FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients taking AZILECT and/or other medicines used to treat Parkinson's disease, behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed.
Slovenian: Pri bolnikih, ki jemljejo zdravilo AZILECT in/ali druga zdravila, ki se uporabljajo za zdravljenje Parkinsonove bolezni, so opazili vedenja, kot so kompulzije, obsesivne misli, odvisnost od iger na srečo, prekomerno zapravljanje denarja, impulzivno vedenje in nenormalna povečana spolna sla ali obsedenost s pretiranim predajanjem mislim ali občutkom v povezavi s spolnostjo.
English: If you think that you may have taken too many AZILECT tablets, contact your doctor or pharmacist immediately.
Slovenian: Če ste vzeli večji odmerek zdravila AZILECT, kot bi smeli Če menite, da ste vzeli preveč tablet zdravila AZILECT, se morate nemudoma posvetovati z zdravnikom ali farmacevtom.
English: Influenza
Slovenian: - gripa (influenca)
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Slovenian: Navodilo za uporabo AZILECT 1 mg tablete razagilin Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Ask your doctor for advice before you drive and operate machines, since Parkinson's disease itself as well as the treatment with AZILECT may influence your ability to do so. AZILECT can make you feel dizzy or drowsy; it can also cause episodes of sudden sleep onset.
Slovenian: Pred vožnjo in upravljanjem strojev prosite za nasvet zdravnika, saj Parkinsonova bolezen sama in zdravljenje z zdravilom AZILECT lahko vplivata na vašo sposobnost upravljanja vozil in strojev.
English: The data collected suggests that Parkinson's disease, and not any medicinal products in particular, is associated with a higher risk of skin cancer (not exclusively melanoma).
Slovenian: povezana z visokim tveganjem karcinoma kože (ne izključno melanoma).
English: In Parkinson's disease patients receiving rasagiline as adjunct therapy to chronic levodopa treatment, there was no clinically significant effect of levodopa treatment on rasagiline clearance.
Slovenian: Levodopa in druga zdravila za Parkinsonovo bolezen Pri bolnikih s Parkinsonovo boleznijo, ki prejemajo razagilin kot dodatno terapijo poleg kronične terapije z levodopo, zdravljenje z levodopo ni klinično pomembno učinkovalo na očistek razagilina.
English: In study II, patients were randomly assigned to receive placebo (229 patients), or rasagiline 1 mg/day (231 patients) or the catechol-O-methyl transferase (COMT) inhibitor, entacapone, 200 mg taken along with scheduled doses of levodopa (LD)/decarboxylase inhibitor (227 patients), and were treated for 18 weeks.
Slovenian: (231 bolnikov) ali katehol-o-metil-transferazni inhibitor (COMT) entakapone 200 mg, skupaj s predvidenimi odmerki levodope (LD)/dekarboksilazni inhibitor (227 bolnikov); zdravljeni so bili 18 tednov.
English: In clinical studies in Parkinson's disease patients the most commonly reported adverse reactions were: headache, depression, vertigo, and flu (influenza and rhinitis) in monotherapy; dyskinesia, orthostatic hypotension, fall, abdominal pain, nausea and vomiting, and dry mouth in adjunct to levodopa therapy; musculoskeletal pain, as back and neck pain, and arthralgia in both regimens.
Slovenian: glavobol, depresija, vrtoglavica in gripa (influenca in rinitis) pri monoterapiji; diskinezija, ortostatska hipotenzija, padec, bolečine v trebuhu, siljenje na bruhanje in bruhanje ter suha usta pri dodatni terapiji k levodopi; mišično-skeletna bolečina, bolečina v hrbtu in vratu in artralgija pri obeh režimih.
English: Carpal tunnel syndrome, Balance disorder accident syndrome*, Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes*
Slovenian: Bolezni živčevja diskinezija distonija, sindrom karpalnega kanala, motnje ravnotežja možgansko-žilni dogodek serotoninski sindrom*, prekomerna dnevna zaspanost in epizode nenadnega spanca*
English: Non-clinical data reveal no special hazard for humans based on the standard studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity, reproduction and development.
Slovenian: 5.3 Predklinični podatki o varnosti Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: In study I, 404 patients were randomly assigned to receive placebo (138 patients), rasagiline 1 mg/day (134 patients) or rasagiline 2 mg/day (132 patients) and were treated for 26 weeks, there was no active comparator.
Slovenian: 1 mg razagilina na dan (134 bolnikov) ali 2 mg razagilina na dan (132 bolnikov); zdravljeni so bili 26 tednov; aktivne primerjave ni bilo.
English: Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes Rasagiline may cause daytime drowsiness, somnolence, and, occasionally, especially if used with other dopaminergic medicinal products - falling asleep during activities of daily living.
Slovenian: Razagilin lahko povzroči dnevno zaspanost, somnolenco, in občasno, zlasti če se uporablja z drugimi dopaminergičnimi zdravili - nastop spanca med dejavnostmi vsakdanjega življenja.
English: Do not take the following medicines while taking AZILECT: - Monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson's disease,
Slovenian: Medtem ko jemljete zdravilo AZILECT, ne jemljite naslednjih zdravil: - zaviralcev monoaminooksidaze (MAO) (npr. za zdravljenje depresije ali Parkinsonove bolezni ali pa za katero koli drugo indikacijo), vključno z zdravili in naravnimi pripravki brez recepta kot je npr. šentjanževka.
English: Orthostatic hypotension*
Slovenian: Žilne bolezni ortostatska hipertenzija*
English: Pregelatinised maize starch Colloidal anhydrous silica Stearic acid
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol koruzni škrob predgelirani koruzni škrob brezvodni koloidni silicijev dioksid stearinska kislina smukec
English: You must wait at least 14 days after stopping AZILECT treatment and starting treatment with MAO inhibitors or pethidine.
Slovenian: Po prenehanju zdravljenja z zdravilom AZILECT morate počakati vsaj 14 dni, preden začnete z zdravljenjem z zaviralci MAO ali petidinom.
English: Serotonin syndrome*, Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes*
Slovenian: Neznana prekomerna dnevna zaspanost in epizode nenadnega spanca*
English: AZILECT tablets are presented as white to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other side.
Slovenian: Zdravilo AZILECT tablete so bele do belkaste, okrogle, ploščate, prirezane tablete z vtisnjenim "GIL"
English: Therefore, in view of the MAO inhibitory activity of rasagiline, concomitant administration of rasagiline and sympathomimetics such as those present in nasal and oral decongestants or cold medicinal products, containing ephedrine or pseudoephedrine, is not recommended (see section 4.4).
Slovenian: Zaradi inhibitorne monoaminooksidazne aktivnosti razagilina sočasna uporaba razagilina in simpatikomimetikov, kot so tisti, ki so prisotni v nazalnih in peroralnih dekongestivih, ali zdravilih proti prehladu, ki vključujejo efedrin ali psevdoefedrin, ni priporočljiva
English: Dermatitis
Slovenian: artritis
English: ≤ 50 mg/daily, trazodone ≤ 100 mg/daily, citalopram ≤ 20 mg/daily, sertraline ≤ 100 mg/daily, and paroxetine ≤ 30 mg/daily (see section 4.5).
Slovenian: V kliničnih preskušanjih z razagilinom niso smeli sočasno uporabljati fluoksetina ali fluvoksamina z razagilinom, lahko pa so bili uporabljeni naslednji antidepresivi in odmerki: amitriptilin ≤ 50 mg dnevno, trazodon ≤ 100 mg dnevno, citalopram ≤ 20 mg dnevno, sertralin ≤ 100 mg dnevno in paroksetin ≤ 30 mg dnevno (glejte poglavje 4.5).
English: In study III, the mean difference compared to placebo was -0.94h, 95% CI [-1.36, -0.51], p<0.0001.
Slovenian: 95 % IZ [-1,36; -0,51]; p < 0,0001.
English: Musculoskeletal pain,
Slovenian: Ušesne bolezni,
English: *See section description of selected adverse reactions Adjunct Therapy
Slovenian: *Glejte poglavje opis izbranih neželenih učinkov Opis izbranih neželenih učinkov
English: The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.4).
Slovenian: SSRI/SNRI/triciklični in tetraciklični antidepresivi Sočasni uporabi razagilina in fluoksetina ali fluvoksamina se je treba izogibati (glejte poglavje 4.4).
English: Uncommon (may affect up to 1 in 100 people) - Stroke (cerebrovascular accident) - Heart attack (myocardial infarction) - Blistering rash (vesiculobullous rash)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - kap (možgansko-žilni dogodek)
English: Not known disorders
Slovenian: Neznana hipotenzija*
English: In study II, the mean difference in the number of hours spent in the “OFF” state compared to placebo was -0.78h, 95% CI [-1.18, -0.39], p=0.0001.
Slovenian: 0,78 ur, 95 % IZ [-1,18; -0,39 ur], p = 0,0001.
English: In this study, the primary measure of efficacy was the change from baseline in the total score of the Unified Parkinson's Disease Rating Scale (UPDRS, parts I-III).
Slovenian: Združeni ocenjevalni lestvici Parkinsonove bolezni (Unified Parkinson's Disease Rating Scale
English: MAO Inhibitors
Slovenian: Inhibitorji monoaminooksidaze (MAO)
English: Common (may affect up to 1 in 10 people) - Abdominal pain - Fall - Allergy - Fever - Flu (influenza) - General feeling of being unwell (malaise) - Neck pain - Chest pain (angina pectoris) - Low blood pressure when rising to a standing position with symptoms like dizziness/light headedness (orthostatic hypotension) - Decreased appetite - Constipation - Dry mouth - Nausea and vomiting
Slovenian: (ortostatska hipotenzija) - zmanjšan apetit - zaprtje - suha usta - siljenje na bruhanje in bruhanje - napenjanje - neustrezni izvidi krvnih preiskav (levkopenija)
English: - Flatulence - Abnormal results of blood tests (leucopenia) - Joint pain (arthralgia) - Musculoskeletal pain - Joint inflammation (arthritis) - Numbness and muscle weakness of the hand (carpal tunnel syndrome) - Decreased weight - Abnormal dreams - Difficulty in muscular coordination (balance disorder) - Depression - Dizziness (vertigo) - Prolonged muscle contractions (dystonia) - Runny nose (rhinitis) - Irritation of the skin (dermatitis) - Rash - Bloodshot eyes (conjunctivitis) - Urinary urgency
Slovenian: - zmanjšanje telesne mase - nenavadne sanje - težave z usklajevanjem delovanja mišic (motnje ravnotežja) - depresija - omotica (vrtoglavica)
English: How to store AZILECT
Slovenian: Shranjevanje zdravila AZILECT
English: Neck pain, Arthritis
Slovenian: - vnetje sklepa (artritis)
English: EU/1/05/322/002 Yttriga vial (glass) 1 vial (flat bottom)
Slovenian: 1 viala (ravnim dnom)
English: (Invented) name Strength Pharmaceutical Form Route of Administration Packaging Package size EU/1/05/322/001 Yttriga vial (glass) 1 vial (V-shaped bottom)
Slovenian: 1 viala (dnom v obliki črke V)
English: (Invented) name
Slovenian: (izmišljeno) ime
English: 4 (4 x 1) prefilled syringes (multipack)
Slovenian: 4 (4 x 1) napolnjene injekcijske brizge (paket)
English: Repeat every 24 hours.
Slovenian: Ponovite vsakih 24 ur.
English: Date of first authorisation: 27 August 1997 Date of latest renewal: 20 July 2012
Slovenian: Datum prve odobritve: 27. avgust 1997 Datum zadnjega podaljšanja: 20. julij 2012
English: (pre- and postoperative)
Slovenian: (pre- in postoperativno)
English: 1, 28700 San Sebastian de los Reyes, Madrid Spain
Slovenian: 1, 28700 San Sebastian de los Reyes, Madrid Španija
English: Blood should not enter the syringe.
Slovenian: Kri ne sme vstopiti v brizgo.
English: The required dose is determined using the following formula:
Slovenian: Potreben odmerek se določi po naslednji formuli:
English: It is important that the recommendations in section 4.2 be followed closely.
Slovenian: Pomembno je, da dosledno upoštevate navodila v poglavju 4.2.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25C.
Slovenian: Kemijsko in fizikalno stabilnost med uporabo so dokazali za 3 ure pri temperaturi do 25 °C.
English: These reactions are potentially life-threatening.
Slovenian: Te reakcije so lahko življenjsko ogrožajoče.
English: The parameters estimated using the final 2-compartment model are shown in Table 2.
Slovenian: Parametri, ki so jih ocenili s pomočjo končnega 2-prostornega modela, so prikazani v preglednici 2.
English: • Dizziness, altered taste
Slovenian: • omotica, spremenjen okus
English: Safety analysis of 25 evaluable patients reflected a safety profile as expected.
Slovenian: Analiza varnosti 25 ovrednotenih bolnikov je dala varnostni profil, ki ustreza pričakovanjem.
English: Frequency of doses (hours)/Duration of Therapy (days)
Slovenian: Pogostost odmerkov (ure)/Trajanje zdravljenja (dnevi)
English: In most of the cases, an infusion rate of up to 4 mL per minute has been used.
Slovenian: V večini primerov so uporabljali hitrost infuzije do 4 ml na minuto.
English: • Fast heart rate, low blood pressure
Slovenian: • hiter srčni utrip, nizek krvni tlak
English: A summary of pharmacokinetic data is presented in Table 1.
Slovenian: Povzetek farmakokinetičnih podatkov je predstavljen v preglednici 1.
English: Paediatric population Allergic reactions might be experienced more frequently in children than in adults.
Slovenian: Pediatrična populacija Pri otrocih se lahko alergijske reakcije pojavijo pogosteje kot pri odraslih.
English: If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Slovenian: Če se taki inhibitorji pojavijo, se lahko stanje pokaže kot nezadosten klinični odziv.
English: Frequencies have been evaluated according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), not known (cannot be estimated from the available data).
Slovenian: Pogostnost je ocenjena v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: BeneFIX can be used for all age groups.
Slovenian: Zdravilo BeneFIX se lahko uporablja pri vseh starostnih skupinah.
English: Administration (Intravenous Injection):
Slovenian: Aplikacija (intravensko injiciranje):
English: Common to < 1/10
Slovenian: Pogosti do < 1/10
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Slovenian: Trombin nato pretvori fibrinogen v fibrin in nastane strdek.
English: Repeat infusion every 8 to 24 hours until threat is resolved.
Slovenian: Ponovite infuzijo vsakih 8 do 24 ur, dokler nevarnost ne mine.
English: The terminal phase has not been covered unambiguously due to lack of data beyond 24 hours in paediatric subjects < 6 years of age.
Slovenian: Končna faza ni nedvoumno raziskana zaradi pomanjkanja podatkov po 24 urah pri pediatričnih osebah, starih < 6 let.
English: - If you are allergic to nonacog alfa or any of the other ingredients of this medicine (listed in section 6).
Slovenian: če ste alergični na nonakog alfa ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: X 1.3 IU/kg
Slovenian: X 1,3 i.e./kg
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Slovenian: To je še posebej pomembno ob zamenjavi laboratorija in/ali reagentov za testiranje.
English: • two alcohol swabs
Slovenian: •dva alkoholna zloženca,
English: • Development of neutralising antibodies (inhibitors)
Slovenian: • razvoj nevtralizirajočih protiteles (inhibitorjev)
English: • Lack of response to treatment (failure to stop or prevent bleeding episodes)
Slovenian: • nezadosten odziv na zdravljenje (neuspešno zaustavljanje ali preprečevanje krvavitev)
English: In the case of shock, the current medical standards for treatment of shock should be observed.
Slovenian: V primeru šoka se ravnajte po trenutno veljavnih medicinskih standardih za zdravljenje šoka.
English: The contents of the pack are:
Slovenian: Pakiranje vsebuje:
English: Mean  SD Pharmacokinetic Parameters Based on Individual Bayes Estimates from Population Pharmacokinetic Analysis
Slovenian: Povprečni  SD farmakokinetični parametri na osnovi posameznih Bayesovih ocen iz populacijske farmakokinetične analize
English: Do not use this medicine after the expiry date which is stated on the outer box and vial label.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale.
English: Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Slovenian: Zdravljenje je treba izvajati pod nadzorom zdravnika, ki je izkušen v zdravljenju hemofilije.
English: Do not stop taking BeneFIX without consulting your doctor.
Slovenian: Ne prenehajte jemati zdravila BeneFIX, ne da bi se posvetovali z zdravnikom.
English: Therefore, if you experience allergic reactions such as those described above, you should be tested for the presence of an inhibitor.
Slovenian: Če boste doživeli alergijske reakcije, kot so opisane zgoraj, vas bo zato treba testirati na prisotnost inhibitorja.
English: Therefore, factor IX should be used during pregnancy and breast-feeding only if clearly indicated.
Slovenian: Zato naj se faktor IX uporablja med nosečnostjo in dojenjem le, če je to nujno potrebno.
English: METHOD OF ADMINISTRATION Use the entire contents.
Slovenian: Porabite vso vsebino.
English: - If you suffer from liver or heart disease or if you have recently had surgery, there is an increased risk for blood clotting (coagulation) complications.
Slovenian: Če imate bolezen jeter ali srca ali če ste bili pred nedavnim operirani, je tveganje za zaplete s strjevanjem krvi (koagulacijo) zvečano.
English: Adults 18 to 60
Slovenian: Odrasli 18 do 60
English: Pharmacotherapeutic group: Antihaemorrhagics, blood coagulation factor IX; ATC code: B02BD04
Slovenian: Farmakoterapevtska skupina: antihemoragiki, krvni koagulacijski faktor IX; oznaka ATC: B02BD04
English: At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Slovenian: Vsaj 1 dan, dokler sodeč po bolečini krvavitev ne izzveni ali je dosežena ozdravitev.
English: This dose and duration will depend upon your individual needs for replacement factor IX therapy and how quickly your body uses up factor IX, which will be checked regularly.
Slovenian: Odmerek in trajanje bosta odvisna od vaših individualnih potreb po nadomestnem zdravljenju s faktorjem IX in od tega, kako hitro vaše telo porabi faktor IX, kar bo treba redno nadzirati.
English: In each of these situations, the benefit of treatment with BeneFIX should be weighed against the risk of these complications.
Slovenian: Pri teh stanjih je treba pretehtati korist zdravljenja z zdravilom BeneFIX v primerjavi s tveganjem za omenjene zaplete.
English: In some cases, these reactions have progressed to severe anaphylaxis.
Slovenian: V nekaterih primerih so te reakcije napredovale do hude anafilaksije.
English: This should be considered during the preparation and administration of BeneFIX.
Slovenian: To je treba upoštevati pri pripravi in dajanju zdravila BeneFIX.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you should only take BeneFIX upon specific instructions from your doctor.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, smete uporabiti zdravilo BeneFIX le po posebnem navodilu zdravnika.
English: White/almost white powder and clear and colourless solvent.
Slovenian: Bel/skoraj bel prašek in bister in brezbarven vehikel.
English: Administration by continuous infusion has not been approved and is not recommended (see also sections 4.4 and 6.6).
Slovenian: Kontinuirana infuzija Dajanje s kontinuirano infuzijo ni odobreno in ni priporočljivo (glejte tudi poglavji 4.4 in 6.6).
English: Clinical studies of BeneFIX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Slovenian: V kliničnih študijah z zdravilom BeneFIX ni sodelovalo dovolj oseb, starih 65 let ali več, da bi določili, ali se odzivajo drugače kot mlajše osebe.
English: The safety and efficacy of using BeneFIX for immune tolerance induction has not been established.
Slovenian: Varnost in učinkovitost uporabe zdravila BeneFIX za indukcijo imunske tolerance nista bili dokazani.
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Slovenian: V teh primerih je priporočljivo, da se obrnete na specializiran center za hemofilijo.
English: Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor IX activity of 30% to 60% (IU/dL)
Slovenian: Ponovite infuzijo vsakih 8-24 ur, dokler se rana ustrezno ne zaceli, nato zdravljenje nadaljujte še vsaj 7 dodatnih dni, da aktivnost faktorja IX vzdržujete na 30 % do 60 % (i.e./dl).
English: Month 6 n = 23 Mean ± SD
Slovenian: 6. mesec n = 23 povprečje ± SD
English: The specific activity of BeneFIX is not less than 200 IU/mg protein.
Slovenian: Specifična aktivnost zdravila BeneFIX je najmanj 200 i.e./mg beljakovin.
English: The reconstituted product does not contain a preservative and should be used immediately, but no longer than 3 hours after reconstitution.
Slovenian: Rekonstituirano zdravilo ne vsebuje konzervansa in ga je treba uporabiti takoj, najpozneje pa 3 ure po rekonstituciji.
English: There are insufficient data to provide information on inhibitor incidence in PUPs (see also section 5.1).
Slovenian: Na voljo ni dovolj podatkov, da bi lahko posredovali informacije o incidenci pojavljanja inhibitorjev pri PUP (glejte tudi poglavje 5.1).
English: Nonacog alfa is a purified protein that has 415 amino acids in a single chain.
Slovenian: Nonakog alfa je prečiščena beljakovina, ki ima 415 aminokislin v eni sami verigi.
English: Two patients underwent surgical procedures (circumcision and port-a-catheter insertion).
Slovenian: Pri dveh bolnikih so izvedli kirurški poseg (cirkumcizija in vstavitev katetra s portom).
English: In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity levels (in % of normal or in IU/dL) in the corresponding period.
Slovenian: V primeru naslednjih hemoragičnih dogodkov aktivnost faktorja IX ne sme pasti pod dano raven plazemske aktivnosti (v % normalne vrednosti ali v i.e./dl) v ustreznem obdobju.
English: BeneFIX 1000 BeneFIX 1500 BeneFIX 2000 BeneFIX 3000
Slovenian: BeneFIX 250 BeneFIX 500 BeneFIX 1000 BeneFIX 1500 BeneFIX 2000 BeneFIX 3000
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.
Slovenian: Posebno v primeru večjih kirurških posegov je nujno treba natančno spremljanje nadomestnega zdravljenja s pomočjo analize koagulacije (plazemska aktivnost faktorja IX).
English: Infants and children had higher clearance, larger volume of distribution, shorter half-life and lower recovery than adolescents and adults.
Slovenian: Dojenčki in otroci imajo večji očistek, večji volumen porazdelitve, krajši razpolovni čas in manjši porast koncentracije faktorja IX v primerjavi z mladostniki in odraslimi.
English: X reciprocal of observed recovery
Slovenian: X recipročna vrednost ugotovljenega porasta koncentracije
English: Note: If you use more than one vial of BeneFIX per infusion, each vial should be reconstituted as per the previous instructions.
Slovenian: Opomba: Če uporabite na infuzijo več kot eno vialo zdravila BeneFIX, morate vsako vialo rekonstituirati po zgornjih navodilih.