FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinical information on overdose is available.
Slovenian: Klinične informacije o prevelikem odmerjanju niso na voljo.
English: Mostly a single dose is sufficient, but a second dose may be needed.
Slovenian: V večini primerov zadostuje enkratni odmerek, vendar bo morda potreben drugi odmerek.
English: Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Slovenian: neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: For IV use.
Slovenian: Za IV uporabo.
English: Ruconest is not recommended for use during pregnancy or breast-feeding, unless the treating physician judges the benefits to outweigh the possible risks.
Slovenian: Ruconest se ne priporoča za uporabo med nosečnostjo ali dojenjem, razen če lečeči zdravnik oceni, da pričakovane koristi prevladajo nad možnimi tveganji.
English: (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: - check the expiry date.
Slovenian: - preverite datum izteka roka uporabnosti.
English: Pharming Group N.V., Darwinweg 24, NL-2333 CR LEIDEN, The Netherlands
Slovenian: Pharming Group N.V., Darwinweg 24, NL-2333 CR LEIDEN, Nizozemska
English: Preparation of solution Step 1: Cleaning and other requirements
Slovenian: 1. korak: Čiščenje in druge zahteve
English: • The risk of formation of anti-C1INH antibodies and therefore the potential risk of formation of neutralising antibodies.
Slovenian: • Tveganje tvorbe protiteles anti-C1INH in s tem morebitno tveganje za tvorjenje nevtralizirajočih protiteles.
English: It is very important that the prepared solution is injected directly into a vein and not into an artery or the surrounding tissue.
Slovenian: Pomembno je, da se pripravljena raztopina injicira neposredno v veno in ne v arterijo ali okoliško tkivo.
English: Each vial of Ruconest is for single use only.
Slovenian: Vsaka viala zdravila Ruconest je samo za enkratno uporabo.
English: Continue to fill the syringe with the volume required.
Slovenian: Nadaljujte s polnjenjem brizge s potrebno količino.
English: Patients must be closely monitored and carefully observed for any symptoms of hypersensitivity throughout the administration period.
Slovenian: Bolnike je treba skrbno spremljati in pozorno opazovati glede kakršnihkoli simptomov preobčutljivosti skozi celotno obdobje dajanja zdravila.
English: Within a single kit box, different components may have different expiry dates.
Slovenian: V posameznem pakiranju imajo lahko različne komponente različne datume izteka roka uporabnosti.
English: = body weight (kg)
Slovenian: = telesna masa (kg)
English: 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.
Slovenian: 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.
English: The complement component (protein) C4, is a substrate for activated C1s.
Slovenian: Sestavina komplementa (beljakovina) C4 je substrat za aktivirane C1.
English: There is no rationale for patients older than 65 years to respond differently to Ruconest.
Slovenian: Ne pričakuje se, da bi se bolniki, starejši od 65 let, na zdravilo Ruconest odzivali drugače.
English: Preparation and handling
Slovenian: Priprava in rokovanje
English: If undissolved powder is still present, repeat the procedure.
Slovenian: Če je v viali še neraztopljen prašek, postopek ponovite.
English: • If blood is present, gently inject the solution into the vein, as shown in the picture.
Slovenian: • Če je prisotna kri, raztopino nežno injicirajte v žilo, kot je prikazano na sliki.
English: Based on the known pharmacology and adverse reaction profile of Ruconest, effects on the ability to drive and use machines are not expected.
Slovenian: Na podlagi znane farmakologije in profila neželenih učinkov zdravila Ruconest ni pričakovati vpliva na sposobnost vožnje in upravljanja s stroji.
English: 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.
Slovenian: Posledično lahko trpijo zaradi nenadzorovane aktivacije sistemov kontakta in komplementa z nastankom vnetnih mediatorjev, ki se klinično pokažejo kot pojav akutnih napadov angioedema.
English: This may indicate that you have developed an allergy to Ruconest.
Slovenian: To lahko kaže, da ste razvili alergijo na zdravilo Ruconest.
English: What Ruconest is and what it is used for What you need to know before you use Ruconest How to use Ruconest
Slovenian: Kaj je zdravilo Ruconest in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ruconest Kako uporabljati zdravilo Ruconest
English: • Any adverse events
Slovenian: • Kakršni koli neželeni dogodki
English: - Batch number and dose - Response to treatment - Any adverse events
Slovenian: - Številko serije in odmerek zdravila - Odziv na zdravljenje - Kakršne koli neželene dogodke
English: 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).
Slovenian: 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).
English: • If there is no blood in the tubing, remove the needle, repeat all steps from beginning of step 11 and reposition the needle.
Slovenian: • Če v cevki ni krvi, odstranite iglo, ponovite vse korake od 11. koraka naprej in znova vstavite iglo.
English: The incidence of adverse reactions was similar for all dose groups and did not increase upon repeated administrations.
Slovenian: Pojavnost neželenih učinkov je bila podobna za vse skupine z različnimi odmerki in se ni povečala po večkratnem dajanju.
English: • Use one alcohol pad to disinfect all vial stoppers and wait for at least 30 seconds until the stoppers have dried.
Slovenian: • Z alkoholno blazinico razkužite vse zaporke vial in počakajte vsaj 30 sekund, da se zaporke osušijo.
English: Adverse reactions were usually mild to moderate in severity.
Slovenian: Neželeni učinki so bili običajno blagi do zmerni.
English: 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).
Slovenian: 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).
English: • The decision on the use of home treatment for an individual patient should be made by the treating physician.
Slovenian: • Odločitev o uporabi zdravljenja doma mora za posameznega bolnika sprejeti lečeči zdravnik.
English: - all vials must be sealed with plastic lid and aluminium cap and without visible damage, such as cracks in glass.
Slovenian: - vse viale morajo biti zapečatene s plastičnim pokrovom in aluminijasto zaporko brez vidnih poškodb, kot so razpoke v steklu.
English: In the study in rats there were no malformed fetuses in either the conestat alfa or the control group.
Slovenian: V študiji na podganah ni prišlo do deformiranosti ploda v skupini, ki je prejemala konestat alfa, niti v kontrolni skupini.
English: No recommendation on a dose adjustment can be made.
Slovenian: Priporočil o prilagoditvi odmerka ni možno dati.
English: Contact your doctor or nearest hospital if this occurs.
Slovenian: V tem primeru se posvetujte z zdravnikom ali najbližjo bolnišnico.
English: Other medicines and Ruconest
Slovenian: Druga zdravila in zdravilo Ruconest
English: • If you need to use a second powder and solvent vial, repeat the above steps.
Slovenian: • Če morate uporabiti drugo vialo s praškom in vehiklom, ponovite zgornje korake.
English: Your dose will be worked out based on your bodyweight.
Slovenian: Vaš odmerek se izračuna na podlagi vaše telesne mase.
English: Pharmacotherapeutic group: Other haematological agents, drugs used in hereditary angioedema, ATC code: B06AC04.
Slovenian: Farmakoterapevtska skupina: druga krvna zdravila, zdravila, za zdravljenje hereditarnega angioedema, oznaka ATC: B06AC04.
English: If you use more Ruconest than you should
Slovenian: Če ste uporabili večji odmerek zdravila Ruconest, kot bi smeli
English: From a microbiological point of view, the medicinal product should be used immediately.
Slovenian: mikrobiološkega stališča je treba zdravilo uporabiti takoj.
English: The distribution volume of conestat alfa was approximately 3 L, comparable to plasma volume.
Slovenian: Volumen porazdelitve konestata alfa je bil približno 3 l, kar je primerljivo s plazemskim volumnom.
English: 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.
Slovenian: Rezultati odprtih študij so bili skladni z zgornjimi ugotovitvami in podpirajo večkratno uporabo zdravila Ruconest pri zdravljenju naslednjih napadov angioedema.
English: - Date and time of treatment
Slovenian: - Datum in čas zdravljenja
English: • Calculate the millilitres of prepared solution to be injected.
Slovenian: • Izračunajte, koliko mililitrov pripravljene tekočine je treba injicirati.
English: After dissolving the powder in water for injections, the solution is clear and colourless.
Slovenian: Po raztopitvi praška v vodi za injekcije je raztopina bistra in brezbarvna.
English: Gently inject the solution into the vein - inject over about 5 minutes.
Slovenian: Nežno injicirajte raztopino v veno - injicirajte približno 5 minut.
English: Do not reuse equipment.
Slovenian: Oprema ni namenjena ponovni uporabi.
English: The information collected should include:
Slovenian: Zbrane informacije morajo zajemati:
English: Ruconest should not be administered simultaneously with tPA.
Slovenian: Zdravila Ruconest se ne sme dajati sočasno z zdravili, ki vsebujejo tPA.
English: If these symptoms occur after administration, they should alert their physician.
Slovenian: Če se po dajanju zdravila pojavijo ti simptomi, morajo nanje opozoriti svojega zdravnika.
English: Reconstitute each vial with 14 ml water for injections (see section on Reconstitution below).
Slovenian: Vsako vialo rekonstituirajte s 14 ml vode za injekcije (glejte poglavje o rekonstituciji spodaj).
English: • Educational material for the Healthcare Professional.
Slovenian: • Izobraževalno gradivo za zdravstvene delavce.
English: 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.
Slovenian: Odločitev o uporabi zdravljenja doma za posameznega bolnika mora sprejeti lečeči zdravnik, ki mora zagotoviti ustrezno usposabljanje in redno preverjanje uporabe.
English: Ruconest will be given to you directly into a vein over a period of approximately 5 minutes by your doctor or by a nurse.
Slovenian: Zdravilo Ruconest vam bo neposredno v veno v trajanju približno 5 minut dal zdravnik ali medicinska sestra.
English: • 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
Slovenian: • 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.
English: 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.
Slovenian: 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.
English: • The existence of a post marketing registry in which healthcare professionals are encouraged to enter patients.
Slovenian: • Obstoj registra po dajanju zdravila v promet, kamor lahko zdravstveni delavci vpisujejo bolnike.
English: The most common adverse reaction observed after administration of Ruconest is headache.
Slovenian: Najpogostejši neželeni učinek, ki so ga opazili po dajanju zdravila Ruconest, je glavobol.
English: 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.
Slovenian: Če za akutno zdravljenje krvnih strdkov prejemate aktivatorje plazminogena tkivnega tipa, se sočasno ne smete zdraviti z zdravilom Ruconest.
English: Step 5: Adding solvent to powder and dissolving
Slovenian: 5. korak: Dodajanje vehikla k prašku in raztapljanje
English: The required volume of the reconstituted solution should be administered as a slow intravenous injection over approximately 5 minutes.
Slovenian: Potrebni volumen rekonstituirane raztopine je treba dati kot počasno intravensko injekcijo v približno
English: • Leave the packaging on the adapter until you attach the syringe in steps 4 and 5.
Slovenian: • Pustite ovojnino na adapterju, dokler ne namestite brizge v 4. in 5. koraku.
English: What Ruconest is and what it is used for
Slovenian: Kaj je zdravilo Ruconest in za kaj ga uporabljamo
English: • Educational material for non-Healthcare Professionals.
Slovenian: • Izobraževalno gradivo za nezdravstvene delavce.
English: You or your caregiver may inject Ruconest only after receiving adequate instructions and training from your doctor or nurse.
Slovenian: 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.
English: • Never exceed the volume of 14 ml per syringe.
Slovenian: • Nikoli ne presezite količine 14 ml na brizgo.
English: The MAH should ensure that, at launch, all Healthcare Professionals who are expected to prescribe Ruconest are provided with an educational pack.
Slovenian: 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.
English: C1INH exerts an inhibitory effect on several proteases (target proteases) of the contact and complement systems.
Slovenian: C1INH ima zaviralni učinek na številne proteaze (tarčne proteaze) sistemov kontakta in komplementa.
English: Potential risks associated with home-treatment are related to the administration itself as well as the handling of adverse reactions, particularly hypersensitivity.
Slovenian: Možna tveganja, povezana z zdravljenjem doma, so povezana s samostojnim dajanjem in obravnavo neželenih učinkov, zlasti preobčutljivosti.
English: • 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.
Slovenian: • 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.
English: For instructions on reconstitution of Ruconest before administration, see section 6.6.
Slovenian: Za navodila glede rekonstitucije zdravila Ruconest pred dajanjem glejte poglavje 6.6.
English: 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).
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • 2 vial adapters
Slovenian: • 2 adapterja za viale
English: Before initiating treatment with Ruconest, patients should be queried about prior exposure to rabbits and signs and symptoms suggestive of an allergic reaction.
Slovenian: Pred uvedbo zdravljenja z zdravilom Ruconest je treba bolnike izprašati o predhodni izpostavljenosti kuncem ter o znakih in simptomih, ki kažejo na alergijsko reakcijo.
English: An aseptic technique should be used for reconstitution, combining and mixing the solutions.
Slovenian: Za rekonstitucijo, kombiniranje in mešanje raztopine je treba uporabiti aseptično tehniko.
English: In case of anaphylactic reactions or shock, emergency medical treatment should be administered.
Slovenian: V primeru anafilaktičnih reakcij ali šoka je treba nuditi nujno medicinsko pomoč.
English: In an open label study 114/119 (95%) attacks treated with a single dose of 50 U/kg reached time to beginning of relief within 4 hours.
Slovenian: V odprti študiji je 114/119 (95 %) napadov, zdravljenih z enim odmerkom 50 e./kg, doseglo čas ublažitve v 4 urah.
English: The table below lists all adverse reactions occurring within 7 days after treatment with Ruconest, as reported in the six treatment studies.
Slovenian: Spodnja preglednica zajema vse neželene učinke, ki so se pojavili v 7 dneh po zdravljenju z zdravilom Ruconest, na podlagi poročil v šestih študijah zdravljenja.
English: • After disinfection, do not touch the stoppers with your fingers or anything else.
Slovenian: • Po razkuževanju se zapork ne dotikajte s prsti ali katerimi koli drugimi predmeti.
English: Broekman Institute B.V. Schoolstraat 21
Slovenian: Broekman Institute B.V.
English: Inform your healthcare professional if this occurs.
Slovenian: V tem primeru obvestite zdravstveno osebje.
English: After swirling, leave the vial on the surface for several minutes until the solution has become clear.
Slovenian: Po vrtenju vialo nekaj minut pustite na delovni površini, dokler se raztopina ne zbistri.
English: • 2 alcohol pads
Slovenian: • 2 alkoholni blazinici
English: • If you are or think you are allergic to rabbits • If you are allergic to conestat alfa or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na konestat alfa ali katero koli sestavino zdravila (navedeno v poglavju 6).
English: What you need to know before you use Ruconest Do not use Ruconest:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Ruconest Ne uporabljajte zdravila Ruconest:
English: Your dose, up to 2 vials, will be worked out based on your weight.
Slovenian: Odmerek, do 2 viali naenkrat, se izračuna na podlagi vaše telesne mase.
English: Dose calculation
Slovenian: Izračun odmerka
English: • Check whether the powder in the vial(s) has dissolved completely and the plunger is completely pushed down in the syringe.
Slovenian: • Preverite, ali se je prašek v viali oz. vialah popolnoma raztopil in da je bat brizge potisnjen do konca.
English: The expiry date on the outer carton reflects the date of the component with the shortest shelf-life.
Slovenian: Datum izteka roka uporabnosti, naveden na zunanji ovojnini (škatli), navaja datum komponente z najkrajšim rokom uporabnosti.
English: Contents of the pack and other information What Ruconest contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ruconest
English: In one animal study reproductive toxicity was observed (see section 5.3).
Slovenian: Ena študija na živalih je pokazala vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: • Take the syringe with solvent that you prepared in step 4.
Slovenian: • Vzemite brizgo z vehiklom, ki ste jo pripravili v 4. koraku.
English: Repeat steps 3 and 4 if you need to prepare a second solution (this requires a second kit).
Slovenian: Če je treba pripraviti še eno raztopino, ponovite 3. in 4. korak (za kar potrebujete drugo pakiranje).
English: Determine the patient's body weight.
Slovenian: Ugotovite telesno maso bolnika.
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: • Načrt za obvladovanje tveganja (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: • Diary to be given to patients before they receive Ruconest.
Slovenian: • Dnevnik, ki ga je treba dati bolniku, preden prejme zdravilo Ruconest.
English: • Allow the number of powder and solvent vials required according to step 1, to reach room temperature.
Slovenian: • Pustite, da potrebno število vial s praškom in vial z vehiklom, zahtevanih v 1. koraku, doseže sobno temperaturo.
English: • That they should be asked to carry the card and always show it to any Healthcare Professional treating them for acute attacks of hereditary angioedema.
Slovenian: • Opozorilo, naj imajo opozorilno kartico pri sebi in jo vedno pokažejo vsakemu zdravstvenemu delavcu, ki jih zdravi zaradi akutnih napadov dednega angioedema.
English: Although cross-reactivity between cow milk and rabbit milk is considered unlikely, the possibility of such a cross-reactivity in a patient who has evidence of clinical allergy to cow milk cannot be excluded and the patient should be observed for signs and symptoms of hypersensitivity following Ruconest administration.
Slovenian: Čeprav je navzkrižna reaktivnost med kravjim in kunčjim mlekom malo verjetna, pri bolnikih, pri katerih je dokazana klinična alergija na kravje mleko, takih navzkrižnih reakcij ni možno izključiti in je bolnika po dajanju zdravila Ruconest treba opazovati glede znakov in simptomov preobčutljivosti.
English: Do not mix or administer Ruconest with other medicines or solutions.
Slovenian: Zdravila Ruconest ne mešajte ali dajajte z drugimi zdravili ali raztopinami.
English: administered (ml) = body weight (kg) times 50 (U/kg) 150 (U/ml)
Slovenian: = telesna masa (kg) krat 50 (e./kg) 150 (e./ml)
English: - Information on the need to keep a diary to document each treatment administered at home and to bring it at each visit.
Slovenian: - Informacije o potrebi pisanja dnevnika za dokumentiranje vsakega odmerka, danega doma, in predložitev tega dnevnika pri vsakem zdravniškem pregledu.
English: No more than 2 doses should be given within 24 hours.
Slovenian: V 24 urah se ne sme dati več kot dva odmerka.
English: • Check that all required components are on the work surface: - 1 or 2 syringes with prepared solution - 1 infusion set with 25G needle - 1 alcohol pad - 1 sterile non-woven pad - 1 self-adhesive plaster - 1 tourniquet - 1 plaster for securing the needle
Slovenian: • Preverite, da so na delovni površini vse potrebne komponente: - 1 ali 2 brizgi s pripravljeno raztopino - 1 komplet za infundiranje z iglo 25G - 1 alkoholna blazinica - 1 sterilni netkani tampon - 1 samolepilni obliž - 1 žilna preveza - 1 obliž za pritrditev igle
English: Never exceed 14 ml per syringe.
Slovenian: Nikoli ne presezite 14 ml na brizgo.