FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients whose vascular tone and renal function depend predominantly on the activity of the reninangiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure (see section 4.5).
Norwegian Bokmål: pasienter med alvorlig kongestiv hjertesvikt eller underliggende nyresykdom, inkludert renal arteriestenose), er akutt hypotensjon, azotemi, oliguri eller sjeldnere også akutt nyresvikt, sett ved behandling med ACE-hemmere eller angiotensin IIantagonister som påvirker dette systemet (se pkt.
English: Sodium:
Norwegian Bokmål: Natrium:
English: The frequency of the side effects listed below is defined using the following convention: Common: may affect up to 1 in 10 people
Norwegian Bokmål: Forekomsten av bivirkningene som vises nedenfor defineres slik: Svært vanlige (≥ 1/10)
English: No specific information is available on the treatment of overdose with Ifirmacombi.
Norwegian Bokmål: behandling av overdose med Ifirmacombi.
English: How to take Ifirmacombi
Norwegian Bokmål: Hvordan du oppbevarer Ifirmacombi
English: Not known Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma)
Norwegian Bokmål: Ikke-melanom hudkreft (basalcellekarsinom og uspesifisert (inkludert cyster og polypper)
English: Ifirmacombi 300 mg/25 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough.
Norwegian Bokmål: Ifirmacombi 300 mg/25 mg er vanligvis foreskrevet av legen når tidligere behandling for høyt blodtrykk ikke førte til tilfredsstillende reduksjon av blodtrykket.
English: Ifirmacombi 300 mg/25 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172) in the film-coating.
Norwegian Bokmål: Ifirmacombi 300 mg/25 mg: mannitol, hydroksypropylcellulose, lavsubstituert hydroksypropylcellulose, natriumstivelseglykolat, talkum, makrogol 6000, hydrogenert lakserolje i tablettkjernen og polyvinylalkohol, titandioksid (E171), makrogol, talkum, gult jernoksid (E172) og rødt jernoksid (E172) i filmdrasjélaget.
English: Electrolyte imbalance:
Norwegian Bokmål: Elektrolyttforstyrrelser:
English: Ifirmacombi 150 mg/12.5 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough.
Norwegian Bokmål: Ifirmacombi 150 mg/12,5 mg er vanligvis foreskrevet av legen når tidligere behandling for høyt blodtrykk ikke førte til tilfredsstillende reduksjon av blodtrykket.
English: Ifirmacombi 150 mg/12.5 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172) in the film-coating.
Norwegian Bokmål: Ifirmacombi 150 mg/12,5 mg: mannitol, hydroksypropylcellulose, lavsubstituert hydroksypropylcellulose, natriumstivelseglykolat, talkum, makrogol 6000, hydrogenert lakserolje i tablettkjernen og polyvinylalkohol, titandioksid (E171), makrogol, talkum, gult jernoksid (E172) og rødt jernoksid (E172) i filmdrasjélaget.
English: Not known: pancreatitis, anorexia, diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite
Norwegian Bokmål: pankreatitt, anoreksi, diaré, forstoppelse, magebesvær, sialadenitt, redusert appetitt
English: Ifirmacombi 300 mg/12.5 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol, talc in the film-coating.
Norwegian Bokmål: Ifirmacombi 300 mg/12,5 mg: mannitol, hydroksypropylcellulose, lavsubstituert hydroksypropylcellulose, natriumstivelseglykolat, talkum, makrogol 6000, hydrogenert lakserolje i tablettkjernen og polyvinylalkohol, titandioksid (E171), makrogol, talkum i filmdrasjélaget.
English: Ifirmacombi 300 mg/12.5 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough.
Norwegian Bokmål: Ifirmacombi 300 mg/12,5 mg er vanligvis foreskrevet av legen når tidligere behandling for høyt blodtrykk ikke førte til tilfredsstillende reduksjon av blodtrykket.
English: Your doctor may need to change your dose and/or to take other precautions:
Norwegian Bokmål: Legen kan endre dosen din og/eller ta andre forholdsregler: - hvis du bruker en ACE-hemmer eller aliskiren (se også informasjon i avsnittene «Bruk ikke
English: - If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Ifirmacombi” and “Warnings and precautions”)
Norwegian Bokmål: Ifirmacombi» og «Advarsler og forsiktighetsregler»).
English: What Ifirmacombi looks like and contents of the pack
Norwegian Bokmål: Hvordan du oppbevarer Ifirmacombi Innholdet i pakningen og ytterligere informasjon
English: Dosage of Ifirmacombi 300 mg/25 mg
Norwegian Bokmål: Dosering for Ifirmacombi 300 mg/25 mg
English: Ifirmacombi 150 mg/12.5 mg film-coated tablets Ifirmacombi 300 mg/12.5 mg film-coated tablets Ifirmacombi 300 mg/25 mg film-coated tablets
Norwegian Bokmål: Ifirmacombi 150 mg/12,5 mg filmdrasjerte tabletter Ifirmacombi 300 mg/12,5 mg filmdrasjerte tabletter Ifirmacombi 300 mg/25 mg filmdrasjerte tabletter
English: Other medicines and Ifirmacombi
Norwegian Bokmål: Sammensetning av Ifirmacombi
English: Not known: vertigo, paraesthesia, light-headedness, restlessness
Norwegian Bokmål: vertigo, parestesi, ørhet, rastløshet
English: Ifirmacombi 150 mg/12.5 mg film-coated tablets Pale pink, biconvex, oval, film-coated tablets.
Norwegian Bokmål: Ifirmacombi 150 mg/12,5 mg filmdrasjerte tabletter Blekt rosa, bikonvekse, ovale, filmdrasjerte tabletter.
English: Not known: weakness, muscle spasm
Norwegian Bokmål: svakhet, muskelspasmer
English: Ifirmacombi 150 mg/12.5 mg and 300 mg/25 mg film-coated tablets Film coating:
Norwegian Bokmål: Ifirmacombi 150 mg/12,5 mg og 300 mg/25 mg filmdrasjerte tabletter
English: What Ifirmacombi contains - The active substances are irbesartan and hydrochlorothiazide.
Norwegian Bokmål: Virkestoffer er irbesartan og hydroklortiazid.
English: Ifirmacombi 300 mg/25 mg Pale pink, biconvex, capsule shaped, film-coated tablets (tablets).
Norwegian Bokmål: Ifirmacombi 300 mg/25 mg Blekt rosa, bikonvekse, kapselformete, filmdrasjerte tabletter (tabletter).
English: Not known: interstitial nephritis, renal dysfunction
Norwegian Bokmål: interstitiell nefritt, nedsatt nyrefunksjon
English: Ifirmacombi 300 mg/12.5 mg White, biconvex, capsule shaped, film-coated tablets (tablets).
Norwegian Bokmål: Ifirmacombi 300 mg/12,5 mg Hvite, bikonvekse, kapselformete, filmdrasjerte tabletter (tabletter).
English: Ifirmacombi 300 mg/12.5 mg film-coated tablets White, biconvex, capsule shaped, film-coated tablets.
Norwegian Bokmål: Ifirmacombi 300 mg/12,5 mg filmdrasjerte tabletter Hvite, bikonvekse, kapselformete, filmdrasjerte tabletter.
English: Ifirmacombi 300 mg/25 mg tablets Irbesartan/Hydrochlorothiazide
Norwegian Bokmål: Ifirmacombi 300 mg/25 mg tabletter irbesartan/hydroklortiazid
English: Blister (OPA/Aluminium/PVC//Aluminium): 14, 28, 30, 56, 56 x 1, 84, 90 and 98 film-coated tablets, in a box.
Norwegian Bokmål: Esker med 14, 28, 30, 56, 56 x 1, 84, 90 og 98 filmdrasjerte tabletter i OPA/aluminium/PVC//aluminium blisterpakninger.
English: Try to take your daily dose at about the same time each day.
Norwegian Bokmål: Du kan ta Ifirmacombi med eller uten mat. Dosen bør tas på samme tid hver dag.
English: Dosage of Ifirmacombi 300 mg/12.5 mg
Norwegian Bokmål: Dosering for Ifirmacombi 300 mg/12,5 mg
English: Ifirmacombi 300 mg/25 mg film-coated tablets Pale pink, biconvex, capsule shaped, film-coated tablets.
Norwegian Bokmål: Ifirmacombi 300 mg/25 mg filmdrasjerte tabletter Blekt rosa, bikonvekse, kapselformete, filmdrasjerte tabletter.
English: Dosage of Ifirmacombi 150 mg/12.5 mg
Norwegian Bokmål: Dosering for Ifirmacombi 150 mg/12,5 mg
English: Ifirmacombi 300 mg/12.5 mg film-coated tablets Film coating:
Norwegian Bokmål: Ifirmacombi 300 mg/12,5 mg filmdrasjerte tabletter
English: Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Norwegian Bokmål: Hver filmdrasjert tablett inneholder 300 mg irbesartan (som irbesartanhydroklorid) og 25 mg hydroklortiazid.)
English: Gastrointestinal disorders
Norwegian Bokmål: Gastrointestinale sykdommer: Ikke kjent:
English: Ifirmacombi 150 mg/12.5 mg film-coated tablets Each film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Norwegian Bokmål: Ifirmacombi 150 mg/12,5 mg filmdrasjerte tabletter Hver filmdrasjerte tablett inneholder 150 mg irbesartan (som irbesartanhydroklorid) og 12,5 mg hydroklortiazid.
English: Each film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Norwegian Bokmål: Hver filmdrasjert tablett inneholder 150 mg irbesartan (som irbesartanhydroklorid) og 12,5 mg hydroklortiazid.
English: - Ifirmacombi 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; - Ifirmacombi 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Ifirmacombi 150 mg/12.5 mg. - Ifirmacombi 300 mg/25 mg may be administered in patients insufficiently controlled by Ifirmacombi 300 mg/12.5 mg.
Norwegian Bokmål: • Ifirmacombi 300 mg/12,5 mg kan gis til pasienter som ikke er tilfredsstillende kontrollert med irbesartan 300 mg eller Ifirmacombi 150 mg/12,5 mg;
English: Cardiac disorders
Norwegian Bokmål: hjerterytmeforstyrrelser
English: Ifirmacombi 300 mg/25 mg film-coated tablets Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Norwegian Bokmål: Ifirmacombi 300 mg/25 mg filmdrasjerte tabletter Hver filmdrasjerte tablett inneholder 300 mg irbesartan (som irbesartanhydroklorid) og 25 mg hydroklortiazid.
English: Ifirmacombi 150 mg/12.5 mg tablets Irbesartan/Hydrochlorothiazide
Norwegian Bokmål: Ifirmacombi 150 mg/12,5 mg tabletter irbesartan/hydroklortiazid
English: Each Ifirmacombi 150 mg/12.5 mg film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Norwegian Bokmål: Hver Ifirmacombi 150 mg/12,5 mg filmdrasjerte tablett inneholder 150 mg irbesartan (som irbesartanhydroklorid) og 12,5 mg hydroklortiazid.
English: Each Ifirmacombi 300 mg/25 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Norwegian Bokmål: Hver Ifirmacombi 300 mg/25 mg filmdrasjerte tablett inneholder 300 mg irbesartan (som irbesartanhydroklorid) og 25 mg hydroklortiazid.
English: Not known: fever
Norwegian Bokmål: feber
English: Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Norwegian Bokmål: Hver filmdrasjert tablett inneholder 300 mg irbesartan (som irbesartanhydroklorid) og 12,5 mg hydroklortiazid.
English: Each Ifirmacombi 300 mg/12.5 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Norwegian Bokmål: Hver Ifirmacombi 300 mg/12,5 mg filmdrasjerte tablett inneholder 300 mg irbesartan (som irbesartanhydroklorid) og 12,5 mg hydroklortiazid.
English: Ifirmacombi 300 mg/12.5 mg film-coated tablets Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Norwegian Bokmål: Ifirmacombi 300 mg/12,5 mg filmdrasjerte tabletter Hver filmdrasjerte tablett inneholder 300 mg irbesartan (som irbesartanhydroklorid) og 12,5 mg hydroklortiazid.
English: Ifirmacombi 300 mg/12.5 mg tablets Irbesartan/Hydrochlorothiazide
Norwegian Bokmål: Ifirmacombi 300 mg/12,5 mg tabletter irbesartan/hydroklortiazid
English: Not known: tinnitus
Norwegian Bokmål: tinnitus
English: Ifirmacombi 300 mg/25 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Norwegian Bokmål: Ifirmacombi 300 mg/25 mg tabletter, filmdrasjerte irbesartan/hydroklortiazid
English: Ifirmacombi 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Norwegian Bokmål: Ifirmacombi 150 mg/12,5 mg tabletter, filmdrasjerte irbesartan/hydroklortiazid
English: Ifirmacombi 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Norwegian Bokmål: Ifirmacombi 300 mg/12,5 mg tabletter, filmdrasjerte irbesartan/hydroklortiazid
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Norwegian Bokmål: Ondartet svulst, malign og Ikke kjent:
English: Warnings and precautions Talk to your doctor before taking Ifirmacombi and if any of the following apply to you: - if you get excessive vomiting or diarrhoea - if you suffer from kidney problems or have a kidney transplant - if you suffer from heart problems - if you suffer from liver problems - if you suffer from diabetes - if you suffer from lupus erythematosus (also known as lupus or SLE) - if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).
Norwegian Bokmål: hvis du lider av hjerteproblemer hvis du lider av leverproblemer hvis du lider av sukkersyke (diabetes) hvis du lider av lupus erythematosus(heter også lupus eller SLE).
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration
Norwegian Bokmål: Styrke Legemiddelform Administrasjonsmåte Indre emballasje Pakningsstørrelse
English: 0.6 ml (10 mg/ml) 1 pre-filled syringe
Norwegian Bokmål: 0,6 ml (10 mg/ml) 1 ferdigfylt sprøyte
English: MA (EU) Number
Norwegian Bokmål: EU-nummer
English: 16904 Solna Sweden
Norwegian Bokmål: 16904 Solna Sverige
English: AT-1020 Vienna Austria
Norwegian Bokmål: AT-1020 Vienna Østerrike
English: 5026 RH Tilburg The Netherlands
Norwegian Bokmål: 5026 RH Tilburg Nederland
English: 41470 Neuss Germany
Norwegian Bokmål: 41470 Neuss Tyskland
English: F-92787 Issy Les Moulineaux, Cedex 9 France
Norwegian Bokmål: F-92787 Issy Les Moulineaux, Cedex 9 Frankrike
English: Janssen-Cilag SpA Via M.Buonarroti, 23 I-20093 Cologno Monzese MI, Italy
Norwegian Bokmål: Janssen-Cilag SpA Via M.Buonarroti, 23 I-20093 Cologno Monzese MI, Italia
English: Janssen-Cilag A/S Bregnerødvej 133 3460 Birkerød Denmark
Norwegian Bokmål: Janssen-Cilag A/S Bregnerødvej 133 3460 Birkerød Danmark
English: Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse Belgium
Norwegian Bokmål: Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse Belgia
English: The Netherlands Janssen-Cilag BV Dr. Paul Janssenweg
Norwegian Bokmål: Janssen-Cilag BV Dr. Paul Janssenweg
English: 56 Eirinis Ave, Pefki, Athens GR-151 21 Greece
Norwegian Bokmål: 56 Eirinis Ave, Pefki, Athens GR-151 21 Hellas
English: 56 Eirinis Ave, Pefki Athens GR-151 21 Greece
Norwegian Bokmål: 56 Eirinis Ave, Pefki Athens GR-151 21 Hellas
English: Experience of overdose is limited.
Norwegian Bokmål: Erfaringer med overdosering er begrenset.
English: The potential risk for pregnant women is unknown.
Norwegian Bokmål: Mulig risiko for gravide kvinner er ukjent.
English: (cannot be estimated from the available data)
Norwegian Bokmål: (kan ikke anslås utifra tilgjengelige data)
English: Frequencies are defined as follows: Very common:
Norwegian Bokmål: Frekvensene er definert som følger: Svært vanlige:
English: Date of latest renewal: 18 September 2017
Norwegian Bokmål: Dato for siste fornyelse: 18. september 2017
English: These symptoms have been of mild and transient nature)
Norwegian Bokmål: Disse symptomene har vært milde og forbigående).
English: This results in protection against the disease.
Norwegian Bokmål: Dette gir beskyttelse mot sykdommen.
English: The following side effects may also occur after receiving this vaccine.
Norwegian Bokmål: Følgende bivirkninger kan også oppstå etter bruk av denne vaksinen.
English: Side effects that have been reported during marketed use include:
Norwegian Bokmål: Bivirkninger som er rapportert under markedsført bruk, omfatter følgende:
English: The vaccine works by specifically stimulating the body's natural defense system of the vaccinated person.
Norwegian Bokmål: Vaksinen fungerer ved spesifikt å stimulere kroppens naturlige forsvarssystem hos den vaksinerte personen.
English: In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
Norwegian Bokmål: Ved overdosering anbefales overvåking av vitale funksjoner og eventuelt symptomatisk behandling.
English: Intervals between Primary Doses
Norwegian Bokmål: Intervaller mellom primærdoser
English: Ask your doctor or nurse how to throw away medicines you no longer use.
Norwegian Bokmål: Spør lege eller sykepleier hvordan du skal kaste legemidler som du ikke lenger bruker.
English: Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency and they are consequently listed with the frequency unknown.
Norwegian Bokmål: Da disse reaksjonene er rapportert frivillig fra en populasjon av ukjent størrelse, er det ikke alltid mulig å gi pålitelige anslag av frekvensen, og de er derfor presentert med frekvensen ikke kjent.
English: See section 5.1 for information on protection against specific group B strains.
Norwegian Bokmål: 5.1 for informasjon om beskyttelse mot bestemte gruppe B-stammer.
English: 1 month after 2nd dose
Norwegian Bokmål: 1 måned etter 2. dose
English: Pack sizes of 1 or 10 syringes.
Norwegian Bokmål: Pakningsstørrelser på 1 eller 10 sprøyter.
English: Feeling faint or fainting.
Norwegian Bokmål: Besvimelsesfornemmelse eller besvimelse.
English: 2, 3, 4, 12 months
Norwegian Bokmål: 2, 3, 4, 12 måneder
English: Antipyretic medication should be initiated according to local guidelines in infants and children (less than 2 years of age).
Norwegian Bokmål: Antipyretisk medisinering skal igangsettes i tråd med lokale retningslinjer hos spedbarn og barn (yngre enn 2 år).
English: Kanamycin is used in early manufacturing process and is removed during the later stages of manufacture.
Norwegian Bokmål: Kanamycin brukes tidlig i produksjonsprosessen og fjernes under senere trinn av produksjonen.
English: If present, the kanamycin level in the vaccine is low.
Norwegian Bokmål: Hvis det finnes, er kanamycinnivået i vaksinen lavt.
English: Adults above 50 years of age
Norwegian Bokmål: Voksne over 50 år
English: Very common: headache
Norwegian Bokmål: Svært vanlige: hodepine
English: There are no data on fertility in humans.
Norwegian Bokmål: Det finnes ingen data på fertilitet hos mennesker.
English: As with many vaccines, healthcare professionals should be aware that a temperature elevation may occur following vaccination of infants and children (less than 2 years of age).
Norwegian Bokmål: Som med mange vaksiner skal helsepersonell være klar over at det kan forekomme en temperaturøkning etter vaksinering av spedbarn og barn (yngre enn 2 år).
English: If present, kanamycin levels in the final vaccine are less than 0.01 micrograms per dose.
Norwegian Bokmål: Hvis det finnes, er kanamycinnivået i den ferdige vaksinen mindre enn 0,01 mikrogram per dose.
English: As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Norwegian Bokmål: Ettersom fordelen med vaksinering er høy for denne spedbarnsgruppen, skal vaksinering ikke tilbakeholdes eller utsettes.
English: 0, 1 months
Norwegian Bokmål: 0, 1 måneder
English: Immunogenicity in special populations
Norwegian Bokmål: Immunogenisitet i spesielle populasjoner
English: Not less than 1 month
Norwegian Bokmål: Ikke mindre enn 1 måned
English: Like all vaccines, this vaccine can cause side effects, although not everybody gets them.
Norwegian Bokmål: Mulige bivirkninger Som alle vaksiner kan denne vaksinen forårsake bivirkninger, men ikke alle får det.
English: Bexsero has no or negligible influence on the ability to drive and use machines.
Norwegian Bokmål: Bexsero har ingen eller ubetydelig påvirkning på evnen til å kjøre bil og bruke maskiner.
English: The suspension is white opalescent liquid.
Norwegian Bokmål: Suspensjonen er en hvit opaliserende væske.
English: This will help to reduce some of the side effects of Bexsero.
Norwegian Bokmål: Dette reduserer noen av bivirkningene til Bexsero.
English: Do NOT use Bexsero:
Norwegian Bokmål: Bruk IKKE Bexsero:
English: What BEXSERO is and what it is used for
Norwegian Bokmål: Hva BEXSERO er og hva det brukes mot
English: What you need to know before you or your child receive BEXSERO
Norwegian Bokmål: Hva du må vite før du eller ditt barn får BEXSERO
English: Most of the primary immunogenicity studies were conducted as randomized, controlled, multicenter, clinical trials.
Norwegian Bokmål: De fleste studier av primær immunogenitet ble utført som randomiserte, kontrollerte kliniske multisenterstudier.
English: - if you or your child receive treatment that blocks the part of the immune system known as complement activation, such as eculizumab.
Norwegian Bokmål: - hvis du eller ditt barn får behandling som blokkerer den delen av immunsystemet kjent som komplementaktivering, som for eksempel eculizumab.
English: 50/50/50 micrograms
Norwegian Bokmål: 50/50/50 mikrogram
English: Not less than 2 months
Norwegian Bokmål: Ikke mindre enn 2 måneder
English: Infants and children (up to 10 years of age)
Norwegian Bokmål: Spedbarn og barn (opp til 10 års alder)
English: Immunogenicity was evaluated in infants, children, adolescents and adults.
Norwegian Bokmål: Immunogenitet ble evaluert hos spedbarn, barn, ungdom og voksne.
English: Before use, the pre-filled syringe should be well shaken in order to form a homogeneous suspension.
Norwegian Bokmål: Før bruk skal den ferdigfylte sprøyten ristes godt for å få en homogen suspensjon.
English: - If you or your child are allergic to the active substances or any of the other ingredients of this vaccine (listed in section 6).
Norwegian Bokmål: - dersom du eller ditt barn er allergisk overfor virkestoffene eller noen av de andre innholdsstoffene i denne vaksinen (listet opp i avsnitt 6).
English: Rare (these may affect up to 1 in 1,000 people) - Kawasaki disease which may include symptoms such as fever that lasts for more than five days,
Norwegian Bokmål: Sjeldne (disse kan ramme opptil 1 av 1000 personer) - Kawasakis sykdom som kan omfatte symptomer som feber som varer i over fem dager,
English: The clinical significance of this observation and the need for additional booster doses to maintain longer term protective immunity has not been established.
Norwegian Bokmål: Den kliniske signifikansen av dette funnet og behovet for ekstra påfyllingsdoser for å opprettholde beskyttende immunitet i lengre tid er ikke fastslått.
English: Pharmacotherapeutic group: meningococcal vaccines, ATC code: J07AH09
Norwegian Bokmål: Farmakoterapeutisk gruppe: meningokokkvaksiner, ATC-kode: J07AH09
English: When fever occurred, it generally followed a predictable pattern, with the majority resolving by the day after vaccination.
Norwegian Bokmål: Når det oppstod feber, fulgte den som regel et forutsigbart mønster, og i de fleste tilfeller var den borte innen dagen etter vaksinering.