FrancophonIA/ELRC3.0 huggingface dataset:
English: No IV initial bolus, 100 IU/kg (1 mg/kg) body weight SC and then 100 IU/kg (1 mg/kg) body weight SC every 24 hours
Croatian: Bez početne i.v. bolusne doze, 100 IU/kg (1 mg/kg) tjelesne težine s.c., a zatim 100 IU/kg (1 mg/kg) tjelesne težine s.c. svaka 24 sata
English: - Changing from Thorinane to treatment with direct oral anticoagulant Stop taking Thorinane.
Croatian: - Prelazak s lijeka Thorinane na liječenje direktnim oralnim antikoagulansima
English: The usual dose is 100 IU (1 mg) for every kilogram of your weight, every 12 hours.
Croatian: Uobičajena doza je 100 IU (1 mg) po kilogramu tjelesne težine svakih 12 sati.
English: Enoxaparin sodium pharmacokinetics appeared similar than control population, after a single 25 IU, 50 IU or 100 IU/kg (0.25, 0.50 or 1.0 mg/kg) IV dose however, AUC was two-fold higher than control.
Croatian: Nakon jednokratne intravenske doze od 25 IU (0,25 mg/kg), 50 IU (0,50 mg/kg) ili 100 IU/kg (1,0 mg/kg), farmakokinetika enoksaparinnatrija činila se sličnom onoj u kontrolnoj skupini, ali je AUC bio dvostruko viši nego u kontrolnoj skupini.
English: Stopping blood clots from forming in the tubes of your dialysis machine
Croatian: Sprječavanje nastanka krvnih ugrušaka u cijevima uređaja za dijalizu
English: A puncture-free interval of at least 24 hours shall be kept between the last injection of enoxaparin sodium at curative doses and the needle or catheter placement (see also section 4.3).
Croatian: - Pri dozama koje se koriste za liječenje Između posljednje injekcije enoksaparinnatrija u terapijskim dozama i uvođenja igle ili katetera mora proći razdoblje od najmanje 24 sata bez ikakvih uboda (vidjeti i dio 4.3).
English: Stopping blood clots forming in your blood in the following situations: Operation or periods of limited mobility due to an illness
Croatian: Kod operacije ili tijekom razdoblja smanjene pokretljivosti zbog bolesti
English: • Proximal DVT (%)
Croatian: • Proksimalni DVT (%)
English: Changing of anticoagulant treatment - Changing from Thorinane to blood thinners called vitamin-K antagonists (e.g. warfarin) Your doctor will request you perform blood tests called INR and tell you when to stop Thorinane accordingly.
Croatian: Promjena antikoagulansa - Prelazak s lijeka Thorinane na lijekove za razrjeđivanje krvi koji se zovu antagonisti vitamina K (npr. varfarin)
English: • The usual dose is 100 IU (1 mg) for every kilogram of weight every 12 hours.
Croatian: • Uobičajena doza je 100 IU (1 mg) po kilogramu tjelesne težine svakih 12 sati.
English: - Changing from blood thinners called vitamin-K antagonists (e.g. warfarin) to Thorinane Stop taking the vitamin-K antagonist.
Croatian: - Prelazak s lijekova za razrjeđivanje krvi koji se zovu antagonisti vitamina K (npr. varfarin) na Thorinane
English: • Bleeding.
Croatian: • krvarenje
English: Thrombocytopenia and thrombocytosis
Croatian: Trombocitopenija i tromboza
English: PRE-FILLED SYRINGE
Croatian: uključujući ketorolak
English: Switch between enoxaparin sodium and oral anticoagulants
Croatian: Prelazak s enoksaparinnatrija na oralne antikoagulanse i obratno
English: The risk of antibody-mediated HIT also exists with LMWHs.
Croatian: Rizik od HIT-a posredovanog protutijelima postoji i kod heparina niske molekulske mase.
English: Major bleeding were respectively 1.7% in the enoxaparin sodium 150 IU/kg (1.5 mg/kg) once a day group, 1.3% in the enoxaparin sodium 100 IU/kg (1 mg/kg) twice a day group and 2.1% in the heparin group.
Croatian: - enoksaparinnatrij svakih 12 sati naspram heparina (-4,2 do 1,7) Stopa velikih krvarenja iznosila je 1,7% u skupini liječenoj enoksaparinnatrijem u dozi od 150 IU/kg (1,5 mg/kg) jedanput na dan, 1,3% u skupini liječenoj enoksaparinnatrijem u dozi od 100 IU/kg (1 mg/kg) dvaput na dan te 2,1% u skupini koja je primala heparin.
English: Retroperitoneal haemorrhage
Croatian: Rijetko: retroperitonejsko krvarenje
English: Isolated cases of prosthetic heart valve thrombosis have been reported in patients with mechanical prosthetic heart valves who have received enoxaparin sodium for thromboprophylaxis.
Croatian: U bolesnika s mehaničkim umjetnim srčanim zaliscima koji su primali enoksaparinnatrij za tromboprofilaksu prijavljeni su izolirani slučajevi tromboze umjetnog srčanog zaliska.
English: See section 4.
Croatian: Za postupak prijavljivanja nuspojava, pogledajte dio 4.
English: Enoxaparin sodium 2,000 IU (20 mg) once a day SC n (%)
Croatian: Enoksaparinnatrij 2000 IU (20 mg) jedanput na dan supkutano n (%)
English: A puncture-free interval of at least 12 hours shall be kept between the last injection of enoxaparin sodium at prophylactic doses and the needle or catheter placement.
Croatian: - Pri dozama koje se koriste za profilaksu Između posljednje injekcije enoksaparinnatrija u profilaktičkim dozama i uvođenja igle ili katetera mora proći razdoblje od najmanje 12 sati bez ikakvih uboda.
English: Thorinane contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Croatian: Sadržaj natrija Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: • Monitoring of platelet counts
Croatian: • Praćenje broja trombocita
English: Posology
Croatian: Indikacija
English: Rare:
Croatian: NN:
English: • Prevention of thrombus formation in extra corporeal circulation during haemodialysis.
Croatian: • sprječavanje nastanka krvnih ugrušaka u izvantjelesnoj cirkulaciji tijekom hemodijalize
English: One pre-filled syringe (0.2 mL) contains 2,000 IU (20 mg) enoxaparin sodium
Croatian: Jedna napunjena štrcaljka (0,2 ml) sadrži 2000 IU (20 mg) enoksaparinnatrija
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NAPUNJENA ŠTRCALJKA
English: One pre-filled syringe (1 mL) contains 10,000 IU (100 mg) enoxaparin sodium
Croatian: Jedna napunjena štrcaljka (1 ml) sadrži 10 000 IU (100 mg) enoksaparinnatrija
English: • Common: Injection site haematoma, injection site pain, other injection site reaction (such as oedema,
Croatian: • Često: hematom na mjestu injiciranja, bol na mjestu injiciranja, ostale reakcije na mjestu injiciranja (kao što su edem, krvarenje, preosjetljivost, upala, masa, bol ili reakcija)
English: • you are going to receive spinal or epidural anesthesia or lumbar puncture (see Operations and
Croatian: • ako ćete primiti spinalnu ili epiduralnu anesteziju ili ići na lumbalnu punkciju (pogledajte odlomak 'Operacije i anestetici'): mora se poštovati vremenski razmak između primjene lijeka
English: Treating blood clots that are in your blood
Croatian: Liječenje krvnih ugrušaka u krvi
English: Each pre-filled syringe of 1.0 mL contains 10,000 IU (100 mg) of enoxaparin sodium.
Croatian: Jedna napunjena štrcaljka od 1,0 ml sadrži 10 000 IU (100 mg) enoksaparinnatrija.
English: Each prefilled syringe contains enoxaparin sodium 10,000 IU anti-Xa activity (equivalent to 100 mg) in 1.0 mL water for injections.
Croatian: Jedna napunjena štrcaljka sadrži 10 000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 100 mg) u 1,0 ml vode za injekcije.
English: All Treated Medical Patients During Acute Illness Total VTE (%)
Croatian: Svi liječeni bolesnici koji su primali produljenu profilaksu Ukupni VTE
English: One pre-filled syringe (0.4 mL) contains 4,000 IU (40 mg) enoxaparin sodium
Croatian: Jedna napunjena štrcaljka (0,4 ml) sadrži 4000 IU (40 mg) enoksaparinnatrija
English: One pre-filled syringe (0.8 mL) contains 8,000 IU (80 mg) enoxaparin sodium
Croatian: Jedna napunjena štrcaljka (0,8 ml) sadrži 8000 IU (80 mg) enoksaparinnatrija
English: One pre-filled syringe (0.6 mL) contains 6,000 IU (60 mg) enoxaparin sodium
Croatian: Jedna napunjena štrcaljka (0,6 ml) sadrži 6000 IU (60 mg) enoksaparinnatrija
English: Each pre-filled syringe of 0.2 mL contains 2,000 IU (20 mg) of enoxaparin sodium.
Croatian: Jedna napunjena štrcaljka od 0,2 ml sadrži 2 000 IU (20 mg) enoksaparinnatrija.
English: Each pre-filled syringe of 0.8 mL contains 8,000 IU (80 mg) of enoxaparin sodium.
Croatian: Jedna napunjena štrcaljka od 0,8 ml sadrži 8 000 IU (80 mg) enoksaparinnatrija.
English: o Initial 3,000 IU (30 mg) bolus
Croatian: o Početna bolusna doza od 3000 IU (30 mg)
English: Each prefilled syringe contains enoxaparin sodium 8,000 IU anti-Xa activity (equivalent to 80 mg) in 0.8 mL water for injections.
Croatian: Jedna napunjena štrcaljka sadrži 8000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 80 mg) u 0,8 ml vode za injekcije.
English: Each pre-filled syringe of 0.4 mL contains 4,000 IU (40 mg) of enoxaparin sodium.
Croatian: Jedna napunjena štrcaljka od 0,4 ml sadrži 4 000 IU (40 mg) enoksaparinnatrija.
English: Each prefilled syringe contains enoxaparin sodium 2,000 IU anti-Xa activity (equivalent to 20 mg) in 0.2 mL water for injections.
Croatian: Jedna napunjena štrcaljka sadrži 2000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 20 mg) u 0,2 ml vode za injekcije.
English: Each prefilled syringe contains enoxaparin sodium 4,000 IU anti-Xa activity (equivalent to 40 mg) in 0.4 mL water for injections.
Croatian: Jedna napunjena štrcaljka sadrži 4000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 40 mg) u 0,4 ml vode za injekcije.
English: Each pre-filled syringe of 0.6 mL contains 6,000 IU (60 mg) of enoxaparin sodium.
Croatian: Jedna napunjena štrcaljka od 0,6 ml sadrži 6 000 IU (60 mg) enoksaparinnatrija.
English: Each prefilled syringe contains enoxaparin sodium 6,000 IU anti-Xa activity (equivalent to 60 mg) in 0.6 mL water for injections.
Croatian: Jedna napunjena štrcaljka sadrži 6000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 60 mg) u 0,6 ml vode za injekcije.
English: Thorinane 2,000 IU (20 mg)/0.2 mL solution for injection
Croatian: Thorinane 2000 IU (20 mg)/0,2 ml otopina za injekciju
English: Thorinane 6,000 IU (60 mg)/0.6 mL solution for injection
Croatian: Thorinane 6000 IU (60 mg)/0,6 ml otopina za injekciju
English: In treatment of DVT with or without PE, patients receiving enoxaparin sodium were treated with either a 100 IU/kg (1 mg/kg) SC
Croatian: Kod liječenja DVT-a praćenog PE-om ili bez njega, bolesnici su primali enoksaparinnatrij u supkutanoj dozi od 100 IU/kg (1 mg/kg) svakih 12 sati ili u supkutanoj dozi od 150 IU/kg (1,5 mg/kg) jedanput na dan.
English: Thorinane 4,000 IU (40 mg)/0.4 mL solution for injection
Croatian: Thorinane 4000 IU (40 mg)/0,4 ml otopina za injekciju
English: Treatment of acute ST-segment elevation myocardial infarction In a large multicenter study, 20,479 patients with STEMI eligible to receive fibrinolytic therapy were randomized to receive either enoxaparin sodium in a single 3,000 IU (30 mg) IV bolus plus a 100 IU/kg (1 mg/kg) SC dose followed by an SC injection of 100 IU/kg (1 mg/kg) every 12 hours or IV unfractionated heparin adjusted based on aPTT for 48 hours.
Croatian: Bolesnici su bili randomizirani za primanje enoksaparinnatrija u jednokratnoj bolusnoj dozi od 3000 IU (30 mg) i.v. plus 100 IU/kg (1 mg/kg) s.c., nakon kojih su slijedile supkutane injekcije enoksaparinnatrija u dozi od 100 IU/kg (1 mg/kg) svakih 12 sati, ili za primanje nefrakcioniranog heparina u intravenskoj dozi prilagođenoj prema aPTV-u tijekom 48 sati.
English: Thorinane 8,000 IU (80 mg)/0.8 mL solution for injection
Croatian: Thorinane 8000 IU (80 mg)/0,8 ml otopina za injekciju
English: • For the prevention of thrombus formation in the extra corporeal circulation during haemodialysis, it is administered through the arterial line of a dialysis circuit.
Croatian: • Za sprječavanje nastanka krvnih ugrušaka u izvantjelesnoj cirkulaciji tijekom hemodijalize,
English: • Switch between enoxaparin sodium and direct oral anticoagulants (DOAC) For patients currently receiving enoxaparin sodium, discontinue enoxaparin sodium and start the DOAC 0 to 2 hours before the time that the next scheduled administration of enoxaparin sodium would be due as per DOAC label.
Croatian: U bolesnika koji trenutno primaju enoksaparinnatrij, njegovu primjenu treba prekinuti, a primjenu DOAK-a započeti 0 do 2 sata prije nego što je trebala biti primijenjena sljedeća doza enoksaparinnatrija, u skladu s informacijama iz sažetka opisa svojstava lijeka za DOAK.
English: Skin necrosis and cutaneous vasculitis have been reported with LMWHs and should lead to prompt treatment discontinuation.
Croatian: Kod primjene heparina niske molekulske mase prijavljeni su nekroza kože i kožni vaskulitis, koji zahtijevaju trenutačan prekid liječenja.
English: o Additional bolus for PCI when last SC administration was given more than 8 hours before balloon inflation For patients being managed with PCI, an additional IV bolus of 30 IU/kg (0.3 mg/kg) is to be administered if last SC administration was given more than 8 hours before balloon inflation.
Croatian: U bolesnika koji se podvrgavaju perkutanoj koronarnoj intervenciji potrebno je primijeniti dodatnu intravensku bolusnu dozu od 30 IU/kg (0,3 mg/kg) ako je posljednja supkutana doza primijenjena više od 8 sati prije napuhavanja balona.
English: Thorinane 2,000 IU (20 mg)/0.2 mL injection enoxaparin sodium
Croatian: Thorinane 2000 IU (20 mg)/0,2 ml otopina za injekciju enoksaparinnatrij
English: The use of enoxaparin sodium has not been adequately studied for thromboprophylaxis in patients with mechanical prosthetic heart valves.
Croatian: Primjena enoksaparinnatrija za tromboprofilaksu u bolesnika s mehaničkim umjetnim srčanim zaliscima nije adekvatno ispitana.
English: Treatment of unstable angina and non ST elevation myocardial infarction In a large multicenter study, 3,171 patients enrolled at the acute phase of unstable angina or non-Q-wave myocardial infarction were randomized to receive in association with acetylsalicylic acid (100 to 325 mg once daily), either SC enoxaparin sodium 100 IU/kg (1 mg/kg) every 12 hours or IV unfractionated heparin adjusted based on aPTT.
Croatian: Liječenje nestabilne angine i infarkta miokarda bez elevacije ST-segmenta U velikom multicentričnom ispitivanju sudjelovao je 3171 bolesnik uključen u ispitivanje u akutnoj fazi nestabilne angine ili infarkta miokarda bez Q-zupca.
English: Thorinane 8,000 IU (80 mg)/0.8 mL injection enoxaparin sodium
Croatian: Thorinane 8000 IU (80 mg)/0,8 ml otopina za injekciju enoksaparin-natrij
English: Thorinane 10,000 IU (100 mg) /1.0 mL injection enoxaparin sodium
Croatian: Thorinane 10 000 IU (100 mg)/1 ml otopina za injekciju enoksaparinnatrij
English: Thorinane 6,000 IU (60 mg)/0.6 mL injection enoxaparin sodium
Croatian: Thorinane 6000 IU (60 mg)/0,6 ml otopina za injekciju enoksaparin-natrij
English: • High platelet counts in the blood.
Croatian: • visok broj trombocita u krvi
English: Thorinane 4,000 IU (40 mg) /0.4 mL injection enoxaparin sodium
Croatian: Thorinane 4000 IU (40 mg)/0,4 ml otopina za injekciju enoksaparin-natrij
English: How to store Thorinane
Croatian: Kako čuvati Inhixu
English: An infusion of 0.5 mg protamine per 100 IU (1 mg) of enoxaparin sodium may be administered if enoxaparin sodium was administered greater than 8 hours previous to the protamine administration, or if it has been determined that a second dose of protamine is required.
Croatian: Ako se enoksaparinnatrij injicirao više od 8 sati prije primjene protamina ili ako se utvrdi da treba primijeniti još jednu dozu protamina, može se primijeniti infuzija 0,5 mg protamina po 100 IU (1 mg) enoksaparinnatrija.
English: There is a lower weight-adjusted clearance in obese subjects with SC dosing.
Croatian: Klirens prilagođen prema tjelesnoj težini u pretilih ispitanika manji je kod supkutane primjene.
English: 0.4 mL of solution in a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a yellow polypropylene plunger rod.
Croatian: 0,4 ml otopine u štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil-gume i žutim klipom od polipropilena s pričvršćenom iglom i pokrovom za iglu.
English: Thorinane 8,000 IU (80 mg)/0.8 mL solution for injection enoxaparin sodium
Croatian: Thorinane 8000 IU (80 mg)/0,8 ml otopina za injekciju enoksaparinnatrij
English: 0.8 mL of solution in a clear, colourless type I neutral glass graduated syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a red polypropylene plunger rod.
Croatian: 0,8 ml otopine u graduiranoj štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, , zatvorenoj čepom od klorbutil-gume i crvenim klipom od polipropilena, s pričvršćenom iglom i pokrovom za iglu
English: • Hepatic impairment
Croatian: • glavobolja
English: Haemorrhages
Croatian: Apsorpcija
English: 0.6 mL of solution in a clear, colourless type I neutral glass graduated syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and an orange polypropylene plunger rod.
Croatian: 0,6 ml otopine u graduiranoj štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil-gume s narančastim klipom od polipropilena, s pričvršćenom glom i pokrovom za iglu
English: Enoxaparin sodium cannot be used interchangeably (unit for unit) with other LMWHs.
Croatian: Enoksaparinnatrij i drugi heparini niske molekulske mase ne mogu se međusobno zamjenjivati (jedinicu za jedinicu).
English: 1.0 mL of solution in a clear, colourless type I neutral glass graduated syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a black polypropylene plunger rod.
Croatian: 1,0 ml otopine u graduiranoj štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, s iglom sa štitnikom koja se ne može odvojiti, zatvorenoj čepom od klorbutil-gume i crnim klipom od polipropilena.
English: Vascular disorders
Croatian: Tablični prikaz nuspojava
English: 0.2 mL of solution in a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a blue polypropylene plunger rod.
Croatian: 0,2 ml otopine u štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil gume s plavim klipom od polipropilena, s pričvršćenom iglom i pokrovom za iglu Pakiranja od 2 i 10 napunjenih štrcaljki.
English: Elderly
Croatian: Dojenje
English: You may need to stay in hospital.
Croatian: Možda ćete morati ostati u bolnici.
English: 31 March every year
Croatian: 31. ožujka svake godine
English: 111 20 Stockholm Sweden
Croatian: 111 20 Stockholm Švedska
English: Please consult your doctor for additional information.
Croatian: Molimo Vas da se obratite svom liječniku za dodatne informacije.
English: The infusion will normally last for 1 to 3 hours and will be given every week.
Croatian: Infuzija će obično trajati od 1 do 3 sata i davat će se svaki tjedan.
English: Most of the time you can still be given this medicine even if these symptoms occur.
Croatian: Većinu vremena i dalje možete dobivati ovaj lijek, čak i ako dođe do tih simptoma.
English: The results are presented in Table 2.
Croatian: Rezultati su prikazani u tablici 2.
English: It is recommended that administration is started as soon as possible.
Croatian: Preporučuje se započeti s primjenom što je ranije moguće.
English: Reductions were evident by week 18 and were maintained to week 53.
Croatian: Smanjenja su bila primijećena do 18. tjedna i održavana su do 53. tjedna.
English: There is no clinical experience in patients over 65 years of age.
Croatian: Nema kliničkih iskustava s bolesnicima starijim od 65 godina.
English: Store in a refrigerator Do not freeze
Croatian: Čuvati u hladnjaku Ne zamrzavati
English: One patient was unclassified / unclassifiable.
Croatian: Jedan bolesnik nije bio klasificiran/nije ga se moglo klasificirati.
English: • Infusion-related reaction (see section entitled “Warnings and precautions”)
Croatian: • Reakcije povezane s infuzijom (vidjeti dio „Upozorenja i mjere opreza“)
English: • Increased blood pressure, decreased blood pressure
Croatian: • Povišen krvni tlak, snižen krvni tlak
English: This medicine has been authorised under “exceptional circumstances”.
Croatian: Ovaj lijek je odobren u „iznimnim okolnostima“.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2 to 8°C.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije uporabe odgovornost su korisnika te ne smiju biti duži od 24 sata pri temperaturi od 2 do 8 °C.
English: Side effects for which frequency is not known (cannot be estimated from available data) are: • Serious allergic reactions
Croatian: Nuspojave za koje je učestalost nepoznata (ne može se procijeniti iz dostupnih podataka) su: • Ozbiljne alergijske reakcije
English: Idursulfase has a molecular weight of approximately 76 kD.
Croatian: Idursulfaza ima molekularnu težinu od otprilike 76 kD.
English: Enzyme replacement therapy is usually administered as a long-term treatment.
Croatian: Enzimska nadomjesna terapija se uobičajeno primjenjuje kao dugotrajno liječenje.
English: Composite (6MWT and %FVC)
Croatian: Kompozitni (6MWT i %FVC)
English: It was not possible, however, to accurately predict individual clinical outcome based on antibody response or genotype.
Croatian: Međutim, nije bilo moguće točno predvidjeti pojedinačan klinički ishod na temelju odgovora protutijela ili genotipa.
English: 205 Alewife Brook Parkway Cambridge, MA 02138 USA
Croatian: 205 Alewife Brook Parkway Cambridge, MA 02138 SAD
English: Speak with your healthcare professional if you are not sure.
Croatian: Razgovarajte sa svojim zdravstvenim radnikom ako niste sigurni.
English: 300 Shire Way Lexington MA 02421 USA
Croatian: 300 Shire Way Lexington MA 02421 SAD
English: Since more than one infusion-related reaction may have occurred during any single infusion, the above numbers are likely to overestimate the true incidence of infusion reactions.
Croatian: S obzirom da je tijekom bilo koje pojedinačne infuzije moglo doći do više od jedne reakcije, navedene brojke vjerojatno precjenjuju stvarnu incidenciju reakcija povezanih s infuzijom.
English: Frequency is given as very common (≥1/10), common (≥1/100 to <1/10) or uncommon (≥1/1,000 to <1/100).
Croatian: Učestalost je definirana kao vrlo česta (≥ 1/10), česta (≥ 1/100 i < 1/10) ili manje česta (1/1000 i <1/100).
English: Talk to your doctor or nurse before using this medicine.
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primijenite ovaj lijek.
English: The recommended dosage in children and adolescents is the same as in adults.
Croatian: Preporučena doza za djecu i adolescente jednaka je kao za odrasle.
English: Date of first authorisation: 08 January 2007 Date of latest renewal: 09 September 2016
Croatian: Datum posljednje obnove: 09. rujna 2016.
English: Other medicines and Elaprase
Croatian: Drugi lijekovi i Elaprase
English: No clinical data exist demonstrating a benefit on the neurological manifestations of the disorder.
Croatian: Ne postoje klinički podaci koji bi dokazivali korist za neurološke manifestacije poremećaja.
English: Once diluted, the solution should be mixed gently, but not shaken.
Croatian: Nakon što je jednom razrijeđena, otopina se treba lagano miješati, ali ne tresti.
English: A higher volume of distribution at steady state (Vss) was observed in the lowest weight groups.
Croatian: Veći volumen distribucije u stanju dinamičke ravnoteže (Vss) uočen je u skupinama s najmanjom težinom.
English: Age (years)
Croatian: Dob (godine)
English: There is no known interaction of this medicine with other medicines.
Croatian: Nisu poznate interakcije ovog lijeka s drugim lijekovima.
English: Specific Obligation 5 - To evaluate the following long term clinical endpoints primarily through the HOS.
Croatian: Posebna obveza 5 - Potrebno je procijeniti sljedeće dugoročne kliničke ishode, primarno putem HOS-a.
English: From a microbiological safety point of view, the diluted product should be used immediately.
Croatian: Sa stajališta mikrobiološke sigurnosti, razrijeđeni lijek treba odmah primijeniti.