FrancophonIA/ELRC3.0 huggingface dataset:
English: Marketing Authorisation Number
Danish: Yderligere oplysninger Markedsføringstilladelse nr.
English: Taking into account that the application was submitted in accordance with the current guidelines (EMEA/CVMP/016/00 and VICH GL7); that bioequivalence with the reference product has been proven; that the clinical effect of ivermectin is related to plasma pharmacokinetics;
Danish: Ansøgningen var indgivet i overensstemmelse med de aktuelle retningslinjer (EMEA/CVMP/016/00 og VICH GL7), bioækvivalensen med referenceproduktet er dokumenteret, den kliniske effekt af ivermectin er relateret til plasmafarmakokinetik har CVMP vedtaget, at der ikke kræves nogen dosisbekræftende undersøgelse for at påvise klinisk effekt.
English: Persistant activity
Danish: Opretholdelse af aktivitet
English: (including inhibited O. ostertagi) (adult and fourth stage larvae) Haemonochus placei (adult and fourth stage larvae) Trichostrongylus spp.
Danish: inhiberede O. ostergagi) (voksne og fjerde stadie larver) Haemonochus placei (voksne og fjerde stadie larver) Trichostrongylus spp.
English: 5.1 Indications For Use:
Danish: 5.1 Indikationer:
English: To avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or in the spine it is recommended to administer the product at the end of warble fly activity and before the larvae reach their resting sites.
Danish: For at undgå sekundære reaktioner på grund af døde Hypoderma larver i spiserøret eller rygsøjlen, anbefales det at give produktet i slutningen af bremse-aktiviteten, og før end at larverne når deres hvilested.
English: 4.2 Pharmacokinetic properties
Danish: 4.2 Farmakokinetiske egenskaber
English: 5.9 Special Warnings for each Target Species
Danish: Særlige advarsler for hver dyreart
English: 6.3 Special Precautions for Storage
Danish: 6.3 Særlige opbevaringsforhold
English: Therefore, the CVMP has recommended the granting of the Marketing Authorisation(s) for which the Summary of Product Characteristics is set out in Annex III for Bovimectin injection.
Danish: Derfor har CVMP anbefalet, at der udstedes markedsføringstilladelse(r) for Bovimectin injection.
English: Use of 17 gauge x ½ inch needle is suggested.
Danish: Brug af 17G x ½ tomme kanyle anbefales.
English: 5.0 Target Species
Danish: 5.0 Dyrearter
English: 5.11 Special Precautions to be taken by the person administering the product to animals Take care to avoid self-administration: the product may cause local irritation and/or pain at the site of injection.
Danish: Pas på selv-administration: produktet kan forårsage lokal-irritation og/eller smerte på injektionsstedet.
English: Name of Veterinary Medicinal Product: Bovimectin Injection, 1%, Solution for injection for Cattle
Danish: Bovimectin Injection, 1 % injektionsvæske, opløsning, til kvæg Deklaration
English: Bovimectin Injection for Cattle has been formulated specifically for use in this species.
Danish: Bovimectin Injection til kvæg er formuleret specielt til kvæg.
English: 5.4 Special Precautions for Use
Danish: Særlige forsigtighedsregler vedrørende brugen
English: (adult and fourth stage larvae) Cooperia spp.
Danish: (voksne og fjerde stadie larver) Cooperia spp.
English: Belgium Bovimec B 1 % w/v (10 mg/ml)
Danish: Bovimec B 1 % w/v (10 mg/ml)
English: Single doses of 4.0 mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression.
Danish: En dosis på 4,0 mg ivermectin pr. kg (20 gange den anbefalede dosis på 0,2 mg pr. kg) injiceret subkutant i kvæg forårsagede, ataxi og depression.
English: Transitory discomfort and a low incidence of soft tissue swelling have been observed at the injection site in some cattle following subcutaneous administration.
Danish: Forbigående ubehag og enkelte tilfælde af lettere hævelse er blevet observeret på injektionsstedet hos enkelte dyr efter subkutan injektion.
English: If using a single-dose hypodermic syringe, use a separate sterile needle to withdraw Bovimectin Injection from the container.
Danish: Såfremt der anvendes en enkeltdosis hypodermisk kanyle bør Bovimectin Injection trækkes op fra beholderen ved brug af en separat, steril nål.
English: (adult and fourth stage larvae) Nematodirus spp.
Danish: (voksne og fjerde stadie larver) Nematodirus spp.
English: Bovimectin Injection for cattle can be administered to beef cows at any stage of pregnancy or lactation provided that the milk is not intended for human consumption.
Danish: Bovimectin Injection til kvæg kan anvendes til køer gennem hele drægtigheds- og laktationsperioden forudsat, at mælken ikke anvendes til konsum.
English: This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite.
Danish: Der sker således en hyperpolarisering af de postsynaptiske celler, hvilket betyder blokering af impulstransmissionen, hvorved parasitterne lammes og dør.
English: Gastro-intestinal roundworms:
Danish: Gastrointestinale rundorme:
English: 4.1 Pharmacodynamic properties
Danish: Farmakologiske egenskaber 4.1 Farmakologiske egenskaber
English: 6.6 Special Precautions for the disposal of unused product or waste material, if any: Any unused veterinary product or waste material derived from the product should be disposed of in accordance with local requirements.
Danish: Bortskaffelse af ubrugte veterinærprodukter og restprodukter skal ske i overensstemmelse med gældende lovgivning.
English: To obtain optimal benefit from the persistent activity of Bovimectin Injection for grazing animals it is recommended that calves which are set-stocked in their first grazing season should be treated 3, 8 and 13 weeks after the day of turn-out.
Danish: For at opnå optimal fordel af den opretholdte aktivitet af Bovimectin Injection i græssende dyr anbefales det, at førstegangsgræssende kalve behandles 3, 8 og 13 uger efter udbinding for at beskytte dyrene mod parasitær gastroenteritis og infektion med lungeorm gennem hele græsningssæsonen, forudsat at alle kalve inkluderes i behandlingsprogrammet, og at ingen ubehandlede kalve udbindes på samme græsningsareal.
English: Bimeda, (a division of Cross Vetpharm Group Limited)
Danish: 6.5 Registreringsindehaver Bimeda, (Cross Vetpharm Group Limited) Broomhill Road,
English: Clinical Particulars
Danish: Kliniske oplysninger
English: 5.6 Interaction with Other Medicaments and other Forms of Interactions: Bovimectin Injection can be used concurrently without adverse effects with foot and mouth disease vaccine or clostridial vaccine, given at separate injection sites.
Danish: Bovimectin Injection kan uden bivirkninger anvendes samtidig med vacciner mod mund- og klovsyge eller clostridier forudsat separate injektionssteder.
English: Package-size
Danish: Indhold Pakningsstørrelse
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS OF THE REFERENCE MEMBER STATE
Danish: BILAG III PRODUKTRESUMÉ
English: Sucking lice:
Danish: Sugende lus:
English: Lungworms: Dictyocaulus viviparus.
Danish: Lungeorm: Dictyocaulus viviparus (voksne og fjerde stadie larver)
English: 5.8 Overdose
Danish: Overdosering
English: Packaging
Danish: PRODUKTRESUMÉ
English: Warbles (parasitic stages): Hypoderma spp.
Danish: Hypoderma spp.
English: Consult your veterinarian on the correct timing of treatment.” 5.5 Use During Pregnancy and Lactation:
Danish: Spørg dyrlægen vedrørende korrekt tidspunkt for behandlingen.
English: Shelf-life: 2 years.
Danish: 2 år.
English: Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA).
Danish: Ivermectin virker ved hæmning af parasitternes nerveledning, idet stoffet stimulerer frigørelsen af -aminosmørsyre (GABA).
English: 6.1 Incompatibilities
Danish: Farmaceutiske oplysninger 6.1 Uforligeligheder
English: 5.10 Withdrawal Periods
Danish: 6.2 Opbevaringstid
English: Target Species
Danish: Specialitetens navn
English: 5.2 Contra-indications
Danish: Kontra-indikationer:
English: 5.7 Posology and Method of Administration
Danish: Drægtighed og diegivning
English: Bovimectin Injection should be given only by subcutaneous injection at the recommended dosage level of 200 mcg ivermectin per kg bodyweight under the loose skin in front of, or behind, the shoulder in cattle.
Danish: Den anbefalede administrationsmåde er subkutan injektion under den løse hud foran eller bagved skulderen.
English: The product should not enter water courses as this may be dangerous to fish and other aquatic organisms.
Danish: Præparatet er stærkt toksisk over for akvatiske organismer.
English: Member State Invented Name
Danish: Særnavn
English: 6.4 Nature and Contents of Container
Danish: 6.4 Emballage
English: Pharmaceutical Form Solution for injection
Danish: Lægemiddelform Injektionsvæske, opløsning.
English: The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gates chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.
Danish: Hos pattedyr fungerer GABA kun som neurotransmitter i centralnervesystemet, og ved anvendelse af ivermectin i anbefalet dosis, penetrerer stoffet kun i ubetydelig grad blodhjernebarrieren.
English: Do not administer by the intravenous or intramuscular route.
Danish: Må ikke injiceres i blodkar eller muskulatur.
English: Broomhill Road, Tallaght,
Danish: Tallaght,
English: The reason for this difference is unknown.
Danish: Årsagen til denne forskel er ukendt.
English: These events have often been transitory.
Danish: Disse hændelser har ofte været kortvarige.
English: Date of first authorisation: 24 October 2003 Date of latest renewal: 22 September 2008
Danish: Dato for første markedsføringstilladelse: 24. oktober 2003 Dato for seneste fornyelse: 22. september 2008
English: The mechanism is unknown.
Danish: Mekanismen er ikke kendt.
English: After first opening: 45 days.
Danish: Efter første åbning: 45 dage.
English: Most of these combinations have not been studied in humans.
Danish: De fleste af disse kombinationer er ikke blevet undersøgt hos mennesker.
English: It may also help to increase the number of T cells called CD4 cells.
Danish: Det kan også bidrage til at øge antallet af de T-celler, der kaldes CD4-celler.
English: Make sure that you understand how to measure and give the right amount of oral solution according to the weight of the person being treated.
Danish: Sørg for, at De forstår, hvordan De skal måle og give den rigtige mængde af oral opløsning i henhold til vægten af den person, som skal behandles.
English: Emtriva oral solution contains:
Danish: Emtriva oral opløsning indeholder:
English: It may harm them,
Danish: Der medfølger et målebæger (se pkt.
English: It is advised to write the date of removal from the refrigerator on the package.
Danish: Det anbefales at skrive datoen for fjernelsen fra køleskabet på emballagen.
English: Whether such neurological disorders are transient or permanent is currently unknown.
Danish: I hvilken udstrækning sådanne neurologiske forstyrrelser er kortvarige eller permanente er p.t. ikke kendt.
English: However, no adjustment in the recommended daily dose for adults should be required unless there is evidence of renal insufficiency.
Danish: Det burde dog ikke være nødvendigt at tilpasse den anbefalede daglige dosis til voksne, med mindre der er tegn på nyreinsufficiens.
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Danish: Indehaveren af denne markedsføringstilladelse skal underrette den Europæiske Kommision om markedsføringsplanerne for det lægemiddel, der er godkendt ved denne beslutning.
English: These may be signs that your body's improved immune system is fighting infection.
Danish: Dette kan være tegn på, at kroppens forbedrede immunforsvar bekæmper infektionen.
English: Swallow the hard capsule with a glass of water.
Danish: De hårde kapsler skal synkes med et glas vand.
English: Per day
Danish: Dagligt
English: • Adults: Your doctor will advise the correct amount of Emtriva oral solution to be taken.
Danish: • Voksne: Deres læge vil oplyse Dem om den korrekte mængde af Emtriva oral opløsning, som skal tages.
English: It is known that the virus can be passed to the baby in breast milk.
Danish: Det er kendt, at virus kan overføres til barnet via mælken.
English: Although the mean Cmax and Cmin were approximately 20% higher and mean AUC was 16% higher in females compared to males, this difference was not considered clinically significant.
Danish: Selv om det gennemsnitlige Cmax og Cmin var ca. 20% højere og det gennemsnitlige AUC var 16% højere hos kvinder i sammenligning med mænd, regnedes denne forskel ikke for at være klinisk signifikant.
English: • If you have problems with your kidneys, your doctor may advise you to take Emtriva less frequently.
Danish: • Hvis De har problemer med Deres nyrer, kan Deres læge råde Dem til at tage Emtriva mindre hyppigt.
English:  If this applies to you, tell your doctor immediately.
Danish:  Hvis dette gælder for Dem, skal De omgående fortælle Deres læge det.
English: 1 See section 4.8, Description of selected adverse reactions for more details.
Danish: 4.8, Beskrivelse af udvalgte bivirkninger for yderligere detaljer.
English: Store in a refrigerator (2°C - 8°C) until opened.
Danish: Opbevares i køleskab (2 °C - 8 °C) indtil åbning.
English: Do not give Emtriva to infants under 4 months of age.
Danish: Giv ikke Emtriva til børn under 4 måneder.
English: Although there are limited clinical data on the use of Emtriva in pregnant women, it is not usually used unless absolutely necessary.
Danish: Selvom der foreligger begrænsede kliniske data om brug af Emtriva til gravide, anvendes Emtriva normalt ikke, medmindre det er absolut nødvendigt.
English: The content of the bottle should be used up within 45 days of opening.
Danish: Flaskens indhold skal anvendes inden 45 dage efter åbning.
English: Where available, resistance testing may be appropriate.
Danish: Resistensafprøvning kan være hensigtsmæssigt, hvor en sådan er mulig.
English: * Assumes a 3-hour haemodialysis session three times a week commencing at least 12 h after administration of the last dose of emtricitabine.
Danish: * Antager en 3-timers hæmodialysesession tre gange om ugen begyndende mindst 12 timer efter administration af den sidste dosis af emtricitabin.
English: The safety and efficacy of these doses have not been clinically evaluated.
Danish: Sikkerheden og virkningen af disse doser er ikke blevet evalueret klinisk.
English: This HIV-1 mutation was observed in vitro and in HIV-1 infected patients.
Danish: Denne hiv 1 mutation blev observeret in vitro og hos hiv 1 inficerede patienter.
English: • You must not take Emtriva during pregnancy unless specifically directed by your doctor.
Danish: • De må ikke tage Emtriva under graviditeten, medmindre De specifikt er blevet instrueret om dette af Deres læge.
English: Emtriva may lower the amount of HIV in the blood (viral load).
Danish: Emtriva kan sænke mængden af hiv i blodet (virusmængden).
English: Emtriva [outer packaging only]
Danish: Emtriva [kun på den ydre emballage]
English: Emtricitabine dose (mg)
Danish: Emtricitabin-dosis (mg)
English: Blisters made of polychlorotrifluorethylene (PCTFE) / polyethylene (PE) / polyvinylchloride (PVC) / aluminium.
Danish: Blistre fremstillet af polychlortrifluorethylen (PCTFE)/polyethylen (PE)/polyvinylchlorid (PVC)/ aluminium.
English: If overdose occurs, the patient should be monitored for signs of toxicity and standard supportive treatment applied as necessary.
Danish: Såfremt der forekommer overdosering, skal patienten monitoreres for tegn på toksicitet, og der skal gives støttende standardbehandling efter behov.
English: If there is evidence of exacerbations of liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Hvis der er tegn på eksacerbationer af leversygdom hos sådanne patienter, bør afbrydelse eller seponering af behandling overvejes.
English: These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Danish: Disse resultater påvirker ikke de aktuelle nationale anbefalinger vedrørende brug af antiretroviral behandling hos gravide med henblik på at undgå vertikal hiv-overførsel.
English: After opening: The solution should be used within 45 days.
Danish: Efter åbning: Opløsningen skal anvendes inden 45 dage.
English: Ethnicity No clinically important pharmacokinetic difference due to ethnicity has been identified.
Danish: Etnisk oprindelse Der er ikke blevet identificeret klinisk vigtige farmakokinetiske forskelle på grund af etnicitet.
English: Tell your doctor about any of the following side effects: Most frequent side effects
Danish: Fortæl Deres læge det, hvis De får en eller flere af følgende bivirkninger: Hyppigste bivirkninger
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000 to < 1/100).
Danish: (≥ 1/10), almindelige (≥ 1/100 til < 1/10) eller ikke almindelige (≥ 1/1.000 til < 1/100).
English: Phenotypic analysis showed no significant changes in emtricitabine susceptibility unless the M184V/I mutation had developed.
Danish: Fenotypeanalyse viste ingen signifikante ændringer i emtricitabindisposition, medmindre der var udviklet M184V/I mutation.
English: Examples of body weight and the corresponding doses and volumes of the oral solution to be taken each day are given in the table below:
Danish: Eksempler på legemsvægt og de tilsvarende doser og mængder af den orale opløsning, som skal tages dagligt, er anført i nedenstående skema:
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: De kan stadig smitte andre med hiv, selvom De tager dette lægemiddel, selvom risikoen er nedsat ved effektiv antiretroviral terapi.
English: The frequency category of uncommon was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in these clinical studies (n = 1,563).
Danish: Hyppighedskategorien ‘ikke almindelig' blev estimeret ud fra en statistisk beregning baseret på det totale antal patienter eksponeret over for emtricitabin i disse kliniske studier (n = 1.563).
English: Animal studies do not indicate reproductive toxicity.
Danish: Dyreforsøg indikerer ikke reproduktionstoksicitet.
English: While taking Emtriva you may still develop infections or other illnesses associated with HIV infection.
Danish: Mens De tager Emtriva, kan De stadig udvikle infektioner eller andre sygdomme forbundet med hiv-infektionen.
English: • If you could get pregnant during treatment with Emtriva, you must use an effective method of contraception to stop you getting pregnant.
Danish: • Hvis De kan blive gravid under behandlingen med Emtriva, skal De anvende en sikker præventionsmetode for at undgå at blive gravid.
English: Use the measuring cup provided in the carton to measure the correct dose.
Danish: Brug målebægeret i æsken til at afmåle den korrekte dosis.
English: If you have taken Emtriva during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: Hvis De har taget Emtriva under Deres graviditet, kan Deres læge bede om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
English: If you would like to switch from taking Emtriva oral solution to Emtriva hard capsules, please talk to your doctor.
Danish: Hvis De gerne vil skifte fra at tage Emtriva oral opløsning til Emtriva hårde kapsler, bedes De tale med Deres læge.
English: It must be used in combination with other antiretrovirals.
Danish: Det skal anvendes i kombination med andre antiretrovirale lægemidler.
English: Table 2: Tabulated summary of adverse reactions associated with emtricitabine based on clinical study and post-marketing experience
Danish: Tabel 2: Resumé af bivirkninger forbundet med emtricitabin baseret på erfaringer fra kliniske studier og efter markedsføring
English: Do not change the dose unless your doctor tells you to.
Danish: De må ikke ændre Deres dosis, medmindre De får besked på det af Deres læge.
English: This dose is half of that approved for infants aged 4 months and over (6 mg/kg).
Danish: Denne dosis er det halve af den dosis, der er godkendt til børn på 4 måneder og ældre (6 mg/kg).
English: If you stop taking Emtriva • Don't stop taking Emtriva without talking to your doctor.
Danish: Hvis De holder op med at tage Emtriva • Hold ikke op med at tage Emtriva uden at tale med Deres læge.
English: The adverse reactions with suspected (at least possible) relationship to treatment in adults from clinical trial and post-marketing experience are listed in Table 2 below by body system organ class and frequency.
Danish: Bivirkningerne med mistænkt (eller i det mindste en mulig) forbindelse med behandlingen af voksne fra kliniske studier og efter markedsføring er anført i Tabel 2 nedenfor efter systemorganklasse og hyppighed.
English: Do not take a double dose to make up for a forgotten hard capsule.
Danish: De må ikke tage en dobbeltdosis som erstatning for den glemte hårde kapsel.
English: • increased triglycerides (fatty acids), bile or sugar in the blood
Danish: • forhøjet mængde af fedtsyrer (triglycerider), galde eller sukker i blodet
English: Keep the carton with you so that you can easily describe what you have taken.
Danish: Tag æsken med, så De let kan vise, hvad De har taget.
English: • Your doctor will prescribe Emtriva with other antiretroviral medicines.
Danish: • Deres læge vil ordinere Emtriva i kombination med anden antiretroviral medicin.
English: Speak with your doctor before you stop, particularly if you are experiencing any side effects or you have another illness.
Danish: Tal med Deres læge, før De ophører med behandlingen, især hvis De oplever bivirkninger eller har en anden sygdom.
English: There is no clinical experience as yet on the co-administration of cytidine analogues.
Danish: Der er endnu ingen klinisk erfaring med samtidig administration af cytidinanaloger.
English: If the production of red blood cells is reduced, a child may have symptoms of tiredness or breathlessness.
Danish: Hvis produktionen af røde blodlegemer er nedsat, kan barnet få symptomer som træthed og åndenød.
English: This indication is based on studies in treatment-naïve patients and treatment-experienced patients with stable virological control.
Danish: Denne indikation er baseret på studier med behandlingsnaive patienter og behandlingserfarne patienter med stabil, virologisk kontrol.
English: In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Danish: For de børn, hvis mor har taget NRTI'er i løbet af graviditeten, opvejer fordelen ved beskyttelsen mod hiv risikoen for at få bivirkninger.
English: Adults with renal insufficiency
Danish: Voksne med nyreinsufficiens
English: In some of these patients, HBV reactivation was associated with more severe liver disease, including decompensation and liver failure.
Danish: Hos nogle af disse patienter var reaktiveringen af HBV forbundet med sværere leversygdom, herunder dekompensation og leversvigt.
English: Emtriva oral solution is a clear, orange to dark orange solution that comes in bottles containing 170 mL with a measuring cup.
Danish: Emtriva oral opløsning er en klar, orange til mørkorange opløsning, som fås i flasker, der indeholder 170 ml, med et målebæger.
English: The apparent total body clearance at steady-state (CL/F) increased with age over the 3-month period with a corresponding decrease in AUC.
Danish: Den tilsyneladende totale clearance ved steady-state (CL/F) steg med alderen i løbet af 3-månedersperioden med et tilsvarende fald i AUC.
English: If you forget to take Emtriva
Danish: Hvis De har glemt at tage Emtriva
English: The YMDD mutation confers resistance to both emtricitabine and lamivudine.
Danish: YMDD-mutationen medfører resistens over for både emtricitabin og lamivudin.