FrancophonIA/ELRC3.0 huggingface dataset:
English: Given in high doses (≥ 5 IU/kg/day) follitropin alfa caused a decrease in the number of viable foetuses without being a teratogen and dystocia similar to that observed with urinary Menopausal Gonadotropin (hMG).
Danish: forårsager follitropin alfa et nedsat antal levedygtige fostre uden at være teratogent og dystoci svarende til det, der er observeret ved urinær menopausal gonadotropin (hMG) udvundet fra urin.
English: Concomitant use of follitropin alfa with other medicinal products used to stimulate ovulation (e.g. hCG, clomifene citrate) may potentiate the follicular response, whereas concurrent use of a GnRH agonist or antagonist to induce pituitary desensitisation may increase the dose of follitropin alfa needed to elicit an adequate ovarian response.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Brug af follitropin alfa samtidig med andre ovulationsstimulerende lægemidler (hCG, clomifencitrat) kan forstærke follikelresponset, mens samtidig GnRH-agonist- eller antagonistinduceret hypofysedesensibilisering kan øge den dosis af follitropin alfa, der er nødvendig for at opnå et adækvat ovarierespons.
English: INFORMATION IN BRAILLE Ovaleap 900 IU/1.5 mL
Danish: INFORMATION I BRAILLESKRIFT Ovaleap 900 IE/1,5 ml
English: Do not use this medicine if you notice it is cloudy or there are particles in it. Do not throw away any medicines via wastewater.
Danish: Brug ikke lægemidlet, hvis du bemærker, at det er uklart eller indeholder partikler.
English: The Ovaleap cartridge is designed for use in conjunction with the Ovaleap Pen only, which is separately available.
Danish: Ovaleap cylinderampullen er kun konstrueret til anvendelse sammen med Ovaleap Pen, som fås separat.
English: If you are developing OHSS your doctor may not give you any hCG in this treatment cycle.
Danish: Hvis du udvikler OHSS, vil din læge måske ikke give hCG i denne behandlingscyklus, og du vil muligvis blive bedt om ikke at have samleje eller at bruge barriereprævention i mindst 4 døgn.
English: In patients undergoing ovulation induction, the incidence of multiple pregnancy is increased compared with natural conception.
Danish: Patienter, der gennemgår ovalutionsinduktion, løber en forhøjet risiko for flerfoldsgraviditet sammenlignet med normal befrugtning.
English: INFORMATION IN BRAILLE Ovaleap 450 IU/0.75 mL
Danish: INFORMATION I BRAILLESKRIFT Ovaleap 450 IE/0,75 ml
English: If you experience the above symptoms your doctor may recommend that you stop treatment.
Danish: I sådanne tilfælde kan din læge anbefale, at du stopper behandlingen.
English: • Abdominal cramps
Danish: • Mavekramper
English: However, the OHSS will only occur if hCG is also administered [see also section 2 under “Ovarian Hyper-Stimulation Syndrome (OHSS)”].
Danish: OHSS vil kun opstå, hvis hCG også indgives [se også pkt.
English: This could cause chest pain, breathlessness, stroke or heart attack [see also section 2 under “Blood clotting problems (thromboembolic events)”].
Danish: Det kan give brystsmerter, stakåndethed, slagtilfælde eller hjerteslag [se også pkt.
English: • Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate.
Danish: polycystisk ovariesyndrom) hos kvinder, som ikke har reageret på behandling med clomifencitrat.
English: INFORMATION IN BRAILLE Ovaleap 300 IU/0.5 mL
Danish: INFORMATION I BRAILLESKRIFT Ovaleap 300 IE/0,5 ml
English: Each mL of the solution contains 600 IU (equivalent to 44 micrograms) follitropin alfa.
Danish: Hver ml opløsning indeholder 600 IE (svarende til 44 mikrogram) follitropin alfa.
English: Nevertheless one could expect Ovarian Hyper-Stimulation Syndrome (OHSS) to occur, which is described in section 4 under “Serious side effects in women".
Danish: Man kan dog antage, at ovarielt hyperstimulationssyndrom (OHSS) indtræder, hvilket beskrives i pkt.
English: Treatment is continued until adequate follicular development has been achieved (as assessed by monitoring of serum oestrogen concentrations and/or ultrasound examination), with the dose adjusted according to the patient's response, to usually not higher than 450 IU daily.
Danish: Behandlingen fortsætter med en dosis tilpasset patientens respons, sædvanligvis ikke højere end 450 IE/dag, til tilstrækkelig follikeludvikling er opnået (vurderet ved kontrol af serumøstrogen og/eller ultralydsundersøgelse).
English: Injection needles (stainless steel; 0.33 mm x 12 mm, 29 G x ½") Pack size of 1 cartridge and 10 injection needles.
Danish: Kanyler (rustfrit stål; 0,33 mm x 12 mm, 29 G x ½").
English: The patient should write down in the patient diary provided with the Ovaleap Pen the date of first use.
Danish: Patienten bør skrive datoen for første anvendelse ned i patientdagbogen, der leveres sammen med Ovaleap Pen.
English: If your body responds too strongly, your treatment with Ovaleap will be stopped and you will not be given any hCG [see also section 2 under “Ovarian Hyper-Stimulation Syndrome (OHSS)”].
Danish: Hvis din krop reagerer for kraftigt, vil behandlingen med Ovaleap blive stoppet, og du vil ikke få hCG [se også pkt.
English: Injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection)
Danish: Reaktioner på injektionsstedet (f.eks. smerte, erytem, hæmatom, hævelse og/eller irritation på injektionsstedet)
English: This side effect is common (may affect up to 1 in 10 people).
Danish: Denne bivirkning er almindelig (kan forekomme hos op til 1 ud af 10 personer)
English: For instructions on the administration with the Ovaleap Pen, see section 6.6.
Danish: For instruktioner om brug af Ovaleap Pen, se pkt.
English: • Ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.
Danish: • Ovaleap anvendes i kombination med behandling med humant choriongonadotropin (hCG) til stimulation af spermatogenesen hos mænd, som har medfødt eller erhvervet hypogonadotrop hypogonadisme.
English: Ovaleap 450 IU/0.75 mL solution for injection EU/1/13/871/002
Danish: Ovaleap 450 IE/0,75 ml injektionsvæske, opløsning EU/1/13/871/002
English: Ovaleap 900 IU/1.5 mL solution for injection EU/1/13/871/003
Danish: Ovaleap 900 IE/1,5 ml injektionsvæske, opløsning EU/1/13/871/003
English: Cartridge (type I glass) with a rubber piston (bromobutyl rubber) and a crimp-cap (aluminium) with a septum (bromobutyl rubber), containing 0.5 mL of solution.
Danish: Cylinderampul (type I glas), med et gummistempel (brombutylgummi) og et beskyttelseslåg (aluminium) med et septum (brombutylgummi), som indeholder 0,5 ml opløsning.
English: Ovaleap 900 IU/1.5 mL: Each cartridge contains 900 IU (equivalent to 66 micrograms) follitropin alfa in 1.5 mL solution.
Danish: Ovaleap 900 IE/1,5 ml: Hver cylinderampul indeholder 900 IE (svarende til 66 mikrogram) follitropin alfa i 1,5 ml opløsning.
English: How to use Ovaleap
Danish: Sådan skal du bruge Ovaleap
English: Ovaleap 900 IU/1.5 mL is available in packs containing 1 cartridge and 20 injection needles.
Danish: Ovaleap 900 IE/1,5 ml leveres i pakninger med 1 cylinderampul og 20 kanyler.
English: Ovaleap is not indicated during breast-feeding.
Danish: Ovaleap er ikke indiceret til ammende kvinder.
English: Ovaleap 450 IU/0.75 mL: Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution.
Danish: Ovaleap 450 IE/0,75 ml: Hver cylinderampul indeholder 450 IE (svarende til 33 mikrogram) follitropin alfa i 0,75 ml opløsning.
English: Ovaleap 450 IU/0.75 mL is available in packs containing 1 cartridge and 10 injection needles.
Danish: Ovaleap 450 IE/0,75 ml leveres i pakninger med 1 cylinderampul og 10 kanyler.
English: NAME OF THE MEDICINAL PRODUCT Ovaleap 300 IU/0.5 mL solution for injection Ovaleap 450 IU/0.75 mL solution for injection Ovaleap 900 IU/1.5 mL solution for injection
Danish: LÆGEMIDLETS NAVN Ovaleap 300 IE/0,5 ml injektionsvæske, opløsning Ovaleap 450 IE/0,75 ml injektionsvæske, opløsning Ovaleap 900 IE/1,5 ml injektionsvæske, opløsning
English: Ovaleap 300 IU/0.5 mL: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.5 mL solution.
Danish: Ovaleap 300 IE/0,5 ml: Hver cylinderampul indeholder 300 IE (svarende til 22 mikrogram) follitropin alfa i 0,5 ml opløsning.
English: A single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG is administered 24-48 hours after the last follitropin alfa injection to induce final follicular maturation.
Danish: En enkelt injektion på 250 mikrogram r-hCG eller 5.000 IE og op til 10.000 IE hCG administreres 24-48 timer efter sidste follitropin alfa-injektion for at inducere follikulær modning.
English: Ovaleap 300 IU/0.5 mL solution for injection
Danish: Ovaleap 300 IE/0,5 ml injektionsvæske, opløsning
English: If an excessive response is obtained, treatment should be stopped and hCG withheld (see section 4.4).
Danish: Hvis et for kraftigt ovarielt respons opnås, bør behandlingen stoppes og hCG-injektionen seponeres (se pkt.
English: 1 cartridge with 1.5 mL solution and 20 injection needles
Danish: 1 cylinderampul med 1,5 ml opløsning og 20 kanyler
English: If you use more Ovaleap than you should
Danish: Hvis du har brugt for meget Ovaleap
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/871/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/871/002
English: When an optimal response is obtained, a single injection of 250 micrograms recombinant human choriogonadotropin alfa (r-hCG) or 5,000 IU up to 10,000 IU hCG should be administered 24-48 hours after the last follitropin alfa injection.
Danish: Når et optimalt respons er opnået, gives en enkelt injektion på 250 mikrogram rekombinant humant choriongonadropin alfa (r-hCG) eller 5.000 IE hCG og op til 10.000 IE hCG 24-48 timer efter den sidste follitropin alfa-injektion.
English: Pregnancy loss
Danish: Ekstrauterin graviditet
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/871/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/871/001
English: What Ovaleap looks like and contents of the pack Ovaleap is a solution for injection (injection).
Danish: Ovaleap er en injektionsvæske, opløsning (injektion).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/871/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/871/003
English: 1 cartridge with 0.75 mL solution and 10 injection needles
Danish: 1 cylinderampul med 0,75 ml opløsning og 10 kanyler
English: NAME OF THE MEDICINAL PRODUCT Ovaleap 900 IU/1.5 mL solution for injection follitropin alfa
Danish: LÆGEMIDLETS NAVN Ovaleap 900 IE/1,5 ml injektionsvæske, opløsning follitropin alfa
English: NAME OF THE MEDICINAL PRODUCT Ovaleap 450 IU/0.75 mL solution for injection follitropin alfa
Danish: LÆGEMIDLETS NAVN Ovaleap 450 IE/0,75 ml injektionsvæske, opløsning follitropin alfa
English: When an optimal response is obtained, a single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG should be administered 24-48 hours after the last follitropin alfa and lutropin alfa injections.
Danish: Når optimalt respons er opnået, gives en enkelt injektion af 250 mikrogram r-hCG eller 5.000 IE og op til 10.000 IE hCG, 24-48 timer efter sidste follitropin alfa og lutropin alfa injektion.
English: If your body responds too strongly, your treatment will be stopped and you will not be given any hCG [see also section 2 under “Ovarian Hyper-Stimulation Syndrome (OHSS)”].
Danish: Hvis din krop reagerer for kraftigt, vil behandlingen blive stoppet, og du vil ikke få hCG [se også pkt.
English: The single injection will be 250 micrograms of r-hCG or 5,000 to 10,000 IU of hCG, 24 to 48 hours after your last injections of Ovaleap and lutropin alfa.
Danish: Den enkelte injektion vil være 250 mikrogram r-hCG eller 5.000 til 10.000 IE hCG, 24 til 48 timer efter de sidste injektioner med Ovaleap og lutropin alfa.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ovaleap 450 IU/0.75 mL injection follitropin alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Ovaleap 450 IE/0,75 ml injektion follitropin alfa s.c.
English: Package leaflet: Information for the user Ovaleap 300 IU/0.5 mL solution for injection Ovaleap 450 IU/0.75 mL solution for injection Ovaleap 900 IU/1.5 mL solution for injection follitropin alfa
Danish: Ovaleap 300 IE/0,5 ml injektionsvæske, opløsning Ovaleap 450 IE/0,75 ml injektionsvæske, opløsning Ovaleap 900 IE/1,5 ml injektionsvæske, opløsning follitropin alfa
English: NAME OF THE MEDICINAL PRODUCT Ovaleap 300 IU/0.5 mL solution for injection follitropin alfa
Danish: LÆGEMIDLETS NAVN Ovaleap 300 IE/0,5 ml injektionsvæske, opløsning follitropin alfa
English: The single injection will be 250 micrograms of r-hCG or 5,000 to 10,000 IU of hCG, 24 to 48 hours after the last Ovaleap injection.
Danish: Den enkelte injektion vil være 250 mikrogram r-hCG eller 5.000 til 10.000 IE hCG, 24 til 48 timer efter den sidste Ovaleap-injektion.
English: Reproductive system neoplasms
Danish: Reproduktionssystemstumorer
English: Tell your doctor before you start treatment, if you or any member of your family have porphyria.
Danish: Hvis du har porfyri, eller nogen i din familie har porfyri, skal du fortælle det til lægen, inden du starter behandlingen.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ovaleap 900 IU/1.5 mL injection follitropin alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Ovaleap 900 IE/1,5 ml injektion follitropin alfa s.c.
English: Ovaleap 300 IU/0.5 mL is available in packs containing 1 cartridge and 10 injection needles.
Danish: Ovaleap 300 IE/0,5 ml leveres i pakninger med 1 cylinderampul og 10 kanyler.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of the solution contains 600 IU (equivalent to 44 micrograms) follitropin alfa*.
Danish: Hver ml opløsning indeholder 600 IE (svarende til 44 mikrogram) follitropin alfa*.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ovaleap 300 IU/0.5 mL injection follitropin alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Ovaleap 300 IE/0,5 ml injektion follitropin alfa s.c.
English: Cartridge (type I glass) with a rubber piston (bromobutyl rubber) and a crimp-cap (aluminium) with a septum (bromobutyl rubber), containing 1.5 mL of solution..
Danish: Ovaleap 900 IE/1,5 ml injektionsvæske, opløsning Cylinderampul (type I glas), med et gummistempel (brombutylgummi) og et beskyttelseslåg (aluminium) med et septum (brombutylgummi), som indeholder 1,5 ml opløsning.
English: 1 cartridge with 0.5 mL solution and 10 injection needles
Danish: 1 cylinderampul med 0,5 ml opløsning og 10 kanyler
English: MARKETING AUTHORISATION NUMBER(S) Ovaleap 300 IU/0.5 mL solution for injection EU/1/13/871/001
Danish: Ovaleap 300 IE/0,5 ml injektionsvæske, opløsning EU/1/13/871/001
English: • Weight gain
Danish: • Vægtøgning
English: Ovaleap contains 0.02 mg per mL of benzalkonium chloride Ovaleap contains 10.0 mg per mL of benzyl alcohol For the full list of excipients, see section 6.1.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Ovaleap indeholder 0,02 mg pr. ml benzalkoniumchlorid Ovaleap indeholder 10,0 mg pr. ml benzylalkohol
English: Cartridge (type I glass) with a rubber piston (bromobutyl rubber) and a crimp-cap (aluminium) with a septum (bromobutyl rubber), containing 0.75 mL of solution..
Danish: Ovaleap 450 IE/0,75 ml injektionsvæske, opløsning Cylinderampul (type I glas), med et gummistempel (brombutylgummi) og et beskyttelseslåg (aluminium) med et septum (brombutylgummi), som indeholder 0,75 ml opløsning.
English: Each cartridge contains 900 IU (equivalent to 66 micrograms) follitropin alfa in 1.5 mL solution.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver cylinderampul indeholder 900 IE (svarende til 66 mikrogram) follitropin alfa i 1,5 ml opløsning.
English: You are more likely to have a miscarriage than the average woman when undergoing assisted reproductive technology or stimulation of your ovaries to produce eggs.
Danish: Når du gennemgår assisteret befrugtning eller stimulation af æggestokkene for at producere æg, er risikoen for en abort større hos dig end hos den gennemsnitlige kvinde.
English: Each cartridge contains 900 IU (equivalent to 66 micrograms) follitropin alfa in 1.5 mL solution for injection.
Danish: Ovaleap 900 IE/1,5 ml injektionsvæske, opløsning Hver cylinderampul indeholder 900 IE (svarende til 66 mikrogram) follitropin alfa i 1,5 ml injektionsvæske, opløsning.
English: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.5 mL solution.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver cylinderampul indeholder 300 IE (svarende til 22 mikrogram) follitropin alfa i 0,5 ml opløsning.
English: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.5 mL solution for injection.
Danish: Ovaleap 300 IE/0,5 ml injektionsvæske, opløsning Hver cylinderampul indeholder 300 IE (svarende til 22 mikrogram) follitropin alfa i 0,5 ml injektionsvæske, opløsning.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.5 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution for injection.
Danish: Ovaleap 450 IE/0,75 ml injektionsvæske, opløsning Hver cylinderampul indeholder 450 IE (svarende til 33 mikrogram) follitropin alfa i 0,75 ml injektionsvæske, opløsning.
English: Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver cylinderampul indeholder 450 IE (svarende til 33 mikrogram) follitropin alfa i 0,75 ml opløsning.
English: Package size
Danish: Pakningsstørrelser
English: Rehydration may be necessary.
Danish: Rehydrering kan være nødvendig.
English: The consecutive treatment should be administered at the same time each day.
Danish: Behandlingen bør foretages på samme tidspunkt hver dag.
English: Do not use on an empty stomach.
Danish: Må ikke anvendes på tom mave.
English: ATCvet code: QP51AX08.
Danish: ATCvet-kode: QP51AX08.
English: Highest values have been found in the liver and the kidney.
Danish: Højeste værdier er fundet i lever og nyrer.
English: - Wash hands after use.
Danish: - Vask hænder efter brug.
English: In both cases, the reduction of oocysts excretion has been demonstrated.
Danish: I begge tilfælde er det vist, at oocyst-udskillelsen reduceres.
English: The maximum concentration in plasma Cmax is 4 ng/ml.
Danish: Den maksimale plasmakoncentration Cmax er 4 ng/ml.
English: The terminal elimination half-life is 11.7 hours after IV administration and 30.84 hours after single oral administration.
Danish: Den terminale eliminations halveringstid er 11,7 timer efter intravenøs indgift og 30,84 timer efter en enkel oral indgift.
English: Once the first calf has been treated, all the forthcoming new-born calves must be systematically treated as long as the risk for diarrhoea due to C. parvum persists.
Danish: Når første kalv er behandlet, skal alle kommende nyfødte kalve behandles på systematisk vis, så længe risikoen for diarre forårsaget af C. parvum foreligger.
English: The product is mainly excreted in the urine.
Danish: Stoffet udskilles hovedsagelig med urinen.
English: Halofuginone
Danish: Halofuginon
English: The active substance in Kriptazen is an allowed substance as described in Table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: De(n) aktive substans(er) i Kriptazen er godkendt(e) substans(er) som beskrevet i tabel 1 i bilag til Kommissionens Forordning (EU) Nr. 37/2010:
English: As symptoms of toxicity may occur at twice the therapeutic dose, it is necessary to apply the recommended dosage strictly.
Danish: Da symptomer på forgiftning kan opstå efter 2 gange terapeutisk dosis, er det nødvendigt nøje at overholde den anbefalede dosering.
English: If eye irritation persists, seek medical advice.
Danish: Hvis øjenirritation vedvarer, søges læge.
English: It is mainly active on the free stages of the parasite (sporozoïte, merozoïte).
Danish: Det er hovedsagelig aktivt på parasittens frie stadier (sporozoit, merozoit).
English: - In case of skin and eye contact wash the exposed area thoroughly with clean water.
Danish: - I tilfælde af hud- og øjenkontakt skylles det berørte område grundigt med rent vand.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne anført under punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: 4) Turn the ring, in order to select the weight of the calf to be treated.
Danish: 4) Drej ringen for at vælge vægten på kalven, der skal behandles.
English: - Repetitive contact with the product may lead to skin allergies.
Danish: - Gentagen kontakt med præparatet kan medføre hudallergier.
English: Halofuginone Halofuginone Bovine 10 μg/kg
Danish: Halofuginon Halofuginon Kvæg 10 μg/kg
English: The frequency of adverse reactions is defined using the following convention: - Very common (more than 1 in 10 animals treated displaying adverse reactions) - Common (more than 1 but less than 10 animals in 100 animals treated) - Uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - Rare (more than 1 but less than 10 animals in 10,000 animals treated) - Very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: Symptoms of toxicity include diarrhoea, visible blood in faeces, decline in milk consumption, dehydration, apathy and prostration.
Danish: Symptomer på forgiftning er diarré, synligt blod i afføringen, nedsat mælkeindtag, dehydrering, apati og nedstemthed.
English: The time necessary to obtain the maximum concentration Tmax is 11 hours.
Danish: Det tager 11 timer at nå den maksimale koncentration Tmax.
English: EU/2/18/234/001 (490 ml bottle) EU/2/18/234/002 (980 ml bottle) EU/2/18/234/003 (490 ml bottle + 4 ml dosing pump) EU/2/18/234/004 (980 ml bottle + 4 ml dosing pump) EU/2/18/234/005 (490 ml bottle + 4-12 ml dosing pump) EU/2/18/234/006 (980 ml bottle + 4-12 ml dosing pump)
Danish: EU/2/18/234/001 (490 ml flaske) EU/2/18/234/002 (980 ml flaske) EU/2/18/234/003 (490 ml flaske + 4 ml doseringspumpe) EU/2/18/234/004 (980 ml flaske + 4 ml doseringspumpe) EU/2/18/234/005 (490 ml flaske + 4-12 ml doseringspumpe) EU/2/18/234/006 (980 ml flaske + 4-12 ml doseringspumpe)
English: The concentrations to inhibit 50% and 90% of the parasites, in an in vitro test system, are IC50 < 0.1 μg/ml and IC90 of 4.5 μg/ml, respectively.
Danish: Den koncentration, der skal til for at dræbe henholdsvis 50 % og 90 % af parasitterne i et in vitro testsystem er IC50 < 0,1 µg/ml og IC90 på 4,5 µg/ml.
English: The apparent volume of distribution is 10 l/kg.
Danish: Det formodede fordelingsvolumen er 10 l/kg.
English: EXP {month/year} Once opened use within 6 months.
Danish: EXP {måneder/år} Efter åbning anvendes indenfor 6 måneder.
English: Do not use in cases of diarrhoea established for more than 24 hours and in weak animals.
Danish: Må ikke bruges i tilfælde af diarré, som er startet for mere end 24 timer siden, samt til svage dyr.
English: The animals should receive enough colostrum according to good breeding practice.
Danish: Kalvene skal gives tilstrækkelig kolostrum ifølge god landmandspraksis.