FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation was renewed on 4 July 2004.
Danish: Denne tilladelse blev fornyet den 4. juli 2004.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Forcaltonin to Unigene UK Limited on 11 January 1999.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Forcaltonin til Unigene UK Limited den 11. januar 1999.
English: This included the results of three studies of the effectiveness and safety of Forcaltonin in 94 women, including 58 with osteoporosis.
Danish: Heri indgik resultaterne af tre undersøgelser af virkningen og sikkerheden af Forcaltonin hos 94 kvinder, hvoraf 58 havde osteoporose.
English: The doses and duration of treatment depend on to the patient's response to the medicine.
Danish: Behandlingens varighed afhænger af patientens reaktion på behandlingen.
English: This side effect is less common when the injection is given in the evening and after meals.
Danish: Den forekommer mindre ofte, når indsprøjtningen gives om aftenen og efter et måltid.
English: The most common side effect found in about 10% of patients is nausea (feeling sick) with or without vomiting.
Danish: Den hyppigste bivirkning (der optræder hos ca. 10 % af patienterne) er kvalme (med eller uden opkastning).
English: Other information about Forcaltonin:
Danish: Andre oplysninger om Forcaltonin:
English: Each ampoule contains 100 IU (International Units) of the active substance salmon calcitonin.
Danish: Hver ampul indeholder 100 IE (internationale enheder) af det aktive stof laksecalcitonin.
English: Salmon calcitonin, either extracted from salmon or synthetic (man-made), has been in use as a medicine since the mid-1970s.
Danish: Laksecalcitonin, enten udvundet af laks eller fremstillet syntetisk, har været brugt som lægemiddel siden midten af 1970'erne.
English: The doctor may decide to perform a skin test to check the patient's allergy status before prescribing the medicine.
Danish: Lægen kan vælge at teste patientens allergistatus ved en priktest, før lægemidlet ordineres.
English: Forcaltonin contains the active ingredient salmon calcitonin, which works in the same way as natural human calcitonin but it is more effective and longer lasting.
Danish: Forcaltonin indeholder det aktive stof laksecalcitonin, der virker på samme måde som naturligt humant calcitonin, men er mere effektivt og virker i længere tid.
English: Forcaltonin is a clear solution for injection.
Danish: Forcaltonin er en klar væske til injektion.
English: In severe or emergency cases, Forcaltonin may be given as an intravenous infusion (10 IU per kg body weightover 6 hours).
Danish: I svære eller akutte tilfælde kan Forcaltonin indgives som intravenøs infusion (10 IE pr. kg legemsvægt) i løbet af seks timer.
English: This side effect is more likely at the start of treatment and tends to decrease or disappear with further doses or smaller doses.
Danish: Denne bivirkning optræder især ved behandlingens begyndelse og vil som regel aftage eller svinde, når behandlingen fortsættes eller doseringen nedsættes.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FORCALTONIN EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) FORCALTONIN EPAR - sammendrag for offentligheden
English: These studies measured the markers of bone metabolism.
Danish: I undersøgelserne registreredes markører for knoglernes stofskifte.
English: They recommended that Forcaltonin be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Forcaltonin.
English: Forcaltonin can only be obtained with a prescription.
Danish: Forcaltonin udleveres kun efter recept.
English: Calcitonin is a hormone produced by the thyroid gland that increases the amount of calcium and phosphorus laid down in the bones and lowers the level of calcium circulating in the blood.
Danish: Calcitonin er et hormon, der produceres af skjoldbruskkirtlen og øger mængden af calcium og fosfor, der indlejres i knoglerne, og sænker calciumindholdet i blodet.
English: Forcaltonin is given by subcutaneous injection (under the skin), intramuscular injection (into a muscle) or intravenous infusion (drip into a vein - only in hypercalcaemia).
Danish: Forcaltonin gives ved subkutan indsprøjtning (under huden), intramuskulær indsprøjtning (i en muskel) eller intravenøs infusion (dryptilførsel i en vene - kun ved hyperkalcæmi).
English: In hypercalcaemia, the recommended starting dose is 100 IU every 6 to 8 hours by subcutaneous or intramuscular injection.
Danish: Ved hyperkalcæmi anbefales en startdosering på 100 IE hver seks til otte timer, indgivet ved subkutan eller intramuskulær indsprøjtning.
English: Forcaltonin should not be used in people who have hypocalcaemia (low calcium levels in the blood) or who may be hypersensitive (allergic) to calcitonin or any of the other ingredients.
Danish: Forcaltonin bør ikke anvendes til patienter, der har hypokalcæmi (for lavt calciumindhold i blodet) eller kan være overfølsomme (allergiske) over for calcitonin eller andre af indholdsstofferne.
English: This may be increased after one or two days, according to the patient's response to treatment, up to a maximum of 400 IU every 6 to 8 hours.
Danish: Afhængigt af patientens reaktion på behandlingen kan denne dosering efter en til to dage øges til højst 400 IE hver seks til otte timer.
English: In Paget's disease, the recommended dosage is 100 IU per day given subcutaneously or intramuscularly, however, a minimum dose of 50 IU three times a week is also effective.
Danish: Ved Pagets sygdom anbefales en dosering på 100 IE dagligt, indgivet subkutant eller intramuskulært, men en mindste dosering på 50 IE tre gange om ugen er også effektiv.
English: It is also used in Paget's disease (a bone disease that involves bone destruction and regrowth that causes deformity), and in hypercalcaemia (increased blood calcium) caused by cancer.
Danish: Desuden anvendes det til Pagets sygdom (en knoglesygdom, der bevirker ændringer i knoglernes nedbrydning og genopbygning) og ved hyperkalcæmi (forhøjet calciumindhold i blodet) forårsaget af kræft.
English: Forcaltonin showed the same effectiveness and safety profile as synthetic salmon calcitonin.
Danish: Forcaltonin har vist sig at have samme virkning og sikkerhedsprofil som syntetisk laksecalcitonin.
English: Why has Forcaltonin been approved?
Danish: Hvorfor er Forcaltonin blevet godkendt?
English: For the full list of side effects reported with Forcaltonin, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Forcaltonin fremgår af indlægssedlen.
English: Other common side effects are skin flushes (face or upper body).
Danish: Andre ofte forekommende bivirkninger er rødme (af ansigt eller overkrop).
English: The Committee for Medicinal products for Human Use (CHMP) concluded that Forcaltonin had been shown to have the same characteristics and properties as synthetic salmon calcitonin.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) har fundet, at Forcaltonin er påvist at have samme egenskaber som syntetisk laksecalcitonin.
English: What is the risk associated with Forcaltonin?
Danish: Hvilken risiko er der forbundet med Forcaltonin?
English: To prevent bone loss, the recommended dosage is 100 IU daily or 50 IU twice daily for 2 to 4 weeks, given subcutaneously or intramuscularly.
Danish: Til forebyggelse af knogletab anbefales en dosering på 100 IE dagligt eller 50 IE to gange dagligt i to til fire uger, indgivet enten subkutant eller intramuskulært..
English: Because salmon calcitonin has been in use for some time, the company presented data to show that Forcaltonin has been compared with synthetic salmon calcitonin.
Danish: Da laksecalcitonin har været anvendt i et stykke tid, har firmaet fremlagt dokumentation for sammenlignende undersøgelser af Forcaltonin og syntetisk laksecalcitonin.
English: They decided that Forcaltonin's benefits are greater than its risks for prevention of bone loss due to sudden immobilisation, such as in patients with recent bone fractures caused by osteoporosis (a disease that makes bones fragile), for treatment of Paget's disease, and treatment of hypercalcaemia of malignancy.
Danish: Udvalget har fundet, at fordelene ved Forcaltonin er større end risiciene ved anvendelse til forebyggelse af knogletab i forbindelse med pludselig ubevægelighed, f.eks. ved nyligt knoglebrud som følge af knogleskørhed, samt til behandling af Pagets sygdom og til behandling af hyperkalcæmi ved ondartede sygdomme.
English: The full EPAR for Forcaltonin is available here.
Danish: Den Europæiske Offentlige Vurderingsrapport (EPAR) for Forcaltonin kan ses i sin helhed her.
English: What benefit has Forcaltonin shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved Forcaltonin?
English: The active substance of Forcaltonin, salmon calcitonin, is a copy of the hormone produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce salmon calcitonin.
Danish: Det aktive stof i Forcaltonin, laksecalcitonin, er en kopi af hormonet og fremstilles ved "rekombinant DNA-teknik" (gensplejsning).
English: What is Forcaltonin used for?
Danish: Hvad anvendes Forcaltonin til?
English: How is Forcaltonin used?
Danish: Hvordan anvendes Forcaltonin?
English: Forcaltonin is used in adults to prevent bone loss due to sudden immobilisation such as in patients with recent bone fractures caused by osteoporosis (a disease that makes bones fragile).
Danish: Forcaltonin anvendes hos voksne til at forebygge knogletab i forbindelse med pludselig ubevægelighed, således hos patienter med nyligt knoglebrud som følge af knogleskørhed.
English: What is Forcaltonin?
Danish: Hvad er Forcaltonin?
English: VIRACEPT 50 mg/g oral powder
Danish: 50 mg/g Oralt pulver
English: • Rash.
Danish: r l
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Danish: Lægemiddelform Indgivelsesvej
English: Number of
Danish: EU-nummer
English: % Fat Number of Subjects
Danish: Indhold Paknings-størrelse
English: Manufacturer
Danish: Emballage
English: 144 g Oral powder
Danish: Oral anvendelse Flaske (HPDE) 144 g
English: Methadone 80 mg + 21 mg qd > 1 month (Nelfinavir 1250mg bid x 8 days
Danish: 1 flaske + 1 g og 5 g polysyren måleske
English: Kύπρος
Danish: Styrke
English: Date of first authorisation: 24/07/2008 Date of last renewal: 15/07/2013
Danish: Dato for første markedsføringstilladelse: 24/07/2008 Dato for sidste forlængelse af markedsføringstilladelse: 15/07/2013
English: The injection volume should not exceed 5 ml per injection site.
Danish: Injektionsvolumet bør ikke overskride 5 ml per injektionssted.
English: Gamithromycin may cause irritation to eyes and/or skin.
Danish: Gamithromycin kan forårsage irritation af øjne og/eller hud.
English: Incompatibilities: Do not mix with other medicinal products.
Danish: Uforligeligheder: Må ikke blandes med andre lægemidler.
English: The swellings typically resolve within 3 to 14 days but may persist in some animals for up to 35 days after treatment.
Danish: Hævelserne forsvinder typisk inden for 3 til 14 dage men kan fortsætte hos nogle dyr i op til 35 dage efter behandling.
English: The MIC and MBC data (cattle and pig) are reported from a representative sample of isolates from field materials within different EU geographic areas.
Danish: Der er rapporteret om MIC og MBC data (kvæg og svin) fra et repræsentativt antal feltisolater inden for forskellige geografiske områder i EU.
English: The periodic safety update report (PSUR) cycle should be re-started for submission of 6- monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals.
Danish: Den periodiske, opdaterede sikkerhedsindberetninger (PSUR) cyklus bør nulstilles før indsendelse af 6 månedlige rapporter (der dækker alle godkendte pakningsstørrelser af produktet) for de næste to år, efterfulgt af årlige rapporter for de efterfølgende to år og derefter på 3 års mellemrum.
English: The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Danish: Hjælpestofferne anført under punkt 6.1 i SPC'et er tilladte hjælpestoffer, hvor table 1 i bilaget til Kommissionens Forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet.
English: Cattle and pigs: None.
Danish: Kvæg og svin: Ingen.
English: To ensure correct dose, body weight should be determined as accurately as possible to avoid underdosing.
Danish: For at sikre korrekt dosis bør legemsvægten bestemmes så nøjagtigt som muligt for at undgå underdosering.
English: Sheep: 29 days.
Danish: Får: 29 dage.
English: The bioavailability of the compound was > 98 % with no gender differences.
Danish: Det aktive stofs biotilgængelighed var > 98 % uden forskelle på køn.
English: This is often referred to as MLSB resistance as it affects macrolides, lincosamides and streptogramins.
Danish: Der refereres ofte til dette som MLSB-resistens, da det har betydning for makrolider, lincosamider og streptograminer.
English: This veterinary medicinal product does not require any special storage conditions.
Danish: Dette veterinære lægemiddel kræver ingen særlige opbevaringsbetingelser.
English: EXP Once opened, use by __/__/__
Danish: EXP Efter anbrud, anvend inden __/__/__
English: The mechanisms involve the alteration of the ribosomal target site, the utilization of active efflux mechanism and the production of inactivating enzymes.
Danish: Mekanismerne omfatter ændring af det ribosomale target site, anvendelse af den aktive efflux mekanisme og dannelse af inaktiverende enzymer.
English: Three mechanisms are generally considered responsible for resistance to the macrolide class of compounds.
Danish: Sædvanligvis anses tre mekanismer at være ansvarlige for resistens over for makrolid antibiotika.
English: The presence of the disease in the herd should be established before metaphylactic use.
Danish: Det skal konstateres, at sygdommen er til stede i besætningen, inden metafylaktisk behandling påbegyndes.
English: Cross resistance may occur with other macrolides.
Danish: Krydsresistens med andre makrolider kan forekomme.
English: People with known hypersensitivity to the macrolide class should avoid contact with the veterinary medicinal product.
Danish: Personer med kendt overfølsomhed over for makrolider bør undgå kontakt med det veterinære lægemiddel.
English: The volume of distribution at steady-state was approximately 39 l/kg.
Danish: Fordelingssvolumenet ved steady-state var ca. 39 l/kg.
English: These local reactions are transient and typically resolve within 2 (pigs) to 4 (sheep) days.
Danish: Disse lokale reaktioner er forbigående og forsvinder typisk inden for 2 (svin) til 4 (får) dage.
English: This special chemistry facilitates rapid absorption at physiological pH and a long duration of action at the target tissues, the lung and the skin.
Danish: Denne specielle kemi muliggør hurtig absorption ved fysiologisk pH og en lang effektvarighed i de ønskede væv, lungen og huden.
English: 4, Chemin du Calquet 31000 Toulouse France
Danish: 4, Chemin du Calquet 31000 Toulouse Frankrig
English: The volume of distribution at steady-state was 25 l/kg.
Danish: Fordelingsvolumen ved steady state var 25 l/kg.
English: Do not use this veterinary medicinal product simultaneously with other macrolides or lincosamides (see section 4.8).
Danish: Må ikke anvendes samtidig med andre makrolider eller lincosamider (se afsnit 4.8).
English: Pigs: 16 days.
Danish: Svin: 16 dage.
English: In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette veterinære lægemiddel ikke blandes med andre veterinære lægemidler.
English: Treatment of foot rot should therefore be undertaken along with other flock management tools, for example providing dry environment.
Danish: Man bør derfor samtidig med behandlingen af klovsyge benytte sig af andre managementværktøjer, som for eksempel at sørge for tørre omgivelser.
English: If skin exposure occurs, wash the affected area immediately with clean water.
Danish: Hvis lægemidlet kommer i kontakt med huden, skal det pågældende område straks vaskes med rent vand.
English: The in vitro data show that gamithromycin acts in a bactericidal manner.
Danish: In vitro-data viser at gamithromycin virker baktericidt.
English: The active substance in ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: Den aktive substans i ZACTRAN 150 mg/ml injektionsvæske, opløsning, til kvæg, får og svin er godkendt substans som beskrevet i tabel 1, i bilag til Kommissionens Forordning (EU) Nr. 37/2010
English: Clinical studies have demonstrated the wide margin of safety for gamithromycin injection in the target species.
Danish: Kliniske undersøgelser har vist en bred sikkerhedsmargen for injektion af gamithromycin i de dyrearter som lægemidlet er beregnet til.
English: Muscle Skin and fat in natural proporti ons
Danish: Muskel Hud og fedt i naturlige proportio ner.
English: The cap may be safely punctured up to 60 times.
Danish: Gummimembranen kan sikkert punkteres op til 60 gange.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: D. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: If eye exposure occurs, flush eyes immediately with clean water.
Danish: Hvis lægemidlet kommer i kontakt med øjnene, skal øjnene øjeblikkeligt skylles med rent vand.
English: Injection site reactions were noted in a dose related manner.
Danish: Reaktioner på injektionsstedet blev iagttaget afhængigt af dosis.
English: Macrolides in general have both bacteriostatic and bactericidal action mediated through disruption of bacterial protein synthesis.
Danish: Makrolider har sædvanligvis både bakteriostatisk og baktericid virkning, idet de ødelægger bakteriens proteinsyntese.
English: Macrolides inhibit bacterial protein biosynthesis by binding to the 50S ribosomal subunit and by preventing peptide chain elongation.
Danish: Makrolider hæmmer den bakterielle proteinbiosyntese ved at binde sig til 50S-ribosom subunit og forhindre forlængelse af peptidkæden.
English: Accumulation of gamithromycin in the lung has been demonstrated by high and sustained concentrations in the lung and bronchial fluid which far exceed those in blood plasma.
Danish: Akkumulation af gamithromycin i lungen er demonstreret ved høje og vedvarende koncentrationer i lungen og i bronkialvæsken som langt overgår de koncentrationer der findes i blodplasma.
English: Meat and offal: Cattle: 64 days Sheep: 29 days Pigs: 16 days
Danish: Kvæg: 64 dage Får: 29 dage Svin: 16 dage
English: The 500 ml vial is for cattle and pigs only.
Danish: Hætteglasset med 500 ml er kun beregnet til kvæg og svin.
English: For multiple vial entry, an automatic dosing device is recommended to avoid excessive broaching of the stopper.
Danish: Ved gentagne doseringer, anbefales et automatisk doseringsapparat for at undgå for hyppig brydning af membranen.
English: Gamithromycin is an azalide, 15-membered semisynthetic macrolide class antibiotic with uniquely positioned alkylated nitrogen at 7a-position of the lactone ring.
Danish: Gamithromycin er et azalid, 15-leddet semisyntetisk makrolid antibiotikum med et alkyleret kvælstofatom i unik position på laktonringens 7a-position.
English: In vitro plasma protein binding studies determined that the mean concentration of the free active substance was 74 %.
Danish: Undersøgelser med in vitro-plasmaproteinbinding viste, at den gennemsnitlige koncentration af fri aktiv substans var 74 %.
English: Use only according to the risk/benefit assessment by the responsible veterinarian.
Danish: Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af risk-benefitforholdet.
English: Monothioglycerol Succinic Acid Glycerol Formal
Danish: Monothioglycerol Succinylsyre Glycerol Formal
English: MIC µg/ml
Danish: µg/ml
English: Actinobacillus pleuropneumoniae Pasteurella multocida Haemophilus parasuis Bordetella bronchiseptica Sheep
Danish: Actinobacillus pleuropneumoniae Pasteurella multocida Haemophilus parasuis Bordetella bronchiseptica Får
English: The bioavailability of gamithromycin was > 92 %.
Danish: Det aktive stofs biotilgængelighed var > 92 %.
English: Use of the veterinary medicinal product should be based on susceptibility testing and take into account official and local policies on the use of antimicrobials in farm animals.
Danish: Anvendelse af det veterinære lægemiddel bør baseres på kendskab til resistensmønster og følge det gældende regelsæt for anvendelse af antibiotika til produktionsdyr.
English: During clinical trials transient injection site swellings were observed.
Danish: I forbindelse med kliniske undersøgelser blev forbigående hævelser på injektionsstedet observeret.
English: 1 ml contains
Danish: 1 ml indeholder
English: The safety of gamithromycin during pregnancy and lactation has not been evaluated in cattle, sheep and pigs.
Danish: Lægemidlets sikkerhed under drægtighed og laktation hos kvæg, får og svin er ikke fastlagt.
English: Treatment of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus and Fusobacterium necrophorum requiring systemic treatment.
Danish: Behandling af infektiøs pododermatitis (klovsyge) forårsaget af virulent Dichelobacter nodosus og Fusobacterium necrophorum, som kræver systemisk behandling.
English: Gamithromycin levels in lung reached a maximum in less than 24 hr, with lung-to-plasma ratio of > 264 indicating that gamithromycin was absorbed rapidly into the target tissue for BRD.
Danish: Gamithromycin værdier i lungen nåede et maximum på mindre end 24 timer med lunge-plasmaratio på > 264, der viser at gamithromycin absorberes hurtigt i målvævet i forb.m.
English: Pigs: 16 days Not authorised for use in animals producing milk for human consumption.
Danish: Svin: 16 dage Må ikke anvendes til dyr hvis mælk er bestemt til menneskeføde.
English: Colourless to pale yellow solution.
Danish: Farveløs til svag gul opløsning.
English: In young adult cattle, sheep and pig studies, gamithromycin was administered by injection at 6, 18, and 30 mg/kg (1, 3, and 5 times the recommended dose) and repeated three times at 0, 5 and 10 days (three times the recommended duration of use).
Danish: I undersøgelser med unge, udvoksede kvæg, får og svin blev gamithromycin injiceret i en dosis på 6, 18 og 30 mg/kg (1, 3 og 5 gange den anbefalede dosis) og gentaget 3 gange dag 0, 5 og 10 (3 gange den anbefalede behandlingsvarighed).
English: Do not use this veterinary medicinal product simultaneously with other macrolides or antibiotics known as lincosamides.
Danish: Må ikke anvendes samtidig med andre makrolider eller antibiotika kendt som lincosamider
English: Antibiotic treatment of benign foot rot is not considered appropriate.
Danish: Det er uhensigtsmæssig at anvende antibiotika til behandling af godartet klovsyge.
English: Avoid simultaneous administration of antimicrobials with a similar mode of action such as other macrolides or lincosamides.
Danish: Undgå samtidig anvendelse med antibiotika, der har samme virkningsmekanisme såsom makrolider eller lincosamider.
English: • Very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: • Meget sjældne (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
English: Cattle and sheep: Subcutaneous use Pigs: Intramuscular use Read the package leaflet before use.
Danish: Kvæg og får: subkutan anvendelse Svin: intramuskulær anvendelse Læs indlægssedlen inden brug.
English: Cardboard box containing 1 vial of 50, 100, 250 or 500 ml.
Danish: Papæske indeholdende 1 hætteglas med 50, 100, 250 eller 500 ml.
English: Withdrawal periods: Meat and offal: Cattle: 64 days.
Danish: Tilbageholdelsestider: Slagtning: Kvæg: 64 dage.