natgillin/translations-raw huggingface dataset:
Congenital malformations, including reports of multiple malformations, have been observed post- marketing in children of patients exposed to CellCept in combination with other immunosuppressants during pregnancy.
Nakon stavljanja lijeka u promet prijavljene su kongenitalne malformacije, uključujući višestruke malformacije, kod djece bolesnica koje su bile izložene lijeku CellCept u kombinaciji s drugim imunosupresivima tijekom trudnoće.
Congenital malformations, including reports of multiple malformations, have been observed post- marketing in children of patients exposed to mycophenolate in combination with other immunosuppressants during pregnancy.
Nakon stavljanja lijeka u promet prijavljene su kongenitalne malformacije, uključujući višestruke malformacije, kod djece bolesnica koje su bile izložene mikofenolatu u kombinaciji s drugim imunosupresivima tijekom trudnoće.
Congenital malformations, including reports of multiple malformations, have been observed post- marketing in children of patients exposed to mycophenolate mofetil during pregnancy in combination with other immunosuppressants.
Nakon stavljanja lijeka u promet prijavljene su kongenitalne malformacije, uključujući višestruke malformacije, kod djece bolesnica koje su bile izložene lijeku Myclausen u kombinaciji s drugim imunosupresivima tijekom trudnoće.
Congenital neutropenia:
Kongenitalna neutropenija:
Congenital neutropenia: the recommended starting dose is 1.2 MU (12 micrograms)/kg/day as a single dose or in divided doses.
Kongenitalna neutropenija: preporučena početna doza je 1,2 MU (12 mikrograma)/kg/dan u jednokratnoj ili podijeljenoj dozi.
congenital or acquired bleeding disorders
prirođenim ili stečenim poremećajima krvarenja
Congenital or acquired coagulation disorders
kongenitalni ili stečeni koagulacijski poremećaji
Congenital or acquired QTc -prolongation.
prirođeno ili stečeno produljenje QTc-intervala.
Congenital or acquired QTc-prolongation.
prirođeno ili stečeno produljenje QTc-intervala
Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
Prirođena ili stečena valvularna oštećenja s klinički značajnim poremećajima u funkciji miokarda koji nisu povezani s plućnom hipertenzijom.
Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
Prirođeni ili stečeni defekti zalistaka s klinički značajnim poremećajima funkcije miokarda koji nisu povezani s plućnom hipertenzijom.
congenital or documented acquired QT prolongation
urođenim ili dokumentiranim stečenim produljenjem QT-intervala
Congenital or documented acquired QTc prolongation
Urođeno ili potvrđeno stečeno produljenje QTc intervala
Congenital, idiopathic or cyclic neutropenia ; filgrastim should be given by subcutaneous injection.
Kongenitalna, idiopatska ili ciklička neutropenija: filgrastim je potrebno primijeniti supkutanom injekcijom.
Congenital, idiopathic or cyclic neutropenia: Filgrastim should be given by subcutaneous injection.
Prirođena, idiopatska ili ciklička neutropenija: filgrastim treba davati u obliku supkutane injekcije.
congestion
Nazalna kongestija
Congestion
Pojačana prokrvljenost
congestion in the nose, sinuses or upper part of the airway bringing air into the lungs
začepljenost nosa, sinusa ili gornjeg dijela dišnih puteva
congestion,
Poremećaji
congestion, dysphonia
okularna hiperemija
congestion, dysphonia
pulmonalna kongestija
congestion, dysphonia
razdoblje
Congestive cardiac failure
Kongestivno zatajenje srca
Congestive heart failure
Kongestivnim zatajenjem srca
Congestive heart failure (CHF)
Kongestivno zatajenje srca
Congestive heart failure (CHF)
Kongestivno zatajivanje srca
Congestive heart failure (CHF): Dose titration in patients with moderate to severe CHF (NYHA Class III–IV) should be exercised with caution (see sections 4.4 and 5.2).
Kongestivno zatajenje srca: Kod bolesnika s umjerenim do teškim kongestivnim zatajenjem srca (NYHA klasa III-IV) treba pažljivo prilagođavati dozu (vidjeti dijelove 4.4 i 5.2).
Congestive heart failure (NYHA Class II – IV) is a common adverse reaction associated with the use of Herceptin and has been associated with a fatal outcome (see section 4.4).
Kongestivno zatajenje srca (NYHA klase II – IV), česta je nuspojava kod primjene lijeka Herceptin, ponekad povezana i sa smrtnim ishodom (vidjeti dio 4.4).
Congestive heart failure (see section 4.4)
kongestivno zatajenje srca (vidjeti dio 4.4)
Congestive heart failure was observed in 0.5% of subjects in each treatment arm.
Kongestivno zatajenje srca zabilježeno je u 0,5% ispitanika u svakoj liječenoj skupini.
congestive heart failure, abnormal heart rhythm, pericarditis (inflammation of the lining of the heart), inflammation and degeneration of muscle tissue and peripheral nerves, kidney problems, sarcoidosis (a disease characterized by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands).
kongestivno zatajenje srca, poremećaj srčanog ritma, perikarditis (upala srčane ovojnice), upala i degeneracija mišićnog tkiva i perifernih živaca, tegobe s bubrezima, sarkoidoza (bolest koju prate stalna vrućica, gubitak tjelesne težine, bol i oticanje zglobova, oštećenja kože i otečene žlijezde).
Congestive heart failure, pericardial effusion, arrhythmia
kongestivno zatajenje srca, perikardijalni izljev, aritmija
Congestive heart failure.
Kongestivno zatajenje srca.
Congestive heart failure/
kongestivno zatajenje srca/
congestive heart failure/cardiac dysfunction*c, pericardial effusion*, arrhythmia (including tachycardia), palpitations
kongestivno zatajenje srca/srčana disfunkcija*c, perikardijalni izljev*, aritmije (uključujući tahikardiju), palpitacije
Congestive heart failure: Tell your doctor if the child has a history of congestive heart failure, because Enbrel needs to be used with caution under these circumstances.
Kongestivno zatajenje srca: obavijestite svog liječnika ako dijete ima kongestivno zatajenje srca, jer je u tom slučaju potreban oprez prilikom primjene Enbrela.
Congestive heart failure: Tell your doctor if you have a history of congestive heart failure, because Benepali needs to be used with caution under these circumstances.
Kongestivno zatajenje srca: Obavijestite svog liječnika ako ste imali kongestivno zatajenje srca, jer je u tom slučaju potreban oprez prilikom primjene Benepalija.
Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because Enbrel needs to be used with caution under these circumstances.
Kongestivno zatajenje srca: obavijestite svog liječnika ako ste Vi ili dijete imali kongestivno zatajenje srca, jer je u tom slučaju potreban oprez prilikom primjene Enbrela.
Congestive heart failureb,d, Supraventricular tachycardia
kongestivno zatajenje srcab,d supraventrikularna tahikardija
conivaptan – diuretic (used to increase low blood sodium levels) boceprevir, telaprevir – antiviral (used to treat Hepatitis C)
konivaptan - diuretik (primjenjuje se za povišenje niske razine natrija u krvi) boceprevir, telaprevir – antivirusni lijek (primjenjuje se za liječenje hepatitisa C)
Conjugate of Haemophilus influenzae type b capsular polysaccharide (PRP) 10 micrograms and tetanus toxoid (T), adsorbed (PRP-T) Approximately 25 micrograms
konjugiran kapsularni polisaharid Haemophilus influenzae tipa b (PRP) 10 mikrograma toksoid tetanusa (T), adsorbiran (PRP-T) otprilike 25 mikrograma
Conjugated oestrogens tablet core
Jezgra tablete konjugiranih estrogena
Conjugated oestrogens/bazedoxifene
Konjugirani estrogeni/bazedoksifen
Conjugated to Corynebacterium diphtheriae CRM197 protein 16.7 to 33.3 micrograms
Konjugiran na protein CRM197 Corynebacterium diphtheriae 16,7 do 33,3 mikrograma
Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate (0.125 mg aluminium).
Konjugirani na proteinski nosač CRM197 i adsorbirani na aluminijev fosfat (0,125 mg aluminija).
Conjunctival
konjuktivalna
Conjunctival adhesion, conjunctival hyperaemia, corneal oedema, corneal perforation, eye irritation,
adhezija spojnice, hiperemija spojnice, edem rožnice, perforacija rožnice, iritacija oka, fotofobija
Conjunctival haemorrhage
hemoragija konjunktive
Conjunctival haemorrhage Accommodation disorder Blindness
Konjunktivalna hemoragija Poremećaji akomodacije Sljepoća
Conjunctival haemorrhage, diplopia
konjunktivalno krvarenje, diplopija
Conjunctival haemorrhage, eye haemorrhage, corneal epithelium defect, eye pain, glaucoma/intraocular pressure increased, ulcerative keratitis
krvarenje spojnice, krvarenje oka, oštećenje epitela rožnice, bol u oku, glaukom/povišen intraokularni tlak, ulcerozni keratitis
Conjunctival haemorrhage, eye pruritus, keratitis, vision blurred, photophobia
krvarenje konjunktive, svrbež oka, keratitis, zamagljen vid, fotofobija
conjunctival hyperaemia
hiperemija konjunktive
conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in up to 44 % in the first year with the incidence of new reports decreasing to 13 % at 2 years and 12 % at 3 years ocular pruritus in up to 14 % of patients in the first year with the incidence of new reports decreasing to 3 % at 2 years and 0 % at 3 years.
konjunktivna hiperemija (većinom u tragovima do blaga i vjerojatno neupalne prirode) i do 44% u prvoj godini primjene s padom incidencije novih prijava na 13% u drugoj i 12% u trećoj godini primjene. svrbež očiju i do 14% u prvoj godini primjene s padom incidencije na 3% u drugoj i 0 % u trećoj godini primjene.
Conjunctival hyperaemia Eye irritation,
poremećaj šarenice, midrijaza, svjetlosne aureole,
Conjunctival hyperaemia,
konjuktivitis
conjunctival hyperaemia, dry eye
konjunktivalna hiperemija, suho oko
conjunctival hyperaemia, ocular pruritus, growth of eyelashes
hiperemija konjunktive, svrbež oka, rast trepavica
conjunctival hyperaemia.
hiperemija konjunktive
Conjunctival irritation
iritacija konjunktive
Conjunctival irritation
konjuktivalna iritacija
Conjunctival oedema, lacrimal disorder, eye discharge, eye pruritus, conjunctival irritation, conjunctivitis, foreign body sensation in eyes, deposit eye, keratitis, blepharitis, corneal decompensation, chalazion, corneal infiltrates, corneal scar, eyelid pruritus, iridocyclitis.
Edem konjunktive, poremećaj suzenja, iscjedak iz oka, svrbež oka, iritacija konjunktive, konjunktivitis, osjećaj stranog tijela u očima, depoziti u oku, keratitis, blefaritis, dekompenzacija rožnice, halacion, infiltracija rožnice, ožiljak na rožnici, svrbež vjeđe, iridociklitis.
Conjunctival/Scleral haemorrhage
Konjunktivalno/skleralno krvarenje
Conjunctivalisation is one of the most important symptoms of LSCD.
Konjunktivizacija je jedan od najvažnijih simptoma LSCD-a.
Conjunctivitis
hiperemija oka,
Conjunctivitis
konjuktivitis
Conjunctivitis
pri gledanju,
Conjunctivitis
retinalna vaskularna
Conjunctivitis
retinopatija,
Conjunctivitis
Vrlo rijetko:
conjunctivitis (a type of eye inflammation)
konjunktivitis (vrsta upale oka)
conjunctivitis (an inflammation of the eye), eye irritation
konjunktivitis (upala oka), iritacija oka
conjunctivitis (an inflammation of the eye), eye irritation
konjunktivitis (upala oka), nadraženost oka
Conjunctivitis (G3/4:
konjuktivitis (G3/4:
Conjunctivitis (G3/4:
konjunktivitis (G3/4:
Conjunctivitis (including conjunctivitis, lacrimal disorder)
konjunktivitis (uključujući konjunktivitis, poremećaje suzenja)
Conjunctivitis (including red eyes, eye discharge and eye pain)
konjunktivitis (uključujući crvenilo, iscjedak i bol u oku)
conjunctivitis (inflamed eye)
konjunktivitis (upala oka)
conjunctivitis (inflammation of the conjuntiva of the eyes)
konjunktivitis (upala konjunktive oka)
Conjunctivitis (red eyes and discharge or pain in the eye)
konjunktivitis (crvene oči te iscjedak ili bol u očima)
Conjunctivitis allergic*
alergijski konjunktivitis
Conjunctivitis Dry eye
Konjunktivitis Sindrom suhog oka
Conjunctivitis Eye irritation
Konjunktivitis Nadraženost oka
conjunctivitis,
konjunktivitis,
Conjunctivitis, blepharitis, and dry eye*, mainly mild (CTC grade 1).
Konjunktivitis, blefaritis i suhoća oka*, uglavnom blagi (CTC stupanj 1).
Conjunctivitis, Eye
nadražaj očiju
Conjunctivitis, Eye discharge, Eyelid inflammation, Eye irritation, Eye swelling, Ocular hyperaemia, Tearing, Visual discomfort
konjunktivitis, iscjedak iz oka, upala vjeđe, iritacija oka, oticanje oka, očna hiperemija, suzenje, nelagoda u očima
Conjunctivitis, eye pain
konjuktivitis, bol u oku
Conjunctivitis, eye pain
Konjunktivitis, bol u oku
Conjunctivitis, maculopathy, photophobia
Konjunktivitis, makulopatija, fotofobija
Conjunctivitis, Retinitis
konjuktivitis, retinitis
Conjunctivitis, vision abnormal, lacrimal gland disorder,
konjunktivitis, poremećaj vida, poremećaj suznih žlijezda,
Conjunctivitis.
Konjunktivitis
Conjunctivitis.
Često: konjunktivitis
Conjunctivitis1, corneal opacity1
Konjunktivitis1, zamućenje rožnice1
Connect one end of the transfer needle to the vaccine bottle of Ingelvac MycoFLEX.
Spojite jedan kraj igle za prijenos cjepiva s bočicom Ingelvac MycoFLEX.
Connect the female luer-lock of the gas tube (with the 0.2 μm bacteriostatic filter) to a pressure regulator.
Spojite ženski luer- nastavak plinske cijevi (s bakteriostatskim filtrom veličine pora 0,2 μm) na regulator tlaka.
Connect the infusion line to the syringe and start the infusion after priming the line with Erbitux or sterile sodium chloride 9 mg/mL (0.9%) solution.
Spojite infuzijsku liniju na štrcaljku te započnite infuziju nakon što se liniju ispuni Erbituxom ili sterilnom otopinom natrijevog klorida 9 mg/ml (0,9%).
Connect the infusion line to the syringe, set and control the rate as explained in section 4.2 and start the infusion after priming the line with Erbitux or sterile sodium chloride 9 mg/mL (0.9%) solution.
Spojite infuzijsku liniju na štrcaljku, postavite i kontrolirajte brzinu kako je objašnjeno u dijelu 4.2 te započnite infuziju nakon što se linija ispuni Erbituxom ili sterilnom otopinom natrijevog klorida 9 mg/ml (0,9%).
Connect the infusion set with NovoRapid PumpCart by attaching the adapter onto your pump.
Povežite infuzijski set s uloškom NovoRapid PumpCart tako što ćete pričvrstiti nastavak na pumpu.
Connect the other end of the filter to the injection set (e.g. butterfly / winged infusion needle or infusion catheter).
Spojite drugi kraj filtera na injekcijski set (npr. iglu za infuziju s krilcima/oblik leptira ili kanilu).
Connect the plunger rod to the syringe by screwing it into the rubber stopper (E).
Umetnite potisnik klipa u štrcaljku zavrtanjem u gumeni čep (E).
Connect the RaplixaSpray device to the ProFibrix air pressure regulator or CO2 pressure regulator and thereby to the medical air or CO2 gas supply set to a pressure setting of 1.5 bar (22 psi).
Spojite uređaj RaplixaSpray na regulator tlaka zraka ProFibrix ili regulator tlaka CO2, a time i na medicinski zrak ili CO2 plin s postavkom tlaka od 1,5 bara (22 psi).
Connect the short tube on the application device to the male luer-lock end of the long gas tube.
Spojite kratku cijev na aplikatoru na muški kraj luer-lock nastavka duge plinske cijevi.
Connect the syringe to the clear part of the transfer device and push the air in the syringe into the vial.
Spojite štrcaljku na prozirni dio naprave za prijenos i potisnite zrak iz štrcaljke u bočicu.
Connect the syringe to the vial adapter
Spojite štrcaljku na nastavak za bočicu
Connections or passageways inside the body between internal organs and skin or other tissues (also called ‘fistula’): Common (may affect up to 1 in 10 people) - these abnormal tube-like connections or passageways can form for example, between the gut and your skin.
Poveznice ili prolazi u tijelu između unutarnjih organa i kože ili drugih tkiva (poznate i kao ‘fistule’): Često (mogu se javiti u manje od 1 na 10 osoba) - te abnormalne poveznice ili prolazi u obliku cjevčice mogu nastati između, primjerice, crijeva i kože.
connective
eritrodizestezije
connective tissue
mišićno
connective tissue
mišićno-koštanog
consciousness
(uključujući
consciousness),
diskinezijae,
consciousness,
razine svijesti, konvulzijed,
Consequently the use of INTEGRILIN is not recommended in these circumstances (see section 4.5).
Stoga se u takvim okolnostima ne preporuča primjena INTEGRILINA (vidjeti dio 4.5).
Consequently, as a precautionary measure, breast-feeding is contra-indicated during and for at least 48 hours after treatment with blinatumomab.
Posljedično, kao mjera predostrožnosti, dojenje je kontraindicirano tijekom i kroz najmanje 48 sati nakon liječenja blinatumomabom.
Consequently, bosentan is not expected to increase the plasma concentrations of medicinal products metabolised by these isoenzymes.
Stoga se ne očekuje da bosentan povećava koncetracije u plazmi lijekova koje metaboliziraju ti izoenzimi.
Consequently, caution is advised when Cymbalta is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Stoga se preporučuje oprez kada se Cymbalta primjenjuje u kombinaciji s drugim lijekovima i tvarima koje djeluju na SŽS, uključujući alkohol i sedative (npr. benzodiazepine, morfinomimetike, antipsihotike, fenobarbital, sedativne antihistaminike).
Consequently, caution is advised when Duloxetine Lilly is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Stoga se preporučuje oprez kada se Duloksetin Lilly primjenjuje u kombinaciji s drugim lijekovima i tvarima koje djeluju na SŽS, uključujući alkohol i sedative (npr. benzodiazepine, morfinomimetike, antipsihotike, fenobarbital, sedativne antihistaminike).
Consequently, caution is advised when Xeristar is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Stoga se preporučuje oprez kada se Xeristar primjenjuje u kombinaciji s drugim lijekovima i tvarima koje djeluju na SŽS, uključujući alkohol i sedative (npr. benzodiazepine, morfinomimetike, antipsihotike, fenobarbital, sedativne antihistaminike).
Consequently, concomitant administration of lopinavir/ritonavir and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Stoga se istodobna primjena tih lijekova mora izbjegavati, osim ako se ona ne ocijeni doista nužnom.
Consequently, concomitant administration with strong CYP3A4 inhibitors (e.g., ketoconazole) should be approached with caution and concomitant administration with strong CYP3A4 inducers (e.g. rifampicin) should be avoided.
Stoga istovremenoj primjeni s jakim inhibitorima CYP3A4 (npr. ketokonazolom) treba pristupati oprezno, a istovremenu primjenu s jakim induktorima (npr. rifampicinom) treba izbjegavati.
Consequently, concomitant administration with strong CYP3A4 inhibitors (e.g., ketoconazole) should be approached with caution and concomitant administration with strong CYP3A4 inducers (e.g., rifampicin) should be avoided.
Zbog toga istovremenoj primjeni s jakim inhibitorima CYP3A4 (npr. ketokonazolom) treba pristupati oprezno, a istovremenu primjenu s jakim induktorima CYP3A4 (npr. rifampicinom) treba izbjegavati.
Consequently, Contacera’s benefit is taken as being the same as that of the reference medicine.
Stoga, se smatra da je korist od VMP-a Contacera jednaka koristi od referentnog VMP-a.
Consequently, INR should be closely monitored after initiating dronedarone in patients taking vitamin K antagonists as per their label.
Stoga se u bolesnika koji uzimaju antagoniste vitamina K mora pažljivo pratiti INR nakon početka liječenja dronedaronom.
Consequently, it is recommended that recently treated animals do not sleep with owners, especially children.
Slijedom navedenog, preporuča se da nedavno liječene životinje ne spavaju s vlasnicima, osobito djecom.
Consequently, newborn infants should be monitored carefully.
Posljedično, novorođenčad se mora pažljivo motriti.
Consequently, newborns should be monitored for B-cell depletion and vaccinations with live virus vaccines should be postponed until the infant’s B-cell count has recovered (see section 4.4).
Posljedično, novorođenčad treba pratiti radi deplecije B limfocita te se mora odgoditi cijepljenje živim virusnim cjepivom dok se broj B limfocita novorođenčeta ne oporavi (vidjeti dio 4.4).
Consequently, no meaningful change in AUC of methylnaltrexone bromide, in addition to Cmax, was observed before and after multiple-dose administration of cimetidine.
U skladu s tim, nije opažena značajna promjena niti AUC metilnaltreksonbromida niti Cmax, prije i poslije višekratnih doza cimetidina.
Consequently, patients with known risk factors for thromboembolism – including prior thrombosis – should be closely monitored.
Kao posljedica toga bolesnike s poznatim čimbenicima rizika za tromboemboliju - uključujući prethodnu trombozu – treba pomno nadzirati.
Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Zbog toga bolesnici s rijetkim nasljednim problemima nepodnošenja galaktoze, pomanjkanjem Lapp laktaze ili s malapsorpcijom glukoze-galaktoze ne bi smjeli uzimati ovaj lijek.
Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Zbog toga bolesnici s rijetkim nasljednim problemima nepodnošenja galaktoze, pomanjkanjem Lapp laktaze ili s malapsorpcijom glukoze-galaktoze ne smiju uzimati ovaj lijek.
Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Zbog toga pacijenti s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
Consequently, Renvela should not be taken simultaneously with ciprofloxacin.
Stoga se Renvela ne bi smjela uzimati istodobno s ciprofloksacinom.
Consequently, Rheumocam’s benefit is taken as being the same as that of the reference medicine.
Stoga, smatra se da su koristi lijeka Rheumocam jednake onima refertnog lijeka.
Consequently, Sevelamer carbonate Zentiva should not be taken simultaneously with ciprofloxacin.
Stoga se Sevelamer carbonate Zentiva ne bi smio uzimati istodobno s ciprofloksacinom.
Consequently, should signs of pulmonary oedema occur when STAYVEER is administered in patients with PAH, the possibility of associated veno- occlusive disease should be considered.
Pojave li se znakovi plućnog edema kod primjene STAYVEERA u bolesnika s PAH, treba razmotriti mogućnost okluzivne bolesti vena.
Consequently, should signs of pulmonary oedema occur when Tracleer is administered in patients with PAH, the possibility of associated veno-occlusive disease should be considered.
Pojave li se znakovi plućnog edema kod primjene Tracleera u bolesnika s PAH, treba razmotriti mogućnost okluzivne bolesti vena.
Consequently, the concomitant use of NSAIDs including Cox-2 inhibitors is not recommended (see section 4.4).
Stoga se ne preporučuje istodobna primjena klopidogrela i nesteroidnih protuupalnih lijekova, uključujući Cox-2 inhibitore (vidjeti dio 4.4.).
Consequently, the frequency of these adverse events is qualified as 'not known'.
Posljedično, učestalost tih štetnih događaja klasificirana je kao