FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients ≥ 75 years of age, the incidences were 4.9% on canagliflozin 100 mg once daily and 8.7% on canagliflozin 300 mg once daily compared to 2.6% in the control group (see sections 4.2 and 4.4).
Danish: Hos patienter ≥ 75 år var incidensen 4,9 % for canagliflozin 100 mg en gang dagligt og 8,7 % for canagliflozin 300 mg en gang dagligt sammenlignet med 2,6 % i kontrolgruppen (se pkt.
English: Canagliflozin 100 mg once daily as dual therapy with metformin produced similar reductions in HbA1c from baseline and 300 mg produced superior (p < 0.05) reductions in HbA1c compared to glimepiride, thus demonstrating non-inferiority.
Danish: I dualbehandling med metformin gav canagliflozin 100 mg en gang dagligt samme reduktioner i HbA1c fra baseline, og 300 mg en gang dagligt gav reduktioner i HbA1c som var resultaterne for glimepirid overlegne (p < 0,05), hvilket påviste canagliflozins non-inferioritet.
English: Vascular disorders uncommon
Danish: Vaskulære sygdomme Ikke almindelig
English: In rare instances, phimosis was reported and sometimes circumcision was performed (see section 4.4).
Danish: Der rapporteredes sjældne tilfælde af fimose, der somme tider endte med omskæring (se pkt.
English: Vokanamet has no or negligible influence on the ability to drive, cycle, and use tools or machines.
Danish: Vokanamet påvirker ikke eller kun i ubetydelig grad evnen til at køre motorkøretøj og betjene maskiner.
English: (E171), iron oxide yellow (E172), and iron oxide red (E172).
Danish: (E171), gul jernoxid (E172) og rød jernoxid (E172).
English: How to take Vokanamet
Danish: Sådan skal du tage Vokanamet
English: Titanium dioxide (E171) Iron oxide red (E172)
Danish: Titandioxid (E171)
English: Dose titration with canagliflozin (added to the optimal dose of metformin) should be considered before the patient is switched to Vokanamet.
Danish: Før patienten skifter til Vokanamet, bør det overvejes at titrere dosis af canagliflozin (som tillæg til den optimale dosis metformin).
English: • Vokanamet 50 mg/1000 mg film-coated tablets (tablets) are beige, capsule-shaped, 21 mm in length, and debossed with “CM” on one side and “551” on the other side.
Danish: • Vokanamet 50 mg/1.000 mg filmovertrukne tabletter er beige, kapselformede, 21 mm lange tabletter præget med “CM” på den ene side og “551” på den anden side
English: As Vokanamet contains metformin, Vokanamet must be discontinued at the time of surgery under general, spinal, or epidural anaesthesia.
Danish: Da Vokanamet indeholder metformin, skal behandling med Vokanamet afbrydes på tidspunktet for kirurgi under generel, spinal eller epidural anæstesi og må tidligst genoptages 48 timer efter kirurgi eller genoptagelse af oral ernæring og under forudsætning af, at nyrefunktionen er blevet vurderet og fundet stabil.
English: If any of the above applies to you, talk to your doctor for further instructions.
Danish: Kontakt lægen for at få yderligere vejledning, hvis noget af ovennævnte gælder for dig.
English: Triple therapy with metformin and sulphonylurea (26 weeks) Canagliflozin + metformin and sulphonylurea
Danish: Ikke relevantc Behandling med tre lægemidler: + metformin og sulfonylurinstof (26 uger) Canagliflozin + metformin og sulfonylurinstof
English: • if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat, contact a doctor or the nearest hospital straight away.
Danish: trækker vejret hurtigt og dybt, er forvirret, er usædvanligt søvnig eller træt, dine ånde lugter sødligt, du har en sødlig eller metallisk smag i munden, eller din urin eller sved lugter anderledes.
English: Enterohepatic circulation of canagliflozin was negligible.
Danish: Der sås kun ubetydelig enterohepatisk cirkulation af canagliflozin.
English: 3.2% of the administered radioactive dose was recovered in faeces as canagliflozin, a hydroxylated metabolite, and an O-glucuronide metabolite, respectively.
Danish: 41,5 %, 7,0 %, og 3,2 % af den administrerede radioaktive dosis genfundet i fæces som henholdsvis canagliflozin, en hydroxyleret metabolit og en O-glukuronidmetabolit.
English: EU/1/14/918/003 (50 mg/850 mg - 180 tablets) EU/1/14/918/006 (50 mg/1000 mg - 180 tablets) EU/1/14/918/009 (150 mg/850 mg - 180 tablets) EU/1/14/918/012 (150 mg/1000 mg - 180 tablets)
Danish: EU/1/14/918/003 (50 mg/850 mg - 180 tabletter) EU/1/14/918/006 (50 mg/1000 mg - 180 tabletter) EU/1/14/918/009 (150 mg/850 mg - 180 tabletter EU/1/14/918/012 (150 mg/1000 mg - 180 tabletter)
English: n Mean percent changes from baseline in serum phosphate were 3.6% and 5.1% for canagliflozin 100 mg and 300 mg, compared to 1.5% for placebo.
Danish: n Middelændringer (%) fra baseline i serumphosphat var henholdsvis 3,6 % og 5,1 % for canagliflozin 100 mg og 300 mg sammenlignet med 1,5 % for placebo.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelige (kan berøre op til 1 ud af 100 personer)
English: Iodinated contrast agents
Danish: Iodholdige kontraststoffer
English: • if you have uncontrolled diabetes, with, for example,severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Danish: (højt blodsukker), kvalme, opkastning, diarré, hurtigt vægttab, laktatacidose (se ”Risiko for laktatacidose” nedenfor) eller ketoacidose.
English: Vokanamet 50 mg/850 mg film-coated tablets Vokanamet 50 mg/1000 mg film-coated tablets Vokanamet 150 mg/850 mg film-coated tablets Vokanamet 150 mg/1000 mg film-coated tablets canagliflozin/metformin hydrochloride
Danish: Vokanamet 50 mg/850 mg filmovertrukne tabletter Vokanamet 50 mg/1.000 mg filmovertrukne tabletter Vokanamet 150 mg/850 mg filmovertrukne tabletter Vokanamet 150 mg/1.000 mg filmovertrukne tabletter canagliflozin/metforminhydrochlorid
English: Difference from glimepiride (adjusted mean) (95% CI)
Danish: glimepirid (justeret middelændring) (95 % CI)
English: In case of suspected symptoms, the patient should stop taking Vokanamet and seek immediate medical attention.
Danish: Patienterne skal informeres om at stoppe med at tage metformin og øjeblikkeligt søge lægehjælp ved symptomer, der kan give mistanke om laktatacidose.
English: Difference from placebo (adjusted mean) (95% CI)
Danish: placebo (justeret middelværdi) (95 % CI)
English: l Mean percent changes from baseline in blood urea nitrogen were 17.1% and 18.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 2.7% for placebo.
Danish: l Middelændringer (%) fra baseline i blod-carbamid var henholdsvis 17,1 % og 18,0 % for canagliflozin 100 mg og 300 mg sammenlignet med 2,7 % for placebo.
English: The reductions in RTG led to increased UGE in subjects with type 2 diabetes treated with either 100 mg or 300 mg once daily of canagliflozin ranging from 77 g/day to 119 g/day across the phase 1 studies; the UGE observed translates to a loss of 308 kcal/day to 476 kcal/day.
Danish: På tværs af fase 1-studierne medførte faldene i RTG øget UGE på fra 77 til 119 g/dag hos forsøgspersoner med type 2-diabetes, der blev behandlet med enten 100 mg eller 300 mg canagliflozin en gang dagligt.
English: Vokanamet 50 mg/850 mg film-coated tablets Vokanamet 50 mg/1000 mg film-coated tablets Vokanamet 150 mg/850 mg film-coated tablets Vokanamet 150 mg/1000 mg film-coated tablets
Danish: Vokanamet 50 mg/850 mg filmovertrukne tabletter Vokanamet 50 mg/1.000 mg filmovertrukne tabletter Vokanamet 150 mg/850 mg filmovertrukne tabletter Vokanamet 150 mg/1.000 mg filmovertrukne tabletter
English: • Vokanamet 50 mg/850 mg film-coated tablets (tablets) are pink, capsule-shaped, 20 mm in length, and debossed with “CM” on one side and “358” on the other side.
Danish: • Vokanamet 50 mg/850 mg filmovertrukne tabletter er lyserøde, kapselformede, 20 mm lange tabletter præget med “CM” på den ene side og “358” på den anden side
English: j Mean changes from baseline in haematocrit were 2.4% and 2.5% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.0% for placebo.
Danish: j Middelændringer fra baseline i hæmatokrit var 2,4 % og 2,5 % for henholdsvis canagliflozin 100 mg og 300 mg sammenlignet med 0,0 % for placebo.
English: 180 (3 x 60) film-coated tablets.
Danish: 1 x 20 filmovertrukne tabletter 1 x 60 filmovertrukne tabletter 180 (3 x 60) filmovertrukne tabletter
English: Film-coating: - 50 mg/850 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
Danish: Filmovertræk - 50 mg/850 mg tabletter: macrogol (3350), polyvinylalkohol, talcum, titandioxid
English: 6.5 Nature and contents of container HDPE bottle with child-resistant closure, induction seal, and desiccant.
Danish: HDPE-beholder med børnesikret lukke, forsegling og tørremiddel.
English: • Vokanamet 150 mg/1000 mg film-coated tablets (tablets) are purple, capsule-shaped, 22 mm in length, and debossed with “CM” on one side and “611” on the other side.
Danish: • Vokanamet 150 mg/1.000 mg filmovertrukne tabletter er lilla, kapselformede, 22 mm lange tabletter præget med “CM” på den ene side og “611” på den anden side
English: k Mean percent changes from baseline in creatinine were 2.8% and 4.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 1.5% for placebo.
Danish: k Middelændringer (%) fra baseline i kreatinin var 2,8 % og 4,0 % for henholdsvis canagliflozin 100 mg og 300 mg sammenlignet med 1,5 % for placebo.
English: • difficulty in breathing
Danish: • vejrtrækningsbesvær
English: • Vokanamet 150 mg/850 mg film-coated tablets (tablets) are light yellow, capsule-shaped, 21 mm in length, and debossed with “CM” on one side and “418” on the other side.
Danish: • Vokanamet 150 mg/850 mg filmovertrukne tabletter er lysegule, kapselformede, 21 mm lange tabletter præget med “CM” på den ene side og “418” på den anden side
English: If you take more Vokanamet than you should
Danish: Hvis du har taget for mange Vokanamet
English: - 150 mg/850 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
Danish: - 150 mg/850 mg tabletter: macrogol (3350), polyvinylalkohol, talcum, titandioxid
English: Change from baseline (adjusted mean)
Danish: Baseline (middelværdi) Ændring fra baseline (justeret middelværdi)
English: What Vokanamet contains
Danish: Vokanamet indeholder:
English: Each 50 mg/1000 mg tablet contains 50 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Danish: En 50 mg/1.000 mg tablet indeholder 50 mg canagliflozin og 1.000 mg metforminhydrochlorid.
English: Each 50 mg/850 mg tablet contains 50 mg of canagliflozin and 850 mg of metformin hydrochloride.
Danish: En 50 mg/850 mg tablet indeholder 50 mg canagliflozin og 850 mg metforminhydrochlorid.
English: Vokanamet 50 mg/850 mg film-coated tablets EU/1/14/918/001 (20 tablets) EU/1/14/918/002 (60 tablets) EU/1/14/918/003 (180 tablets)
Danish: Vokanamet 50 mg/850 mg filmovertrukne tabletter EU/1/14/918/001 (20 tabletter) EU/1/14/918/002 (60 tabletter) EU/1/14/918/003 (180 tabletter)
English: Each 150 mg/1000 mg tablet contains 150 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Danish: En 150 mg/1.000 mg tablet indeholder 150 mg canagliflozin og 1.000 mg metforminhydrochlorid.
English: - 50 mg/1000 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
Danish: - 50 mg/1.000 mg tabletter: macrogol (3350), polyvinylalkohol, talcum, titandioxid
English: The increased UGE with SGLT2 inhibition also translates to an osmotic diuresis, with the diuretic effect leading to a reduction in systolic blood pressure; the increase in UGE results in a loss of calories and therefore a reduction in body weight, as has been demonstrated in studies of patients with type 2 diabetes.
Danish: Den øgede udskillelse af glucose i urin (UGE) pga. SGLT-2-hæmning udmønter sig også i osmotisk diurese, og den diuretiske virkning fører til fald i systolisk blodtryk.
English: Each 150 mg/850 mg tablet contains 150 mg of canagliflozin and 850 mg of metformin hydrochloride.
Danish: En 150 mg/850 mg tablet indeholder 150 mg canagliflozin og 850 mg metforminhydrochlorid.
English: increased levels of “ketone bodies” in your urine or blood rapid weight loss feeling sick or being sick stomach pain excessive thirst fast and deep breathing confusion unusual sleepiness or tiredness a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Danish: Kontakt straks lægen eller nærmeste skadestue, hvis du får en af følgende bivirkninger: Diabetisk ketoacidose (sjælden - kan berøre op til 1 ud af 1.000 personer) Symptomerne på diabetisk ketoacidose (se også afsnittet Advarsler og forholdsregler i punkt 2) er: forhøjet niveau af “ketonstoffer” i urinen eller blodet hurtigt vægttab kvalme eller opkastning mavesmerter voldsom tørst hurtig og dyb vejrtrækning forvirring usædvanlig søvnighed eller træthed dine ånde lugter sødligt, du har en sødlig eller metallisk smag i munden, eller din urin eller sved lugter anderledes
English: Steady-state was reached after 4 days to 5 days of once-daily dosing with canagliflozin 100 mg to 300 mg. Canagliflozin does not exhibit time-dependent pharmacokinetics, and accumulated in plasma up to 36% following multiple doses of 100 mg and 300 mg.
Danish: Den tilsyneladende terminale halveringstid (t1/2) (udtrykt som middelværdi ± standardafvigelse) var 10,6 ± 2,13 timer og 13,1 ± 3,28 timer for henholdsvis 100 mg og 300 mg. Steady state blev nået efter 4-5 dage ved daglig administration af canagliflozin 100300 mg. Canagliflozin udviser ikke tidsafhængig farmakokinetik, og op til 36 % akkumuleres i plasma efter gentagne doser på 100 mg og 300 mg.
English: Kidney function
Danish: Nedsat leverfunktion
English: Difference from sitagliptin (adjusted mean) (95% CI)
Danish: sitagliptin (justeret middeltal) (95 % CI)
English: Canagliflozin increased the incidence of testicular Leydig cell tumours in male rats at all doses tested (10, 30, and 100 mg/kg); the lowest dose of 10 mg/kg is approximately 1.5 times the clinical dose of 300 mg based on AUC exposure.
Danish: Den højeste dosis på 100 mg/kg resulterede i op til 14 gange eksponeringen (målt som AUC) ved den kliniske dosis på 300 mg. Canagliflozin øgede incidensen af Leydig-celletumorer i testiklerne hos hanrotter ved alle de undersøgte doser (10, 30 og 100 mg/kg).
English: Vokanamet 150 mg/850 mg film-coated tablets Macrogol (3350)
Danish: Vokanamet 150 mg/850 mg filmovertrukne tabletter Macrogol (3350)
English: Vokanamet 50 mg/1000 mg film-coated tablets Macrogol (3350)
Danish: Vokanamet 50 mg/1.000 mg filmovertrukne tabletter Macrogol (3350)
English: Vokanamet 50 mg/850 mg film-coated tablets Macrogol (3350)
Danish: Vokanamet 50 mg/850 mg filmovertrukne tabletter Macrogol (3350)
English: What Vokanamet looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: m Mean percent changes from baseline in blood potassium were 0.5% and 1.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.6% for placebo.
Danish: m Middelændringer (%) fra baseline i serumkalium var henholdsvis 0,5 % og 1,0 % for canagliflozin 100 mg og 300 mg sammenlignet med 0,6 % for placebo.
English: Vokanamet 150 mg/1000 mg film-coated tablets Macrogol (3350)
Danish: Vokanamet 150 mg/1.000 mg filmovertrukne tabletter Macrogol (3350)
English: Tel: +372 617 7410
Danish: EE-11415 Tallinn Tel: +372 617 7410
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 150 mg canagliflozin, and 850 mg metformin hydrochloride.
Danish: En filmovertrukket tablet indeholder canagliflozinhemihydrat svarende til 150 mg canagliflozin og 850 mg metforminhydrochlorid.
English: The tablet is beige, capsule-shaped, 21 mm in length, immediate-release, film-coated, and debossed with “CM” on one side and “551” on the other side.
Danish: Vokanamet 50 mg/1.000 mg filmovertrukne tabletter En beige, kapselformet tablet, 21 mm lang, med konventionel (umiddelbar) udløsning, filmovertrukket og præget med “CM” på den ene side og “551” på den anden side.
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 150 mg canagliflozin, and 1000 mg metformin hydrochloride.
Danish: En filmovertrukket tablet indeholder canagliflozinhemihydrat svarende til 150 mg canagliflozin og 1.000 mg metforminhydrochlorid.
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 50 mg canagliflozin, and 850 mg metformin hydrochloride.
Danish: En filmovertrukket tablet indeholder canagliflozinhemihydrat svarende til 50 mg canagliflozin og 850 mg metforminhydrochlorid.
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 50 mg canagliflozin, and 1000 mg metformin hydrochloride.
Danish: En filmovertrukket tablet indeholder canagliflozinhemihydrat svarende til 50 mg canagliflozin og 1.000 mg metforminhydrochlorid.
English: • vaginal yeast infection.
Danish: • svampeinfektion i skeden.
English: Gastrointestinal disorders very common
Danish: Mave-tarm-kanalen Meget almindelige
English: Vokanamet 150 mg/850 mg film-coated tablets EU/1/14/918/007 (20 tablets) EU/1/14/918/008 (60 tablets) EU/1/14/918/009 (180 tablets)
Danish: Vokanamet 150 mg/1.000 mg filmovertrukne tabletter EU/1/14/918/010 (20 tabletter) EU/1/14/918/011 (60 tabletter) EU/1/14/918/012 (180 tabletter)
English: shock (see section 4.4);
Danish: Vokanamet (angivet i punkt 6)
English: Compared to sitagliptin as triple therapy with metformin and sulphonylurea (52 weeks) Canagliflozin 300 mg + metformin and sulphonylurea (N = 377)
Danish: Canagliflozin 300 mg + metformin og sulfonylurinstof (N = 377)
English: What Vokanamet is and what it is used for What you need to know before you take Vokanamet How to take Vokanamet
Danish: Det skal du vide, før du begynder at tage Vokanamet Sådan skal du tage Vokanamet Bivirkninger
English: The tablet is pink, capsule-shaped, 20 mm in length, immediate-release, film-coated, and debossed with “CM” on one side and “358” on the other side.
Danish: Vokanamet 50 mg/850 mg filmovertrukne tabletter En lyserød, kapselformet tablet, 20 mm lang, med konventionel (umiddelbar) udløsning, filmovertrukket og præget med “CM” på den ene side og “358” på den anden side.
English: The tablet is purple, capsule-shaped, 22 mm in length, immediate-release, film-coated, and debossed with “CM” on one side and “611” on the other side.
Danish: Vokanamet 150 mg/1.000 mg filmovertrukne tabletter En lilla, kapselformet tablet, 22 mm lang, med konventionel (umiddelbar) udløsning, filmovertrukket og præget med “CM” på den ene side og “611” på den anden side.
English: Vokanamet 50 mg/1000 mg film-coated tablets EU/1/14/918/004 (20 tablets) EU/1/14/918/005 (60 tablets) EU/1/14/918/006 (180 tablets)
Danish: Vokanamet 50 mg/1.000 mg filmovertrukne tabletter EU/1/14/918/004 (20 tabletter) EU/1/14/918/005 (60 tabletter) EU/1/14/918/006 (180 tabletter) Vokanamet 150 mg/850 mg filmovertrukne tabletter EU/1/14/918/007 (20 tabletter) EU/1/14/918/008 (60 tabletter) EU/1/14/918/009 (180 tabletter)
English: 6 months.
Danish: 6 måneder.
English: Interim and final results will be submitted in accordance with the protocol.
Danish: Foreløbige og endelige resultater vil blive fremsendt i overensstemmelse med protokollen.
English: Initiation of the study by July
Danish: Igangsættelse af studiet er juli
English: Results to be provided in the simplified PSUR.
Danish: Resultater skal gives i den simplificerede PSUR.
English: - Allergic reactions:
Danish: - Allergiske reaktioner:
English: Adults and elderly:
Danish: Voksne og ældre:
English: No case of overdose have been reported.
Danish: Der er ikke rapporteret tilfælde af overdosering.
English: If this applies to you then your vaccination will usually be postponed until you are feeling better.
Danish: Hvis det er tilfældet for dig, vil din vaccination som regel blive udskudt, til du har det bedre.
English: Information from non-clinical studies
Danish: Information fra ikke-kliniske undersøgelser
English: What HUMENZA contains
Danish: HUMENZA indeholder
English: These measures will help to protect the environment.
Danish: Disse foranstaltninger tages af hensyn til miljøet.
English: The safety has been assessed after each administration.
Danish: Sikkerhed blev vurderet efter hver indgivelse.
English: After mixing: - Active substance:
Danish: Efter sammenblanding: - Aktivt stof:
English: HUMENZA has been given "conditional approval".
Danish: HUMENZA er godkendt med en ”betinget godkendelse”.
English: Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly around the world.
Danish: Pandemisk influenza er en slags influenza, som forekommer med årtiers mellemrum, og som hurtigt spredes over hele verden.
English: Clinical data suggest that a single dose may be sufficient.
Danish: Kliniske data tyder på, at en enkelt dosis kan være tilstrækkelig.
English: - if you have a severe infection with a high temperature (over 38°C).
Danish: - hvis du har en alvorlig infektion med høj feber (over 38 °C).
English: - There is any suspicion that the partially used vial has been contaminated.
Danish: - Der er nogen mistanke om, at det delvist brugte hætteglas er blevet kontamineret.
English: Pandemic influenza vaccine should be used in accordance with Official Guidance.
Danish: Pandemisk influenzavaccine skal anvendes i henhold til officielle retningslinjer.
English: Prophylaxis of influenza in an officially declared pandemic situation (see sections 4.2 and 5.1).
Danish: Influenzaprofylakse i en officielt erklæret pandemisk situation (se afsnit 4.2 og 5.1).
English: Tell the doctor requesting these tests that you have recently been given HUMENZA.
Danish: Fortæl lægen, som bestiller disse test, at du for nylig har fået HUMENZA.
English: In the first few weeks after vaccination with HUMENZA the results of these tests may not be correct.
Danish: I de første par uger efter vaccination med HUMENZA er det muligt, at resultaterne af disse test ikke er korrekte.
English: Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant or if you are breastfeeding.
Danish: Fortæl det til din læge, hvis du er gravid, tror du kan være gravid eller planlægger at blive gravid, eller hvis du ammer.
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease.
Danish: Når en person vaccineres, producerer immunsystemet (kroppens naturlige forsvarssystem) sin egen beskyttelse (antistoffer) mod sygdommen.
English: - Side effects related to the central nervous system:
Danish: - Bivirkninger relateret til centralnervesystemet:
English: - There is visible evidence of contamination, such as change in appearance.
Danish: - Der er synligt tegn på kontaminering, såsom en ændring af udseende.
English: You should discuss with your doctor whether you should receive HUMENZA.
Danish: Du skal diskutere med din læge, om du bør få HUMENZA.
English: Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Danish: Din læge eller sygeplejerske vil give dig vaccinen i overensstemmelse med de officielle anbefalinger.
English: The use of HUMENZA may be considered during pregnancy and lactation if this is thought to be necessary, taking into account official recommendations.
Danish: Anvendelsen af HUMENZA kan overvejes under graviditet og amning, hvis det vurderes som nødvendigt, idet de officielle anbefalinger tages i betragtning.
English: The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Danish: Den immunologiske respons kan være mindsket, hvis patienten gennemgår immununsupprimerende behandling.
English: These side effects may occur with HUMENZA.
Danish: Disse bivirkninger kan opstå ved brug af HUMENZA.
English: The symptoms (signs) of pandemic flu are similar to those of an ordinary flu but may be more severe.
Danish: Symptomerne (tegnene) på pandemisk influenza minder om en almindelig influenza, men de kan være mere alvorlige.