FrancophonIA/ELRC3.0 huggingface dataset:
English: Following PCI, the reduced infusion dose of 0.25 mg/kg/h may be resumed for 4 to 12 hours as clinically necessary.
Croatian: Nakon PCI-ja, može se nastaviti smanjenom dozom infuzije od 0,25 mg/kg/sat tijekom 4-12 sati, prema kliničkim potrebama.
English: The ACUITY Trial (Patients with unstable angina/non-ST segment elevated myocardial infarction (UA/NSTEMI))
Croatian: ACUITY ispitivanje (bolesnici s nestabilnom anginom/infarktom miokarda bez elevacije ST segmenta (UA/NSTEMI))
English: • Angiox is contraindicated in patients with severe renal insufficiency (glomerular filtration rate (GFR) < 30 ml/min) and in dialysis-dependent patients.
Croatian: • Angiox je kontraindiciran u bolesnika s teškom bubrežnom insuficijencijom (brzina glomerularne filtracije, GFR < 30 ml/min) i u bolesnika ovisnih o dijalizi.
English: Major Adverse Cardiac/Ischaemic Events (MACE) was defined as the occurrence of any of the following; death, reinfarction, stroke or ischaemic target vessel revascularisation.
Croatian: Revaskularizacija ishemične ciljne žile Moždani udar definiran je kao pojava jednog od sljedećeg: smrt, ponovni infarkt, moždani udar ili revaskularizacija ishemične ciljne žile.
English: • severe renal impairment (GFR<30 ml/min) and in dialysis-dependent patients.
Croatian: • teškim oštećenjem bubrega (GFR<30 ml/min) i u bolesnika ovisnih o dijalizi.
English: The recommended dose of bivalirudin for patients undergoing PCI is an intravenous bolus of 0.75 mg/kg body weight followed immediately by an intravenous infusion at a rate of 1.75 mg/kg body weight/hour for at least the duration of the procedure.
Croatian: Preporučena doza bivalirudina za bolesnike podvrgnute PCI-ju je intravenski bolus od 0,75 mg/kg tjelesne težine, nakon čega odmah slijedi intravenska infuzija brzinom od 1,75 mg/kg tjelesne težine/sat, barem tijekom trajanja postupka.
English: REPLACE-2 study results: 30-day endpoints (intent-to-treat and per-protocol populations
Croatian: Tablica 5. Rezultati ispitivanja REPLACE-2: 30-dnevni ishodi (populacija s namjerom liječenja (ITT) i populacija prema planu ispitivanja)
English: 50 ml] of glucose solution or sodium chloride solution) 1 ml contains 5 mg bivalirudin.
Croatian: - Nakon razrjeđivanja (miješanje 5 ml pripremljene otopine u vrećicu s infuzijom [ukupnog volumena 50 ml] otopine glukoze ili natrijeva klorida) 1ml sadrži 5 mg bivalirudina.
English: If the medically managed patient proceeds to PCI, an additional bolus of 0.5 mg/kg of bivalirudin should be administered before the procedure and the infusion increased to 1.75 mg/kg/h for the duration of the procedure.
Croatian: Ako medikamentozno liječen bolesnik ide na PCI, prije postupka treba primijeniti dodatni bolus od 0,5 mg/kg bivalirudina, a infuziju treba povećati na 1,75 mg/kg/sat tijekom trajanja postupka.
English: INR increased d
Croatian: Pretrage povećan INR
English: Adverse reactions for bivalirudin are listed by system organ class in Table 1.
Croatian: Nuspojave na bivalirudin navedene su prema klasifikaciji organskih sustava u tablici 1.
English: Bival + GP IIb/IIIa inhibitor
Croatian: Bival + inhibitor GP IIb/IIIa
English: • When this treatment is finished, the infusion may go back to 0.25 mg/kg body weight per hour
Croatian: • Po završetku ove terapije, brzinu infuzije se može vratiti na 0,25 mg/kg tjelesne težine na sat tijekom dodatnih 4 do 12 sati.
English: + GP IIb/IIIa inhibitor (%)
Croatian: + inhibitor GP IIb/IIIa (%)
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava intrakranijalno krvarenje
English: Adverse events were more frequent in females and in patients more than 65 years of age in both the bivalirudin and the heparin-treated comparator groups compared to male or younger patients.
Croatian: U usporedbi s muškim ili mlađim bolesnicima, nuspojave su bile učestalije u žena i bolesnika starijih od 65 godina u obje uspoređivane grupe ispitanika (liječeni bivalirudinom ili heparinom).
English: Medicinal products with dose concentration incompatibilities
Croatian: Inkompatibilni lijekovi ovisno o koncentraciji doze
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE
English: 6%) of bivalirudin-treated patients and in 67 (3.9%) of patients treated with heparin plus a GP IIb/IIIa inhibitor.
Croatian: Trombocitopenija je u ispitivanju HORIZONS prijavljena u 26 (1,6%) bolesnika liječenih bivalirudinom i u 67 (3,9%) bolesnika liječenih heparinom i inhibitorom GP IIb/IIIa.
English: • 0.75 mg/kg body weight as an intravenous injection, followed immediately by an infusion (drip) into vein of 1.75 mg/kg body weight, per hour for at least the duration of the PCI.
Croatian: • 0,75 mg/kg tjelesne težine kao injekcija u venu, nakon čega odmah slijedi infuzija (drip) u venu od 1,75 mg/kg tjelesne težine na sat barem tijekom trajanja PCI-ja.
English: The incidence of both ACUITY-scale and TIMI-scale bleeding events to day 30 for the per protocol population are presented in Table 7.
Croatian: Incidencija krvarenja, prema ljestvicama ACTUITY i TIMI, do 30 dana u populaciji s namjerom liječenja (ITT) prikazana je u tablici 6. Incidencija krvarenja, prema ljestvicama ACTUITY i TIMI za 30 dana za populaciju prema planu ispitivanja prikazana je u tablici 7.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva osip, urtikarija
English: Just prior to surgery, a 0.5 mg/kg bolus dose should be administered followed by a 1.75 mg/kg/h intravenous infusion for the duration of the surgery.
Croatian: Neposredno prije operacije treba primijeniti bolus dozu od 0,5 mg/kg, nakon čega slijedi intravenska infuzija od 1,75 mg/kg/sat tijekom operacije.
English: ACUITY major bleeding was defined as any one of the following: intracranial, retroperitoneal, intraocular, access site haemorrhage requiring radiological or surgical intervention, ≥5 cm diameter haematoma at puncture site, reduction in haemoglobin concentration of ≥4 g/dl without an overt source of bleeding, reduction in haemoglobin concentration of ≥3 g/dl with an overt source of bleeding, re-operation for bleeding, use of any blood product transfusion.
Croatian: Veliko krvarenje u ispitivanju definirano je kao jedno od sljedećih: intrakranijalno, retroperitonealno, intraokularno, krvarenje na pristupnom mjestu koje je zahtijevalo radiološku ili kiruršku intervenciju, hematom na ubodnom mjestu promjera ≥5 cm, smanjenje koncentracije hemoglobina od ≥4 g/dl bez očitog izvora krvarenja, smanjenje koncentracije hemoglobina od ≥3 g/dl s očitim izvorom krvarenja, ponovna operacija zbog krvarenja ili uporaba bilo kojeg krvnog pripravka za transfuziju.
English: Lyophilised powder: Do not store above 25C.
Croatian: Liofilizirani prašak: Ne čuvati na temperaturi iznad 25 C.
English: Bivalirudin is metabolized by proteases, including thrombin.
Croatian: Proteaze, uključujući trombin metaboliziraju bivalirudin.
English: heparin  GP IIb/IIIa inhibitor (N=3,008)
Croatian: heparin  inhibitor GP IIb/IIIa (N=3008)
English: or to hirudins
Croatian: 6.1 ili na hirudin
English: Aseptic procedures should be used for the preparation and administration of Angiox.
Croatian: Za pripremu i primjenu Angioxa moraju se upotrijebiti aseptički postupci.
English: After reconstitution 1 ml contains 50 mg bivalirudin.
Croatian: Nakon rekonstitucije 1 ml sadrži 50 mg bivalirudina.
English: Patients with unstable angina/non-ST segment elevated myocardial infarction (UA/NSTEMI)
Croatian: Bolesnici s nestabilnom anginom/infarktom miokarda bez elevacije ST segmenta (UA/NSTEMI)
English: Diluted solution: Do not store above 25C.
Croatian: Razrijeđena otopina: Ne čuvati na temperaturi iznad 25 C.
English: Medicinal products with dose concentration incompatibilities to bivalirudin.
Croatian: Tablica 9. Lijekovi koji su, ovisno o koncentraciji doze, inkompatibilni s bivalirudinom.
English: After dilution 1 ml contains 5 mg bivalirudin.
Croatian: Nakon razrjeđivanja 1 ml sadrži 5 mg bivalirudina.
English: REPLACE-2 major bleeding was defined as the occurrence of any of the following: intracranial haemorrhage, retroperitoneal haemorrhage, blood loss leading to a transfusion of at least two units of whole blood or packed red blood cells, or bleeding resulting in a haemoglobin drop of more than 3 g/dl, or a fall in haemoglobin greater than 4 g/dl (or 12% of haematocrit) with no bleeding site identified.
Croatian: Veliko krvarenje ispitivanja REPLACE-2 definirano je kao pojava bilo kojeg od sljedećeg: intrakranijalno krvarenje, retroperitonealno krvarenje, gubitak krvi za koje je potrebna transfuzija od najmanje dvije jedinice pune krvi ili koncentrata eritrocita, ili krvarenje koje je uzrokovalo pad hemoglobina za više od 3 g/dl, ili pad hemoglobina za više od 4 g/dl (ili hematokrit od 12%) bez identificiranja mjesta krvarenja.
English: Intraocular haemorrhage
Croatian: Poremećaji oka intraokularno krvarenje
English: Major bleeding was defined as the occurrence of any of the following: intracranial haemorrhage, retroperitoneal haemorrhage, blood loss leading to a transfusion of at least two units of whole blood or packed red blood cells, or bleeding resulting in a haemoglobin drop of more than 3 g/dl, or a fall in haemoglobin greater than 4 g/dl (or 12% of haematocrit) with no bleeding site identified.
Croatian: Veliko krvarenje definirano je kao pojava bilo kojeg od sljedećeg: intrakranijalno krvarenje, retroperitonealno krvarenje, gubitak krvi za koje je potrebna transfuzija od najmanje dvije jedinice pune krvi ili koncentrata eritrocita, ili krvarenje koje je uzrokovalo pad hemoglobina za više od 3 g/dl, ili pad hemoglobina za više od 4 g/dl (ili hematokrita od 12%) bez identificiranja mjesta krvarenja.
English: pvalue*
Croatian: p-vrijednost*
English: After dilution 1ml contains 5 mg bivalirudin.
Croatian: Nakon razrjeđivanja 1ml sadrži 5 mg bivalirudina.
English: The Medicines Company UK Ltd Teл.
Croatian: The Medicines Company UK Ltd Tel.
English: Intent-to-treat
Croatian: Namjera liječenja
English: Both minor and major bleeds were significantly less frequent with bivalirudin than the heparin plus GP IIb/IIIa inhibitor comparator group.
Croatian: Oboje, mala i velika krvarenja, bila su značajno manje učestala u grupi bolesnika liječenih bivalirudinom nego u uspoređivanoj grupi ispitanika liječenoj heparinom s inhibitorom GP IIb/IIIa.
English: 2% in patients receiving bivalirudin versus 1.9% in patients receiving UFH plus GP IIb/IIIa inhibitor (p=0.1553).
Croatian: Incidencija tromboze stenta između 24 sata i 30 dana bila je 1,2% u bolesnika koji su primali bivalirudin naspram 1,9% u bolesnika koji su primali UFH s inhibitorom GP IIb/IIIa (p=0,1553).
English: • If you are taking blood thinners or medicines to prevent blood clots (anticoagulants or antithrombotics e.g. warfarin, dabigatran, apixaban, rivaroxaban, acetylsalicylic acid,
Croatian: (antikoagulanse ili antitrombotike primjerice varfarin, dabigatran, apiksaban, rivaroksaban,
English: Healthcare professionals should refer to the Summary of Product Characteristics for full prescribing information.
Croatian: Za potpune informacije o propisivanju, zdravstveni djelatnici trebaju proučiti Sažetak opisa svojstava lijeka.
English: Arm A UFH/enox +GP IIb/IIIa inhibitor (N=4,603)
Croatian: Grupa A UFH/enoks + inhibitor GP IIb/IIIa (N=4603)
English: Arm B bival +GP IIb/IIIa inhibitor (N=4,604)
Croatian: Grupa B bival + inhibitor GP IIb/IIIa (N=4604)
English: Angiox should be administered with caution in breast-feeding mothers.
Croatian: Angiox se mora primjenjivati oprezno kod majki koje doje.
English: The infusion of 1.75 mg/kg body weight/hour may be continued for up to 4 hours post-PCI and at a reduced dose of 0.25 mg/kg body weight/hour for an additional 4 - 12 hours as clinically necessary.
Croatian: Infuzija od 1,75 mg/kg tjelesne težine/sat može biti nastavljena do 4 sata nakon PCI-ja i smanjenom dozom od 0,25 mg/kg tjelesne težine/sat tijekom dodatnih 4 - 12 sati, ako je to klinički potrebno.
English: 1 vial contains 250 mg bivalirudin.
Croatian: 1 bočica sadrži 250 mg bivalirudina.
English: The infusion may be followed by an infusion at a lower dose of 0.25 mg/kg body weight
Croatian: Nakon infuzije može uslijediti infuzija nižom dozom od 0,25 mg/kg tjelesne težine tijekom dodatnih 4 do 12 sati.
English: • Angiox must be administered as a bolus dose followed immediately by an intravenous infusion,
Croatian: • Angiox mora biti primijenjen kao bolus doza nakon čega odmah mora slijediti intravenska infuzija, čak i ako je planiran kratak PCI postupak.
English: • 0.1 mg/kg body weight as an intravenous injection, followed by an infusion (drip) into vein of 0.25 mg/kg body weight per hour for up to 72 hours.
Croatian: • 0,1 mg/kg tjelesne težine kao injekcija u venu, nakon čega slijedi infuzija (drip) u venu od 0,25
English: If you get any side effects, talk to your doctor.
Croatian: Ako primijetite bilo koju nuspojavu potrebno je obavijestiti liječnika.
English: In STEMI patients the infusion of 1.75 mg/kg body weight/hour should be continued for up to 4 hours post-PCI and continued at a reduced dose of 0.25 mg/kg body weight/hour for an additional 4 - 12 hours as clinically necessary (see section 4.4).
Croatian: U bolesnika sa STEMI-jem infuziju od 1,75 mg/kg tjelesne težine/sat treba nastaviti do 4 sata nakon PCI-ja i smanjenom dozom od 0,25 mg/kg tjelesne težine/sat tijekom dodatnih 4-12 sati, ako je to klinički potrebno (vidjeti dio 4.4).
English: Hälsa Pharma GmbH Nikolaus Dürkopp-Str. 4A 33602 Bielefeld GERMANY
Croatian: 4A 33602 Bielefeld NJEMAČKA
English: Haloperidol lactate
Croatian: 10 mg/ml haloperidol laktat
English: In STEMI patients the infusion of 1.75 mg/kg body weight/hour should be continued for up to 4 hours post-PCI and continued at a reduced dose of 0.25 mg/kg/h for an additional 4 - 12 hours as clinically necessary (see section 4.4).
Croatian: U bolesnika sa STEMI-jem infuziju od 1,75 mg/kg tjelesne težine/sat treba nastaviti do 4 sata nakon PCI-ja i smanjenom dozom infuzije od 0,25 mg/kg/sat tijekom dodatnih 4-12 sati, ako je to klinički potrebno (vidjeti dio 4.4).
English: Arm B bival +GP IIb/IIIa inhibitor (N=2,924)
Croatian: Grupa B Bival + inhibitor GP IIb/IIIa (N=2924)
English: Both major and minor bleeds were significantly less frequent with bivalirudin alone than the heparin plus GP IIb/IIIa inhibitor and bivalirudin plus GP IIb/IIIa inhibitor groups.
Croatian: Velika i mala krvarenja bila su značajno manje učestala u grupi bolesnika koji su primali samo bivalirudin, naspram grupe ispitanika liječene heparinom s inhibitorom GP IIb/IIIa te grupe ispitanika liječene bivalirudinom s inhibitorom GP IIb/IIIa.
English: • Angiox is contraindicated in patients with severe renal insufficiency (glomerular filtration rate
Croatian: • Angiox je kontraindiciran u bolesnika s ozbiljnom bubrežnom insuficijencijom (brzina glomerularne filtracije, GFR < 30 ml/min) i bolesnika ovisnih o dijalizi
English: Bival + GP IIb/IIIa inhibitor (N=2,924)
Croatian: Bival + inhibitor GP IIb/IIIa (N=2924) %
English: : +47 80056935 eller +47 22310956
Croatian: : +372 8000044560 või +372 8801076
English: Famotidine
Croatian: Doziranje
English: When bivalirudin is combined with a platelet inhibitor or an anti-coagulant medicine, clinical and biological parameters of haemostasis should be regularly monitored.
Croatian: Potrebno je redovito nadzirati kliničke i biološke parametre hemostaze, kada se bivalirudin kombinira s inhibitorom trombocita ili antikoagulansom.
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta krvarenje iz uha
English: Peritoneal haemorrhage, Retroperitoneal haematoma, Vomiting
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja epistaksa, hemoptiza, faringealno krvarenje pulmonalno krvarenje, dispneja a
English: Quadruple endpoint Triple endpoint* Components: Death Myocardial Infarction Major bleeding** (based on nonTIMI criteria - see section 4.8) Urgent revascularisation * excludes major bleeding component.
Croatian: Veliko krvarenje** (nije temeljeno na TIMI kriterijima -vidjeti dio 4.8)
English: Unplanned
Croatian: Tijekom
English: Major bleeding occurred most frequently at the sheath puncture site.
Croatian: Velika krvarenja najčešće su se pojavila na mjestu uboda, odnosno uvodnice.
English: - Each vial contains 250 mg bivalirudin.
Croatian: - Jedna bočica sadrži 250 mg bivalirudina.
English: Protocol defined major bleeding
Croatian: Veliko krvarenje definirano planom ispitivanja TIMI Veliko (ne
English: Promethazine HCl
Croatian: Ferrer-Galenica A.E.
English: • 0.5 mg/kg body weight for the intravenous injection, followed by an infusion into vein of 1.75 mg/kg body weight, per hour for the duration of the PCI.
Croatian: • 0,5 mg/kg tjelesne težine kao injekcija u venu, nakon čega slijedi infuzija (drip) u venu od 1,75
English: Pericardial haemorrhage,
Croatian: Nikolaus Dürkopp-Str.
English: To ensure appropriate administration of bivalirudin, the completely dissolved, reconstituted and diluted product should be thoroughly mixed prior to administration (see section 6.6).
Croatian: Da bi se osigurala odgovarajuća primjena bivalirudina, potpuno otopljeni, rekonstituirani i razrijeđeni lijek treba temeljito promiješati prije primjene (vidjeti dio 6.6), a bolus (dozu) treba dati brzom intravenskom injekcijom kako bi se osiguralo da cijeli bolus dosegne ciljna tkiva bolesnika prije početka postupka.
English: The Medicines Company UK Ltd Tel. Nr.: +370 880031794 arba +370 852140678
Croatian: Nr.: +370 880031794 arba +370 852140678
English: The Medicines Company UK Ltd Tel. : +36 (0) 680986235 vagy +36 (0) 617777410
Croatian: : +36 (0) 680986235 vagy +36 (0) 617777410
English: Rash, Urticaria
Croatian: Prijavljivanje nuspojava
English: Epistaxis, Haemoptysis, Pharyngeal haemorrhage
Croatian: acetilsalicilatnu kiselinu, klopidogrel, prasurgel, tikagrelor).
English: Intracranial haemorrhage
Croatian: Oštećenje jetre
English: Ear haemorrhage
Croatian: Tablični sažetak nuspojava
English: The Medicines Company UK Ltd Tel. : +372 8000044560 või +372 8801076
Croatian: The Medicines Company UK Ltd Tlf.: +47 80056935 eller +47 22310956
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the Member States
Croatian: Popis naziva, farmaceutskog oblika, jačina lijekova, puta primjene, nositelja odobrenja u državama članicama
English: Pfizer ApS, Lautrupvang 8, 2750 Ballerup Denmark
Croatian: Pfizer ApS, Lautrupvang 8, 2750 Ballerup Danska
English: 2909 LD, Capelle a/d Ijssel The Netherlands
Croatian: Capelle a/d Ijssel Nizozemska
English: Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Vienna
Croatian: Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Beč
English: Acipimox Olbetam 250 mg kemény kapszula
Croatian: Olbetam 250 mg Kemény kapszula
English: Sandwich, Kent CT13 9NJ United Kingdom
Croatian: Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ Ujedinjeno Kraljevstvo
English: Pfizer Gyógyszerkereskedelmi Kft. Alkotás St 53
Croatian: Pfizer Gyógyszerkereskedelmi Kft.
English: Luxembourg PFIZER S.A. Boulevard de la Plaine 17 1050 Ixelles
Croatian: Luksemburg PFIZER S.A. Boulevard de la Plaine 17 1050 Ixelles
English: via Isonzo, 71 04100 Latina Italy
Croatian: Pfizer Italia S.r.l. via Isonzo, 71 04100 Latina Italija
English: Acipimox Olbetam 250 mg Capsules 250 mg capsule
Croatian: Olbetam 250mg Capsules
English: Marketing authorisaton holder INN Invented name
Croatian: Međunarodni nezaštićeni naziv (INN)
English: 1123 Budapest
Croatian: Budimpešta Mađarska
English: Pfizer Italia S.r.l.
Croatian: PFIZER S.A.
English: Belgium PFIZER S.A. Boulevard de la Plaine 17 1050 Ixelles
Croatian: Boulevard de la Plaine 17 1050 Ixelles
English: The Netherlands Pfizer B.V. Rivium Westlaan 142
Croatian: Pfizer B.V.
English: Acipimox Olbetam - Kapseln
Croatian: Olbetam - Kapseln 250 mg
English: EU (MA) number Invented name
Croatian: Broj EU (MA) Izmišljeno ime
English: Atlantic salmon (Salmo salar)
Croatian: Atlantski losos (Salmo salar)
English: --1 5.1 - 9.4 μg pUK-SPDV-poly2#1 DNA plasmid
Croatian: --1 5.1 - 9.4 μg pUK-SPDV-poli2#1 DNA plazmid
English: Bag (ethyl vinyl acetate)
Croatian: Vrećica (etil vinil acetat)
English: Packaging Content Package size
Croatian: Put primjene Pakovanje Sadržaj Veličina pakovanja
English: Zero degree days
Croatian: 1 vrećica Nula stupnja dana
English: Results were similar between the two treatment groups.
Croatian: Rezultati su bili slični u obje liječene skupine.
English: • Additional risk minimisation measures
Croatian: • Dodatne mjere minimalizacije rizika
English: Studies with regard to other stages of the development have not been carried out.
Croatian: Nisu provedena ispitivanja drugih stadija razvoja.
English: Talk to your doctor first.
Croatian: Najprije porazgovarajte s liječnikom.
English: ATC code: A16AB04.
Croatian: ATK oznaka: A16AB04.
English: Genotoxic and carcinogenic potential are not expected.
Croatian: Ne očekuje se genotoksičan ni kancerogen potencijal.
English: The educational pack should contain the following:
Croatian: Edukacijski paket mora sadržavati sljedeće:
English: MA 01701 United States
Croatian: MA 01701
English: Antibody status should be regularly monitored.
Croatian: Treba redovito provjeravati status protutijela.
English: For the purpose of this table, ≥1% is defined as reactions occurring in 2 or more patients.
Croatian: Za potrebe ove tablice, ≥ 1% se definira kao reakcije koje su se javile u 2 ili više bolesnika.
English: Your doctor may advise that you can be treated at home provided you meet certain criteria.
Croatian: Liječnik Vam može savjetovati liječenje kod kuće pod uvjetom da zadovoljavate određene kriterije.
English: Please contact your doctor if you would like to be treated at home.
Croatian: Molimo obratite se svom liječniku ako želite provoditi liječenje kod kuće.
English: Talk to your doctor or pharmacist before using Fabrazyme.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite Fabrazyme.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products in the same infusion.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima u istoj infuziji.
English: Eye disorders --
Croatian: Poremećaji oka --
English: These reported symptoms resemble the natural course of Fabry disease.
Croatian: Prijavljeni simptomi nalikuju prirodnom tijeku Fabryjeve bolesti.
English: 1105 BP Amsterdam The Netherlands
Croatian: 1105 BP Amsterdam Nizozemska
English: You may need to be given additional medicines to prevent such reactions from occurring.
Croatian: Možda ćete morati uzeti dodatne lijekove kako bi se spriječila pojava takvih reakcija.
English: Because this condition is slowly progressive, early detection and treatment is critical to achieve the best outcomes.
Croatian: Budući da ova bolest sporo napreduje, rano otkrivanje i liječenje od ključne su važnosti za postizanje najboljeg ishoda.
English: The current medical standards for emergency treatment are to be observed.
Croatian: Treba se pridržavati važećih medicinskih standarda za hitno liječenje.
English: Do not shake or excessively agitate the infusion bag.
Croatian: Nemojte tresti niti prekomjerno protresati infuzijsku vrećicu.
English: The frequency of these reactions decreased over time.
Croatian: Učestalost tih reakcija s vremenom se smanjila.
English: What Fabrazyme is and what it is used for
Croatian: Što je Fabrazyme i za što se koristi
English: Date of first authorisation: 03 August 2001 Date of last renewal: 03 August 2006
Croatian: Datum posljednje obnove odobrenja: 3. kolovoza 2006.
English: Do not use filter needles and avoid foaming.
Croatian: Nemojte koristiti filtar igle i izbjegavajte pjenjenje.
English: If you use more Fabrazyme than you should
Croatian: Ako primijenite više lijeka Fabrazyme nego što ste trebali
English: Other medicines and Fabrazyme
Croatian: Drugi lijekovi i Fabrazyme