FrancophonIA/ELRC3.0 huggingface dataset:
English: Asthenia, Chest pain, Infusion site erythema, Infusion site extravasation, Infusion site inflammation, Infusion site pain, Injection site oedema, Injection site pain, Injection site pruritus, Injection site swelling, Oedema peripheral
Danish: Asteni, brystsmerter, erytem på infusionsstedet, ekstravasation på infusionsstedet, inflammation på infusionsstedet, smerter på infusionsstedet, ødem på injektionsstedet, smerter på injektionsstedet, kløe på injektionsstedet, hævelse på injektionsstedet, perifert ødem
English: If you forget to use Flebogamma DIF
Danish: Hvis du har glemt at bruge Flebogamma DIF
English: Hypersensitivity to the active substance (human immunoglobulins) or to any of the excipients (see sections 4.4 and 6.1).
Danish: Overfølsomhed over for det aktive stof (humane immunglobuliner) eller over for et eller flere af hjælpestofferne (se pkt.
English: Therefore patients receiving measles vaccine should have their antibody status checked.
Danish: Derfor bør antistofstatus kontrolleres hos patienter, der får vaccine mod mæslinger.
English: 0.4 g/kg/d for 5 days
Danish: 0,4 g/kg/dag i 5 dage
English: Special precautions
Danish: Særlige forsigtighedsregler
English: What you need to know before you use Flebogamma DIF
Danish: Det skal du vide, før du begynder at bruge Flebogamma DIF
English: For patients experiencing adverse reactions, it is advisable to reduce the infusion rate in subsequent infusions and limit the maximum rate to 0.04 ml/kg/min or administer IVIg at a 5% concentration (see section 4.4).
Danish: For patienter, der oplever bivirkninger, tilrådes det at reducere infusionshastigheden i efterfølgende infusioner og begrænse den maksimale hastighed til 0,04 ml/kg/minut eller indgive IVIg i en koncentration på 5 % (se pkt.
English: However, as in adult population, overdose may lead to fluid overload and hyperviscosity as with any other intravenous immunoglobulins.
Danish: Information om overdosering hos børn er ikke blevet fastlagt med Flebogamma DIF. Som hos den voksne population kan overdosering imidlertid medføre væske-overload og hyperviskositet som ved ethvert andet intravenøst immunglobulin.
English: Blood pressure fluctuation, Flushing
Danish: Svingende blodtryk, rødme
English: Rare (may affect up to 1 in 1000 infusions):
Danish: Sjælden (kan forekomme ved op til 1 ud af 1.000 infusioner):
English: Flebogamma DIF should not be mixed with other medicines or intravenous solutions and it should be administered by a separate intravenous line.
Danish: Flebogamma DIF må ikke blandes med andre lægemidler eller intravenøse væsker.
English: Pack size of 1 vial.
Danish: Pakningsstørrelse: 1 hætteglas.
English: *PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines.
Danish: *PSAF= opnåede ikke mindst en fordobling i IgG-antistoftiter over for pneumokok-polysaccharid og polypeptid-antigenvacciner.
English: MARKETING AUTHORISATION HOLDER Instituto Grifols, S.A.
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Instituto Grifols, S.A.
English: ● radicular syndrome (neck or back pain and other symptoms such as numbness, tingling and weakness in the arms or legs)
Danish: ● nakke- eller rygsmerter og andre symptomer såsom følelsesløshed, snurren og svaghed i arme eller ben (radikulært syndrom)
English: The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers.
Danish: Sikkerheden ved brugen af dette lægemiddel under graviditet er ikke påvist i kontrollerede kliniske forsøg.
English: • diseases which increase blood viscosity • age over 65
Danish: • sygdomme, som øger blodets viskositet (tykkelse)
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial of 10 ml, 50 ml, 100 ml and 200 ml, that is to say essentially “sodium free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. hætteglas med 10 ml, 50 ml, 100 ml og 200 ml, dvs. det er i det væsentlige natriumfrit.
English: The solution is clear or slightly opalescent and colourless or pale yellow.
Danish: Opløsningen er klar eller let opaliserende samt farveløs eller lysegul.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Replacement therapy in adults, children and adolescents (2 - 18 years) in: - Primary immunodeficiency syndromes (PID) with impaired antibody production - Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l
Danish: KLINISKE OPLYSNINGER 4.1 Terapeutiske indikationer Substitutionsterapi hos voksne, børn og unge (2-18 år) ved: - Primære immundefektsyndromer (PID) med nedsat antistofproduktion - Sekundære immundefekter (SID) hos patienter, der lider af svære eller tilbagevendende infektioner, ineffektiv antimikrobiel behandling og enten påvist specifikt antistofsvigt (proven specific antibody failure, PSAF)* eller serum-IgG-niveau på <4 g/l
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A and parvovirus B19 viruses.
Danish: De forholdsregler, der tages, anses for at være effektive mod forskellige vira såsom hiv, hepatitis B og hepatitis C samt mod vira som hepatitis A og parvovirus B19.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL (0.5 g and 2.5 g)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLASSETS ETIKET (0,5 g og 2,5 g)
English: Very common Very common
Danish: Meget almindelig Meget almindelig
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs anvendelse.
English: 10 ml, 50 ml, 100 ml, 200 ml or 400 ml solution in a vial (type II glass) with stopper (chloro-butyl-rubber).
Danish: 10 ml, 50 ml, 100 ml, 200 ml eller 400 ml opløsning i hætteglas (type II-glas) med prop (klorbutyl-gummi).
English: Migraine
Danish: Hovedpine
English: * PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines
Danish: *PSAF= opnåede ikke mindst en fordobling i IgG-antistoftiter over for pneumokok-polysaccharid og polypeptid-antigenvacciner
English: ● injection site reaction
Danish: • reaktion på injektionsstedet
English: ● hypotension (low blood pressure)
Danish: ● lavt blodtryk (hypotension)
English: ● conjunctivitis (inflammation of the conjuntiva of the eyes)
Danish: ● øjenbetændelse (conjunctivitis)
English: It was observed that the proportion of headache, pyrexia, tachycardia and hypotension in children was higher than in adults.
Danish: Det blev observeret, at hovedpine, pyreksi, takykardi og hypotension var hyppigere hos børn end hos voksne.
English: 50 ml, 100 ml or 200 ml solution in a vial (type II glass) with stopper (chloro-butyl-rubber).
Danish: 50 ml, 100 ml eller 200 ml opløsning i hætteglas (type II-glas) med prop (klorbutyl-gummi).
English: Primary immune thrombocytopenia
Danish: Primær immun trombocytopeni
English: Bicytopenia, Leukopenia
Danish: Blod og lymfesystem Bicytopeni, leukopeni
English: Three to six months are required after the initiation of therapy for equilibration (steady-state IgG levels) to occur.
Danish: Ligevægt (steady-state IgGniveauer) indtræder 3-6 måneder efter behandlingsopstart.
English: Feeling jittery, Influenza like illness, Infusion site erythema, Infusion site pain, General physical health deterioration
Danish: Anspændthed, influenzalignende symptomer, erytem på infusionsstedet, smerter på infusionsstedet, almen forringelse af det fysiske helbred
English: ● diarrhoea
Danish: ● diarré
English: Product issues
Danish: Produktspecifikt
English: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
Danish: Kronisk, inflammatorisk demyelinerende polyradikuloneuropati (CIDP)
English: Productive cough
Danish: Produktiv hoste
English: Flebogamma DIF is supplied as 0.5 g/10 ml, 2.5 g/50 ml, 5 g/100 ml, 10 g/200 ml and 20 g/400 ml vials.
Danish: Flebogamma DIF leveres i hætteglas med enten 0,5 g/10 ml, 2,5 g/50 ml, 5 g/100 ml, 10 g/200 ml og 20 g/400 ml.
English: Chest discomfort, Chest pain, Fatigue, Feeling cold, Infusion site reaction, Malaise, Oedema peripheral, Pain
Danish: Ubehag i brystkassen, brystsmerter, træthed, kuldefølelse, reaktion på infusionsstedet, utilpashed, perifert ødem, smerter
English: ● insomnia
Danish: ● søvnløshed (insomni)
English: 2 g/kg in divided doses over 2 - 5 consecutive days every 2 - 4 weeks every 4 - 8 weeks in divided doses over 2 - 5 days
Danish: 2 g/kg legemsvægt fordelt på doser over 2-5 på hinanden følgende dage hver 2. til 4. uge hver 4. til 8. uge fordelt på doser over 2-5 dage
English: Flebogamma DIF 100 mg/ml is contraindicated in children aged 0 to 2 years (see section 4.3).
Danish: Flebogamma DIF 100 mg/ml er kontraindiceret til børn i alderen 0-2 år (se pkt.
English: ● influenza (flu)
Danish: ● influenza
English: At the beginning of your infusion you will receive Flebogamma DIF at a slow rate (0.01 ml/kg/min).
Danish: I starten af infusionen får du tilført Flebogamma DIF med langsom hastighed (0,01 ml/kg/min).
English: 0.8 - 1 g/kg or
Danish: 0,8 - 1 g/kg legemsvægt eller
English: Chronic inflammatory demyelinating polyneuropathy (CIDP)
Danish: Kronisk, inflammatorisk demyelinerende polyneuropati (CIDP)
English: ● cyanosis (bluish discoloration of the skin)
Danish: ● blålig misfarvning af huden (cyanose)
English: • productive cough
Danish: • produktiv hoste
English: Pyrexia, Rigors
Danish: Pyreksi, rystelser
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (0.5 g)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (0,5 g)
English: • blood volume decrease
Danish: • nedsat blodmængde
English: Metabolism and nutrition disorders
Danish: Metabolisme og ernæring Nedsat appetit
English: Maintenance dose:
Danish: Startdosis:
English: In patients at risk for thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable.
Danish: Til patienter med risiko for tromboemboliske bivirkninger skal IVIg-præparater gives med den lavest mulige infusionshastighed og dosis.
English: Human normal immunoglobulin ……….. 50 mg (purity of at least 97% of IgG)
Danish: Humant normalt immunglobulin ………… 50 mg (renhed på mindst 97 % IgG)
English: Adverse reactions may occur more frequently - in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion - in patients with an untreated infection or underlying chronic inflammation
Danish: Bivirkninger kan forekomme hyppigere - hos patienter, der får humant normalt immunglobulin for første gang, eller i sjældne tilfælde, når patienten skifter humant normalt immunglobulinpræparat, eller hvis der er gået lang tid siden forrige infusion
English: Asthma, Cough, Dyspnoea, Epistaxis, Nasal discomfort, Laryngeal pain
Danish: Astma, hoste, dyspnø, epistaksis, ubehag i næsen, laryngeale smerter
English: Flebogamma DIF 50 mg/ml is contraindicated in children aged 0 to 2 years (see section 4.3).
Danish: Flebogamma DIF 50 mg/ml er kontraindiceret til børn i alderen 0-2 år (se pkt.
English: Flebogamma DIF is supplied as 5 g/50 ml, 10 g/100 ml and 20 g/200 ml.
Danish: Flebogamma DIF leveres i hætteglas med enten 5 g/50 ml, 10 g/100 ml og 20 g/200 ml.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially “sodium free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. hætteglas, dvs. det er i det væsentlige natriumfrit.
English: Blood pressure systolic decreased, Haemoglobin decreased, Heart rate decreased, Reticulocyte count increased
Danish: Fald i systolisk blodtryk, fald i hæmoglobin, fald i hjertefrekvens, stigning i retikulocyttal
English: Flebogamma DIF is a solution for infusion.
Danish: Flebogamma DIF er en infusionsvæske, opløsning.
English: The maximum IgA content is 50 micrograms/ml.
Danish: Det maksimale IgA-indhold er 50 mikrogram/ml.
English: In patients at risk for acute renal failure, IVIg products should be administered at the minimum rate of infusion and dose practicable.
Danish: Til patienter med risiko for akut nyresvigt bør IVIg-præparater gives med den lavest mulige infusionshastighed og dosis.
English: Human normal immunoglobulin …………..100 mg (purity of at least 97% IgG)
Danish: Humant normalt immunglobulin....................100 mg (renhed på mindst 97 % IgG)
English: Immunomodulation in adults, children and adolescents (2 - 18 years) in: - Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count - Guillain Barré syndrome - Kawasaki disease (in conjunction with acetylsalicylic acid; see 4.2) - Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) - Multifocal motor neuropathy (MMN)
Danish: Immunmodulation hos voksne, børn og unge (2-18 år) ved: - Primær immun trombocytopeni (ITP) hos patienter med høj blødningsrisiko eller før kirurgiske indgreb for at korrigere trombocyttallet - Guillain-Barrés syndrom - Kawasakis syndrom (sammen med acetylsalicylsyre, se pkt.
English: The maximum IgA content is 100 micrograms/ml.
Danish: Det maksimale IgA-indhold er 100 mikrogram/ml.
English: Maintenance doses: 1 g/kg over 1 - 2 consecutive days every 3 weeks.
Danish: Vedligeholdelsesdoser: 1 g/kg i løbet af 1-2 på hinanden følgende dage hver 3. uge.
English: A Post-Authorisation Safety Study suggested a higher rate of infusions associated with potentially related adverse events for Flebogamma DIF 100 mg/ml compared to Flebogamma DIF 50 mg/ml (see section 5.1).
Danish: Et sikkerhedsstudie efter udstedelse af markedsføringstilladelse tydede på, at infusion af Flebogamma DIF 100 mg/ml hyppigere var forbundet med potentielt relaterede bivirkninger end infusion af Flebogamma DIF 50 mg/ml (se pkt.
English: The solution should be clear or slightly opalescent and colourless or pale yellow.
Danish: Opløsningen skal være klar eller let opaliserende samt farveløs eller lysegul.
English: Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella.
Danish: Behandling med immunglobulin kan svække virkningen af vacciner med levende svækket virus som fx mæslinger, røde hunde, fåresyge og skoldkopper i en periode på mindst 6 uger og op til 3 måneder.
English: Loop diuretics Avoidance of concomitant use of loop diuretics
Danish: Slyngediuretika Undgå samtidig anvendelse af slyngediuretika.
English: • overweight
Danish: • overvægt
English: Haemolytic anaemia can develop subsequent to IVIg therapy due to enhanced red blood cells (RBC) sequestration.
Danish: Hæmolytisk anæmi kan opstå efter IVIg-behandling pga. øget sekvestrering af erytrocytter.
English: At the beginning of your infusion you will receive Flebogamma DIF at a slow rate (0.01 - 0.02 ml/kg/min).
Danish: I starten af infusionen får du tilført Flebogamma DIF med langsom hastighed (0,01-0,02 ml/kg/min).
English: Common (may affect up to 1 in 10 infusions):
Danish: Almindelig (kan forekomme ved op til 1 ud af 10 infusioner):
English: • infusion site reactions (erythema, extravasation, inflammation, pain)
Danish: • reaktioner på infusionsstedet (rødmen af huden, blodudtrædning, betændelse, smerter)
English: • blood pressure fluctuation
Danish: • svingende blodtryk
English: • device dislocation
Danish: • forskydning af anordning
English: It was observed that the proportion of headache, fever, heart rate increased and low blood pressure in children was higher than in adults.
Danish: Det blev observeret, at hovedpine, feber, øget puls og lavt blodtryk var hyppigere hos børn end hos voksne.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 August 2007
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: It contains trace amounts of IgA (lower than 100 micrograms/ml).
Danish: Lægemidlet indeholder spormængde af IgA (mindre end 100 mikrogram/ml).
English: In the case of measles, this impairment may persist for up to 1 year.
Danish: Virkningen af vacciner mod mæslinger kan være svækket i op til et år.
English: 0.4 - 0.8 g/kg
Danish: 0,4 - 0,8 g/kg legemsvægt
English: ● abdominal pain (including abdominal pain upper)
Danish: ● mavesmerter (herunder smerter i den øverste del af maven)
English: Other medicines and Flebogamma DIF
Danish: Brug af anden medicin sammen med Flebogamma DIF
English: Potential complications can often be avoided by ensuring that patients: - are not sensitive to human normal immunoglobulin by initially injecting the product slowly (at an initial rate of 0.01 - 0.02 ml/kg/min) - are carefully monitored for any symptoms throughout the infusion period.
Danish: Forsigtighedsregler vedrørende brugen Mulige komplikationer kan ofte undgås ved at sikre, at patienten: - ikke er overfølsom over for humant normalt immunglobulin ved indledningsvist at injicere præparatet langsomt (med en initial infusionshastighed på 0,01-0,02 ml/kg/minut).
English: Again, if tolerated, advance to 0.04 ml/kg/min for the third 30 minutes.
Danish: Igen, hvis det tolereres, øges til 0,04 ml/kg/min i de næste 30 minutter.
English: ● acne
Danish: ● akne
English: Potential complications can often be avoided by ensuring that patients: - are not sensitive to human normal immunoglobulin by initially injecting the product slowly (at an initial rate of 0.01 ml/kg/min) - are carefully monitored for any symptoms throughout the infusion period.
Danish: Forsigtighedsregler vedrørende brugen Mulige komplikationer kan ofte undgås ved at sikre, at patienten: - ikke er overfølsom over for humant normalt immunglobulin, ved indledningsvist at injicere præparatet langsomt (med en initial infusionshastighed på 0,01 ml/kg/minut).
English: If well tolerated, the rate of administration may gradually be increased to a maximum of 0.1 ml/kg/min.
Danish: Hvis patienten tåler dette, kan hastigheden øges gradvist til maksimalt 0,1 ml/kg/minut.
English: Uncommon (may affect up to 1 in 100 infusions):
Danish: Ikke almindelig (kan forekomme ved op til 1 ud af 100 infusioner):
English: Primary immunodeficiency syndromes Starting dose:
Danish: Kronisk, inflammatorisk demyelinerende Startdosis:
English: 0.2 - 0.4 g/kg every 3 - 4 weeks
Danish: 0,2 - 0,4 g/kg legemsvægt hver 3. til 4. uge
English: ● tremor (to tremble)
Danish: ● rysten (tremor)
English: ● myalgia (muscle pain)
Danish: ● muskelsmerter (myalgi)
English: METHOD AND ROUTE(S) OF ADMINISTRATION To hang pull here
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Træk her for ophængning
English: What Flebogamma DIF is
Danish: Hvad er Flebogamma DIF
English: • 0.8 - 1 g/kg given on day one; this dose may be repeated once within 3 days.
Danish: Der findes to forskellige doseringsskemaer: - 0,8-1 g/kg; dosis kan gentages én gang inden for 3 dage.
English: It contains trace amounts of IgA (lower than 50 micrograms/ml).
Danish: Lægemidlet indeholder spormængde af IgA (mindre end 50 mikrogram/ml).
English: What Flebogamma DIF is and what it is used for What you need to know before you use Flebogamma DIF How to use Flebogamma DIF Possible side effects
Danish: Det skal du vide, før du begynder at bruge Flebogamma DIF Sådan skal du bruge Flebogamma DIF Bivirkninger
English: • blood pressure increased
Danish: ● stigning i blodtrykket
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (2.5 g, 5 g, 10 g and 20 g)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE EMBALLAGE (2,5 g, 5 g, 10 g og 20 g)
English: • high blood pressure
Danish: • for højt blodtryk
English: Dizziness, Tremor
Danish: Pruritus, udslæt
English: Cardiovascular disorder
Danish: Hjerte-kar-sygdomme
English: Depending on how comfortable you feel, your doctor may then gradually increase the infusion rate (up to 0.08 ml/kg/min).
Danish: Hvis du ikke føler ubehag eller får gener, kan lægen gradvist øge infusionshastigheden (op til 0,08 ml/kg/min).
English: • hypersensitivity
Danish: • overfølsomhed
English: Maintenance dose: 1 g/kg in divided doses over 2 - 5 days every 3 weeks over 1 - 2 days
Danish: Vedligeholdelsesdosis: 1 g/kg legemsvægt fordelt på doser over 2-5 dage hver 3. uge over 1-2 dage
English: Patients with a kidney problem
Danish: Patienter med nedsat nyrefunktion
English: ● hypertension (high blood pressure)
Danish: ● forhøjet blodtryk (hypertension)
English: Blood pressure systolic decreased
Danish: Fald i systolisk blodtryk
English: • 0.4 g/kg given daily for two to five days.
Danish: - 0,4 g/kg dagligt i 2-5 dage.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for infusion.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Infusionsvæske, opløsning.
English: ● hypersensitivity
Danish: ● overfølsomhed
English: To hang pull here
Danish: Træk her til ophængning.
English: Pruritus, Rash pruritic
Danish: Pruritus, kløende udslæt
English: ● maculopathy (illness of the macula, in the retina of the eyes)
Danish: ● sygdom i macula i øjets nethinde (makulopati)
English: Flushing, Haematoma, Lymphoedema, Systolic hypertension, Thrombosis
Danish: Rødmen, hæmatom, lymfødem, systolisk hypertension, trombose
English: ● fatigue
Danish: ● træthed
English: ● haematoma
Danish: ● sløret syn
English: Each vial of 10 ml contains: 0.5 g of human normal immunoglobulin Each vial of 50 ml contains: 2.5 g of human normal immunoglobulin Each vial of 100 ml contains: 5 g of human normal immunoglobulin Each vial of 200 ml contains: 10 g of human normal immunoglobulin Each vial of 400 ml contains: 20 g of human normal immunoglobulin
Danish: Hvert 10 ml hætteglas indeholder: 0,5 g humant normalt immunglobulin Hvert 50 ml hætteglas indeholder: 2,5 g humant normalt immunglobulin Hvert 100 ml hætteglas indeholder: 5 g humant normalt immunglobulin Hvert 200 ml hætteglas indeholder: 10 g humant normalt immunglobulin Hvert 400 ml hætteglas indeholder: 20 g humant normalt immunglobulin
English: It was observed that the proportion of headache, chills, pyrexia, nausea, vomiting, hypotension, heart rate increase and back pain in children was higher than in adults.
Danish: Det blev observeret, at hovedpine, kulderystelser, pyreksi, kvalme, opkastning, hypotension, øget puls og rygsmerter var hyppigere hos børn end hos voksne.
English: • chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain
Danish: • kulderystelser, hovedpine, svimmehed, feber, opkastning, allergiske reaktioner, kvalme,
English: Depending on how comfortable you feel, your doctor may then gradually increase the infusion rate (up to 0.1 ml/kg/min).
Danish: Hvis du ikke føler ubehag eller får gener, kan lægen gradvist øge infusionshastigheden (op til 0,1 ml/kg/min).
English: It was observed that the proportion of headache, chills, fever, nausea, vomiting, low blood pressure, heart rate increase and back pain in children was higher than in adults.
Danish: Det blev observeret, at hovedpine, kulderystelser, feber, kvalme, opkastning, lavt blodtryk, øget puls og rygsmerter var hyppigere hos børn end hos voksne.
English: ● chest discomfort/chest pain
Danish: ● utilpashed i brystet/brystsmerter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/404/006-008
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/404/006-008
English: ● influenza like illness
Danish: ● influenzalignende sygdom
English: ● syncope vasovagal (temporary loss of consciousness)
Danish: ● midlertidig bevidstløshed (vasovagal synkope)
English: Very common Common
Danish: Meget almindelig Almindelig
English: DATE OF REVISION OF THE TEXT
Danish: DATO FOR ÆNDRING AF TEKSTEN MD/ÅÅÅÅ
English: ● hyperhidrosis (excessive sweating)
Danish: • kraftig svedtendens (hyperhidrose)
English: ● urticaria
Danish: ● udslæt