natgillin/translations-raw huggingface dataset:
Since there are no clinical data on the safety of tadalafil in these patients, the use of tadalafil is not recommended.
Ker za te bolnike kliničnih podatkov o varnosti tadalafila ni, uporaba tadalafila pri teh bolnikih ni priporočljiva.
In patients with severe renal impairment the use of tadalafil is not recommended (see sections 4.4 and 5.2).
Pri bolnikih s hudo ledvično okvaro uporaba tadalafila ni priporočljiva (glejte poglavji 4.4 in 5.2).
The table below lists the adverse reactions reported during the placebo-controlled clinical study in patients with PAH treated with tadalafil.
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.
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.
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%.
Talmanco tablets contain lactose.
Zdravilo Talmanco vsebuje laktozo.
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.
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.
PVC/PE/PVdC-Alu perforated unit dose blisters in carton containing 28 x 1 and 56 x 1 film-coated tablets.
PVC/PE/PVdC-alu perforirani enoodmerni pretisni omoti v škatlah s po 28 x 1 ali 56 x 1 filmsko obloženo tableto.
3 Actual MedDRA terms included are abdominal discomfort, abdominal pain, abdominal pain lower,
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.
Ritonavir (500 mg or 600 mg twice daily) increased tadalafil (20 mg) single-dose exposure (AUC) by 32% and decreased Cmax by 30%.
Ritonavir (500 ali 600 mg dvakrat na dan) je biološko uporabnost (AUC) tadalafila (20 mg) povečal za 32% in Cmax zmanjšala za 30%.
For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the use of tadalafil is not recommended (see section 4.5).
Pri bolnikih, ki sočasno jemljejo močne zaviralce CYP3A4, kot na primer ketokonazol ali ritonavir, uporaba tadalafila ni priporočljiva (glejte poglavje 4.5).
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.
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.
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.
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.
METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite navodilo za uporabo.
How to take Talmanco
Kako jemati zdravilo Talmanco
Talmanco is supplied as a 20 mg tablet.
Zdravilo Talmanco je na voljo kot 20 mg tableta.
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.
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.
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).
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).
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.
Ker o uporabi tadalafila pri bolnikih z venookluzivno boleznijo ni kliničnih podatkov, se uporaba tadalafila pri teh bolnikih ne priporoča.
NAME OF THE MEDICINAL PRODUCT Talmanco 20 mg film-coated tablets
IME ZDRAVILA Talmanco 20 mg filmsko obložene tablete
Gastrointestinal disorders Nausea, Dyspepsia (including abdominal pain/discomfort3)
Bolezni prebavil navzea, dispepsija (vključno z bolečino/nelagodje m v trebuhu3)
Talmanco 20 mg film-coated tablets tadalafil
Talmanco 20 mg filmsko obložene tablete tadalafil
Priapism5, Penile haemorrhage, Haematospermia
priapizem5, krvavitev iz penisa, hematospermija podaljšana erekcija
For patients chronically taking potent inducers of CYP3A4, such as rifampicin, the use of tadalafil is not recommended (see section 4.5).
Pri bolnikih, ki sočasno jemljejo močne induktorje CYP3A4, kot na primer rifampicin, uporaba tadalafila ni priporočljiva (glejte poglavje 4.5).
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).
(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).
Do not take Talmanco: if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
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.
NAME OF THE MEDICINAL PRODUCT Talmanco 20 mg film-coated tablets tadalafil
IME ZDRAVILA Talmanco 20 mg filmsko obložene tablete tadalafil
year is 96.4%.
Pri bolnikih, pri katerih so bili podatki na voljo, je bilo preživetje po enem letu 96,4%.
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):
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
Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing of tadalafil in these patients is not recommended.
Študij pri bolnikih s hudo cirozo jeter (razred C po Child-Pughu) niso opravili, zato pri teh bolnikih uporaba tadalafila ni priporočljiva.
6.6 Special precautions for disposal
6.4 Posebna navodila za shranjevanje
Talmanco contains lactose
Zdravilo Talmanco vsebuje laktozo
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.
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.
Very Common (may affect more than 1 in 10 people) headache.
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - zamegljen vid,
What Talmanco contains
Kaj vsebuje zdravilo Talmanco
Priapism has been reported in men treated with PDE5 inhibitors.
Pri moških, ki so se zdravili z zaviralci PDE5, so poročali o priapizmu.
Common (may affect up to 1 in 10 people) allergic reactions including skin rashes.
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
Film-coating:
Okvara jeter:
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
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,
Pulmonary arterial hypertension (PAH) etiologies were predominantly idiopathic PAH (61.0%) and related to collagen vascular disease (23.5%).
(61,0%) in povezana z vaskularno sistemsko boleznijo veziva (23,5%).
Syncope, Migraine5
sinkopa, migrena5 epileptični napadi5, tranzitorna amnezija5
The dose may be increased to 40 mg once per day, based on individual efficacy and tolerability.
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.
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).
in III. funkcijskem razredu po razvrstitvi SZO pri odraslih, za izboljšanje sposobnosti za telesno obremenitev (glejte poglavje 5.1).
Nervous system disorders Headache
Bolezni živčevja glavobol6
STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 20 mg tadalafil.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 20 mg tadalafila.
How to store Talmanco
Shranjevanje zdravila Talmanco
Urticaria5, Hyperhydrosis (sweating)
Bolezni kože in podkožja izpuščaj koprivnica hiperhidroza (znojenje) 5
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).
po Child-Pughu) niso bile opravljene, zato pri teh bolnikih uporaba tadalafila ni priporočljiva (glejte poglavji 4.4 in 5.2).
Visual defects and cases of NAION have been reported in connection with the intake of tadalafil and other PDE5 inhibitors.
V povezavi z jemanjem tadalafila in drugih zaviralcev PDE5 so poročali o okvarah vida in primerih NAION.
Renal impairment
Insuficienca ledvic
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.
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%.
Alcohol concentrations were not affected by co-administration with tadalafil (10 mg or 20 mg).
Sočasno jemanje tadalafila (10 mg ali 20 mg) ni vplivalo na koncentracije alkohola.
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.
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.
excessive sweating.
Insuficienca jeter
Palpitations2, 5
Neznana pogostnost1
Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breast-feeding.
Če ste noseči ali dojite, se po nasvet o uporabi katerega koli zdravila obrnite na zdravnika ali farmacevta.
Anhydrous lactose
Bolezni sečil hematurija
Microcrsytalline cellulose (PH 101) Croscarmellose sodium
Jedro tablete povidon (K-25) natrijev lavrilsulfat poloksamer 188 laktoza, brezvodna mikrokristalna celuloza (PH 101) natrijev karmelozat, premreženi silicijev dioksid, koloidni, brezvodni magnezijev stearat
swelling of the eyelids, eye pain, red eyes, heart attack and stroke.
Splošne težave in spremembe na mestu aplikacije otečen obraz, bolečina v prsnem košu
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.
1 O dogodkih v študijah za pridobitev dovoljenja za promet niso poročali in jih iz razpoložljivih podatkov ni mogoče oceniti.
EU/2/11/126/001 MS-H Vaccine
EU/2/11/126/001 Cepivo MS-H 10 5.7 do 10 7.0 enote spreminjanja barve (CCU)/odmerek
Chickens
Karenca
Invented Name
Številka EU Izmišljeno ime
1 bottle N/A
Steklenička LDPE
Target species Route of administration
Ciljne živalske vrste
Eye drop, suspension
Suspenzija za očesne kapljice piščanci
Withdrawal period
Okularna uporaba
Ocular use LDPE bottle 30ml
30 ml
1 spot-on applicator
1 aplikator za kožni nanos
However, there is no evidence to date to support this hypothesis.
Vendar do sedaj ni podatkov, ki bi podpirali to domnevo.
Add, to all products (if not already present):
Dodajte za vsa zdravila (če še ne obstaja):
The product should not be re-applied (within 7 weeks) to cattle.
Zdravilo se govedu (v obdobju sedmih tednov) ne sme dajati ponovno.
− education, training and guidance for end-users.
− izobraževanje, usposabljanje in usmerjanje končnih uporabnikov.
− intensified data collection relating to pharmacovigilance reports; and
− okrepljeno zbiranje podatkov v zvezi s farmakovigilančnimi poročili; ter
• implementation of a risk management plan addressing the following risk mitigation and surveillance measures:
• izvajanje načrta obvladovanja tveganj, ki obravnava naslednje ukrepe za zmanjševanje tveganj in nadzor:
Higher incidence values were reported in Sweden (0.011%) and France (0.007%).
O večji pojavnosti so poročali na Švedskem (0,011 %) in v Franciji (0,007 %).
• UK/V/0325/001 - Closamectin Pour-On (UK, Ireland);
• UK/V/0325/001 - Closamectin Pour-On (Združeno kraljestvo, Irska);
This should be done before their implementation and for any future changes to the measures deemed necessary.
To bi morali storiti pred začetkom izvajanja zadevnih ukrepov oziroma za kakršne koli prihodnje morebiti potrebne spremembe ukrepov.
The average number of affected animals per adverse event report in the EU was 3.9.
Povprečno število prizadetih živali na posamezno poročilo o neželenem dogodku v EU je znašalo 3,9 živali.
Closamectin Pour-On Solution and associated names is authorised in several EU Member States.
Zdravilo Closamectin Pour-On Solution in povezana imena je odobreno v več državah članicah EU.
It was also recommended to ensure data collection on a representative sample of unaffected treated animals within the same herd.
Prav tako je bilo priporočeno, da se zagotovi zbiranje podatkov za reprezentativni vzorec neprizadetih zdravljenih živali v isti čredi.
A single risk management plan should be presented covering all products included within the scope of this procedure.
Predloži se enoten načrt obvladovanja tveganj, ki zajema vsa zdravila, zajeta s tem postopkom.
These measures were considered to be appropriate to mitigate the risks observed following treatment.
Ti ukrepi so bili ocenjeni kot ustrezni za zmanjšanje tveganj, opaženih po zdravljenju.
Overall summary of the scientific evaluation of Closamectin Pour-On Solution and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Closamectin Pour-On Solution in povezanih imen (glejte Prilogo I)
It was proposed that third parties involved in pharmacovigilance activities related to these products (e.g distributors) be made aware of the risk management measures proposed.
Predlagano je bilo, da se tretje osebe, vključene v dejavnosti farmakovigilance, povezane s temi zdravili (npr. distributerji), seznanijo s predlaganimi ukrepi za obvladovanje tveganj.
Information should also be collected on the affected herd and husbandry system in general, including herd health status.
Hkrati bi morali zbirati podatke o prizadeti čredi in sistemu živinoreje na splošno, vključno z zdravstvenim stanjem črede.
The aforementioned products have the same qualitative and quantitative composition and consequently it was considered that the animal health issues described were applicable to these products as well.
Kakovostna in količinska sestava zgoraj navedenih zdravil je enaka, zato je bilo ocenjeno, da opisane težave v zvezi z zdravjem živali veljajo tudi za ta zdravila.
• UK/V/0368/001 - Closiver 5mg/ml & 200 mg/ml Pour-On (UK); Closamectin 5mg/ml & 200 mg/ml Pour-On (Austria, Belgium, Czech Republic, Denmark, Germany, Greece, Italy, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden);
• UK/V/0368/001 - Closiver 5 mg/ml & 200 mg/ml Pour-On (Združeno kraljestvo); Closamectin 5 mg/ml & 200 mg/ml Pour-On (Avstrija, Belgija, Češka republika, Danska, Nemčija, Grčija, Italija, Poljska, Portugalska, Romunija, Slovaška, Slovenija, Španija in Švedska);
It was noted that these events often involved more than one animal within affected herds.
Ugotovljeno je bilo, da so ti dogodki v prizadetih čredah pogosto zajemali več kot eno žival.
CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS is a veterinary medicinal product which has been authorised in France since 25 May 2011 following a decentralised procedure (DCP) (UK/V/0369/001) with the United Kingdom (UK) as reference Member State.
CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS je zdravilo za uporabo v veterinarski medicini, ki je v Franciji odobreno od 25. maja 2011 dalje na podlagi decentraliziranega postopka (UK/V/0369/001), v katerem je bilo Združeno kraljestvo referenčna država članica.
The national competent authorities of Member State(s) or the reference Member State, as applicable, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Pristojni nacionalni organi ene ali več držav članic ali referenčne države članice, kot je ustrezno, zagotovijo, da imetnik dovoljenja za promet z zdravilom izpolnjuje naslednje pogoje:
Closivet Solución Pour- On Ivermectin Closantel
Closivet Solución Pour- On Closantel in Ivermectin
Other treatment options have limited activity against immature fluke.
Druge možnosti zdravljenja so omejeno učinkovite proti nedoraslim metljajem.
Sales volumes should also be reported separately for specific products for each Member State.
Prav tako bi morali za vsako posamezno zdravilo ločeno poročati o prodanih količinah v vsaki državi članici.
Although the overall incidence of adverse events was considered to be within acceptable limits (0.006% in the last annual periodic safety update report (PSUR)) the continued occurrence of serious adverse events and the severity of subsequent losses on farms in France were considered significant, which led to the suspension of the marketing authorisation in France on 6 July 2015.
Čeprav je bilo ocenjeno, da je skupna pojavnost neželenih dogodkov znotraj dopustnih meja (0,006 % v zadnjem letnem redno posodobljenem poročilu o varnosti zdravila (PSUR)), so bili stalni pojavi resnih neželenih dogodkov in resnost posledičnih izgub na kmetijah v Franciji ocenjeni za pomembne, zaradi česar je bilo dovoljenje za promet z zdravilom v Franciji 6. julija 2015 začasno umaknjeno.
List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, marketing authorisation holder in the Member States
Seznam imen, farmacevtskih oblik in jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe, imetnikov dovoljenja za promet z zdravilom v državah članicah
From 2000 until 30 June 2015, a total of 371 adverse events reports were reported in the EU, 65% of which, according to the MAH, concerned animal toxicity, mainly in France (120 reports) and the UK (91 reports).
Od leta 2000 do 30. junija 2015 so v EU poročali o 371 neželenih dogodkih, pri čemer jih je po podatkih imetnika dovoljenja za promet z zdravilom 65 % zadevalo toksičnost pri živalih, zlasti v Franciji (120 poročil) in v Združenem kraljestvu (91 poročil).
This may suggest that risk factors exist in the field, leading to either overexposure of some animals to closantel or enhanced intrinsic sensitivity of these animals to the toxic effects of closantel.
To kaže na to, da na terenu obstajajo dejavniki tveganja, ki vodijo bodisi k prekomerni izpostavljenosti nekaterih živali klozantelu ali okrepljeni intrinzični občutljivosti teh živali na toksične učinke klozantela.
Additional investigations were initiated in animals affected in 2015, involving monitoring vitamins A, E and selenium blood levels in samples from both affected and unaffected animals.
Pri živalih, prizadetih leta 2015, so bile opravljene dodatne preiskave, ki so vključevale spremljanje ravni vitaminov A in E ter selena v vzorcih krvi prizadetih in neprizadetih živali.
The risk management plan should be submitted to the national competent authorities within 3 months of the Commission Decision and maintained until such time as the concerned national competent authorities consider that the risk profile of the product has been sufficiently characterised and all appropriate risk mitigation and surveillance measures have been implemented.
Načrt obvladovanja tveganj se predloži pristojnim nacionalnim organom v treh mesecih od izdaje sklepa Komisije in se izvaja, dokler zadevni pristojni nacionalni organi ne sklenejo, da je bil profil tveganja zdravila zadovoljivo opredeljen, in dokler se ne izvedejo vsi ustrezni ukrepi za zmanjševanje tveganj in nadzor.
From the literature review reported it appeared that variability existed between animals in terms of their clinical response to a same level of overdose.
Iz pregleda literature, o katerem so poročali, je bilo razvidno, da so med živalmi obstajale razlike, kar zadeva njihov klinični odziv na enako raven prekomernega odmerka.
The overall EU incidence of adverse events, in relation to sales volumes was classified as ‘very rare' (0.003%) and considered within acceptable limits.
Skupna pojavnost neželenih dogodkov v EU je bila glede na prodane količine opredeljena kot „zelo redka“ (0,003 %) in po ocenah spada v okvir dopustnih meja.
This follow-up should also continue to investigate other potential risk factors which may also play a role in the adverse events observed, including, for example, aspects related to animal husbandry.
V okviru tega nadaljnjega spremljanja bi morali še naprej preiskovati tudi druge možne dejavnike tveganja, ki lahko imajo prav tako vlogo pri opaženih neželenih učinkih, vključno med drugim z vidiki, povezanimi z živinorejo.
The data reviewed did not indicate age, sex, breed or geographical distribution as potential risk factors for the adverse events observed.
Pregledani podatki niso vsebovali podatkov o starosti, spolu, pasmi ali geografski porazdelitvi kot možnih dejavnikih tveganja za opažene neželene dogodke.