FrancophonIA/ELRC3.0 huggingface dataset:
English: In subsequent studies, in male paediatric patients above the age of 7, a reduction in pain was observed after 9 and 12 months of Replagal therapy compared to pretreatment baseline.
Croatian: U narednim studijama, kod pedijatrijskih muških bolesnika starijih od 7 godina primijećeno je smanjenje boli nakon 9 i 12 mjeseci liječenja Replagalom u usporedbi sa stanjem prije primjene liječenja.
English: Replagal reduced left ventricle mass in treated patients compared to placebo treated patients.
Croatian: Replagal je smanjio masu lijevog ventrikula kod liječenih bolesnika u usporedbi s bolesnicima liječenih placebom.
English: A single patient could be affected by several adverse reactions.
Croatian: Kod jednog bolesnika može se pojaviti više nuspojava.
English: Do not use Replagal if you notice that there is discolouration or other foreign particles present.
Croatian: Replagal se ne smije upotrijebiti ako primijetite promjenu boje ili ako su prisutne vidljive čestice.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON / 3.5 ML VIAL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE / BOČICA OD 3,5 ML
English: After 6 months of therapy there was a significant reduction in pain in the Replagal treated patients compared with placebo (p=0.021), as measured by the Brief Pain Inventory (a validated pain measurement scale).
Croatian: Nakon 6 mjeseci liječenja utvrđeno je znatno smanjenje boli kod bolesnika koji su primali Replagal u odnosu na bolesnike koji su primali placebo (p=0,021) izmjereno indeksom Brief Pain Inventory (validirana ljestvica za mjerenje boli).
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA
English: In clinical studies, neuropathic pain medicinal products (such as carbamazepine, phenytoin and gabapentin) were administered concurrently to most patients without any evidence of interaction.
Croatian: U kliničkim ispitivanjima kod većine su bolesnika istodobno primijenjeni lijekovi za ublažavanje neuropatskih bolova (kao što su karbamazepin, fenitoin i gabapentin) bez dokaza o interakcijama.
English: Among 9 boys with left ventricular mass (LVMI) indexed to height2.7 within the normal range for children (<39 g/m2.7 in boys) at baseline, LVMI remained stable at levels below the left ventricular hypertrophy
Croatian: Od 9 dječaka s masom lijevih ventrikula (engl. left ventricular mass, LVMI) indeksiranom na visinu2,7 unutar raspona normalnih vrijednosti za djecu (<39 g/m2,7 u dječaka) na početku ispitivanja, LVMI je ostao stabilan na razinama ispod praga hipertrofije lijevog ventrikula (engl. left ventricular hypertrophy, LVH) tijekom 6,5 godina liječenja.
English: Serious infusion reactions have been reported uncommonly; symptoms reported include pyrexia, rigors, tachycardia, urticaria, nausea/vomiting, angioneurotic oedema with throat tightness, stridor and swollen tongue.
Croatian: Ozbiljne reakcije povezane s infuzijom nisu uobičajene, a prijavljeni simptomi uključuju pireksiju, tresavicu, tahikardiju, urtikariju, mučninu/povraćanje, angioneurotski edem sa stezanjem u grlu, stridor i oticanje jezika.
English: Treatment with the enzyme has been shown to reduce accumulation of Gb3 in many cell types including endothelial and parenchymal cells.
Croatian: Pokazalo se da liječenje enzimom smanjuje nakupljanje Gb3 u mnogim vrstama stanica uključujući i endotelne stanice te stanice parenhima.
English: The most commonly reported adverse reactions were infusion associated reactions, which occurred in 13.7% of adult patients treated with Replagal in clinical trials.
Croatian: U kliničkim ispitivanjima najčešće zabilježene nuspojave su reakcije povezane s infuzijom, pojavile su se u 13,7 % odraslih bolesnika liječenih Replagalom.
English: After one year of treatment with agalsidase alfa 0.2 mg/kg every other week, the abnormally high eGFR decreased from 143.4 ± 6.8 to 121.3 ± 5.6 mL/min/1.73 m2 in this subgroup and these eGFRs stabilized in the normal range during 4 years of
Croatian: Nakon jedne godine liječenja agalzidazom alfa 0,2 mg/kg svaki drugi tjedan, abnormalno povišena eGFR smanjila se sa 143,4 ± 6,8 na 121,3 ± 5,6 ml/min/1,73 m2 u ovoj podskupini i te su se vrijednosti eGFR stabilizirale unutar raspona normalnih vrijednosti tijekom 4 godine liječenja Replagalom 0,2 mg/kg, kao i vrijednosti eGFR kod bolesnika u kojih nije bilo hiperfiltracije.
English: Each ml of Replagal contains 1 mg of agalsidase alfa.
Croatian: Jedan ml Replagala sadrži 1 mg agalzidaze alfa.
English: The infusion can be temporarily interrupted (5 to 10 minutes) until symptoms subside and the infusion may then be restarted.
Croatian: Infuzija lijeka može se kratkotrajno (5 do 10 minuta) prekinuti dok se simptomi ne povuku i nakon toga se može nastaviti.
English: In each treatment group, LVMI remained stable over the treatment period of the study.
Croatian: U svakoj liječenoj skupini, indeks mase lijevog ventrikula ostao je stabilan za vrijeme liječenja u okviru ispitivanja.
English: How to store Replagal
Croatian: Kako čuvati Replagal
English: Nervous system disorders headache dizziness, dysgeusia, neuropathic pain, tremor, hypersomnia, hypoesthesia, paraesthesia parosmia
Croatian: Poremećaji živčanog sustava glavobolja omaglica, disgeuzija, neuropatska bol, tremor, hipersomnija, hipoestezija, parestezija parosmija
English: The reductions in LV mass observed by echocardiography in both male and female Fabry patients over 24 to 36 months of Replagal treatment were associated with meaningful symptom improvement as measured using the NYHA and CCS in Fabry patients with severe heart failure or anginal symptoms at baseline.
Croatian: Smanjenje mase lijevog ventrikula, zabilježeno ehokardiografski kod muških i ženskih bolesnika s Fabryjevom bolešću tijekom 24 - 36 mjeseci liječenja Replagalom, bilo je povezano sa značajnim poboljšanjem simptoma mjerenih pomoću NYHA-a i CCS-a kod bolesnika s Fabryjevom bolešću u kojih je prije početka liječenja bilo prisutno teško zatajenje srca ili anginalni simptomi.
English: It is not known whether Replagal is excreted in human milk.
Croatian: Nije poznato izlučuje li se Replagal u majčino mlijeko.
English: Sodium phosphate monobasic, monohydrate polysorbate 20 sodium chloride sodium hydroxide water for injections
Croatian: natrijev dihidrogenfosfat, hidrat polisorbat 20 natrijev klorid natrijev hidroksid voda za injekcije
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03/08/2001
Croatian: Datum prvog odobrenja: 03.08.2001.
English: In paediatric patients >7 yrs of age, 1/16 male patients tested positive for IgG anti-agalsidase alfa antibodies during the study.
Croatian: U pedijatrijskih bolesnika starijih od 7 godina, 1 od ukupno 16 muških bolesnika imao je pozitivna IgG protutijela anti-agalzidaza alfa tijekom ispitivanja.
English: These effects include chills, headache, nausea, fever, facial flushing (redness), tiredness, low blood pressure, unsteadiness, sweating, difficulty breathing, itching, shaking, cough and vomiting.
Croatian: Te nuspojave uključuju zimicu, glavobolju, mučninu, vrućicu, crvenilo lica uz osjećaj vrućine, umor, niski krvni tlak, nestabilnost, znojenje, otežano disanje, svrbež, drhtanje, kašalj i povraćanje.
English: If severe hypersensitivity or anaphylactic reactions occur, the administration of Replagal should be discontinued immediately and appropriate treatment initiated.
Croatian: U slučaju teške reakcije preosjetljivosti ili anafilaktičke reakcije, infuzija Replagala mora se odmah prekinuti i započeti odgovarajuće liječenje.
English: Subsequent open label studies demonstrated significant reduction from baseline in left ventricular mass by echocardiography in both male and female Fabry patients over 24 to 36 months of Replagal treatment.
Croatian: Kasnija otvorena ispitivanja pokazala su značajno smanjenje mase lijevog ventrikula u odnosu na početne vrijednosti, mjereno ehokardiografski, kod muških i ženskih bolesnika s Fabryjevom bolešću tijekom 24 - 36 mjeseci liječenja Replagalom.
English: Adverse drug reactions reported in patients with history of end stage renal disease were similar to those reported in the general patient population.
Croatian: Bolesnici s bolešću bubrega Prijavljene nuspojave lijeka kod bolesnika sa završnim stadijem bubrežne bolesti jednake su prijavljenim nuspojavama u općoj populaciji bolesnika.
English: Ear and labyrinth disorders tinnitus, tinnitus aggravated
Croatian: Poremećaji uha i labirinta tinitus, pogoršavanje tinitusa
English: Consistent with the clinical effects of Replagal, treatment with the enzyme reduced accumulation of Gb3 in many cell types, including renal glomerular and tubular epithelial cells, renal capillary endothelial cells (cardiac and dermal capillary endothelial cells were not examined) and cardiac myocytes.
Croatian: U skladu s kliničkim učincima Replagala, liječenje enzimom smanjilo je nakupljanje Gb3 u mnogim vrstama stanica uključujući epitelne stanice glomerula i tubula bubrega te stanice endotela kapilara bubrega (stanice endotela kapilara srca i kože nisu bile predmet ovog istraživanja) i srčane miocite.
English: The onset of infusion related reactions has generally occurred within the first 2-4 months after initiation of treatment with Replagal although later onset (after 1 year) has been reported as well.
Croatian: Početak reakcija povezanih s infuzijom obično je opažen u prva 2 - 4 mjeseca nakon početka primjene
English: • Dilute the total volume of Replagal concentrate required in 100 ml of 9 mg/ml (0.9%) sodium chloride solution for infusion.
Croatian: • Razrijedite ukupan volumen potrebnog koncentrata Replagala u 100 ml 0,9% otopine natrijevog klorida za infuziju (9 mg/ml).
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane od najozbiljnije do najmanje ozbiljne.
English: Skin and subcutaneous tissue disorders acne, erythema, pruritus, rash, livedo reticularis angioneurotic oedema,
Croatian: Poremećaji kože i potkožnog tkiva akne, eritem, svrbež, osip, livedo reticularis angioneurotski edem, urtikarija hiperhidroza
English: Patients with hepatic impairment No studies have been performed in patients with hepatic impairment.
Croatian: Bolesnici s oštećenjem funkcije jetre Nisu provedena ispitivanja kod bolesnika s oštećenom funkcijom jetre.
English: Vascular disorders flushing hypertension hypotension
Croatian: Krvožilni poremećaji crvenilo uz osjećaj vrućine hipertenzija hipotenzija
English: Each vial of 3.5 ml of concentrate contains 3.5 mg of agalsidase alfa.
Croatian: Svaka bočica s 3,5 ml koncentrata sadrži 3,5 mg agalzidaze alfa.
English: NAME OF THE MEDICINAL PRODUCT Replagal 1 mg/ml concentrate for solution for infusion.
Croatian: NAZIV LIJEKA Replagal 1 mg/ml koncentrat za otopinu za infuziju.
English: After the first 6 months of therapy mean decreases of approximately 20 - 50 % were observed in plasma, urine sediment, liver, kidney, and heart biopsy samples.
Croatian: Nakon prvih 6 mjeseci liječenja srednje sniženje vrijednosti od otprilike 20 - 50% opaženo je u plazmi, sedimentu urina,
English: Cardiac disorders tachycardia, palpitations cardiac arrhythmias (atrial fibrillation, ventricular extrasystoles, tachyarrhythmia), myocardial ischaemia, heart failure
Croatian: (fibrilacija atrija, ventrikularne ekstrasistole, tahiaritmija), ishemija miokarda, zatajenje srca
English: What Replagal is and what it is used for What you need to know before you are given Replagal How Replagal is given
Croatian: Što morate znati prije nego počnete primati Replagal Kako se Replagal daje
English: As α-galactosidase A is itself an enzyme, it would be an unlikely candidate for cytochrome P450 mediated drug-drug interactions.
Croatian: A enzim, nije vjerojatno da će sudjelovati u interakciji s drugim lijekovima putem citokroma P450.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Replagal 1 mg/ml sterile concentrate agalsidase alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Replagal 1 mg/ml sterilni koncentrat agalzidaza alfa
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Primjena u venu
English: Eye disorders corneal reflex decreased, lacrimation increased
Croatian: Poremećaji oka oslabljeni kornealni refleks,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/189/001-003
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/189/001-003
English: Each time you are treated it will take 40 minutes for Replagal to be given to you in a vein.
Croatian: Svaka infuzija traje 40 minuta tijekom koje se Replagal daje kroz venu na Vašoj ruci.
English: Replagal has to be diluted in 9 mg/ml (0.9%) sodium chloride solution before use.
Croatian: Replagal mora biti prije primjene razrijeđen u 0,9 %-tnoj otopini natrijevog klorida (9 mg/ml).
English: The following adverse reactions have been identified for agalsidase alfa:
Croatian: Za agalzidazu alfa zabilježene su sljedeće nuspojave:
English: This would be about 14 mg or 4 vials (glass bottles) of Replagal for an average size (70 kg) individual.
Croatian: Za prosječnog bolesnika (70 kg) to je oko 14 mg ili 4 bočice (staklene bočice) Replagala Primjena u djece i adolescenata
English: Dilute the total volume of Replagal concentrate required in 100 ml 9 mg/ml sodium chloride solution for infusion (0.9%w/v).
Croatian: Razrijedite ukupan volumen potrebnog koncentrata Replagala u 100 ml 0,9% -tne otopine natrijevog klorida za infuziju (9 mg/ml).
English: Reduction in their hypernormal eGFRs was observed within 6 months of initiating Replagal therapy.
Croatian: opaženo je u razdoblju od 6 mjeseci nakon početka liječenja Replagalom.
English: Caution should be exercised when prescribing to breast-feeding women.
Croatian: Potreban je oprez kada se lijek propisuje ženama koje doje.
English: Replagal 1 mg/ml concentrate for solution for infusion Agalsidase alfa
Croatian: Replagal 1 mg/ml koncentrat za otopinu za infuziju agalzidaza alfa
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL 3.5 ML PRESENTATION
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA OD 3,5 ML
English: Clearance normalised for body weight was 2.66 and 2.10 ml/min/kg for males and females, respectively.
Croatian: 2,66, a za žene 2,10 ml/min/kg.
English: After 6 months of therapy Replagal significantly reduced pain in patients when compared to placebo (dummy) treated patients.
Croatian: Nakon 6 mjeseci terapije, Replagal je značajno smanjio bol kod bolesnika u usporedbi s bolesnicima liječenih placebom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/189/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/189/001
English: Common: may affect up to 1 in 10 people: - tingling or numbness or pain in fingers or toes, change in the taste of food, eyes tearing, blink reflex abnormal, ears ringing, shakes, prolonged sleep - palpitations, increased heart rate, increased blood pressure - cough, chest pain or tightness, hoarseness, sore or tight throat, sticky throat secretions, runny nose, cold symptoms - vomiting, abdominal pain or discomfort, diarrhoea - acne, red or itchy or mottled skin, rash at the infusion site - back or limb pain, muscle pain, joint pain, muscle and bone discomfort, swelling of the extremities or joints - feeling cold or hot, flu-like symptoms, feeling sick, feeling lack of energy
Croatian: poremećeni refleks treptanja, zvonjava u ušima, drhtanje, dugotrajno spavanje - lupanje srca, ubrzan rad srca, povišenje krvnog tlaka - kašalj, bol ili stezanje u prsnom košu, promuklost, grlobolja ili stezanje u grlu, ljepljiv sekret iz grla, curenje nosa, simptomi prehlade
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, Section 4.2)
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
English: Replagal was also associated with improved myocardial contractility, a decrease in mean QRS duration and a concomitant decrease in septal thickness on echocardiography.
Croatian: smanjenjem srednjeg trajanja QRS kompleksa i istodobnim smanjenjem debljine septuma na ehokardiografiji.
English: Replagal is a concentrate for solution for infusion.
Croatian: Replagal je koncentrat za otopinu za infuziju.
English: In paediatric patients <7 yrs of age, 0/7 male patients tested positive for IgG anti-agalsidase alfa antibodies.
Croatian: U pedijatrijskih bolesnika mlađih od 7 godina, niti jedan od ukupno 7 muških bolesnika nije bio pozitivan na IgG protutijela anti-agalzidaza alfa.
English: Anaphylactic reaction, hypersensitivity
Croatian: Poremećaji imunološkog sustava anafilaktička reakcija, preosjetljivost
English: Treatment with Replagal resulted in an 11.5 g decrease in left ventricular mass as measured by magnetic resonance imaging (MRI) in the controlled study, while patients receiving placebo exhibited an increase in left ventricular mass of 21.8 g. In addition, in the first study involving 25 patients, Replagal effected a significant reduction in cardiac mass after 12 to 18 months of maintenance therapy (p<0.001).
Croatian: Kod bolesnika koji su u kontroliranom ispitivanju primali Replagal utvrđeno je smanjenje mase lijevog ventrikula za 11,5 g mjereno magnetskom rezonancijom (MR), dok su bolesnici koji su primali placebo pokazivali povećanje mase lijevog ventrikula za 21,8 g.
English: Most side effects are mild to moderate.
Croatian: Većina je nuspojava blaga do umjerena.
English: Patients with renal impairment No dose adjustment is necessary in patients with renal impairment.
Croatian: Nije potrebna prilagodba doze kod bolesnika koji imaju oštećenje funkcije bubrega.
English: *agalsidase alfa is the human protein α-galactosidase A produced in a human cell line by genetic engineering technology.
Croatian: *agalzidaza alfa ljudski je protein α-galaktozidaza
English: Study in patients switching from agalsidase beta to Replagal (agalsidase alfa) 100 patients [(naïve (n=29); or previously treated with agalsidase beta who switched to Replagal (n=71)) were treated for up to 30 months in an open label, uncontrolled study.
Croatian: 100 bolesnika [prethodno neliječenih (n=29) ili prethodno liječenih agalzidazom beta koji su prešli na
English: Pharmacodynamic data suggest that at a dose of 0.2 mg/kg Replagal, the reductions in plasma Gb3 are more or less comparable between adolescents and young children (see section 5.1).
Croatian: Farmakodinamički podaci upućuju da su pri dozi od 0,2 mg/kg Replagala smanjenja plazmatskog Gb3
English: Infusion related reactions reported in the postmarketing setting (also see section 4.4) may include cardiac events such as cardiac arrhythmias (atrial fibrillation, ventricular extrasystoles, tachyarrhythmia), myocardial ischemia, and heart failure in patients with Fabry disease involving the heart structures.
Croatian: Opis odabranih nuspojava Reakcije povezane s infuzijom prijavljene nakon stavljanja lijeka na tržište (vidjeti i dio 4.4.) mogu uključivati i srčane događaje kao što su srčane aritmije (fibrilacija atrija, ventrikularne ekstrasistole,
English: In male paediatric patients ≥ 7 years of age, heart rate variability was abnormal at baseline and improved after 6 months of Replagal therapy in 15 boys and the improvement was sustained through 6.5 years of Replagal 0.2 mg/kg therapy in an open-label long-term extension study in 9 boys.
Croatian: 15 dječaka, a poboljšanje je održano kod 9 dječaka tijekom 6,5 godina liječenja Replagalom 0,2 mg/kg u nastavku otvorenog dugotrajnog ispitivanja.
English: After 12 to 54 months of therapy, 17% of Replagal treated patients were still antibody positive whereas 7% showed evidence for the development of immunologic tolerance, based on the disappearance of IgG antibodies over time.
Croatian: dok je 7 % bolesnika razvilo imunološku toleranciju, što je potvrđeno nestankom IgG protutijela tijekom vremena.
English: After 12 to 18 months of maintenance therapy, Replagal improved renal function as measured by inulin based glomerular filtration rate by 8.7 ± 3.7 ml/min.
Croatian: Replagal je poboljšao funkciju bubrega mjereno brzinom glomerularne filtracije inulina za 8,7 ± 3,7 ml/min (p=0,030).
English: What Replagal is and what it is used for The active substance in Replagal is agalsidase alfa (1mg/ml).
Croatian: Djelatna tvar u Replagalu je agalzidaza alfa (1 mg/ml).
English: This pain reduction persisted through 4 years of Replagal therapy in 9 patients (in patients 7 - 18 years of age).
Croatian: 9 bolesnika (od 7 do 18 godina starosti).
English: Table 1 System organ class
Croatian: Klasifikacija organskih sustava
English: It is produced by switching on the gene for α-galactosidase A in cells.
Croatian: Stvara se aktivacijom gena za alfa-galaktozidazu
English: Most undesirable effects were mild to moderate in severity.
Croatian: Nuspojave su uglavnom bile blage do umjerene težine.
English: Musculoskeletal, connective tissue and bone disorders musculoskeletal discomfort, myalgia, back pain, limb pain, peripheral swelling, arthralgia, joint swelling sensation of heaviness
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva nelagoda u mišićno koštanom sustavu, mialgija, bol u leđima, bol u ekstremitetima, periferno oticanje, artralgija, oticanje zglobova osjećaj težine
English: Agalsidase alfa is unlikely to be a candidate for drug-drug interactions.
Croatian: Nije vjerojatno da će doći do interakcije između agalzidaze alfa i drugih lijekova.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products - Enzymes.ATC code: A16AB03.
Croatian: Farmakoterapijska skupina: ostali lijekovi s djelovanjem na probavni sustav i metabolizam - enzimi.
English: After 6 months of therapy Replagal stabilised renal function compared with a decline in placebo treated patients.
Croatian: Nakon 6 mjeseci liječenja Replagalom došlo je do stabilizacije bubrežne funkcije za razliku od bolesnika koji su primali placebo kod kojih je došlo do pogoršanja bubrežne funkcije.
English: Borderline IgE antibody positivity not associated with anaphylaxis has been reported in clinical trials in a very limited number of patients.
Croatian: U vrlo ograničenom broju bolesnika uključenih u klinička ispitivanja prijavljena je granična pozitivnost na IgE protutijela koja nije povezana s anafilaksom.
English: Based on the analysis of pre- and post-dose liver biopsies in males with Fabry Disease, the tissue halflife has been estimated to be in excess of 24 hours and hepatic uptake of the enzyme estimated to be 10% of administered dose.
Croatian: Fabryjevom bolešću procjenjuje se da poluvijek lijeka u tkivu iznosi 24 sata i da se u jetri pohrani oko
English: Tell your doctor if you experience any side effects whilst having the infusion.
Croatian: Ako primijetite bilo koju nuspojavu dok primate infuziju, obavijestite svog liječnika.
English: METHOD OF ADMINISTRATION Read the package leaflet before use
Croatian: Prije uporabe pročitati Uputu o lijeku
English: Patients with renal disease
Croatian: Kod muških pedijatrijskih bolesnika oboljelih od
English: Respiratory, thoracic and mediastinal disorders cough, hoarseness, throat tightness, dyspnoea, nasopharyngitis, pharyngitis, throat secretion increased, rhinorrhoea oxygen saturation decreased
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja kašalj, promuklost, stezanje u grlu, dispneja, nazofaringitis, faringitis,
English: Two patients with right bundle branch block in the studies conducted reverted to normal following therapy with Replagal.
Croatian: Nakon primjene Replagala došlo je do normalizacije nalaza kod dva bolesnika koji su imali blok desne grane u provedenim ispitivanjima.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Idiosinkrazijske reakcije povezane s infuzijom