FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Bele, okrogle, na obeh straneh izbočene, filmsko obložene tablete z zaobljenimi robovi (premera približno 10,7 mm) z vtisnjenim znakom “M” na eni strani ter znakom “TA20” na drugi strani.
English: 6 Headache was the most commonly reported adverse reaction.
Slovenian: 6 Najpogostejši neželeni učinek, o katerem so poročali, je bil glavobol.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg tadalafil.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 20 mg tadalafila.
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.
Slovenian: Zdravilo je na voljo v pretisnih omotih s po 28 ali 56 tabletami in v perforiranih enoodmernih pretisnih omotih s po 28 x 1 ali 56 x 1 filmsko obloženo tableto.
English: Respiratory, thoracic and mediastinal disorders Nasopharyngitis (including nasal congestion, sinus congestion and rhinitis)
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora nazofaringitis (vključno s nosno kongestijo, sinusno kongestijo in rinitisom)
English: When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) there was no pharmacokinetic interaction.
Slovenian: Ko so v študiji klinične farmakologije tadalafil v omerku 10 mg dajali skupaj s teofilinom (neselektivnim zaviralcem fosfodiesteraze), do farmakokinetičnih interakcij ni prišlo.
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.
Slovenian: Redko (pojavijo se lahko pri največ 1 od 1.000 bolnikov) so poročali o neželenih učinkih: - delna, začasna ali stalna izguba vida na eno ali obe očesi in resno alergijsko reakcijo, ki povzroči otekanje obraza ali grla.
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).
Slovenian: Tadalafil v odmerku 40 mg je povečal srčni iztok (0,6 L/min) in zmanjšal tlak v pljučni arteriji (-4,3 mm Hg) ter pljučni žilni upor (-029 dyn.s/cm5) v primerjavi z osnovnim stanjem (p < 0,05).
English: Additionally, improvements compared to placebo were observed with tadalafil 40 mg in the physical functioning, role-physical, bodily pain, general health, vitality and social functioning domains of the SF-36.
Slovenian: Izboljšanje pri 40 mg tadalafila v primerjavi s placebom se je pokazalo tudi v naslednjih domenah SF36: fizično funkcioniranje, fizična vloga, telesna bolečina, splošno zdravstveno stanje, vitalnosti in socialna funkcija.
English: Anti-hypertensives (including Calcium channel blockers) The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner.
Slovenian: Antihipertenzivne učinkovine (vključno z antagonisti kalcijevih kanalčkov) Sočasno jemanje doksazocina (4 mg in 8 mg na dan) in tadalafila (5 mg na dan in 20 mg v enkratnem odmerku) znatno poveča učinek zniževanja krvnega tlaka tega zaviralca adrenergičnih receptorjev alfa.
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).
Slovenian: Za placebo korigirano mediano povečanje 6MWD je bilo pri bolnikih, ko so prejemali tadalafila 40 mg sočasno z bosentanom (n = 39), 17 metrov (p = 0,09; 95% interval zaupanja: -7,1, 43,0; predhodno določena Hodges-Lehmanova metoda) (povprečna vrednost 23 metrov, 95% interval zaupanja: -2,4, 47,8) in pri bolnikih, ki so prejemali samo 40 mg tadalafila (n = 37), 39 metrov (p < 0,01; 95% interval zaupanja: 13,0, 66,0; predhodno določena Hodges-Lehmanova metoda) (povprečna vrednost 44 metrov, 95% interval zaupanja: 19,7, 69,0).
English: Reproductive system and breast disorders Increased uterine bleeding4
Slovenian: Motnje reprodukcije in dojk podaljšano krvavenje iz maternice4
English: Method of administration Talmanco is for oral use.
Slovenian: Način uporabe Zdravilo Talmanco je za peroralno uporabo.
English: Musculoskeletal and connective tissue disorders Myalgia, Back pain, Pain in extremity (including limb discomfort)
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija, bolečina v hrbtu, bolečina v udih (vključno z nelagodjem v udih)
English: Clinical non-MedDRA term to include reports of abnormal/excessive menstrual bleeding conditions such as menorrhagia, metrorrhagia, menometrorrhagia, or vaginal hemorrhage.
Slovenian: 4 Klinični izrazi (ne po MedDRA) vključujejo poročila o nenormalnem/prekomernem krvavenju med menstruacijo kot so menoreja, metroragija, menometroragija in vaginalna krvavitev.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
English: Tadalafil 20 mg administered to healthy subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure (mean maximal decrease of 1.6/0.8 mm Hg, respectively), in standing systolic and diastolic blood pressure (mean maximal decrease of 0.2/4.6 mm Hg, respectively), and no significant change in heart rate.
Slovenian: Tadalafil v odmerku 20 mg, ki so ga dali zdravim posameznikom, v primerjavi s placebom ni povzročil pomembne razlike sistoličnega oz. diastoličnega krvnega tlaka leže (povprečni maksimalni padec 1,6 mm Hg oziroma 0,8 mm Hg), sistoličnega oz. diastoličnega krvnega tlaka stoje (povprečni maksimalni padec 0,2 mm Hg oziroma 4,6 mm Hg) ter nobene pomembne spremembe srčne frekvence.
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.
Slovenian: Zdravilo Talmanco so bele, okrogle, na obeh straneh izbočene, filmsko obložene tablete z zaobljenimi robovi z vtisnjenim znakom “M” na eni strani ter znakom “TA20” na drugi strani.
English: Film-coated tablet
Slovenian: Filmsko obložene tablete
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.
Slovenian: Druge sestavine zdravila so: povidon, natrijev lavrilsulfat, poloksamer 188, brezvodna laktoza (glejte poglavje 2 'Zdravilo Talmanco vsebuje laktozo'), mikrokristalna celuloza (PH 101), premreženi natrijev karmelozat, brezvodni koloidni silicijev dioksid in magnezijev stearat.
English: Since there are no clinical data on the safety of tadalafil in these patients, the use of tadalafil is not recommended.
Slovenian: Ker za te bolnike kliničnih podatkov o varnosti tadalafila ni, uporaba tadalafila pri teh bolnikih ni priporočljiva.
English: In patients with severe renal impairment the use of tadalafil is not recommended (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih s hudo ledvično okvaro uporaba tadalafila ni priporočljiva (glejte poglavji 4.4 in 5.2).
English: The table below lists the adverse reactions reported during the placebo-controlled clinical study in patients with PAH treated with tadalafil.
Slovenian: V preglednici prikazan povzetek neželenih učinkov Spodnja preglednica navaja neželene učinke, o katerih so poročali med s placebom kontrolirano klinično študijo, pri bolnikih s PAH, zdravljenih s tadalafilom.
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.
Slovenian: Antagonisti receptorja za endotelin -1 (npr. bosentan) Bosentan (125 mg dvakrat na dan), ki je substrat CYP2C9 in CYP3A4 in zmeren induktor CYP3A4, CYP2C9 in verjetno CYP2C19, je po večkratni uporabi sistemsko biološko uporabnost tadalafila (40 mg enkrat na dan) zmanjšal za 42% in Cmax za 27%.
English: Talmanco tablets contain lactose.
Slovenian: Zdravilo Talmanco vsebuje laktozo.
English: if you have ever had loss of vision - a condition described as “stroke of the eye” (non-arteritic anterior ischemic optic neuropathy - NAION) if you have had a heart attack in the last 3 months if you have low blood pressure if you are taking riociguat.
Slovenian: Če jemljete kako obliko nitrata ali o tem niste prepričani, povejte zdravniku, ste kadar koli izgubili vid - stanje, ki je opisano kot "očesna kap " (nearteritična anteriorna ishemična optična nevropatija - NAION), ste v zadnih treh mesecih preboleli srčni infarkt, imate nizek krvni tlak, jemljete riociguat.
English: PVC/PE/PVdC-Alu perforated unit dose blisters in carton containing 28 x 1 and 56 x 1 film-coated tablets.
Slovenian: PVC/PE/PVdC-alu perforirani enoodmerni pretisni omoti v škatlah s po 28 x 1 ali 56 x 1 filmsko obloženo tableto.
English: 3 Actual MedDRA terms included are abdominal discomfort, abdominal pain, abdominal pain lower,
Slovenian: 3 Dejanski izrazi po MedDRA vključujejo izraze nelagodje v trebuhu, bolečina v trebuhu, bolečina v spodnjem delu trebuha, bolečina v zgornjem delu trebuha, nelagodje v želodcu.
English: Ritonavir (500 mg or 600 mg twice daily) increased tadalafil (20 mg) single-dose exposure (AUC) by 32% and decreased Cmax by 30%.
Slovenian: Ritonavir (500 ali 600 mg dvakrat na dan) je biološko uporabnost (AUC) tadalafila (20 mg) povečal za 32% in Cmax zmanjšala za 30%.
English: For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the use of tadalafil is not recommended (see section 4.5).
Slovenian: Pri bolnikih, ki sočasno jemljejo močne zaviralce CYP3A4, kot na primer ketokonazol ali ritonavir, uporaba tadalafila ni priporočljiva (glejte poglavje 4.5).
English: During tadalafil 20 mg and 40 mg once daily dosing, steady-state plasma concentrations are attained within 5 days, and exposure is approximately 1.5-fold of that after a single dose.
Slovenian: Stanje dinamičnega ravnovesja je pri odmerkih od 20 mg do 40 mg z odmerjanjem enkrat na dan doseženo v petih dneh, biološka uporabnost pa je približno 1,5-krat večja kot po enkratnem odmerku.
English: Ritonavir (200 mg twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) single dose exposure (AUC) 2-fold with no change in Cmax.
Slovenian: Ritonavir (200 mg dvakrat na dan), ki je zaviralec CYP3A4, CYP2C9, CYP2C19 in CYP2D6, je biološko uporabnost (AUC) tadalafila (20 mg) povečal za 2-krat in na Cmax ni imel vpliva.
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite navodilo za uporabo.
English: How to take Talmanco
Slovenian: Kako jemati zdravilo Talmanco
English: Talmanco is supplied as a 20 mg tablet.
Slovenian: Zdravilo Talmanco je na voljo kot 20 mg tableta.
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.
Slovenian: V stanju dinamičnega ravnovesja je tadalafil (40 mg enkrat na dan) biološko uporabnost (AUC) etinilestradiola zvišal za 26% in Cmax za 70% v primerjavi z jemanjem peroralnega kontraceptiva s placebom.
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).
Slovenian: Induktor CYP3A4, rifampicin (600 mg na dan), je zmanjšal AUC tadalafila za 88% in Cmax za 46% v primerjavi z vrednostmi AUC in Cmax za tadalafil sam (10 mg).
English: Since there are no clinical data on administration of tadalafil to patients with veno-occlusive disease, administration of tadalafil to such patients is not recommended.
Slovenian: Ker o uporabi tadalafila pri bolnikih z venookluzivno boleznijo ni kliničnih podatkov, se uporaba tadalafila pri teh bolnikih ne priporoča.
English: NAME OF THE MEDICINAL PRODUCT Talmanco 20 mg film-coated tablets
Slovenian: IME ZDRAVILA Talmanco 20 mg filmsko obložene tablete
English: Gastrointestinal disorders Nausea, Dyspepsia (including abdominal pain/discomfort3)
Slovenian: Bolezni prebavil navzea, dispepsija (vključno z bolečino/nelagodje m v trebuhu3)
English: Talmanco 20 mg film-coated tablets tadalafil
Slovenian: Talmanco 20 mg filmsko obložene tablete tadalafil
English: Priapism5, Penile haemorrhage, Haematospermia
Slovenian: priapizem5, krvavitev iz penisa, hematospermija podaljšana erekcija
English: For patients chronically taking potent inducers of CYP3A4, such as rifampicin, the use of tadalafil is not recommended (see section 4.5).
Slovenian: Pri bolnikih, ki sočasno jemljejo močne induktorje CYP3A4, kot na primer rifampicin, uporaba tadalafila ni priporočljiva (glejte poglavje 4.5).
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).
Slovenian: (p = 0,0004; 95% interval zaupanja: 9,5, 44,0; predhodno določena Hodges-Lehmanova metoda) (povprečna vrednost 33 metrov, 95% interval zaupanja: 15.2, 50.3).
English: Do not take Talmanco: if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Talmanco, če: ste alergični na tadalafil ali katero koli sestavino tega zdravila (navedeno v poglavju 6), jemljete kakršno koli obliko nitratov, kot je amil nitrit, ki se uporabljajo pri zdravljenju bolečine za prsnico.
English: NAME OF THE MEDICINAL PRODUCT Talmanco 20 mg film-coated tablets tadalafil
Slovenian: IME ZDRAVILA Talmanco 20 mg filmsko obložene tablete tadalafil
English: year is 96.4%.
Slovenian: Pri bolnikih, pri katerih so bili podatki na voljo, je bilo preživetje po enem letu 96,4%.
English: These events were not seen in clinical studies for pulmonary arterial hypertension and therefore frequency is not known (frequency cannot be estimated from the available data):
Slovenian: Teh učinkov v kliničnih študijah za pljučno arterijsko hipertenzijo niso opazili, zato je pogostnost neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): - otekanje vek, bolečina v očesu, rdeče oči, srčni infarkt in možganska kap
English: Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing of tadalafil in these patients is not recommended.
Slovenian: Študij pri bolnikih s hudo cirozo jeter (razred C po Child-Pughu) niso opravili, zato pri teh bolnikih uporaba tadalafila ni priporočljiva.
English: 6.6 Special precautions for disposal
Slovenian: 6.4 Posebna navodila za shranjevanje
English: Talmanco contains lactose
Slovenian: Zdravilo Talmanco vsebuje laktozo
English: Physicians should carefully consider whether their patients with certain underlying conditions, such as severe left ventricular outflow obstruction, fluid depletion, autonomic hypotension or patients with resting hypotension, could be adversely affected by such vasodilatory effects.
Slovenian: Zdravnik naj skrbno ovrednoti, ali bi lahko vazodilatacijski učinek negativno vplival na določena že prisotna stanja, kot so huda zapora iztoka iz levega ventrikla, izguba tekočine, avtonomna hipotenzija ali prikrita hipotenzija.
English: Very Common (may affect more than 1 in 10 people) headache.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - zamegljen vid,
English: What Talmanco contains
Slovenian: Kaj vsebuje zdravilo Talmanco
English: Priapism has been reported in men treated with PDE5 inhibitors.
Slovenian: Pri moških, ki so se zdravili z zaviralci PDE5, so poročali o priapizmu.
English: Common (may affect up to 1 in 10 people) allergic reactions including skin rashes.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - alergijske reakcije, vključno s kožnimi izpuščaji - bolečina v prsih - ne uporabljajte nitratov, ampak poiščite zdravniško pomoč
English: Film-coating:
Slovenian: Okvara jeter:
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
Slovenian: Pred začetkom jemanja tega zdravila se posvetujte z zdravnikom ali farmacevtom, če imate: poleg pljučne hipertenzije še kakšno drugo težavo s srcem, težave s krvnim tlakom, katero koli dedno očesno bolezen,
English: Pulmonary arterial hypertension (PAH) etiologies were predominantly idiopathic PAH (61.0%) and related to collagen vascular disease (23.5%).
Slovenian: (61,0%) in povezana z vaskularno sistemsko boleznijo veziva (23,5%).
English: Syncope, Migraine5
Slovenian: sinkopa, migrena5 epileptični napadi5, tranzitorna amnezija5
English: The dose may be increased to 40 mg once per day, based on individual efficacy and tolerability.
Slovenian: Pri bolnikih z blago do zmerno ledvično okvaro je priporočen začetni odmerek 20 mg enkrat na dan. Odmerek se lahko zveča na 40 mg enkrat na dan, odvisno od učinkovitosti in prenašanja zdravila pri posamezniku.
English: Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).
Slovenian: in III. funkcijskem razredu po razvrstitvi SZO pri odraslih, za izboljšanje sposobnosti za telesno obremenitev (glejte poglavje 5.1).
English: Nervous system disorders Headache
Slovenian: Bolezni živčevja glavobol6
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 20 mg tadalafil.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 20 mg tadalafila.
English: How to store Talmanco
Slovenian: Shranjevanje zdravila Talmanco
English: Urticaria5, Hyperhydrosis (sweating)
Slovenian: Bolezni kože in podkožja izpuščaj koprivnica hiperhidroza (znojenje) 5
English: Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing of tadalafil is not recommended (see sections 4.4 and 5.2).
Slovenian: po Child-Pughu) niso bile opravljene, zato pri teh bolnikih uporaba tadalafila ni priporočljiva (glejte poglavji 4.4 in 5.2).
English: Visual defects and cases of NAION have been reported in connection with the intake of tadalafil and other PDE5 inhibitors.
Slovenian: V povezavi z jemanjem tadalafila in drugih zaviralcev PDE5 so poročali o okvarah vida in primerih NAION.
English: Renal impairment
Slovenian: Insuficienca ledvic
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.
Slovenian: Ketokonazol (200 mg na dan), je biološko uporabnost (AUC) tadalafila (10 mg) po enkratnem odmerku povečal za 2-krat in Cmax za 15% glede na vrednosti AUC in Cmax za tadalafil sam. Ketokonazol (400 mg na dan) je povečal biološko uporabnost (AUC) tadalafila (20 mg) za 4-krat in Cmax za 22%.
English: Alcohol concentrations were not affected by co-administration with tadalafil (10 mg or 20 mg).
Slovenian: Sočasno jemanje tadalafila (10 mg ali 20 mg) ni vplivalo na koncentracije alkohola.
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.
Slovenian: 5 Neželeni učinki so bili vključeni v preglednico kot posledica podatkov iz obdobja trženja ali podatkov iz kliničnih študij o uporabi tadafila za zdravljenje erektilne disfunkcije.
English: excessive sweating.
Slovenian: Insuficienca jeter
English: Palpitations2, 5
Slovenian: Neznana pogostnost1
English: Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breast-feeding.
Slovenian: Če ste noseči ali dojite, se po nasvet o uporabi katerega koli zdravila obrnite na zdravnika ali farmacevta.
English: Anhydrous lactose
Slovenian: Bolezni sečil hematurija
English: Microcrsytalline cellulose (PH 101) Croscarmellose sodium
Slovenian: Jedro tablete povidon (K-25) natrijev lavrilsulfat poloksamer 188 laktoza, brezvodna mikrokristalna celuloza (PH 101) natrijev karmelozat, premreženi silicijev dioksid, koloidni, brezvodni magnezijev stearat
English: swelling of the eyelids, eye pain, red eyes, heart attack and stroke.
Slovenian: Splošne težave in spremembe na mestu aplikacije otečen obraz, bolečina v prsnem košu
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.
Slovenian: 1 O dogodkih v študijah za pridobitev dovoljenja za promet niso poročali in jih iz razpoložljivih podatkov ni mogoče oceniti.
English: EU/2/11/126/001 MS-H Vaccine
Slovenian: EU/2/11/126/001 Cepivo MS-H 10 5.7 do 10 7.0 enote spreminjanja barve (CCU)/odmerek
English: Chickens
Slovenian: Karenca
English: Invented Name
Slovenian: Številka EU Izmišljeno ime
English: 1 bottle N/A
Slovenian: Steklenička LDPE
English: Target species Route of administration
Slovenian: Ciljne živalske vrste
English: Eye drop, suspension
Slovenian: Suspenzija za očesne kapljice piščanci
English: Withdrawal period
Slovenian: Okularna uporaba
English: Ocular use LDPE bottle 30ml
Slovenian: 30 ml
English: 1 spot-on applicator
Slovenian: 1 aplikator za kožni nanos
English: However, there is no evidence to date to support this hypothesis.
Slovenian: Vendar do sedaj ni podatkov, ki bi podpirali to domnevo.
English: Add, to all products (if not already present):
Slovenian: Dodajte za vsa zdravila (če še ne obstaja):
English: The product should not be re-applied (within 7 weeks) to cattle.
Slovenian: Zdravilo se govedu (v obdobju sedmih tednov) ne sme dajati ponovno.
English: − education, training and guidance for end-users.
Slovenian: − izobraževanje, usposabljanje in usmerjanje končnih uporabnikov.
English: − intensified data collection relating to pharmacovigilance reports; and
Slovenian: − okrepljeno zbiranje podatkov v zvezi s farmakovigilančnimi poročili; ter
English: • implementation of a risk management plan addressing the following risk mitigation and surveillance measures:
Slovenian: • izvajanje načrta obvladovanja tveganj, ki obravnava naslednje ukrepe za zmanjševanje tveganj in nadzor:
English: Higher incidence values were reported in Sweden (0.011%) and France (0.007%).
Slovenian: O večji pojavnosti so poročali na Švedskem (0,011 %) in v Franciji (0,007 %).
English: • UK/V/0325/001 - Closamectin Pour-On (UK, Ireland);
Slovenian: • UK/V/0325/001 - Closamectin Pour-On (Združeno kraljestvo, Irska);