natgillin/translations-raw huggingface dataset:
Safety information has been included in the summary of product characteristics and the package leaflet for Cortacare, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers. 
V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
Because Cortacare is a hybrid medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Cortacare hibridno zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The hydrocortisone in Cortacare is in a special chemical form (di-ester) so the medicine is able to get into the outer layer of the skin and remain there for longer. 
Hidrokortizon v zdravilu Cortacare ima posebno kemijsko obliko (diester), tako da lahko zdravilo pride v zunanjo plast kože in tam ostane dalj časa.
Why is Cortacare authorised in the EU? 
Zakaj je bilo zdravilo Cortacare odobreno v EU?
What is Cortacare and what is it used for? 
Kaj je zdravilo Cortacare in za kaj se uporablja?
Other information about Cortacare 
Druge informacije o zdravilu Cortacare
The precautions are the same as for the reference medicine since Cortacare is a hybrid medicine. 
Previdnostni ukrepi so enaki kot pri referenčnem zdravilu, saj je zdravilo Cortacare hibridno zdravilo.
The active substance in Cortacare, hydrocortisone aceponate, is a corticosteroid or ‘steroid' which acts in the skin cells by stopping the release of chemicals which are involved in inflammation. 
Učinkovina v zdravilu Cortacare, hidrokortizon aceponat, je kortikosteroid oziroma steroid, ki deluje tako, da v celicah kože zaustavi sproščanje kemičnih snovi, ki sodelujejo pri vnetju.
How has Cortacare been studied? 
Kako je bilo zdravilo Cortacare raziskano?
There was no need for ‘bioequivalence' studies to investigate whether Cortacare is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. 
Izvedba študije „bioekvivalence“, s katero bi raziskali, ali se zdravilo Cortacare absorbira podobno kot referenčno zdravilo in tako doseže enako raven učinkovine v krvi, ni bila potrebna.
Cortacare is a ‘hybrid medicine'. 
Zdravilo Cortacare je „hibridno zdravilo“.
For more information about using Cortacare, see the package leaflet or contact your veterinarian or pharmacist. 
Za več informacij glede uporabe zdravila Cortacare glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
This makes the medicine more effective at low doses in skin conditions. 
Zato je zdravilo pri kožnih boleznih učinkovitejše že pri manjših odmerkih.
Cortacare is a corticosteroid veterinary medicine used to treat inflamed and itchy skin conditions in dogs. 
Cortacare je kortikosteroidno zdravilo za uporabo v veterinarski medicini, ki se uporablja za zdravljenje kožnih bolezni z vnetjem in srbenjem pri psih.
composition of Cortacare is the same as the reference medicine and when sprayed onto the skin, the active substance in both products is expected to be absorbed in the same way. 
namreč enaka kot pri referenčnem zdravilu, in če se zdravilo daje s pršenjem po koži, se pričakuje, da se bo učinkovina iz obeh zdravil enako absorbirala.
Therefore, the Agency's view was that, as for Cortavance, the benefit of Cortacare outweighs the identified risk and it can be authorised for use in the EU. 
Zato je menila, da koristi zdravila Cortacare enako kot pri zdravilu Cortavance odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
Cortacare is available as a spray and can only be obtained with a prescription. 
Zdravilo Cortacare je na voljo v obliki pršila, njegovo predpisovanje in izdaja pa je le na recept.
The reference medicine for Cortacare is Cortavance. 
Referenčno zdravilo zdravila Cortacare je zdravilo Cortavance.
How is Cortacare used? 
Kako se zdravilo Cortacare uporablja?
Ref. EMEA/727640/2009 EMEA/H/C/1057 
: EMA/727640/2009 EMEA/H/C/1057
The main measure of effectiveness was the number of patients who were cured. 
Glavno merilo učinkovitosti je bilo število bolnikov, ki so bili ozdravljeni.
The company presented results from two main studies involving 991 adults with complicated infections of the skin and soft tissues. 
Družba je predložila rezultate dveh glavnih študij, v katerih je bilo vključenih 991 odraslih bolnikov z zapletenimi okužbami kože in mehkih tkiv.
The CHMP also noted that some bacteria already show a level of resistance to the antibiotic even before it is in general use. 
CHMP je tudi menil, da nekatere bakterije že sedaj kažejo določeno raven odpornosti proti antibiotiku, čeprav še ni v splošni uporabi.
There were also concerns that the medicine may cause side effects affecting the heart (such as QTc interval prolongation, an alteration of the electrical activity of the heart) and the liver. 
Obstajali so tudi zadržki, da zdravilo morda povzroča neželene učinke, ki vplivajo na srce (kot je podaljšanje intervala QTc, sprememba električne aktivnosti srca) in jetra.
Complicated means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment. 
„Zapletena“ pomeni, da je okužbo težko pozdraviti, ker se je razširila v globoka tkiva pod kožo, ker je morda potreben kirurški poseg ali ker ima bolnik druga stanja, ki lahko vplivajo na odziv na zdravljenje.
Around half of the patients were treated with Mersarex, while the others were treated with linezolid (another antibiotic). 
Približno polovico bolnikov so zdravili z zdravilom Mersarex, druge pa so zdravili z linezolidom (drugim antibiotikom).
The effects of Mersarex were first tested in experimental models before being studied in humans. 
Učinki zdravila Mersarex so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Bacteria need this protein to produce the active form of folic acid, which they need to multiply. 
Bakterije potrebujejo to beljakovino za izdelavo aktivne oblike folne kisline, ki jo potrebujejo za razmnoževanje.
Questions and answers on the withdrawal of the marketing authorisation application for Mersarex iclaprim 
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Mersarex iklaprim
Mersarex was expected to be used to treat complicated infections of the skin and the ‘soft tissues' below the skin. 
Zdravilo Mersarex naj bi se uporabljalo za zdravljenje zapletenih okužb kože in „mehkih tkiv“ pod kožo.
The CHMP was of the opinion that the results did not show that Mersarex was as good as the comparator medicine and that there were insufficient data from clinical studies to justify the dosage proposed by the company. 
CHMP je menil, da rezultati ne kažejo, da je zdravilo Mersarex enako dobro kot primerjalno zdravilo in da podatki iz kliničnih študij niso zadostni za utemeljitev odmerjanja, ki ga predlaga družba.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Mersarex? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Mersarex?
On 21 October 2009, Arpida A/S officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Mersarex, for the treatment of adults with complicated skin and soft tissue infections. 
Družba Arpida A/S je dne 21. oktobra 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Mersarex, namenjenim zdravljenju odraslih bolnikov z zapletenimi okužbami kože in mehkih tkiv.
The letter from the company notifying the CHMP of the withdrawal of the application is available here. 
Dopis, s katerim družba agencijo EMEA obvešča o umiku vloge, je na voljo tukaj.
What is Mersarex? 
Kaj je zdravilo Mersarex?
The active substance in Mersarex, iclaprim, is an antibiotic of the group ‘dihydrofolate reductase inhibitors'. 
Zdravilna učinkovina zdravila Mersarex, iklaprim, je antibiotik iz skupine „zaviralcev dihidrofolatreduktaze“.
It was expected to work by blocking the action of a bacterial protein called dihydrofolate reductase. 
Delovala naj bi z zaviranjem delovanja bakterijske beljakovine, imenovane dihidrofolatreduktaza.
The study looked at whether Mersarex given for up to 14 days was as good as linezolid. 
V študiji so opazovali, ali je do 14 dni zdravljenja z zdravilom Mersarex enako dobro kot uporaba linezolida.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Mersarex could not have been approved for the treatment of complicated infections of the skin and the soft tissues. 
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj CHMP je Odbor v času umika vloge izrazil določene zadržke in je začasno menil, da zdravila Mersarex ni mogoče odobriti za zdravljenje zapletenih okužb kože in mehkih tkiv.
What was Mersarex expected to be used for? 
Za kaj naj bi se zdravilo Mersarex uporabljalo?
By blocking the action of dihydrofolate reductase, the medicine was expected to slow down the growth and spread of the bacteria. 
Zdravilo naj bi z zaviranjem delovanja dihidrofolat-reduktaze upočasnilo rast in širjenje bakterij.
Mersarex is a concentrate for solution for infusion (drip into a vein). 
Zdravilo Mersarex je koncentrat za raztopino za infundiranje (kapalno infuzijo v veno).
How was Mersarex expected to work? 
Kako naj bi zdravilo Mersarex delovalo?
The company informed the CHMP that there are no patients currently using Mersarex in clinical trials or compassionate use programmes. 
Družba je obvestila CHMP, da v kliničnih preskušanjih ali programih sočutne uporabe ni bolnikov, ki bi trenutno jemali zdravilo Mersarex.
It contains the active substance iclaprim. 
Vsebuje zdravilno učinkovino iklaprim.
Treatment initiation pack: 14 tablets + 14 tablets + 14 tablets + 14 tablets 
Paket za začetno zdravljenje: 14 tablet + 14 tablet + 14 tablet + 28tablet
1 bottle + 1 measuring cup + 1 oral syringe + 1 adaptor 
1 steklenica + 1 merica + 1 brizga za peroralno dajanje + 1 adapter
Film-coated tablet Oral use 
Filmsko obložena tableta
EU/1/19/1383/028 Lacosamide UCB 50 / 100/ 
Lakozamid UCB 50 / 100/ 200 mg
Oral use bottle (glass) 
Lakozamid UCB 10 mg/ml Sirup steklenica (steklo)
Syrup 
14 tablets
MA (EU) number Invented name 
MA (EU) številka Izmišljeno ime
London, 21 August 2008 Doc. 
London, 21. avgust 2008 Sklic dok.
International non-proprietary name (INN): ketoprofen 
Mednarodno nelastniško ime (INN): ketoprofen
The main measure of effectiveness was the change in the severity of pain after 12 weeks of treatment. 
Glavno merilo učinkovitosti je bila sprememba v jakosti bolečine po 12. tednih zdravljenja.
The study compared the effectiveness of three different doses of Diractin (25 mg, 50 mg and 100 mg twice a day) with that of placebo (a dummy treatment). 
V študiji so primerjali učinkovitost treh različnih odmerkov zdravila Diractin (25 mg, 50 mg in 100 mg dvakrat dnevno) s placebom (navidezno zdravilo).
The effectiveness of Diractin was studied in one main study involving 866 patients with osteoarthritis of the knee. 
Učinkovitost zdravila Diractin so raziskovali v eni glavni študiji, ki je vključevala 866 bolnikov z osteoartritisom kolena.
The effects of Diractin were first tested in experimental models before being studied in humans. 
Učinki zdravila Diractin so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
What were the main concerns of the CHMP at that time? 
Kateri so bili glavni zadržki CHMP v tistem času?
The company informed the CHMP that there are no consequences for patients currently included in clinical trials. 
Družba je obvestila CHMP, da zavrnitev nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih.
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Diractin? 
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Diractin?
Questions and answers on the withdrawal of the marketing application for Diractin 
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Diractin
The CHMP was concerned that the effectiveness of Diractin had not been sufficiently demonstrated in the single main study: compared with placebo, Diractin did not reduce pain levels to an extent that would be relevant for patients. 
CHMP je bil imel zadržke, da učinkovitosti zdravila Diractin v eni sami glavni študiji niso zadostno dokazali: zdravilo Diractin v primerjavi s placebom ni zmanjšalo ravni bolečine do mere, ki bi bila za bolnike primerna.
On 23 July 2008, IDEA AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Diractin, for the treatment of the symptoms of inflammation and pain associated with osteoarthritis. 
Družba IDEA AG je dne 23. julija 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Diractin za zdravljenje simptomov vnetja in bolečin, povezanih z osteoartritisom.
In Diractin gel, the ketoprofen is contained in special, small, fatty particles (called ‘Transfersomes') that are expected to carry the ketoprofen through the skin and release it deep below the skin, where the inflammation in osteoarthritis occurs. 
Ketoprofen se v gelu Diractin nahaja v posebnih, majhnih, maščobnih delcih (imenovanih transfersomi), za katere se pričakuje, da bodo prenesli ketoprofen skozi kožo in ga sprostili globoko pod kožo, kjer se pri osteoartritisu pojavi vnetje.
It was to be available as a gel containing 22.9 mg of ketoprofen per gram of gel. 
Zdravilo je na voljo v obliki gela, ki vsebuje 22,9 mg ketoprofena na gram gela.
Diractin is a medicine that contains the active substance ketoprofen. 
Diractin je zdravilo, ki vsebuje zdravilno učinkovino ketoprofen.
The active substance in Diractin, ketoprofen, is a non-steroidal anti-inflammatory drug (NSAID). 
Zdravilna učinkovina zdravila Diractin, ketoprofen, je nesteroidno protivnetno zdravilo (NSAID).
No compassionate use programmes with Diractin are being conducted. 
Programov sočutne uporabe z zdravilom Diractin ni.
What is Diractin? 
Kaj je zdravilo Diractin?
Diractin was expected to be used to treat the symptoms of inflammation and pain associated with osteoarthritis (a condition that causes swelling and pain in the joints). 
Zdravilo Diractin naj bi se uporabljalo za zdravljenje simptomov vnetja in bolečin, povezanih z osteoartritisom (stanjem, ki povzroča otekline in bolečine v sklepih).
What was Diractin expected to be used for? 
Za kaj naj bi se zdravilo Diractin uporabljalo?
It is expected to work by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process. 
Pričakovali so, da bo zdravilna učinkovina zavirala encim, imenovan ciklooksigenaza, ki sodeluje pri proizvajanju prostaglandinov, snovi, ki so vključene v vnetne procese.
By reducing the production of prostaglandins, Diractin is expected to reduce the inflammation and pain caused by osteoarthritis. 
Pričakovali so, da se bosta z zmanjšanjem proizvodnje prostaglandinov zmanjšala tudi vnetje in bolečina, ki ju povzroča osteoartritis.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that any benefits of Diractin did not outweigh the identified risks. 
CHMP je v času umika menil, da koristi zdravila Diractin ne odtehtajo znanih tveganj.
How is Diractin expected to work? 
Kako naj bi zdravilo Diractin delovalo?
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Diractin 
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da se zdravila Diractin ne more odobriti za zdravljenje simptomov vnetja in bolečine, povezanih z osteoartritisom.
Do not open before use. 
Ne odpirajte pred uporabo.
4 vials: 
4 viale:
Not known (cannot be estimated from available data) 
- Neznana pogostnost (ni je mogoče oceniti iz razpoložljivih podatkov):
Grounds for one additional renewal 
Razlogi za eno dodatno podaljšanje
The clinical significance of these antibodies is not known. 
Klinični pomen teh protiteles ni znan.
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000), not known (cannot be estimated from the available data). 
zelo pogosti (≥ 1/10); pogosti (≥ 1/100, < 1/10); občasni (≥ 1/1000, < 1/100); redki (≥ 1/10.000, < 1/1000); zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Indeed, there has been a limited exposure due to a recent and limited marketing of the product (launched in the EU only in August 2011 and marketed in only few Member States). 
Izpostavljenost je bila namreč majhna zaradi omejenega trženja zdravila in njegovega nedavnega začetka (v EU se je začelo tržiti šele v avgustu 2011 in samo v nekaj državah članicah).
Not surprisingly, the antibody peak concentration was higher after the second exposure. 
Ni presenetljivo, da je koncentracija protiteles bila največja po drugi izpostavitvi.
Date of first authorisation: 19 February 2009 Date of renewal: 19 February 2014 
Datum podaljšanja dovoljenja za promet: 19. februar 2014
Treatment requires a single surgery. 
Zdravljenje zahteva samo en kirurški poseg.
It is possible they may impair the effectiveness of this medicine or cause an immune system response. 
Morda bodo poslabšala učinkovitost tega zdravila ali povzročila odziv imunskega sistema.
Place it subcutaneously if possible. 
Če je mogoče, jo postavite subkutano.
It has been observed following use (see section 4.8). 
To so opazili po uporabi (glejte poglavje 4.8).
For intraosseous use. 
Za intraosalno uporabo.
This should be considered in follow-up of patients with CT or X-ray. 
To je treba upoštevati pri sledenju bolnikov s CT ali rentgenografijo.
The collagen matrix is insoluble and consists of particles with a size range of 75-425µm. 
Kolagenski matriks je netopen in je sestavljen iz delcev, velikih 75-425 µm.
Read all of this leaflet carefully before you are administered this medicine because it contains important information for you. 
Preden prejmete to zdravilo, natančno preberite navodilo, saj vsebuje pomembne informacije za vas.
This is normally done under a full general anaesthetic so you will not be awake during the surgery. 
Ta se navadno opravi pod splošno anestezijo, zato med posegom ne boste budni.
The results of radiological and histological examinations in this study showed bone healing following the initial and repeat exposure in the same animal. 
Rezultati radioloških in histoloških preiskav v tej študiji so pokazali celjenje kosti pri začetni in ponavljajoči se izpostavitvi pri isti živali.
Olympus Biotech Corporation 9 Technology Drive West Lebanon NH 03784 USA 
Olympus Biotech Corporation 9 Technology Drive West Lebanon NH 03784 ZDA
The maximum dose of this medicine should not exceed 2 units (6.6 mg eptotermin alfa) since its effectiveness and safety in higher doses has not been studied. 
Največji odmerek tega zdravila ne sme presegati 2 enot (6,6 mg eptotermina alfa), saj učinkovitosti in varnosti pri večjih odmerkih niso raziskovali.
This effect, termed solid state carcinogenicity, has been frequently observed in rats in which solid materials (plastics or metals) were implanted subcutaneously. 
Ta učinek, imenovan karcinogenost trdnih snovi, so pogosto opazili pri podganah, ki so jim podkožno vsadili trdne snovi (plastične ali kovinske).
The reconstituted medicinal product should be used immediately. 
Rekonstituirano zdravilo je treba uporabiti takoj.
A small quantity (one unit) of this medicine is reconstituted and placed directly on each side of the spine at the site requiring fusion. 
Majhna količina (ena enota) tega zdravila se rekonstituira in nanese neposredno na obe strani hrbtenice na mestu, kjer je potrebna fuzija.
Do not insert a needle through the stoppers. 
Ne vstavljajte igel skozi zamaška.
What Opgenra is and what it is used for. 
Kaj je zdravilo Opgenra in za kaj ga uporabljamo
Single dose and repeat dose studies in a range of animal models (rats and primates) were performed. 
Opravljene so bile študije enkratnih in večkratnih odmerkov na nizu živalskih modelov (podganah in primatih).
However, there is no evidence to suggest that heterotopic ossification is linked to sarcoma development in humans. 
Vendar ni dokazov, da je heterotopična okostenitev povezana z razvojem sarkoma pri človeku.
However the rate of malformations was similar to those from historical controls. 
Vendar je bila stopnja deformacij podobna kot pri kontrolah iz preteklih preskusov.
Repeat use of this bone morphogenetic protein (BMP) is not recommended.” 
Ponavljajoča se uporaba tega proteina za morfogenezo kosti (BMP) ni priporočena.”
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch. 
Natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov izdelovalca, odgovornega za sproščanje zadevne serije.
In another study a difference in body weight gain was seen in the immunized adult females between lactation days 14 to 21 when compared to the control animals. 
V drugi študiji so opazili razliko pri pridobivanju telesne mase pri imuniziranih odraslih samicah med 14. in 21. dnem laktacije v primerjavi z živalmi iz kontrolne skupine.
The CHMP recommend an additional five-year renewal based on the following pharmacovigilance grounds: the clinical experience with the product in the designated indication has been very limited in the EU during the first 5-year period of marketing authorisation. 
Odbor za zdravila za uporabo v humani medicini (CHMP) priporoča dodatno petletno podaljšanje na podlagi naslednjih farmakovigilančnih razlogov: v prvih 5 letih veljavnosti dovoljenja za promet je bilo v EU pridobljenih zelo malo kliničnih izkušenj z uporabo zdravila za določeno indikacijo.
In a clinical study of the medicinal product, antibodies to the protein eptotermin alfa were detected in 194 out of 207 (94%) patients treated with it and 18 out of 86 (21%) treated with autograft bone (control group). 
V klinični študiji so protitelesa proti eptoterminu alfa določili pri 194 od 207 (94 %) bolnikov, zdravljenih s tem zdravilom, in pri 18 od 86 (21 %) bolnikov, zdravljenih z avtolognim presadkom kosti (kontrolna skupina).
Opgenra must not be used in patients who: 
Zdravilo Opgenra se ne sme uporabljati pri bolnikih:
The frequency and severity of post-operative adverse events was similar in both test and control groups. 
Pogostnost in resnost neželenih učinkov po kirurškem posegu sta bili pri obeh preskusnih in kontrolnih skupinah podobni.
The pivotal study with 295 patients involved un-instrumented postero-lateral lumbar spine fusion in 208 patients treated with Opgenra. 
Ključna študija pri 295 bolnikih je vključila neistrumentalno postero-lateralno lumbalno fuzijo pri 208 bolnikih, ki so se zdravili z zdravilo Opgenra.
Clinical studies to investigate the efficacy and safety of this medicinal product in cervical spine surgery have not been performed; consequently its use outside the region of the lumbar spine cannot be recommended. 
Kliničnih študij učinkovitosti in varnosti tega zdravila pri kirurških posegih na cervikalni hrbtenici niso opravili, zato uporaba zunaj lumbalnega območja hrbtenice ni priporočena.