natgillin/translations-raw huggingface dataset:
Injektion af Virbagen Omega kan være årsag til følgende forbigående symptomer hos hunde og katte:
The injection of Virbagen Omega may cause the following temporary symptoms in dogs and cats:
Interferoner er en gruppe proteiner, der produceres naturligt som reaktion på virusinfektioner.
Interferons are a family of naturally occurring proteins that are produced in response to viral infections.
Virbagen Omega virker ved at stimulere immunsystemet til at angribe viruset.
Virbagen Omega works by stimulating the immune system to attack the virus.
Andre oplysninger om Virbagen Omega:
Other information about Virbagen Omega:
• træthed i behandlingsperioden (kun hos katte)
• fatigue during the treatment, in cats only
Hos katte, der var inficeret med FIV, var dødeligheden lav (5 %) og ændredes ikke ved behandlingen.
In cats infected by FIV, the mortality rate was low (5%) and was not changed by the treatment.
Der blev givet Virbagen Omega 2,5 mio IE/kg intravenøst i 3 dage.
Virbagen Omega 2.5 MU/kg was given intravenously for 3 days.
• blød afføring til let diarré (kun hos katte)
• soft faeces to mild diarrhoea, in cats only
Hos alle kattene (hvad enten de var FeLV-positive, FIV-positive eller var inficeret med begge virus) indtrådte der en gradvis bedring i de kliniske symptomer, så at kattenes livskvalitet blev forbedret.
In the population of cats (whether they were FeLV positive, FIV positive or co-infected by both viruses, there was a reduction of clinical signs over time, improving the quality of life of cats.
Katte: Suspensionen gives ved subkutan injektion (indsprøjtning under huden) én gang dagligt i 5 på hinanden følgende dage.
Cats: The suspension should be injected subcutaneously (under the skin) once daily for 5 consecutive days.
Dosis er 1 mio IE/kg kropsvægt.
The dose is 1 MU/kg bodyweight.
Virbagen Omega er et lyofilisat (en frysetørret pellet) med opløsningsvæske, der benyttes til at fremstille en suspension til indsprøjtning.
Virbagen Omega is a lyophilisate (freeze dried pellet) and solvent that is made into a suspension for injection.
Dosis er 2,5 mio. IE/kg kropsvægt.
The dose is 2.5 MU/kg bodyweight.
Hunde: Suspensionen gives ved intravenøs injektion (indsprøjtning i en vene) én gang dagligt i 3 på hinanden følgende dage.
Dogs: The suspension should be injected intravenously (into a vein) once daily for 3 consecutive days.
Omega interferon produceres af en celle, der har fået indsat et gen (dna), som gør den i stand til at producere stoffet.
The omega interferon is made by a cell that has received a gene (DNA), which makes it able to produce omega interferon.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Virbagen Omega.
They recommended that Virbagen Omega should be given a marketing authorisation.
Virbagen Omega indeholder det aktive stof rekombinant omega interferon.
Virbagen Omega contains the active substance recombinant omega interferon.
Hvorfor blev Virbagen Omega godkendt?
Why has Virbagen Omega been approved?
Virbagen Omega anvendes til at forebygge dødelighed og mindske de kliniske tegn på parvovirose (en meget smitsom virussygdom) hos hunde, der er over én måned gamle.
Virbagen Omega is used to reduce mortality and clinical signs of parvovirosis (a highly contagious viral infection of dogs) in dogs from one month of age.
Hvilken risiko er der forbundet med Virbagen Omega?
What is the risk associated with Virbagen Omega?
Hos katte med FeLV fik behandlingen de kliniske symptomer til at aftage i løbet af fire måneder, og dødeligheden var mindre.
In the treatment of cats with FeLV, there was a reduction of clinical signs over 4 months and a reduction in the mortality rate.
Det kunstigt fremstillede omega interferon virker på samme måde som naturligt produceret omega interferon.
The replacement omega interferon acts in the same way as naturally produced omega interferon.
virkning blev hovedsagelig bedømt ved sammenligning af dødeligheden hos de behandlede og de ubehandlede hunde.
The main measure of effectiveness was the mortality rate compared with dogs that had not been treated.
Det aktive stof i Virbagen Omega, omega interferon, fremstilles ved "rekombinant teknologi".
The active substance of Virbagen Omega, omega interferon, is produced by a method known as ‘recombinant technology'.
Udvalget for Veterinærlægemidler (CVMP) fandt, at fordelene ved Virbagen Omega er større end risiciene til mindskelse af dødelighed og kliniske tegn ved parvovirose hos hunde over én måned gamle og til behandling af infektion med FeLV (felin leukæmivirus) og/eller FIV hos katte, som er over ni uger gamle, og hvis tilstand ikke er kritisk.
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Virbagen Omega are greater than any risks to reduce mortality and clinical signs of parvovirosis in dogs from one month of age, and to treat cats infected with FeLV (feline leukaemia virus) and/or FIV in non-terminal cats from the age of 9 weeks.
Hvad er Virbagen Omega?
What is Virbagen Omega?
Hvordan blev virkningen af Virbagen Omega undersøgt?
How has the effectiveness of Virbagen Omega been studied?
Behandlingens virkning blev hovedsagelig bedømt ved sammenligning af dødeligheden og de kliniske tegn hos de behandlede og ubehandlede katte.
The main measure of effectiveness was the mortality rate compared with cats that had not been treated and clinical signs after treatment.
Hos katte, der ikke havde anæmi, blev dødeligheden på ca. 50 % mindsket med 20 %.
In non-anaemic cats, the mortality rate (50 %) was reduced by 20%.
Hos katte med FeLV og anæmi blev dødeligheden på ca. 60 % mindsket med ca. 30 %.
In anaemic cats, the mortality rate in cats infected by FeLV (about 60%) was reduced by about 30%.
Hvad anvendes Virbagen Omega til?
What is Virbagen Omega used for?
Virbagen Omega blev undersøgt hos hanhunde og tæver, der var over fem uger gamle og havde parvovirose.
Virbagen Omega has been studied in dogs (males and females) of at least five weeks old that were infected with parvovirosis.
Virbagen Omega anvendes desuden til behandling af infektion med FeLV (felin leukæmivirus) og/eller FIV (felin immundefektvirus) hos katte, der er over 9 uger, og hvis tilstand ikke er kritisk.
Virbagen Omega is also used to treat cats infected with FeLV (feline leukaemia virus) and/or FIV (feline immunodeficiency virus), in non-terminal cats from the age of 9 weeks.
Virbagen Omega blev desuden undersøgt til behandling af infektion med FeLV og/eller FIV hos over 9 uger gamle katte med eller uden anæmi.
Virbagen Omega has also been studied in the treatment of anaemic or non-anaemic cats infected with FeLV and/or FIV, from the age of 9 weeks.
Hvilken fordel viser undersøgelserne ved Virbagen Omega?
What benefit has Virbagen Omega shown during the studies?
Virbagen Omega leveres i hætteglas med enten 5 mio. IE eller 10 mio. IE af det aktive stof rekombinant omega interferon af felin type (dvs. fra katte).
Virbagen Omega contains the active substance recombinant omega interferon of feline origin (from cats) at 5 MU/ vial or 10 MU/ vial.
Hvordan virker Virbagen Omega?
How does Virbagen Omega work?
Hvis du tager PANTOZOL Control i længere perioder, kan det medføre yderligere risici i form af:
If you take PANTOZOL Control for longer periods, this may cause additional risks, such as:
PANTOZOL Control kan medføre, at andre lægemidler ikke virker ordentligt.
PANTOZOL Control may stop certain other medicines from working properly.
PANTOZOL Control påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
PANTOZOL Control has no or negligible influence on the ability to drive and use machines.
PANTOZOL Control 20 mg enterotabletter bør ikke tygges eller knuses, men skal sluges hele med væske før et måltid.
PANTOZOL Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
For at undgå denne interferens bør PANTOZOL Control seponeres mindst 5 dage inden måling af CgA (se pkt.
To avoid this interference, PANTOZOL Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
PANTOZOL Control må ikke bruges af børn og unge under 18 år pga. manglende dokumentation for sikkerhed i denne aldersgruppe.
PANTOZOL Control should not be used by children and adolescents under 18 years of age due to a lack of safety information in this younger age group.
PANTOZOL Control bør ikke anvendes til børn og unge under 18 år på grund af utilstrækkelige data vedrørende sikkerhed og virkning.
PANTOZOL Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Stop med at tage PANTOZOL Control, når du er symptomfri.
Stop taking PANTOZOL Control when you are completely symptom-free.
Hallucinationer , forvirring (især hos prædisponerede patienter, samt forværring af allerede eksisterende symptomer)
Hallucination; Confusion (especially in pre-disposed patients, as well as the aggravation of these symptoms in case of pre-existence)
Indenfor hver frekvensgruppe er bivirkningerne opstillet efter faldende alvorlighed.
Within each frequency grouping adverse reactions are presented in order of decreasing seriousness.
I nedenstående tabel er bivirkningerne ordnet efter MedDRA frekvensklassifikation:
Within the following table, adverse reactionsare ranked under the MedDRA frequency classification:
Hvis du har taget for meget PANTOZOL Control Fortæl det til lægen eller apoteket hvis du har taget mere end den anbefalede dosis.
If you take more PANTOZOL Control than you should Tell your doctor or pharmacist if you have taken more than the recommended dose.
Den øgede mortalitet er kun blevet rapporteret for rotteunger inden afvænning (op til 21 dage gamle), hvilket anslås at korrespondere med spædbørn op til
The increased mortality has only been reported in pre-weaning rat pups (up to 21 days age) which is estimated to correspond to infants up to the age of 2 years old.
PANTOZOL Control findes i aluminim/aluminium-blister med eller uden kartonforstærkning.
PANTOZOL Control is available in Alu/Alu blisters with or without cardboard reinforcement.
Hvis sådanne hudreaktioner optræder, navnlig på hudområder udsat for sollys, og er ledsaget af arthralgi, bør patienten straks søge læge, og lægen bør overveje at seponere PANTOZOL Control.
If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping PANTOZOL Control.
Overskrid ikke den anbefalede daglige dosis på 20mg pantoprazol.
Do not exceed this recommended dose of 20 mg pantoprazole daily.
- methotrexat (bruges til behandling af reumatoid artrit, psoriasis og cancer) - hvis du tager methotrexat, kan din læge midlertidigt stoppe din behandling med PANTOZOL Control, da PANTOZOL Control kan forøge niveauet af methotrexat i blodet.
You may need further blood tests - methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your PANTOZOL Control treatment because pantoprazole can increase levels of methotrexate in the blood.
PANTOZOL Control indeholder det aktive stof pantoprazol, som blokerer den ”pumpe”, der producerer mavesyre.
PANTOZOL Control contains the active substance pantoprazole, which blocks the ‘pump' that produces stomach acid.
Tag ikke PANTOZOL Control samtidigt med anden medicin, som begrænser mængden af syre i din mave, så som andre syrepumpehæmmere (omeprazol, lansoprazol eller rabeprazol) eller en H2-antagonist (f.eks. ranitidin, famotidin).
Do not take PANTOZOL Control with other medicines which limit the amount of acid produced in your stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).
Du kan opleve lindring af dine symptomer på sure opstød og halsbrand efter kun en dags behandling med PANTOZOL Control, men denne medicin har ikke til hensigt at give øjeblikkelig lindring.
You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with PANTOZOL Control, but this medicine is not meant to bring immediate relief.
StevensJohnson syndrom, Lyell syndrome, erythema multiforme, lysfølsomhed
Stevens-Johnson syndrome; Lyell syndrome;
Du må ikke tage PANTOZOL Control, hvis du tager HIV-proteasehæmmere.
You must not use PANTOZOL Control if you are taking HIV protease inhibitors.
Du må gerne tage PANTOZOL Control samtidig med syreneutraliserende medicin (f.eks. magaldrat, alginsyre, natriumbicarbonat, aluminiumhydroxid, magnesiumcarbonat eller kombinationer heraf), hvis det er nødvendigt.
However, you may take PANTOZOL Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.
Hvis du har glemt at tage PANTOZOL Control
If you forget to take PANTOZOL Control
PANTOZOL Control indeholder: - Aktivt stof: Pantoprazol.
What PANTOZOL Control contains - The active substance is pantoprazole.
PANTOZOL Control kan reducere absorptionen af aktive stoffer, hvis biotilgængelighed er pH-afhængig (fx. ketoconazol).
PANTOZOL Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).
Den anbefalede dosis eren tablet daglig.
The recommended dose is one tablet a day.
- undgå store måltider - spis langsomt - hold op med at ryge - reducer indtaget af alkohol og koffein - vægttab (ved overvægt) - undgå tætsiddende tøj eller bælte - undgå at spise tre timer før sengetid
- Avoid large meals - Eat slowly - Stop smoking - Reduce alcohol and caffeine consumption - Reduce weight (if overweight) - Avoid tight-fitting clothing or belts - Avoid eating less than three hours before bedtime - Elevate bedhead (if you suffer from nocturnal symptoms) - Reduce intake of food that can cause heartburn.
PANTOZOL Control bør ikke anvendes under graviditet.
Pantoprazole should not be used during pregnancy.
Tag ikke PANTOZOL Control -tabletter i mere end 4 uger uden at kontakte lægen.
Do not take PANTOZOL Control tablets for more than 4 weeks without consulting your doctor.
- du skal have taget en særlig blodprøve (chromogranin A) - hvis du tager HIV-proteasehæmmere såsom atazanavir; nelfinavir (til behandling af
Control - if you are due to have a specific blood test (Chromogranin A) - if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of
Det kan foreksempel være: Chokolade, pebermynte, spearmint, fed og friturestegt mad, syreholdig mad, krydret mad, citrusfrugter, frugtjuice og tomater.
spearmint, fatty and fried food, acidic food, spicy food, citrus fruits and fruit juices, tomatoes.
Du kan finde yderligere information om PANTOZOL Control på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Hyponatræmi, hypomagnesæ mi, Hypokalcæmi
Hyponatraemia, Hypomagnesaemia
Det skal du vide, før du begynder at tage PANTOZOL Control
What you need to know before you take PANTOZOL Control
PANTOZOL Control bør ikke anvendes under amning.
PANTOZOL Control should not be used during breast-feeding.
Fortæl det straks til lægen før eller efter du har taget medicinen, hvis du oplever nogle af følgende symptomer, som kan være et tegn på en anden, mere alvorlig, sygdom: - uventet vægttab (som ikke er relateret til diæt eller et motionsprogram) - opkastning, især ved gentagelse - blodigt opkast, dette kan ses som mørkt kaffegrums i dit opkast - du opdager blodig afføring, som kan være sort eller tjærefarvet - synkebesvær eller smerte i forbindelse med synkning - du ser bleg ud eller føler dig sløj (blodmangel) - brystsmerter - mavesmerter - kraftig og/eller vedvarende diaré, da dette lægemiddel er forbundet med en let øget risiko for infektiøs diaré - hvis du får udslæt, især på de dele af huden, der er udsat for sol, skal du snarest sige det til lægen, da du kan være nødt til at holde op med at tage PANTOZOL Control.
Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease: - an unintentional loss of weight (not related to a diet or an exercise programme) - vomiting, particularly if repeated - vomiting blood; this may appear as dark coffee grounds in your vomit - you notice blood in your stools; which may be black or tarry in appearance - difficulty in swallowing or pain when swallowing - you look pale and feel weak (anaemia) - chest pain - stomach pain - severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.
Se brug af andet medicin sammen med PANTOZOL Control.
See ‘Other medicines and PANTOZOL Control'.
Agranulocytose Trombocytopeni, leukopeni, pancytopeni
Agranulocytosis Thrombocytopenia; Leukopenia,
PANTOZOL Control bruges til korttidsbehandling af reflukssymptomer (f.eks. halsbrand og sure opstød) hos voksne.
PANTOZOL Control is used for the short-term treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults.
Enterotabletterne er gule, ovale, bikonvekse filmovertrukne tabletter præget med ”P20” på den ene side.
What PANTOZOL Control looks like and contents of the pack The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side.
Udslæt/eksante m/ eruptioner, Kløe
Rash / exanthema / eruption;
Det skal du vide, før du begynder at tage PANTOZOL Control Sådan skal du tage PANTOZOL Control Bivirkninger
What PANTOZOL Control is and what it is used for What you need to know before you take PANTOZOL Control How to take PANTOZOL Control Possible side effects
Sådan skal du tage PANTOZOL Control
How to take PANTOZOL Control
PANTOZOL Control er indiceret til korttidsbehandling af reflukssymptomer (fx halsbrand, syreregurgitation) hos voksne.
PANTOZOL Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
”PANTOZOL Control indeholder”).
PANTOZOL Control'.
Kontakt din læge, før du tager PANTOZOL Control - hvis du er blevet behandlet for halsbrand eller fordøjelsesbesvær uafbrudt i mere end 4 uger - hvis du er over 55 år og daglig tager medicin uden recept mod fordøjelsesbesvær
Talk to your doctor before taking PANTOZOL Control - if you have been treated for heartburn or indigestion continuously for 4 or more weeks - if you are over 55 years old and taking non-prescription indigestion treatment on a daily basis - if you are over 55 years old with any new or recently changed reflux symptoms - if you have previously had a gastric ulcer or stomach surgery - if you have liver problems or jaundice (yellowing of skin or eyes) - if you regularly see your doctor for serious complaints or conditions - if you are due to have an endoscopy or a breath test called a C-urea test. - if you have ever had a skin reaction after treatment with a medicine similar to PANTOZOL
PANTOZOL Control 20 mg enterotabletter Pantoprazol
PANTOZOL Control 20 mg gastro-resistant tablets Pantoprazole
Tag ikke PANTOZOL Control: - hvis du er allergisk over for pantoprazol eller et af de øvrige indholdsstoffer (angivet i afsnit 6
Do not take PANTOZOL Control: - if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6) - if you are taking HIV protease inhibitors such as atazanavir; nelfinavir (for the treatment of
Depression (og forværring af allerede eksisterende symptomer)
Sleep disorders Depression (and all aggravations)
Husk også at nævne andre negative virkninger så som ledsmerter.
Remember to also mention any other ill-effects like pain in your joints Your doctor may decide that you need some tests.
PANTOZOL Control 20 mg, enterotabletter
PANTOZOL Control 20 mg gastro-resistant tablets
Hallucinationer, forvirring (specielt hos patienter som i forvejen har haft disse symptomer); nedsat natrium; magnesium i blodet, udslæt, eventuelt med ledsmerter, en stikkende, prikkende, snurrende eller brændende fornemmelse eller følelsesløshed, tyktarmsbetændelse, der giver vedvarende, vandig diarré.
- Frequency not known: hallucination, confusion (especially in patients with a history of these symptoms); decreased level of sodium in blood; decreased level of magnesium in blood, rash, possibly with pain in the joints;
Brug af anden medicin sammen med PANTOZOL Control Fortæl det til lægen eller apoteket, hvis du tager, har taget eller overvejer at tage andet medicin.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Graviditet og amning
Abdominal pain and discomfort
Diaré kvalme/opkast ning, udspilet abdomen og oppustethed, forstoppelse, tørhed i munden, abdominale smerter og ubehag
feeling of tingling, prickling, pins and needles, burning sensation or numbness, inflammation in the large bowel, that causes persistent watery diarrhoea.
Den fuldstændige EPAR for Aerivio Spiromax findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Aerivio Spiromax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Aerivio Spiromax.
This is a summary of the European public assessment report (EPAR) for Aerivio Spiromax.
Udvalget anbefalede, at Aerivio Spiromax godkendes til anvendelse i EU.
The Committee recommended that Aerivio Spiromax be approved for use in the EU.
De to aktive stoffer i Aerivio Spiromax er velkendte og findes i flere lægemidler, der anvendes til at behandle astma og KOL, enten alene eller i kombination med andre lægemidler.
The two active substances in Aerivio Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Det betyder, at Aerivio Spiromax svarer til et "referencelægemiddel", der hedder Seretide Diskus (også kaldet Seretide Accuhaler), der indeholder de samme aktive stoffer.
This means that Aerivio Spiromax is similar to a ‘reference medicine' called Seretide Diskus (also known as Seretide Accuhaler), which contains the same active substances.
Aerivio Spiromax fås imidlertid kun i en enkelt, høj styrke, hvorimod referencelægemidlet fås i tre styrker (den samme høje styrke samt to lavere styrker).
However, Aerivio Spiromax is available only as a single high strength, whereas the reference medicine is available in three strengths, the same high strength and two lower strengths.
Aerivio Spiromax er et "hybridt lægemiddel".
Aerivio Spiromax is a ‘hybrid medicine'.
Da Aerivio Spiromax kun fås i en enkelt, høj styrke (der indeholder 50 mikrogram salmeterol og 500 mikrogram fluticasonpropionat), bør patienterne - hvis der opstår behov for en lavere styrke - skifte til en anden kombination af salmeterol og fluticasonpropionat, hvor fluticasonpropionat-indholdet er lavere.
Since Aerivio Spiromax is only available in one high strength (containing 50 micrograms of salmeterol and 500 micrograms of fluticasone propionate), should a lower strength become appropriate, patients should be switched to an alternative combination of salmeterol and fluticasone propionate containing a lower
Det virker ved at binde sig til beta2-receptorerne i muskelcellerne i luftvejene.
It works by attaching to receptors known as beta-2 receptors in the muscles of the airways.