FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean maximum plasma anti-Xa activity level is observed 3 to 5 hours after SC injection and achieves approximately 0.2, 0.4, 1.0 and 1.3 anti-Xa IU/mL following single SC administration of 2,000 IU, 4,000 IU, 100 IU/kg and 150 IU/kg (20 mg, 40 mg, 1 mg/kg and 1.5 mg/kg) doses, respectively.
Slovenian: Povprečna največja aktivnost anti-Xa v plazmi se pojavi od 3 do 5 ur po subkutanem injiciranju in doseže po enkratni subkutani uporabi 2.000 i.e. (20 mg) približno 0,2 anti-Xa i.e./ml, po 4.000 i.e. (40 mg) približno 0,4 anti-Xa i.e./ml, po 100 i.e./kg (1 mg/kg) približno 1,0 anti-Xa i.e./ml in po 150 i.e./kg (1,5 mg/kg) približno 1,3 anti-Xa i.e./ml.
English: 1 x 3,000 IU (30 mg) IV bolus plus 100 IU/kg (1 mg/kg) body weight SC and then 100 IU/kg (1 mg/kg) body weight SC every 24 hours
Slovenian: 1 x intravenski bolus 3.000 i.e. (30 mg) in obenem 100 i.e./kg (1 mg/kg) telesne mase subkutano, nato 100 i.e./kg (1 mg/kg) telesne mase subkutano na 24 ur
English: • Mechanical prosthetic heart valves
Slovenian: • Mehanične protetične srčne zaklopke
English: • Rare: Cholestatic liver injury*
Slovenian: • Redki: Holestatska okvara jeter*
English: • Skin necrosis / cutaneous vasculitis
Slovenian: • Nekroza kože/kožni vaskulitis
English: • Thorinane is added to the tube leaving the body (arterial line) at the start of the dialysis session.
Slovenian: • Zdravilo Thorinane se na začetku dialize da v cevko, ki vodi iz telesa (v arterijsko linijo).
English: • Proximal DVT (%)
Slovenian: Proksimalne GVT (%)
English: The usual dose is 100 IU (1 mg) for every kilogram of your weight, every 12 hours.
Slovenian: Običajen odmerek je 100 i.e. (1 mg) na kilogram telesne mase na 12 ur.
English: • you are going to receive spinal or epidural anesthesia or lumbar puncture (see Operations and
Slovenian: • če boste prejeli spinalno ali epiduralno anestezijo ali lumbalno punkcijo (glejte Operacije in anestezija): upoštevati je treba zakasnitev med uporabo zdravila Thorinane in tem postopkom.
English: • Renal impairment
Slovenian: • Okvara ledvic
English: o For patients with a high venous thromboembolism (VTE) risk who undergo abdominal or pelvic surgery for cancer an extended thromboprophylaxis up to 4 weeks is
Slovenian: o Pri bolnikih z večjo ortopedsko operacijo je priporočljiva podaljšana o Pri bolnikih z velikim tveganjem za vensko trombembolijo (VTE) s trebušno ali medenično operacijo zaradi raka je priporočljiva podaljšana tromboprofilaksa do 4
English: • The usual dose is 100 IU (1 mg) for every kilogram of weight every 12 hours.
Slovenian: • Običajen odmerek je 100 i.e. (1 mg) na kilogram telesne mase na 12 ur.
English: Immuno-allergic thrombocytopeni a
Slovenian: Imuno-alergijska trombocitopenija
English: • Severe renal impairment
Slovenian: • Huda okvara ledvic
English: Enoxaparin sodium 2,000 IU (20 mg) once a day SC n (%)
Slovenian: Natrijev enoksaparinat 2.000 i.e. (20 mg) enkrat na dan subkutano n (%)
English: • Common: Injection site haematoma, injection site pain, other injection site reaction (such as oedema,
Slovenian: • Pogosti: Hematom na mestu injiciranja, bolečina na mestu injiciranja, druge reakcije na mestu injiciranja (na primer edem, krvavitev, preobčutljivost, vnetje, masa, bolečina ali reakcija)
English: How to store Thorinane
Slovenian: Kako si injicirate zdravilo Thorinane
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
Slovenian: Brez začetnega intravenskega bolusa 100 i.e./kg (1 mg/kg) telesne mase subkutano, nato 100 i.e./kg (1 mg/kg) telesne mase subkutano na 24 ur
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.
Slovenian: Zdravljenje nestabilne angine pektoris in miokardnega infarkta brez dviga spojnice ST V veliki multicentrični študiji so 3.171 bolnikov, vključenih v akutni fazi nestabilne angine pektoris ali miokardnega infarkta brez zobca Q, randomizirali na prejemanje natrijevega enoksaparinata 100 i.e./kg (1 mg/kg) subkutano na 12 ur ali nefrakcioniranega heparina intravensko s prilagoditvijo glede na aPTČ.
English: • For acute STEMI, treatment is to be initiated with a single IV bolus injection immediately followed by a
Slovenian: • Intravensko (bolusno) injiciranje (samo za indikacijo akutni STEMI): Zdravljenje akutnega STEMI je treba začeti z eno intravensko bolusno injekcijo, ki ji neposredno sledi subkutana injekcija.
English: • Skin rash (hives, urticaria).
Slovenian: • Izpuščaj na koži (koprivnica)
English: The 2 hours preoperative initiation of enoxaparin sodium 2,000 IU (20 mg) is not compatible with neuraxial anaesthesia.
Slovenian: Dvourna predoperacijska uvedba 2.000 i.e. (20 mg) natrijevega enoksaparinata ni združljiva z
English: One pre-filled syringe (0.2 mL) contains 2,000 IU (20 mg) enoxaparin sodium
Slovenian: Ena napolnjena injekcijska brizga (0,2 ml) vsebuje 2.000 i.e. (20 mg) natrijevega enoksaparinata
English: No difference in major bleeding was found between the enoxaparin sodium and the placebo group.
Slovenian: Med natrijevim enoksaparinatom in placebom niso ugotovili razlik v večjih krvavitvah.
English: SC injection Do not mix with other products.
Slovenian: Subkutano injiciranje Zdravila Thorinane ne smete mešati z drugimi injekcijami ali infuzijami.
English: One pre-filled syringe (1 mL) contains 10,000 IU (100 mg) enoxaparin sodium
Slovenian: Ena napolnjena injekcijska brizga (1 ml) vsebuje 10.000 i.e. (100 mg) natrijevega enoksaparinata
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.
Slovenian: Menjava antikoagulantnih zdravil - Prehod z zdravila Thorinane na sredstva za redčenje krvi, imenovana antagonisti vitamina K (npr. varfarin)
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.
Slovenian: Bolnikom, ki trenutno prejemajo natrijev enoksaparinat, slednjega ukinite in uvedite DOAC od 0 do 2 uri pred časom, ko bi bil na vrsti naslednji redni odmerek natrijevega enoksaparinata (v skladu z navodili za uporabo DOAC).
English: - concomitant use of medications affecting haemostasis (see section 4.5).
Slovenian: - nevrološka ali oftalmološka operacija, - sočasna uporaba zdravil, ki poslabšajo hemostazo (glejte poglavje 4.5).
English: Extracorporeal use (in the dialysis circuit).
Slovenian: subkutana, intravenska uporaba izventelesna uporaba (v dializnem obtoku)
English: One pre-filled syringe (0.4 mL) contains 4,000 IU (40 mg) enoxaparin sodium
Slovenian: Ena napolnjena injekcijska brizga (0,4 ml) vsebuje 4.000 i.e. (40 mg) natrijevega enoksaparinata
English: - Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac, - Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants (see section 4.2).
Slovenian: - drugi trombolitiki (npr. alteplaza, reteplaza, streptokinaza, tenekteplaza, urokinaza) in
English: • Haemorrhage
Slovenian: • Glavobol
English: 5) Hold the syringe in the hand you write with (like a pencil) and with your other hand, gently pinch the cleaned area of your abdomen between your forefinger and thumb to make a fold in the skin.
Slovenian: Z drugo roko nežno stisnite očiščeni del kože na trebuhu med palec in kazalec, da bo nastala kožna guba.
English: One pre-filled syringe (0.8 mL) contains 8,000 IU (80 mg) enoxaparin sodium
Slovenian: Ena napolnjena injekcijska brizga (0,8 ml) vsebuje 8.000 i.e. (80 mg) natrijevega enoksaparinata
English: No dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment.
Slovenian: Pri bolnikih z zmerno (očistek kreatinina 30-50 ml/min) in blago (očistek kreatinina 50-80 ml/min) okvaro ledvic odmerka ni treba prilagoditi.
English: Each prefilled syringe contains enoxaparin sodium 8,000 IU anti-Xa activity (equivalent to 80 mg) in 0.8 mL water for injections.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 8.000 i.e. aktivnosti anti-Xa natrijevega enoksaparinata (to ustreza 80 mg) v 0,8 ml vode za injekcije.
English: One pre-filled syringe (0.6 mL) contains 6,000 IU (60 mg) enoxaparin sodium
Slovenian: Ena napolnjena injekcijska brizga (0,6 ml) vsebuje 6.000 i.e. (60 mg) natrijevega enoksaparinata
English: • Total DVT (%)
Slovenian: Vse GVT (%)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NAPOLNJENA INJEKCIJSKA BRIZGA
English: Following oral administration of even large doses, it is unlikely that enoxaparin sodium will be absorbed.
Slovenian: Po peroralni uporabi absorpcija natrijevega enoksaparinata ni verjetna, tudi v primeru zaužitja velikih odmerkov ne.
English: Thorinane 6,000 IU (60 mg)/0.6 mL solution for injection
Slovenian: Thorinane 6.000 i.e. (60 mg)/ 0,6 ml raztopina za injiciranje
English: Each pre-filled syringe of 1.0 mL contains 10,000 IU (100 mg) of enoxaparin sodium.
Slovenian: Ena 1,0 ml napolnjena injekcijska brizga vsebuje 10.000 i.e. (100 mg) natrijevega enoksaparinata.
English: Each prefilled syringe contains enoxaparin sodium 2,000 IU anti-Xa activity (equivalent to 20 mg) in 0.2 mL water for injections.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 2.000 i.e. aktivnosti anti-Xa natrijevega enoksaparinata (to ustreza 20 mg) v 0,2 ml vode za injekcije.
English: Solution for injection in pre-filled syringe 2 pre-filled syringes
Slovenian: 2 napolnjeni injekcijski brizgi 10 napolnjenih injekcijskih brizg
English: Each prefilled syringe contains enoxaparin sodium 6,000 IU anti-Xa activity (equivalent to 60 mg) in 0.6 mL water for injections.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 6.000 i.e. aktivnosti anti-Xa natrijevega enoksaparinata (to ustreza 60 mg) v 0,6 ml vode za injekcije.
English: Discard any unused medicine.
Slovenian: Neporabljeno zdravilo je treba v celoti zavreči.
English: Each prefilled syringe contains enoxaparin sodium 4,000 IU anti-Xa activity (equivalent to 40 mg) in 0.4 mL water for injections.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 4.000 i.e. aktivnosti anti-Xa natrijevega enoksaparinata (to ustreza 40 mg) v 0,4 ml vode za injekcije.
English: Thorinane 10,000 IU (100 mg)/1.0 mL solution for injection
Slovenian: Thorinane 10.000 i.e. (100 mg)/1,0 ml raztopina za injiciranje
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.
Slovenian: Pri bolnikih z mehaničnimi protetičnimi srčnimi zaklopkami, ki so za tromboprofilakso dobivali natrijev enoksaparinat, so bili opisani posamezni primeri tromboze na protetični srčni zaklopki.
English: Thorinane 8,000 IU (80 mg)/0.8 mL solution for injection
Slovenian: Thorinane 8.000 i.e. (80 mg)/0,8 ml raztopina za injiciranje
English: Each pre-filled syringe of 0.8 mL contains 8,000 IU (80 mg) of enoxaparin sodium.
Slovenian: Ena 0,8 ml napolnjena injekcijska brizga vsebuje 8000 i.e. (80 mg) natrijevega enoksaparinata.
English: Treating blood clots that are in your blood
Slovenian: Zdravljenje krvnih strdkov v krvi
English: Thorinane 4,000 IU (40 mg)/0.4 mL solution for injection
Slovenian: Thorinane 4.000 i.e. (40 mg)/ 0,4 ml raztopina za injiciranje
English: Thorinane 2,000 IU (20 mg)/0.2 mL solution for injection
Slovenian: Thorinane 2.000 i.e. (20 mg)/ 0,2 ml raztopina za injiciranje
English: Each pre-filled syringe of 0.6 mL contains 6,000 IU (60 mg) of enoxaparin sodium.
Slovenian: Ena 0,6 ml napolnjena injekcijska brizga vsebuje 6000 i.e. (60 mg) natrijevega enoksaparinata.
English: Following repeated SC administration no accumulation takes place.
Slovenian: Po ponavljajoči se subkutani uporabi se zdravilo ne kopiči.
English: Skin necrosis and cutaneous vasculitis have been reported with LMWHs and should lead to prompt treatment discontinuation.
Slovenian: Med uporabo NMH sta bila opisana nekroza kože in kožni vaskulitis; če se pojavi kateri od njiju, je treba zdravljenje nemudoma prekiniti.
English: Each pre-filled syringe of 0.4 mL contains 4,000 IU (40 mg) of enoxaparin sodium.
Slovenian: Ena 0,4ml napolnjena injekcijska brizga vsebuje 4000 i.e. (40 mg) natrijevega enoksaparinata.
English: PRE-FILLED SYRINGE
Slovenian: Žilne bolezni
English: Each pre-filled syringe of 0.2 mL contains 2,000 IU (20 mg) of enoxaparin sodium.
Slovenian: Ena 0,2 ml napolnjena injekcijska brizga vsebuje 2000 i.e. (20 mg) natrijevega enoksaparinata.
English: Blood and the lymphatic system disorders
Slovenian: Bolezn i krvi in limfati čnega sistem a β
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.
Slovenian: Bolniki, zdravljeni s PKI, morajo dobiti dodaten intravenski odmerek 30 i.e./kg (0,3 mg/kg), če je bil zadnji subkutani odmerek uporabljen več kot 8 ur pred balonskim širjenjem.
English: Thorinane 2,000 IU (20 mg)/0.2 mL injection enoxaparin sodium
Slovenian: Thorinane 2.000 i.e. (20 mg)/0,2 ml raztopina za injiciranje natrijev enoksaparinat
English: Thorinane 10,000 IU (100 mg) /1.0 mL injection enoxaparin sodium
Slovenian: Thorinane 10.000 i.e. (100 mg)/1,0 ml raztopina za injiciranje natrijev enoksaparinat
English: Accidental overdose with enoxaparin sodium after IV, extracorporeal or SC administration may lead to haemorrhagic complications.
Slovenian: Naključno preveliko odmerjanje intravensko, izventelesno ali subkutano uporabljenega natrijevega enoksaparinata lahko povzroči krvavitvene zaplete.
English: - 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.
Slovenian: Prenehajte jemati antagonist vitamina K. Zdravnik vam bo naročil, da opravite preiskavo krvi, imenovano INR, in vam bo glede na to povedal, kdaj začnite uporabljati zdravilo Thorinane.
English: Thorinane 8,000 IU (80 mg)/0.8 mL injection enoxaparin sodium
Slovenian: Thorinane 8.000 i.e. (80 mg)/0,8 ml raztopina za injiciranje enoksaparin
English: Thorinane 6,000 IU (60 mg)/0.6 mL injection enoxaparin sodium
Slovenian: Thorinane 6.000 i.e. (60 mg)/0,6 ml raztopina za injiciranje enoksaparin
English: You will be given 2,000 IU (20 mg) or 4,000 IU (40 mg) of Thorinane each day.
Slovenian: 4.000 i.e. (40 mg) zdravila Thorinane na dan.
English: Do not use if the date has passed.
Slovenian: Če se je rok uporabnosti iztekel, zdravila ne uporabite.
English: Tabulated summary list of adverse reactions
Slovenian: Seznam neželenih učinkov v preglednici
English: Stopping blood clots from forming in the tubes of your dialysis machine
Slovenian: Preprečitev nastajanje krvnih strdkov v cevkah dializne naprave
English: Vascular disorders
Slovenian: Trombocitopenij
English: This could be a
Slovenian: Njim bi lahko celo škodovalo,
English: Thorinane 4,000 IU (40 mg) /0.4 mL injection enoxaparin sodium
Slovenian: Thorinane 4.000 i.e. (40 mg)/0,4 ml raztopina za injiciranje natrijev enoksaparinat
English: • High platelet counts in the blood.Headache.
Slovenian: • Veliko število trombocitov v krvi • Glavobol
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.
Slovenian: 0,2 ml raztopine v injekcijski brizgi iz prozornega, brezbarvnega, nevtralnega stekla tipa I, opremljeni z injekcijsko iglo in ščitnikom igle, z gumijasto zaporko iz klorobutila in z modrim polipropilenskim batom.
English: Instructions on injecting yourself with Thorinane
Slovenian: Preden si injicirate zdravilo Thorinane
English: Haemorrhages
Slovenian: Krvavitve
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.
Slovenian: Če je od aplikacije natrijevega enoksaparinata do uporabe protamina preteklo več kot 8 ur, ali če se izkaže, da je potreben drugi odmerek protamina, je mogoče uporabiti infuzijo 0,5 mg protamina na 100 i.e. (1 mg) natrijevega enoksaparinata.
English: SC injection.
Slovenian: Subkutano injiciranje
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.
Slovenian: 0,8 ml raztopine v graduirani injekcijski brizgi iz prozornega, brezbarvnega, nevtralnega stekla tipa I, opremljeni z injekcijsko iglo in ščitnikom igle, z gumijasto zaporko iz klorobutila in z rdečim polipropilenskim batom.
English: • Low weight
Slovenian: • Majhna telesna masa
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.
Slovenian: 1,0 ml raztopine v graduirani injekcijski brizgi iz prozornega, brezbarvnega, nevtralnega stekla tipa I, opremljeni z injekcijsko iglo in ščitnikom igle, z gumijasto zaporko iz klorobutila in s črnim polipropilenskim batom.
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.
Slovenian: 0,6 ml raztopine v graduirani injekcijski brizgi iz prozornega, brezbarvnega, nevtralnega stekla tipa I, opremljeni z injekcijsko iglo in ščitnikom igle, z gumijasto zaporko iz klorobutila in z oranžnim polipropilenskim batom.
English: • Thorinane can be given by injection into your vein (intravenous) after certain types of heart attack or operation.
Slovenian: • Po določenih vrstah srčnega infarkta ali operacijah se zdravilo Thorinane lahko injicira v veno
English: Water for injections
Slovenian: 6.1 Seznam pomožnih snovi Voda za injekcije
English: Thrombocytopenia and thrombocytosis
Slovenian: Trombocitopenija in trombocitoza
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.
Slovenian: 0,4 ml raztopine v injekcijski brizgi iz prozornega, brezbarvnega, nevtralnega stekla tipa I, opremljeni z injekcijsko iglo in ščitnikom igle, z gumijasto zaporko iz klorobutila in z rumenim polipropilenskim batom.
English: Headache.
Slovenian: Glejte
English: The dose regimen of 100 IU/kg (1 mg/kg) administered twice daily should be used in all other patients such as those with obesity, with symptomatic PE, cancer, recurrent VTE or proximal (vena iliaca) thrombosis.
Slovenian: Pri vseh drugih bolnikih, npr. debelih bolnikih, bolnikih s simptomatsko PE, rakom, ponovno VTE ali proksimalno trombozo (vena iliaca), je priporočljivo uporabiti odmerno shemo 100 i.e./kg (1 mg/kg) dvakrat na dan.
English: After repeated SC administration of the 100 IU/kg (1 mg/kg) twice daily regimen, the steady-state is reached from day 3 to 4 with mean exposure about 65% higher than after a single dose and mean maximum and trough anti-Xa activity levels of about 1.2 and 0.52 IU/mL, respectively.
Slovenian: Povprečna izpostavljenost je približno 65 % večja kot po enkratnem odmerku, povprečna največja raven aktivnosti anti-Xa je približno 1,2 i.e./ml in povprečna najmanjša raven okoli 0,52 i.e./ml.
English: Elderly
Slovenian: Dojenje
English: 31 March every year
Slovenian: 31. marec vsako leto
English: You may need to stay in hospital.
Slovenian: Morda boste morali ostati v bolnišnici.
English: 111 20 Stockholm Sweden
Slovenian: 111 20 Stockholm Švedska
English: Date of first authorisation: 08 January 2007 Date of latest renewal: 09 September 2016
Slovenian: Datum prve odobritve: 8. januar 2007 Datum zadnjega podaljšanja: 9. september 2016
English: The results are presented in Table 2.
Slovenian: Rezultati so predstavljeni v tabeli 2.
English: It is recommended that administration is started as soon as possible.
Slovenian: Infundiranje je priporočeno začeti čim prej.
English: Reductions were evident by week 18 and were maintained to week 53.
Slovenian: Zmanjšanja so se pokazala do 18. tedna in se ohranila do 53. tedna.
English: The current medical standards for emergency treatment are to be observed.
Slovenian: Treba je upoštevati trenutne zdravstvene standarde za nujno zdravljenje.
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.
Slovenian: Če ni porabljeno takoj, je uporabnik odgovoren za čas in pogoje hranjenja pred uporabo, ti pa ne bi smeli trajati dlje kot 24 ur pri 2 do 8 °C.
English: There is no clinical experience in patients over 65 years of age.
Slovenian: Kliničnih izkušenj pri bolnikih, starejših od 65 let, ni.
English: The recommended dosage in children and adolescents is the same as in adults.
Slovenian: Priporočeni odmerek pri otrocih in mladostnikih je enak kot pri odraslih.
English: • Increased blood pressure, decreased blood pressure
Slovenian: • zvišanje krvnega tlaka, znižanje krvnega tlaka
English: Most of the time you can still be given this medicine even if these symptoms occur.
Slovenian: Večinoma vam bodo to zdravilo dajali tudi, če se pojavijo ti simptomi.
English: • Infusion-related reaction (see section entitled “Warnings and precautions”)
Slovenian: • učinki, povezani z infundiranjem (glejte poglavje »Opozorila in previdnostni ukrepi«)
English: Side effects for which frequency is not known (cannot be estimated from available data) are: • Serious allergic reactions
Slovenian: Neželeni učinki, katerih pogostnost ni znana (ni je mogoče oceniti iz razpoložljivih podatkov), so: • resne alergijske reakcije
English: Frequency is given as very common (≥1/10), common (≥1/100 to <1/10) or uncommon (≥1/1,000 to <1/100).
Slovenian: Pogostnost neželenih učinkov je navedena kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) ali občasni ( 1/1.000 do <1/100).
English: % Predicted FVC 4.2 (1.6)
Slovenian: % pričakovana FVK 4,2 (1,6)
English: 205 Alewife Brook Parkway Cambridge, MA 02138 USA
Slovenian: 205 Alewife Brook Parkway Cambridge, MA 02138 ZDA
English: 300 Shire Way Lexington MA 02421 USA
Slovenian: 300 Shire Way Lexington, MA 02421 ZDA
English: Enzyme replacement therapy is usually administered as a long-term treatment.
Slovenian: Encimska nadomestna terapija se ponavadi izvaja kot dolgotrajno zdravljenje.
English: Adverse reactions only reported during the post marketing period are also included in the table with a frequency “not known” (cannot be estimated from the available data).
Slovenian: Neželeni učinki, o katerih so poročali samo v obdobju trženja, so tudi vključeni v preglednico s pogostnostjo »neznana« (ni mogoče oceniti iz razpoložljivih podatkov).
English: Institution of positive-airway pressure may be necessary in some cases.
Slovenian: V nekaterih primerih bo mogoče treba vzpostaviti pozitivni tlak v dihalnih poteh.
English: Age (years)
Slovenian: Starost (v letih)
English: Urine GAG levels (μg GAG/mg creatinine)
Slovenian: Ravni GAG v urinu (μg GAG/mg kreatinina)