FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each unit dose (pipette) delivers: Active substances: Stronghold Plus spot-on solution
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna jedinična doza (pipeta) sadrži:
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako zamijetite bilo koju ozbiljnu nuspojavu ili druge nuspojave koje nisu opisane u uputi o VMP,
English: Name and address of the manufacturer responsible for batch release
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije u promet Zoetis Belgium SA
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Stronghold Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Stronghold Plus 30 mg/5 mg spot-on solution for cats >2.5-5 kg Stronghold Plus 60 mg/10 mg spot-on solution for cats >5-10 kg
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Stronghold Plus 15 mg/2,5 mg otopina za nakapavanje za mačke ≤2,5 kg Stronghold Plus 30 mg/5 mg otopina za nakapavanje za mačke >2,5-5 kg Stronghold Plus 60 mg/10 mg otopina za nakapavanje za mačke >5-10 kg
English: PACKAGE LEAFLET Stronghold Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Stronghold Plus 30 mg/5 mg spot-on solution for cats >2.5-5 kg Stronghold Plus 60 mg/10 mg spot-on solution for cats >5-10 kg
Croatian: UPUTA O VMP ZA Stronghold Plus 15 mg/2,5 mg otopina za nakapavanje za mačke ≤2,5 kg Stronghold Plus 30 mg/5 mg otopina za nakapavanje za mačke >2,5-5 kg Stronghold Plus 60 mg/10 mg otopina za nakapavanje za mačke >5-10 kg
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Stronghold Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Stronghold Plus 30 mg/5 mg spot-on solution for cats >2.5-5 kg Stronghold Plus 60 mg/10 mg spot-on solution for cats >5-10 kg Selamectin/sarolaner
Croatian: Stronghold Plus 30 mg/5 mg otopina za nakapavanje za mačke >2,5-5 kg Stronghold Plus 60 mg/10 mg otopina za nakapavanje za mačke >5-10 kg selamektin/sarolaner
English: Special precautions for storage
Croatian: Otopina za nakapavanje
English: • Then drink a large glass of water or any other drink.
Croatian: • Nakon toga popijte veliku čašu vode ili nekog drugog pića.
English: • Information on crisis or infections
Croatian: • Informacije o krizi ili infekcijama
English: Do not stop your treatment unless advised by your doctor.
Croatian: Terapiju nemojte prekinuti osim ako Vam to ne savjetuje liječnik.
English: It can be taken with a glass of water or a very small amount of food.
Croatian: Može se uzeti s čašom vode ili vrlo malom količinom hrane.
English: Most (61%) had a normal outcome with regard to term and normal birth.
Croatian: Ishod većine (61%) bio je normalan što se tiče termina i normalnog poroda.
English: Always take Siklos exactly as your doctor has told you.
Croatian: Siklos uvijek uzmite točno onako kako Vam je rekao liječnik.
English: Depending on the dose you take, these tests may be performed every two weeks or every two months.
Croatian: Ovisno o dozi koju uzimate, ove se pretrage mogu obavljati svaka dva tjedna ili svaka dva mjeseca.
English: This leaflet was last approved in
Croatian: Ova uputa je zadnji puta odobrena u .
English: Siklos is not recommended during pregnancy.
Croatian: Uzimanje Siklosa ne preporučuje se tijekom trudnoće.
English: • Key signs and symptoms of serious adverse reactions
Croatian: • Ključne znakove i simptome ozbiljnih nuspojava
English: • Need for contraception
Croatian: • Potrebu za kontracepcijom
English: If you take more Siklos than you should
Croatian: Ako uzmete više Siklosa nego što ste trebali
English: The use of effective contraception is strongly recommended.
Croatian: Svakako se preporučuje korištenje učinkovite kontracepcije.
English: Continue as normal when it is time to take the next dose as prescribed by your doctor.
Croatian: Normalno nastavite terapiju kad dođe vrijeme za sljedeću dozu lijeka kako je to propisao Vaš liječnik.
English: What Siklos is and what it is used for
Croatian: Što je Siklos i za što se koristi
English: No information is available regarding pharmacokinetic differences due to age (except paediatric patients), gender or race.
Croatian: Ne postoje dostupni podaci o farmakokinetičkim razlikama zbog dobi (osim za pedijatrijske bolesnike), spola ili rase.
English: Rash, melanonychia, alopecia
Croatian: osip, melanonihija, alopecija
English: This can cause acute pain crises and organ damage.
Croatian: To uzrokuje akutne bolne krize i oštećenje organa.
English: Like all medicines, Siklos can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Siklos može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: The prescribed dose of Siklos must be taken once daily, preferably in the morning before breakfast.
Croatian: Propisana doza Siklosa mora se uzimati jednom dnevno, po mogućnosti ujutro prije doručka.
English: Your doctor will tell you how much of Siklos to take each day and will describe the dose in whole, half or quarter tablets.
Croatian: Liječnik će Vam reći koliko Siklosa trebate uzeti svaki dan te će odrediti dozu u cijelim, polovinama ili četvrtinama tableta.
English: Your doctor will tell you how long to take Siklos.
Croatian: Liječnik će Vas uputiti koliko dugo ćete uzimati Siklos.
English: Other medicines and Siklos
Croatian: Drugi lijekovi i Siklos
English: • Risk of medication error due to the availability of two different strengths
Croatian: • Rizik medikacijske pogreške zbog dostupnosti lijeka u dvije različite jačine
English: Patients who are stable on lower doses should be monitored every 2 months.
Croatian: Bolesnike čije je stanje stabilno uz manje doze treba kontrolirati svaka 2 mjeseca.
English: If you cannot swallow the tablets, you can disintegrate them in water immediately before use:
Croatian: Ako ne možete progutati tablete, možete ih otopiti u vodi neposredno prije uzimanja:
English: Geriatric, gender, race
Croatian: Gerijatrijski bolesnici, spol, rasa
English: Thus, the data on a limited number of exposed pregnancies indicate no adverse effects on pregnancy or on the health of the foetus/newborn.
Croatian: Stoga podaci o ograničenom broju izloženih trudnoća ukazuju da nije bilo štetnih učinaka na trudnoću ili zdravlje fetusa/novorođenčeta.
English: What Siklos is and what it is used for What you need to know before you take Siklos How to take Siklos
Croatian: Što je Siklos i za što se koristi Što morate znati prije nego počnete uzimati Siklos Kako uzimati Siklos
English: • Risk to male and female fertility, potential risk to foetus and breast feeding
Croatian: • Rizik za plodnost žena i muškaraca, potencijalni rizik za plod i dojenje
English: Frequencies are defined as very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane kao: vrlo često (> 1/10), često (> 1/100 i < 1/10), manje često (> 1/1000 i < 1/100), rijetko (> 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Recovery from myelosuppression is usually rapid when therapy is discontinued.
Croatian: Oporavak od mijelosupresije obično je brz nakon prekida terapije.
English: Absence or low amount of sperm in the semen (azoospermia or oligospermia).
Croatian: Izostanak ili mali broj spermija u sjemenoj tekućini (azoospermija ili oligospermija).
English: 5 Weight gain may be an effect of improved general conditions.
Croatian: 5 Dobivanje na težini može biti posljedica oporavka općeg stanja organizma.
English: E-mail : contact@addmedica.com
Croatian: : contact@addmedica.com
English: It is currently unknown how long patients should be treated with Siklos.
Croatian: Trenutno nije poznato koliko bi dugo bolesnici trebali primati terapiju Siklosom.
English: Conforming to the individual dose, the tablet or the half or quarter of the tablet should be taken once daily, preferably in the morning before breakfast and, where necessary, with a glass of water or a very small amount of food.
Croatian: U skladu s individualnim doziranjem, cijelu, polovicu ili četvrtinu tablete treba uzimati jednom dnevno, poželjno ujutro prije doručka i, s čašom vode ili vrlo malom količinom hrane.
English: Neutropenia is generally the first and most common manifestation of haematological suppression.
Croatian: Neutropenija je općenito prvi i najčešći simptom hematološke supresije.
English: 4 Oligospermia and azoospermia are in general reversible, but have to be taken into account when fatherhood is desired (see section 5.3).
Croatian: 4 Oligospermija i azospermija općenito su reverzibilne, ali ih je potrebno uzeti u obzir ako muškarac želi postati ocem (vidjeti dio 5.3).
English: The patient information pack should contain the following key elements:
Croatian: Paket s informacijama za bolesnika mora sadržavati sljedeće ključne elemente:
English: It is recommended that blood counts are monitored for several weeks after overdose since recovery may be delayed.
Croatian: Preporučuje se praćenje krvne slike tijekom nekoliko tjedana nakon predoziranja jer oporavak može trajati duže.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Croatian: Studije na životinjama ukazale su na reproduktivnu toksičnost (vidjeti dio 5.3).
English: Thrombocytopenia and anaemia occur less frequently, and are rarely seen without a preceding neutropenia.
Croatian: Trombocitopenija i anemija javljaju se manje često, a rijetko su opažene bez prethodne neutropenije.
English: A dose producing haematological toxicity should not be tried more than two times.
Croatian: Doza koja za posljedicu ima hematološku toksičnost ne bi se smjela primjeniti više od dvaput.
English: • Handling of broken tablets
Croatian: • Rukovanje razlomljenim tabletama
English: Treatment may then be reinstituted at a reduced dose.
Croatian: Terapija se tada može ponovno uvesti u smanjenoj dozi.
English: Gradual dose titration may help to diminish these effects (see section 4.2).
Croatian: Postupna titracija doze može pomoći u ublažavanju ovih učinaka (vidjeti dio 4.2).
English: In the other cases with known evolution, pregnancy had been interrupted either voluntarily or upon medical advice.
Croatian: U ostalim poznatim slučajevima, trudnoća je bila prekinuta namjerno ili nakon savjeta liječnika.
English: Gastrointestinal disturbances, vomiting, gastrointestinal ulcer, severe hypomagnesaemia
Croatian: gastrointestinalne smetnje, povraćanje, gastrointestinalni ulkus, teška hipomagnezemija
English: • Need for periodic blood counts and dose adjustment
Croatian: • Potrebu za periodičnim krvnim pretragama i prilagođavanjem doze
English: Treatment with Siklos and concomitant immunisation with live virus vaccines should only be performed if benefits clearly outweigh potential risks.
Croatian: Liječenje Siklosom uz istodobnu imunizaciju cjepivima sa živim virusima trebala bi se provoditi samo ako prednosti značajno nadmašuju potencijalne rizike.
English: If you take more Siklos than you should or if a child has taken any, contact your doctor or the nearest hospital immediately as you may need urgent medical treatment.
Croatian: Ako uzmete više Siklosa nego što ste trebali ili ako je dijete uzelo lijek, odmah se obratite liječniku ili najbližoj bolnici jer će Vam možda trebati hitna medicinska pomoć.
English: • When to seek urgent attention from the health care provider
Croatian: • Kada zatražiti hitnu pomoć liječnika
English: If you experience (or have experienced) any of the above, please tell your doctor.
Croatian: Ako imate (ili ste imali) bilo koju od gore navedenih tegoba, molimo o tome obavijestite svog liječnika.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX05.
Croatian: Farmakoterapijska skupina: Antineoplastici, ostale antineoplastici, ATK oznaka: L01XX05.
English: UNIQUE IDENTIFIER- 2D BARCODE
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom
English: The toxic range may be characterised by the following results of blood tests: Neutrophils
Croatian: Raspon toksičnosti mogu određivati sljedeći nalazi krvnih pretraga: Neutrofili
English: What Siklos looks like and contents of the pack
Croatian: Kako Siklos izgleda i sadržaj pakiranja
English: Unused broken tablets must be replaced in the bottle and must be used within three months.
Croatian: Neupotrijebljene izlomljene tablete moraju se spremiti natrag u bocu i moraju se upotrijebiti u roku od tri mjeseca.
English: The tablet can be divided into four equal parts.
Croatian: Tableta se može razdijeliti na četiri jednaka dijela.
English: The treatment guide for physicians should contain the following key elements:
Croatian: Vodič za terapiju namijenjen liječnicima mora sadržavati sljedeće ključne elemente:
English: If you stop taking Siklos
Croatian: Ako prestanete uzimati Siklos
English: When taking Siklos you will have regular blood tests and check your liver and kidney.
Croatian: Tijekom uzimanja Siklosa morat ćete obavljati redovite krvne pretrage i kontrole jetre i bubrega.
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe Siklos are provided with a physician information pack containing the following:
Croatian: Nositelj odobrenja će osigurati da prije stavljanja lijeka u promet svi liječnici od kojih se očekuje propisivanje Siklosa prime paket s informacijama za liječnike koji sadrži sljedeće:
English: • Place the required dose (preferably broken if Siklos 1000 mg tablet is used) in a teaspoon and add some water.
Croatian: • Potrebnu dozu (po mogućnosti razlomljenu ako se radi o Siklos tabletama od 1000 mg) stavite u čajnu žličicu i dodajte malo vode.
English: Weight gain5
Croatian: dobivanje na težini5
English: The same decrease was observed for the number of hospital admissions and the number of days of hospitalisation in the treated groups.
Croatian: Jednako smanjenje uočeno je i u broju prijema u bolnicu te u broju dana hospitalizacije za liječene skupine.
English: Prophylactic administration of folic acid is recommended.
Croatian: Preporučuje se profilaktička primjena folne kiseline.
English: The tablet can be divided into two equal parts.
Croatian: Tableta se može razdijeliti na dva jednaka dijela.
English: Patients should be advised not to drive or operate machines, if dizziness is experienced while taking Siklos.
Croatian: Bolesnike treba savjetovati da ne upravljaju vozilima i ne rade sa strojevima ako tijekom uzimanja Siklosa osjećaju omaglicu.
English: Infections and infestations: Not known:
Croatian: Infekcije i infestacije: Nepoznato:
English: Severe hepatic impairment (Child-Pugh classification C).
Croatian: Teško oštećenje funkcije jetre (Child-Pugh stadij C).
English: Conventional long-term studies to evaluate the carcinogenic potential of hydroxycarbamide have not been performed.
Croatian: Klasične dugoročne studije u cilju procjenjivanja kancerogenog potencijala hidroksikaramida nisu se provodile.
English: Toxic ranges of myelosuppression as described in section 4.2.
Croatian: Toksična mijelosupresija sukladno vrijednostima navedenim u dijelu 4.2.
English: An updated RMP shall be submitted on a yearly basis.
Croatian: Dopunjeni RMP podnosi svake godine.
English: In an open single-dose study in adult patients with Sickle Cell Syndrome (Yan JH et al, 2005) the influence of renal function on pharmacokinetics of hydroxycarbamide was assessed.
Croatian: U otvorenoj studiji jednokratnog doziranja kod odraslih bolesnika sa sindromom srpastih stanica (Yan JH et al, 2005) ocijenjivao se utjecaj renalne funkcije na farmakokinetiku hidroksikarbamida.
English: The MAH must implement this educational plan nationally, prior to marketing, and as agreed with the competent authorities in the Member States
Croatian: Nositelj odobrenja obvezan je ovaj plan edukacije provesti na nacionalnoj razini prije stavljanja lijeka na tržište i u skladu s dogovorom postignutim s nadležnim tijelima u zemljama članicama.
English: For the storage of unused broken tablets, see section 5 “How to store Siklos”.
Croatian: Upute o čuvanju neiskorištenih tableta pročitajte u dijelu 5 „Kako čuvati Siklos“.
English: België/Belgique/Belgien
Croatian: België/Belgique/Belgien Addmedica
English: Hence, no interaction is to be expected in case of concomitant administration with substances being substrates of cytochromes P450 or P-glycoprotein.
Croatian: Stoga se ne očekuje interakcija u slučaju istodobne primjene tvari koje su supstrati citokroma P450 ili P-glikoproteina.
English: Systemic and cutaneous lupus erythematous
Croatian: sistemski i kožni eritemski lupus
English: Continuous follow-up of the growth of treated children and adolescents is recommended.
Croatian: Preporučuje se kontinuirano praćenje rasta djece i adolescenti koja primaju terapiju.
English: 30 tablets
Croatian: 90 tableta
English: Under exceptional circumstances a maximum dose of 35 mg/kg b.w./day might be justified under close haematological monitoring (see section 4.4).
Croatian: U iznimnim slučajevima maksimalna doza od 35 mg/kg tjelesne težine/dnevno može biti opravdana uz strogo praćenje hematoloških parametara (vidjeti dio 4.4).
English: If blood counts are within the toxic range Siklos should be temporarily discontinued until blood counts recover.
Croatian: Ako broj krvnih stanica padne unutar toksičnih vrijednosti, terapiju Siklosom treba privremeno prekinuti, dok se ne oporavi normalan broj krvnih stanica.
English: Anyone handling Siklos should wash their hands before and after contact with the tablets.
Croatian: Svatko tko rukuje Siklosom treba prije i nakon doticaja s tabletom oprati ruke.
English: Because of the rarity of long term data on treatment with hydroxycarbamide in children less than 2 years of age, dose regimens have not been established and thus, in this population, the treatment with hydroxycarbamide is not recommended.
Croatian: Zbog malobrojnih dugoročnih podataka o terapiji hidroksikarbamidom u djece mlađe od 2 godine, nisu ustanovljeni režimi doziranja te se stoga za ovu populaciju liječenje hidroksikarbamidom ne preporučuje.
English: It is unknown whether this leukemogenic effect is secondary to hydroxycarbamide or is associated with the patient's underlying disease.
Croatian: Nije poznato je li taj leukemogeni učinak sekundarni učinak hidroksikarbamida ili je povezan s osnovnom bolešću bolesnika.
English: 1 Haematological recovery usually occurs within two weeks of withdrawal of hydroxycarbamide.
Croatian: 1 Krvna se slika obično oporavlja unutar dva tjedna nakon prekida uzimanja hidroksikarbamida.
English: Haemodialysis reduced the exposure to hydroxycarbamide by 33% (see sections 4.2 and 4.4).
Croatian: Hemodijalizom je izloženost hidroksikarbamidu smanjena za 33% (vidjeti dio 4.2 i 4.4).
English: Generally, the patient's antibody response to vaccines may be decreased.
Croatian: Općenito, bolesnikova reakcija antitijela na cjepivo može biti umanjena.
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Based on the limited amount of available information, in case of an exposure to hydroxycarbamide of pregnant female patients or pregnant partners of male patients, treated by hydroxycarbamide, a careful follow-up with adequate clinical, biological and ultrasonographic examinations should be considered.
Croatian: Na temelju ograničene količine dostupnih informacija, u slučaju izloženosti trudnih bolesnica ili trudnih partnerica muških bolesnika liječenih hidroksikarbamidom treba razmotriti pažljivo praćenje putem odgovarajućih kliničkih, bioloških i ultrazvučnih pretraga.
English: The biotransformation pathways as well as the metabolites are not fully characterised.
Croatian: Nisu u potpunosti utvrđeni putevi biotransformacije ni metaboliti.
English: • As soon as the tablet is disintegrated, swallow the content of the teaspoon.
Croatian: • Čim se tableta rastopi, progutajte sadržaj čajne žličice.
English: 5 How to store Siklos Contents of the pack and other information
Croatian: Kako čuvati Siklos Sadržaj pakiranja i druge informacije
English: The time to reach maximum plasma concentration and the percentage of the dose excreted in urine were increased in children compared to adults.
Croatian: Vrijeme potrebno za dostizanje maksimalne koncentracije u plazmi i postotak doze koji se izlučio u urin bili su povećani kod djece, u usporedbi s vrijednostima kod odraslih bolesnika.
English: In case of non-response (re-occurrence of crises or no decrease in crisis rate) the daily dose may be increased by steps of 2.5 to 5 mg/kg b.w./day using the most appropriate strength.
Croatian: Ako nema odgovora kod bolesnika (recidiv krize ili izostanak smanjenja stope javljanja krize) dnevna se doza može povećati u koracima od 2,5 do 5 mg/kg tjelesne težine/dnevno do postizanja najprikladnije jačine doze.
English: For patients who are not able to swallow the tablets, these can be disintegrated immediately before use in a small quantity of water in a teaspoon.
Croatian: Bolesnici koji ne mogu progutati tabletu mogu je neposredno prije uzimanja otopiti u maloj količini vode u čajnoj žličici.
English: Each half of tablet is embossed “H” on one side.
Croatian: Svaka polovica tablete ima otisnuto slovo „H“ na jednoj strani.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Croatian: Detaljnijee informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: When the maximum tolerated dose is not reached transient myelotoxicity usually occurs in less than 10% of patients, while under the maximum tolerated dose more than 50% can experience reversible bone marrow suppression.
Croatian: Kada nije postignuta maksimalna podnošljiva doza, prolazna mijelotoksičnost obično se javlja u manje od 10% bolesnika, dok je kod maksimalno podnošljive doze kod više od 50% bolesnika zabilježena reverzibilna supresija koštane srži.
English: The maximum plasma levels and the apparent volume of distribution related to body weight were well comparable between age groups.
Croatian: Maksimalne plazmatske koncentracije i prividni volumen distribucije prema težini tijela bili su usporedivi između dobnih skupina.
English: • Treatment guide for physicians
Croatian: • Vodič za terapiju namijenjen liječnicima
English: Siklos has minor influence on the ability to drive and use machines.
Croatian: Siklos malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Luxembourg/Luxemburg
Croatian: Luxembourg/Luxemburg Addmedica
English: Very rare side effects (may affect up to 1 in 10,000 people) or unknown frequency (frequency cannot be estimated from the available data):
Croatian: Vrlo rijetke nuspojave (mogu se javiti kod do 1 na 10 000 osoba) ili nuspojave nepoznate učestalosti (učestalost nije moguće procijeniti na temelju dostupnih podataka):
English: In patients with a creatinine clearance ≤ 60 ml/min the initial Siklos dose should be decreased by 50%.
Croatian: Kod bolesnika s klirensom kreatinina ≤ 60 ml/min početnu dozu Siklosa treba smanjiti za 50%.
English: Also, in rats testicular atrophy with decreased spermatogenesis occurred, while in dogs reversible spermatogenic arrest was noted.
Croatian: Kod štakora se osim toga pojavila atrofija testisa sa smanjenjem spermatogeneze, dok je kod pasa zabilježen reverzibilan zastoj spermatogeneze.
English: Siklos must not be administered to patients with severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.3, 4.4 and 5.2).
Croatian: Siklos se ne smije primjenjivati bolesnicima s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) (vidjeti dijelove 4.3, 4.4 i 5.2).