FrancophonIA/ELRC3.0 huggingface dataset:
English: Sweet's syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred very rarely (likely to occur in fewer than 1 in 1,000 patients) but other factors may play a role.
Slovenian: Redko (verjetno je, da se bo pojavil pri manj kot 1 od 1.000 bolnikov) se je pojavil Sweetov sindrom (izbočene boleče spremembe slivove barve na okončinah in včasih tudi na obrazu in vratu s povišano telesno temperaturo), tu lahko vplivajo tudi drugi dejavniki.
English: Pegfilgrastim
Slovenian: pegfilgrastima ANC
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 ml solution for injection.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima* v 0,6 ml raztopine za injiciranje.
English: Neupopeg contains the active substance pegfilgrastim.
Slovenian: Zdravilo Neupopeg vsebuje zdravilno učinkovino pegfilgrastim.
English: Very rare (< 1/10,000) events of cutaneous vasculitis have been reported in patients treated with Neupopeg.
Slovenian: Pri bolnikih, zdravljenih z Neupoegom, so zelo redko (< 1/10.000) poročali o primerih kožnega vaskulitisa.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use.
Slovenian: IME ZDRAVILA IN POT(I) UPORABE
English: Rare (≥ 1/10,000 to < 1/1,000) pulmonary adverse effects, in particular interstitial pneumonia, have been reported after G-CSF administration.
Slovenian: Po uporabi G-CSF so opisani redki primeri (≥ 1/10.000 do < 1/1.000) neželenih učinkov na pljučih, zlasti intersticijske pljučnice.
English: Do not use Neupopeg if you notice it is cloudy or there are particles in it.
Slovenian: Če opazite, da je Neupopeg moten ali da v njem plavajo delci, ga ne smete uporabiti.
English: • Keep used syringes out of the reach and sight of children.
Slovenian: • Uporabljene injekcijske brizge shranjujte nedosegljivo otrokom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING UNBLISTERED SYRINGE OUTER CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLICA Z INJEKCIJSKO BRIZGO V NEPRETISNI OVOJNINI
English: ** The concentration is 20 mg/ml if the PEG moiety is included The potency of this product should not be compared to the potency of another pegylated or nonpegylated protein of the same therapeutic class.
Slovenian: ** Če je vključen še delež PEG, je koncentracija 20 mg/ml.
English: The needle cover on the pre-filled pen contains a derivative of latex and may cause severe allergic reactions.
Slovenian: Pokrovček igle pri napolnjenem injekcijskem peresniku vsebuje derivat lateksa in lahko povzroča hude alergijske reakcije.
English: The safety and efficacy of Neupopeg have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Slovenian: Pri bolnikih, ki dobivajo kemoterapijo, povezano z odloženo mielosupresijo, na primer nitrozouree, varnosti in učinkovitosti Neupopega niso ovrednotili.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/228/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/02/228/001
English: One 6 mg dose (a single pre-filled syringe) of Neupopeg is recommended for each chemotherapy cycle, administered as a subcutaneous injection approximately 24 hours following cytotoxic chemotherapy.
Slovenian: Za vsak cikel kemoterapije priporočajo en 6-miligramski odmerek (eno napolnjeno injekcijsko brizgo) Neupopega, ki je dan v obliki subkutane injekcije približno 24 ur po citotoksični kemoterapiji.
English: Do not lift the prefilled pen.
Slovenian: Ne dvigajte napolnjenega injekcijskega peresnika.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/228/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/02/228/002
English: • Keep used pens out of the reach and sight of children.
Slovenian: • Uporabljene injekcijske peresnike shranjujte nedosegljivo otrokom.
English: NAME OF THE MEDICINAL PRODUCT Neupopeg 6 mg solution for injection in a pre-filled pen.
Slovenian: IME ZDRAVILA Neupopeg 6 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Neupopeg 6 mg solution for injection in a pre-filled pen pegfilgrastim
Slovenian: Neupopeg 6 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku pegfilgrastim
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/228/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/02/228/003
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml (10 mg/ml) solution for injection.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima v 0,6 ml (10 mg/ml) raztopine za injiciranje.
English: Neupopeg is essentially sodium-free.
Slovenian: Neupopeg je pravzaprav brez natrija.
English: Disposing of used pre-filled pens
Slovenian: Odlaganje rabljenih napolnjenih injekcijskih peresnikov Odlaganje rabljenih napolnjenih injekcijskih peresnikov
English: Rare (likely to occur in fewer than 1 in 1000 patients)cases of breathing problems have been reported after taking G-CSFs.
Slovenian: Po uporabi G-CSF so opisani redki (verjetno je, da se bodo pojavili pri manj kot 1 od 1000 bolnikov) primeri težav dihanja.
English: NAME OF THE MEDICINAL PRODUCT Neupopeg 6 mg injection Pegfilgrastim
Slovenian: Neupopeg 6 mg injekcija pegfilgrastim
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled pen contains 6 mg of pegfilgrastim in 0.6 ml (10 mg/ml) solution for injection.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsak napolnjen injekcijski peresnik vsebuje 6 mg pegfilgrastima v 0,6 ml (10 mg/ml) raztopine za injiciranje.
English: If there are particles in it, you must not use it. For a more comfortable injection, leave at room temperature for approximately 30 minutes.
Slovenian: Da bo injiciranje manj neprijetno, pustite napolnjen injekcijski peresnik stati 30 minut zunaj hladilnika.
English: The abdomen can be considered when the thigh and back of arm are judged by a healthcare professional to be inappropriate.
Slovenian: Če zdravstveni delavec oceni, da stegno ali zadnji del nadlakta nista primerni mesti, lahko injicirate v trebuh.
English: Water for injections
Slovenian: OZNAKA NAPOLNJENE INJEKCIJSKE BRIZGE
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a single use pre-filled syringe (0.6 ml).
Slovenian: Raztopina za injiciranje v napolnjeni injekcijski brizgi (0,6 ml) za enkratno uporabo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/228/001-002
Slovenian: EU/1/02/228/001-002
English: NAME OF THE MEDICINAL PRODUCT Neupopeg 6 mg solution for injection Pegfilgrastim
Slovenian: Neupopeg 6 mg raztopina za injiciranje pegfilgrastim
English: NAME OF THE MEDICINAL PRODUCT Neupopeg 6 mg solution for injection in a pre-filled pen Pegfilgrastim
Slovenian: NAVODILO ZA UPORABO Neupopeg 6 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku pegfilgrastim
English: Injecting Neupopeg yourself
Slovenian: Samoinjiciranje Neupopega
English: What Neupopeg looks like and contents of the pack Neupopeg is a solution for injection in a pre-filled syringe (6 mg/0.6 ml).
Slovenian: Neupopeg je raztopina za injiciranje v napolnjeni injekcijski brizgi (6 mg/0,6 ml).
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Neupopeg 6 mg solution for injection in a pre-filled syringe pegfilgrastim
Slovenian: NAVODILO ZA UPORABO Neupopeg 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi pegfilgrastim
English: Driving and Using Machines
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev
English: If you have questions about how to inject, please ask your doctor, nurse, pharmacist for assistance.
Slovenian: Če ste negotovi glede samoinjiciranja ali če imate kakšna vprašanja, se za pomoč obrnite na svojega zdravnika ali medicinsko sestro.
English: Proceed with the next dose immediately and continue as advised by your doctor.
Slovenian: Takoj nadaljujte z naslednjim odmerkom in nadaljujte, kot vam je svetoval zdravnik.
English: It is recommended that not more than 4 mL per minute be administered.
Slovenian: Priporoča se, da se ne uporabi več kot 4 mL zdravila na minuto.
English: OTHER Octapharma-Logo
Slovenian: DRUGI PODATKI Octapharma-Logo
English: How often you need an injection will depend on how well Nuwiq is working for you.
Slovenian: Kako pogosto potrebujete injekcijo, je odvisno od tega, kako dobro zdravilo Nuwiq deluje v vašem primeru.
English: Inject the solution into the vein at a slow speed, not faster than 4 mL per minute.
Slovenian: Raztopino injicirajte v veno počasi, ne hitreje kot 4 mL na minuto.
English: Unopened vial 2 years
Slovenian: 6.3 Rok uporabnosti Neodprta viala 2 leti
English: Date of latest renewal: 26 april 2019
Slovenian: Datum prve odobritve: 22. julij 2014 Datum zadnjega podaljšanja: 26. april 2019
English: A CVAD is an external connector that allows access to the bloodstream through a catheter without injection through the skin.
Slovenian: CVAD je zunanji priključek, ki omogoča dostop v krvni obtok skozi kateter brez injekcije skozi kožo.
English: The way Nuwiq is used in children and adolescents does not differ from the way it is used in adults.
Slovenian: Način uporabe zdravila Nuwiq pri otrocih in mladostnikih se ne razlikuje od načina uporabe pri odraslih.
English: 33 (82.5%) patients did not experience any bleeds and 36 (90.0%) patients had no spontaneous bleeds.
Slovenian: Pri 33 (82,5%) bolnikih ni prišlo do nobenih krvavitev, pri 36 (90,0%) bolnikih pa ni prišlo do spontanih krvavitev.
English: Because factor VIII products may have to be given more often in children and adolescents, a central venous access device (CVAD) may need to be fitted.
Slovenian: Ker je včasih pri otrocih in mladostnikih potrebno zdravila s faktorjem VIII dajati pogosteje, bo morda treba namestiti napravo za centralni venski dostop (CVAD).
English: Once the medicinal product has been taken out of the refrigerator, it must not be returned to the refrigerator.
Slovenian: Ko je zdravilo enkrat vzeto iz hladilnika, se ga ne sme več vrniti vanj.
English: Your doctor will calculate your dose of Nuwiq (in international units = IU) depending on your condition and body weight, and on whether it is used for prevention or treatment of bleeding.
Slovenian: Zdravnik bo izračunal velikost odmerka zdravila Nuwiq (v mednarodnih enotah = i.e.) glede na vaše stanje in telesno maso ter v skladu s tem, ali se uporablja za preprečevanje ali zdravljenje krvavitev.
English: Nuwiq can be used for all age groups.
Slovenian: Zdravilo Nuwiq se lahko uporablja za vse starostne skupine.
English: Do not store Nuwiq in the refrigerator again after it has been stored at room temperature.
Slovenian: Zdravila Nuwiq ne hranite znova v hladilniku, potem ko je že bilo shranjeno pri sobni temperaturi.
English: Do not use the medicine in case you notice visible signs of deterioration of the tamper proof of packaging especially of the syringe and/or the vial.
Slovenian: Ne uporabljajte tega zdravila, če opazite vidne znake poškodbe varnostnega zapirala pakiranja, še posebej tistega na brizgi in/ali viali.
English: You might need a higher dose of Nuwiq or a different product to control bleedings.
Slovenian: Morda boste potrebovali večji odmerek zdravila Nuwiq ali drugo zdravilo za nadzor krvavitev.
English: There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to Nuwiq.
Slovenian: Obstaja majhna verjetnost, da pride do anafilaktične reakcije (huda, nenadna alergijska reakcija) na zdravilo Nuwiq.
English: These data were corroborated by a long-term follow-up of 49 of these children who were treated for an additional median period of approximately 30 months (range from 9.5 to 52 months); during this period 45% of children had no spontaneous bleeds.
Slovenian: izmed teh otrok, ki so jih nadalje zdravili v obdobju z mediano približno 30 mesecev (razpon od 9,5 do 52 mesecev); v tem obdobju 45% otrok ni imelo spontanih krvavitev.
English: However for patients who have received previous treatment with factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Slovenian: Vendar pa je pri bolnikih, ki so se predhodno že zdravili s faktorjem VIII (zdravljenje je trajalo več kot 150 dni), tveganje občasno (pri manj kot 1 od 100 bolnikov).
English: Pharmacotherapeutic group: Antihaemorrhagics, blood coagulation factor VIII, ATC code: B02BD02.
Slovenian: Farmakoterapevtska skupina: Antihemoragiki, koagulacijski faktor VIII, oznaka ATC: B02BD02.
English: However depending on the body weight and posology, the patient could receive more than one vial (see section 2 for information on content per vial).
Slovenian: Vendar pa lahko glede na telesno maso in odmerjanje bolnik prejme več kot eno vialo (glejte poglavje 2 za informacije o vsebnosti na vialo).
English: A non-neutralizing anti-factor VIII antibody was detected in one adult patient (see Table 1).
Slovenian: Nenevtralizirajoča protitelesa za faktor VIII so odkrili pri enem odraslem bolniku (glejte preglednico 1).
English: Octapharma AB Lars Forssells gata 23 112 75 Stockholm Sweden
Slovenian: Octapharma AB Lars Forssells gata 23 112 75 Stockholm Švedska
English: The dose of Nuwiq is calculated depending on your body weight and the factor VIII levels to be achieved.
Slovenian: Odmerek zdravila Nuwiq se izračuna glede na vašo telesno maso in raven faktorja VIII, ki jo je treba doseči.
English: One mL of reconstituted solution contains 7.35 mg sodium (18.4 mg sodium per vial).
Slovenian: En mL rekonstituirane raztopine vsebuje 7,35 mg natrija (18,4 mg natrija na vialo).
English: Frequency of adverse drug reactions (ADRs) in clinical trials
Slovenian: Pogostnost pojava neželenih učinkov zdravila (NUZ) v kliničnih preskušanjih
English: Nuwiq is produced by recombinant DNA technology in genetically modified human embryonic kidney (HEK) 293F cells.
Slovenian: Zdravilo Nuwiq je izdelano s tehnologijo rekombinantne DNK v gensko spremenjenih humanih embrionalnih ledvičnih celicah (HEK) 293F.
English: See section 2, “Nuwiq contains sodium”.
Slovenian: Glejte poglavje 2, "Zdravilo Nuwiq vsebuje natrij".
English: Frequency, type and severity of adverse reactions in children and adolescents are assumed to be the same as in adults.
Slovenian: Domneva se, da so pogostnost, vrsta in resnost neželenih učinkov pri otrocih enaki kot pri odraslih in mladostnikih.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni "brez natrija".
English: One International Unit (IU) of factor VIII activity is equivalent to the quantity of factor VIII in one mL of normal human plasma.
Slovenian: Ena mednarodna enota (i.e.) aktivnosti faktorja VIII ustreza količini faktorja VIII v enem mililitru normalne humane plazme.
English: AUC = Area under the curve (FVIII:C), T1/2 = Terminal half-life,
Slovenian: AUC = Površina pod krivuljo (FVIII:C), T1/2 = Končna razpolovna doba,
English: The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII medicines.
Slovenian: Nastanek zaviralcev (protiteles) je znan zaplet, ki se lahko pojavi med zdravljenjem z vsemi zdravili s faktorjem VIII.
English: The mean ± SD annualised bleeding rate was 1.2 ± 3.9 and the mean ± SD dose were 52.2 ± 12.2 IU/kg per injection and 99.7 ± 25.6 IU/kg per week.
Slovenian: Povprečna ± SD stopnja krvavitve, normalizirane na eno leto, je bila 1,2 ± 3,9, povprečni ± SD odmerek pa je bil 52,2 ± 12,2 i.e./kg na injiciranje in 99,7 ± 25,6 i.e./kg na teden.
English: If severe, sudden allergic reactions (anaphylactic) occur (very rare: may affect up to 1 in 10,000 people), the injection must be stopped immediately.
Slovenian: (anafilaktične) reakcije (zelo redko, lahko se pojavijo pri največ 1 na 10.000 ljudi), morate injiciranje zdravila takoj ustaviti.
English: Do not increase the total dose of Nuwiq to control your bleeding without consulting your doctor.
Slovenian: Ne povečujte skupnega odmerka zdravila Nuwiq za nadzor vaše krvavitve, ne da bi se posvetovali z zdravnikom.
English: Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL).
Slovenian: Infuzijo ponavljajte na vsakih 8-24 h, dokler se rana zadostno ne zaceli, nato nadaljujte s terapijo še najmanj naslednjih 7 dni za vzdrževanje aktivnosti faktorja VIII med 30 in 60 % (i.e./dL).
English: If this happens, your or your child´s medicines may stop working properly and you or your child may experience persistent bleeding.
Slovenian: Če pride do tega, zdravilo pri vas ali vašem otroku ne bo več učinkovito in se lahko pojavi krvavitev, ki se ne ustavi.
English: The specific activity of Nuwiq is approximately 9500 IU/mg protein.
Slovenian: Specifična aktivnost zdravila Nuwiq znaša približno 9500 i.e./mg beljakovin.
English: The posology is the same in adults and children and adolescents, however, shorter dose intervals or higher doses may be necessary for children and adolescents.
Slovenian: Odmerjanje je pri odraslih, otrocih in mladostnikih enako, vendar pa so pri otrocih in mladostnikih lahko potrebni krajši intervali med odmerki ali višji odmerki.
English: Clinical efficacy and in vivo recovery of Nuwiq was not affected in this patient.
Slovenian: Klinična učinkovitost ter in vivo uporabnost zdravila Nuwiq pri tem bolniku nista bili prizadeti.
English: What you need to know before you use Nuwiq 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Nuwiq 3.
English: The median consumption of Nuwiq for prophylaxis per month was 521.9 IU/kg.
Slovenian: Mediana porabe zdravila Nuwiq za preventivo na mesec je bila 521,9 i.e./kg.
English: Specific studies with long-term repeated administration such as reproduction toxicity, chronic toxicity, and carcinogenicity were not performed with Nuwiq due to the immune response to heterologous proteins in all non-human mammalian species.
Slovenian: Specifične študije z dolgotrajno ponavljajočimi se odmerki zdravila Nuwiq na sposobnost razmnoževanja, kronično toksičnost in karcinogeni potencial niso bile izvedene zaradi imunskega odgovora vseh nehumanih sesalcev na heterologne beljakovine.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.5 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2,5 mL
English: Nuwiq is for intravenous use.
Slovenian: Zdravilo Nuwiq je namenjeno intravenski uporabi.
English: Paediatric population The listed warnings and precautions apply both to adults and children and adolescents.
Slovenian: Navedena opozorila in previdnostni ukrepi veljajo za odrasle, otroke in mladostnike.
English: If you have injected more Nuwiq than you should, please inform your doctor.
Slovenian: Če ste si vbrizgali več zdravila Nuwiq, kot bi smeli, o tem obvestite svojega zdravnika.
English: In the case of the following haemorrhagic events, factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dL) in the corresponding period.
Slovenian: V primeru spodaj navedenih krvavitev aktivnost faktorja VIII v ustreznem časovnem obdobju ne sme pasti pod navedeno stopnjo plazemske aktivnosti (v % od normale ali i.e./dL).
English: In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk.
Slovenian: Pri bolnikih z obstoječimi srčno-žilnimi dejavniki tveganja lahko nadomestno zdravljenje s faktorjem VIII poveča srčno-žilno tveganje.
English: No studies were performed on the mutagenic potential of Nuwiq.
Slovenian: Študije potencialne mutagenosti zdravila Nuwiq niso bile opravljene.
English: If you have the impression that the effect of Nuwiq is insufficient, talk to your doctor.
Slovenian: Če imate občutek, da je učinek zdravila Nuwiq nezadosten, se posvetujte z zdravnikom.
English: If you or your child´s bleeding is not being controlled with Nuwiq, tell your doctor immediately.
Slovenian: Če krvavitev pri vas ali vašem otroku z zdravilom Nuwiq ni obvladana, morate to nemudoma povedati zdravniku.
English: Of note, annualised bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Slovenian: normalizirane na eno leto, ni primerljiva med različnimi koncentrati faktorjev in tudi ne med kliničnimi študijami.
English: The usual dose of Nuwiq is 20 to 40 IU per kg body weight, given every 2 to 3 days.
Slovenian: Običajen odmerek zdravila Nuwiq je 20 do 40 i.e. na kg telesne mase, daje pa se ga vsaka 2 do 3 dni.
English: If your plasma factor VIII fails to reach expected levels with Nuwiq, or if bleeding is not adequately controlled, it could be due to the development of factor VIII inhibitors.
Slovenian: Če vaš plazemski faktor VIII s pomočjo zdravila Nuwiq ne dosega pričakovane ravni ali če krvavitev ni ustrezno obvladana, je to lahko posledica nastanka zaviralcev faktorja VIII.
English: Nuwiq replaces the missing factor VIII and is used for treatment and prevention of bleeding in patients with haemophilia A and can be used for all age groups.
Slovenian: Zdravilo Nuwiq nadomešča manjkajoči faktor VIII in se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A. Zdravilo Nuwiq je primerno za uporabo pri vseh starostnih skupinah.
English: What Nuwiq is and what it is used for 2.
Slovenian: Kaj je zdravilo Nuwiq in za kaj ga uporabljamo 2.
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by approximately 2% of normal activity or 2 IU/dL.
Slovenian: Izračun potrebnega odmerka faktorja VIII sloni na empirični ugotovitvi, da 1 mednarodna enota (i.e.) faktorja VIII na kilogram telesne mase poveča plazemsko aktivnost faktorja VIII za 2 % normalne aktivnosti ali 2 i.e./dL.
English: The immunogenicity of Nuwiq was evaluated in clinical trials in 190 previously treated patients with severe haemophilia A (129 adult and 61 paediatric patients).
Slovenian: Imunogenost zdravila Nuwiq so ocenili v kliničnih preskušanjih pri 190 predhodno zdravljenih bolnikih s hudo hemofilijo A (129 odraslih in 61 pediatričnih bolnikov).
English: For children and adolescents not previously treated with factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients).
Slovenian: Pri otrocih in mladostnikih, ki se predhodno še niso zdravili z zdravili s faktorjem VIII, se lahko zelo pogosto (pri več kot 1 od 10 bolnikov) pojavijo zaviralna protitelesa (glejte poglavje 2).
English: Therefore, Nuwiq should be used during pregnancy and breast-feeding only if clearly indicated.
Slovenian: Zato smete zdravilo uporabljati med nosečnostjo in dojenjem samo, če je nujno potrebno.
English: Nuwiq is usually injected into a vein (intravenously) by your doctor or a nurse who are experienced in the care of patients with haemophilia A. You or someone else might also give your Nuwiq injection, but only after receiving adequate training.
Slovenian: Zdravilo Nuwiq v veno (intravensko) običajno vbrizga zdravnik ali medicinska sestra, ki ima izkušnje z zdravljenjem bolnikov s hemofilijo A. Morda bi lahko vi ali kdo drug prav tako dal injekcijo zdravila Nuwiq, vendar šele po ustreznem usposabljanju.
English: Excipient related considerations (sodium content) This medicinal product contains less than 1 mmol sodium (23 mg) per vial.
Slovenian: Smernice glede pomožnih snovi (vsebnost natrija) To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo.
English: It is strongly recommended that every time that Nuwiq is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Slovenian: Močno priporočamo, da vsakič, ko bolnik prejme zdravilo Nuwiq, zabeležite ime in številko serije zdravila, da ohranite povezavo med bolnikom in serijo zdravila.