natgillin/translations-raw huggingface dataset:
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
Before initiating treatment with Ruconest, patients should be queried about prior exposure to rabbits and signs and symptoms suggestive of an allergic reaction.
Pred uvedbo zdravljenja z zdravilom Ruconest je treba bolnike izprašati o predhodni izpostavljenosti kuncem ter o znakih in simptomih, ki kažejo na alergijsko reakcijo.
An aseptic technique should be used for reconstitution, combining and mixing the solutions.
Za rekonstitucijo, kombiniranje in mešanje raztopine je treba uporabiti aseptično tehniko.
In case of anaphylactic reactions or shock, emergency medical treatment should be administered.
V primeru anafilaktičnih reakcij ali šoka je treba nuditi nujno medicinsko pomoč.
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.
V odprti študiji je 114/119 (95 %) napadov, zdravljenih z enim odmerkom 50 e./kg, doseglo čas ublažitve v 4 urah.
The table below lists all adverse reactions occurring within 7 days after treatment with Ruconest, as reported in the six treatment studies.
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.
• After disinfection, do not touch the stoppers with your fingers or anything else.
• Po razkuževanju se zapork ne dotikajte s prsti ali katerimi koli drugimi predmeti.
Inform your healthcare professional if this occurs.
V tem primeru obvestite zdravstveno osebje.
After swirling, leave the vial on the surface for several minutes until the solution has become clear.
Po vrtenju vialo nekaj minut pustite na delovni površini, dokler se raztopina ne zbistri.
• 2 alcohol pads
• 2 alkoholni blazinici
• 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).
• če ste alergični na konestat alfa ali katero koli sestavino zdravila (navedeno v poglavju 6).
What you need to know before you use Ruconest Do not use Ruconest:
Kaj morate vedeti, preden boste uporabili zdravilo Ruconest Ne uporabljajte zdravila Ruconest:
Your dose, up to 2 vials, will be worked out based on your weight.
Odmerek, do 2 viali naenkrat, se izračuna na podlagi vaše telesne mase.
Dose calculation
Izračun odmerka
• Check whether the powder in the vial(s) has dissolved completely and the plunger is completely pushed down in the syringe.
• Preverite, ali se je prašek v viali oz. vialah popolnoma raztopil in da je bat brizge potisnjen do konca.
The expiry date on the outer carton reflects the date of the component with the shortest shelf-life.
Datum izteka roka uporabnosti, naveden na zunanji ovojnini (škatli), navaja datum komponente z najkrajšim rokom uporabnosti.
Contents of the pack and other information What Ruconest contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ruconest
In one animal study reproductive toxicity was observed (see section 5.3).
Ena študija na živalih je pokazala vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
• Take the syringe with solvent that you prepared in step 4.
• Vzemite brizgo z vehiklom, ki ste jo pripravili v 4. koraku.
Repeat steps 3 and 4 if you need to prepare a second solution (this requires a second kit).
Če je treba pripraviti še eno raztopino, ponovite 3. in 4. korak (za kar potrebujete drugo pakiranje).
Determine the patient's body weight.
Ugotovite telesno maso bolnika.
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.
• 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.
• Diary to be given to patients before they receive Ruconest.
• Dnevnik, ki ga je treba dati bolniku, preden prejme zdravilo Ruconest.
• Allow the number of powder and solvent vials required according to step 1, to reach room temperature.
• Pustite, da potrebno število vial s praškom in vial z vehiklom, zahtevanih v 1. koraku, doseže sobno temperaturo.
• 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.
• Opozorilo, naj imajo opozorilno kartico pri sebi in jo vedno pokažejo vsakemu zdravstvenemu delavcu, ki jih zdravi zaradi akutnih napadov dednega angioedema.
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.
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.
Do not mix or administer Ruconest with other medicines or solutions.
Zdravila Ruconest ne mešajte ali dajajte z drugimi zdravili ali raztopinami.
administered (ml) = body weight (kg) times 50 (U/kg) 150 (U/ml)
= telesna masa (kg) krat 50 (e./kg) 150 (e./ml)
- Information on the need to keep a diary to document each treatment administered at home and to bring it at each visit.
- Informacije o potrebi pisanja dnevnika za dokumentiranje vsakega odmerka, danega doma, in predložitev tega dnevnika pri vsakem zdravniškem pregledu.
No more than 2 doses should be given within 24 hours.
V 24 urah se ne sme dati več kot dva odmerka.
• 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
• 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
Never exceed 14 ml per syringe.
Nikoli ne presezite 14 ml na brizgo.
Pack size of 1.
Velikost pakiranja 1 viala.
• 1 infusion set with 35 cm tubing and 25G needle
• 1 komplet za infundiranje s 35 cm cevko in iglo 25 G
• The potential risk of an immune complex-mediated type III hypersensitivity reaction due to the formation of antibodies directed against Host Related Impurities (HRI).
• Morebitno tveganje preobčutljivostne reakcije tipa III, povzročene z imunskimi kompleksi, zaradi tvorbe protiteles proti nečistotam, povezanim z gostiteljem (HRI).
If you experience allergic reactions e.g. hives, rash, itching, dizziness, wheezing, difficulty breathing or your tongue swells up following the administration of Ruconest, you should seek emergency medical assistance so that symptoms of your allergic reaction can be treated urgently.
Če imate alergijske reakcije, tj. koprivnico, izpuščaje, srbenje, vrtoglavico, hropenje, težave pri dihanju ali vaš jezik oteče po dajanju zdravila Ruconest, morate poiskati nujno medicinsko pomoč, da se lahko simptome vaše alergijske reakcije nemudoma zdravi.
• Leave the remainder of the solvent in the vial and discard the vial.
• Preostali vehikel pustite v viali in jo zavrzite.
Before Ruconest can be administered, the powder needs to be dissolved in the solvent included in the package (see section 3).
Pred injiciranjem zdravila Ruconest se mora prašek popolnoma raztopiti v vehiklu, priloženem v pakiranju (glejte poglavje 3).
Gently inject the solution of the second syringe.
Nežno injicirajte raztopino druge brizge.
However headache or vertigo have been reported following the use of Ruconest, but may also occur as a result of an attack of HAE.
Vendar pa so po uporabi zdravila Ruconest poročali o glavobolu ali vrtoglavici, ki pa se lahko pojavita tudi zaradi napada HAE.
The plasma protein C1INH is the main regulator of activation of the contact and complement systems in vivo.
Plazemska beljakovina C1INH je glavni uravnalec aktivacije sistemov kontakta in komplementa in vivo.
Ruconest is intended for intravenous administration after reconstitution with water for injections.
Zdravilo Ruconest je namenjeno za intravenozno uporabo po rekonstituciji z vodo za injekcije.
• After the powder has dissolved, the solution should be clear and colourless.
• Ko se prašek raztopi, mora biti raztopina bistra in brezbarvna.
Do not remove the adapter packaging.
Ne odstranite embalaže adapterja.
Emergency medical treatment should be available immediately to be administered in case of anaphylactic reactions or shock.
Na voljo mora biti takojšnja nujna medicinska pomoč za primer anafilaktične reakcije ali šoka.
• That patients with clinical evidence of cow's milk allergy may have antibodies cross reacting with the rabbit milk impurities in Ruconest.
• Da imajo lahko bolniki s klinično dokazano alergijo na kravje mleko protitelesa, ki povzročijo navzkrižno reakcijo z nečistotami kunčjega mleka v zdravilu Ruconest.
• Disinfect the injection site thoroughly with an alcohol pad and let the skin dry.
• Mesto injiciranja dobro razkužite z alkoholno blazinico in pustite, da se koža osuši.
Embryofetal studies in rat and rabbit; Daily single doses of vehicle or 625 U/kg/administration of rhC1INH were administered intravenously to mated rats and rabbits.
Študije razvoja zarodka/plodu pri podganah in kuncih; enkratni dnevni odmerek vehikla ali 625 e./kg rhC1INH sta bila dana intravensko podganam in kuncem v obdobju parjenja.
In HAE patients, Ruconest at a dose of 50 U/kg increases plasma C1INH activity level to greater than 0.7 U/ml for approximately 2 hours (see section 5.2).
Pri bolnikih s HAE zdravilo Ruconest v odmerku 50 e/kg poveča raven aktivnosti C1INH v plazmi na raven, višjo od 0,7 e/ml, za približno 2 uri (glejte poglavje 5.2).
Ruconest is supplied in a carton box containing one vial.
Zdravilo Ruconest je na voljo v kartonski škatli, ki vsebuje eno vialo.
• 1 vial of 20 ml solvent
• 1 vialo z 20 ml vehikla
Do not remove the syringe packaging.
Ne odstranite embalaže brizge.
• Hold the adapter with one hand.
• Z eno roko držite adapter.
Disinfect the injection site with an alcohol pad.
Mesto injiciranja razkužite z alkoholno blazinico.
Fertility There are no data on the effects of Ruconest on male or female fertility.
O učinkih zdravila Ruconest na moško ali žensko plodnost ni podatkov.
How to use Ruconest
Kako uporabljati zdravilo Ruconest
Ruconest is indicated for treatment of acute angioedema attacks in adults and adolescents with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency.
Zdravilo Ruconest je indicirano za zdravljenje akutnih napadov angioedema pri odraslih in mladostnikih s hereditarnim (dednim) angioedemom (HAE: Hereditary Angioedema) zaradi pomanjkanja zaviralca esteraze C1.
The amino acid sequence of conestat alfa is identical to that of endogenous C1INH.
Aminokislinsko zaporedje konestata alfa je identično zaporedju endogenega C1INH.
HAE patients have a heterozygous deficiency of the plasma protein C1INH.
Bolniki s HAE imajo heterozigotno pomanjkanje plazemske beljakovine C1INH.
• Put the vial adapters on the work surface.
• Adapterje za viale položite na delovno površino.
This should be taken into consideration by patients on a controlled sodium diet.
To morajo upoštevati bolniki, ki so na dieti za nadzorovanim vnosom natrija.
Tabulated lists of adverse reactions
Tabelarični seznam neželenih učinkov
Never use any kit component after the expiry date stated on the big outer carton.
Nobene komponente v kompletu ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini (veliki škatli).
• Put the powder and solvent vials required on a flat and clean surface.
• Potrebne viale s praškom in vehiklom položite na ravno in čisto površino.
The educational material for the Healthcare Professional should include information on the following key elements:
Izobraževalno gradivo za zdravstvene delavce mora vsebovati informacije o naslednjih ključnih elementih:
• Leave the syringe on the adapter and gently swirl the vial for approximately half a minute.
• Brizgo pustite pritrjeno na adapter in nato približno pol minute nežno vrtite vialo.
1 Unit of conestat alfa activity is defined as the equivalent of C1 esterase inhibiting activity present in 1 ml of pooled normal plasma.
1 enota konestata alfa je opredeljena kot enakovredna zaviralni aktivnosti esteraze C1 v 1 ml zlitja normalne plazme.
• Feel, with your other hand, for an appropriate vein.
• Z drugo roko zatipajte ustrezno žilo.
• Ensure the kit package is complete and contains all components listed in section 6 of this leaflet.
Preden začnete • Prepričajte se, da je ovojnina celovita in vsebuje vse komponente, navedene v 6. poglavju teh navodil za uporabo.
Continue to fill the syringe with 14 ml solvent.
Nadaljujte s polnjenjem brizge s 14 ml vehikla.
The reconstituted solution in each vial should be visually inspected for particulate matter and discoloration.
Rekonstituirano raztopino v vsaki viali je treba vizualno pregledati glede trdnih delcev in spremembe barve.
• The need to inform patients about the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis, and that they should alert their physician if these symptoms occur.
• Obveznost informiranja bolnika o zgodnjih znakih preobčutljivostnih reakcij, ki vključujejo koprivnico, splošno urtikarijo, stiskanje v prsih, hropenje, hipotenzijo in anafilakso, in da morajo na te simptome opozoriti svojega zdravnika, če se pojavijo.
• Check that no air is present in the syringe, infusion tube or the needle.
• Preverite, da v brizgi, cevki za infundiranje ali igli ni zraka.
• In addition to the kit, the following is required: - a tourniquet - plaster for securing the needle
• Poleg kompleta potrebujete še: - žilno prevezo - obliž za pritrditev igle
Ruconest is administered into a vein over about 5 minutes.
Zdravilo Ruconest se injicira v veno približno 5 minut.