B diseases.
Danish: • hvis dit barn tidligere har haft en allergisk reaktion mod andre vacciner mod difteri, tetanus, pertussis (kighoste) eller hepatitis B.
English: • if your child has a tendency to seizures/fits due to a fever, or if there is a history in the family of this
Danish: • hvis dit barn har tendens til kramper/krampeanfald på grund af feber, eller hvis der findes
English: The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of
Danish: Virus er tilstede i kropsvæsker såsom blod, sæd, vagianlsekret eller spyt
English: * reported by the parents as adversely affecting the child's daily activities For both vaccination groups, the majority of the reactions were short lasting.
Danish: * Rapporteret af forældre som en bivirkning, der påvirkede barnets daglige aktiviteter.
English: As for any vaccination, the risk-benefit of immunising with Tritanrix HepB or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.
Danish: Som ved andre vaccinationer skal risiko og fordele ved immunisering med Tritanrix HepB vurderes og en udskydelse af vaccinationen bør overvejes for spædbørn og børn, som lider af en begyndende eller fremskridende alvorlig neurologiske lidelse.
English: In the event of either being observed, discard the vaccine.
Danish: I tilfælde af observation af et af de nævnte forhold skal vaccinen kasseres.
English: Tritanrix HepB is indicated for active immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from 6 weeks onwards (see section 4.2).
Danish: Tritanrix HepB er indiceret til aktiv immunisering mod difteri, tetanus, pertussis og hepatitis B (HBV) hos børn fra 6 uger og opefter (Se afsnit 4.2).
English: The surface antigen of the HBV (HBsAg) is produced by culture of genetically-engineered yeast cells (Saccharomyces cerevisiae) which carry the gene coding for the major surface antigen of the HBV.
Danish: dyrkning af gensplejsede gærceller (Saccharomyces cerevisiae), som bærer genet, der koder for det vigtigste overfladeantigen af HBV.
English: The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and even death.
Danish: Bakterierne frigiver også et toksin (giftstof), som kan give nerveskade, hjerteproblemer og endda
English: Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.
Danish: Fortæl det altid til lægen eller apoteket, hvis dit barn tager anden medicin eller har brugt det for nylig.
English: Tritanrix HepB is a white, slightly milky liquid presented in a glass vial for 2 doses (1 ml) or in a glass vial
Danish: Tritanrix HepB er en hvid, næsten mælkeagtig væske i et hætteglas med 2 dosis (1 ml) eller i et
English: ♦ Very rare (side effects which may occur in less than 10,000 doses of vaccine):
Danish: ♦ Meget sjælden (bivirkninger som optræder for mindre end 10.000 doser af vaccinen)
English: You will be informed by the doctor or nurse when you should
Danish: Lægen eller sygeplejersken vil give dig besked om, hvornår du skal komme igen til efterfølgende injektioner.
English: Tritanrix HepB is a white, slightly milky liquid presented in a glass vial for 1 dose (0.5 ml).
Danish: Tritanrix HepB er en hvid, næsten mælkeagtig væske i et hætteglas med 1 dosis (0,5 ml).
English: This is a multidose container.
Danish: Dette er et hætteglas til flergangsdosering.
English: Tritanrix HepB is available in pack of 1.
Danish: Tritanrix HepB findes i pakninger med 1 hætteglas.
English: Marketing Authorisation Holder and Manufacturer
Danish: Indehaveren af markedsføringstilladelsen og fremstiller:
English: Side effects that occurred during clinical trials with Tritanrix HepB were as follows:
Danish: Følgende bivirkninger optrådte ved de kliniske forsøg med Tritanrix HepB:
English: 0.5 ml of suspension in a vial (type I glass) with a plunger stopper (rubber butyl) - pack size of 1.
Danish: 0,5 ml suspension i hætteglas (type I glas) med en propstopper (butylgummi) - pakningsstørrelse er 1.
English: • Clinical trials: In clinical studies, the most commonly reported adverse events were reactions at the injection site, including redness, swelling and pain.
Danish: • Kliniske undersøgelser I kliniske studier var reaktioner ved injektionsstedet, herunder rødme, hævelse og smerte, de oftest rapporterede bivirkninger.
English: BEFORE YOUR CHILD RECEIVES TRITANRIX HepB Tritanrix HepB should not be given:
Danish: DET SKAL DU VIDE, FØR DIT BARN MODTAGER TRITANRIX HepB Tag ikke Tritanrix HepB:
English: Percentage of subjects with antibody titres ≥ assay cut-off one month after primary vaccination with
Danish: Procentdel af personer med antistoftiter ≥ den fastsatte grænseværdi (assay cut-off) 1 måned
English: Water for injections
Danish: Natriumklorid Vand til injektion.
English: Take special care with Tritanrix HepB:
Danish: Vær ekstra forsigtig med at tage Tritanrix HepB:
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER/FREMSTILLERE AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: ♦ Very common (side effects which may occur in more than 1 per 10 doses of vaccine):
Danish: ♦ Meget almindelig (bivirkninger som optræder ved mere end 1 ud af 10 doser af vaccinen)
English: Hypersensitivity after previous administration of diphtheria, tetanus, pertussis or hepatitis B vaccines.
Danish: Overfølsomhed efter forudgående indgift af difteri, tetanus, pertussis eller hepatitis B vacciner.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MULTIDOSE VIAL
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER FOR FLERDOSIS FORPAKNINGER
English: DTPw-HBV vaccine
Danish: DTPw-HBV vaccine i.m.
English: B. CONDITIONS OF THE MARKETING AUTHORISATION • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE
Danish: • BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Tritanrix HepB - Suspension for injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Tritanrix HepB - Suspension til injection
English: ♦ bleeding or bruising more easily than normal If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
Danish: ♦ blødning eller tendens til blå mærker i højere grad end normalt Tal med lægen eller apoteket, hvis en bivirkning bliver værre eller du bemærker bivirkning, som ikke
English: It is recommended that in patients with thrombocytopenia or bleeding disorders the vaccine be administered
Danish: Det anbefales at administrere vaccinen subkutant hos patienter med thrombocytopeni eller
English: WHAT TRITANRIX HepB IS AND WHAT IT IS USED FOR Tritanrix HepB is a vaccine used in children to prevent four diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough) and hepatitis B. The vaccine works by causing the body to produce its own protection
Danish: Tritanrix HepB er en vaccine, som anvendes til børn for at beskytte mod fire sygdomme: difteri, tetanus (stivkrampe), pertussis (kighoste) samt hepatitis B. Vaccinen virker ved at hjælpe kroppen til selv at producere egne beskyttelse (antistoffer) mod disse sygdomme.
English: • sore throat and discomfort when swallowing • gastrointestinal symptoms such as vomiting and diarrhoea
Danish: • Halsbetændelse eller ondt i halsen og synktebesvær • Symptomer fra mave-tarmkanalen såsom opkastinger og diarré
English: - If you have any further questions, ask your doctor or your pharmacist.
Danish: - Spørg lægen eller på apoteket, hvis der er mere, du vil vide.
English: The HBsAg assembles spontaneously, in the absence of chemical treatment, into spherical particles of 20 nm in average diameter containing non-glycosylated HBsAg polypeptide and a lipid matrix consisting mainly of phospholipids.
Danish: Disse indeholder ikke-glycosyleret HBsAg polypeptid og en lipidmatrix, der hovedsagligt består af phospholipider.
English: Tritanrix HepB contains diphtheria (D), tetanus (T) toxoids, inactivated pertussis bacteria (Pw) and the purified major surface antigen of the hepatitis B virus (HBV), adsorbed on aluminium salts.
Danish: Tritanrix HepB indeholder difteri (D), tetanus (T) toxoider, inaktiverede pertussis bakterier (Pw) og det oprensede vigtigste overfladeantigen af hepatitis B virus (HBV), som er adsorberet til aluminiumssalte.
English: • allergic reactions, including anaphylactic and anaphylactoid reactions.
Danish: • Overfølsomhedsreaktioner (anafylaktiske reaktioner).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIDOSE VIAL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE FOR FLERDOSIS FORPAKNINGER
English: In clinical studies, the most commonly reported adverse events were reactions at the injection site, including redness, swelling and pain.
Danish: I kliniske studier var reaktioner ved injektionsstedet, herunder rødme, hævelse og smerte, de oftest rapporterede bivirkninger.
English: 5 ml of suspension in a vial (type I glass) for 10 doses with a plunger stopper (rubber butyl) - pack size of
Danish: 5 ml suspension i hætteglas (type I glas) til 10 doser, med en propstopper (butylgummi)
English: General disorders and administration site conditions: very common: fever, swelling, pain and redness very rare: allergic reactions including anaphylactic and anaphylactoid reactions and serum sickness very common: unusual crying, irritability
Danish: Almene symptomer og reaktioner på administrationsstedet: Meget almindelig: Feber, hævelse, smerte og rødme