FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients randomised to secukinumab received 10 mg/kg intravenously at weeks 0, 2, and 4, followed by either 75 mg or 150 mg subcutaneously every month starting at week 8.
Danish: Patienter, der var randomiseret til secukinumab, fik 10 mg/kg intravenøst ved uge 0, 2 og 4 efterfulgt af enten 75 mg eller 150 mg subkutant hver måned begyndende ved uge 8.
English: Lower respiratory tract infections Not known Mucosal and cutaneous candidiasis (including oesophageal candidiasis)
Danish: Mukosal eller kutan candidiasis (inklusive candidiasis i øsofagus)
English: DO NOT USE if the syringe is broken.
Danish: BRUG IKKE sprøjten, hvis injektionssprøjten er beskadiget.
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) - pre-filled pen
Danish: DELPAKNING AF MULTIPAKNING (UDEN BLUE BOX) - fyldt pen
English: ASDAS-CRP major improvement * p<0.05, ** p<0.01, *** p<0.001; versus placebo All p-values adjusted for multiplicity of testing based on pre-defined hierarchy, except BASDAI 50 and ASDAS-CRP
Danish: ASDAS-CRP væsentlig forbedring * p<0,05, ** p<0,01, *** p<0,001; versus placebo
English: Diarrhoea Uncommon Inflammatory bowel disease
Danish: Mave-tarm-kanalen Almindelig Diarré Ikke almindelig
English: PASI 75 response n (%)
Danish: PASI 75-respons n (%)
English: Cosentyx is available in unit packs containing 1 or 2 pre-filled pens and in multipacks containing 6 (3 packs of 2) pre-filled pens.
Danish: Cosentyx fås i enkeltpakninger med 1 eller 2 fyldte penne og i multipakninger med 6 (3 pakninger med 2) fyldte penne.
English: • redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis)
Danish: • rødme og afskalning af huden på store dele af kroppen, evt. med kløe og smerter
English: Based on your response, your doctor may increase your dose to 300 mg.
Danish: Din læge kan øge dosis til 300 mg, alt afhængig af din reaktion.
English: Cosentyx 150 mg solution for injection is supplied in a single-use pre-filled pen for individual use.
Danish: Cosentyx 150 mg injektionsvæske, opløsning, leveres i en fyldt pen til individuel engangsbrug.
English: At week 16, patients who were randomised to placebo at baseline were re-randomised to receive secukinumab (either 150 mg or 300 mg subcutaneously) every month.
Danish: Ved uge 16 blev patienter, der var randomiseret til placebo ved baseline, re-randomiseret til at få secukinumab (enten 150 mg eller 300 mg subkutant) hver måned.
English: Do not use if the lyophilised powder has not fully dissolved or if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Danish: Må ikke anvendes, hvis det lyofiliserede pulver ikke er helt opløst, eller hvis væsken indeholder umiddelbart synlige partikler, er uklar eller tydeligt brun.
English: At week 16, patients who were randomised to placebo at baseline were re-randomised to receive secukinumab (either 75 mg or 150 mg subcutaneously) every month.
Danish: Ved uge 16 blev patienter, der var randomiseret til placebo ved baseline, re-randomiseret til at få secukinumab (enten 75 mg eller 150 mg subkutant) hver måned.
English: The recommended dose is 300 mg of secukinumab by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
Danish: Den anbefalede dosis er 300 mg secukinumab med subkutan injektion, med indledende dosering i ugerne 0, 1, 2, 3 og 4, fulgt af månedlig vedligeholdelsesdosering.
English: Patients randomised to secukinumab received 10 mg/kg intravenously at weeks 0, 2, and 4, followed by either 150 mg or 300 mg subcutaneously every month.
Danish: Patienter, der var randomiseret til secukinumab, fik 10 mg/kg intravenøst ved uge 0, 2 og 4 efterfulgt af enten 150 mg eller 300 mg subkutant hver måned.
English: - The other ingredients are sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 80.
Danish: - Øvrige indholdsstoffer: sukrose, histidin, histidinhydrochloridmonohydrat og polysorbat 80.
English: In PsA study 2, at week 24, secukinumabtreated patients with concomitant MTX use had a higher ACR 20 response (47.7% and 54.4% for 150 mg and 300 mg, respectively, compared to placebo 20.0%) and ACR 50 response (31.8% and 38.6% for 150 mg and 300 mg, respectively, compared to placebo 8.0%).
Danish: I PsA-studie 2 ved uge 24 havde patienter behandlet med secukinumab med samtidig brug af MTX et højere ACR20-respons (47,7 % og 54,4 % for henholdsvis 150 mg og 300 mg) sammenlignet med placebo (20,0 %) og ACR50-respons (31,8 % og 38,6 % for henholdsvis 150 mg og 300 mg) sammenlignet med placebo (8,0 %).
English: • discharge from the eye with itching, redness and swelling (conjunctivitis)
Danish: • udflåd fra øjnene med kløe, rødme og hævelse (konjunktivitis)
English: Inspection window Internal needle cover
Danish: Vindue Indvendig kanyledæksel
English: Patient Instructions for Use
Danish: Brugsanvisning til patienter
English: After reconstitution, 1 ml of solution contains 150 mg secukinumab.
Danish: Efter rekonstitution, 1 ml opløsning indeholder 150 mg secukinumab.
English: Disposing of your Cosentyx SensoReady pen:
Danish: Sådan bortskaffer du din Cosentyx SensoReady-pen:
English: Cosentyx is available in unit packs containing 1 or 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.
Danish: Cosentyx fås i enkeltpakninger med 1 eller 2 fyldte injektionssprøjter og i multipakninger med 6 (3 pakninger med 2) fyldte injektionssprøjter.
English: Multipack containing 6 (3 x 2) pre-filled syringes
Danish: Multipakning indeholder 6 (3 x 2) fyldte injektionssprøjter
English: Do not shake or invert the vial.
Danish: Hætteglasset må ikke rystes eller vendes på hovedet.
English: Multipack: 6 (3 packs of 2) pre-filled pens
Danish: Multipakning: 6 (3 pakninger med 2) fyldte penne
English: Multipack containing 6 (3 x 2) pre-filled pens
Danish: Multipakning indeholder 6 (3 x 2) fyldte penne
English: Store in the refrigerator between 2°C and 8°C.
Danish: Opbevares i køleskab mellem 2°C - 8°C.
English: Cosentyx is available in packs containing one vial.
Danish: Cosentyx fås i pakninger med ét hætteglas.
English: PASI 90 response n (%)
Danish: PASI 90-respons n (%)
English: Single use.
Danish: Subkutan anvendelse Engangsbrug.
English: • Each 300 mg dose is given as two injections of 150 mg.
Danish: • Hver dosis på 300 mg gives som to indsprøjtninger på hver 150 mg.
English: Cosentyx 150 mg solution for injection is supplied in a single-use pre-filled syringe for individual use.
Danish: Cosentyx 150 mg injektionsvæske, opløsning, leveres i en fyldt injektionssprøjte til individuel engangsbrug.
English: Solution for injection in a pre-filled pen
Danish: Injektionsvæske, opløsning i en fyldt pen secukinumab
English: PASI 100 response n (%) 0 (0.0%) 5
Danish: PASI 100-respons n (%) 0 (0,0 %) 5
English: Each 300 mg dose is given as two subcutaneous injections of 150 mg.
Danish: Hver 300 mg dosis gives som to subkutane injektioner på 150 mg.
English: Serious infections have been observed in patients receiving secukinumab in the post-marketing setting.
Danish: Efter markedsføring er der blevet observeret alvorlige infektioner hos patienter som modtog secukinumab.
English: Cosentyx 150 mg injection secukinumab
Danish: Cosentyx 150 mg injektionsvæske secukinumab s.c.
English: You should not be given certain types of vaccines (live vaccines) while using Cosentyx.
Danish: (levende vacciner), mens du bruger Cosentyx.
English: SYRINGE LABEL
Danish: ETIKET PÅ SPRØJTE
English: Multipack: 6 (3 packs of 2) pre-filled syringes
Danish: Multipakning: 6 (3 pakninger med 2) fyldte injektionssprøjter
English: Store the pen sealed in its box to protect from light.
Danish: Opbevar pennen forseglet i pakningen for at beskytte mod lys.
English: In both study 3 and study 4, patients randomised to secukinumab received 150 mg or 300 mg doses at weeks 0, 1, 2, 3 and 4, followed by the same dose every month.
Danish: I både studie 3 og studie 4 blev patienter randomiseret til secukinumab doser på 150 mg eller 300 mg i ugerne 0, 1, 2, 3 og 4, fulgt af samme dosis hver måned.
English: OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) - pre-filled syringe
Danish: YDERKARTON FOR MULTIPAKNING (INKLUSIVE BLUE BOX) - fyldt injektionssprøjte
English: Oral herpes
Danish: Almindelig Oral herpes Ikke almindelig
English: PASI 100 response n(%) 0 (0.0%) 10
Danish: PASI 100-respons n (%) 0 (0,0 %) 10
English: DO NOT invert the vial.
Danish: VEND IKKE hætteglasset på hovedet.
English: For other patients, the recommended dose is 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
Danish: Til andre patienter er den anbefalede dosis 150 mg s.c. med initial dosering uge 0, 1, 2, 3 og 4 efterfulgt af månedlig vedligeholdelsesdosering.
English: Cosentyx 150 mg powder for solution for injection
Danish: Cosentyx 150 mg pulver til injektionsvæske, opløsning
English: PASI 100 response n (%)
Danish: PASI 100-respons n (%)
English: • Cotton ball or gauze.
Danish: • Vatkugle eller gaze
English: Week 24 *p<0.05 based on nominal, but non adjusted, p-value 1secukinumab 150 mg or 300 mg s.c. at weeks 0, 1, 2, 3, and 4 followed by the same dose every month 10 mg/kg at weeks 0, 2 and 4 followed by subcutaneous doses of 75 mg or 150 mg
Danish: 1Secukinumab 150 mg eller 300 mg s.c. ved uge 0, 1, 2, 3, og 4, efterfulgt af den samme dosis hver måned 10 mg/kg ved uge 0, 2 og 4 efterfulgt af subkutane doser på 75 mg eller 150 mg
English: Each pre-filled pen contains 150 mg secukinumab.
Danish: Hver enkelt fyldt pen indeholder 150 mg secukinumab.
English: At each timepoint you will receive a 300 mg dose given as two injections of 150 mg.
Danish: Hver gang får du en dosis på 300 mg, der gives som to indsprøjtninger på hver 150 mg.
English: Preparing the Cosentyx pre-filled syringe ready for use Note: For a 300 mg dose, prepare 2 pre-filled syringes and inject the contents of both.
Danish: Bemærk: Til en dosis på 300 mg skal der klargøres 2 fyldte sprøjter, og indholdet af dem begge skal indsprøjtes.
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) - pre-filled syringe
Danish: DELPAKNING AF MULTIPAKNING (UDEN BLUE BOX) - fyldt injektionssprøjte
English: What Cosentyx is and what it is used for What you need to know before you use Cosentyx How to use Cosentyx
Danish: Det skal du vide, før du begynder at bruge Cosentyx Sådan skal du bruge Cosentyx Bivirkninger
English: Enthesitis resolution n (%) ‡ Week 16
Danish: Enthesitis-ophør n (%) ‡
English: Each pre-filled pen contains 150 mg secukinumab in 1 ml.
Danish: Hver fyldt pen indeholder 150 mg secukinumab i 1 ml.
English: What is in this leaflet
Danish: Gigt i rygsøjlen
English: The recommended dose is 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
Danish: Den anbefalede dosis er 150 mg s.c. med initial dosering uge 0, 1, 2, 3 og 4 efterfulgt af månedlig vedligeholdelsesdosering.
English: Each vial of powder for solution for injection contains
Danish: Hvert enkelt hætteglas med pulver til injektionsvæske, opløsning,
English: Patients randomised to secukinumab received 150 mg or 300 mg doses at weeks 0, 1, 2, 3 and 4, followed by the same dose every month.
Danish: Patienter, der var randomiseret til secukinumab, fik doser på 150 mg eller 300 mg i ugerne 0, 1, 2, 3 og 4, fulgt af samme dosis hver måned.
English: What Cosentyx looks like and contents of the pack Cosentyx solution for injection is a clear liquid.
Danish: Cosentyx injektionsvæske, opløsning, er en klar væske.
English: Store the pens in the original package in order to protect from light.
Danish: Opbevar pennen i den originale yderpakning for at beskytte mod lys.
English: Patients randomised to secukinumab received 75 mg, 150 mg or 300 mg subcutaneously at weeks 0, 1, 2, 3 and 4, followed by the same dose every month.
Danish: Patienter, der var randomiseret til secukinumab, fik 75 mg, 150 mg eller 300 mg subkutant ved uge 0, 1, 2, 3 og 4 efterfulgt af samme dosis hver måned.
English: Patients randomised to secukinumab received 75 mg or 150 mg subcutaneously at weeks 0, 1, 2, 3 and 4, followed by the same dose every month.
Danish: Patienter, der var randomiseret til secukinumab, fik 75 mg eller 150 mg subkutant ved uge 0, 1, 2, 3 og 4 efterfulgt af samme dosis hver måned.
English: Week 24 *p<0.05 based on nominal, but non adjusted, p-value secukinumab 150 mg or 300 mg s.c. at weeks 0, 1, 2, 3, and 4 followed by the same dose every month 10 mg/kg at weeks 0, 2 and 4 followed by subcutaneous doses of 75 mg or 150 mg
Danish: Gennemsnitlig ændring ved uge 24 *p<0,05 baseret på nominel, men ikke justeret p-værdi Secukinumab 150 mg eller 300 mg s.c. ved uge 0, 1, 2, 3, og 4, efterfulgt af den samme dosis hver måned
English: Instructions for use of Cosentyx pre-filled syringe
Danish: Anvisninger til brug af Cosentyx fyldt injektionssprøjte
English: BLISTER OF PRE-FILLED SYRINGE
Danish: BLISTER MED FYLDT INJEKTIONSSPRØJTE
English: Store the syringe sealed in its box to protect from light.
Danish: Opbevar injektionssprøjten forseglet i pakningen for at beskytte mod lys.
English: Patients randomised to receive placebo who were responders at week 16 were crossed over to receive secukinumab (either 150 mg or 300 mg subcutaneously) at week 24 followed by the same dose every month.
Danish: Patienter, der var randomiseret til placebo, og som havde responderet ved uge 16, skiftede behandling til at få secukinumab (enten 150 mg eller 300 mg subkutant) ved uge 24 efterfulgt af samme dosis hver måned.
English: Store the syringes in the original package in order to protect from light.
Danish: Opbevar sprøjten i den originale yderpakning for at beskytte mod lys.
English: Dispose of the used syringe in a sharps container (closable, puncture resistant container).
Danish: Smid den brugte kanyle i en kanyleboks til skarpe genstande (en beholder, der kan aflukkes og ikke kan gennembrydes).
English: Pack containing 1 pre-filled syringe
Danish: Pakning indeholder 1 fyldt injektionssprøjte
English: Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Danish: Må ikke bruges, hvis væsken indeholder umiddelbart synlige partikler, er uklar eller er tydeligt brun.
English: One vial contains 150 mg secukinumab.
Danish: 1 hætteglas indeholder 150 mg secukinumab.
English: The condition is an inflammatory disease of the joints, often accompanied by psoriasis.
Danish: Cosentyx bruges til at behandle en sygdom, der hedder psoriasisgigt, og er en betændelsestilstand i leddene, ofte i følgeskab med psoriasis.
English: Cosentyx 150 mg powder for solution for injection secukinumab
Danish: Cosentyx 150 mg pulver til injektionsvæske, opløsning secukinumab
English: One pre-filled pen contains 150 mg secukinumab in 1 ml of solution.
Danish: 1 fyldt pen indeholder 150 mg secukinumab i 1 ml opløsning.
English: Patients randomised to receive placebo who were non-responders at week 16 (early rescue) were crossed over to receive secukinumab (either 150 mg or 300 mg subcutaneously) at week 16 followed by the same dose every month.
Danish: Patienter, der var randomiseret til placebo, og som ikke havde responderet ved uge 16 (tidlig erstatningsbehandling), skiftede behandling til at få secukinumab (enten 150 mg eller 300 mg subkutant) ved uge 16 efterfulgt af samme dosis hver måned.
English: Each pre-filled syringe contains 150 mg secukinumab in 1 ml.
Danish: Hver fyldt injektionssprøjte indeholder 150 mg secukinumab i 1 ml.
English: CARTON OF UNIT PACK - pre-filled syringe
Danish: KARTON FOR ENKELTPAKNING - fyldt injektionssprøjte
English: Rhinorrhoea
Danish: Almindelig Rinoré
English: Plunger
Danish: Psoriasisgigt
English: Sucrose
Danish: Placebo
English: If you use more Cosentyx than you should
Danish: Hvis du har brugt for meget Cosentyx
English: Each vial of powder contains 150 mg secukinumab.
Danish: Hvert hætteglas med pulver indeholder 150 mg secukinumab.
English: Each pre-filled syringe contains 150 mg secukinumab.
Danish: Hver enkelt fyldt injektionssprøjte indeholder 150 mg secukinumab.
English: • Psoriatic arthritis
Danish: • Psoriasisgigt
English: To prepare Cosentyx 150 mg powder for solution for injection, please adhere to the following instructions:
Danish: Overhold venligst nedenstående anvisninger ved klargøring af Cosentyx 150 mg pulver til injektionsvæske, opløsning:
English: Cosentyx 150 mg solution for injection in pre-filled syringe secukinumab
Danish: Cosentyx 150 mg injektionsvæske, opløsning i fyldt injektionssprøjte secukinumab
English: In the TRANSFIGURE study, secukinumab was superior to placebo at week 16 (46.1% for 300 mg, 38.4% for 150 mg and 11.7% for placebo) as assessed by significant improvement from baseline in the Nail Psoriasis Severity Index (NAPSI %) for patients with moderate to severe plaque psoriasis with nail involvement.
Danish: I TRANSFIGURE-studiet var secukinumab superior i forhold til placebo ved uge 16 (46,1% for 300 mg, 38,4% for 150 mg og 11% for placebo).
English: Cosentyx 150 mg solution for injection in pre-filled pen
Danish: Cosentyx 150 mg injektionsvæske, opløsning, i fyldt pen
English: Cosentyx 150 mg solution for injection in pre-filled pen secukinumab
Danish: Cosentyx 150 mg injektionsvæske, opløsning i fyldt pen secukinumab s.c.
English: Your Cosentyx pre-filled syringe
Danish: Din Cosentyx fyldte injektionssprøjte
English: Patients randomised to placebo who were non-responders at week 16 (early rescue) and other placebo patients at week 24 were crossed over to receive secukinumab (either 75 mg or 150 mg subcutaneously) followed by the same dose every month.
Danish: Patienter, der var randomiseret til placebo, og som ikke havde responderet ved uge 16 (tidlig erstatningsbehandling), skiftede behandling til at få secukinumab (enten 75 mg eller 150 mg subkutant) ved uge 16 efterfulgt af samme dosis hver måned.
English: Finger grips
Danish: Fingerkant
English: Number of patients randomised
Danish: Behandlingsuger n = antal evaluerbare patienter
English: Uncommon Urticaria Rare
Danish: Meget almindelig
English: How to use the Cosentyx pre-filled syringe
Danish: Sådan bruger du Cosentyx fyldt injektionssprøjte
English: Storage of the Cosentyx pre-filled syringe
Danish: Klargøring af Cosentyx fyldt injektionssprøjte
English: Syringe guard wings
Danish: Kanyle Kanyleskjold Hætte
English: One pre-filled syringe contains 150 mg secukinumab in 1 ml of solution.
Danish: 1 fyldt injektionssprøjte indeholder 150 mg secukinumab i 1 ml opløsning.
English: Do not place fingers on the windows.
Danish: Placér ikke fingrene over vinduet.
English: - Headache and muscular pain.
Danish: - Hovedpine og muskelsmerter.
English: The vaccine was immunogenic in mice and rabbits.
Danish: Vaccinen var immunogen i mus og kaniner.
English: Pack size of 1 or 10 or 20.
Danish: Pakningsstørrelser med 1, 10 eller 20.
English: This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for
Danish: Denne vaccine opfylder WHO's anbefalinger (nordlige halvkugle) samt EU's bestemmelser for
English: The vaccine is a colourless and opalescent suspension.
Danish: Vaccinen er en farveløs og opaliserende suspension.
English: * In some cases, local redness lasted up to 7 days.
Danish: * I visse tilfælde varede lokal rødme ved i op til 7 dage
English: The use of IDflu should be based on official recommendations.
Danish: IDflu skal anvendes i overensstemmelse med officielle anbefalinger.
English: Tests for HIV-1, hepatitis C virus and HTLV-1 may be affected.
Danish: Test for HIV-1, hepatitis C-virus og HTLV-1 kan blive påvirket.
English: Overdose is unlikely to have any untoward effect.
Danish: Det er usandsynligt, at overdosering vil medføre en uønsket effekt.
English: You should see your doctor immediately if you experience symptoms of angioedema, such as:
Danish: De skal straks kontakte en læge, hvis De oplever symptomer på angioødem, som f.eks.:
English: The transient false positive reactions could be due to the IgM response by the vaccine.
Danish: De forbigående falsk positive resultater kan skyldes IgM-respons på vaccinen.
English: In repeated-dose toxicity studies in rabbits there was no significant evidence of systemic toxicity.
Danish: I toksicitetsundersøgelser med gentagne doser i kaniner var der ingen signifikante tegn på systemisk toksicitet.
English: Genotoxicity and carcinogenic potential were not assessed because these studies are not appropriate for a vaccine.
Danish: Genotoksicitet og carcinogent potentiale blev ikke undersøgt, eftersom sådanne undersøgelser ikke er relevante for vacciner.
English: Micro-Injection System
Danish: Mikroinjektionssystem
English: B A/New Caledonia/ 20/99 A/Wisconsin/ 67/2005 B/Malaysia/ 2506/2004 N = 2,586
Danish: B A/New Caledonia/ 20/99 A/Wisconsin/ 67/2005 B/Malaysia/ 2506/2004
English: The following side effects have been reported with other vaccines given to prevent flu.
Danish: Nedenstående bivirkninger har været indberettet med andre vacciner, som blev givet for at forebygge influenza.
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden De får dette lægemiddel, da den indeholder vigtige oplysninger.
English: • Whenever the risk management system is modified, especially as the result of new information is received that may lead to a significant change to benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Date of latest renewal: 24 February 2014
Danish: Dato for første markedsføringstilladelse: 24 februar 2009 Dato for seneste fornyelse: 24 februar 2014
English: Most of side effects listed above disappeared without treatment within 1 to 3 days after onset.
Danish: De fleste af ovennævnte bivirkninger forsvandt uden behandling i løbet af 1 til 3 dage efter begyndelsen.
English: Interference with serological testing: See section 4.5.
Danish: Interferens med serologiske test: Se pkt.
English: * propagated in fertilised hens' eggs from healthy chicken flocks
Danish: * opformeret i befrugtede hønseæg fra raske kyllingebesætninger
English: In some cases, redness at the injection site lasted up to 7 days.
Danish: I nogle tilfælde varede rødmen ved injektionsstedet op til 7 dage.
English: • Vessel inflammation which may result in very rare cases in temporary kidney problems.
Danish: • Årebetændelse, som kan føre til meget sjældne tilfælde af midlertidige nyreproblemer
English: The recommended site of administration is the region of the deltoid.
Danish: Det anbefalede injektionssted er området over m. deltoideus.
English: The immunological response may be diminished if the patient is undergoing immunosuppressant
Danish: Det immunologiske respons kan reduceres, hvis patienten er i behandling med immunsuppressiva.
English: Seroprotection is generally obtained within 2 to 3 weeks.
Danish: Serobeskyttelse opnås generelt inden for 2 til 3 uger.
English: Nevertheless, single and repeated administrations led to transient local erythema and oedema.
Danish: Ikke desto mindre medførte enkelt og gentagne injektioner forbigående lokalt erytem og ødem.