natgillin/translations-raw huggingface dataset:
One pre-filled syringe (1 mL) contains 10,000 IU (100 mg) enoxaparin sodium
Ena napolnjena injekcijska brizga (1 ml) vsebuje 10.000 i.e. (100 mg) natrijevega enoksaparinata
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.
Menjava antikoagulantnih zdravil - Prehod z zdravila Thorinane na sredstva za redčenje krvi, imenovana antagonisti vitamina K (npr. varfarin)
• 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.
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).
- concomitant use of medications affecting haemostasis (see section 4.5).
- nevrološka ali oftalmološka operacija, - sočasna uporaba zdravil, ki poslabšajo hemostazo (glejte poglavje 4.5).
Extracorporeal use (in the dialysis circuit).
subkutana, intravenska uporaba izventelesna uporaba (v dializnem obtoku)
One pre-filled syringe (0.4 mL) contains 4,000 IU (40 mg) enoxaparin sodium
Ena napolnjena injekcijska brizga (0,4 ml) vsebuje 4.000 i.e. (40 mg) natrijevega enoksaparinata
- 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).
- drugi trombolitiki (npr. alteplaza, reteplaza, streptokinaza, tenekteplaza, urokinaza) in
• Haemorrhage
• Glavobol
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.
Z drugo roko nežno stisnite očiščeni del kože na trebuhu med palec in kazalec, da bo nastala kožna guba.
One pre-filled syringe (0.8 mL) contains 8,000 IU (80 mg) enoxaparin sodium
Ena napolnjena injekcijska brizga (0,8 ml) vsebuje 8.000 i.e. (80 mg) natrijevega enoksaparinata
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.
Pri bolnikih z zmerno (očistek kreatinina 30-50 ml/min) in blago (očistek kreatinina 50-80 ml/min) okvaro ledvic odmerka ni treba prilagoditi.
Each prefilled syringe contains enoxaparin sodium 8,000 IU anti-Xa activity (equivalent to 80 mg) in 0.8 mL water for injections.
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.
One pre-filled syringe (0.6 mL) contains 6,000 IU (60 mg) enoxaparin sodium
Ena napolnjena injekcijska brizga (0,6 ml) vsebuje 6.000 i.e. (60 mg) natrijevega enoksaparinata
• Total DVT (%)
Vse GVT (%)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NAPOLNJENA INJEKCIJSKA BRIZGA
Following oral administration of even large doses, it is unlikely that enoxaparin sodium will be absorbed.
Po peroralni uporabi absorpcija natrijevega enoksaparinata ni verjetna, tudi v primeru zaužitja velikih odmerkov ne.
Thorinane 6,000 IU (60 mg)/0.6 mL solution for injection
Thorinane 6.000 i.e. (60 mg)/ 0,6 ml raztopina za injiciranje
Each pre-filled syringe of 1.0 mL contains 10,000 IU (100 mg) of enoxaparin sodium.
Ena 1,0 ml napolnjena injekcijska brizga vsebuje 10.000 i.e. (100 mg) natrijevega enoksaparinata.
Each prefilled syringe contains enoxaparin sodium 2,000 IU anti-Xa activity (equivalent to 20 mg) in 0.2 mL water for injections.
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.
Solution for injection in pre-filled syringe 2 pre-filled syringes
2 napolnjeni injekcijski brizgi 10 napolnjenih injekcijskih brizg
Each prefilled syringe contains enoxaparin sodium 6,000 IU anti-Xa activity (equivalent to 60 mg) in 0.6 mL water for injections.
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.
Discard any unused medicine.
Neporabljeno zdravilo je treba v celoti zavreči.
Each prefilled syringe contains enoxaparin sodium 4,000 IU anti-Xa activity (equivalent to 40 mg) in 0.4 mL water for injections.
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.
Thorinane 10,000 IU (100 mg)/1.0 mL solution for injection
Thorinane 10.000 i.e. (100 mg)/1,0 ml raztopina za injiciranje
Isolated cases of prosthetic heart valve thrombosis have been reported in patients with mechanical prosthetic heart valves who have received enoxaparin sodium for thromboprophylaxis.
Pri bolnikih z mehaničnimi protetičnimi srčnimi zaklopkami, ki so za tromboprofilakso dobivali natrijev enoksaparinat, so bili opisani posamezni primeri tromboze na protetični srčni zaklopki.
Thorinane 8,000 IU (80 mg)/0.8 mL solution for injection
Thorinane 8.000 i.e. (80 mg)/0,8 ml raztopina za injiciranje
Each pre-filled syringe of 0.8 mL contains 8,000 IU (80 mg) of enoxaparin sodium.
Ena 0,8 ml napolnjena injekcijska brizga vsebuje 8000 i.e. (80 mg) natrijevega enoksaparinata.
Treating blood clots that are in your blood
Zdravljenje krvnih strdkov v krvi
Thorinane 4,000 IU (40 mg)/0.4 mL solution for injection
Thorinane 4.000 i.e. (40 mg)/ 0,4 ml raztopina za injiciranje
Thorinane 2,000 IU (20 mg)/0.2 mL solution for injection
Thorinane 2.000 i.e. (20 mg)/ 0,2 ml raztopina za injiciranje
Each pre-filled syringe of 0.6 mL contains 6,000 IU (60 mg) of enoxaparin sodium.
Ena 0,6 ml napolnjena injekcijska brizga vsebuje 6000 i.e. (60 mg) natrijevega enoksaparinata.
Following repeated SC administration no accumulation takes place.
Po ponavljajoči se subkutani uporabi se zdravilo ne kopiči.
Skin necrosis and cutaneous vasculitis have been reported with LMWHs and should lead to prompt treatment discontinuation.
Med uporabo NMH sta bila opisana nekroza kože in kožni vaskulitis; če se pojavi kateri od njiju, je treba zdravljenje nemudoma prekiniti.
Each pre-filled syringe of 0.4 mL contains 4,000 IU (40 mg) of enoxaparin sodium.
Ena 0,4ml napolnjena injekcijska brizga vsebuje 4000 i.e. (40 mg) natrijevega enoksaparinata.
PRE-FILLED SYRINGE
Žilne bolezni
Each pre-filled syringe of 0.2 mL contains 2,000 IU (20 mg) of enoxaparin sodium.
Ena 0,2 ml napolnjena injekcijska brizga vsebuje 2000 i.e. (20 mg) natrijevega enoksaparinata.
Blood and the lymphatic system disorders
Bolezn i krvi in limfati čnega sistem a β
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.
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.
Thorinane 2,000 IU (20 mg)/0.2 mL injection enoxaparin sodium
Thorinane 2.000 i.e. (20 mg)/0,2 ml raztopina za injiciranje natrijev enoksaparinat
Thorinane 10,000 IU (100 mg) /1.0 mL injection enoxaparin sodium
Thorinane 10.000 i.e. (100 mg)/1,0 ml raztopina za injiciranje natrijev enoksaparinat
Accidental overdose with enoxaparin sodium after IV, extracorporeal or SC administration may lead to haemorrhagic complications.
Naključno preveliko odmerjanje intravensko, izventelesno ali subkutano uporabljenega natrijevega enoksaparinata lahko povzroči krvavitvene zaplete.
- 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.
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.
Thorinane 8,000 IU (80 mg)/0.8 mL injection enoxaparin sodium
Thorinane 8.000 i.e. (80 mg)/0,8 ml raztopina za injiciranje enoksaparin
Thorinane 6,000 IU (60 mg)/0.6 mL injection enoxaparin sodium
Thorinane 6.000 i.e. (60 mg)/0,6 ml raztopina za injiciranje enoksaparin
You will be given 2,000 IU (20 mg) or 4,000 IU (40 mg) of Thorinane each day.
4.000 i.e. (40 mg) zdravila Thorinane na dan.
Do not use if the date has passed.
Če se je rok uporabnosti iztekel, zdravila ne uporabite.
Tabulated summary list of adverse reactions
Seznam neželenih učinkov v preglednici
Stopping blood clots from forming in the tubes of your dialysis machine
Preprečitev nastajanje krvnih strdkov v cevkah dializne naprave
Vascular disorders
Trombocitopenij
This could be a
Njim bi lahko celo škodovalo,
Thorinane 4,000 IU (40 mg) /0.4 mL injection enoxaparin sodium
Thorinane 4.000 i.e. (40 mg)/0,4 ml raztopina za injiciranje natrijev enoksaparinat
• High platelet counts in the blood.Headache.
• Veliko število trombocitov v krvi • Glavobol
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.
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.
Instructions on injecting yourself with Thorinane
Preden si injicirate zdravilo Thorinane
Haemorrhages
Krvavitve
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.
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.
SC injection.
Subkutano injiciranje
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.
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.
• Low weight
• Majhna telesna masa
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.
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.
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.
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.
• Thorinane can be given by injection into your vein (intravenous) after certain types of heart attack or operation.
• Po določenih vrstah srčnega infarkta ali operacijah se zdravilo Thorinane lahko injicira v veno
Water for injections
6.1 Seznam pomožnih snovi Voda za injekcije
Thrombocytopenia and thrombocytosis
Trombocitopenija in trombocitoza
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.
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.
Headache.
Glejte
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.
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.
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.
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.
31 March every year
31. marec vsako leto
You may need to stay in hospital.
Morda boste morali ostati v bolnišnici.
Date of first authorisation: 08 January 2007 Date of latest renewal: 09 September 2016
Datum prve odobritve: 8. januar 2007 Datum zadnjega podaljšanja: 9. september 2016
The results are presented in Table 2.
Rezultati so predstavljeni v tabeli 2.
It is recommended that administration is started as soon as possible.
Infundiranje je priporočeno začeti čim prej.
Reductions were evident by week 18 and were maintained to week 53.
Zmanjšanja so se pokazala do 18. tedna in se ohranila do 53. tedna.
The current medical standards for emergency treatment are to be observed.
Treba je upoštevati trenutne zdravstvene standarde za nujno zdravljenje.
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.
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.
There is no clinical experience in patients over 65 years of age.
Kliničnih izkušenj pri bolnikih, starejših od 65 let, ni.
The recommended dosage in children and adolescents is the same as in adults.
Priporočeni odmerek pri otrocih in mladostnikih je enak kot pri odraslih.
• Increased blood pressure, decreased blood pressure
• zvišanje krvnega tlaka, znižanje krvnega tlaka
Most of the time you can still be given this medicine even if these symptoms occur.
Večinoma vam bodo to zdravilo dajali tudi, če se pojavijo ti simptomi.
• Infusion-related reaction (see section entitled “Warnings and precautions”)
• učinki, povezani z infundiranjem (glejte poglavje »Opozorila in previdnostni ukrepi«)
Side effects for which frequency is not known (cannot be estimated from available data) are: • Serious allergic reactions
Neželeni učinki, katerih pogostnost ni znana (ni je mogoče oceniti iz razpoložljivih podatkov), so: • resne alergijske reakcije
Frequency is given as very common (≥1/10), common (≥1/100 to <1/10) or uncommon (≥1/1,000 to <1/100).
Pogostnost neželenih učinkov je navedena kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) ali občasni ( 1/1.000 do <1/100).
% Predicted FVC 4.2 (1.6)
% pričakovana FVK 4,2 (1,6)
205 Alewife Brook Parkway Cambridge, MA 02138 USA
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Enzyme replacement therapy is usually administered as a long-term treatment.
Encimska nadomestna terapija se ponavadi izvaja kot dolgotrajno zdravljenje.
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).
Neželeni učinki, o katerih so poročali samo v obdobju trženja, so tudi vključeni v preglednico s pogostnostjo »neznana« (ni mogoče oceniti iz razpoložljivih podatkov).
Institution of positive-airway pressure may be necessary in some cases.
V nekaterih primerih bo mogoče treba vzpostaviti pozitivni tlak v dihalnih poteh.
Age (years)
Starost (v letih)
Urine GAG levels (μg GAG/mg creatinine)
Ravni GAG v urinu (μg GAG/mg kreatinina)
Patients were classified into the following groups: missense (13), complete deletion/large rearrangement (8), and frameshift/ splice site mutations (5).
Bolniki so bili razvrščeni v naslednje skupine: missense mutacija (13), popolna delecija/obsežna preureditev (8) ter mutacija frameshift/splice site (5).
There is no known interaction of this medicine with other medicines.
Ni znanih interakcij tega zdravila z drugimi zdravili.
The infusion will normally last for 1 to 3 hours and will be given every week.
Infundiranje ponavadi traja od 1 do 3 ur, zdravilo pa vam dajejo enkrat tedensko.
From a microbiological safety point of view, the diluted product should be used immediately.
Z vidika mikrobiološke varnosti morate zdravilo porabiti takoj.
Heterozygous females were not studied in the clinical trials.
Heterozigotskih žensk v kliničnih preskušanjih niso preučevali.
Adverse reaction (preferred term)
Neželeni učinek (priporočeni izraz)
Pack sizes of 1, 4 and 10 vials.
Velikosti pakiranja: 1, 4 in 10 vial.
Paediatric population The dose for children and adolescents is the same as for adults, 0.5 mg/kg body weight weekly.
Pediatrična populacija Odmerek za otroke in mladostnike je enak kot za odrasle, 0,5 mg/kg telesne mase na teden.
In individual cases, socalled ‘neutralising antibodies' may develop, which may diminish activity of Elaprase and your response to treatment.
V posameznih primerih se lahko razvijejo tako imenovana »nevtralizirajoča protitelesa«, ki lahko zmanjšajo delovanje zdravila Elaprase in odziv na zdravljenje.
• Difficulty breathing, cough, low oxygen levels in your blood
• težave pri dihanju, kašelj, nizka raven kisika v krvi
P-value (compared with placebo)
Vrednost P (v primerjavi s placebom)
Do not infuse Elaprase concomitantly in the same intravenous line with other medicinal products.
Zdravila Elaprase ne infundirajte skupaj v isti intravenski liniji z drugimi zdravili.
If you have problems breathing, with or without bluish skin, tell your doctor straight away and seek immediate medical assistance.
Če imate težave pri dihanju, s pomodrelo kožo ali brez nje, se takoj posvetujte z zdravnikom in poiščite takojšno zdravniško pomoč.
Idursulfase is produced in a human cell line by genetic engineering technology (it involves the introduction of genetic information into human cells in the lab, which will then produce the desired product).
Idursulfaza se izdeluje v humani celični liniji s tehnologijo genskega inženiringa (ki vključuje uvajanje genetskih informacij v človeške celice v laboratoriju, ki bo izdelal želeno zdravilo).
Mean changes from 0.07 l to 0.31 l and percent ranged from 6.3% to 25.5% (maximum at Month 30).
Srednje spremembe so bile od 0,07 l do 0,31 l, odstotni delež pa od 6,3 % do 25,5 % (največji je bil v 30. mesecu).
Specific Obligation 4 - To submit data regarding immunogenicity after reexposure to idursulfase within Annual Reassessments.
Posebna obveznost 4 - Predložiti podatke o imunogenosti po ponovni izpostavitvi idursulfazi z vsakoletnimi ponovnimi ocenami.
This medicine has been authorised under “exceptional circumstances”.
Zdravilo je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
Table 1: Adverse reactions from clinical trials and post-marketing experience in patients treated with Elaprase.
Tabela 1: Neželeni učinki iz kliničnih preskušanj in obdobja trženja pri bolnikih, zdravljenih z zdravilom Elaprase.
This endpoint differed significantly from placebo for patients treated weekly (p=0.0049).
Ta končna točka se je bistveno razlikovala pri bolnikih, ki so prejemali placebo, in bolnikih, ki so enkrat tedensko prejemali zdravilo (p = 0,0049).
The occurrence of an adverse reaction in a single patient is defined as common in view of the number of patients treated.
Pojav neželenega učinka pri enem bolniku je zaradi števila sodelujočih bolnikov opredeljen kot pogost.
Upon internalization by cells, it is localized within cellular lysosomes, thereby limiting distribution of the protein.
Po internalizaciji v celicah je encim nameščen v lizosomih, zaradi česar je porazdelitev beljakovine omejena.
Adverse reactions reported in the paediatric population were, in general, similar to those reported in adults.
Neželeni učinki, o katerih so poročali pri pediatrični populaciji, so bili na splošno podobni kot neželeni učinki, o katerih so poročali pri odraslih.
Overall, there was no apparent trend in either systemic exposure or clearance rate of idursulfase with respect to either age or body weight.
Na splošno ni bilo očitnih trendov v sistemski izpostavljenosti ali stopnji očistka idursulfaze v povezavi s starostjo ali telesno maso.
Pharmacotherapeutic group: Other alimentary tract and metabolism products - enzymes, ATC code: A16AB09.
Farmakoterapevtska skupina: druga zdravila za zdravljenje bolezni prebavil in presnove - encimi, oznaka ATC: A16AB09.
This medicine contains 11.1 mg sodium (main component of cooking/table salt) in each vial.
To zdravilo vsebuje 11,1 mg natrija (glavne sestavine kuhinjske/jedilne soli) v eni viali.
Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).
Zdravilo Elaprase je indicirano za dolgotrajno zdravljenje bolnikov s Hunterjevim sindromom (mukopolisaharidoza II, MPS II).
The nature of your genotype (a genetic make up of all active genes in human cells, which determines one's specific, individual characteristics) may influence your therapeutic response to this medicine, as well as your risk of developing antibodies and infusion-related side effects.
Narava vašega genotipa (genske sestave vseh aktivnih genov v človeških celicah, ki določa posameznikove posebne, individualne značilnosti) lahko vpliva na terapevtski odziv na to zdravilo ter na tveganje za razvoj protiteles in pojav neželenih učinkov, povezanih z infuzijo.
Management of patients must be decided on an individual basis (see section 4.8).
Zdravljenje je treba določiti za vsakega bolnika posebej (glejte poglavje 4.8).
In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj.
Late emergent symptoms and signs of anaphylactoid/anaphylactic reactions have been observed as long as 24 hours after an initial reaction.
Pozne simptome in znake anafilaktoidnih/anafilaktičnih reakcij so opazili tudi 24 ur po prvi reakciji.
Over time the number of these infusion-associated reactions decreases.
Sčasoma se število teh učinkov, povezanih z infundiranjem, zmanjšuje.
If you use more Elaprase than you should
Če ste uporabili večji odmerek zdravila Elaprase, kot bi smeli
Composite (6MWT and %FVC)
Sestavljeni rezultat (6MWT in %FVK)
This is equivalent to 0.6% of the recommended maximum daily dietary intake of sodium for an adult.
To je enako 0,6 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
The fifth patient, who had preexisting cardiopathy, was diagnosed with ventricular premature complexes and pulmonary embolism during the study.
Pri petem bolniku z obstoječo kardiopatijo so med študijo diagnosticirali prezgodnje ventrikularne komplekse in pljučno embolijo.