FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with tadalafil in one or more subsets of the paediatric population in the treatment of pulmonary arterial hypertension (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med tadalafil i en eller flere undergrupper af den pædiatriske population ved behandling af pulmonal arteriel hypertension (PAH) (se pkt.
English: These events have either been assigned a frequency of “Not known,” as the frequency in PAH patients cannot be estimated from the available data or assigned a frequency based on the clinical study data from the pivotal placebo-controlled study of tadalafil.
Danish: Disse bivirkninger er enten angivet med frekvensen 'ikke kendt', da frekvensen hos PAH-patienter ikke kan estimeres ud fra de forhåndenværende data, eller angivet med en frekvens baseret på data fra det pivotale kliniske placebo-kontrollerede studie med tadalafil.
English: Hypromellose (2910/15 mPa·s) (E464) Titanium dioxide (E171)
Danish: Lactosemonohydrat Hypromellose (2910/15 mPa·s) (E464) Titandioxid (E171)
English: Posology The recommended dose is 40 mg (2 x 20 mg) taken once daily with or without food.
Danish: Dosering Den anbefalede dosis er 40 mg (2 x 20 mg) en gang daglig taget enten med eller uden mad.
English: Tadalafil should not be used during breast-feeding.
Danish: Tadalafil bør ikke anvendes under amning.
English: Do not take Talmanco: if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
Danish: Hvis du er allergisk overfor tadalafil eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: The filmcoating contains lactose monohydrate (see section 2 ‘Talmanco contains lactose'), hypromellose (E464), titanium dioxide (E171) and triacetin.
Danish: Filmovertrækningen indeholder lactosemonohydrat (se afsnit 2 'Talmanco indeholder lactose'), hypromellose (E464), titandioxid (E171) og triacetin.
English: Talk to your doctor or pharmacist before taking this medicine if you have: any heart problems other than your pulmonary hypertension problems with your blood pressure any hereditary eye disease an abnormality of red blood cells (sickle cell anaemia) cancer of the bone marrow (multiple myeloma) cancer of the blood cells (leukaemia) any deformation of your penis, or unwanted or persistent erections lasting more than 4 hours a serious liver problem a serious kidney problem
Danish: Tal med din læge eller apotekspersonalet, før du tager dette lægemiddel, hvis du har: andre hjerteproblemer end din pulmonale hypertension problemer med dit blodtryk en arvelig øjensygdom unormale røde blodlegemer (seglcelleanæmi) knoglemarvskræft (myelomatose) blodkræft (leukæmi) nogen form for deformitet af penis eller uønskede eller vedvarende erektioner, som varer i mere end 4 timer alvorlige problemer med din lever alvorlige problemer med dine nyrer
English: Tadalafil 40 mg increased cardiac output (0.6 L/min) and reduced pulmonary artery pressures (-4.3 mm Hg) and pulmonary vascular resistance (-209 dyn.s/cm5) compared to baseline (p < 0.05).
Danish: Tadalafil 40 mg forøgede det kardielle output (0,6 l/min) og reducerede det pulmonale arterietryk (-4,3 mm Hg) og den pulmonale vaskulære modstand (-209 dyn.s/cm5) sammenlignet med baseline (p < 0,05).
English: The most commonly reported adverse reactions, occurring in ≥ 10% of patients in the tadalafil 40 mg treatment arm, were headache, nausea, back pain, dyspepsia, flushing, myalgia, nasopharingitis and pain in extremity.
Danish: De hyppigst rapporterede bivirkninger, som blev set hos ≥ 10% af patienterne i behandlingsarmen med 40 mg tadalafil, var hovedpine, kvalme, rygsmerter, dyspepsi, rødmen, myalgi, nasopharyngitis og smerter i ekstremiteterne.
English: The incidence of clinical worsening by week 16 in patients treated with tadalafil 40 mg (5%; 4 of 79 patients) was less than placebo (16%; 13 of 82 patients).
Danish: Hyppigheden af klinisk forværring i uge 16 var lavere hos patienter, der blev behandlet med tadalafil 40 mg (5%; 4 af 79 patienter), end for placebogruppen (16%; 13 ud af 82 patienter).
English: This medicine is available in blister packs containing 28 or 56 tablets and in perforated unit dose blister packs containing 28 x 1 or 56 x 1 tablets.
Danish: Dette lægemiddel fås i blisterpakninger indeholdende 28 eller 56 tabletter og i perforerede enkeltdosisblisterpakninger indeholdende 28 x 1 eller 56 x 1 tabletter.
English: Poloxamer 188
Danish: Natriumlaurilsulfat Poloxamer 188
English: The safety and efficacy of tadalafil in the paediatric population has not yet been established.
Danish: Tadalafils sikkerhed og virkning hos den pædiatriske population er endnu ikke klarlagt.
English: If you experience any of the following side effects stop using the medicine and seek medical help immediately:
Danish: Hvis du får nogen af disse bivirkninger, skal du stoppe med at tage dette lægemiddel og straks søge læge:
English: Talmanco is supplied as a 20 mg tablet.
Danish: Talmanco findes som en 20 mg tablet.
English: The active substance is tadalafil.
Danish: Aktivt stof: tadalafil.
English: If you or anyone else takes more tablets than they should, tell your doctor or go to a hospital immediately, taking the medicine or pack with you.
Danish: Hvis du eller andre har taget flere tabletter, end du eller de skulle, skal du kontakte din læge eller tage på skadestuen med det samme.
English: Sudden cardiac death2, 5, Tachycardia2, 5
Danish: Pludselig hjertedød2,5, takykardi
English: The table below lists the adverse reactions reported during the placebo-controlled clinical study in patients with PAH treated with tadalafil.
Danish: I tabellen nedenfor er angivet de bivirkninger, der er rapporteret i det placebo-kontrollerede kliniske studie med PAH-patienter, der blev behandlet med tadalafil.
English: Only tadalafil 40 mg achieved the protocol defined level of significance with a placeboadjusted median increase in 6MWD of 26 metres (p = 0.0004; 95% CI: 9.5, 44.0; Pre-specified Hodges-Lehman method) (mean 33 metres, 95% CI: 15.2, 50.3).
Danish: Kun tadalafil 40 mg opnåede det signifikansniveau, der var defineret i protokollen, med en placebokorrigeret gennemsnitlig stigning i 6MWD på 26 meter (p = 0,0004; 95% CI: 9,5-44,0; Præspecificeret Hodges-Lehman metode) (gennemsnit 33 meter, 95% CI: 15,2-50,3).
English: Very Common (may affect more than 1 in 10 people) headache.
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 personer) Hovedpine.
English: Unstable angina pectoris, Ventricular arrhythmia, Myocardial Infarction2
Danish: Ustabil angina pectoris, ventrikulær arytmi, myokardieinfarkt
English: Tell your doctor or pharmacist if you are already taking: bosentan (another treatment for pulmonary arterial hypertension) nitrates (for chest pain) alpha blockers used to treat high blood pressure or prostate problems riociguat rifampicin (to treat bacterial infections) ketoconazole tablets (to treat fungal infections) ritonavir (for HIV treatment) tablets for erectile dysfunction (PDE5 inhibitors)
Danish: Tal med lægen eller apotekspersonalet, hvis du allerede tager: bosentan (en anden behandling for pulmonal arteriel hypertension) nitrater (for brystsmerter) alfa-blokkere til behandling af for højt blodtryk eller prostataproblemer riociguat rifampicin (til behandling af bakterieinfektioner) ketoconazol-tabletter (til behandling af svampeinfektioner) ritonavir (HIV-behandling) tabletter for problemer med potensen (PDE5-hæmmere)
English: The other ingredients in the tablet core are povidone, sodium laurilsulfate, poloxamer 188, anhydrous lactose (see section 2 ‘Talmanco contains lactose'), microcrystalline cellulose (PH 101), croscarmellose sodium, colloidal anhydrous silica and magnesium stearate.
Danish: Øvrige indholdsstoffer i tabletkernen: povidon, natriumlaurilsulfat, poloxamer 188, vandfri lactose (se afsnit 2 'Talmanco indeholder lactose'), mikrokrystallinsk cellulose (PH 101), croscarmellosenatrium, vandfri kolloid silica og magnesiumstearat.
English: A white, film-coated, round, biconvex, bevelled edge tablet (approximately 10.7 mm diameter) debossed with ‘M' on one side of the tablet and ‘TA20' on the other side.
Danish: En hvid, filmovertrukken, rund, bikonveks tablet (ca. 10,7 mm i diameter) med afskåret kant mærket 'M' på den ene side og 'TA20' på den anden.
English: PDE5 inhibitors, such as Talmanco, have been shown to increase the hypotensive effects of this medicine.
Danish: PDE5-hæmmere, så som Talmanco, har vist sig at øge den blodtrykssænkende virkning af denne medicin.
English: Healthy elderly subjects (65 years or over), had a lower oral clearance of tadalafil, resulting in 25% higher exposure (AUC) relative to healthy subjects aged 19 to 45 years after a 10 mg dose.
Danish: Raske ældre forsøgspersoner (65 år eller derover) udviste en lavere clearance af tadalafil efter oral indgift af en dosis på 10 mg, hvilket resulterede i en 25% højere eksponering (AUC) end hos raske forsøgspersoner mellem 19 og 45 år.
English: Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/kg or approximately 180 ml of 40% alcohol [vodka] in an 80 kg male), but in some subjects, postural dizziness and orthostatic hypotension were observed.
Danish: Tadalafil (20 mg) forstærkede ikke det gennemsnitlige blodtryksfald forårsaget af alkohol (0,7 g/kg eller ca. 180 ml 40% alkohol [vodka] til en mand på 80 kg), men hos nogle forsøgspersoner blev der observeret ortostatisk svimmelhed og ortostatisk hypotension.
English: Tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh Class A and B) is comparable to exposure in healthy subjects when a dose of 10 mg is administered.
Danish: Eksponeringen for tadalafil (AUC) hos forsøgspersoner med mild og moderat lever funktions nedsættelse (Child-Pugh klasse A og B) er sammenlignelig med eksponeringen hos raske forsøgs personer ved administration af en dosis på 10 mg.
English: General disorders and administration site conditions Facial oedema, Chest pain 1 Events not reported in registration studies and cannot be estimated from the available data.
Danish: Almene symptomer og reaktioner på administrationsstedet Ansigtsødem, brystsmerter 1 Hændelser, der ikke blev rapporteret i de kliniske registreringsstudier, og som ikke kan estimeres ud fra forhåndenværende data.
English: Partial, temporary or permanent decrease or loss of vision in one or both eyes and serious allergic reaction which causes swelling of the face or throat.
Danish: Visse bivirkninger er indberettet sjældent (kan forekomme hos op til 1 ud af 1.000 personer): Delvis, midlertidig eller permanent nedsættelse eller tab af synet på det ene eller begge øjne og alvorlig allergisk reaktion, som medfører hævelse i ansigtet eller svælget.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://ema.europa.eu
English: 5 The adverse reactions have been included in the table as a result of postmarketing or clinical study data from the use of tadalafil in the treatment of erectile dysfunction; and in addition, the frequency estimates are based on only 1 or 2 patients experiencing the adverse reaction in the pivotal placebocontrolled study of tadalafil.
Danish: 5 Bivirkningerne i tabellen er data fra postmarketing eller kliniske studier, hvor tadalafil blev brugt til behandling af erektil dysfunktion, og i tillæg hertil er frekvensestimatet baseret på kun 1 eller 2 patienters oplevelse af disse bivirkninger i det pivotale placebo-kontrollerede studie med tadalafil.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The proportion of patients with improvement in WHO functional class by week 16 was similar in the tadalafil 40 mg and placebo groups (23% vs. 21%).
Danish: Antallet af patienter med forbedring i WHO-funktionsklasse efter uge 16 var ens i gruppen, der fik tadalafil 40 mg, og placebogruppen (23% versus 21%).
English: What you need to know before you take Talmanco
Danish: Det skal du vide, før du begynder at tage Talmanco
English: increased or abnormal uterine bleeding.
Danish: Øget eller unormal blødning fra livmoderen.
English: Clinical non-MedDRA term to include reports of abnormal/excessive menstrual bleeding conditions such as menorrhagia, metrorrhagia, menometrorrhagia, or vaginal hemorrhage.
Danish: 4 Kliniske ikke-MedDRA-termer inkluderer unormale/voldsomme tilstande relateret til menstruationsblødninger, såsom menoragi, metroragi, menometroragi eller vaginal hæmoragi.
English: The placebo-adjusted median increase in 6MWD was 17 metres (p = 0.09; 95% CI: -7.1, 43.0; Prespecified Hodges-Lehman method) (mean 23 metres, 95% CI: -2.4, 47.8) in those patients who received tadalafil 40 mg in addition to their concomitant bosentan (n = 39), and was 39 metres (p < 0.01, 95% CI: 13.0, 66.0; Pre-specified Hodges-Lehman method) (mean 44 metres, 95% CI: 19.7, 69.0) in those patients who received tadalafil 40 mg alone (n = 37).
Danish: Den placebokorrigerede gennemsnitlige stigning i 6MWD var 17 meter (p=0,09; 95% CI: -7,1-43,0; præspeciferet Hodges-Lehman metode) (gennemsnitlig 23 meter, 95% CI; -2,4-47,8) hos de patienter, der fik tadalafil 40 mg i tillæg til deres samtidige medicin bosentan (n = 39), og var 39 meter (p < 0,01, 95% CI: 13,0-66,0; præspeficiceret Hodges-Lehman metode) (gennemsnit 44 meter, 95% CI: 19,7-69,0) hos de patienter, som kun fik tadalafil 40 mg (n = 37).
English: EXPIRY DATE EXP:
Danish: EXP:
English: Less than 0.0005% of the administered dose appeared in the semen of healthy subjects.
Danish: Hos raske forsøgspersoner genfandt man mindre end 0,0005% af den administrerede dosis i sperma.
English: Tadalafil exposure (AUC) in patients with diabetes was approximately 19% lower than the AUC value for healthy subjects after a 10 mg dose.
Danish: Eksponeringen for tadalafil (AUC) efter en dosis på 10 mg hos patienter med diabetes var ca. 19% lavere end AUC hos raske forsøgspersoner.
English: PVC/PE/PVdC-Alu perforated unit dose blisters in carton containing 28 x 1 and 56 x 1 film-coated tablets.
Danish: PVC/PE/PVdC-Alu perforerede blisterpakninger med enkeltdoser i pakninger indeholdende 28 x 1 og 56 x 1 filmovertrukne tabletter.
English: What Talmanco looks like and contents of the pack This medicine is a white, film-coated, round, biconvex, bevelled edge tablet marked with ‘M' on one side of the tablet and ‘TA20' on the other side.
Danish: Dette lægemiddel er en hvid, filmovertrukken, rund, bikonveks tablet med afskåret kant mærket 'M' på den ene side af tabletten og 'TA20' på den anden side.
English: Talmanco tablets contain lactose.
Danish: Talmanco-tabletter indeholder lactose..
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 20 mg tadalafil.
Danish: ANGIVELSE AF AKTIVT STOF Hver filmovertrukken tablet indeholder 20 mg tadalafil.
English: nausea, indigestion (including abdominal pain or discomfort).
Danish: Kvalme, fordøjelsesproblemer (herunder mavesmerter eller ubehag).
English: At steady-state, tadalafil (40 mg once per day) increased ethinylestradiol exposure (AUC) by 26% and Cmax by 70% relative to oral contraceptive administered with placebo.
Danish: Ved stady-state øger tadalafil (40 mg en gang daglig) ethinylestradioleksponeringen (AUC) med 26% og Cmax med 70% relativt til oral kontraception givet sammen med placebo.
English: What Talmanco contains
Danish: Talmanco indeholder:
English: Talmanco contains lactose
Danish: Talmanco indeholder lactose
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Dette lægemiddel bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Rare (may affect up to 1 in 1,000 people) sudden loss of vision.
Danish: Sjældne (kan forekomme hos op til 1 ud af 1.000 personer) Pludseligt opstået synstab
English: Microcrsytalline cellulose (PH 101) Croscarmellose sodium
Danish: Mikrokrystallinsk cellulose (PH 101) Croscarmellosenatrium Vandfri kolloid silica Magnesiumstearat
English: irregular heartbeat.
Danish: Uregelmæssige hjerteslag (puls).
English: Respiratory, thoracic and mediastinal disorders Nasopharyngitis (including nasal congestion, sinus congestion and rhinitis)
Danish: Hypotension Hypertension Luftveje, thorax og mediastinum Nasofaryngitis(in klusive tilstopning af næsen, tilstopning af sinus og rhinitis)
English: migraine.
Danish: Migræne.
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på den eller de fremstiller, der er ansvarlige for batchfrigivelse
English: Ritonavir (500 mg or 600 mg twice daily) increased tadalafil (20 mg) single-dose exposure (AUC) by 32% and decreased Cmax by 30%.
Danish: Ritonavir (500 mg eller 600 mg to gange daglig) øger tadalafil (20 mg) enkelt-dosis-eksponering (AUC) med 32% og nedsætter Cmax med 30%.
English: Talmanco 20 mg film-coated tablets tadalafil
Danish: Talmanco 20 mg filmovertrukne tabletter tadalafil
English: What Talmanco is and what it is used for Talmanco contains the active substance tadalafil.
Danish: Talmanco indeholder det aktive stof tadalafil.
English: Bosentan (125 mg twice daily), a substrate of CYP2C9 and CYP3A4 and a moderate inducer of CYP3A4, CYP2C9 and possibly CYP2C19, reduced tadalafil (40 mg once per day) systemic exposure by 42% and Cmax by 27% following multiple dose co-administration.
Danish: Endotelin 1- receptorantagonister (f.eks. bosentan) Flere gange samtidig indgift af bosentan (125 mg to gange daglig), substrat for CYP2C9 og CYP3A4 og en moderat induktor af CYP3A4, CYP2C9 og sandsynligvis CYP2C19, og tadalafil (40 mg en gang daglig) reducerede den systemiske eksponering af tadalafil med 42% og Cmax med 27%.Virkningen af tadalafil hos patienter, der allerede er i behandling med bosentan, er ikke påvist endegyldigt (se pkt.
English: In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates.
Danish: Det er vist i kliniske studier, at tadalafil forstærker den hypotensive effekt af nitrater.
English: year is 96.4%.
Danish: Overlevelsesraten efter 1 år var 96,4% for de patienter, der var data for.
English: penile bleeding.
Danish: Blødning fra penis.
English: Antimicrobial medicinal products (e.g. rifampicin) A CYP3A4 inducer, rifampicin (600 mg daily), reduced tadalafil AUC by 88% and Cmax by 46%, relative to the AUC and Cmax values for tadalafil alone (10 mg).
Danish: Rifampicin (600 mg daglig), en CYP3A4-induktor, reducerer tadalafil AUC med 88% og Cmax med 46%, relativt til AUC og Cmax for tadalafil alene (10 mg).
English: How to take Talmanco
Danish: Sådan skal du tage Talmanco
English: NAME OF THE MEDICINAL PRODUCT Talmanco 20 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Talmanco 20 mg filmovertrukne tabletter
English: Ketoconazole (200 mg daily), increased tadalafil (10 mg) single dose exposure (AUC) 2-fold and Cmax by 15%, relative to the AUC and Cmax values for tadalafil alone.
Danish: Ketoconazol (200 mg daglig) øger tadalafils (10 mg) enkeltdosiseksponering (AUC) 2 gange og Cmax med 15%, relativt til AUC og Cmax-værdier for tadalafil alene.
English: Uncommon (may affect up to 1 in 100 people) seizures.
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer) Kramper.
English: muscle aches, back pain and pain in the extremity (including limb discomfort).
Danish: muskelsmerter, rygsmerter og smerter i ekstremiteterne (herunder ubehag i lemmer).
English: NAME OF THE MEDICINAL PRODUCT Talmanco 20 mg film-coated tablets tadalafil
Danish: LÆGEMIDLETS NAVN Talmanco 20 mg filmovertrukne tabletter tadalafil
English: Musculoskeletal and connective tissue disorders Myalgia, Back pain, Pain in extremity (including limb discomfort)
Danish: Muskuloskeletale og bindevævslidelser Myalgi, rygsmerter, ekstremitetssmerter (inklusive ubehag i benene)
English: chest pain - do not use nitrates, but seek immediate medical assistance.
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 personer) Allergiske reaktioner herunder hududslæt Brystsmerter - brug ikke nitrater, men søg straks lægehjælp
English: Gastrointestinal disorders Nausea, Dyspepsia (including abdominal pain/discomfort3)
Danish: Mave-tarmkanalen Kvalme, dyspepsi (inklusive mavesmerter/ube hag3)
English: Ketoconazole (400 mg daily) increased tadalafil (20 mg) single dose exposure (AUC) 4-fold and Cmax by 22%.
Danish: Ketoconazol (400 mg daglig) øger tadalafil (20 mg) enkeltdosiseksponering (AUC) 4 gange og Cmax med 22%.
English: Keep this leaflet.
Danish: Se også pkt.
English: Stroke
Danish: Hæmaturi
English: fast heart rate.
Danish: Høj puls.
English: If you take more Talmanco than you should
Danish: Hvis du har taget for meget Talmanco
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Talmanco Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: fainting.
Danish: Opkast.
English: What you need to know before you take Talmanco 3.
Danish: Det skal du vide, før du begynder at tage Talmanco Sådan skal du tage Talmanco Bivirkninger
English: flushing, nasal and sinus congestion (blocked nose).
Danish: Rødmen, tilstoppet næse og tilstoppede bihuler (stoppet næse).
English: Nervous system disorders Headache
Danish: Nervesystemet Hovedpine6
English: blurred vision.
Danish: Sløret syn
English: Tabulated list of adverse reactions
Danish: Overfølsomheds -reaktioner
English: nosebleed.
Danish: Næseblod.
English: Common (may affect up to 1 in 10 people)
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 personer) Uklart syn.
English: Priapism5, Penile haemorrhage, Haematospermia
Danish: Kramper5, forbigående hukommelsestab5
English: Haematuria
Danish: Hæmospermi
English: acid reflux.
Danish: Nældefeber.
English: Pharmaceutical Form Route of Administration
Danish: Lægemiddelform Administration Emballage Indhold (Koncentration)
English: 10 5.7 to colour changing units (CCU)/dose
Danish: 10 5.7 til 10 farveskiftende enheder (CCU)/dosis
English: Eye drop, suspension
Danish: Øjendråber, suspension
English: Ocular use LDPE bottle 30ml
Danish: LDPE-flaske 30 ml
English: 1 bottle N/A
Danish: 1 flaske Ikke relevant
English: Withdrawal period
Danish: Tilbageholdels estid
English: Strength Pharmaceutical Form
Danish: Lægemiddelform Dyrearter, som lægemidlet er beregnet til
English: 1 spot-on applicator
Danish: 1 spot-onapplikator
English: Pharmaceutical form
Danish: Lægemiddelform Dyrearter, som lægemidlet er beregnet til
English: However, there is no evidence to date to support this hypothesis.
Danish: Der er imidlertid hidtil ingen evidens til at underbygge denne hypotese.
English: The product should not be re-applied (within 7 weeks) to cattle.
Danish: Påføringen af lægemidlet bør ikke gentages (inden for 7 uger) til kvæg.
English: Member State (EU/EEA)
Danish: (EU/EEA)
English: Add, to all products (if not already present):
Danish: Følgende skal tilføjes alle produkter (hvis de ikke allerede findes):
English: This should be done before their implementation and for any future changes to the measures deemed necessary.
Danish: Dette bør finde sted, før de gennemføres og ved alle fremtidige ændringer af de foranstaltninger, der findes nødvendige.
English: − education, training and guidance for end-users.
Danish: − information, oplæring og vejledning for slutbrugerne.
English: The average number of affected animals per adverse event report in the EU was 3.9.
Danish: Det gennemsnitlige antal berørte dyr pr. bivirkningsindberetning i EU var 3,9.