natgillin/translations-raw huggingface dataset:
Millilitres of prepared solution to be injected below 84 kg bodyweight in kg divided by three 
Število mililitrov, ki jih je treba injicirati do 84 kg telesna masa v kg deljeno s tri več kot 84 kg
- Body weight of 84 kg or greater 
- Telesna masa 84 kg ali več
The efficacy and safety of Ruconest as a treatment of acute angioedema attacks in patients with HAE has been evaluated in two double blind randomized placebo controlled and four open label clinical studies. 
HAE so ocenili v dveh dvojno slepih, randomiziranih, s placebom nadzorovanih študijah in štirih odprtih kliničnih študijah.
Water for injections should be added slowly to avoid forceful impact on the powder and mixed gently to minimise foaming of the solution. 
Vodo za injekcije je treba dodati počasi, da se izognete močnemu curku na prašek, in rahlo premešati, da v največji možni meri omejite penjenje raztopine.
• Dizziness, throat irritation 
• Vrtoglavica, draženje v grlu
Leave the syringe on the adapter. 
Brizgo pustite pritrjeno na adapter.
Powder for solution for injection 1 vial 
prašek za raztopino za injiciranje 1 viala
Conestat alfa is a recombinant (not blood-derived) form of human C1 inhibitor (rhC1INH). 
Konestat alfa je rekombinantna (ni proizvedena iz krvi) oblika humanega zaviralca C1 (rhC1INH).
Remove the needle cap from the needle of the infusion set and carefully insert the needle into the vein. 
Odstranite pokrovček igle s kompleta za infundiranje in jo previdno vstavite v žilo.
• Safely dispose of the used infusion set with needle, any unused solution, the syringe and the empty vial in an appropriate medical waste container as these materials may hurt others if not disposed of properly. 
• Uporabljeni komplet za infundiranje skupaj z iglo, vso neporabljeno raztopino, brizgo in prazno vialo varno odstranite v ustrezni zabojnik za medicinske odpadke, saj lahko ti pripomočki poškodujejo druge, če niso primerno odstranjeni.
Conestat alfa is the recombinant analogue of the human C1 esterase inhibitor (rhC1INH) produced by recombinant DNA technology in the milk of transgenic rabbits. 
Konestat alfa je rekombinantni analog humanega zaviralca esteraze C1 (rhC1INH), pridobljen s tehnologijo rekombinantne DNA v mleku transgenskih kuncev.
• Hold the adapter with the other hand and attach the syringe. 
• Z drugo roko primite adapter in namestite brizgo.
Ruconest is to be used by adults and adolescents with a rare inherited blood disorder, called Hereditary Angioedema (HAE). 
Zdravilo Ruconest lahko uporabljajo odrasli in mladostniki z redko dedno krvno boleznijo, imenovano dedni (hereditarni) angioedem.
• Use of Ruconest is only approved in acute attacks of hereditary angioedema. 
• Zdravilo Ruconest se lahko uporablja samo pri akutnih napadih hereditarnega (dednega) angioedema.
Please safely dispose of the used infusion set with needle, any unused solution, the syringe and the empty vial in an appropriate medical waste container as these materials may hurt others if not disposed of properly. 
Odstranjevanje Prosimo, da uporabljeni komplet za infundiranje skupaj z iglo, vso neporabljeno raztopino, brizgo in prazno vialo varno odstranite v ustrezni zabojnik za medicinske odpadke, saj lahko ti pripomočki poškodujejo druge, če niso primerno odstranjeni.
Inhibition kinetics were found to be comparable with those observed for plasma-derived human C1INH. 
Ugotovili so, da je kinetika zaviranja primerljiva s tisto, ugotovljeno za humani C1INH, pridobljen iz plazme.
• Batch number and dose 
• Številko serije in odmerek zdravila
Ruconest is presented as a single glass vial containing a white to off-white powder for solution for injection together with one glass vial containg a clear, colourless solvent to dissolve the powder. 
Zdravilo Ruconest je pakirano kot ena steklena viala z belim do belkastim praškom za raztopino za injiciranje skupaj s stekleno vialo, ki vsebuje bistro, brezbarvno tekočino za raztopitev praška.
One case of hypersensitivity was observed in clinical trials with Ruconest. 
V kliničnih preizkušanjih z zdravilom Ruconest so opazili en primer preobčutljivosti.
100 U/kg n =16 
100 e/kg n =16
While keeping it vertical, slowly draw in 14 ml solvent. 
Držite ga v navpičnem položaju in počasi izsesajte 14 ml vehikla.
Name and address of the manufacturers of the biological active substance 
SPROŠČANJE SERIJ Ime in naslov izdelovalcev biološke zdravilne učinkovine
• Secure the needle by applying the plaster, around 7 cm long, over the wings of the needle. 
• Obliž dolžine približno 7 cm namestite čez krilca in zavarujte iglo.
• Hives and swelling of the skin 
• Koprivnica in otekanje kože
• Summary of Product Characteristics and Patient Information Leaflet for Ruconest 
• Povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Ruconest.
- unfold the tubing and gently inject this solution, similar to the first syringe 
- sprostite cevko in nežno injicirajte to raztopino po enakem postopku kot prvo 13. korak: Po injiciranju
Abdominal discomfort Oral paraesthesia 
Bolezni prebavil diareja slabost nelagodje v trebuhu oralna parestezija
50 U/kg n =12 
50 e/kg n =12
Ruconest will be initiated by a doctor who is specialised in the diagnosis and treatment of hereditary angioedema. 
Zdravilo Ruconest bo uvedel zdravnik specialist za diagnosticiranje in zdravljenje hereditarnega angioedema.
• Copies of the patient card to be given to patients before they receive Ruconest. 
• Opozorilno kartico za bolnika, ki jo mora bolnik prejeti pred začetkom uporabe zdravila
• That they are receiving Ruconest for treatment of acute attack of hereditary angioedema. 
• Da prejemajo zdravilo Ruconest za zdravljenje akutnih napadov dednega angioedema.
• Remove the needle cap. 
• Odstranite pokrov igle.
Draw in the required volume of prepared solution. 
Izsesajte zahtevano količino pripravljene raztopine.
In the randomized controlled trials 39/41 (95%) of patients treated with Ruconest reached time to beginning of relief within 4 hours. 
V randomiziranih, nadzorovanih študijah je 39/41 (95 %) bolnikov, zdravljenih z zdravilom Ruconest,
• Next, put the self-adhesive plaster on the injection site. 
• Nato na mesto injiciranja namestite samolepilni obliž.
Ruconest is supplied with an administration kit in a carton box containing: 
Zdravilo Ruconest je na voljo skupaj s kompletom za dajanje zdravila v kartonski škatli, ki vsebuje:
Talk to your doctor before using Ruconest. 
Pred uporabo zdravila Ruconest se posvetujte z zdravnikom.
No more than 2 doses, calculated according to step 7, should be given within 24 hours. 
Skladno z izračunom iz 7. koraka v 24 urah ne smete prejeti več kot dveh odmerkov.
Scientific literature indicates an interaction of tissue-type plasminogen activator (tPA) and C1INH containing medicinal products. 
Znanstvena literatura navaja medsebojno delovanje zdravil, ki vsebujejo tkivni aktivator plazminogena
What Ruconest looks like and contents of the pack 
Izgled zdravila Ruconest in vsebina pakiranja
If you have prepared: - one vial with solution, draw up the volume as calculated - two vials and your bodyweight is below 84 kg, draw up in a similar way: a)14 ml from the first vial b) from the second vial, the difference between your calculated volume and the 14 ml from the first vial 
- dve viali in je vaša telesna masa manj kot 84 kg, vbrizgajte na podoben način: a) 14 ml iz prve viale b) iz druge viale vbrizgajte razliko med vašo izračunano količino in 14 ml iz prve viale - dve viali in je vaša telesna masa več kot 84 kg, iz vsake viale vbrizgajte 14 ml v vsako brizgo
An additional dose of 50 U/kg was administered for 13/133 (10%) attacks. 
Dodatni odmerek 50 e./kg je bil dan pri 13/133
If not used immediately in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8ºC, unless reconstitution has taken place in controlled and validated aseptic conditions. 
24 ur pri temperaturi 2 ºC do 8 ºC, razen če je bila rekonstitucija opravljena v kontroliranih in validiranih aseptičnih pogojih.
• Necessary skills have to be acquired by non-Healthcare Professionals before Ruconest may be safely and effectively administered outside of a Healthcare Professional setting. 
• Nezdravstveni delavec mora pred tem pridobiti potrebne spretnosti za varno in učinkovito dajanje zdravila Ruconest zunaj zdravstvene ambulante.
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja koprivnica
Solvent for Ruconest Water for injections 
vehikel za zdravilo Ruconest voda za injekcije
In case of an insufficient clinical response, an additional dose (50 U/kg body weight up to 4200 U) can be administered (see section 5.1). 
V primeru nezadostnega kliničnega odziva se lahko da dodatni odmerek (50 e./kg telesne mase do 4200 e.) (glejte poglavje 5.1).
Ruconest is presented as a single glass vial containing a white to off-white powder for solution for injection. 
Zdravilo Ruconest je pakirano kot ena steklena viala z belim do belkastim praškom za raztopino za injiciranje.
There are limited data on the use of this medicinal product in home- or self administration. 
Podatkov o uporabi tega zdravila pri zdravljenju doma ali ob samostojnem dajanju je malo.
• Place the syringe on the work surface, taking care not to touch the surface or any other object with the syringe tip. 
• Brizgo položite na delovno površino, pri čemer pazite, da se s konico brizge ne boste dotaknili površine ali katerega koli drugega predmeta.
• Hold this end with one hand, attach the syringe tip end and secure by turning clockwise until it stops. 
• Ta konec držite z eno roko, namestite konico brizge in jo zavrtite v smeri urinega kazalca, da zaskoči.
• Position the tourniquet above the injection site - preferably the middle part of the upper arm. 
• Žilno prevezo namestite nad mesto za injiciranje - če je mogoče, na sredo nadlakti.
The active substance is conestat alfa. 
Zdravilna učinkovina je konestat alfa.
The effect of conestat alfa on the following target proteases was assessed in vitro: activated C1s, kallikrein, factor XIIa and factor XIa. 
In vitro so ugotavljali učinek konestata alfa na naslednje tarčne proteaze: aktivirani C1, kalikrein,
• That Ruconest is derived from milk of transgenic rabbits and contains trace of rabbit proteins. 
• Da je zdravilo Ruconest pridobljeno iz mleka transgenskih kuncev in vsebuje sledove kunčjih beljakovin.
100 U/kg n =13 
100 e/kg n =13
Hepatic impairment may prolong the plasma half-life of conestat alfa, but this is not thought to be a clinical concern. 
Kliničnih izkušenj z uporabo zdravila Ruconest pri bolnikih z jetrno okvaro ni. Jetrna okvara lahko podaljša plazemski razpolovni čas konestata alfa, vendar se meni, da to ni klinično pomembno.
If two syringes were prepared: fold over the tubing to prevent backflow, unscrew the empty syringe from the infusion set (counter clockwise) and immediately replace it with the second syringe. 
Če sta pripravljeni dve brizgi: preganite cevko, da preprečite povratni tok, prazno brizgo odvijte s kompleta za infundiranje (zavrtite v smeri, ki je nasprotna vrtenju urinega kazalca) in jo nemudoma nadomestite z drugo brizgo.
• That Ruconest is contra indicated in all patients with known or suspected rabbit allergy. 
• Da je zdravilo Ruconest kontraindicirano pri vseh bolnikih z znano alergijo na kunce ali sumom nanjo.
Once reconstituted, the product should be used immediately. 
Po rekonstituciji je treba zdravilo takoj uporabiti.
- 2 adapters if 1 powder and 1 solvent vial is required - 4 adapters if 2 powder and 2 solvent vials are required 
- 2 adapterja potrebujete v primeru 1 viale s praškom in 1 viale z vehiklom - 4 adapterje potrebujete v primeru 2 vial s praškom in 2 vial z vehiklom
• Put the adapter onto a powder vial, piercing the stopper, until it snaps onto the vial neck. 
• Adapter nastavite na vialo s praškom, pritiskajte na zaporko, dokler ne zaskoči na vrat viale.
• Take a sterile syringe out of its packaging. 
• Sterilno brizgo odstranite iz ovojnine.
There is no excretion, as conestat alfa is cleared from the circulation via receptor-mediated endocytosis followed by complete hydrolysis/degradation in the liver. 
Izločanje Izločanja v obliki nespremenjenega konestata alfa ni, saj se konestat alfa očisti iz krvnega obtoka s presnovo v jetrih z od receptorja odvisno endocitozo, ki ji sledi popolna hidroliza/razgradnja.
• Fold down the yellow protection cap over the needle. 
• Prek igle poveznite rumeni pokrovček.
• Remove the packaging from the adapter on the powder vial. 
• Odstranite ovojnino z adapterja na viali s praškom.
Do not use this medicine if, after dissolving, you notice particles in the solution or if the solution is discolored. 
Ne uporabljajte tega zdravila, če po raztapljanju raztopina spremeni barvo ali vsebuje delce.
Ruconest contains sodium (19.5 mg per vial) 
Zdravilo Ruconest vsebuje natrij (19,5 mg na vialo)
Step 10: Preparation of the infusion set 
10. korak: Priprava kompleta za infundiranje
Draw in 14 ml of solvent. 
Izsesajte 14 ml vehikla.
Saline n = 13 
Fiziološka raztopina n = 13
• 1 syringe 
• 1 brizga
• date and time of the administration 
• datum in čas injiciranja
• Push the solvent slowly, in a single motion, into the powder vial in order to minimise foaming. 
• Z eno potezo vehikel počasi vbrizgajte v vialo s praškom, da v največji možni meri preprečite penjenje.
Hold the syringe with the tip pointing upwards and gently press the plunger to fill the infusion set with the solution. 
Brizgo držite tako, da je konica obrnjena navzgor, in nežno pritisnite bat, da se komplet za infundiranje napolni z raztopino.
One administration kit contains: 
En komplet za dajanje zdravila vsebuje:
Each vial of Ruconest (2100 U) should be reconstituted with 14 ml water for injections. 
Rekonstitucija Vsako vialo zdravila Ruconest (2100 e.) se rekonstituira s 14 ml vode za injekcije.
Always use this medicine exactly as described in this leaflet or as your doctor or nurse have told you. 
Pri uporabi tega zdravila natančno upoštevajte napotke v tem navodilu ali navodila zdravnika ali medicinske sestre.
Solvent vial: 20 ml of water for injections in a vial (type 1 glass) with a stopper (siliconized chlorobutyl rubber) and a flip-off seal (aluminium and coloured plastic). 
Viala z vehiklom: 20 ml vode za injekcije v viali (steklo vrste 1) z zaporko (silikonizirana klorobutilna guma) in tesnilom »flip-off« (aluminij in barvna plastika).
• Carefully insert the needle of the infusion set, at the flattest possible angle, into the vein. 
• Iglo iz kompleta za infundiranje pod najnižjim možnim kotom previdno vstavite v žilo.
Inject over about 
Injiciranje v veno
• Do not use the prepared solution if it is cloudy, contains particles or has changed colour. 
• Če je pripravljena raztopina motna, vsebuje delce ali je spremenila barvo, je ne uporabite.
Saline n = 16 
Fiziološka raztopina n =16
In case of an insufficient clinical response, an additional dose (50 U/kg body weight up to 4200 U) can be administered. 
V primeru nezadostnega kliničnega odziva se lahko da dodatni odmerek (50 e./kg telesne mase do
Ruconest should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of hereditary angioedema. 
Zdravilo Ruconest je treba uvesti po navodilih in pod nadzorom zdravnika z izkušnjami pri diagnosticiranju in zdravljenju dednega angioedema.
Biotransformation and elimination 
Biotransformacija
• Take a packaged adapter in one hand and remove the lid. 
• Z eno roko primite adapter v ovojnini in odstranite pokrov.
• Repeat steps 4 and 5 if you need to prepare a second solution. 
• Če je treba pripraviti še eno raztopino, ponovite 4. in 5. korak.
- Instruction in handling possible adverse drug reactions including an acute hypersensitivity reaction - Information on the need to keep a diary to document each treatment administered at home and to bring it at each visit. 
- Navodila za takojšnjo nujno medicinsko pomoč v primeru neuspešnega dostopa v veno, v primeru neučinkovanja, kakršnega koli neželenega učinka, vključno s preobčutljivostjo, ali po samostojnem dajanju zdravila Ruconest zaradi akutnega laringalnega napada HAE - Informacije o potrebi pisanja dnevnika za dokumentiranje vsakega odmerka, danega doma, in predložitev tega dnevnika pri vsakem zdravniškem pregledu.
- Body weight up to 84 kg One intravenous injection of 50 U/kg body weight. 
Ena intravenska injekcija 50 e./kg telesne mase.
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora draženje v grlu
Each vial of Ruconest (2100 U) should be reconstitued with 14 ml of solvent. 
Vsako vialo zdravila Ruconest (2100 e.) je treba rekonstituirati s 14 ml vehikla.
The reconstituted solution contains 150 U/ml conestat alfa and appears as a clear colourless solution. 
Rekonstituirana raztopina vsebuje 150 e./ml konestata alfa in je bistra, brezbarvna raztopina.
Unlock the syringe from the adapter by turning counter clockwise and discard the vial with adapter. 
Brizgo odstranite z adapterja tako, da jo zavrtite v nasprotno smer, in zavrzite vialo z adapterjem.
Patients should be advised not to drive and use machines if they experience headache or vertigo. 
naj ne vozijo ali upravljajo strojev, če se pri njih pojavi glavobol ali vrtoglavica.
The solvent should be added slowly to avoid forceful impact on the powder and mixed gently to minimise foaming of the solution. 
Vehikel dodajajte počasi, da se izognete močnemu curku na prašek, in rahlo mešajte, da v največji možni meri omejite penjenje raztopine.
2100 U of conestat alfa powder in a 25 ml vial (type 1 glass) with a stopper (siliconized chlorobutyl rubber) and a flip-off seal (aluminium and coloured plastic). 
2100 e. praška konestata alfa v 25 ml viali (steklo vrste 1) z zaporko (silikonizirana klorobutilna guma) in tesnilom „flip-off“ (aluminij in barvna plastika).
Contents of the pack and other information 
Shranjevanje zdravila Ruconest Vsebina pakiranja in dodatne informacije
There is no experience with the use of Ruconest in pregnant and breast-feeding women. 
Z uporabo zdravila Ruconest pri nosečnicah in doječih materah ni izkušenj.
• That Ruconest should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of hereditary angioedema. 
• Da je treba zdravilo Ruconest uvesti po navodilih in pod nadzorom zdravnika z izkušnjami pri diagnosticiranju in zdravljenju dednega angioedema.
corresponding to 2100 units per 14 ml after reconstitution, or a concentration of 150 units/ml. 
2100 enotam na 14 ml po rekonstituciji ali koncentraciji 150 enot/ml.
- 1 syringe if 1 powder and 1 solvent vial is required - 2 syringes if 2 powder and 2 solvent vials are required 
- 1 brizgo potrebujete v primeru 1 viale s praškom in 1 viale z vehiklom - 2 brizgi potrebujete v primeru 2 vial s praškom in 2 vial z vehiklom2.
Before Ruconest can be administered, it needs to be dissolved in water for injections, by a healthcare professional. 
Pred dajanjem mora zdravstveni delavec zdravilo Ruconest raztopiti v vodi za injekcije.
These patients have a shortage of the C1 inhibitor protein in their blood. 
Tem bolnikom v krvi primanjkuje beljakovine, imenovane zaviralec
Solvent vial: Do no store above 25°C. 
Viala z vehiklom: Shranjujte pri temperaturi do 25 °C.
• 1 self-adhesive plaster 
• 1 samolepilni obliž
Each powder vial contains approximately 19.5 mg sodium. 
Ena viala s praškom vsebuje približno 19,5 mg natrija.
Disinfect the rubber stoppers of the powder and solvent vials and put a vial adapter onto each solvent and powder vial until it snaps onto the vial neck. 
Razkužite gumijasto zaporko viale s praškom in viale z vehiklom, nato pa adapterja za vialo nastavite na vialo z vehiklom in na vialo s praškom, da zaskočita na vrat viale.
Do not use this medicine if you notice particles in the solution or if the solution is discolored. 
Ne uporabljajte tega zdravila, če raztopina spremeni barvo, ali če vsebuje delce.
- Body weight of 84 kg or greater One intravenous injection of 4200 U (two vials). 
• Ena intravenska injekcija 4200 e. (dve viali).
Powder vial: 2100 U of conestat alfa powder in a vial (type 1 glass) with a stopper (siliconized chlorobutyl rubber) and a flip-off seal (aluminium and coloured plastic). 
Viala s praškom: 2100 e. praška konestata alfa v viali (steklo vrste 1) z zaporko (silikonizirana klorobutilna guma) in tesnilom „flip-off“ (aluminij in barvna plastika).
• 1 sterile non-woven pad 
• 1 sterilni netkani tampon
Gently press the syringe plunger to carefully fill the infusion set with the prepared solution. 
Nežno pritisnite bat brizge tako, da se komplet za infundiranje napolni s pripravljeno raztopino.
The doses evaluated in the clinical studies ranged from a single vial of 2100 U (corresponding to 18-40 U/kg), to 50 and 100 U/kg. 
2100 e. (kar ustreza 18-40 e./kg) do 50 in 100 e./kg.
Step 6: Check prepared solutions 
6. korak: Preverjanje pripravljene raztopine
• Put the syringe(s) on the work surface. 
• Brizgo ali brizgi položite na delovno površino.
The other ingredients are sucrose, sodium citrate (E331) and citric acid. 
Pomožne snovi so saharoza, natrijev citrat (E331) in citronska kislina.
Ruconest 2100 Units powder for solution for injection conestat alfa 
Ruconest 2100 Enot prašek za raztopino za injiciranje konestat alfa
For patients up to 84 kg calculate the volume required to be administered according to the formula below: 
Telesna masa do 84 kg • Za bolnike s telesno maso do 84 kg izračunajte potrebno količino v skladu s spodnjo preglednico:
• 1 powder vial 
• 1 viala z vehiklom
• Hold the syringe with the tip pointing upwards. 
• Brizgo držite tako, da je konica obrnjena navzgor.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA
• If you have prepared two syringes: - fold over the tubing near the connector of the infusion set to prevent backflow - unscrew the empty syringe from the infusion set and immediately replace it with the second syringe 
• Če ste pripravili dve brizgi: - preganite cevko v bližini konektorja kompleta za injiciranje, s tem boste preprečili povratni tok
General disorders and administration site conditions 
Splošne težave in spremembe na mestu aplikacije oteklina
After reconstitution with 14 ml water for injections, the solution contains 150 U conestat alfa per ml. 
2100 e. konestata alfa Po rekonstituciji s 14 ml vode za injekcije vsebuje raztopina 150 e. konestata alfa na ml.
Step 12: Administration of the prepared solution 
12. korak: Aplikacija pripravljene raztopine
• Known or suspected allergy to rabbits (see section 4.4) • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 
• Znana alergija na kunce ali sum nanjo (glejte poglavje 4.4).
Ruconest 2100 Units powder and solvent for solution for injection conestat alfa 
Ruconest 2100 Enot prašek in vehikel za raztopino za injiciranje konestat alfa
Each vial of Ruconest contains approximately 19.5 mg sodium. 
Ena viala zdravila Ruconest vsebuje približno 19,5 mg natrija.
Check with your doctor or nurse if you are not sure. 
Če ste negotovi, se posvetujte z zdravnikom ali medicinsko sestro.
The reconstituted solution in each vial contains 2100 U conestat alfa at 150 U/ml. 
Rekonstituirana raztopina v vsaki viali vsebuje 2100 e. konestata alfa kar ustreza 150 e./ml.