natgillin/translations-raw huggingface dataset:
Fluconazole 400 mg QD (Indinavir 1,000 mg TID)
Antimikotiki Flukonazol 400 mg QD (indinavir 1000 mg TID)
This means you will take a total of six 400 mg capsules (2400 mg) each day.
To pomeni, da boste vzeli skupaj šest 400 mg kapsul (2.400 mg) vsak dan.
CRIXIVAN 200 mg hard capsules indinavir
CRIXIVAN 200 mg trde kapsule indinavir
Indinavir and cimetidine can be co-administered without dose adjustment.
Indinavir in cimetidin se lahko uporabljata sočasno brez prilagajanja odmerka.
Alternatively, CRIXIVAN may be administered with a low-fat, light meal.
Izjemoma se ga lahko jemlje skupaj z lahkim obrokom z malo maščobami.
Inform your doctor as soon as possible if you develop severe muscle pain or weakness.
Če se pojavijo hude bolečine v mišicah ali mišična oslabelost, se takoj, ko je mogoče, posvetujte z zdravnikom.
CRIXIVAN 400 mg hard capsules Indinavir
CRIXIVAN 400 mg trde kapsule indinavir
Efavirenz AUC and Cmin : ↔
AUC in Cmin efavirenza: ↔
Tadalafil dose should not exceed a maximum of 10 mg in a 72 hour period in patients receiving concomitant indinavir therapy.
Pri bolnikih, ki sočasno prejemajo indinavir, odmerek tadalfila v 72-ih urah ne sme preseči maksimalnega odmerka 10 mg.
Indinavir AUC24hr:220 % Indinavir Cmin:↑ 24-fold (Relative to Indinavir 800 mg TID alone*) Ritonavir AUC24hr: 
AUC24 h indinavirja:  220 % Cmin indinavirja: ↑ 24-krat (glede na samostojno uporabljen 800 mg TID*)
Interaction with indinavir/ritonavir not studied Ritonavir induces glucuronidation and as a result is expected to decrease the plasma concentrations of atovaquone.
Ritonavir inducira glukuronidacijo, zato se pričakuje zmanjšana koncentracija atovakona v plazmi.
Always take this medicine exactly as your doctor, pharmacist or nurse has told you.
Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta.
• dry mouth
• odrevenelost ust
Dose reduction of CRIXIVAN to 600 mg every 8 hours is recommended with administering itraconazole concurrently.
Pri sočasni uporabi z itrakonazolom se priporoča zmanjšanje odmerka zdravila CRIXIVAN na 600 mg na vsakih 8 ur.
Interaction with indinavir/ritonavir not studied Ritonavir may modify P-glycoprotein mediated fexofenadine efflux when coadministered resulting in increased concentrations of fexofenadine.
Ritonavir lahko ob sočasnem dajanju spremeni izliv feksofenadina, ki ga povzroča Pglikoprotein, kar povzroča povečane koncentracije feksofenadina.
Saquinavir 600 mg SD (hard gel capsule formulation) (Indinavir 800 mg TID)
Sakvinavir 600 mg SD (formulacija kapsule s trdim gelom) (indinavir 800 mg TID)
Careful monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with indinavir.
Kadar se ta zdravila uporabljajo sočasno z indinavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
Indinavir and NRTIs can be co-administered without dose adjustment.
Indinavir in zaviralci NRT se lahko uporabljajo sočasno brez prilagajanja odmerka.
Medicinal product interactions
FARMACEVTSKI PODATKI
A dose reduction of ketoconazole should be considered when coadministered with indinavir/ritonavir.
Pri sočasnem dajanju z indinavirjem/ritonavirjem je treba razmisliti o zmanjšanju odmerka ketokonazola.
Indinavir AUC24hr: 178 % Indinavir Cmin:11-fold; (Relative to Indinavir 800 mg TID alone*) Ritonavir AUC:  72 % Ritonavir Cmin:  62 %
AUC24 h indinavirja:  178 % Cmin indinavirja:  11-krat (glede na samostojno uporabljen 800 mg TID*)
Careful monitoring of therapeutic and adverse effects is recommended when morphine is concomitantly administered with indinavir/ritonavir.
Kadar se morfin uporablja sočasno z indinavirjem/ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
CRIXIVAN 200 mg hard capsules are supplied in HDPE bottles with a polypropylene cap and a foil seal containing 180, 270 or 360 capsules.
CRIXIVAN 200 mg trde kapsule so na voljo v HDPE plastenkah s polipropilenskim zamaškom in zaščitno folijo.
• Do not take CRIXIVAN with food that is high in calories, fat and protein.
• Ne jemljite zdravila CRIXIVAN z visokokaloričnim obrokom, bogatim z maščobami in proteini, ker to zmanjšuje zmožnost absorpcije zdravila v telesu in s tem njegovo učinkovitost.
Caution is warranted and therapeutic concentration monitoring is recommended for quinidine when coadministered with CRIXIVAN.
Kadar se kinidin daje sočasno z zdravilom CRIXIVAN, je treba biti previden in spremljati terapevtsko koncentracijo.
ANTIHISTAMINES Fexofenadine
ANIHISTAMINIKI Feksofenadin
Indinavir AUC24hr:68 % Indinavir Cmin: ↑ 10-fold (Relative to Indinavir 800 mg TID alone*) Ritonavir AUC24hr: 
AUC24 h indinavirja:  68 % Cmin indinavirja: ↑ 10-krat (glede na samostojno uporabljen 800 mg TID*)
How to store CRIXIVAN
Shranjevanje zdravila CRIXIVAN
Careful monitoring of therapeutic and adverse effects is recommended when carbamazepine is concomitantly administered with indinavir/ritonavir.
Kadar se karbamazepin uporablja sočasno z indinavirjem/ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
Combinations of atazanavir with or without ritonavir and Crixivan have not been studied and co-administration of these medicinal products is not recommended due to risk of worsening of these adverse reactions.
Kombinacij atazanavirja z ritonavirjem ali brez skupaj z zdravilom Crixivan niso preučevali.
Indinavir and isoniazid can be co-administered without dose adjustment.
Indinavir in izoniazid se lahko uporabljata sočasno brez prilagajanja odmerka.
Careful monitoring of therapeutic and adverse effects is recommended when ketoconazole is concomitantly administered with indinavir/ritonavir.
Kadar se ketokonazol uporablja sočasno z indinavirjem/ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of ketoconazole.
Indinavir in ritonavir zavirata CYP3A4, zato se pričakuje, da bosta povečala koncentracije ketokonazola v plazmi.
Erythromycin, Itraconazole Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of erythromycin and itraconazole.
Indinavir in ritonavir zavirata CYP3A4, zato se pričakuje povečana koncentracija eritromicina in itrakonazola v plazmi.
Careful monitoring of therapeutic and adverse effects is recommended when fentanyl is concomitantly administered with indinavir/ritonavir.
Kadar se fentanil uporablja sočasno z indinavirjem/ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of carbamazepine.
Indinavir in ritonavir zavirata CYP3A4, zato se pričakuje povečana koncentracija karbamazepina v plazmi.
Careful monitoring of therapeutic and adverse effects is recommended when buspirone is concomitantly administered with indinavir/ritonavir.
Kadar se buspiron uporablja sočasno z indinavirjem/ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
 dihydropyridine calcium channel blocker concentration
 koncentracija blokatorja kalcijevih kanalčkov, dihidropiridinskega tipa
Careful monitoring of therapeutic and adverse effects is recommended when loratidine is concomitantly administered with indinavir/ritonavir.
Kadar se loratidin uporablja sočasno z indinavirjem/ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
8 hours, produced AUC0-8hr values of 27,412 nM*h, peak plasma concentrations of 12,182 nM, and plasma concentrations at 8 hours post dose of 122 nM.
Pri s HIV okuženih pediatričnih bolnikih so bile pri jemanju trdih kapsul indinavirja v odmerkih 500 mg/m2 vsakih 8 ur AUC0-8h vrednosti 27.412 nM*h, najvišje plazemske koncentracije 12.182 nM, plazemske koncentracije 8 ur po odmerku pa 122 nM. AUC in najvišje plazemske koncentracije so bile večinoma podobne tistim pri s HIV okuženih odraslih, ki so prejemali priporočeni odmerek 800 mg vsakih 8 ur.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of fentanyl.
Indinavir in ritonavir zavirata CYP3A4, zato se pričakuje povečana koncentracija fentanila v plazmi.
*)historical controls
Iz preteklih kontrolnih raziskav.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Poročali so tudi o pojavu avtoimunih bolezni (kot sta Gravesova bolezen in avtoimunski hepatitis) ob imunski reaktivaciji.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of loratidine.
Indinavir in ritonavir zavirata CYP3A4, zato se pričakuje povečana koncentracija loratidina v plazmi.
Interaction study with Lopinavir/ritonavir + rosuvastatin:
Študija o medsebojnem delovanju med lopinavirjem/ritonavirjem in rosuvastatinom: AUC rosuvastatina  2,08-krat;
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of buspirone.
Indinavir in ritonavir zavirata CYP3A4, zato se pričakuje povečana koncentracija buspirona v plazmi.
Careful monitoring of therapeutic and adverse effects is recommended when dexamethasone is concomitantly administered with indinavir/ritonavir.
Kadar se deksametazon uporablja sočasno z indinavirjem/ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of tacrolimus.
Indinavir in ritonavir zavirata CYP3A4, zato se pričakuje povečana koncentracija takrolimusa v plazmi.
Careful monitoring of therapeutic and adverse effects is recommended when atovaquone is concomitantly administered with indinavir/ritonavir.
Kadar se atovakon uporablja sočasno z indinavirjem/ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
Dizziness and blurred vision have been reported during treatment with CRIXIVAN.
Vpliv na sposobnost upravljanja vozil in strojev Med zdravljenjem z zdravilom CRIXIVAN so poročali o omotici in zamegljenem vidu.
Rosuvastatin AUC  2.08-fold Rosuvastatin Cmax  4.66-fold (Mechanism unknown)
Cmax rosuvastatina  4,66-krat.
HISTAMINE H2 ANTAGONIST Cimetidine 600 mg BID (Indinavir 400 mg SD)
Cimetidin 600 mg BID (indinavir 400 mg SD)
Careful monitoring of therapeutic and adverse effects is recommended when fexofenadine is concomitantly administered with indinavir/ritonavir.
Kadar se takrolimus uporablja sočasno z indinavirjem/ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
Antifungals
Mutagenost
International Non-proprietary Name (INN): anecortave
Mednarodno nelastniško ime (INN): anecortave
The two main clinical studies were carried out in patients aged between 51 and 96 years of age, and lasted up to two years.
Dve glavni klinični raziskavi sta bili opravljeni na bolnikih, starih od 51 do 96 let, in sta trajali do dve leti.
The Company has informed the CHMP that there are clinical trials currently running in Europe.
Podjetje je CHMP obvestilo, da v Evropi trenutno potekajo klinične raziskave.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Če sodelujete v klinični raziskavi ali programu sočutne pomoči in potrebujete več informacij o vašem zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
The Company also plans to continue their compassionate use programme on a case-by-case basis.
Podjetje tudi namerava nadaljevati s programom sočutne uporabe na podlagi presoje posameznih primerov.
QUESTIONS AND ANSWERS ON WITHDRAWAL OF MARKETING APPLICATION for RETAANE
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA ODOBRITEV DOVOLJENJA ZA PROMET za zdravilo RETAANE
After the CHMP had assessed the responses from the Company to a list of questions, there were still unresolved outstanding issues.
Po tem, ko je CHMP ocenil odgovore podjetja na seznam vprašanj, so še vedno ostala nekatera nerešena vprašanja.
The letter from the Company notifying the EMEA of the withdrawal of Retaane is available here.
Dopis podjetja, s katerim EMEA obvešča o umiku, je na voljo tukaj.
Based on the review of the initial documentation, the CHMP prepares a list of questions (at day 120), which is sent to the Company.
Na podlagi pregleda začetne dokumentacije CHMP pripravi seznam vprašanj (dan 120), ki ga pošlje podjetju.
Compared to photodynamic therapy, Retaane was not as effective.
V primerjavi s fotodinamičnim zdravljenjem zdravilo Retaane ni bilo tako učinkovito.
Therefore, at the time of the withdrawal, the CHMP's view was that the benefit had not been sufficiently demonstrated and did not outweigh the identified risks.
Posledično je CHMP v času umika menil, da korist ni bila dokazana v zadostni meri in ni večja od znanih tveganj.
The CHMP had concerns that the effectiveness of Retaane was less than what they expected to see: Compared to placebo, Retaane has some effectiveness, but many patients were ‘lost' (exited the study) before the end of the study; and this affects the reliability of the results.
CHMP je imel pomisleke, da je učinkovitost zdravila Retaane manjša od pričakovane: v primerjavi s placebom je zdravilo Retaane izkazalo določeno učinkovitost, vendar je bilo veliko bolnikov »izgubljenih« (izstopili so iz raziskave) pred zaključkom raziskave, kar vpliva na zanesljivost rezultatov.
The studies measured visual acuity (the results of an eye test) to see how the patients had responded to treatment.
V raziskavi so merili ostrino vida (rezultati očesnega testa), da bi ugotovili, kako so se bolniki odzvali na zdravljenje.
It is able to stop or slow down the development of new blood vessels by interfering with the production of the proteins needed to build the vessels, and of the growth factors needed for the blood vessels to spread.
Lahko zavre ali upočasni razvoj novih krvnih žil tako, da vpliva na tvorbo beljakovin, potrebnih za oblikovanje žil, in rastnih faktorjev, potrebnih za širjenje žil.
Retaane was to be injected every 6 months directly into the space behind the eye, as a ‘depot' injection (a type of injection where the medicine is prepared in such a way that it is absorbed by the body very slowly).
Zdravilo Retaane bi se naj vsakih 6 mesecev injiciralo neposredno v prostor za očesom kot depo injekcija (vrsta injekcije, pri kateri je zdravilo pripravljeno tako, da ga telo zelo počasi absorbira).
The effects of Retaane were first tested in experimental models before being studied in humans.
Učinki zdravila Retaane so bili najprej preizkušeni s pomočjo izkustvenih modelov, šele nato pa so jih raziskali na ljudeh.
The CHMP normally takes up to 210 days to evaluate a new application.
CHMP za oceno nove vloge navadno potrebuje do 210 dni.
How far into the evaluation was the application when it was withdrawn?
Kako daleč je bil postopek ocenjevanja vloge ob umaknitvi vloge?
Retaane was expected to be used to stop or slow down the development of these new blood vessels (neovascularisation) in the eye.
Zdravilo Retaane bi se naj uporabljalo za zaustavitev ali upočasnitev razvoja teh novih žil (neovaskularizacije) v očeh.
What is Retaane?
Kaj je zdravilo Retaane?
This disease affects the central part of the retina (called the macula), at the back of the eye and causes loss of vision.
Ta bolezen prizadene osrednji del mrežnice (imenovan makula), ki leži na zadnji strani očesa, ter povzroči poslabšanje vida.
What documentation has been presented by the Company to support the application to the CHMP?
Katero dokumentacijo je podjetje predložilo CHMP za podkrepitev svoje vloge?
Following CHMP opinion, it usually takes around 2 months for the European Commission to give a licence.
Evropska komisija navadno potrebuje za izdajo dovoljenja na podlagi mnenja CHMP še dva meseca.
Anecortave, the active substance in Retaane, is similar in structure to cortisol, a natural hormone in the body.
Anekortav, zdravilna učinkovina v zdravilu Retaane, je po strukturi podobna kortizolu, naravnemu hormonu v telesu.
Based on the review of the data submitted and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Retaane could not be approved for the treatment of subfoveal choroidal neovascularisation with classic component due to age-related macular degeneration.
Na podlagi pregleda predloženih podatkov in odgovorov podjetja na seznam vprašanj, ki ga je poslal CHMP, je imel CHMP v času umika vloge zadržke in se je nagibal k predhodnemu mnenju, da zdravila Retaane ni mogoče odobriti za uporabo pri zdravljenju subfovealne horoidalne neovaskularizacije (CNV) s klasično komponento, povezane s starostno degeneracijo makule (ADM).
The application was at Day 180 when the Company withdrew.
Ko je podjetje zahtevalo umik vloge, je bila vloga v postopku 180. dan.
The wet form of the disease is caused by abnormal blood vessels under the retina and the macula, which may bleed and leak fluid.
Vlažno obliko te bolezni povzročajo nenormalne žile pod mrežnico in makulo, ki lahko krvavijo in prepuščajo tekočino.
Retaane is a suspension for injection onto the outer part of the eye ball.
Zdravilo Retaane je suspenzija za injiciranje, ki se daje v zunanji del zrkla.
Retaane was expected to be used to treat patients with the wet form of age-related macular degeneration.
Zdravilo Retaane naj bi se uporabljalo za zdravljenje bolnikov z vlažno obliko starostne degeneracije makule.
One compared Retaane at various strengths (3 mg, 15 mg or 30 mg) with a dummy treatment (placebo) in 128 patients.
V prvi raziskavi so pri 128 bolnikih primerjali zdravilo Retaane v različnih jakostih (3 mg, 15 mg ali 30 mg) s placebom.
It contains 30 mg/ml of the active substance anecortave acetate.
Zdravilo Retaane vsebuje 30 mg/ml zdravilne učinkovine anekortavov acetat.
What was Retaane expected to be used for?
Za kaj naj bi se zdravilo Retaane uporabljalo?
The Company plans to continue the two clinical trials in wet AMD patients, as well as the clinical trial in dry AMD patients at risk of developing wet AMD.
Podjetje namerava nadaljevati z dvema kliničnima raziskavama pri bolnikih z vlažno obliko ADM in s klinično raziskavo pri bolnikih s suho obliko ADM, pri katerih obstaja tveganje, da se razvije v vlažno obliko ADM.
may, before giving an opinion, ask any remaining question(s) (at day 180).
odgovore na vprašanja, jih CHMP pregleda in pred objavo mnenja zastavi še morebitno/a novo/a vprašanje/a (dan 180).
What are the consequences of the withdrawal for patients undergoing clinical trials /
Kakšne so posledice umika za bolnike, vključene v klinična preizkušanja /programe sočutne uporabe zdravila Retaane?
The second compared the effect of Retaane 15 mg to photodynamic therapy (the standard treatment for the wet form of AMD, where laser treatment is used to destroy the newly formed blood vessels) in 530 patients.
V drugi raziskavi so pri 530 bolnikih primerjali učinek zdravila Retaane v jakosti 15 mg s fotodinamičnim zdravljenjem (standardno zdravljenje vlažne oblike starostne degeneracije makule, pri katerem se uporablja laserski postopek za uničevanje novo nastalih žil).
How is Retaane expected to work?
Kako naj bi zdravilo Retaane delovalo?
have officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for Retaane, for the treatment of subfoveal choroidal neovascularisation (CNV) with classic component due to age-related macular degeneration (AMD).
Dne 28. februarja 2006 je podjetje Alcon Laboratories (Združeno kraljestvo) Limited uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želijo umakniti svojo vlogo za izdajo dovoljenja za promet z zdravilom Retaane, namenjenim za zdravljenje subfovealne horoidalne neovaskularizacije (CNV) s klasično komponento, povezane s starostno degeneracijo makule (ADM).
The study was well conducted and according to current scientific standards.
Študija je bila dobro izvedena in v skladu s trenutnimi znanstvenimi standardi.
On 27 September 2012 a plenary meeting of the Standing Committee on Veterinary Medicinal Products took place.
27. septembra 2012 je potekalo plenarno zasedanje stalnega odbora za zdravila za uporabo v veterinarski medicini.
The application was submitted to Germany as reference Member State and Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and the United Kingdom as concerned Member States.
Predlagatelj je vlogo predložil Nemčiji kot referenčni državi članici ter zadevnim državam članicam Avstriji, Belgiji, Bolgariji, Cipru, Češki republiki, Danski, Estoniji, Franciji, Grčiji, Madžarski, Irski, Italiji, Latviji, Litvi, Luksemburgu, Malti, Nizozemski, Poljski, Portugalski, Romuniji, Slovaški, Sloveniji, Španiji in Združenemu kraljestvu.
Seven sites in three countries have been investigated.
Pod drobnogled so vzeli sedem lokacij v treh državah.
The Member States concerned failed to reach an agreement regarding the product and consequently the matter was referred to the CVMP on 19 December 2011.
Zadevne države članice niso uspele doseči dogovora v zvezi z zdravilom, zato je bila zadeva 19. decembra 2011 predložena odboru CVMP.
These higher doses and duration of treatment are authorised in a number of EU Member States, e.g. Denmark, the Netherlands and the United Kingdom.
Omenjeni večji odmerki in trajanje zdravljenja so odobreni v več državah članicah EU, na primer na Danskem, Nizozemskem in v Združenem kraljestvu.
Strength Animal species
Ciljna živalska vrsta
List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Seznam imen, farmacevtska oblika, jakost zdravila za uporabo v veterinarski medicini, ciljna živalska vrsta, način uporabe , predlagatelj v državi članici
As the activity of florfenicol is time dependent, the active concentration has to be above MIC for a certain time.
Ker je delovanje florfenikola odvisno od časa, mora biti aktivna koncentracija določen čas nad MIK.
This should include sufficiently large number of target animals to ensure the validity of the results in terms of both clinical relevance and statistical significance.
V študijo mora vključiti zadostno število ciljnih živali, da zagotovi veljavne rezultate, tako v smislu klinične kot tudi statistične pomembnosti.
On 31 August 2012, during the written phase of the Standing Committee procedure, the Netherlands submitted an objection to the opinion adopted by CVMP on 13 June 2012.
31. avgusta 2012, med pisnim delom postopka stalnega odbora, je Nizozemska vložila ugovor zoper mnenje, ki ga je 13. junija 2012 sprejel CVMP.
The design of the field study should follow the design of the field study V-0049-0059 in terms of the inclusion/exclusion criteria and clinical endpoints.
Terensko študijo mora zasnovati po vzorcu terenske študije V-0049-0059, tj. vključiti mora podobne vključitvene/izključitvene kriterije in klinične končne točke.
According to the legal provisions set out in Annex I of Directive 2001/82/EC a positive control product should be an authorised product according to current European legislation.
Glede na zakonske določbe iz Priloge I Direktive 2001/82/ES mora biti zdravilo za pozitivno kontrolo odobreno zdravilo, ki je skladno z veljavno evropsko zakonodajo.
Relevance of the choice of positive control product
Relevantnost izbire zdravila za pozitivno kontrolo