natgillin/translations-raw huggingface dataset:
A drug utilisation study to characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers was also considered.
Razmatralo se također ispitivanje iskoristivosti lijeka kako bi se opisale prakse propisivanja lijekova u uobičajenoj kliničkoj upotrebi u reprezentativnoj skupini liječnika koji propisuju lijek.
In this study almost 67% of women prescribed CPA-containing preparations remembered after the discussion with their healthcare professional that their individual prescription was written for acne and/or PCOS, indicating that the skin condition was discussed during the counselling and was mentioned as the main reason to prescribe CPA/EE (2mg/0.035mg).
U ovom ispitivanju gotovo 67% žena kojima su propisani pripravci s CPA zapamtilo je nakon razgovora sa svojim liječnikom da su im recepti propisani zbog akni i/ili sindroma policističnih jajnika, što pokazuje da se tijekom savjetovanja govorilo o stanju kože i bilo je spomenuto kao glavni razlog propisivanja CPA/EE (2 mg/0,035 mg).
A total of 175 cases (all serious, medically confirmed (38.3%, n=67 in total) and non-medically confirmed (61.7%, n=108 in total)) reporting thrombotic / thromboembolic events (TE) irrespective of their nature (arterial, venous and unspecified) occurring in female patients in association with CPA/EE (2mg/0.035mg) were received by the MAH from worldwide sources additionally to the 968 TE cases presented in the main analysis.
Nositelj odobrenja primio je iz različitih izvora diljem svijeta prijave za ukupno 175 slučajeva, svi ozbiljni, medicinski potvrđeni (38,3%, n=67 ukupno) i za one koji nisu bili medicinski potvrđeni (61,7%, n=108 ukupno)) trombotskih / tromboembolijskih događaja bez obzira na njihovu prirodu (arterijski, venski i neodređeno) zabilježenih u bolesnica povezano s CPA/EE (2 mg/0,035 mg) uz 968 tromboembolijskih slučajeva opisanih u glavnoj analizi.
The PRAC considered all the above data for the CPA/EE (2mg/0.035mg) containing medicinal products and recommended clarification on the indication of the products.
PRAC je razmotrio sve prethodno navedene podatke za lijekove koji sadrže CPA/EE (2 mg/0,035 mg) i preporučilo pojašnjenje indikacija za te lijekove.
• The PRAC also noted the available data concerning the hormonal contraceptive effect of cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products.
• PRAC se također osvrnuo na dostupne podatke koji se odnose na hormonsko-kontracepcijski učinak lijekova koji sadrže ciproteron acetat/etinilestradiol (2 mg/0,035 mg).
The contraceptive effect of CPA/EE (2mg/0.035mg) was investigated in several studies at the time of authorisation.
Kontracepcijski učinak CPA/EE (2 mg/0,035 mg) istraživan je u nekoliko ispitivanja u vrijeme davanja odobrenja za stavljanje lijeka u promet.
The PRAC considered all the cumulative efficacy and safety data submitted for the indications of acne and seborrhea, hirsutism and alopecia.
Povjerenstvo za procjenu rizika na području farmakovigilancije (PRAC) razmotrilo je sve kumulativne podatke o djelotvornosti i sigurnosti podnesene za indikacije akni i seboreje, hirzutizma i alopecije.
Non-fatal cases
Slučajevi koji nisu imali smrtni ishod
The MAH commented that data from these two studies indicate that, even where the primary reason for consultation is almost certainly contraception, 63% of prescriptions for CPA/EE (2mg/0.035mg) could be linked by the patients themselves to acne and/or other hyperandrogenous conditions.
Nositelj odobrenja komentirao je da podaci iz ta dva ispitivanja pokazuju da, čak i kada je primarni razlog savjetovanja gotovo sigurno kontracepcija, 63% recepata za CPA/EE (2 mg/0,035 mg) same bolesnice/pacijentice mogu povezati s aknama i/ili drugim stanjima hiperandrogenemije.
Scientific conclusions and grounds for the variation to the terms of the marketing authorisations subject to conditions
Sveukupni zaključak i uvjeti davanja odobrenja za stavljanje lijeka u promet
CPA/EE (2mg/0.035mg) containing medicinal products have anti-androgenic effects.
Lijekovi koji sadrže CPA/EE (2 mg/0,035 mg) imaju androgene učinke.
There were no cases reporting ATE with a fatal outcome.
Nije bilo slučajeva prijavljenih događaja arterijske tromboembolije sa smrtnim ishodom.
In addition the contraceptive effect of CPA/EE (2mg/0.035mg) was investigated in a European Active Surveillance (EURAS) study.
Osim istraživanja s obzirom na učinak sprječavanja začeća, CPA/EE (2 mg/0,035 mg) je istraživan u europskom ispitivanju aktivnog nadzora (European Active Surveillance, EURAS).
Post-marketing reporting
Prijave poslije stavljanja lijeka na tržište
The PRAC reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience on the safety of cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products, as well as stakeholders' submissions in particular with regards to the thromboembolic events.
PRAC je pregledao sve dostupne podatke kliničkih ispitivanja, farmakološko-epidemioloških studija, objavljene literaturne podatke, iskustva nakon stavljanja lijeka u promet s obzirom na sigurnost lijekova koji sadrže ciproteron acetat/etinilestradiol (2 mg/0,035 mg), kao i podnošenja dioničara posebice s obzirom na tromboembolijske događaje.
The PRAC considered that a Direct Healthcare Professional Communication (DHPC) was needed to communicate the outcome of the present review.
PRAC smatra da ishod ove revizije treba navesti u Izravnom priopćenju zdravstvenim djelatnicima (DHPC).
A total of 789 (81.5%) of 968 retrieved cases reported one or more VTEs in association with CPA/EE (2mg/0.035mg) use.
Ukupno 789 (81,5%) od 968 dohvaćenih slučajeva zabilježilo je jednu ili više događaja venske tromboembolije povezanih s upotrebom CPA/EE (2 mg/0,035 mg).
These studies (INAS-OC and INAS-SCORE) investigate the safety of the combined oral contraceptive drugs YAZ (3 mg drospirenone/0.020mg ethinylestradiol) and Qlaira (dienogest/estradiol valerate, step down dose regimen) respectively.
Ta ispitivanja (INAS-OC i INAS-SCORE) istražuju sigurnost kombiniranih peroralnih kontracepcijskih tableta YAZ (3 mg drospirenon/0,020 mg etinilestradiol) i Qlaira (dienogest/estradiol valerat u režimu prema nižim dozama).
The wording of the indication of cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products varies between the EU Member States.
Tekst indikacije za lijekove koji sadrže ciproteron acetat/etinilestradiol (2 mg/0,035 mg) razlikuje se među zemljama članicama EU.
• The PRAC reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience on the safety of cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products, as well as stakeholders' submissions in particular with regards to the risk of thromboembolic events.
• PRAC je pregledao sve dostupne podatke kliničkih ispitivanja, farmakološko-epidemioloških studija, objavljene literaturne podatke, iskustva nakon stavljanja lijeka u promet s obzirom na sigurnost lijekova koji sadrže ciproteron acetat/etinilestradiol (2 mg/0,035 mg), kao i podnošenja dioničara posebice s obzirom na rizik za tromboembolijske događaje.
Subsequent studies (Lidegaard et al. 2003, Seaman et al. 2004), the latter addressing the issue of confounding, concluded that the absolute risk of VTE among women taking CPA/EE is not significantly greater than for women on COCs.
2004), s tim da se ovo drugo ispitivanje bavilo čimbenicima koji su ometali rezultate, zaključila su da apsolutni rizik od VTE među ženama koje uzimaju CPA/EE nije značajno veći od rizika u žena koje uzimaju kombinirane peroralne kontraceptive.
In comparison with other medical treatment options, no clinical differences in hirsutism were detected when CPA/EE (2mg/0.035mg) was compared to other medicinal products (spironolactone, finasteride, GnRH analogues, ketoconazole).
U usporedbi s drugim opcijama medicinskog liječenja, kliničke razlike hirzutizma nisu detektirane kada je CPA/EE (2 mg/0,035 mg) uspoređen s drugim lijekovima (spironolakton, finasterid, GnRH analozi, ketokonazol). jedina razlika u kliničkom ishodu bio je značajno poboljšan rezultat Ferriman Gallwe (FG) u 12 mjeseci kada se ciproteron acetat usporedio s flutamidom.
Direct questioning of the prescribing physician would be needed to ascertain this true proportion.
Da bi se ustanovio točan omjer trebalo bi pitati izravno liječnika koji je recept propisao.
Benefit-risk balance
Omjer koristi i rizika
The CMDh, having considered the PRAC recommendation dated 16 May 2013 with regards to the cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products, agrees with the recommendation therein as stated below:
Razmotrivši preporuke Povjerenstva za ocjenu rizika na području farmakovigilancije PRAC od 16. svibnja 2013. s obzirom na lijekove koji sadrže ciproteron acetat/etinilestradiol (2 mg/0,035 mg), CMDh prihvaća niže navedene preporuke:
Finally educational material for prescribers on the risk of VTEs and ATEs as well for patients for awareness of the VTEs and ATEs symptoms have been requested by PRAC for submission within the risk management plan.
Konačno, PRAC traži da podnesen plan upravljanja rizikom uključi i edukacijski materijal za liječnike koji propisuju lijek o riziku za VTE i ATE, a također i za bolesnike zbog upoznavanja sa simptomima VTE i ATE.
The PRAC concluded that the risk-benefit balance of cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal product(s) in the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism, in women of reproductive age remains favourable subject to the restrictions, warnings, other changes to the product information, additional pharmacovigilance activities and additional risk minimisation measures agreed.
PRAC zaključuje da omjer rizika i koristi za lijekove koji sadrže ciproteron acetat/etinilestradiol (2 mg/0,035 mg) za liječenje umjerenih do teških akni povezanih s osjetljivošću na androgene (sa seborejom ili bez nje) i/ili hirzutizma, u žena reproduktivne dobi ostaje povoljan uz ograničenja, upozorenja, druge promjene informacije o lijeku, dodatnim farmakovigilancijskim aktivnostima i dodatnim dogovorenim mjerama minimizacije rizika.
It also noted the available data concerning the hormonal contraceptive effect of CPA/EE (2mg/0.035mg) containing medicinal products.
Također se osvrnulo na dostupne podatke za hormonski i kontracepcijski učinak lijekova koji sadrže CPA/EE (2 mg/0,035 mg).
Cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products are known to increase risk of thromboembolic events (TE).
Poznato je da lijekovi koji sadrže ciproteron acetat/etinilestradiol (2 mg/0,035 mg) povećavaju rizik od tromboembolijskih događaja (TE).
Studies show considerable variability in their relative risk compared to non-use or other COCs and in their absolute risk for VTE.
U apsolutnom riziku od VTE, ispitivanja pokazuju znatnu varijabilnost relativnog rizika u usporedbi s neupotrebom kontraceptiva ili drugim kombiniranim peroralnim kontraceptivima.
In this study, around 60% of women prescribed a CPA/EE-containing preparation specifically reported in the baseline questionnaire that their CPA/EE (2mg/0.035mg) prescription was due to acne and/or polycystic ovary syndrome (PCOS).
U tom ispitivanju oko 60% žena kojima je propisan pripravak s CPA/EE, posebno je izjavilo u upitniku ispunjavanom na početku ispitivanja, da su dobile recept za CPA/EE (2 mg/0,035 mg) zbog akni i/ili sindroma policističnih jajnika (PCOS.
The PRAC in accordance with Article 107j(3) of Directive 2001/83/EC, recommended by majority that a. the marketing authorisation holders should sponsor a post-authorisation safety study together with the follow up evaluation of the results of that study, as well as a drug utilisation study (see Annex IV - Conditions of marketing Authorisations); b. the marketing authorisation holders should implement risk minimisation measures; c. the marketing authorisations of the cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products (see Annex I) should be varied (in accordance with changes to the product information as set out in Annex III).
PRAC u skladu s člankom 107j(3) Direktive 2001/83/EZ, preporučuje većinom svojih članova da a. nositelji odobrenja trebaju sponzorirati sigurnosno ispitivanje poslije odobrenja za stavljanje lijeka u promet zajedno s praćenjem u svrhu procjene rezultata tog ispitivanja, a također i ispitivanje korisnosti lijeka (vidjeti Dodatak IV - Uvjeti davanja odobrenja);
With exception of study report AI58, no cases of VTEs or ATEs were reported in patients from the 10 MAH- sponsored clinical trials with (CPA/EE) (2mg/0.035mg).
S izuzetkom izvješća AI58, u 10 kliničkih ispitivanja s CPA/EE koja je sponzorirao nositelj odobrenja (2 mg/0,035 mg) u bolesnika nisu zabilježeni slučajevi venske ili arterijske tromboembolije.
The protocol of drug utilisation study in order to better characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription should be also be submitted as part of the RMP.
Plana potrebno je također podnijeti protokol za ispitivanje iskoristivosti lijeka kako bi se bolje opisale prakse propisivanja lijekova u uobičajenoj kliničkoj upotrebi u reprezentativnoj skupini liječnika koji propisuju lijek te radi procjene glavnih razloga propisivanja.
Overall summary of the scientific evaluation of cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal product(s) by PRAC
PRAC-ov cjelokupni sažetak znanstvene procjene lijeka koji sadrži / lijekova koji sadrže ciproteron acetat/etinilestradiol (2 mg/0,035 mg)
French assessment report February 2013 Rationale for the triggering of procedure under Article 107i of Directive 2001/83/EC on cyproterone/ethinylestradiol (2mg/0.035mg) presented by ANSM, France history of VTE before prescribing EE-containing medicinal products (e.g. combined oral contraceptives (COC)) is, therefore, recommended in the product information of the products.
Izvješće procjene za Francusku, obrazloženje iz veljače 2013. za poticanje postupka prema članku 107i Direktive 2001/83/EZ za ciproteron/etinilestradiol (2 mg/0,035 mg) koje je podnijela Francuska agencija za lijekove (ANSM).
• The PRAC is of the opinion that the benefits of cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products continue to outweigh the risks in the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism, in women of reproductive age.
• PRAC smatra da koristi lijekova koji sadrže ciproteron acetat/etinilestradiol (2 mg/0,035 mg) i dalje nadilazi rizike u liječenju umjerenih do teških akni povezanih s osjetljivošću na androgene (sa seborejom ili bez nje) i/ili hirzutizma u žena reproduktivne dobi.
There are two large, ongoing post-marketing surveillance studies which yield incidental data on the use of CPA/EE (2mg/0.035mg) containing medicinal products.
U tijeku su dva velika ispitivanja nadzora nakon stavljanja lijeka u promet koje daju usputne podatke o upotrebi lijekova koji sadrže ciproteron acetat/etinilestradiol (2 mg/0,035 mg).
The PRAC is of the opinion that the benefits of CPA/EE (2mg/0.035mg) containing medicinal products continue to outweigh the risks in the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism, in women of reproductive age.
PRAC smatra da koristi od lijekova koji sadrže CPA/EE (2 mg/0,035 mg) i dalje nadilazi rizike u liječenju umjerenih do teških akni povezanih s osjetljivošću na androgene (sa seborejom ili bez nje) i/ili hirzutizma u žena reproduktivne dobi.
Compared with a corresponding reporting frequency ranging between 0.8 and 1.5 per 100,000 women-years during the previous six PSUR periods, there is no evidence of an overall increased reporting frequency of thrombotic /thromboembolic events.
U usporedbi s odgovarajućom učestalošću prijava u rasponu od 0,8 i 1,5 na 100 000 žena-godina tijekom prethodnih 6 razdoblja
Hormone preparations containing CPA/EE (2mg/0.035mg) are part of the comparator arms in these studies.
Hormonske pripravke koji sadrže ciproteron acetat/etinilestradiol (2 mg/0,035 mg), uzimali su dijelovi usporedbenih skupina u tim ispitivanjima.
This translates into a global spontaneous reporting rate of 1.2 non-fatal TE reports per 100,000 women-years with CPA/EE (2mg/0.035mg).
To se prenosi u stopu globalnih spontanih prijava od 1,2 izvješća o tromboembolijskim događajima bez smrtnog ishoda na 100 000 žena-godina uz primjenu CPA/EE (2 mg/0,035 mg).
This translates into the global spontaneous reporting rate of 0.10 fatal TE reports per 100,000 womenyears with CPA/EE (2mg/0.035mg).
To se prenosi u globalnu stopu spontanog izvještavanja od 0,10 prijava trombotskih događaja sa smrtnim ishodom na 100 000 žena-godina uz primjeni CPA/EE (2 mg/0,035 mg).
This translates into reporting rate of 1.05 ADR reports per 100,000 women-years with CPA/EE (2mg/0.035mg).
To se prenosi u stopu globalnih izvješća od 1,05 izvješća o nuspojavama na 100 000 žena-godina za upotrebu CPA/EE (2 mg/0,035 mg).
The PRAC concluded that the benefit-risk balance of cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products is favourable as the benefits continue to outweigh the risks in the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age.
PRAC je zaključio da je omjer koristi i rizika za lijekove koji sadrže ciproteron acetat/etinilestradiol (2 mg/0,035 mg) povoljan, jer su koristi u liječenju umjerenih do teških akni povezanih s osjetljivošću na androgene (sa seborejom ili bez nje) i/ili hirzutizma u žena reproduktivne dobi i dalje veći od rizika.
This translates into reporting rate of 0.07 ADR reports per 100,000 women-years with CPA/EE (2mg/0.035mg).
To se prenosi u stopu globalnih izvješća od 0,07 izvješća o nuspojavama na 100 000 žena-godina za upotrebu CPA/EE (2 mg/0,035 mg).
Levetiracetam Actavis must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Levetiracetam Actavis se mora uzimati dva puta na dan, jednom ujutro i jednom navečer, u približno isto vrijeme svaki dan.
A risk of birth defects for your unborn child cannot be completely excluded.
Rizik od prirođenih mana za Vaše nerođeno dijete ne može se u potpunosti isključiti.
Excipient with known effect:
Pomoćne tvari s poznatim učinkom:
Height (cm) x ks
visina (cm) x ks
No data are available.
Nisu dostupni podaci.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
Package Leaflet: Information for the patient
Uputa o lijeku: Informacija za bolesnika
Take the number of tablets following your doctor´s instructions.
Uzmite količinu tableta prema uputama liječnika.
Date of first authorisation: 03 October 2011 Date of latest renewal:08 September 2016
Datum posljednje obnove odobrenja: 8.rujna 2016.
Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may result in a loss of its effect.
Nemojte uzeti makrogol (lijek koji se koristi kao laksativ) tijekom sat vremena prije i sat vremena nakon uzimanja levetiracetama jer to može uzrokovati gubitak njegova učinka.
Contact your doctor if you took more tablets than you should.
Obavijestite liječnika ako ste uzeli više tableta nego što ste trebali.
• limp or difficulty walking
• šepanje ili poteškoće s hodom.
The requirements for submission of periodic safety update report for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal
Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenima na europskom internetskom portalu za lijekove.
The major metabolic pathway (24 % of the dose) is an enzymatic hydrolysis of the acetamide group.
Glavni je metabolički put (24% doze) enzimska hidroliza acetamidne skupine.
<1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
(≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000) i vrlo rijetko (<1/10 000).
Other unidentified components accounted only for 0.6 % of the dose.
Ostali neidentificirani metaboliti odgovaraju samo 0,6% doze.
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX14.
Farmakoterapijska skupina: antiepileptici, ostali antiepileptici, ATK oznaka: N03AX14.
One was obtained by hydroxylation of the pyrrolidone ring (1.6 % of the dose) and the other one by opening of the pyrrolidone ring (0.9 % of the dose).
Jedan nastaje hidroksilacijom (1,6% doze), a drugi otvaranjem pirolidonskog prstena (0,9% doze).
• elevated/abnormal values in a liver function test;
• povišene/nenormalne vrijednosti testova jetrene funkcije;
Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation).
Levetiracetam se koristi za oblik epilepsije u kojem napadaji u početku zahvaćaju samo jednu stranu mozga ali bi se nakon toga mogli proširiti na veća područja obje strane mozga (parcijalni napadaji sa sekundarnom generalizacijom ili bez nje).
Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose increase.
Uslijed mogućih razlika u osjetljivosti među pojedincima, u nekih bolesnika može se javiti somnolencija ili drugi simptomi vezani za središnji živčani sustav, osobito na početku liječenja ili nakon povećanja doze.
The film-coated tablets must be taken orally, swallowed with a sufficient quantity of liquid and may be taken with or without food.
Filmom obložene tablete uzimaju se peroralno, progutaju se s dovoljnom količinom tekućine, a mogu se uzeti sa ili bez hrane.
What Levetiracetam Actavis is and what it is used for
Što je Levetiracetam Actavis i za što se koristi
ETTEN-LEUR, 4879AC Netherlands
ETTEN-LEUR, 4879AC Nizozemska
• A small number of people being treated with anti-epileptics such as Levetiracetam Actavis have had thoughts of harming or killing themselves.
• Mali broj ljudi liječenih antiepilepticima kao što je Levetiracetam Actavis imali su misli o samoozljeđivanju ili samoubojstvu.
Example: if your daily dose is 1,000 mg, you might take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
Primjer: ako je Vaša dnevna doza 1000 mg, mogli biste uzeti 2 tablete od 250 mg ujutro i 2 tablete od
Aluminium/PVC blister packs.
Aluminij/PVC blisteri.
• as an add-on to other antiepileptic medicines to treat:
• kao dodatna terapija uz druge antiepileptike u liječenju:
• if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).
• ako ste alergični na levetiracetam, derivate pirolidona ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
Therefore a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73 m2.
Stoga se preporučuje 50%-tno smanjenje dnevne doze održavanja ako je klirens kreatinina < 60 ml/min/1,73 m2.
• severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction],
• teške alergijske reakcije (DRESS, anafilaktička reakcija [teška i važna alergijska reakcija],