FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VEPACEL suspension for injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) VEPACEL, injektionsvæske, suspension
English: Other medicines and VEPACEL
Danish: Brug af anden medicin sammen med VEPACEL
English: After first opening, the vaccine should be used immediately.
Danish: Vaccinen skal anvendes omgående efter første åbning.
English: One pack of 20 multidose vials (type I glass) of 5 ml suspension (10 x 0.5 ml doses) with a stopper (bromobutyl rubber).
Danish: En pakning med 20 flerdosishætteglas (type I glas) a 5 ml suspension (10 x 0,5 ml doser) med prop (brombutylgummi).
English: If you are not sure, talk to your doctor or nurse before having this vaccine.
Danish: Tal med din læge eller sygeplejerske, inden du bliver vaccineret, hvis du ikke er sikker.
English: • abnormal, reduced sensation
Danish: • unormal nedsat følelse
English: ** ≥ 4-fold increase in MN titer *** geometric mean increase
Danish: ** ≥4-dobbelt stigning i MN-titer *** geometrisk middelstigning
English: • stomach pain, upset stomach
Danish: • mavepine, fordøjelsesproblemer
English: 1 pre-filled syringe (0.5 ml)
Danish: 1 fyldt injektionssprøjte (0,5 ml)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL - SINGLE DOSE PRE-FILLED SYRINGE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET - ENKELTDOSIS FYLDT INJEKTIONSSPRØJTE
English: 20 multidose vials (10 doses of 0.5 ml per vial)
Danish: 20 multidosishætteglas (10 doser af 0,5 ml pr. hætteglas)
English: Cross-reactive immune response against related H5N1 strains In a clinical study in adults aged 18 to 59 years (N=265) and in older people aged 60 years and above (N=270) after vaccination with the A/Vietnam/1203/2004 strain vaccine, the rate of subjects with cross-neutralising antibodies as measured by MN (titre ≥ 20) was as follows:
Danish: Krydsreaktivt immunrespons mod beslægtede H5N1-stammer I et klinisk studie hos voksne mellem 18 og 59 år (N=265) og ældre personer på 60 år og derover (N=270) efter vaccination med A/Vietnam/1203/2004-stammen var andelen af personer med krydsneutraliserende antistoffer, målt med MN (titer ≥20), følgende:
English: Visually inspect the suspension prior to administration.
Danish: Efterse suspensionen før anvendelsen.
English: After primary vaccination the rate of subjects with neutralising antibody titres > 20, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in adults aged 18 to 59 years and in older people aged 60 years and above were as follows:
Danish: Efter primær vaccination var andelen af personer med neutraliserende antistoftitre >20, serokonverteringsværdier og serokonverteringfaktor, målt med mikroneutraliseringsanalyse (MN) hos voksne fra 18 til 59 år og ældre personer på 60 år og derover, som følger:
English: ** ≥ 4-fold increase in MN titre *** geometric mean increase
Danish: ** ≥4-dobbelt stigning i MN-titer *** geometrisk gennemsnitsstigning
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 10 DOSE VIAL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON - HÆTTEGLAS MED 10 DOSER
English: Clinical trials were conducted with the H5N1 vaccine (see section 5.1 for more information on the H5N1 vaccines) in approximately 3700 subjects (ranging in age groups from 18 to 59 years and 60 years and above) and special risk groups of approximately 300 subjects each, consisting of immunocompromised subjects and patients with chronic disease conditions.
Danish: 5.1 for yderligere oplysninger vedrørende H5N1-vacciner) er undersøgt i kliniske forsøg hos ca. 3.700 personer (i aldersgrupperne fra 18 til 59 år og fra 60 år og derover) og hos ca 300 personer i særlige risikogrupper, med immunkompromitering og kroniske sygdomme.
English: PHARMACEUTICAL FORM AND CONTENTS Suspension for injection
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, suspension
English: VEPACEL is presented as a suspension for injection in a pre-filled syringe.
Danish: Hvad VEPACEL udseende og pakningsstørrelse VEPACEL leveres som en suspension til injektion i en fyldt sprøjte.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Multidose vial (10 doses of 0.5 ml)
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Multidosishætteglas (10 doser af 0,5 ml)
English: There are no post-marketing data available for VEPACEL.
Danish: Der foreligger ingen data for VEPACEL efter markedsføringen.
English: • hardness, redness, swelling or bruising at the injection site
Danish: • hårdhed, rødme, hævelse eller mindre blødning ved indsprøjtningsstedet
English: How VEPACEL is given
Danish: Sådan får du VEPACEL
English: Trometamol Sodium Chloride Water for injections Polysorbate 80
Danish: Natriumchlorid Vand til injektionsvæsker Polysorbat 80
English: • vertigo (a spinning sensation)
Danish: • svimmelhed (en snurrende fornemmelse)
English: 1 pack of a pre-filled syringe containing a single dose of 0.5 ml suspension for injection with a latex-free plunger (halogeno-butyl-rubber) without needles.
Danish: En pakning med 1 fyldt injektionssprøjte med en enkelt dosis a 0,5 ml injektionsvæske, suspension med en latexfri stempelprop (halogenbutylgummi) uden nåle.
English: Very rare (affects less than 1 user in 10,000):
Danish: Meget sjælden (forekommer hos: mindre end 1 bruger ud af 10.000):
English: Immune response against A/Vietnam/1203/2004 (H5N1) The immunogenicity of the A/Vietnam/1203/2004 strain vaccine has been evaluated in three clinical studies in adults aged 18 - 59 years (N=961) and in two clinical studies in subjects aged 60 years and older (N=391) following a 0, 21 day schedule.
Danish: Immunrespons mod A/Vietnam/1203/2004 (H5N1) Immunogeniciteten af vaccine med A/Vietnam/1203/2004-stammen er vurderet i tre kliniske forsøg med voksne på 18-59 år (N=961) og i to kliniske forsøg med personer på 60 år og derover (N=391), der blev vaccineret på dag 0 og dag 21.
English: PHARMACEUTICAL FORM Suspension for injection.
Danish: LÆGEMIDDELFORM Injektionsvæske, suspension i flerdosisbeholder.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Pre-filled syringe (0.5ml)
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Fyldt sprøjte (0,5 ml)
English: Very common (affects more than 1 user in 10):
Danish: Meget almindelig (forekommer hos flere end 1 ud af 10 brugere):
English: Infants, children and adolescents from the age of 6 months to 17 years and adults from the age of 18 years:
Danish: Spædbørn, børn og unge i alderen fra 6 måneder til 17 år og voksne i alderen 18 år og derover: Der gives en dosis på 0,5 ml.
English: However, if co-administration with another vaccine is indicated, immunisation should be carried out on separate limbs.
Danish: Hvis det er nødvendigt med samtidig indgift af andre vacciner, bør dette ske ved injektion i forskellige ekstremiteter.
English: One pack of 1 single dose pre-filled syringe (type I glass) containing 0.5 ml suspension for injection, with a latex-free plunger stopper (halogeno-butyl rubber) without needles.
Danish: En pakning med 1 fyldt injektionssprøjte (type I glas) med en enkelt dosis a 0,5 ml injektionsvæske, suspension med en latexfri stempelprop (halogenbutylgummi) uden nåle.
English: VEPACEL must not be administered intravascularly.
Danish: VEPACEL må ikke gives intravaskulært.
English: Rare: neuralgia, transient thrombocytopenia.
Danish: Ikke almindelig: Generaliserede hudreaktioner Sjælden: Neuralgi, forbigående trombocytopeni.
English: After vaccination the rate of subjects with neutralising antibody titres ≥ 20, seroconversion rate and seroconversion factor as measured by MN assay in immunocompromised subjects and patients with chronic disease conditions were as follows:
Danish: Efter vaccination var andelen af personer med neutraliserende antistoftitre ≥20, serokonverteringsværdier og serokonverteringsfaktor, målt med mikroneutraliseringsanalyse (MN), hos immunkompromitterede personer og patienter med kroniske sygdomme som følger:
English: Immune system disorders: anaphylactic reaction, hypersensitivity Nervous system disorders: febrile convulsion Skin and subcutaneous tissue disorders: angioedema Muscoluskeletal and connective tissue disorders: pain in extremity
Danish: Hud og subkutane væv: Angioødem Knogler, led, muskler og bindevæv: Ekstremitetssmerter
English: MINIMUM PARTICULARS ATTACHED TO THE OUTER CARTON OF MULTIDOSE CONTAINER AND PRE-FILLED SYRINGE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ DEN YDRE EMBALLAGE FLERDOSISBEHOLDER OG FYLDT INJEKTIONSSPRØJTE
English: Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleeding.
Danish: Ved vaccination af personer med trombocytopeni eller blødningsforstyrrelse, hvor intramuskulær injektion kan være kontraindiceret, bør fordele og risici derfor vurderes nøje.
English: After vaccination, the rate of subjects with neutralizing antibody titers ≥ 20, seroconversion rate and seroconversion factor, as measured by MN assay, in infants, children, and adolescents aged 6 months to 17 years were as follows:
Danish: Efter vaccination var seroprotektionsværdi, serokonversionsværdi og serokonversionsfaktor for anti-HA-antistof, målt med enkelt radial hæmolyse (SRH), hos spædbørn, børn og unge i alderen fra 6 måneder til 17 år som følger:
English: Influenza virus (whole virion, inactivated), containing antigen of*strain: A/Vietnam/1203/2004 (H5N1) 7.5 micrograms** * produced in Vero cells ** haemagglutinin
Danish: Influenzavirus (hel virion, inaktiveret) indeholdende antigen* af stamme: A/Vietnam/1203/2004 (H5N1) 7,5 mikrogram** * produceret i vero-celler ** hæmagglutinin
English: A heterologous booster vaccination with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 strain vaccine has been administered in a time frame of 12 to 24 months after priming vaccination with two doses of the A/Vietnam/1203/2004 strain vaccine in three clinical studies in adults aged 18 to 59 years and in older people aged 60 years and above.
Danish: En boostervaccination med en 7,5 µg heterolog ikke-adjuveret formulering af A/Indonesia/05/2005stamme blev administreret over en tidsperiode på 12 til 24 måneder efter indledende vaccination med to doser af A/Vietnam/1203/2004-stammen i tre kliniske studier hos voksne i alderen 18 til 59 år og ældre personer på 60 og derover.
English: Rare (affects 1 to 10 users in 10,000):
Danish: Sjælden (forekommer hos 1 til 10 brugere ud af 10.000):
English: Influenza-like illness
Danish: • influenzalignende sygdom
English: A booster with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 strain vaccine administered 12 months after a single dose priming vaccination with the A/Vietnam/1203/2004 strain vaccine was also evaluated in adults aged 18 to 59 years.
Danish: En booster med en 7,5 µg ikke-adjuveret formulering af A/Indonesia/05/2005-stammen er blevet administreret 12 måneder efter en enkelt dosis indledende vaccination med A/Vietnam/1203/2004stammen hos voksne i alderen 18 til 59 år.
English: • fatigue (feeling tired)
Danish: • træthed (træthedsfornemmelse)
English: Common (affects 1 to 10 users in 100):
Danish: Almindelig (forekommer hos mellem 1 og 10 ud af 100 brugere):
English: - if you have had any allergic reaction to any ingredient of the vaccine (see section 6 at the end of the leaflet) or trace residues (formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein).
Danish: 6 til sidst i indlægssedlen) eller sporrester (formaldehyd, benzonase, saccharose, trypsin, vero-værtscelleprotein).
English: Seroneutralization rates (MN titer ≥ 20) at 21 days after a booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains, were as follows:
Danish: Seroneutraliseringsværdier (MN titer ≥20) 21 dage efter en boostervaccination med en 7,5 µg dosis af A/Indonesia/05/2005-stammen, testet imod både de homologe og heterologe stammer, var som følger:
English: SUBCUTANEOUS TISSUE DISORDERS
Danish: HUD OG SUBKUTANE VÆV
English: There are no post-marketing surveillance data available for VEPACEL.
Danish: Der foreligger ingen data fra bivirkningsovervågning efter markedsføringen af VEPACEL.
English: Seroneutralisation rates (MN titre ≥ 20) at 21 days after a 12 to 24 months booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains were as follows:
Danish: Seroneutraliseringsværdier (MN-titer ≥20) 21 dage efter en 12-24 måneders boostervaccination med en 7,5 µg dosis af A/Indonesia/05/2005-stammen testet imod både de homologe og heterologe stammer var følgende:
English: Influenza virus (whole virion, inactivated) containing antigen of strain: A/Vietnam/1203/2004 (H5N1)
Danish: Influenzavirus (hel virion, inaktiveret) indeholder antigen af stamme: A/Vietnam/1203/2004 (H5N1) 7,5 mikrogram
English: Seroneutralisation rates (MN titre ≥ 20) at 21 days after a 12 months booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains were as follows:
Danish: Seroneutraliseringsværdier (MN-titer ≥20) 21 dage efter en 12 måneders boostervaccination med en 7,5 µg dosis af A/Indonesia/05/2005-stammen testet imod både de homologe og heterologe stammer var som følger:
English: Injection site pruritus Axillary pain
Danish: Pruritus på injektionsstedet, Skuldersmerter
English: - if you have previously had a severe allergic reaction to any ingredient of VEPACEL (these are listed at the end of the leaflet - section 6) or to any substances that may be present in trace (very low) amounts: formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein.
Danish: 6) eller på eventuelle stoffer, der kan være til stede i (meget lave) spormængder: formaldehyd, benzonase, saccharose, trypsin, vero-værtscelleprotein.
English: History of anaphylactic reactions to the active substance, or to any of the excipients listed in section 6.1, or trace residues (formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein).
Danish: 6.1, eller spor heraf (formaldehyd, benzonase, saccharose, trypsin, vero-værtscelleprotein).
English: There are no data with VEPACEL using the subcutaneous route.
Danish: Der foreligger ingen data om subkutan anvendelse af VEPACEL.
English: • bruising at the injection site
Danish: • blåt mærke på injektionsstedet
English: Uncommon (affects 1 to 10 users in 1,000):
Danish: Ikke almindelig (forekommer hos mellem 1 og 10 ud af 1.000 brugere):
English: Very Common Very Common
Danish: Almindelig Meget almind.
English: MARKETING AUTHORISATION NUMBER EU/1/12/752/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/12/752/001
English: MARKETING AUTHORISATION NUMBER EU/1/12/752/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/12/752/002
English: • sleepiness
Danish: • ørepine
English: Diarrhea Vomiting Nausea
Danish: NERVESYSTEMET Vertigo Hovedpine
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 17/02/2012
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: What VEPACEL is and what it is used for What you need to know before you receive VEPACEL How VEPACEL is given
Danish: Det skal du vide, før du vaccineres med VEPACEL Sådan får du VEPACEL
English: • stuffy or runny nose
Danish: • tilstoppet næse eller løbende næse
English: Seroneutralisation rate* Immunocompromised subjects Patients with chronic disease conditions Tested against
Danish: serokonverteringsværdier og serokonverteringsfaktor, målt med mikroneutraliseringsanalyse (MN), hos immunkompromitterede personer og patienter med kroniske sygdomme som følger:
English: NAME OF THE MEDICINAL PRODUCT VEPACEL suspension for injection in multidose container Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
Danish: VEPACEL, injektionsvæske, suspension i flerdosisbeholder Præpandemisk influenzavaccine (H5N1) (hel virion, inaktiveret, fremstillet i cellekultur)
English: Nasal congestion Rhinorrhea Dry throat
Danish: Tilstoppet næse Rinorré
English: Hyperhidrosis Pruritis Rash
Danish: HUD OG SUBKUTANE VÆV Hyperhidrose Pruritus
English: PEEL OFF´S (1 PEEL OFF PER DOSIS)
Danish: AFRIVNINGSSTRIMLER (1 AFRIVNINGSSTRIMMEL PR.
English: Uncommon Very Common
Danish: Almindelig Ikke almindelig
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/752/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/752/002
English: - If you get any of the side effects, talk to your doctor or nurse.
Danish: - Kontakt lægen eller sygeplejersken, hvis en bivirkning bliver værre, eller du får bivirkninger,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/752/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/752/001
English: NAME OF THE MEDICINAL PRODUCT VEPACEL suspension for injection in a pre-filled syringe Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
Danish: VEPACEL, injektionsvæske, suspension i fyldt injektionssprøjte Præpandemisk influenzavaccine (H5N1) (hel virion, inaktiveret, fremstillet i cellekultur)
English: After removing the syringe cap, attach the needle immediately and remove the needle shield prior to administration.
Danish: Når injektionssprøjtens hætte er fjernet, påsættes nålen straks.
English: Immediate Packaging
Danish: Emballage Indhold
English: Content (concentration)
Danish: (Koncentration)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Component 1:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Komponent 1:
English: Read this before you open the package
Danish: Læs dette, før du åbner pakningen
English: Such substances should be removed to the greatest possible extent before applying the product.
Danish: Sådanne stoffer skal så vidt muligt fjernes, inden produktet appliceres.
English: An updated RMP should be submitted:
Danish: Der skal indsendes en opdateret RMP
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: I overensstemmelse med artikel 114 i Rådets direktiv 2001/83/EF skal den officielle batchfrigivelse foretages af et statslaboratorium eller af et laboratorium, der er udpeget til dette formål.
English: Multiple bleeding sites may be treated simultaneously.
Danish: Flere blødningssteder kan behandles samtidigt.
English: Human albumin
Danish: Humant albumin
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af shock skal der iværksættes medicinsk standardbehandling for shock.
English: At the Cmax, the plasma concentration represented only 1 to 2% of the applied dose.
Danish: Ved Cmax repræsenterede plasmakoncentrationen kun 1 til 2 % af den applicerede dosis.
English: The frequency of this type of event is not known (cannot be estimated from available data).
Danish: Hyppigheden af denne type hændelser er ukendt (kan ikke vurderes ud fra de forhåndenværende data).
English: Read all of this leaflet carefully before this medicine is used to treat you, because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden dette lægemiddel bruges til behandling af dig, da den indeholder vigtige oplysninger.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/868/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/13/868/001
English: In animal studies EVARREST was absorbed by 56 days when used at the anticipated clinical dose.
Danish: I dyreforsøg var EVARREST absorberet i løbet af 56 dage, når det blev anvendt i den forventede kliniske dosis.
English: EVARREST can be used in an actively bleeding field.
Danish: EVARREST kan anvendes i et aktivt blødende område.
English: You must not be treated with EVARREST if you are allergic to human fibrinogen or human thrombin or to any of the other ingredients of this medicine (listed in section 6).
Danish: Du ma ikke blive behandlet med EVARREST, hvis du er allergisk over for humant fibrinogen eller humant thrombin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 September 2013
Danish: Dato for første markedsføringstilladelse: 29. september 2013
English: It is left in place and is absorbed by the body in approximately 8 weeks.
Danish: Det fjernes ikke igen og absorberes af kroppen i løbet af ca. 8 uger.
English: The surgeon will apply EVARREST during your operation.
Danish: Kirurgen vil påføre EVARREST under din operation.
English: In the integrated analyses, 381 patients were treated with EVARREST and 272 patients were treated with control treatment.
Danish: I den integrerede analyse blev 381 patienter behandlet med EVARREST, og 272 patienter blev behandlet med en kontrolbehandling.
English: EVARREST is not recommended for use in children and adolescents under 18 years of age.
Danish: EVARREST anbefales ikke til brug hos børn og unge under 18 år.
English: EVARREST must not be stored above 25°C and must not be frozen.
Danish: EVARREST må ikke opbevares over 25 °C og må ikke nedfryses.
English: Maintain compression for approximately 3 minutes, to control the bleeding.
Danish: Oprethold kompressionen i ca. 3 minutter for at kontrollere blødningen.
English: The following categories are used to rank the adverse reactions by frequency of occurrence: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); and very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Følgende kategorier anvendes til at rangordne bivirkninger efter, hvor hyppigt de forekommer: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000) og meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Your surgeon must not treat you with EVARREST in the following circumstances: EVARREST must not be applied inside blood vessels.
Danish: Din kirurg må ikke behandle dig med EVARREST under følgende omstændigheder: EVARREST må ikke anvendes inden i blodkar.
English: As a consequence, intravascular pharmacokinetic studies were not performed in man.
Danish: Som følge deraf er der ikke udført intravaskulære farmakokinetiske studier hos mennesker.
English: No interaction studies have been performed.
Danish: Der er ikke udført interaktionsforsøg.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the 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 modtages 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: If these symptoms occur during surgery, the use of the product should be stopped immediately.
Danish: Hvis disse symptomer opstår under operationen, bør anvendelsen af produktet straks ophøre.
English: The product should only be administered according to the instructions recommended for this product (see section 6.6).
Danish: Dette produkt må kun administreres i henhold til de instruktioner, der anbefales til produktet (se pkt.
English: Remove excess blood or fluid from the site of application if required to improve visibility.
Danish: Fjern overskydende blod eller væske fra appliceringsstedet, hvis det er nødvendigt for at forbedre udsynet.
English: In isolated cases, these reactions have progressed to severe anaphylaxis.
Danish: I isolerede tilfælde er disse progredieret til svær anafylaksi.
English: Supportive treatment in adult surgery where standard surgical techniques are insufficient (see section
Danish: Understøttende behandling hos voksne under kirurgi, hvor kirurgiske standardteknikker er utilstrækkelige(se pkt.