natgillin/translations-raw huggingface dataset:
Rilonacept Regeneron is used to treat CAPS that are causing severe symptoms in adults and children aged 12 years and older, including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). 
Zdravilo Rilonacept Regeneron se uporablja za zdravljenje CAPS s hudimi simptomi, vključno s familiarnim avtoinflamatornim sindromom zaradi mraza (FCAS) in Muckle-Wellsovim sindromom (MWS), pri odraslih in otrocih, starejših od 12 let.
Rilonacept Regeneron was more effective than placebo at treating symptoms of CAPS. 
Zdravilo Rilonacept Regeneron je bilo pri zdravljenju simptomov CAPS učinkovitejše od placeba.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rilonacept Regeneron. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Rilonacept Regeneron, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
In the first part of one main study involving 47 patients with CAPS, patients were given either Rilonacept Regeneron or placebo (a dummy treatment) for six weeks. 
V prvem delu glavne študije, ki je vključevala 47 bolnikov s CAPS, so bolniki šest tednov prejemali bodisi zdravilo Rilonacept Regeneron bodisi placebo (zdravilo brez zdravilne učinkovine).
Other information about Rilonacept Regeneron: 
Druge informacije o zdravilu Rilonacept Regeneron :
By attaching to interleukin-1 beta, it blocks its activity, helping to relieve the symptoms of the disease. 
Rilonacept z vezavo na interlevkin-1beta zavira njegovo delovanje in tako pomaga ublažiti simptome bolezni.
In the second part of the study, all patients were given Rilonacept Regeneron treatment before receiving either Rilonacept Regeneron or placebo for another nine weeks. 
V drugem delu študije so vsi bolniki najprej prejemali zdravilo Rilonacept Regeneron, nato pa so naslednjih devet tednov prejemali bodisi zdravilo Rilonacept Regeneron bodisi placebo.
What measures are being taken to ensure the safe use of Rilonacept Regeneron? 
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Rilonacept Regeneron?
The active substance in Rilonacept Regeneron, rilonacept, is an interleukin inhibitor. 
Zdravilna učinkovina zdravila Rilonacept Regeneron, rilonacept, je zaviralec interlevkina.
What benefit has Rilonacept Regeneron shown during the studies? 
Kakšne koristi je zdravilo Rilonacept Regeneron izkazalo med študijami?
For the full list of all side effects reported with Rilonacept Regeneron, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rilonacept Regeneron, glejte navodilo za uporabo.
It works by attaching to chemical messengers in the body called interleukin-1beta and interleukin-1 alpha. One of these messengers, interleukin-1 beta, is produced at high levels in patients with CAPS, causing inflammation. 
Deluje tako, da se veže na kemična prenašalca v telesu, imenovana interlevkin-1beta in interlevkin-1alfa.
Rilonacept Regeneron is a powder and solvent that are made up into a solution for injection. 
Zdravilo Rilonacept Regeneron sestavljata prašek in vehikel, ki se zmešata v raztopino za injiciranje.
What information is still awaited for Rilonacept Regeneron? 
Katere informacije o zdravilu Rilonacept Regeneron še pričakujemo?
Rilonacept Regeneron rilonacept 
Rilonacept Regeneron1
What is the risk associated with Rilonacept Regeneron? 
Kakšna tveganja so povezana z zdravilom Rilonacept Regeneron?
Blocking interleukin-1 may interfere with the body's immune response to infection and there have been reports of serious infections in patients taking Rilonacept Regeneron. 
Zaviranje interlevkina-1 lahko ovira imunski odziv telesa na okužbe.
Why has Rilonacept Regeneron been approved? 
Zakaj je bilo zdravilo Rilonacept Regeneron odobreno?
Rilonacept Regeneron is given as injections under the skin. 
Zdravilo Rilonacept Regeneron se injicira v podkožje.
A week later, the patient should start receiving once weekly injections of 160 mg. For children aged from 12 to 17 years, the dose will depend on the patient's weight. 
Teden dni kasneje mora bolnik začeti prejemati injekcije po 160 mg enkrat tedensko.
How has Rilonacept Regeneron been studied? 
Kako je bilo zdravilo Rilonacept Regeneron raziskano?
How is Rilonacept Regeneron used? 
Kako se zdravilo Rilonacept Regeneron uporablja?
What is Rilonacept Regeneron? 
Kaj je zdravilo Rilonacept Regeneron?
What is Rilonacept Regeneron used for? 
Za kaj se zdravilo Rilonacept Regeneron uporablja?
How does Rilonacept Regeneron work? 
Kako zdravilo Rilonacept Regeneron deluje?
Date of first authorisation: 28 October 2010 Date of latest renewal: 18 September 2015 
Datum prve odobritve: 28. oktober 2010 Datum zadnjega podaljšanja: 18. september 2015
5 minutes. 
5 minutah.
Do not give this medicine to children under 12 years old. 
Tega zdravila ne dajajte otrokom, mlajšim od 12 let.
This testing should be provided free of charge. 
To testiranje je treba zagotoviti brezplačno.
• Wash your hands carefully. 
• Dobro si umijte roke.
Genotoxic and carcinogenic potential is not expected. 
Ne pričakuje se genotoksičnosti in kancerogenega potenciala.
Small amounts of foam are acceptable. 
Majhne količine pene so sprejemljive.
Data in patients older than 65 years are limited. 
Podatkov pri bolnikih, starejših od 65 let, je malo.
• Inspect vials and other components. 
• Preglejte viale in druge komponente.
All adapters supplied with the kit are identical. 
Vsi adapterji, dobavljeni v kompletu, so enaki.
The medicinal product should be used immediately (see section 6.3). 
Zdravilo je treba uporabiti takoj (glejte poglavje 6.3).
Chemical and physical in-use stability has been demonstrated for 48 hours between 5˚C and 25˚C. 
Kemična in fizikalna stabilnost med uporabo je bila dokazana do 48 ur med 5 ˚C in 25 ˚C.
• Response to treatment 
• Odziv na zdravljenje
Hypersensitivity reactions cannot be excluded. 
Preobčutljivostnih reakcij ni mogoče izključiti.
The adapter must remain in its plastic packaging. 
Adapter mora ostati v svoji plastični ovojnini.
Step 9: Required components 
9. korak: Zahtevane komponente
The instructions for use are clearly described in the doctor's information leaflet and are attached. 
Navodila za uporabo so jasno opisana v navodilih za uporabo za zdravnika in so priložena.
Elderly (≥65 years old) 
Starejši (≥65 let):
The efficacy and safety in adolescent patients were consistent with that seen in adults. 
Učinkovitost in varnost pri mladoletnih bolnikih sta bili enaki kot pri odraslih.
The table below shows the results (primary and secondary endpoints) of the two randomized controlled trials: 
Spodnja preglednica prikazuje rezultate (primarni in sekundarni opazovani dogodek) dveh randomiziranih, nadzorovanih študij:
Marketing Authorisation Holder: Pharming Group N.V. 
Imetnik dovoljenja za promet: Pharming Group N.V.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik
Paediatric population The safety and efficacy of Ruconest in children (age 0 to 12 years) have not yet been established. 
Pediatrična populacija Varnost in učinkovitost zdravila Ruconest pri otrocih, starih 0 do 12 let, še nista dokazani.
The elimination half-life of conestat alfa was approximately 2 hours. 
Razpolovni čas izločanja konestata alfa je bil približno 2 uri.
No formal distribution studies have been performed. 
Formalne študije o porazdelitvi niso bile izvedene.
Time (minutes) to minimal symptoms median (95% CI) 
Povprečni čas do minimalnih simptomov (95 % CI)
This can lead to repeated attacks of swelling, pain in the abdomen, difficulty breathing and other symptoms. 
To lahko vodi k ponavljajočim se napadom otekanja, bolečinam v trebuhu, težavam pri dihanju in drugim simptomom.
Step 14: Documenting the administration Please record (e.g. in your diary): 
14. korak: Dokumentiranje injiciranja Prosimo, zabeležite (npr. v svojem dnevniku):
No clinical information on overdose is available. 
Klinične informacije o prevelikem odmerjanju niso na voljo.
Mostly a single dose is sufficient, but a second dose may be needed. 
V večini primerov zadostuje enkratni odmerek, vendar bo morda potreben drugi odmerek.
Very rare (<1/10,000), Not known (cannot be estimated from the available data). 
neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
For IV use. 
Za IV uporabo.
Ruconest is not recommended for use during pregnancy or breast-feeding, unless the treating physician judges the benefits to outweigh the possible risks. 
Ruconest se ne priporoča za uporabo med nosečnostjo ali dojenjem, razen če lečeči zdravnik oceni, da pričakovane koristi prevladajo nad možnimi tveganji.
(pharmacovigilance or risk minimisation) milestone being reached. 
(farmakovigilančni ali povezan z zmanjševanjem tveganja).
- check the expiry date. 
- preverite datum izteka roka uporabnosti.
Preparation of solution Step 1: Cleaning and other requirements 
1. korak: Čiščenje in druge zahteve
• The risk of formation of anti-C1INH antibodies and therefore the potential risk of formation of neutralising antibodies. 
• Tveganje tvorbe protiteles anti-C1INH in s tem morebitno tveganje za tvorjenje nevtralizirajočih protiteles.
It is very important that the prepared solution is injected directly into a vein and not into an artery or the surrounding tissue. 
Pomembno je, da se pripravljena raztopina injicira neposredno v veno in ne v arterijo ali okoliško tkivo.
Each vial of Ruconest is for single use only. 
Vsaka viala zdravila Ruconest je samo za enkratno uporabo.
Continue to fill the syringe with the volume required. 
Nadaljujte s polnjenjem brizge s potrebno količino.
Patients must be closely monitored and carefully observed for any symptoms of hypersensitivity throughout the administration period. 
Bolnike je treba skrbno spremljati in pozorno opazovati glede kakršnihkoli simptomov preobčutljivosti skozi celotno obdobje dajanja zdravila.
Within a single kit box, different components may have different expiry dates. 
V posameznem pakiranju imajo lahko različne komponente različne datume izteka roka uporabnosti.
= body weight (kg) 
= telesna masa (kg)
Nine adolescent HAE patients (aged 13 to 17 years) were treated with 50 U/kg for 26 acute angioedema attacks, and 7 (aged 16 to 17 years) with 2100 U for 24 acute angioedema attacks. 
Devet bolnikov mladostnikov s HAE (starih 13 do 17 let) je bilo zdravljenih s 50 e./kg zaradi 26 akutnih napadov angioedema in 7 (starih 16 do 17 let) z 2100 e. zaradi 24 akutnih napadov angioedema.
The complement component (protein) C4, is a substrate for activated C1s. 
Sestavina komplementa (beljakovina) C4 je substrat za aktivirane C1.
There is no rationale for patients older than 65 years to respond differently to Ruconest. 
Ne pričakuje se, da bi se bolniki, starejši od 65 let, na zdravilo Ruconest odzivali drugače.
Preparation and handling 
Priprava in rokovanje
If undissolved powder is still present, repeat the procedure. 
Če je v viali še neraztopljen prašek, postopek ponovite.
• If blood is present, gently inject the solution into the vein, as shown in the picture. 
• Če je prisotna kri, raztopino nežno injicirajte v žilo, kot je prikazano na sliki.
Based on the known pharmacology and adverse reaction profile of Ruconest, effects on the ability to drive and use machines are not expected. 
Na podlagi znane farmakologije in profila neželenih učinkov zdravila Ruconest ni pričakovati vpliva na sposobnost vožnje in upravljanja s stroji.
As a result they may suffer from uncontrolled activation of contact and complement systems, with formation of inflammatory mediators, which clinically becomes manifest as the occurrence of acute angioedema attacks. 
Posledično lahko trpijo zaradi nenadzorovane aktivacije sistemov kontakta in komplementa z nastankom vnetnih mediatorjev, ki se klinično pokažejo kot pojav akutnih napadov angioedema.
This may indicate that you have developed an allergy to Ruconest. 
To lahko kaže, da ste razvili alergijo na zdravilo Ruconest.
What Ruconest is and what it is used for What you need to know before you use Ruconest How to use Ruconest 
Kaj je zdravilo Ruconest in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ruconest Kako uporabljati zdravilo Ruconest
• Any adverse events 
• Kakršni koli neželeni dogodki
- Batch number and dose - Response to treatment - Any adverse events 
- Številko serije in odmerek zdravila - Odziv na zdravljenje - Kakršne koli neželene dogodke
The clinical experience supporting safety of Ruconest consists of 300 administrations (83 administrations to healthy subjects or asymptomatic HAE patients and 217 administrations to 119 HAE patients). 
Klinične izkušnje, ki podpirajo varnost zdravila Ruconest, zajemajo 300 dajanj (83 dajanj zdravim osebam ali asimptomatičnim bolnikom s HAE in 217 dajanj 119 bolnikom s HAE).
• If there is no blood in the tubing, remove the needle, repeat all steps from beginning of step 11 and reposition the needle. 
• Če v cevki ni krvi, odstranite iglo, ponovite vse korake od 11. koraka naprej in znova vstavite iglo.
The incidence of adverse reactions was similar for all dose groups and did not increase upon repeated administrations. 
Pojavnost neželenih učinkov je bila podobna za vse skupine z različnimi odmerki in se ni povečala po večkratnem dajanju.
• Use one alcohol pad to disinfect all vial stoppers and wait for at least 30 seconds until the stoppers have dried. 
• Z alkoholno blazinico razkužite vse zaporke vial in počakajte vsaj 30 sekund, da se zaporke osušijo.
Adverse reactions were usually mild to moderate in severity. 
Neželeni učinki so bili običajno blagi do zmerni.
The European Medicines Agency has deferred the obligation to submit the results of studies with Ruconest in one or more subsets of the paediatric population in treatment of acute angioedema attacks (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Ruconest za eno ali več podskupin pediatrične populacije za zdravljenje akutnih napadov angioedema (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
• The decision on the use of home treatment for an individual patient should be made by the treating physician. 
• Odločitev o uporabi zdravljenja doma mora za posameznega bolnika sprejeti lečeči zdravnik.
- all vials must be sealed with plastic lid and aluminium cap and without visible damage, such as cracks in glass. 
- vse viale morajo biti zapečatene s plastičnim pokrovom in aluminijasto zaporko brez vidnih poškodb, kot so razpoke v steklu.
In the study in rats there were no malformed fetuses in either the conestat alfa or the control group. 
V študiji na podganah ni prišlo do deformiranosti ploda v skupini, ki je prejemala konestat alfa, niti v kontrolni skupini.
No recommendation on a dose adjustment can be made. 
Priporočil o prilagoditvi odmerka ni možno dati.
Contact your doctor or nearest hospital if this occurs. 
V tem primeru se posvetujte z zdravnikom ali najbližjo bolnišnico.
Other medicines and Ruconest 
Druga zdravila in zdravilo Ruconest
• If you need to use a second powder and solvent vial, repeat the above steps. 
• Če morate uporabiti drugo vialo s praškom in vehiklom, ponovite zgornje korake.
Your dose will be worked out based on your bodyweight. 
Vaš odmerek se izračuna na podlagi vaše telesne mase.
Pharmacotherapeutic group: Other haematological agents, drugs used in hereditary angioedema, ATC code: B06AC04. 
Farmakoterapevtska skupina: druga krvna zdravila, zdravila, za zdravljenje hereditarnega angioedema, oznaka ATC: B06AC04.
If you use more Ruconest than you should 
Če ste uporabili večji odmerek zdravila Ruconest, kot bi smeli
From a microbiological point of view, the medicinal product should be used immediately. 
mikrobiološkega stališča je treba zdravilo uporabiti takoj.
The distribution volume of conestat alfa was approximately 3 L, comparable to plasma volume. 
Volumen porazdelitve konestata alfa je bil približno 3 l, kar je primerljivo s plazemskim volumnom.
The results of the open label studies were consistent with the above findings and support the repeated use of Ruconest in the treatment of subsequent attacks of angioedema. 
Rezultati odprtih študij so bili skladni z zgornjimi ugotovitvami in podpirajo večkratno uporabo zdravila Ruconest pri zdravljenju naslednjih napadov angioedema.
- Date and time of treatment 
- Datum in čas zdravljenja
• Calculate the millilitres of prepared solution to be injected. 
• Izračunajte, koliko mililitrov pripravljene tekočine je treba injicirati.
After dissolving the powder in water for injections, the solution is clear and colourless. 
Po raztopitvi praška v vodi za injekcije je raztopina bistra in brezbarvna.
Gently inject the solution into the vein - inject over about 5 minutes. 
Nežno injicirajte raztopino v veno - injicirajte približno 5 minut.
Do not reuse equipment. 
Oprema ni namenjena ponovni uporabi.
The information collected should include: 
Zbrane informacije morajo zajemati:
Ruconest should not be administered simultaneously with tPA. 
Zdravila Ruconest se ne sme dajati sočasno z zdravili, ki vsebujejo tPA.
If these symptoms occur after administration, they should alert their physician. 
Če se po dajanju zdravila pojavijo ti simptomi, morajo nanje opozoriti svojega zdravnika.
Reconstitute each vial with 14 ml water for injections (see section on Reconstitution below). 
Vsako vialo rekonstituirajte s 14 ml vode za injekcije (glejte poglavje o rekonstituciji spodaj).
• Educational material for the Healthcare Professional. 
• Izobraževalno gradivo za zdravstvene delavce.
The decision on the use of home-treatment for an individual patient should be made by the treating physician, who should ensure that appropriate training is provided and the use reviewed at intervals. 
Odločitev o uporabi zdravljenja doma za posameznega bolnika mora sprejeti lečeči zdravnik, ki mora zagotoviti ustrezno usposabljanje in redno preverjanje uporabe.
Ruconest will be given to you directly into a vein over a period of approximately 5 minutes by your doctor or by a nurse. 
Zdravilo Ruconest vam bo neposredno v veno v trajanju približno 5 minut dal zdravnik ali medicinska sestra.
• The importance of monitoring for clinical signs and symptoms of hypersensitivity and that patients should immediately seek medical care if they develop such symptoms during or after receiving 
• Pomen spremljanja kliničnih znakov in simptomov preobčutljivosti in da morajo bolniki nemudoma poiskati zdravniško pomoč , če razvijejo take simptome med prejemanjem ali po prejemu zdravila Ruconest.
If your symptoms get worse and/or you develop a rash, tingling, difficulty breathing or your face or tongue swells up, get medical attention immediately. 
Če se vaši simptomi poslabšajo in/ali se pri vas pojavijo izpuščaji, mravljinčenje, težave pri dihanju ali pa vam oteče obraz ali jezik, takoj poiščite medicinsko pomoč.
• The existence of a post marketing registry in which healthcare professionals are encouraged to enter patients. 
• Obstoj registra po dajanju zdravila v promet, kamor lahko zdravstveni delavci vpisujejo bolnike.
The most common adverse reaction observed after administration of Ruconest is headache. 
Najpogostejši neželeni učinek, ki so ga opazili po dajanju zdravila Ruconest, je glavobol.
If you are receiving tissue type plasminogen activator as acute treatment for blood clots, you should not be treated with Ruconest at the same time. 
Če za akutno zdravljenje krvnih strdkov prejemate aktivatorje plazminogena tkivnega tipa, se sočasno ne smete zdraviti z zdravilom Ruconest.
Step 5: Adding solvent to powder and dissolving 
5. korak: Dodajanje vehikla k prašku in raztapljanje
The required volume of the reconstituted solution should be administered as a slow intravenous injection over approximately 5 minutes. 
Potrebni volumen rekonstituirane raztopine je treba dati kot počasno intravensko injekcijo v približno
• Leave the packaging on the adapter until you attach the syringe in steps 4 and 5. 
• Pustite ovojnino na adapterju, dokler ne namestite brizge v 4. in 5. koraku.
What Ruconest is and what it is used for 
Kaj je zdravilo Ruconest in za kaj ga uporabljamo
• Educational material for non-Healthcare Professionals. 
• Izobraževalno gradivo za nezdravstvene delavce.
You or your caregiver may inject Ruconest only after receiving adequate instructions and training from your doctor or nurse. 
Vi ali vaš skrbnik lahko zdravilo Ruconest injicirate šele po tem, ko ste s strani vašega zdravnika ali medicinske sestre prejeli ustrezna navodila in usposabljanje.
• Never exceed the volume of 14 ml per syringe. 
• Nikoli ne presezite količine 14 ml na brizgo.
The MAH should ensure that, at launch, all Healthcare Professionals who are expected to prescribe Ruconest are provided with an educational pack. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo do začetka trženja vsi zdravstveni delavci, za katere se pričakuje, da bodo predpisovali zdravilo Ruconest, prejeli izobraževalno gradivo.
C1INH exerts an inhibitory effect on several proteases (target proteases) of the contact and complement systems. 
C1INH ima zaviralni učinek na številne proteaze (tarčne proteaze) sistemov kontakta in komplementa.
Potential risks associated with home-treatment are related to the administration itself as well as the handling of adverse reactions, particularly hypersensitivity. 
Možna tveganja, povezana z zdravljenjem doma, so povezana s samostojnim dajanjem in obravnavo neželenih učinkov, zlasti preobčutljivosti.
• For some patients the physician may decide that Ruconest may be administered outside of a clinic setting by a non-Healthcare Professional such as a family member or by self-administration. 
• Pri nekaterih bolnikih lahko zdravnik sprejeme odločitev, da se lahko zdravilo Ruconest daje izven bolnišnične ustanove, kar lahko izvaja nezdravstveni delavec, na primer družinski član, ali pa bolnik sam.
For instructions on reconstitution of Ruconest before administration, see section 6.6. 
Za navodila glede rekonstitucije zdravila Ruconest pred dajanjem glejte poglavje 6.6.
Prior to launch of the product in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the National Competent Authority (NCA). 
Pred pričetkom trženja zdravila v vsaki državi članici se imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovori o vsebini in obliki izobraževalnega gradiva.
In a rabbit embryotoxicity study an increase in the incidence of fetal cardiac vessel defects (1.12% in the treatment group versus 0.03% in historical controls) was observed for animals that were administered conestat alfa. 
študiji toksičnosti za zarodek na kuncih so opazili večjo pojavnost okvare srčnih žil ploda (1,12 % v zdravljeni skupini glede na 0,03 % v predhodnih kontrolah) pri živalih, ki so prejemale konestat alfa.
Efficacy of Ruconest as a treatment for acute angioedema attacks was demonstrated by significantly shorter time to beginning of relief of symptoms and time to minimal symptoms and few therapeutic failures. 
Učinkovitost zdravila Ruconest pri zdravljenju akutnih napadov angioedema je bila dokazana s pomembno krajšim časom do začetka ublažitve simptomov in časom do minimalnih simptomov ter z maloštevilnimi terapevtskimi neuspehi.
• 2 vial adapters 
• 2 adapterja za viale