natgillin/translations-raw huggingface dataset:
The review covered medicines authorised via national procedures in individual EU Member States, whose marketing authorisation applications included data from Semler's bioanalytical site (Semler Research Center Private Ltd, 75A, 15th Cross, 1st Phase, JP Nagar, Bangalore 560 078, Karnataka, India) and from Semler's clinical site (PA Arcade, #21, 22, 23, Kodigehali Main Road, Sahakaranagar Post, Bangalore 560 092, Karnataka, India).
Pregled je zajel zdravila, ki so dovoljenje za promet prejela po nacionalnem postopku v posameznih državah članicah EU, njihove vloge za pridobitev dovoljenja za promet pa so vključevale podatke z bioanalitskega mesta družbe Semler (Semler Research Center Private Ltd, 75A, 15th Cross, 1st Phase, JP Nagar, Bangalore 560 078, Karnataka, Indija) in s kliničnega mesta družbe Semler (PA Arcade, #21, 22, 23, Kodigehali Main Road, Sahakaranagar Post, Bangalore 560 092, Karnataka, Indija).
This is because during this review, alternative studies from different sources were provided that show bioequivalence.
Med tem pregledom so bile namreč predložene druge študije iz različnih virov, ki dokazujejo biološko enakovrednost.
Semler is a contract research organisation (CRO) with an analytical and a clinical site located in Bangalore, India.
Družba Semler je pogodbena raziskovalna organizacija z analitskim in kliničnim mestom v Bangaloreju v Indiji.
• Generic medicines containing abacavir/lamivudine (used to treat HIV), which were approved on the basis of studies conducted at Semler, can remain on the market in the EU.
• Generična zdravila, ki vsebujejo abakavir/lamivudin (ki se uporabljajo za zdravljenje okužbe z virusom HIV), odobrena na podlagi študij, opravljenih v družbi Semler, lahko ostanejo na trgu v EU.
The Agency also recommended that medicines being evaluated for authorisation and which rely only on bioequivalence studies from this site should not be authorised until bioequivalence is demonstrated using alternative data.
Agencija je priporočila tudi, da zdravila, ki so trenutno v postopku vrednotenja za pridobitev dovoljenja za promet in so podprta samo s študijami biološke enakovrednosti, opravljenimi na tem mestu, ne smejo pridobiti dovoljenja za promet, dokler se biološka enakovrednost ne dokaže z drugimi podatki.
The findings from FDA and WHO inspections called into question the quality management system in place at Semler, and thus the reliability of the data of all bioequivalence studies, including those used to support marketing authorisation applications in the EU.
Izsledki inšpekcijskih pregledov agencije FDA in organizacije SZO so pod vprašaj postavili vzpostavljeni sistem za upravljanje kakovosti v družbi Semler in posledično zanesljivost podatkov vseh študij biološke enakovrednosti, vključno s tistimi, ki podpirajo vloge za pridobitev dovoljenj za promet z zdravili v EU.
On 21 July 2016, the European Medicines Agency (EMA) recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd, Bangalore, India.
Evropska agencija za zdravila (EMA) je 21. julija 2016 priporočila začasni umik dovoljenj za promet z več zdravili, ki so dovoljenje pridobila po nacionalnem postopku, pri katerih so bile študije biološke enakovrednosti opravljene v družbi Semler Research Centre Private Ltd v Bangaloreju v Indiji.
EMA's Committee for Medicinal Products for Human Use (CHMP) concluded that the studies conducted at Semler cannot be accepted in marketing authorisation applications in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA je zaključil, da študije, opravljene v družbi Semler, pri vlogah za pridobitev dovoljenj za promet z zdravili v EU niso sprejemljive.
Bioequivalence studies performed at the site cannot be used to support medicines approval in the EU
Študij biološke enakovrednosti, opravljenih na tem mestu, ni mogoče uporabiti v podporo odobritvam zdravil v EU
These sites conduct the analytical and clinical parts of bioequivalence studies, some of which are used to support marketing authorisation applications of medicines in the EU.
Na teh mestih opravljajo analitski in klinični del študij biološke enakovrednosti, od katerih so nekatere uporabljene v podporo vlogam za pridobitev dovoljenj za promet z zdravili v EU.
• A number of medicines for use in the EU rely on studies carried out at the Semler site in India.
• Številna zdravila, ki se uporabljajo v EU, so podprta s študijami, opravljenimi v družbi Semler v Indiji.
The Semler site also performs bioequivalence studies for some medicines authorised in the US and medicines included in the WHO prequalification programme3.
Družba Semler opravlja tudi študije biološke enakovrednosti za nekatera zdravila, ki imajo dovoljenje za promet v ZDA, in zdravila, vključena v prekvalifikacijski program SZO3.
• Medicines that have been suspended can have their suspension lifted if the companies provide alternative data demonstrating bioequivalence.
• Za preklic začasnega umika dovoljenja za promet z zdravili, katerih dovoljenje za promet je bilo začasno umaknjeno, morajo družbe predložiti druge podatke, ki dokazujejo biološko enakovrednost.
EMA's review followed an FDA inspection1 that identified several issues at Semler's bioanalytical site, including the substitution and manipulation of subjects' clinical samples.
Pregled agencije EMA je sledil inšpekcijskemu pregledu agencije FDA1, s katerim so na bioanalitskem mestu družbe ugotovili več pomanjkljivosti, vključno z zamenjevanjem in manipulacijo kliničnih vzorcev preiskovancev.
It also included ongoing marketing authorisation applications for medicines which use study data from these sites.
Pregled je vključeval tudi trenutno obravnavane vloge za pridobitev dovoljenj za promet z zdravili, v katerih so uporabljeni podatki z omenjenih mest.
No generic medicine authorised centrally via EMA was tested in these sites.
Na teh mestih ni bilo preskušeno nobeno generično zdravilo, ki je dovoljenje za promet pridobilo po centraliziranem postopku prek agencije EMA.
The studies, called ‘bioequivalence' studies, are usually the basis for approving generic medicines.
Te študije, imenovane študije „biološke enakovrednosti“, so običajno podlaga za pridobitev dovoljenja za promet za generična zdravila.
Bioequivalence studies usually form the basis for approval of generic medicines.
Študije biološke enakovrednosti so običajno podlaga za pridobitev dovoljenja za promet za generična zdravila.
The World Health Organization (WHO) also raised serious concerns2 regarding data integrity and manipulation of study samples following its own inspections of Semler's bioanalytical and clinical sites.
Svetovna zdravstvena organizacija (SZO) je po lastnem inšpekcijskem pregledu bioanalitskih in kliničnih mest družbe Semler prav tako izpostavila resne pomisleke2 o integriteti podatkov in manipulaciji vzorcev iz študij.
• The bioequivalence studies performed at the Semler site have been found to be flawed, so they cannot be relied on. As a result, several medicines approved in the EU have been suspended.
• Ugotovljeno je bilo, da so študije biološke enakovrednosti, opravljene v družbi Semler, prirejene, zato niso zanesljive.
• Medicines still under evaluation cannot be granted authorisation in the EU on the basis of studies conducted at Semler; further data would have to be provided to support authorisation.
• Zdravila v postopku vrednotenja ne morejo pridobiti dovoljenja za promet v EU na podlagi študij, opravljenih v družbi Semler.
The application was withdrawn in Germany, Norway and Spain, but the procedure was positively ended in all other Member States on 7 March 2003.
Prijava je bila umaknjena v Nemčiji, na Norveškem in v Španiji, vendar je bil postopek pozitivno izpeljan v vseh drugih državah članicah, dne 7. marca 2003.
09 August 2005 EMEA/CHMP/145829/2005
9. avgust 2005 EMEA/CHMP/145829/2005
The final opinion was converted into a Decision by the European Commission on 09 August 2005.
Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 9. avgusta 2005.
OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Crestor 5 mg
MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 29(2)1 ZA Crestor 5 mg
The Rapporteur and Co-Rapporteur appointed were Dr P. Nilsson and Dr. G. Calvo, respectively.
Poročevalec je bil Dr. P Nilsson in soporočevalec Dr. G. Calvo.
Written explanations were provided by the Marketing Authorisation Holder on 07 February 2005.
Pisna pojasnila je predložil imetnik dovoljenja za promet, dne 7. februarja
The arbitration procedure started on 18 November 2004.
Postopek obravnave se je pričel 18. novembra 2004.
International Non-Proprietary Name (INN): Rosuvastatin calcium
Mednarodno nelastniško ime (INN): Rosuvastatin v obliki kalcijeve soli
On the basis of the marketing authorisation for Crestor (5 mg) granted by The Netherlands, on 21 July 2004 the applicant submitted an application for Mutual Recognition to 13 Concerned Member States.
Na osnovi dovoljenja za promet za zdravilo Crestor (5 mg), ki ga je dodelila Nizozemska dne 21. julija 2004, je prosilec trinajstim zadevnim državam članicam vložil prošnjo za medsebojno priznavanje.
The main issue during the procedure was whether the 5 mg strength should be the recommended start dose for all patients.
Glavno vprašanje v toku postopka je bilo, ali naj bi bila jakost 5 mg priporočeni začetni odmerek za vse bolnike.
As part of the marketing authorisation for rosuvastatin within Europe, AstraZeneca committed to apply for a 5-mg dose of rosuvastatin together with any necessary variations within 12 months of completion of the Mutual Recognition Process for the 10 mg, 20 mg and 40 mg formulations.
Kot del dovoljenja za promet z rosuvastatinom znotraj Evrope, se je AstraZeneca obvezala, da bo v roku 12 mesecev po zaključku postopka za medsebojno priznavanje prijavila 5 miligramski odmerek rosuvastatina, skupaj z vsakršnimi potrebnimi variacijami,za odmerke z 10 mg, 20 mg in 40 mg.
During its April 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Crestor 5 mg or Crestor 10 mg as start dose.
V toku sestanka aprila 2005, je bil CHMP glede na vse predložene podatke ter vse znanstvene diskusije z Odborom, mnenja, da je razmerje med koristmi in tveganji za zdravilo Crestor ugodno - in sicer v smislu, da naj bi bil začetni odmerek zdravila 5 ali 10 mg.
The approved use in The Netherlands was a 5 mg start dose for patients with predisposing factors to myopathy, and 10 mg as the recommended start dose for patients without these predisposing factors.
5 mg za bolnike s predispozicijskimi dejavniki za miopatijo, ter 10 mg kot priporočeni začetni odmerek za bolnike brez teh dejavnikov.
This procedure started on 04 August 2004.
Postopek se je priček 4. avgusta 2004.
Crestor (rosuvastatin calcium) is a selective 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) that has been approved for use as a lipid-regulating agent in the management of patients with dyslipidaemia.
metilglutaril koencima A (HMG-CoA) (statin), ki je bil odobren kot sredstvo za regulacijo lipidov pri zdravljenju bolnikov z dislipidemijo.
The issue was referred for arbitration by the UK on 1 November 2004 (day 89).
Zadeva je bila dne 1. novembra 2004 (89.
Changes to SPC section 4.2 (Posology and method of administration) and 4.4 (Special warnings and special precautions for use) arising from the arbitration process were agreed by CHMP and a positive opinion was adopted on 21 April 2005.
(Odmerjanje in način uporabe) ter 4.4 (Posebna opozorila in previdnostni ukrepi za uporabo) Povzetka glavnih značilnosti zdravila, ki izhajajo iz postopka obravnave.
A Marketing Authorisation for Crestor (10 to 40 mg) was originally granted to AstraZeneca in The
Dovoljenje za promet z zdravilom za Crestor (10 do 40 mg) je bilo prvotno dodeljeno podjetju AstraZeneca na Nizozemskem, dne 6. novembra 2002, 7. decembra 2002 pa je bil sprožen postopek za medsebojno priznavanje.
Cancidas is used to treat the following infections in children, adolescents and adults:
Zdravilo Cancidas se uporablja za zdravljenje naslednjih okužb pri otrocih, mladostnikih in odraslih:
Due to poor enrolment, the study was terminated early and only 51 patients were randomized.
Zaradi slabe vključenosti je bila študija zgodaj zaključena in randomiziranih je bilo le 51 bolnikov.
Cancidas will always be prepared and given to you by a healthcare professional.
Zdravilo Cancidas bo vedno pripravil in vam ga dal zdravstveni delavec.
• if you are allergic to caspofungin or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na kaspofungin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The mechanism of resistance has not been established.
Mehanizma odpornosti še niso ugotovili.
If this occurs, caspofungin should be discontinued and appropriate treatment administered.
Če se ta pojavi, je treba kaspofungin ukiniti in uporabiti ustrezno zdravljenje.
Do not use this medicine after the expiry date which is stated on the carton and the vial (the first two numbers are the month; the next four numbers are the year).
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na viali (prvi dve številki pomenita mesec, naslednje štiri pa leto).
This is because Cancidas can affect the way some other medicines work.
To je zato, ker lahko zdravilo Cancidas vpliva na delovanje nekaterih drugih zdravil.
Date of first authorisation: 24 October 2001.
Datum prve odobritve: 24. oktober 2001 Datum zadnjega podaljšanja: 07. september 2011
• you have ever had liver problems - you might need a different dose of this medicine
• če ste kadar koli imeli težave z jetri - morda boste potrebovali drugačen odmerek tega zdravila.
Based on this study, no posology recommendations for neonates and infants can be made.
Na podlagi te študije priporočil za odmerjanje pri novorojenčkih in dojenčkih ni mogoče podati.
This belongs to a group of medicines called antifungals.
Spada v skupino zdravil, imenovanih antimikotiki.
N Engl J Med 1987 Oct 22;317(17):1098 (letter)
N Engl J Med 1987 Oct 22;317(17):1098 (pismo)
The elimination of caspofungin from plasma is slow with a clearance of 10-12 ml/min.
Izločanje kaspofungina iz plazme je počasno, očistek znaša 10-12 ml/min.
3 for 96 hours) and fever (>38.0°C) not responding to ≥96 hours of parenteral antibacterial therapy.
3 96 ur) in zvišano telesno temperaturo (> 38.0 °C), ki se nista odzivali na ≥ 96-urno parenteralno protibakterijsko terapijo.
Pharmacotherapeutic group: antimycotics for systemic use, ATC Code: J02AX04
Farmakoterapevtska skupina: antimikotiki za sistemsko zdravljenje, oznaka ATC: J02AX04
Aseptically add 10.5 ml of water for injection.
Aseptično dodajte 10,5 ml vode za injekcije.
Not Recommended
Ne priporočamo.
Also some other medicines can affect the way Cancidas works.
Prav tako lahko nekatera druga zdravila vplivajo na delovanje zdravila Cancidas.
Caspofungin resistance in Candida has been observed but the incidence may differ by species or region.
Odpornost proti kaspofunginu pri Candidi so opazili, vendar se pojavnost odpornosti lahko razlikuje glede na vrsto ali območje.
DO NOT MIX OR CO-INFUSE CANCIDAS WITH ANY OTHER MEDICINES, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medicinal products.
ZDRAVILA CANCIDAS NE MEŠAJTE IN NE INFUNDIRAJTE SKUPAJ S KATERIM KOLI DRUGIM ZDRAVILOM, ker ni podatkov o kompatibilnosti zdravila CANCIDAS in drugih substanc, aditivov in zdravil za intravensko uporabo.
You will be given Cancidas:
Zdravilo Cancidas boste prejeli:
70 mg (from two 50 mg vials)**
70 mg (iz dveh vial po 50 mg)**
The incidence of resistance to caspofungin by various clinical isolates of Aspergillus is rare.
Pojavnost odpornosti proti kaspofunginu pri različnih kliničnih izolatih vrste Aspergillus je redka.
If you have been given more Cancidas than you should Your doctor will decide how much Cancidas you need and for how long each day.
Če ste uporabili večji odmerek zdravila Cancidas, kot bi smeli Zdravnik se bo odločil, koliko zdravila Cancidas boste prejeli dnevno in trajanje zdravljenja.
Alternatively, the volume (ml)
Druga možnost je, da količino (ml)
• Cancidas has not been studied in pregnant women.
• Uporabe zdravila Cancidas pri nosečnicah niso preučevali.
What you need to know before you are given Cancidas
Kaj morate vedeti, preden boste dobili zdravilo Cancidas
If you are worried that you may have been given too much Cancidas, tell your doctor or nurse straight away.
Če pa vas skrbi, da ste morda dobili prevelik odmerek zdravila Cancidas, se takoj pogovorite z zdravnikom ali medicinsko sestro.
Other medicines and Cancidas
Druga zdravila in zdravilo Cancidas
What Cancidas is and what it is used for What you need to know before you are given Cancidas How to use Cancidas
Kaj je zdravilo Cancidas in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Cancidas Kako uporabljati zdravilo Cancidas Možni neželeni učinki
• cough, serious breathing difficulties - if you are an adult and have invasive aspergillosis you may be experiencing a serious respiratory problem that could result in respiratory failure.
• kašelj, resne težave pri dihanju - če ste odrasli in imate invazivno aspergilozo, imate lahko resne težave z dihanjem, ki lahko povzročijo zastoj dihanja,
• phenytoin or carbamazepine (used for the treatment of seizures)
• fenitoin ali karbamazepin (ki se uporabljata za zdravljenje napadov krčev)
Toxic epidermal necrolysis and StevensJohnson syndrome (see section 4.4)
toksična epidermalna nekroliza in StevensJohnsonov sindrom (glejte poškodba kože poglavje 4.4)
INSTRUCTIONS FOR USE IN ADULT PATIENTS
NAVODILA ZA UPORABO PRI ODRASLIH BOLNIKIH
Driving and using machines There is no information to suggest that Cancidas affects your ability to drive or operate machinery.
Vpliv na sposobnost upravljanja vozil in strojev Ni podatkov, ki bi kazali, da zdravilo Cancidas vpliva na sposobnost vožnje ali upravljanja strojev.
Reported clinical and laboratory abnormalities among all adults treated with caspofungin (total 1,780) were typically mild and rarely led to discontinuation.
Klinične in laboratorijske nepravilnosti, o katerih so poročali, so bile pri vseh odraslih, zdravljenih s kaspofunginom (skupno 1.780), po navadi blage in so le redko vodile v prekinitev zdravljenja.
In clinical studies, 1,865 adult individuals received single or multiple doses of caspofungin: 564 febrile neutropaenic patients (empirical therapy study), 382 patients with invasive candidiasis, 228 patients with invasive aspergillosis, 297 patients with localised Candida infections, and 394 individuals enrolled in Phase I studies.
V kliničnih študijah je 1.865 odraslih oseb dobilo enkratne ali večkratne odmerke kaspofungina: 564 bolnikov s febrilno nevtropenijo (študija empiričnega zdravljenja), 382 bolnikov z invazivno kandidiazo, 228 bolnikov z invazivno aspergilozo, 297 bolnikov z lokaliziranimi okužbami s Candido in 394 oseb vključenih v študije I. faze.
• The active substance is caspofungin.
• Učinkovina je kaspofungin.
The mechanism of resistance identified is FKS1 and/or FKS2 (for C. glabrata) gene mutations.
Ugotovili so, da odpornost omogočijo mutacije na genih FKS1 in/ali FKS2 (pri C. glabrata).
The most frequent diagnoses were bloodstream infections (candidaemia) (77 %, n = 186) and Candida peritonitis (8 %, n = 19); patients with Candida endocarditis, osteomyelitis, or meningitis were excluded from this study.
Najpogostejši diagnozi sta bili okužba krvi (kandidemija) (77 %, n = 186) in kandidiazni peritonitis (8 %, n = 19); bolniki s kandidiaznim endokarditisom, osteomielitisom ali meningitisom so bili iz študije izključeni.
Patients in the caspofungin group experienced breakthrough infections due to the following uncommon yeasts and moulds: Trichosporon species (1), Fusarium species (1), Mucor species (1), and Rhizopus species (1).
Bolniki v kaspofunginski skupini so doživeli izbruh okužbe z naslednjimi redkimi vrstami kvasovk in plesni: Trichosporon (1), Fusarium (1), Mucor (1) in Rhizopus (1).
Do not use Cancidas
Ne uporabljajte zdravila Cancidas
The following adverse reactions were reported during clinical studies and/or post-marketing use: System Organ
V kliničnih študijah in/ali v obdobju trženja so poročali o naslednjih neželenih učinkih: Organski sistem Pogosti
The solution for infusion is prepared by aseptically adding the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250 ml infusion bag or bottle.
Raztopino za infundiranje pripravite tako, da ustrezno količino pripravljenega koncentrata (kot je prikazano v spodnji preglednici) aseptično dodate v 250 ml infuzijsko vrečko ali steklenico.
Caspofungin has in vitro activity against Aspergillus species (Aspergillus fumigatus [N = 75], Aspergillus flavus [N = 111], Aspergillus niger [N = 31], Aspergillus nidulans [N = 8], Aspergillus terreus [N = 52], and Aspergillus candidus [N = 3]).
In vitro je kaspofungin učinkovit proti Aspergillus sp. (Aspergillus fumigatus n = 75, Aspergillus flavus n = 111, Aspergillus niger n = 31, Aspergillus nidulans n = 8, Aspergillus terreus n = 52 in Aspergillus candidus n = 3).
• Loss of appetite, increase in amount of body fluid, imbalance of salt in the body, high sugar level in the blood, low calcium level in the blood, increase calcium level in the blood, low magnesium level in the blood, increase in acid level in the blood
• izguba apetita, povečanje količine telesne tekočine, porušeno ravnotežje soli v telesu, visoke vrednosti sladkorja v krvi, nizke vrednosti kalcija v krvi, zvišane vrednosti kalcija v krvi, nizke vrednosti magnezija v krvi, zvišane vrednosti kisline v krvi
Cancidas may also cause Serious Cutaneous Adverse Reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
Zdravilo Cancidas lahko povzroči tudi resne kožne neželene učinke, kot npr. Stevens-Johnsonov sindrom (SJS) in toksično epidermalno nekrolizo (TEN).
Supplied in packs of 1 vial.
Na voljo so škatle z 1 vialo.
What Cancidas is and what it is used for
Kaj je zdravilo Cancidas in za kaj ga uporabljamo
Cancidas contains sucrose (a type of sugar).
Zdravilo Cancidas vsebuje saharozo (vrsta sladkorja).
Intravenous use after reconstitution and dilution.
Intravenska uporaba po predhodni pripravi in razredčenju.
• Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients.
• Empirično zdravljenje domnevnih glivnih okužb (npr. s Candido ali Aspergillusom) pri febrilnih, nevtropeničnih odraslih ali pediatričnih bolnikih.
Only a trained healthcare professional who has read the complete directions should prepare the medicine (please see below “Instructions of how to reconstitute and dilute Cancidas”).
Zdravilo lahko pripravi le usposobljeni zdravstveni delavec, ki je prebral celotno navodilo (v nadaljevanju glejte "Navodilo za pripravo in razredčevanje zdravila Cancidas").
INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS
NAVODILA ZA UPORABO PRI PEDIATRIČNIH BOLNIKIH
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands or
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Nizozemska ali