natgillin/translations-raw huggingface dataset:
No overall differences in safety or efficacy were observed between older and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Med starejšimi in mlajšimi bolniki niso opazili splošnih razlik glede varnosti ali učinkovitosti, vendar ni mogoče izključiti večje občutljivosti pri nekaterih starejših posameznikih.
This should be considered when the decision is made for a therapy longer than 6 months.
To je treba upoštevati, kadar se odločate o zdravljenju, daljšem od 6 mesecev.
Special attention is recommended for patients with pre-existing cardiopulmonary disease.
Posebna pozornost se priporoča pri bolnikih z obstoječo kardiopulmonalno boleznijo.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Obvestite svojega zdravnika, če jemljete, ste pred kratkim jemali ali boste začeli jemati katero koli drugo zdravilo.
The potential clinical relevance of these findings is currently unknown; however no adverse effects were associated with the presence of vacuoles.
Morebitni klinični pomen teh ugotovitev trenutno ni znan, vendar so bili neželeni učinki povezani s prisotnostjo vakuol.
This medicine will be stored in a healthcare facility where it is administered.
To zdravilo se shranjuje v zdravstveni ustanovi, kjer se uporablja.
Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co. Dublin Ireland
Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co. Dublin Irska
The CHMP agrees with the scientific conclusions made by the PRAC.
Skupina CMDh se strinja z znanstvenimi zaključki odbora PRAC.
Although the 4-week regimen also demonstrated efficacy for the primary endpoint, this regimen was associated with increased frequency of infusion reactions.
Čeprav so pri 4-tedenskem režimu pokazali učinkovitost za primarni opazovani dogodek, je bil ta režim povezan s povečano pogostnostjo reakcij na infundiranje.
People with gout have too much uric acid in their body.
Osebe s protinom imajo preveč sečne kisline v telesu.
The results of the on-going reproductive toxicity studies are not available (see section 5.3).
Rezultati potekajočih študij reproduktivne toksičnosti niso na voljo (glejte poglavje 5.3).
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden vzamete to zdravilo.
Haemolysis and/or Methemoglobinemia
Hemoliza in/ali methemoglobinemija
Instructions for preparation:
Navodila za pripravo:
The potency of this product should not be compared to the one of another pegylated or non-pegylated protein of the same therapeutic class.
Jakost tega zdravila se ne sme primerjati z jakostjo drugega pegiliranega ali nepegiliranega proteina iz istega terapevtskega razreda.
• Appropriate aseptic technique should be used when preparing the infusion.
• Pri pripravi infuzije je treba uporabiti aseptično tehniko.
The optimal treatment duration has not been established (see section 4.4).
Optimalnega trajanja zdravljenja niso določili (glejte poglavje 4.4).
The data for long-term treatment from controlled clinical studies are limited.
Podatki o dolgotrajnem zdravljenju iz nadzorovanih kliničnih preskušanj so omejeni.
It is unknown whether the development of anti-PEG antibodies may reduce the efficacy of other PEGylated medicinal products.
Ni znano, ali lahko razvoj protiteles proti PEG zmanjša učinkovitost drugih PEGiliranih zdravil.
PSURs The PSUR cycle for the medicinal product should follow the standard requirements.
PSUR Cikel PSUR za zdravilo mora slediti standardnim zahtevam.
Your doctor may also ask you to wait after your treatment to be sure that you do not have an infusion-related reaction.
Zdravnik vas bo morda prav tako prosil, da počakate po zdravljenju, s čimer se bo prepričal, da nimate reakcije, povezane z infundiranjem.
You will receive KRYSTEXXA every 2 weeks.
Zdravilo KRYSTEXXA boste prejeli vsaka 2 tedna.
Do not use KRYSTEXXA if you are pregnant or breast-feeding, since it is not known how it will affect you or your baby.
Ne uporabljajte zdravila KRYSTEXXA, če ste noseči ali dojite, saj ni znano, kako bo vplivalo na vas ali vašega otroka.
Therefore, KRYSTEXXA should not be used during breast-feeding unless the clear benefit to the mother can overcome the unknown risk to the newborn/infant.
Zato se zdravilo KRYSTEXXA ne sme uporabljati med dojenjem, razen če obstaja jasna korist za mater, ki je večja od neznanega tveganja za novorojenčka/dojenčka.
4.6 Fertility, Pregnancy and Lactation
4.6 Plodnost, nosečnost in dojenje
In addition, a further amendment regarding the extension of the time of observation following the end of infusion from 1 hour to 2 hours as a precautionary measure has been included along with a statement that delayed-type hypersensitivity reactions have also been reported.
Poleg tega je bil vključen dodatni popravek glede podaljšanja časa opazovanja po koncu infundiranja z ene ure na dve uri kot previdnostni ukrep, skupaj z izjavo o poročilih zapoznelih preobčutljivostnih reakcij.
• a swelling of the throat, tongue or other part of your body
• otekanje grla, jezika ali drugega dela telesa,
From a bacteriological point of view, the product should be used immediately.
Z bakteriološkega stališča je treba zdravilo porabiti takoj.
If you have a reaction during the infusion, your doctor may stop or adjust the treatment.
Če imate med infundiranjem reakcijo, bo zdravnik morda prekinil ali prilagodil zdravljenje.
Take these medicines as directed by your doctor.
Pri jemanju teh zdravil upoštevajte navodila svojega zdravnika.
In the pregnant rat study there was no evidence of embryotoxicity or teratogenicity at 46 times the clinical exposure (AUC).
V študiji na brejih podganah ni bilo dokazov o embriotoksičnosti ali teratogenosti pri 46-kratni klinični izpostavljenosti (AUC).
Non-clinical studies to evaluate the carcinogenic and mutagenic potential have not been performed.
Predkliničnih študij za ocenjevanje kancerogenega in mutagenega potenciala niso izvedli.
The decision to treat with KRYSTEXXA should be based on an on-going assessment of the benefits and risks for the individual patient (see section 4.4).
Odločitev za zdravljenje z zdravilom KRYSTEXXA mora temeljiti na stalni oceni koristi in tveganj pri posameznem bolniku (glejte poglavje 4.4).
The average number of gout flares per patient was 10 during the 18 months prior to study entry.
Povprečno število napadov protina na bolnika je bilo 10 v prvih 18 mesecih pred vključitvijo v študijo.
• a rash, itching or hives tell your doctor or nurse IMMEDIATELY, since any of these may be signs of a serious allergic reaction.
• izpuščaj, srbenje ali mehurje, se TAKOJ posvetujte z zdravnikom ali medicinsko sestro, saj so to lahko znaki resne alergijske reakcije.
The average molecular mass of pegloticase is approximately 545 kDa of which the protein moiety constitutes approximately 137 kDa.
Povprečna molekulska masa peglotikaze je približno 545 kDa, od katere funkcionalna skupina proteinov predstavlja približno 137 kDa.
The long-term risk of prophylactic medications to prevent infusion reactions, such as glucocorticoids, should also be taken into consideration.
Treba je upoštevati dolgoročno tveganje profilaktičnih zdravil za preprečevanje reakcij na infundiranje, kot so glukokortikoidi.
The following convention has been used for classification of the adverse reactions reported in the Phase 3 clinical trials (see Table 1 below): very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Neželeni učinki, o katerih so poročali v kliničnih preskušanjih 3. faze, so bili razvrščeni na naslednji način (glejte spodnjo preglednico 1): zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000); zelo redki (< 1/10.000), neznano (ni mogoče oceniti iz razpoložljivih podatkov).
However, due to variability in the AUC values, AUC proportionality was not seen which might be a reflection of antibody clearance for some of the subjects.
Zaradi variabilnosti vrednosti AUC niso opazili sorazmernosti AUC, kar je lahko posledica očistka protiteles pri nekaterih preskušancih.
If patients experience treatment-related symptoms affecting their ability to concentrate and react (i.e. headache or dizziness), it is recommended that they do not drive or use machines until the effect subsides.
Če se pri bolnikih pojavijo simptomi, povezani z zdravljenjem, ki vplivajo na zmožnost koncentracije in reakcije (tj. glavobol ali omotica), je priporočljivo, da ne vozijo in ne upravljajo strojev, dokler ti učinki ne izginejo.
It is especially important to tell your doctor if you are currently taking other urate-lowering medicines (such as allopurinol or Febuxostat) or medicines containing polyethylene glycol (PEG) (such as pegylated interferon or Doxorubicin).
Še zlasti pomembno je, da zdravnika obvestite, če trenutno jemljete druga zdravila za zniževanje ravni urata (kot je alopurinol ali febuksostat) ali zdravila, ki vsebujejo polietilenglikol (PEG) (kot je pegilirani interferon ali doksorubicin).
It is recommended that patients suspected of receiving an overdose be monitored, and general supportive measures be initiated as no specific antidote has been identified.
Priporoča se, da se pri bolnikih, pri katerih obstaja sum, da je prišlo do prevelikega odmerjanja, opravlja spremljanje in uvedejo splošni podporni ukrepi, saj ni posebnega antidota.
These medicines may put you at higher risk of infusion reaction.
Ta zdravila vam lahko povečajo tveganje za reakcije na infundiranje.
All patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) should be screened for G6PD deficiency before starting KRYSTEXXA.
Pri vseh bolnikih s povečanim tveganjem za pomanjkanje G6PD (npr. bolnikih afriškega ali sredozemskega porekla) je treba opraviti presejanje za pomanjkanje G6PD, preden se uvede zdravilo KRYSTEXXA.
Allergic reactions usually happen within 2 hours of the infusion, but may also happen at a later time.
Alergijske reakcije se navadno pojavijo v 2 urah infundiranja, včasih pa tudi pozneje.
Patients over 100 kg body weight
Bolniki s telesno maso, večjo od 100 kg
The degree of vacuolization and the number of tissues affected appeared to be dependent both on the applied pegloticase dose and the duration of exposure.
Stopnja vakuolizacije in število prizadetih tkiv sta bila odvisna od uporabljenega odmerka peglotikaze in trajanja izpostavljenosti.
The recommended dose of KRYSTEXXA is 8 mg.
Priporočeni odmerek zdravila KRYSTEXXA je 8 mg.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravilo se ne sme mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6. 6.3 Rok uporabnosti
Pharmacotherapeutic group: Anti-gout preparations, other anti-gout preparations, ATC code: M04AX02
Farmakoterapevtska skupina: zdravila za zdravljenje protina, druga zdravila za zdravljenje protina, oznaka ATC: M04AX02
The solution should be used within 4 hours of dilution (see section 6.6).
Raztopino je treba uporabiti v 4 urah po redčenju (glejte poglavje 6.6).
Assessment Time point
Časovna točka ocene
Very limited data are available about retreatment after interruption of therapy for more than 4 weeks.
Podatki o ponovnem zdravljenju po več kot 4-tedenski prekinitvi zdravljenja so zelo omejeni.
Prenatal and postnatal development study in rats, as well as the embryofetal development study in rabbits are ongoing.
Trenutno potekajo prenatalne in postnatalne študije razvoja pri podganah ter študije embriofetalnega razvoja pri kuncih.
Anti-pegloticase antibodies were associated with an increase in CL and Vc as determined by compartmental analysis.
Protitelesa proti peglotikazi so bila povezana s povečanjem CL in Vc, kot se je določilo s prostorno analizo.
It is recommended to start this treatment 1 week before initiation of KRYSTEXXA and continue for at least 6 months, unless medically contraindicated or not tolerated.
Priporočljivo je, da se to zdravljenje začne 1 teden pred uvedbo zdravila KRYSTEXXA in traja vsaj 6 mesecev, razen če je kontraindicirano ali ga bolnik ne prenaša.
Delayed-type hypersensitivity reactions have also been reported.
Poročali so tudi o zapoznelih preobčutljivostnih reakcijah.
Based on similar efficacy and safety profiles of pegloticase in patients with creatinine clearance below and above 50 ml/min, no dose adjustment is required for patients with renal impairment (see section 5.2).
Na podlagi podobnih profilov učinkovitosti in varnosti za peglotikazo pri bolnikih z očistkom kreatinina pod in nad 50 ml/min, pri bolnikih z ledvično okvaro ni potrebno prilagajanje odmerka (glejte poglavje 5.2).
The pharmacokinetics of KRYSTEXXA has not been studied in children and adolescents.
Farmakokinetike zdravila KRYSTEXXA niso proučevali pri otrocih in mladostnikih.
The Phase 1 pharmacokinetics showed proportionality within the dose interval (0.5 - 8 mg) as reflected in Cmax values.
Farmakokinetika 1. faze je pokazala sorazmernost znotraj razpona odmerka (0,5-8 mg), kar se kaže z vrednostmi Cmax.
If haemolysis and/or methemoglobinemia occur in patients receiving KRYSTEXXA, treatment should be immediately and permanently discontinued and appropriate measures initiated.
Če se pri bolnikih, ki prejemajo zdravilo KRYSTEXXA, pojavi hemoliza in/ali methemoglobinemija, je treba zdravljenje takoj in za stalno prekiniti ter uvesti ustrezne ukrepe.
Within each frequency grouping and system organ class, adverse reactions are presented in order of decreasing seriousness.
V posameznih razvrstitvah pogostnosti in organskih sistemih so neželene reakcije navedene po padajoči resnosti.
In the post-marketing setting, severe anaphylactic reactions have been reported, including loss of consciousness, circulatory collapse, and cardiac arrest, which required transfer to hospital emergency department.
V obdobju trženja zdravila so poročali o hudih anafilaktičnih reakcijah, vključno z izgubo zavesti, cirkulatornim kolapsom in srčnim zastojem, ki so zahtevale obisk bolnišničnega oddelka za nujno pomoč.
It is unknown whether pegloticase or its metabolites are excreted in human milk.
Ni znano, ali se peglotikaza ali njeni presnovki izločajo v materino mleko.
Week 25
Teden 25
The European Medicines Agency has deferred the obligation to submit the results of studies with KRYSTEXXA in one or more subset of the paediatric population in the treatment and/or prevention of hyperuricaemia related to Tumour Lysis Syndrome (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom KRYSTEXXA za eno ali več podskupin pediatrične populacije za zdravljenje in/ali preprečevanje hiperurikemije, povezane s sindromom tumorske lize (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Overall Complete Tophus Resolution (Pooled Analysis of GOUT 1 and GOUT 2)
Preglednica 3: Splošna popolna ozdravitev tofa (združena analiza študij GOUT 1 in GOUT 2)
• If you have a rare blood problem called glucose 6-phosphate dehydrogenase (G6PD) deficiency or favism.
• če imate redko krvno bolezen, imenovano pomanjkanje glukoza-6-fosfat dehidrogenaze (G6PD) ali favizem.
The safety and efficacy of KRYSTEXXA in children and adolescents aged below 18 years has not been established.
Varnost in učinkovitost zdravila KRYSTEXXA pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
Very common: Dermatitis, urticaria, pruritus, skin irritation, dry skin
Zelo pogosti: dermatitis, urtikarija, pruritus, draženje kože, suha koža
The embryofetal development study in rats does not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Študije embriofetalnega razvoja na podganah ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja in razvoja.
Anaphylaxis (characterized by stridor, wheezing, peri-oral/lingual oedema, or hemodynamic instability, with or without rash or urticaria) occurred in 14 (5.1%) of 273 total patients treated with KRYSTEXXA in clinical studies.
Anafilaksa (za katero so značilni stridor, sopenje, perioralni/lingvalni edem ali hemodinamska nestabilnost z izpuščajem ali urtikarijo ali brez njiju) se je pojavila pri 14 (5,1 %) od skupno 273 bolnikov, zdravljenih z zdravilom KRYSTEXXA v kliničnih študijah.
Pegloticase is used to treat severe long-term gout in adult patients who also have one or more painful deposits of uric acid crystals under the skin that cause difficulty in carrying out daily activities and who do not respond or cannot take other anti-gout medicines.
Peglotikaza se uporablja za zdravljenje hudega dolgotrajnega protina pri odraslih bolnikih, ki imajo enega ali več bolečih depozitov kristalov sečne kisline pod kožo, ki povzročajo težave pri opravljanju vsakodnevnih dejavnosti in se ne odzivajo na druga zdravila proti protinu ali jih ne prenašajo.
The effect of treatment on tophi was assessed using standardized digital photography and image analysis by a Central Reader blinded to treatment assignment.
Učinkovitost zdravljenja proti tofom so ocenili s standardizirano digitalno fotografijo in analizo slik s pomočjo centra za osrednje analize (Central Reader), ki ni bil seznanjen z razporeditvijo zdravljenja.
The solution should be used within 4 hours of dilution.
Raztopino je treba uporabiti v 4 urah po redčenju.
Crealta Pharmaceuticals Ireland Limited
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Crealta Pharmaceuticals Ireland Limited
For instructions on the preparation of the medicinal product before administration, see section 6.6.
Za navodila glede priprave zdravila pred dajanjem glejte poglavje 6.6.
The efficacy and safety of KRYSTEXXA was assessed in two replicate Phase III pivotal trials (GOUT 1 and GOUT 2) that were conducted in 212 adult patients with chronic gout refractory to allopurinol.
Učinkovitost in varnost zdravila KRYSTEXXA so ocenili v dveh repliciranih ključnih preskušanjih 3. faze (GOUT 1 in GOUT 2), ki sta bili opravljeni pri 212 odraslih bolnikih s kroničnim protinom, neodzivnim na alopurinol.
Week 13
Teden 13
The PK/PD analysis showed that higher doses were associated with lower uric acid levels and a more rapid decrease in these levels than lower doses.
Farmakakokinetična/farmakodinamična analiza je pokazala, da so bili večji odmerki povezani z nižjimi ravnmi sečne kisline in hitrejšim zniževanjem teh ravni v primerjavi z manjšimi odmerki.
KRYSTEXXA is not recommended during pregnancy.
Uporaba zdravila KRYSTEXXA ni priporočljiva med nosečnostjo.
Do not use this medicine after the expiry date which is stated on the label and the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki in škatli poleg oznake „Uporabno do“.
Therefore, in view of available data regarding anaphylaxis and infusion reactions, the Pharmacovigilance Risk Assessment Committee considered that changes to the product information were warranted.
Ob upoštevanju razpoložljivih podatkov glede anafilakse in reakcij zaradi infundiranja je Odbor za oceno tveganja na področju farmakovigilance ocenil, da so ocene za spremembo informacij za zdravilo utemeljene.
8 mg Pegloticase Every 2 Weeks (N = 62)
8 mg peglotikaze vsaka 2 tedna (N = 62)
The revised order of the two corresponding paragraphs is to emphasize the correlation between concomitant medication with urate lowering products and serum uric acid measurement.
Popravljen vrstni red dveh zadevnih odstavkov poudarja korelacijo med sočasnim zdravljenjem z zdravili za zniževanje ravni uratov in merjenjem sečne kisline.
The duration of treatment should be based upon maintenance of response (serum uric acid levels < 6 mg/dl) and clinical judgment.
Trajanje zdravljenja mora temeljiti na vzdrževanju odziva (ravni sečne kisline v serumu < 6 mg/dl) in na klinični presoji.
The vial should not be shaken.
Viala se ne sme pretresti.
Before you start treatment with KRYSTEXXA, your doctor may recommend that you take other medicines (such as an antihistamine, paracetamol and a corticosteroid) to help reduce the risk that you will get infusion-related reactions due to this treatment.
Preden začnete zdravljenje z zdravilom KRYSTEXXA, bo zdravnik morda priporočil, da vzamete druga zdravila (kot so antihistaminik, paracetamol in kortikosteroid), ki bodo pomagala zmanjšati tveganje za reakcije, povezane z infundiranjem.
Week 19
Teden 19
Glucose-6-phosphate dehydrogenase (G6PD) deficiency and other cellular metabolic disorders known to cause haemolysis and methemoglobinemia.
Pomanjkanje glukoze-6-fosfat dehidrogenaze (G6PD) ali druge celularne presnovne motnje, za katere je znano, da povzročajo hemolizo in methemoglobinemijo.
This dose is not adjusted for weight, age or kidney disease.
Ta odmerek ni prilagojen telesni masi, starosti ali ledvični bolezni.
An increase in gout flares is frequently observed upon treatment initiation, probably as a result of mobilization of urate from tissue deposits.
Med uvedbo zdravljenja se pogosto opazi povečanje napadov protina, kar je verjetno posledica mobilizacije urata naloženega v tkivu.
Pegloticase belongs to the class anti-gout medicines.
Peglotikaza spada v skupino zdravil proti protinu.
For the PEG moiety, urinary excretion is likely to be the major route of elimination.
Pri skupini PEG je verjetno glavna pot izločanja z urinom.
In repeated dose toxicity studies with KRYSTEXXA in rats and dogs, the occurrence of pegloticase-containing vacuoles was observed in different tissues.
V študijah toksičnosti z večkratnim odmerjanjem zdravila KRYSTEXXA pri podganah in psih so v različnih tkivih opazili vakuole, ki so vsebovale peglotikazo.
- if you are currently taking other medicines to lower your uric acid level - if you have been told you have heart failure - if you have ever been told you have an enzyme deficiency that causes anaemia - if you weigh over 100 kg - if you have been treated with KRYSTEXXA before
- če trenutno jemljete druga zdravila za zniževanje ravni sečne kisline; - če so vam povedali, da imate srčno popuščanje; - če so vam povedali, da imate pomanjkanje encima, ki povzroča anemijo; - če tehtate več kot 100 kg;
Pegloticase is a uricase enzyme conjugated with mPEG at an average degree of substitution of 40.8 moles of mPEG/mole of protein (10.2 moles of mPEG/monomeric sub-unit of the mature homotetrameric uricase protein).
Peglotikaza je encim urikaze, konjugiran z mPEG pri povprečni stopnji substitucije 40,8 mola mPEG/mol proteina (10,2 mola mPEG/monomerne podenote zrelega homotetramernega proteina urikaze).
Many infusion-related reactions resolved with slowing, or stopping the infusion, before restarting the infusion at a slower rate.
Mnoge reakcije, povezane z infundiranjem, so izginile ob upočasnitvi ali prekinitvi infundiranja, preden se je infundiranje ponovno začelo z manjšo hitrostjo.
The applicant should conduct a long-term EU observational study to end December 2018 on safety of pegloticase use in adult hyperuricemic patients with severe debilitating chronic tophaceous gout and efficacy and safety data in reexposed patients.
M0402: Opazovalna študija peglotikaze v obdobju trženja v EU Predlagatelj mora opraviti dolgotrajno opazovalno študijo v EU do konca decembra 2018 glede varnosti uporabe peglotikaze pri odraslih hiperuremičnih bolnikih s hudim onesposabljajočim kroničnim protinom s tofi ter podatkov o učinkovitosti in varnosti pri ponovno izpostavljenih bolnikih.
KRYSTEXXA should not be administered if two consecutive levels above 6 mg/dl (360 µmol/L) have been measured (see section 4.4).
Zdravilo KRYSTEXXA se ne sme uporabiti, če sta bili izmerjeni dve zaporedni ravni nad 6 mg/dl (360 µmol/l) (glejte poglavje 4.4).