FrancophonIA/ELRC3.0 huggingface dataset:
English: If you feel faint or dizzy during or after the injections, tell your doctor before injecting your next dose.
Croatian: Ako tijekom ili nakon ubrizgavanja osjećate nesvjesticu ili omaglicu, prije ubrizgavanja sljedeće doze o tome obavijestite svog liječnika.
English: This section contains information on how to give yourself an injection of Ceplene.
Croatian: Ovaj dio sadrži informacije o načinu samoprimjene injekcije Ceplenea.
English: Ceplene must be injected 1 to 3 minutes later.
Croatian: Ceplene se mora ubrizgati 1 do 3 minute kasnije.
English: 1 Take 1 vial out of the carton.
Croatian: 1 Izvadite 1 bočicu iz kutije.
English: Interleukin-2 (IL-2) is commercially available as a recombinant IL-2; aldesleukin.
Croatian: Interleukin-2 (IL-2) je komercijalno dostupan kao rekombinantni IL-2, aldesleukin.
English: Concurrent administration of medicinal products with cardiotoxicity or blood pressure lowering effects may increase the toxicity of Ceplene.
Croatian: Istodobna primjena kardiotoksičnih lijekova ili lijekova s učinkom snižavanja krvnog tlaka mogu povećati toksičnost Ceplenea.
English: The most common adverse reactions experienced by 30% or more of patients receiving IL-2 and Ceplene (listed in descending order of frequency) were: flushing, headache, fatigue, injection site granuloma, pyrexia and injection site erythema.
Croatian: Najčešće nuspojave koje je imalo 30% ili više bolesnika koji su primali IL-2 i Ceplene (navedene prema padajućem redoslijedu učestalosti) su: crvenilo uz osjećaj vrućine, glavobolja, umor, granulom na mjestu injiciranja, pireksija i eritem na mjestu injiciranja.
English: Double check the vial label to make sure you are using the correct medicine.
Croatian: 4. Dvaput provjerite naljepnicu na bočici kako biste se uvjerili da uzimate ispravan lijek.
English: Place the pre-prepared syringes containing IL-2, Ceplene and an opened alcohol wipe where you can reach them.
Croatian: Unaprijed pripremljene štrcaljke koje sadrže IL-2 i Ceplene te otvorenu alkoholnu maramicu postavite tamo gdje ćete ih moći dosegnuti.
English: One to 3 minutes after the subcutaneous administration of IL-2 has been completed, Ceplene should be administered by slow subcutaneous injection at a rate not to exceed 0.1 mL (0.1 mg histamine dihydrochloride) per minute.
Croatian: Jednu do 3 minute nakon dovršetka supkutane primjene IL-2, Ceplene se mora primjeniti polaganim supkutanim injiciranjem brzinom koja ne smije prelaziti 0,1 ml (0,1 mg histamindiklorida) po minuti.
English: Caution should be used for patients with any of the following: symptomatic peripheral arterial disease, past or present peptic or oesophageal ulcer disease with a history of bleeding, clinically significant renal disease and stroke within the last 12 months.
Croatian: Oprez je potreban u bolesnika koji imaju bilo što od sljedećeg: simptomatsku bolest perifernih arterija, koji su imali ili imaju peptički ulkus ili ulkus na jednjaku uz anamnezu krvarenja, klinički značajnu bolest bubrega i moždani udar unutar 12 mjeseci.
English: Do not use Ceplene
Croatian: Nemojte primjenjivati Ceplene
English: Double check the syringe to make sure that you have withdrawn the correct amount.
Croatian: 15. Štrcaljku dvaput provjerite kako biste provjerili da ste uvukli točnu količinu.
English: • a history of auto-immune disease (a disease where the immune system attacks the body's own cells or tissues, such as systemic lupus, rheumatoid arthritis, inflammatory bowel disease or psoriasis).
Croatian: • anamnezu autoimune bolesti (bolest u kojoj imunološki sustav napada stanice vlastitog tijela ili tkiva, poput sistemskog lupusa, reumatoidnog artritisa, upalne bolesti crijeva ili psorijaze).
English: Administration of Ceplene or IL-2 by rapid infusion or into vascular spaces, at higher doses than the approved ones, may exaggerate the adverse reactions associated with Ceplene.
Croatian: Primjena Ceplenea ili IL-2 brzim infundiranjem ili njihova primjena u krvožilne prostore, pri višim dozama od odobrenih, može prekomjerno pojačati nuspojave povezane s Cepleneom.
English: A study was performed to measure the PK of histamine in normal volunteers compared to patients with mild, moderate, and severe hepatic impairment.
Croatian: Provedeno je ispitivanje za mjerenje PK histamina u normalnih dobrovoljaca u usporedbi s bolesnicima s blagim, umjerenim i teškim oštećenjem funkcije jetre.
English: IL-2 is administered twice daily as a subcutaneous injection 1 to 3 minutes prior to the administration of Ceplene; each dose of IL-2 is 16,400 IU/kg (1 µg/kg).
Croatian: IL-2 se primjenjuje dvaput dnevno kao supkutana injekcija 1 do 3 minute prije primjene Ceplenea; svaka doza IL-2 je 16 400 IU/kg (1 µg/kg).
English: By inhibiting oxidase function and reducing ROS production, Ceplene protects IL-2-activated NK cells and T cells from oxygen free radical-induced inhibition and apoptosis.
Croatian: Inhibiranjem funkcije oksidaze i smanjenjem stvaranja ROS-a, Ceplene štiti NK i T stanice aktivirane s IL-2 od inhibicije i apoptoze izazvane slobodnim radikalima kisika.
English: Ceplene is used in adult patients, together with IL-2, to treat a particular type of leukaemia called acute myeloid leukaemia (AML) which is a cancer of blood forming cells in the bone marrow.
Croatian: Ceplene se, zajedno s IL-2, koristi u odraslih bolesnika za liječenje određenog tipa leukemije pod nazivom akutna mijeloična leukemija (AML), raka stanica u koštanoj srži koje stvaraju krv.
English: It is recommended that you always have someone with you when injecting this medicine, such as an adult family member, friend or other care provider who could help you if you feel light-headed or faint.
Croatian: Preporučuje se da uz Vas uvijek bude netko pri ubrizgavanju ovog lijeka, poput odraslog člana obitelji, prijatelja ili zdravstvenog djelatnika koji Vam mogu pomoći ako osjetite ošamućenost ili nesvjesticu.
English: The usual dose of Ceplene is 0.5 mL of solution twice a day given as a slow subcutaneous injection (in the layer of tissue just under the skin).
Croatian: Uobičajena doza Ceplenea je 0,5 ml otopine dvaput dnevno davana kao spora supkutana injekcija (u sloj tkiva odmah ispod kože).
English: No carcinogenicity studies have been performed on Ceplene.
Croatian: Nisu provedena ispitivanja karcinogenosti Ceplenea.
English: Patients should remain at rest for 20 minutes after injection of Ceplene.
Croatian: Bolesnici moraju mirovati najmanje 20 minuta nakon injiciranja Ceplenea.
English: The diluted IL-2 (aldesleukin) is aseptically drawn up into sterile polypropylene tuberculin syringes and capped for each patient at 1 µg/kg dose, with a minimum standard dosage volume of 0.25 mL (50 µg) and a maximum dose of 0.5 mL (100 µg).
Croatian: Razrijeđeni IL-2 (aldesleukin) aseptički se navlači u sterilne polipropilenske tuberkulinske štrcaljke i zatvara zatvaračem za svakog bolesnika u dozi 1 µg/kg, s najmanjim standardnim volumenom doziranja od 0,25 ml (50 µg) i najvećom dozom od 0,5 ml (100 µg).
English: • Abnormal redness of the skin (erythema), increased sweating (hyperhidrosis), night sweats and itching (pruritus)
Croatian: • abnormalno crvenilo kože (eritem), pojačano znojenje (hiperhidroza) , noćno znojenje i svrbež
English: For patients experiencing grade 3 and 4 (including hypotension, arrhythmia) toxicities - treatment should be discontinued until the event is resolved.
Croatian: Za bolesnike sa stupnjem toksičnosti 3 i 4 (uključujući hipotenziju, aritmiju) - liječenje se mora prekinuti dok se toksičnost ne povuče.
English: IL-2 (aldesleukin) should be aseptically reconstituted, diluted and dispensed in capped polypropylene tuberculin syringes by the pharmacy based on the individual patient's weight (see administration chart for aldesleukin below) at the recommended dose of 16 400 IU/kg (1 µg/kg).
Croatian: Ljekarna mora IL-2 (aldesleukin) aseptički rekonstituirati, razrijediti i izdati u polipropilenskim tuberkulinskim štrcaljkama sa zatvaračem, na temelju individualne težine bolesnika (vidjeti niže navedenu tablicu za primjenu aldesleukina) u preporučenoj dozi od 16 400 IU/kg (1 µg/kg).
English: It is not known whether histamine crosses the placenta.
Croatian: Nije poznato prolazi li histamin kroz posteljicu.
English: For dosing instructions for Ceplene in combination with IL-2, see posology below.
Croatian: Za upute o doziranju Ceplenea u kombinaciji s IL-2, vidjeti niže navedeno doziranje.
English: • Beta-blockers, such as propranolol, metoprolol, atenolol.
Croatian: • beta-blokatori, poput propranolola, metoprolola, atenolola.
English: Dose modification
Croatian: Modifikacija doze
English: • Feeling your own heart beat (palpitations)
Croatian: • osjet vlastitih otkucaja srca (palpitacije)
English: Treatment cycles
Croatian: Ciklusi liječenja
English: Abnormal WBC counts - the dose of IL-2 can be reduced by 20% for the remaining duration of the treatment course and if abnormal WBC counts re-occur during the following cycle a permanent IL-2 reduction is recommended.
Croatian: Abnormalan broj bijelih krvnih stanica - doza IL-2 može se smanjiti za 20% za preostalo trajanje tijeka liječenja, a ako se tijekom sljedećeg ciklusa liječenja opet pojavi abnormalan broj bijelih krvnih stanica, preporučuje se trajno smanjenje IL-2.
English: Ceplene can be administered via an ambulatory infusion syringe pump or by controlled manual subcutaneous injection by syringe with a timer.
Croatian: Ceplene se može primjenjivati pomoću pumpe za štrcaljku za ambulantnu infuziju ili pomoću štrcaljke s programatorom vremena, rukom kontroliranim supkutanim injiciranjem.
English: If bubbles appear in the syringe, push the solution slowly back into the vial and withdraw the solution again.
Croatian: Ako se u štrcaljki pojave mjehurići, otopinu polagano pogurajte natrag u bočicu te ponovno uvucite otopinu.
English: Rapid injection can cause a drop in your blood pressure and make you feel faint or even pass out.
Croatian: Brzo ubrizgavanje može uzrokovati pad krvnog tlaka te možete osjetiti nesvjesticu ili se čak onesvijestiti.
English: The excretion of histamine in milk has not been studied in animals, but at maternotoxic doses in rats, offspring showed slight toxicity during early lactation (see section 5.3).
Croatian: Na životinjama nije ispitano izlučivanje histamina u mlijeko, no pri dozama toksičnim za majku u štakora, potomci su pokazali blagu toksičnost u početku dojenja (vidjeti dio 5.3).
English: Sodium chloride, water for injections, and sodium hydroxide and/or hydrochloric acid to adjust the pH.
Croatian: Natrijev klorid, voda za injekcije i natrijev hidroksid i/ili kloridna kiselina za podešavanje pH.
English: It is unknown whether histamine is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se histamin u majčino mlijeko kod ljudi.
English: Pick up the sterile syringe.
Croatian: 7. Uzmite sterilnu štrcaljku.
English: The MAH shall provide yearly updates on any new information concerning efficacy and safety of the product in patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (IL-2).
Croatian: Nositelj odobrenja će podnositi godišnja ažuriranja o svim novim informacijama o djelotvornosti i sigurnosti lijeka u bolesnika s akutnom mijeloičnom leukemijom u prvoj remisiji, istodobno liječenih interleukinom-2 (IL-2).
English: Do not use Ceplene after the expiry date which is stated on the carton and vial label.
Croatian: Ceplene se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice.
English: • Increase in the number of a certain type of white blood cells in the blood (eosinophilia) and decrease in the number of blood platelets (thrombocytopenia)
Croatian: • povećanje broja određenog tipa bijelih krvnih stanica u krvi (eozinofilija) i smanjenje broja krvnih pločica (trombocitopenija)
English: IL-2 is injected twice daily as a subcutaneous injection (in the layer of tissue just under the skin) 1 to 3 minutes before the injection of Ceplene.
Croatian: IL-2 se ubrizgava dvaput dnevno kao supkutana injekcija (u sloj tkiva odmah ispod kože) 1do 3 minute prije ubrizgavanja Ceplenea.
English: • Altered taste (dysgeusia)
Croatian: • promjena osjeta okusa (disgeuzija)
English: Ceplene maintenance therapy should be administered following completion of consolidation therapy in patients concomitantly treated with IL-2 under the supervision of a physician experienced in the management of acute myeloid leukaemia.
Croatian: Ceplene je kao terapiju održavanja potrebno primijeniti nakon završetka konsolidacijske terapije u bolesnika istodobno liječenih s IL-2, pod nadzorom liječnika s iskustvom u liječenju akutne mijeloične leukemije.
English: Ceplene inhibits NAPDH oxidase which initiates the formation and release of ROS from phagocytes.
Croatian: Ceplene inhibira NAPDH oksidazu koja potiče stvaranje i otpuštanje SRK iz fagocita.
English: If you accidentally inject more than you were told to, contact your doctor or pharmacist immediately.
Croatian: Ako nehotično ubrizgate više lijeka nego što ste trebali, odmah se obratite svojem liječniku ili ljekarniku.
English: The concomitant administration of Ceplene and IL-2 therefore aims to optimise the anti-leukaemic functions of NK cells and T cells.
Croatian: Stoga istodobna primjena Ceplenea i IL-2 cilja na optimizaciju antileukemijskih funkcija NK stanica i T stanica.
English: Doses of Ceplene and IL-2 should be modified as necessary based on individual patient tolerance to treatment.
Croatian: Doze Ceplenea i IL-2 po potrebi se moraju modificirati, ovisno o podnošljivosti liječenja u svakog bolesnika.
English: Treatment periods and treatment breaks
Croatian: Razdoblja liječenja i razdoblja prekida
English: Ceplene and IL-2 are administered for 10 treatment cycles: each cycle consists of a treatment period of 21 days (3 weeks) followed by a three-week or six-week treatment-free period.
Croatian: Ceplene i IL-2 primjenjuju se kroz 10 ciklusa liječenja: svaki ciklus sastoji se od razdoblja liječenja od 21 dana (3 tjedna) nakon čega slijedi trotjedno ili šesterotjedno razdoblje bez liječenja.
English: Skin and subcutaneous tissue disorders dry skin
Croatian: Poremećaji kože i potkožnog tkiva suha koža vrlo često
English: • Inflammation of the lung (pneumonia)
Croatian: • upala pluća (pneumonija)
English: Place the syringe on a clean flat surface.
Croatian: Štrcaljku položite na čistu ravnu površinu.
English: For CR1 patients, the median duration of leukaemia-free survival increased from 291 days (9.7 months) to 450 days (15 months) after Ceplene/IL-2 versus no maintenance treatment (Intention to Treat [ITT], p=0.01.
Croatian: bolesnika, medijan trajanja preživljenja bez leukemije povećao se s 291 dana (9,7 mjeseci) na 450 dana (15 mjeseci) nakon liječenja Ceplene/IL-2 naspram neliječenja terapijom održavanja (eng.
English: • Decrease in the number of red blood cells (anaemia)
Croatian: • smanjenje broja crvenih krvnih stanica (anemija)
English: Slowly pull back the plunger to draw the solution into the syringe, filling it to the level (number of millilitres) instructed by your doctor.
Croatian: Klip polako povucite unazad kako biste uvukli otopinu u štrcaljku, puneći je do razine (broj mililitara) prema uputama Vašeg liječnika.
English: Remove the plastic cap from the vial, exposing the stopper with the inner rubber circle.
Croatian: 5. Uklonite plastični zatvarač s bočice, otkrivajući čep s unutarnjim gumenim krugom.
English: • If you have further questions, please ask your doctor, pharmacist or nurse.
Croatian: • Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: • The active substance is histamine dihydrochloride.
Croatian: • Djelatna tvar je histamindiklorid.
English: 1 prepared syringe for your IL-2 injection (refer to the IL-2 package leaflet and your doctor's dose instructions).
Croatian: • 1 pripremljenu štrcaljku za Vašu injekciju IL-2 (pogledajte uputu o lijeku za IL-2 i upute
English: H1 receptor blocking antihistamines or neuroleptics (anti-psychotics) with H1 receptor blocking properties that might decrease efficacy of Ceplene should be avoided.
Croatian: Moraju se izbjegavati antihistaminici koji blokiraju H1 receptor ili neuroleptici (antispihotici) koji imaju svojstvo blokiranja H1 receptora što može smanjiti djelotvornost Ceplenea.
English: *see dose modification for provisions for the modification to dose and dosage schedule
Croatian: *za odredbe o modifikaciji doze i rasporedu doziranja vidjeti modifikaciju doze.
English: Patients with cardiac disease should be evaluated for ventricular ejection fraction and wall function by echocardiography or nuclear medicine stress test and then treated with caution.
Croatian: U bolesnika s bolešću srca potrebno je ehokardiografijom ili nuklearno medicinskim stres testom procijeniti ejekcijsku frakciju ventrikula i funkciju stijenke, a zatim liječenje nastaviti s oprezom.
English: Plasma drug levels were not predictive of adverse effects, however, and effects did not correlate closely with drug exposure.
Croatian: Razine lijeka u plazmi nisu pretkazivale nuspojave, a nuspojave nisu bile uzajamno povezane s izlaganjem lijeku.
English: Use an alcohol wipe to clean the rubber part of the stopper.
Croatian: 6. Upotrijebite alkoholnu maramicu da biste očistili gumeni dio čepa.
English: Although the degree of renal impairment has no demonstrable effect on the pharmacokinetic disposition of Ceplene, caution is warranted when Ceplene is administered to patients with severe renal impairment.
Croatian: Iako stupanj oštećenja funkcije bubrega nema dokazani učinak na farmakokinetiku Ceplenea, nalaže se oprez kada se Ceplene primjenjuje u bolesnika s teškim oštećenjem funkcije bubrega.
English: The adverse reactions considered at least possibly related to the treatment of low-dose IL-2 with Ceplene in AML studies (n=280 for the IL-2 and Ceplene treatment arm) are listed below by body system organ, class and frequency.
Croatian: Nuspojave za koje se smatralo kako je malo vjerojatno da su povezane s liječenjem niskom dozom IL-2 i Ceplenea tijekom ispitivanja AML-a (n=280 za skupinu liječenu IL-2 i Cepleneom) dolje su navedene prema tjelesnim organskim sustavima, klasi i učestalosti.
English: Metabolism and nutrition disorders anorexia
Croatian: Poremećaji metabolizma i prehrane anoreksija često
English: -for grade 3 and 4 toxicity, treatment should be discontinued and not resumed until events have been resolved.
Croatian: - za toksičnost stupnja 3 i 4, liječenje se mora prekinuti i ne smije se nastaviti dok se simptomi ne povuku.
English: The twice daily dosing of IL-2 and Ceplene should be separated by a minimum of 6 hours.
Croatian: Razmak između doziranja IL-2 i Ceplenea dvaput dnevno mora biti najmanje 6 sati.
English: Use only clear and colourless solution.
Croatian: Upotrijebite samo bistru i bezbojnu otopinu.
English: It is recommended that you always have someone with you when injecting Ceplene, such as an adult family member, friend, or other care provider to help you if you feel light-headed or faint.
Croatian: Preporučuje se da uz Vas uvijek bude netko dok ubrizgavate Ceplenea, poput odraslog člana obitelji, prijatelja ili zdravstvenog djelatnika koji Vam mogu pomoći ako osjetite ošamućenost ili nesvjesticu.
English: Administration of Ceplene can cause hypotension and may result in dizziness, light-headedness and blurred vision.
Croatian: Primjena Ceplenea može uzrokovati hipotenziju što može rezultirati omaglicom, ošamućenošću i zamagljenim vidom.
English: Slightly pull back the plunger.
Croatian: Klip lagano povlačite unatrag.
English: Replace the cover on the needle.
Croatian: 13. Vratite pokrov na iglu.
English: Blood and lymphatic system disorders anaemia
Croatian: Poremećaji krvi i limfnog sustava anemija često
English: With the needle cover on, pull back the plunger and draw air into the syringe to the level (number of millilitres) instructed by your doctor.
Croatian: Dok je igla još zaštićena pokrovom, klip povucite natrag i uvucite zrak u štrcaljku do razine (broj mililitara) kako Vas je uputio liječnik.
English: Solution for injection 14 vials
Croatian: Otopina za injekciju 14 bočica
English: • Decrease in the number of a certain type of white blood cells (neutropenia)
Croatian: • smanjenje broja određene vrste bijelih krvnih stanica (neutropenija)
English: Animal studies revealed no adverse effects on fertility apart from a slight reduction in implantations and viable foetuses (see section 5.3).
Croatian: Ispitivanja na životinjama nisu otkrila nuspojave vezane uz plodnost, osim blagog smanjenja broja implantiranja i vitalnih fetusa (vidjeti dio 5.3).
English: Tricyclic anti-depressants may have H1 and H2 receptor blocking properties and should be avoided.
Croatian: Triciklički antidepresivi mogu imati svojstvo blokiranja H1 i H2 receptora te ih se mora izbjegavati.
English: Apply gentle pressure with the alcohol wipe over the injection site without rubbing it. 14.
Croatian: 13. Alkoholnom maramicom primijenite lagani pritisak na mjesto ubrizgavanja, bez trljanja.
English: 6.6 Special precaution for disposal and other handling
Croatian: 6.6 Posebne mjere opreza za zbrinjavanje i druga rukovanja lijekom
English: If not, use another vial and inform your doctor or pharmacist.
Croatian: Ako nije, uzmite drugu bočicu i o tome obavijestite svog liječnika ili ljekarnika.
English: Endocrine disorders hypothyroidism
Croatian: Endokrini poremećaji hipotireoza često
English: Nervous system disorders headache, dizziness, dysgeusia Very common
Croatian: Poremećaji živčanog sustava glavobolja, omaglica, disgeuzija vrlo često
English: Dilute IL-2 dispensed in capped polypropylene tuberculin syringes is to be prepared by the pharmacy in a controlled aseptic environment and stored in a refrigerator at 2°C - 8°C.
Croatian: Razrijeđeni IL-2 izdan u polipropilenskim tuberkulinskim štrcaljkama sa zatvaračem ljekarna mora pripremiti u kontroliranim aseptičkim uvjetima i pohraniti u hladnjak na 2°C - 8° C.
English: Ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia (AML) in first remission concomitantly treated with interleukin-2 (IL-2).
Croatian: Ceplene je kao terapija održavanja indiciran u odraslih bolesnika s akutnom mijeloičnom leukemijom (AML) u prvoj remisiji, istodobno liječenih interleukinom-2 (IL-2).
English: Gastrointestinal disorders nausea, dyspepsia, diarrhoea Very common vomiting, abdominal pain upper, dry mouth, gastritis, abdominal distention
Croatian: Poremećaji probavnog sustava mučnina, dispepsija, proljev vrlo često povraćanje, bol u gornjem dijelu abdomena, suha usta, gastritis, distenzija abdomena često
English: • Joint and muscle pain (arthralgia and myalgia)
Croatian: • bol u zglobovima i mišićima (artralgija i mijalgija)
English: Ceplene and low dose IL-2 have been investigated in other clinical studies at different doses (1 mg histamine dihydrochloride twice a day) and with different dose regimens of low-dose IL-2 and interferon-alfa.
Croatian: Druga onkološka ispitivanja (uznapredovali tumor) Ceplene i niska doza IL-2 istraživani su i u drugim kliničkim ispitivanjima pri različitim dozama (1,0 mg histamindiklorida dvaput na dan) i pri različitim režimima niske doze IL-2 i interferona-alfa.
English: • Steroids such as prednisone and dexamethasone.
Croatian: • steroidi poput prednizona i deksametazona.
English: Ceplene is for subcutaneous use only.
Croatian: Način primjene Ceplene se primjenjuje samo supkutano.
English: The pharmacokinetics of histamine are similar in healthy volunteers with normal renal function compared to volunteers with mild, moderate, or severe renal impairment.
Croatian: Farmakokinetika histamina u zdravih dobrovoljaca s normalnom funkcijom bubrega, slična je onoj u dobrovoljaca s blagim, umjerenim ili teškim oštećenjem funkcije bubrega.
English: Ceplene has moderate influence on the ability to drive and use machines.
Croatian: Ceplene umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • Tingling, prickling or numbness of the skin (paraesthesia)
Croatian: • trnci, peckanje ili obamrlost kože (parestezija)