natgillin/translations-raw huggingface dataset:
Pregabalin Sandoz is a medicine used to treat adults with the following conditions:
Pregabalin Sandoz je zdravilo, ki se uporablja za zdravljenje odraslih z naslednjimi boleznimi:
• neuropathic pain (pain due to nerve damage), including peripheral neuropathic pain, such as the pain experienced by patients with diabetes or herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
• nevropatsko bolečino (bolečino zaradi poškodbe živcev), vključno s periferno nevropatsko bolečino, kot se pojavlja pri bolnikih z diabetesom ali pasovcem, in centralno nevropatsko bolečino, kot se pojavlja pri bolnikih s poškodbo hrbtenjače;
The Committee recommended that Pregabalin Sandoz be approved for use in the EU.
Priporočil je, da se zdravilo Pregabalin Sandoz odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Pregabalin Sandoz?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pregabalin Sandoz?
This means that Pregabalin Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Lyrica.
The active substance in Pregabalin Sandoz, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Zdravilna učinkovina v zdravilu Pregabalin Sandoz, pregabalin, ima podobno strukturo kot telesu lastni „živčni prenašalec“ gama-aminomaslena kislina (GABA), vendar ima bistveno drugačne biološke učinke.
Pregabalin Sandoz is a ‘generic medicine'.
Pregabalin Sandoz je „generično zdravilo“.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Sandoz has been shown to have comparable quality and to be bioequivalent to Lyrica.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pregabalin Sandoz primerljivo raven kakovosti kot zdravilo Lyrica ter da mu je biološko enakovredno.
After three to seven days, the dose can be increased to 300 mg per day.
Po treh do sedmih dneh se lahko odmerek poveča na 300 mg na dan. Odmerki se lahko povečajo še do dvakrat, dokler ni dosežen najučinkovitejši odmerek.
For more information about treatment with Pregabalin Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Pregabalin Sandoz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Because Pregabalin Sandoz is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Pregabalin Sandoz generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
A risk management plan has been developed to ensure that Pregabalin Sandoz is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Pregabalin Sandoz je bil pripravljen načrt obvladovanja tveganj.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pregabalin Sandoz, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What are the benefits and risks of Pregabalin Sandoz?
Kakšne so koristi in tveganja, povezani z zdravilom Pregabalin Sandoz?
For practical information about using Pregabalin Sandoz, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Pregabalin Sandoz naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Doctors may need to lower the dose in patients who have kidney problems.
Pri bolnikih z ledvičnimi težavami bo zdravnik morda moral odmerek zmanjšati.
Stopping treatment with Pregabalin Sandoz should also be done gradually, over at least a week.
Največji dovoljeni odmerek je 600 mg na dan. Tudi prenehanje zdravljenja z zdravilom Pregabalin Sandoz mora potekati postopno, in sicer mora trajati najmanj en teden.
Because Pregabalin Sandoz is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Lyrica.
Ker je zdravilo Pregabalin Sandoz generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Lyrica.
Other information about Pregabalin Sandoz
Druge informacije o zdravilu Pregabalin Sandoz
What is Pregabalin Sandoz and what is it used for?
Kaj je zdravilo Pregabalin Sandoz in za kaj se uporablja?
Why is Pregabalin Sandoz approved?
Zakaj je bilo zdravilo Pregabalin Sandoz odobreno?
How has Pregabalin Sandoz been studied?
Kako je bilo zdravilo Pregabalin Sandoz raziskano?
How is Pregabalin Sandoz used?
Kako se zdravilo Pregabalin Sandoz uporablja?
It is not intended to provide practical advice on how to use Pregabalin Sandoz.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Pregabalin Sandoz contains the active substance pregabalin.
Zdravilo Pregabalin Sandoz vsebuje zdravilno učinkovino pregabalin.
How does Pregabalin Sandoz work?
Kako zdravilo Pregabalin Sandoz deluje?
20ml (10 mg/ml) 3 vials
200 mg Koncentrat za raztopino za infundiranje intravenska uporaba viala (steklena) 20 ml (10 mg/ml) 3 viale
Pharmaceutical form
Jakost farmacevtska oblika
Annex I List of nationally authorised medicinal products
Priloga I Seznam nacionalno odobrenih zdravil
PARATABS RETARD PARACETAMOL 500MG TABLET
PARATABS RETARD PARACETAMOL 500 MG TABLETE
PARACETAMOL 650MG TABLET, TRAMADOL 75MG TABLET
PARACETAMOL 650 MG TABLETE, TRAMADOL 75 MG TABLETE
ATPALAIDAVIMO TABLETĖS
VABASTAVAD TABLETID
DORETA 75 MG/650 MG PAILGINTO
KRKA, D.D., NOVO MESTO DORETA 75 MG/650 MG PAILGINTO
[the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
[trenutno odobrene spodaj navedene indikacije je treba izbrisati (specifični vrstni red besed pri navajanju indikacij se lahko med posameznimi izdelki razlikuje)]
• Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
• Simptomatsko zdravljenje kroničnih, patoloških, kognitivnih in nevrosenzoričnih obolenj pri starejših osebah (razen Alzheimerjeve bolezni in drugih oblik demence)
• Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
• Pomožno zdravljenje zmanjšane ostrine vida in motnje vidnega polja, domnevno žilnega izvora
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.