natgillin/translations-raw huggingface dataset:
All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets. 
Vsakršno sklicevanje na zgoraj navedene indikacije je treba izbrisati iz zadevnih poglavij navodil za uporabo.
• Symptomatic treatment of veno-lymphatic insufficiency All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics. 
• Simptomatsko zdravljenje obolenj žilno-limfnega sistema Vsakršno sklicevanje na zgoraj navedene indikacije je treba izbrisati iz preostalih zadevnih poglavij povzetkov glavnih značilnosti zdravil.
• Prophylaxis of migraine headache 
• Profilaksa migrenskega glavobola
Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets 
Spremembe zadevnih poglavij povzetkov glavnih značilnosti zdravil in navodil za uporabo
4.1 Therapeutic indications 
A. Povzetek glavnih značilnosti zdravila 4.1 Terapevtske indikacije
the MAHs should identify a patient population for which the benefit risk ratio of tetrazepam containing medicines is positive on the basis of scientifically relevant supportive data. 
imetniki dovoljenj za promet morajo na podlagi znanstveno utemeljenih podatkov opredeliti populacijo bolnikov, pri katerih je razmerje med tveganji in koristmi zdravil, ki vsebujejo tetrazepam, pozitivno.
For the suspension to be lifted, the National competent authorities of Member States shall verify that the following conditions are fulfilled by the MAHs: 
Za preklic začasnega umika morajo nacionalni pristojni organi držav članic preveriti, ali imetniki dovoljenj za promet z zdravili izpolnjujejo naslednje pogoje:
Annex III Conditions for lifting the suspension of the marketing authorisations 
Priloga III
Two clinical trials were carried out under field conditions. 
Opravljeni sta bili dve klinični preskušanji v terenskih pogojih.
A disagreement between the Member States on the efficacy of the product was not solved. 
Nestrinjanje med državami članicami glede učinkovitosti zdravila ni bilo rešeno.
Germany CEVA Animal Health Limited 
Nemčija CEVA Animal Health Limited
Assessment of the efficacy of Tildren 
Vrednotenje učinkovitosti zdravila Tildren
Further, a complementary analysis assessed the percentage of horses with no or minimal lameness and the percentage of horses with normal level of activity. 
Poleg tega so v dopolnilni analizi ocenili odstotek konjev z minimalno šepavostjo ali brez šepavosti ter odstotek konjev z normalno ravnjo aktivnosti.
Consequently, in the absence of any demonstrated benefit of this component the risk-benefit analysis for the product is negative, therefore presenting an unacceptable serious risk to human or animal health or to the environment. 
Posledično mora biti zaradi odsotnosti dokazanih koristi analiza tveganja in koristnih učinkov zdravila negativna, torej predstavlja nesprejemljivo resno tveganje za zdravje ljudi, živali ali okolja.
However, in the assessment for this opinion only those horses suffering from bone spavin and treated with 0.1 mg/kg/day for 10 days are included. 
Vendar so v vrednotenje za to mnenje vključeni le konji z bramorjem kosti, ki so bili zdravljeni 10 dni z odmerkom 0,1 mg/kg/dan.
List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route(s) of administration, marketing authorisation holder in the member states 
Seznam imen, farmacevtskih oblik, jakosti zdravila za uporabo v veterinarski medicini, živalskih vrst, poti uporabe zdravila in imetnikov dovoljenja za promet z zdravilom v državah članicah
Nevertheless the analysis of the Periodic Safety Update Report demonstrated that the number of serious adverse reactions was small and the CVMP concluded that there are no major concerns regarding the safety of the product. 
Vendar je analiza rednih posodobljenih poročil o varnosti zdravila pokazala, da je število resnih neželenih reakcij majhno, zato je CVMP zaključil, da ni poglavitnih zadržkov glede varnosti zdravila.
There are considered to be significant deficiencies in the data provided by the Marketing Authorisation Holder in support of the efficacy of product. 
Obstajajo pomembne pomanjkljivosti v podatkih, ki jih je imetnik dovoljenja za promet predložil v podporo učinkovitosti zdravila.
Tiludronate belongs to the biphosphonates family. 
Tiludronat spada v skupino bifosfonatov.
Condition for the lifting of the suspension 
Pogoj za preklic zadržanja
Frequency and route of administration 
Pogostost in pot uporabe zdravila
The dose of 1 mg/kg was selected as the dose producing approximately 75 % inhibition of bone resorption. 
Odmerek 1 mg/kg je bil izbran kot odmerek, ki povzroči približno 75-odstotno inhibicijo resorpcije kostnine.
Scientific conclusions and grounds for suspension or refusal of the granting of the marketing authorisation 
Znanstveni zaključki in podlaga za zadržanje ali zavrnitev odobritve dovoljenja za promet z zdravilom
It is common for horses affected by this disease to have reduced performance. 
Konji s to boleznijo imajo pogosto zmanjšano zmogljivost.
1 mg/kg body weight (5 ml reconstituted solution per 100 kg) 
1 mg/kg telesne mase (5 ml rekonstituirane raztopine na 100 kg)
Not permitted for use in lactating animals producing milk for human consumption 
nič dni; ni dovoljena uporaba pri živalih v laktaciji, katerih mleko je namenjeno prehrani ljudi.
The data demonstrate a treatment effect on lameness whereas the role of exercise in connection with treatment was considered unresolved. 
Podatki kažejo učinek zdravljenja na šepavost, vloga vadbe v povezavi z zdravljenjem pa se šteje za nerazrešeno.
Therefore Belgium and Sweden considered that the benefit/risk balance was negative for Tildren, as the efficacy of the product had not been sufficiently demonstrated. 
Zato sta Belgija in Švedska menili, da je razmerje koristi in tveganja za zdravilo Tildren negativno, saj učinkovitost zdravila ni bila zadostno dokazana.
Horses Once (the treatment may be repeated on the advice of the veterinary surgeon) Intravenous use 
500mg konji enkrat (zdravljenje se lahko ponovi po posvetovanju z veterinarjem) intravenska uporaba
Such lesions in the hock joint are responsible for varying degrees of lameness, often with an insidious onset, and leading to a complete ankylosis of the affected joints in the later stages of the disease. 
Takšne lezije skočnega sklepa so odgovorne za različne stopnje šepavosti, pogosto s prikritim začetkom, v končnih fazah bolezni pa povzročijo popolno ankilozo prizadetih sklepov.
On the other hand treatment with Tildren has been associated with abdominal disorders. 
Na drugi strani pa je bilo zdravljenje z zdravilom Tildren povezano s trebušnimi boleznimi.
Tiludronate is incorporated into the bone matrix and the osteoclasts where it affects ATP-dependent intracellular enzymes leading to apoptosis. 
Tiludronat se vključi v kostni matriks in osteoklaste, kjer učinkuje na od ATP odvisne znotrajcelične encime, kar povzroči apoptozo.
TILDREN 500 mg, lyophilisate for solution for infusion (Tiludronic acid) is a product indicated as an aid in the treatment of clinical signs of lameness associated with bone spavin in combination with a controlled exercise regime in horses over 3 years of age. 
TILDREN 500 mg liofilizat za raztopino za infundiranje (tiludronska kislina) je zdravilo, indicirano kot pomoč pri zdravljenju kliničnih znakov šepavosti, povezanih z bramorjem kosti v kombinaciji z nadzorovanim režimom vadbe pri konjih, starejših od 3 let.
The CVMP was asked to assess if the efficacy of Tildren had been demonstrated and to conclude on the benefit/risk balance. 
CVMP so prosili za ugotovitev, ali je bila učinkovitost zdravila Tildren dokazana, in za mnenje glede razmerja med koristmi in tveganji.
The efficacy of Tildren for the treatment of bone spavin in horses should be demonstrated through the provision of appropriate field data clearly demonstrating that the administration of the product at an adequate dose shows a specific benefit unrelated to the concomitant use of NSAIDs or horse specific exercise programs. 
Učinkovitost zdravila Tildren za zdravljenje bramorja kosti pri konjih je treba dokazati s predložitvijo ustreznih terenskih podatkov, ki jasno dokazujejo, da uporaba zdravila z ustreznim odmerkom povzroči specifično korist, ki ni povezana s sočasno uporabo nesteroidnih protivnetnih zdravil ali za konje specifičnimi programi vadbe.
The resulting effect of osteoclast inhibition is inhibition of bone resorption. 
Ta učinek inhibicije osteoklastov povzroči inhibicijo resorpcije kosti.
In the view of Belgium and Sweden the clinical trial performed according to the recommended dosage failed to show a statistical significant effect of the product. 
Belgija in Švedska sta menili, da rezultati kliničnega preskušanja, kjer so uporabili priporočeni odmerek, ne kažejo statistično pomembnega učinka zdravila.
In the first study a number of criteria were chosen to evaluate efficacy, including lameness score, response to treatment, effect of pain on palpation or mobilisation of the limb, response to flexion test and level of activity. 
V prvi študiji so za oceno učinkovitosti izbrali več kriterijev, vključno s točkovanjem šepavosti, odzivom na zdravljenje, učinek bolečine na otipavanje ali premikanje uda, odziv pri preskusu upogibanja in raven aktivnosti.
In the second study, efficacy was judged on the criteria of lameness score, level of exercise, assessed according to the type of animals and the combination of changes in lameness score and exercise level. 
V drugi študiji so učinkovitost ocenjevali s kriteriji točkovanja šepavosti, ravni vadbe, ki so jo vrednotili glede na vrsto živali, ter kombinacijo sprememb v točkovanju šepavosti in ravni vadbe.
Tiludronate is considered to reduce pain as bone disorders with increased osteoclastic bone resorption are frequently associated with pain. 
Šteje se, da tiludronat zmanjša bolečino, saj so bolezni kosti, ki obsegajo povečano osteoklastno resorpcijo kosti, pogosto povezane z bolečino.
Its main cellular target is the mature osteoclast, the cell responsible for bone resorption. 
Njegova glavna ciljna celica je dozorel osteoklast, tj. celica, odgovorna za resorpcijo kosti.
Overall summary of the scientific evaluation of TILDREN 500 mg lyophilisate for solution for infusion 
Splošni povzetek znanstvenega vrednotenja zdravila TILDREN 500 mg liofilizat za raztopino za infundiranje
They considered that the selected dose was shown to produce concentrations in bone that are in the range of concentrations shown to inhibit bone resorption in vitro systems and that PK/PD modelling used was adequate to derive a pharmacologically active dose using a marker of bone resorption. 
Menili so, da izbrani odmerek dokazano zagotovi koncentracije v kosti, ki so v razponu koncentracij in ki dokazano zavirajo resorpcijo kosti v sistemih in vitro ter da je izbrano modeliranje farmakokinetike in farmakodinamike zadostno za izpeljavo farmakološko aktivnega odmerka z označevalcem resorpcije kostnine.
Applicant or Marketing Authorisation Holder 
Predlagatelj ali imetnik dovoljenja za promet z zdravilom
The CVMP, however, concluded that the arguments presented by the MAH were not adequate to demonstrate efficacy given the data presented and concerns remained with regard to the influence of the variable exercise programmes and the concomitant use of NSAIDs. 
Vendar je CVMP menil, da argumenti, ki jih je predstavil imetnik dovoljenja za promet z zdravilom, ne zadostujejo za dokaz učinkovitosti glede na predložene podatke in preostale zadržke glede vpliva različnih programov vadbe ter sočasne uporabe nesteroidnih protivnetnih zdravil.
Tildren 500 mg lyophilisate for solution for infusion 
Tildren 500 mg liofilizat za raztopino za infundiranje liofilizat za raztopino za infundiranje
Grounds for refusal of the granting of the marketing authorisation 
Podlaga za zavrnitev odobritve dovoljenja za promet z zdravilom
With regard to the influence of exercise, the MAH concluded that the variation in exercise had been controlled to avoid any influence on the objective evaluation of the effect of the Tildren treatment. 
Imetnik dovoljenja za promet z zdravilom je v zvezi z vplivom vadbe menil, da so bile razlike pri vadbi nadzorovane, da bi preprečili vpliv na objektivno ocenjevanje učinka zdravljenja z zdravilom Tildren.
In both the treated and the placebo group lameness improved but there was no statistically significant difference between groups. 
Šepanje se je izboljšalo v skupini, ki je prejemala zdravilo, in v skupini, ki je prejemala placebo, vendar med skupinama ni bili statistično pomembne razlike.
A number of further questions were addressed to the Marketing Authorisation Holder (MAH) relating to the dosage, clarification of the statistical analyses, the concomitant NSAID treatment and the influence of exercise. 
Imetniku dovoljenja za promet z zdravilom so bila poslana številna dodatna vprašanja v zvezi z odmerjanjem, razjasnitvijo statističnih analiz, sočasnega zdravljenja z nesteroidnimi protivnetnimi zdravili in vplivom vadbe.
The second clinical study was performed in accordance with GCP to assess the efficacy and the safety of tiludronic acid administered as a single infusion at the dose of 1 mg/kg bw in the treatment of bone spavin in horses. 
Druga klinična študija je bila opravljena v skladu z dobro klinično prakso za oceno učinkovitosti in varnosti tiludronske kisline, uporabljene v eni infuziji z odmerkom 1 mg/kg telesne mase za zdravljenje bramorja kosti pri konjih.
The first clinical study was carried out in accordance with GCP to assess the efficacy and tolerance of tiludronic acid in the treatment of 3 clinical conditions including bone spavin and to compare two dosage regimes with treatment administering a placebo (vehicle only). 
Prvo klinično preskušanje je bilo opravljeno v skladu z dobro klinično prakso za oceno učinkovitosti in prenašanja tiludronske kisline pri zdravljenju treh kliničnih stanj, vključno z bramorjem kosti, in za primerjavo dveh režimov odmerjanja pri zdravljenju in uporabi placeba (samo vehikla).
With regard to the concomitant NSAID treatment, the MAH concluded there were no statistical differences between the treated and placebo groups having received NSAID treatment and therefore had not included this treatment in the statistical analysis. 
Imetnik dovoljenja za promet z zdravilom je v zvezi z zdravljenjem z nesteroidnimi protivnetnimi zdravili menil, da ni statistično pomembnih razlik med skupinama, ki sta prejemali zdravilo oz. placebo ter bili zdravljeni z nesteroidnimi protivnetnimi zdravili, zato tega zdravljenja niso vključili v statistično analizo.
As bone resorption and bone formation are two coupled processes responsible for the integrity of bone mechanical properties, the inhibition of resorption secondarily leads to a slow-down in bone formation and, consequently, to a slow down in remodelling. 
Resorpcija in nastajanje kostnine sta povezana procesa, odgovorna za integriteto kostnih mehanskih lastnosti, inhibicija resorpcije pa posledično povzroči upočasnitev nastajanja kostnine in nato upočasnitev remodeliranja.
Tiludronate has anti-inflammatory and anti-arthritic properties by acting on macrophages. 
Tiludronat ima zaradi delovanja na makrofage protivnetne in protiartritične lastnosti.
With regard to dosage the MAH responded that there is no existing model in the horse to mimic bone spavin and the dose was extrapolated from a model of bone resorption in rats using an allometric extrapolation. 
Imetnik dovoljenja za promet z zdravilom je v zvezi z odmerjanjem odgovoril, da pri konjih ni obstoječega modela, ki bi posnemal bramor kosti, zato so odmerek ekstrapolirali iz modela resorpcije kostnine pri podganah z alometrično ekstrapolacijo.
Further tiludronate inhibits the enzyme secretion by chondrocytes or synovial cells. 
Poleg tega tiludronat zavira izločanje encimov iz hondrocitov oz. sinovijskih celic.
Bone spavin is a degenerative joint disease, characterized by bone modelling changes, articular cartilage destruction, and marginal osteophyte formation. 
Bramor kosti je degenerativna bolezen sklepov, za katero so značilne spremembe modeliranja kosti, uničenje sklepnega hrustanca in zmanjšano nastajanja osteofitov.
These enzymes are responsible for the degradation of the joint cartilage matrix. 
Ti encimi so odgovorni za razgradnjo matriksa sklepnega hrustanca.
The marked improvement in the placebo group was unexpected and may have been influenced by concomitant treatment with NSAIDs and the specific exercise program. 
Bistveno izboljšanje v skupini, ki je prejemala placebo, je nepričakovano.
By inhibiting bone resorption, tiludronate acts as a regulator of bone metabolism in situation where there is extensive bone resorption. 
V okoliščinah obsežne resorpcije kostnine tiludronat z inhibicijo resorbcije kostnine uravnava presnovo kostnine.
This summary was last updated in 12-2010. 
Povzetek je bil nazadnje posodobljen 12-2010.
The marketing authorisation is valid for an unlimited period. 
Dovoljenje za promet z zdravilom je veljavno za nedoločen čas.
The European Commission granted a marketing authorisation valid throughout the European Union for Plavix to Sanofi Pharma Bristol-Myers Squibb SNC on 15 July 1998. 
Evropska komisija je dovoljenje za promet z zdravilom Plavix, veljavno po vsej Evropski uniji, odobrila družbi Sanofi Pharma Bristol-Myers Squibb SNC dne 15. julija 1998.
Plavix is used to prevent problems caused by blood clots in adults who have: 
Zdravilo Plavix se uporablja za preprečevanje težav, ki jih povzročajo krvni strdki, pri odraslih, ki:
The full EPAR for Plavix can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Plavix je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Plavix is converted into its active form in the body. 
Zdravilo Plavix se v svojo aktivno obliko pretvori v telesu.
For more information about treatment with Plavix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Plavix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
For genetic reasons, some patients may not be able to convert Plavix as effectively as others, which could reduce their response to the medicine. 
Zaradi genetskih razlogov nekateri bolniki zdravila Plavix morda ne morejo tako učinkovito pretvarjati, kar lahko zmanjša njihov odziv na zdravilo.
There was also a reduction in the patients who had a stent inserted. 
Do zmanjšanja tveganja je prišlo tudi pri bolnikih, ki so imeli vstavljen stent.
This is a summary of the European public assessment report (EPAR) for Plavix. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Plavix.
Plavix can be started between a few days and 35 days after the attack; 
Zdravilo Plavix se lahko začne dajati od nekaj dni po napadu do 35 dni po njem;
This showed that Plavix reduces the risk of an event. 
To je dokaz, da zdravilo Plavix znižuje tveganje za pojav dogodka.
In other words, about 10 patients in 1,000 will avoid having a new ischaemic event two years after starting Plavix instead of aspirin. 
Z drugimi besedami, približno 10 bolnikov od 1000 se bo izognilo novemu ishemičnemu napadu v dveh letih po pričetku prejemanja zdravila Plavix namesto aspirina.
The CHMP decided that Plavix's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Plavix večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
What benefit has Plavix shown during the studies? 
Kakšne koristi je zdravilo Plavix izkazalo med študijami?
In CAPRIE, there were 939 events in the Plavix group, and 1,020 in the aspirin group. 
V študiji CAPRIE, je bilo v skupini, ki je prejemala zdravilo Plavix, 939 dogodkov, v skupini, zdravljeni z aspirinom, pa 1 020.
Plavix should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients. 
Zdravila Plavix ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) klopidogrel ali katero koli drugo sestavino zdravila.
The standard dose of Plavix is one 75-mg tablet once a day. 
Priporočeni odmerek zdravila Plavix je ena 75-miligramska tableta enkrat dnevno.
Plavix was more effective than aspirin at preventing new ischaemic events. 
Zdravilo Plavix je bilo pri preprečevanju novih ishemičnih dogodkov učinkovitejše od aspirina.
In acute coronary syndrome, treatment generally starts with a loading dose of one 300-mg tablet or four 75-mg tablets. 
Pri akutnem koronarnem sindromu se zdravljenje na splošno začne z udarnim odmerkom ene 300-miligramske tablete ali štirih 75-miligramskih tablet.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Plavix. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Plavix, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Some of these patients may have had a stent (a short tube) placed in an artery to prevent it from closing up. 
Nekaterim bolnikom je bil morda v arterijo vstavljen stent (kratka cevka), da prepreči njeno zamašitev.
It must not be used in patients who have severe liver disease or a disease that may cause bleeding such as a stomach ulcer or bleeding in the brain. 
Ne sme se uporabljati pri bolnikih, ki imajo resno obolenje jeter ali bolezen, ki povzroča krvavitev, kot je želodčna razjeda ali možganska krvavitev.
In acute coronary syndrome and atrial fibrillation, Plavix is used together with aspirin, the dose of which should not be higher than 100 mg. 
Pri akutnem koronarnem sindromu in atrijski fibrilaciji se zdravilo Plavix uporablja skupaj z aspirinom, katerega odmerek ne sme biti višji od 100 mg.
This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke. 
To preprečuje, da bi trombociti postali lepljivi, zmanjšuje tveganje za nastanek krvnih strdkov ter prispeva k preprečitvi novega srčnega napada ali kapi.
This means that fewer patients will have new ischaemic events if they receive Plavix than if they receive aspirin. 
To pomeni, da bo manj bolnikov doživelo nov ishemični napad, če bodo jemali zdravilo Plavix, kot pa če bodo jemali aspirin.
Other information about Plavix 
Druge informacije o zdravilu Plavix:
Plavix can be started between seven days and six months after the stroke; 
Zdravilo Plavix se lahko začne jemati od sedem dni po napadu do šest mesecev po njem;
The most common side effects with Plavix (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising and bleeding where the skin is punctured. 
Najpogostejši neželeni učinki zdravila Plavix (opaženi pri 1 do 10 bolnikih izmed 100) so hematomi (kopičenje krvi pod kožo), epistaksa (krvavitve iz nosu), gastrointestinalna hemoragija (krvavitve v želodcu ali črevesju), driska, bolečine v trebuhu, dispepsija (zgaga), podplutbe in krvavitve na mestu predrte kože.
What is the risk associated with Plavix? 
Kakšna tveganja so povezana z zdravilom Plavix?
It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding. 
Uporablja se pri bolnikih, pri katerih obstaja vsaj en dejavnik tveganja za vaskularni dogodek, kot je srčni napad ali kap, ki ne morejo jemati antagonistov vitamina K (drugega zdravila, ki preprečuje krvne strdke) in pri katerih obstaja nizko tveganje za krvavitve.