natgillin/translations-raw huggingface dataset:
The MAH agreed with the authorities that GCP violations have happened at the bioanalytical testing facility of the contract laboratory and has taken extensive measures to correct these facts for future clinical trials.
Imetnik dovoljenja za promet z zdravilom se je strinjal z organi, da je bila v pogodbenem laboratoriju za izvajanje bioanalitičnega preskušanja kršena dobra klinična praksa, in je sprejel obsežne ukrepe za odpravo tovrstnih kršitev v prihodnjih kliničnih preskušanjih.
Critical violations of fundamental standards of ICH GCP and internationally accepted laboratory standards during the bioanalytical analyses of the blood samples from both GOS/001 (1month depot formulation) and GOS/002 (1 and 3-month depot formulation) were uncovered.
V obeh študijah GOS/001 (enomesečna depo formulacija) in GOS/002 (eno- in trimesečna depo formulacija) so bile med izvajanjem bioanalitičnih analiz vzorcev krvi ugotovljene kritične kršitve temeljnih standardov dobre klinične prakse ICH in mednarodno sprejetih laboratorijskih standardov.
Interaction with other medicinal products and other forms of interaction:
Medsebojno delovanje z drugimi zdravili ter druge oblike interakcij:
The outside temperature during treatment with Dany's BienenWohl should be at least 3 °C.
Zunanja temperatura med zdravljenjem z zdravilom Dany's BienenWohl mora biti vsaj 3 °C.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14/06/2018
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET <Datum pridobitve:> <14/06/2018>
PSUR submissions shall be synchronised and submitted at the same frequency as for the reference product.
Poročila PSUR se časovno uskladijo in predložijo v enakih časovnih presledkih kot za referenčno zdravilo.
The use of Dany's BienenWohl with the above dosing scheme only applies to hives with vertical frames that can be accessed from the top, as the treatment of bees in other types of hives has not been investigated.
Uporaba zdravila Dany's BienenWohl po zgornji shemi odmerjanja velja le za panje s pokončnimi satniki, do katerih lahko dostopate z vrha, saj zdravljenja čebel v drugih vrstah panjev niso proučevali.
Do not exceed the recommended dose and do not administer this veterinary medicinal product more than once.
Ne presezite priporočenega odmerka in tega zdravila za uporabo v veterinarski medicini ne uporabite več kot enkrat.
Dany's BienenWohl should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Zdravilo Dany's BienenWohl ne sme priti v vodotoke, ker je lahko nevarno za ribe in druge vodne organizme.
EU/2/18/225/002 (750 g solution)
EU/2/18/225/002 (raztopina s 750 g)
MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001-002
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/18/225/001-002
Dany's BienenWohl must only be applied only once in brood-free colonies.
Zdravilo Dany's BienenWohl se sme uporabiti samo enkrat, in sicer pri kolonijah brez zalege.
Dany's BienenWohl should not be used when honey supers are present.
Zdravilo Dany's BienenWohl se ne sme uporabljati v prisotnosti mediščnih naklad.
MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001 (375 g solution)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/18/225/001 (raztopina s 375 g)
Mix with Dany's BienenWohl solution before use.
Pred uporabo zmešajte z Dany's BienenWohl raztopino.
Dany's BienenWohl has corrosive properties on corrosion-sensitive parts of beekeeping equipment.
Zdravilo Dany's BienenWohl na delih čebelarske opreme, občutljivih za korozijo, deluje jedko.
Powder and solution for bee-hive dispersion.
Prašek in raztopina za disperzijo za čebeljo družino.
Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Dany's BienenWohl prašek in raztopina za 39,4 mg/ml disperzijo za čebeljo družino za medonosne čebele
NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion oxalic acid dihydrate
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dany's BienenWohl prašek in raztopina za 39,4 mg/ml disperzijo za čebeljo družino oksalna kislina dihidrat
Name and address of the manufacturer responsible for batch release
A. PROIZVAJALEC ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca zdravila odgovornega za sproščanje serij
NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl solution for bee-hive dispersion oxalic acid dihydrate
Dany's BienenWohl raztopina za disperzijo za čebeljo družino oksalna kislina dihidrat
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA RAZLIČNA
Mix with Dany's BienenWohl powder as instructed, before use.
Pred uporabo po navodilih zmešajte z Dany's BienenWohl praškom.
The active substance in Dany's BienenWohl is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina v zdravilu Dany's BienenWohl je dovoljena učinkovina, kot je navedena v tabeli 1
NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder for bee-hive dispersion sucrose
Dany's BienenWohl prašek za disperzijo za čebeljo družino saharoza
The standard dose of Clopidogrel DURA is one 75 mg tablet once a day, taken with or without food.
Običajni odmerek zdravila Clopidogrel DURA je ena 75-miligramska tableta enkrat na dan, ki se vzame s hrano ali brez nje.
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel DURA to Mylan dura GmbH on 21 September 2009.
Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel DURA, veljavno po vsej Evropski uniji, odobrila družbi Mylan dura GmbH dne 21. septembra 2009.
This means that Clopidogrel DURA is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
To pomeni, da je zdravilo Clopidogrel DURA podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
Clopidogrel DURA can be given to the following groups of patients:
Zdravilo Clopidogrel DURA se lahko daje naslednjim skupinam bolnikov:
Clopidogrel DURA is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Zdravilo Clopidogrel DURA se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel DURA has been shown to have comparable quality and to be bioequivalent to Plavix.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel DURA primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
Because Clopidogrel DURA is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Ker je zdravilo Clopidogrel DURA generično zdravilo in je biološko enakovredno referenčnemu zdravilu, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Clopidogrel DURA can be started between a few days and 35 days after the attack;
Zdravilo Clopidogrel DURA se lahko začne jemati nekaj dni po napadu do 35 dni po njem;
The Committee recommended that Clopidogrel DURA be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Clopidogrel DURA odobri dovoljenje za promet.
What are the benefit and risk of Clopidogrel DURA?
Kakšne so koristi in tveganja, povezana z zdravilom Clopidogrel DURA?
Other information about Clopidogrel DURA:
Druge informacije o zdravilu Clopidogrel DURA:
Clopidogrel DURA can be started between seven days and six months after the
Zdravilo Clopidogrel DURA se lahko začne jemati od sedem dni po napadu do šest mesecev po njem;
Because Clopidogrel DURA is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Ker je zdravilo Clopidogrel DURA generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
Clopidogrel DURA is a ‘generic medicine'.
Zdravilo Clopidogrel DURA je „generično zdravilo“.
Clopidogrel DURA is a medicine that contains the active substance clopidogrel.
Clopidogrel DURA je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
The active substance in Clopidogrel DURA, clopidogrel, is an inhibitor of platelet aggregation.
Zdravilna učinkovina v zdravilu Clopidogrel DURA, klopidogrel, je zaviralec agregacije trombocitov.
Why has Clopidogrel DURA been approved?
Zakaj je bilo zdravilo Clopidogrel DURA odobreno?
The full EPAR for Clopidogrel DURA can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Clopidogrel DURA je na voljo tukaj.
How has Clopidogrel DURA been studied?
Kako je bilo zdravilo Clopidogrel DURA raziskano?
What is Clopidogrel DURA used for?
Za kaj se zdravilo Clopidogrel DURA uporablja?
How is Clopidogrel DURA used?
Kako se zdravilo Clopidogrel DURA uporablja?
What is Clopidogrel DURA?
Kaj je zdravilo Clopidogrel DURA?
How does Clopidogrel DURA work?
Kako zdravilo Clopidogrel DURA deluje?
1 bottle
1 stekleničke
40 mg/ml Oral solution bottle (glass)
40 mg/ml peroralna raztopina Peroralna uporaba stekleničke (iz stekla)
The reasons being the following:
Razlogi so bili naslednji:
BACKGROUND INFORMATION (2)
OSNOVNE INFORMACIJE (2)
The Reference Member State was France and the Concerned Member States were Belgium, the Czech Republic, Germany, Italy, Spain and the United Kingdom.
Referenčna država članica je bila Francija, zadevne države članice pa Belgija, Češka, Nemčija, Italija, Španija in Združeno kraljestvo.
The withdrawal period for milk was 2.5 days.
Karenca za mleko je bila 2,5 dneva.
The final opinion was converted into a Decision by the European Commission on 5 September 2008.
Končno mnenje je bilo spremenjeno v sklep Evropske komisije z dnem 5. septembra 2008.
Belgium referred the issue to the EMEA on 28 July 2005.
Belgija je zadevo zato napotila na agencijo EMEA dne 28. julija 2005.
The product was accepted by the Czech Republic, Italy and Spain.
Zdravilo so potrdile Češka, Italija in Španija.
During the written procedure a request was received from France for a scientific assessment of new studies made available by the Marketing Authorisation Holder.
Med pisnim postopkom je Francija posredovala prošnjo za znanstveno oceno novih študij, ki jih je dal na razpolago imetnik dovoljenja za promet.
The arbitration procedure started on 8 September 2005 with the adoption of a list of questions.
Arbitražni postopek se je pričel 8. septembra 2005 s sprejemom seznama vprašanj.
The reasons for the suspension were the same as those identified in the May 2006 CVMP meeting.
Razlogi za začasni preklic so bili enaki kot na zasedanju CVMP maja 2006.
The procedure for evaluation of the new data started on 15 April 2008.
Postopek ocenjevanja novih podatkov se je pričel 15. aprila 2008.
On 25 October 2006 the European Commission forwarded a draft decision to the Standing Committee on Veterinary Medicinal Products for adoption by written procedure.
Dne 25. oktobra 2006 je Evropska komisija posredovala osnutek svojega sklepa Stalnemu odboru za zdravila za uporabo v veterinarski medicini v sprejem po pisnem postopku.
The product is used in the treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica in cattle and for the treatment of respiratory infections due to Pasteurella multocida in pigs.
Zdravilo se uporablja pri zdravljenju okužb dihal, ki jih povzročata Pasteurella multocida in Mannheimia haemolytica pri govedu, ter za zdravljenje okužb dihal, ki jih povzroča Pasteurella multocida pri prašičih.
The rapporteur was Mr. J. Schefferlie and the co-rapporteur was Prof. R. Kroker.
Poročevalec je bil dr. J. Schefferlie, soporočevalec pa prof. R. Kroker.
• the currently authorised withdrawal periods are inadequate to ensure that foodstuffs obtained from treated animals do not contain residues which might constitute a health hazard to the consumer.
• trenutno odobrene karence ne zagotavljajo, da živila, proizvedena s predelavo zdravljenih živali, ne vsebujejo za potrošnikovo zdravje potencialno nevarnih ostankov.
Concerns were raised by Belgium, Germany and the United Kingdom regarding the inadequacy of the withdrawal periods and the applications were withdrawn from these countries.
Belgija, Nemčija in Združeno kraljestvo pa sta izrazili pomisleke glede ustreznosti karenc in vloge so bile v obeh državah umaknjene.
The rapporteur was Mrs. R. Kearsley and the co-rapporteur was Prof. C. Friis.
Poročevalka je bila ga. dr. R. Kearsley, soporočevalec pa prof. C. Friis.
A mutual recognition procedure was started on 28 April 2005.
Postopek medsebojnega priznavanja se je pričel 28. aprila 2005.
The detailed grounds for the request were submitted to the EMEA on 18 July 2006 and the evaluation procedure for the re-examination started on 19 July 2006.
Podrobna podlaga za to prošnjo je bila agenciji EMEA predložena dne 18. julija 2006, 19. julija 2006 pa se je pričel postopek vrednotenja v okviru ponovne presoje.
Therefore, the Committee adopted by consensus an opinion recommending the lifting of the suspension of the marketing authorisations for the above-mentioned product.
Odbor je zato soglasno sprejel mnenje, s katerim priporoča umik začasnega preklica dovoljenj za promet za zgoraj navedeni zdravili.
• the currently established withdrawal periods for cattle and pigs are inadequate to ensure that residues do not exceed the MRLs;
• trenutno določene karence za govedo in prašiče ne zagotavljajo, da ostanki ne bodo presegli mejnih vrednosti ostankov (MRL);
During its June 2006 meeting, the CVMP appointed Dr. R. Breathnach as rapporteur for the assessment of the grounds for the request for re-examination of the opinion.
Med svojim zasedanjem junija 2006 je CVMP določil dr. R. Breathnacha za poročevalca pri ocenjevanju oz. za ponovno presojo mnenja.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the SPC in Annex III.
Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, povzetek glavnih značilnosti zdravila pa v Dodatku III.
On 14 November 2006 the European Commission suspended the written procedure and on 16 November 2006, requested the CVMP to consider the new residue studies in the assessment of the referral and to revise as appropriate the opinion of 13 September 2006.
Dne 14. novembra 2006 je Evropska komisija prekinila pisni postopek ter 16. novembra 2006 zaprosila CVMP, naj v svoji oceni razlogov za napotitev upošteva tudi nove študije ostankov in ustrezno dopolni svoje mnenje z dne 13. septembra 2006.
The scope of the referral was to agree whether the proposed withdrawal periods of 58 days for cattle and 35 days for pigs were adequately established.
Namen napotitve je bila uskladitev mnenj glede tega, ali sta bili predlagani karenci 58 dni za govedo in 35 dni za prašiče pravilno določeni.
Furthermore, the Committee recommends varying the marketing authorisations of the veterinary medicinal products referred to in Annex I in accordance with the Summary of Product Characteristics (SPC) as set out in Annex III.
Odbor poleg tega priporoča spremembo dovoljenj za promet za zdravila za uporabo v veterinarski medicini, navedena v Dodatku I, v skladu s povzetkom glavnih značilnosti zdravila, navedenem v Dodatku III.
The Marketing Authorisation Holder submitted further new residue studies to the CVMP on 14 April 2008.
Imetnik dovoljenja za promet je odboru CVMP dne 14. aprila 2008 predložil nove študije ostankov.
On 1 June 2006, the MAH notified the EMEA of its intention to request the reexamination of the CVMP opinion in accordance with Article 36(4)2.
Dne 1. junija 2006 je imetnik dovoljenja za promet obvestil agencijo EMEA, da namerava ponovno zaprositi CVMP za preučitev karence v skladu s členom 36(4)2.
FOLLOW-UP OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR Suramox 15 % LA and its associated name Stabox 15 % LA International Non-Proprietary Name (INN): Amoxicillin
DODATNO MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 351 ZA Suramox 15 % LA in z njim povezano ime Stabox 15 % LA Mednarodno nelastniško ime (INN): amoksicilin
• it was not possible to establish a withdrawal period for cattle and pigs based on the data available;
• na podlagi predloženih podatkov ni bilo mogoče določiti karence za govedo in prašiče;
A Marketing Authorisation for Suramox 15% LA was previously granted to Virbac S.A. in France on 6 July 2004 based on an abridged application citing Duphamox LA as reference medicinal product.
Dovoljenje za promet za zdravilo Suramox 15 % LA je bilo prvotno podeljeno podjetju Virbac S.A. iz Francije dne 6. julija 2004, in sicer na podlagi skrajšane vloge, v kateri je bilo zdravilo Duphamox LA navedeno kot referenčno zdravilo.
The Marketing Authorisation Holder submitted the new residue studies to the CVMP on 9 January 2007 and provided oral explanations to the Committee on 13 March 2007.
Imetnik dovoljenja za promet je nove študije ostankov posredoval CVMP dne 9. januarja 2007 ter 13. marca 2007 Odboru podal tudi ustna pojasnila.
In both species the product is administered intramuscularly at a dose of 15 mg amoxicillin/kg bw (equivalent to 1 ml of Suramox 15% LA / 10 kg bw) twice with a 48 hour interval between doses.
Pri obeh živalskih vrstah se zdravilo daje dvakrat v 48-urnem razmaku med obema injiciranjima, in sicer intramuskularno v odmerku 15 mg amoksicilina/1 kg telesne mase (kar je enakovredno 1 ml zdravila Suramox 15 % LA/10 kg telesne mase).
The Marketing Authorisation Holder (MAH) subsequently provided written explanations to the Committee on 16 January 2006.
Imetnik dovoljenja za promet je dne 16. januarja 2006 Odboru predložil pisna pojasnila.
The withdrawal periods established for Suramox 15% LA were 58 days in cattle for meat and offal and 35 days in pigs for meat and offal.
Karenca, določena za zdravilo Suramox 15 % LA, je bila 58 dni pri govedu za meso in drobovino ter 35 dni pri prašičih za meso in drobovino.
On 13 June 2007 the European Commission adopted a Commission Decision suspending the national marketing authorisations for Suramox 15% LA and Stabox 15% LA, but providing an opportunity for the decision to be reviewed further to a new opinion formulated by the CVMP on the basis of the assessment of new residue depletion studies.
Dne 13. junija 2007 je Evropska komisija sprejela sklep, s katerim izreka začasni preklic nacionalnih dovoljenj za promet za zdravili Suramox 15 % LA in Stabox 15 % LA, ki pa hkrati dopušča možnost ponovne presoje tega sklepa v primeru, da bo CVMP na podlagi ocene novih študij o izločanju ostankov sprejel novo mnenje.
On 14 March 2007 the CVMP, having considered the new residue studies, concluded that it was not possible to set a withdrawal period for Suramox 15% LA and Stabox 15% LA, for either cattle or pig meat and offal and therefore recommended by consensus the suspension of the above marketing authorisations for the above-mentioned products.
Dne 14. marca 2007 je CVMP ob upoštevanju novih študij ostankov zaključil, da za zdravili Suramox 15 % LA in Stabox 15 % LA ni mogoče določiti karence ne za goveje meso in drobovino niti za meso in drobovino prašičev, zaradi česar je soglasno sprejel priporočilo, da se zgoraj omenjena dovoljenja za promet za zadevna zdravila začasno prekličejo.
During its June 2008 meeting the CVMP considered the new residue studies submitted with regard to Suramox 15% LA and concluded that withdrawal periods can now be set for both cattle and pigs for Suramox 15% LA and Stabox 15% LA.
CVMP je na svojem zasedanju v juniju 2008 preučil nove študije ostankov, predložene za zdravilo Suramox 15% LA, in zaključil, da je sedaj za zdravili Suramox 15% LA in Stabox 15 % LA možno določiti karenco tako za govedo kot tudi za prašiče.
On 13 September 2006 the CVMP considered the detailed grounds for the re-examination of the opinion and confirmed its previous opinion concluding that the marketing authorisations for Suramox 15% LA should be suspended.
Dne 13. septembra 2006 je CVMP obravnaval dostavljeno dokumentacijo in potrdil svoje prvotno mnenje, s katerim priporoča začasni preklic dovoljenja za promet za zdravilo Suramox 15 % LA.
Suramox 15% LA is an injectable suspension containing amoxicillin, which is a beta-lactam antibiotic belonging to the penicillin group.
Zdravilo Suramox 15 % LA je suspenzija za injiciranje, ki vsebuje amoksicilin, t.j.
During its May 2006 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion recommending the suspension of the marketing authorisations for Suramox 15% LA and the Stabox 15% LA, for cattle and pigs.
Med svojim zasedanjem maja 2006 je CVMP na podlagi vseh posredovanih podatkov in znanstvene razprave soglasno sprejel mnenje in z njim priporočil začasni preklic dovoljenja za promet z zdraviloma Suramox 15 % LA in Stabox 15 % LA, namenjenima za zdravljenje goveda in prašičev.
There were three groups in this study.
V tej raziskavi so bile tri skupine.
There is no experience in children.
Izkušenj pri otrocih ni.
(95% confidence interval)
(95% interval zaupanja)
(Percent of Patients)
(odstotek bolnikov)
Infections may progress more rapidly and be more severe.
Okužbe lahko napredujejo hitreje in so hujše.
Patient's Name: _____________________ Doctor's Name: _____________________ Doctor's Phone: _____________________
Zdravnikovo ime: ____________________ Zdravnikov telefon: ____________________
Other opportunistic infections:
Druge oportunistične okužbe:
If this happens, do not use the syringe or vial.
Če se to zgodi, brizge ali viale ne uporabite.
Some patients were treated for up to 60 months duration.
Nekatere bolnike so zdravili do 60 mesecev.
In Study III, these improvements were maintained throughout 52 weeks.
V raziskavi III so se ta izboljšanja ohranila 52 tednov.
Quality of Life
Kvaliteta življenja
This includes tuberculosis.
To velja tudi za tuberkulozo.
Available data suggest that Trudexa does not worsen or cause strictures.
Razpoložljivi podatki kažejo, da Trudexa ne poslabša in ne povzroči striktur.
The injection is complete when the yellow indicator stops moving.
Injiciranje je končano, ko se rumeni kazalnik neha premikati.
It should be noted that in the majority of those reports, tuberculosis was extra-pulmonary, i.e. disseminated.
Opozoriti je treba, da je bila v večini teh primerov tuberkuloza zunajpljučna, tj. diseminirana.
An updated risk management plan should be provided as per the CHMP guideline on the risk management systems for medicinal products for human use.
Predložen bo posodobljen načrt upravljanja tveganja (“Risk Management Plan”) v skladu z navodili odbora CHMP “Guideline on the risk management systems for medicinal products for human use”.
Study III also had a primary endpoint of changes in quality of life.
Študija III je imela kot primarno končno točko tudi spremembe v kakovosti življenja.
• protein in urine.
• beljakovine v urinu.
This may cause severe allergic reactions in patients sensitive to latex.
To lahko povzroči hude alergijske reakcije pri bolnikih, občutljivih za lateks.
Because the elimination of adalimumab may take up to five months, monitoring should be continued throughout this period.
Ker lahko eliminacija adalimumaba traja do pet mesecev, je treba bolnike ves ta čas nadzirati.
Significant response was first observed at Week 2 and maintained through 24 weeks (Table 8).
Značilen odziv so najprej opazili po 2 tednih in se je ohranil do 24. tedna (tabela 8).
What should I do before I give myself a subcutaneous injection of Trudexa?
Kaj moram narediti, preden si dam podkožno injekcijo Trudexe?
Serious infections:
Resne okužbe:
Table 1 Undesirable Effects in Clinical Studies
Tabela 1 Neželeni učinki v kliničnih študijah