natgillin/translations-raw huggingface dataset:
The company that makes Azilect has agreed that its scientific data can be used for Rasagiline ratiopharm (‘informed consent').
Družba, ki proizvaja zdravilo Azilect, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Razagilin ratiopharm („uporaba dokumentacije s soglasjem“).
By increasing levels of dopamine in the parts of the brain that control movement and coordination, Rasagiline ratiopharm improves the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
S povečevanjem ravni dopamina v delih možganov, ki nadzorujejo gibe in koordinacijo, zdravilo Razagilin ratiopharm lajša znake in simptome Parkinsonove bolezni, kot sta okornost in počasnost gibov.
The most common side effect with Rasagiline ratiopharm (seen in more than 1 patient in 10) is headache.
Najpogostejši neželeni učinek zdravila Razagilin ratiopharm (ki lahko prizadene več kot 1 osebo od 10) je glavobol.
Rasagiline ratiopharm has been shown in three studies, involving 1,563 patients, to be effective in both relieving the symptoms of Parkinson's disease and in reducing the time patients spend in their ‘off' periods.
Zdravilo Razagilin ratiopharm je v treh študijah, v katere je bilo vključenih 1 563 bolnikov, učinkovito olajšalo simptome Parkinsonove bolezni in skrajšalo čas, ki so ga bolniki preživeli v stanju „izklopa“.
Rasagiline ratiopharm is a medicine used to treat adults with Parkinson's disease (a progressive brain disorder that causes shaking, slow movement and muscle stiffness).
Zdravilo Razagilin ratiopharm se uporablja za zdravljenje odraslih s Parkinsonovo boleznijo (napredujočo boleznijo možganov, ki povzroča tresenje, počasno gibanje in okorelost mišic).
It blocks the enzyme monoamine oxidase type B, which breaks down the neurotransmitter dopamine in the brain.
Razagilin blokira encim monoaminooksidaza tipa B, ki razgrajuje živčni prenašalec dopamin v možganih.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rasagiline ratiopharm, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Razagilin ratiopharm in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
A risk management plan has been developed to ensure that Rasagiline ratiopharm is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Razagilin ratiopharm je bil pripravljen načrt obvladovanja tveganj.
It is not intended to provide practical advice on how to use Rasagiline ratiopharm.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For more information about treatment with Rasagiline ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Razagilin ratiopharm preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
There should be at least 14 days between stopping treatment with Rasagiline ratiopharm and starting treatment with another monoamine-oxidase inhibitor or with pethidine.
Med prenehanjem zdravljenja z zdravilom Razagilin ratiopharm in začetkom zdravljenja z drugim zaviralcem monoaminooksidaz ali petidinom mora preteči najmanj 14 dni.
In the two other studies, Rasagiline ratiopharm was given as ‘add-on' to patients with later stage disease who were already being treated with levodopa, and compared with placebo and another medicine entacapone (also used as add-ons).
V dveh drugih študijah so zdravilo Razagilin ratiopharm dajali kot dopolnilno zdravljenje bolnikom z napredovalo boleznijo, ki so se že zdravili z levodopo, ter ga primerjali s placebom in drugim zdravilom entakaponom (ki se prav tako uporablja kot dopolnilno zdravljenje).
Rasagiline ratiopharm can be used either alone, or as an add-on to levodopa (another medicine used in Parkinson's disease) in patients who are having ‘fluctuations' towards the end of the period between levodopa doses.
Zdravilo Razagilin ratiopharm se lahko uporablja samostojno ali kot dodatek levodopi (drugemu zdravilu, ki se uporablja pri Parkinsonovi bolezni) pri bolnikih z „nihanji“ proti koncu obdobja med dvema odmerkoma levodope.
The active substance in Rasagiline ratiopharm, rasagiline, is a ‘monoamine oxidase B inhibitor'.
Zdravilna učinkovina zdravila Razagilin ratiopharm, razagilin, je „zaviralec monoaminooksidaz tipa B“.
For practical information about using Rasagiline ratiopharm, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Razagilin ratiopharm naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Rasagiline ratiopharm must not be used with other monoamine oxidase inhibitors including medicines and herbal preparations without prescription such as St John's wort (used to treat depression).
Zdravilo Razagilin ratiopharm se ne sme uporabljati z drugimi zaviralci monoaminooksidaz, vključno z zdravili in zeliščnimi pripravki brez recepta, kot je šentjanževka (ki se uporablja za zdravljenje depresije).
Other information about Rasagiline ratiopharm
Druge informacije o zdravilu Razagilin ratiopharm
What benefits of Rasagiline ratiopharm have been shown in studies?
Kakšne koristi je zdravilo Razagilin ratiopharm izkazalo v študijah?
What is Rasagiline ratiopharm and what is it used for?
Kaj je zdravilo Razagilin ratiopharm in za kaj se uporablja?
What are the risks associated with Rasagiline ratiopharm?
Kakšna tveganja so povezana z zdravilom Razagilin ratiopharm?
Why is Rasagiline ratiopharm approved?
Zakaj je bilo zdravilo Razagilin ratiopharm odobreno?
Rasagiline ratiopharm contains the active substance rasagiline.
Zdravilo Razagilin ratiopharm vsebuje zdravilno učinkovino razagilin.
Rasagiline ratiopharm must not be used in patients who have severe problems with their liver.
Zdravilo Razagilin ratiopharm se ne sme uporabljati pri bolnikih s hudimi težavami z jetri, pri bolnikih z zmernimi težavami z jetri pa njegovo jemanje ni priporočljivo.
For the full list of all side effects reported with Rasagiline ratiopharm, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Razagilin ratiopharm, glejte navodilo za uporabo.
For the full list of all side effects and restrictions with Rasagiline ratiopharm, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev, o katerih so poročali pri uporabi zdravila Razagilin ratiopharm, glejte navodilo za uporabo.
How is Rasagiline ratiopharm used?
Kako se zdravilo Razagilin ratiopharm uporablja?
How does Rasagiline ratiopharm work?
Kako zdravilo Razagilin ratiopharm deluje?
Further information on Cortacare can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Cortacare so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Cortacare received a marketing authorisation valid throughout the EU on 27 August 2018.
Za zdravilo Cortacare je bilo 27. avgusta 2018 izdano dovoljenje za promet, veljavno po vsej EU.
As for every medicine, the company provided studies on the quality of Cortacare.
Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Cortacare.
This reduces swelling, redness and itching.
S tem zmanjša oteklino, rdečico in srbenje.
An overview of Cortacare and why it is authorised in the EU
Pregled zdravila Cortacare in zakaj je odobreno v EU
Two sprays is sufficient to treat an area of skin 10 cm by 10 cm. Care should be taken to avoid spraying the eyes of the dog.
Dvakratni razpršitvi zadostujeta za zdravljenje predela kože velikosti 10 x 10 cm. Treba je paziti, da ne pršite v oči psa.
The European Medicines Agency concluded that, in accordance with EU requirements, Cortacare has been shown to be comparable to Cortavance.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Cortacare primerljivo z zdravilom Cortavance.
It contains the active substance hydrocortisone aceponate.
Vsebuje učinkovino hidrokortizon aceponat.
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Cortavance, and do not need to be repeated for Cortacare.
Študije o koristih in tveganjih učinkovine pri odobrenem načinu uporabe so že bile izvedene z referenčnim zdravilom Cortavance, zato jih ni treba ponoviti za zdravilo Cortacare.
What are the benefits and risks of Cortacare?
Kakšne so koristi in tveganja zdravila Cortacare?
Cortacare is sprayed onto the affected area of skin at a distance of about 10 cm once daily for a week.
Zdravilo Cortacare se razprši po prizadetem predelu kože z razdalje približno 10 cm enkrat na dan, sedem dni zapored.
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?