natgillin/translations-raw huggingface dataset:
Handling procedures for both presentations are described below. 
Postopki za ravnanje z obema oblikama so opisani spodaj.
Talk to your doctor about when to use the injections and how long to keep using them. 
Posvetujte se z zdravnikom o tem, kako uporabljati injekcije in kako dolgo nadaljevati z njihovo uporabo.
Date of first authorisation: 23 February 1996 Date of latest renewal: 23 February 2006 
Datum zadnjega podaljšanja: 23. februar 2006
To achieve the best results, follow the prescribed dose carefully. 
Da boste dosegli najboljše uspehe, natančno upoštevajte predpisani odmerek.
• If you are allergic to mouse, hamster or cow proteins (such as cows' milk). 
• če ste alergični na mišje, hrčkove ali kravje beljakovine (npr. kravje mleko).
Clearance appears related with age, therefore in younger patients clearance may be increased by more than 50%. 
Kot kaže, je očistek povezan s starostjo, zato je lahko očistek pri mlajših bolnikih za več kakor 50 % večji.
The equipment is for single use only. 
Oprema je namenjena samo za enkratno uporabo.
You will usually need hospital care. 
Verjetno boste potrebovali zdravljenje v bolnišnici.
Distribution, elimination and linearity 
Porazdelitev, izločanje in linearnost
The pharmacokinetic profiles indicated dose proportionality. 
Farmakokinetični profili so pokazali sorazmernost odmerku.
1 KIU equals 1,000 IU (International Units). 
je enako 1.000 i.e. (mednarodnih enot).
• Inject slowly over 2 to 5 minutes. 
• Injicirajte počasi, v času od 2 do 5 minut.
• Check the name, strength and colour of the package, to make sure it contains the correct product. 
• Preverite ime, jakost in barvo pakiranja; tako se boste prepričali, da vsebuje pravo zdravilo.
The pharmacokinetics were similar across sex and ethnic groups. 
Farmakokinetika je bila med spoloma in etničnima skupinama podobna.
The mean in vivo plasma recovery was approximately 20%. 
Povprečna in vivo obnova v plazmi je bila približno 20 %.
• Lack of effect or decreased response to treatment. 
• Pomanjkljiv učinek ali zmanjšan odziv na zdravljenje.
• Wash your hands and dry them properly using a clean towel or air dry. 
• Umijte si roke in jih povsem osušite s čisto brisačo ali na zraku.
Current clinical experience does not warrant a general differentiation in dosing between children and adults, although children have faster clearance than adults. 
Trenutne klinične izkušnje ne zahtevajo splošno drugačnega odmerjanja pri otrocih in pri odraslih, čeprav je očistek pri otrocih hitrejši kot pri odraslih.
- Increased fibrin degradation products 
- zvišanje razgradnih produktov fibrina
Remind your doctor if you have a history of allergic reactions as you may need to be monitored more carefully. 
Zdravnika opozorite, če ste kdaj imeli alergijsko reakcijo, kajti morda vas bo moral natančneje spremljati.
All findings in the preclinical safety programme were related to the pharmacological effect of rFVIIa. 
Vsi izsledki v programu predklinične varnosti so bili povezani s farmakološkim učinkom rFVIIa.
The dose schedule should not be intentionally increased above the recommended doses due to the absence of information on the additional risk that may be incurred. 
Razporeda odmerkov se ne sme namenoma povečati nad priporočene odmerke, ker ni informacij o dodatnih tveganjih, ki jih to lahko povzroči.
• Each time you use NovoSeven, tell your doctor or hospital as soon as possible. 
• Vsakokrat, ko uporabite zdravilo NovoSeven, o tem čim prej obvestite zdravnika ali bolnišnico.
- Angina pectoris 
- angina pektoris
• In cases of a mild or moderate bleed, you should treat yourself as early as possible, ideally at home. 
• V primerih blage ali zmerne krvavitve morate samozdravljenje začeti čim prej, najbolje doma.
The duration of home therapy should not exceed 24 hours. 
Zdravljenje na domu ne sme trajati več kot 24 ur.
Pharmacotherapeutic group: Blood coagulation factors, ATC code: B02BD08 
Farmakoterapevtska skupina: krvni koagulacijski faktorji, oznaka ATC: B02BD08.
The mean terminal half-life ranged from 3.9 to 6.0 hours. 
Povprečni terminalni razpolovni čas sega od 3,9 do 6,0 ur.
Invasive procedure/surgery 
Invazivni postopki/operacija
Start treatment of a bleed as early as possible, ideally within 2 hours. 
Zdravljenje krvavitve začnite čim prej, najbolje v 2 urah.
• If bleeding is not controlled within 24 hours, contact your doctor immediately. 
• Če krvavitev ni obvladana v 24 urah, se nemudoma posvetujte s svojim zdravnikom.
IX > 5 Bethesda Units (BU) 
5 Bethesda-enot (BU),
Do not treat yourself for longer than 24 hours without consulting your doctor. 
Sami se ne smete zdraviti več kot 24 ur, ne da bi se posvetovali z zdravnikom.
• Do not use this medicine after the expiry date that is stated on the carton. 
• Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
This incompatibility may prevent administration of the drug and/or result in damage to the needleless connector. 
Ta nezdružljivost lahko prepreči aplikacijo zdravila in/ali povzroči okvaro brezigelnega konektorja.
Follow the instructions for use for the needleless connector. 
Upoštevajte navodila za uporabo brezigelnega konektorja.
The dose should be repeated after 2 hours and then at 2 - 3 hour intervals for the first 24 - 48 hours depending on the intervention performed and the clinical status of the patient. 
Odmerek je treba ponoviti čez 2 uri in potem v 2- do 3-urnih presledkih v prvih 24 do 48 urah, odvisno od opravljenega posega in bolnikovega kliničnega stanja.
If not used immediately, the conditions prior to use are the responsibility of the user and the in-use storage time must not be longer than as stated above. 
Če zdravilo ni uporabljeno takoj, so pogoji pred uporabo odgovornost uporabnika in čas shranjevanja med uporabo ne sme biti daljši, kot je navedeno zgoraj.
• If you have a serious blood infection 
• če imate resno okužbo krvi,
- Therapeutic response decreased* 
- zmanjšan terapevtski odziv*
Treatment with NovoSeven, alone or in combination with antifibrinolytics and/or platelets, was defined as effective when bleeding was stopped for at least 6 hours. 
Zdravljenje z zdravilom NovoSeven, samim ali v kombinaciji z antifibrinolitiki in/ali s trombociti, je bilo opredeljeno kot učinkovito, če se je krvavitev ustavila za vsaj 6 ur.
* Lack of efficacy (therapeutic response decreased) has been reported. 
* Opisano je bilo pomanjkanje učinkovitosti (zmanjšan terapevtski odziv).
In most cases of blood clots, the patients were predisposed to blood clotting disorders. 
V večini primerov krvnih strdkov so bolniki imeli nagnjenost k motnjam strjevanja krvi.
• If not reconstituted, pooled or used as recommended the in-use times and conditions prior to use are the responsibility of the user. 
• Če zdravilo ni pripravljeno, združeno ali uporabljeno, kot je priporočeno, so čas in pogoji med uporabo odgovornost uporabnika.
- Hypersensitivity (see sections 4.3 and 4.4) 
- preobčutljivost (glejte poglavji 4.3 in 4.4)
The excretion of rFVIIa in milk has not been studied in animals. 
Izločanje rFVIIa v mleko pri živalih ni raziskano.
As a precautionary measure, it is preferable to avoid use of NovoSeven during pregnancy. 
Iz previdnosti se je uporabi zdravila NovoSeven med nosečnostjo bolje izogniti.
• If you are allergic to eptacog alfa (active compound of NovoSeven) or any of the other ingredients in this medicine (listed in section 6). 
• če ste alergični na eptakog alfa (učinkovina v zdravilu NovoSeven) ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
Follow the instructions for proper use for your connector and CVAD in consultation with your doctor or nurse. 
Upoštevajte navodila za pravilno uporabo konektorja in CVD v dogovoru z zdravnikom ali medicinsko sestro.
The dose will be worked out by your doctor, based on your body weight, condition and type of bleed. 
Odmerek bo določil zdravnik na podlagi vaše telesne mase, vašega stanja in vrste krvavitve.
OTHER SPECIAL WARNINGS, IF NECESSARY EXPIRY DATE 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
This complex activates factor IX into factor IXa and factor X into factor Xa, leading to the initial conversion of small amounts of prothrombin into thrombin. 
Ta kompleks aktivira faktor IX v faktor IXa in faktor X v faktor Xa, kar povzroči začetno pretvorbo majhne količine protrombina v trombin.
At least three doses should be administered to secure effective haemostasis. 
Za zagotovitev učinkovite hemostaze je treba aplicirati vsaj tri odmerke.
The mechanism of action includes the binding of factor VIIa to exposed tissue factor. 
Mehanizem delovanja vključuje vezavo faktorja VIIa na izpostavljeni tkivni faktor.
In case of shock, standard medical treatment for shock should be implemented. 
V primeru šoka uporabite standardne ukrepe za zdravljenje šoka.
Dose and frequency of injections should be adapted to each individual. 
Odmerek in pogostnost injiciranja je treba prilagoditi posamezniku.
• The infusion pump must only be operated by trained hospital personnel. 
• Z infuzijsko črpalko sme ravnati le usposobljeno bolnišnično osebje.
► If you notice any of these serious side effects, get medical help immediately. 
► Če opazite katerega koli od teh resnih neželenih učinkov, nemudoma poiščite zdravniško pomoč.
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with NovoSeven should be made taking into account the benefit of breast-feeding to the child and the benefit of NovoSeven therapy to the woman. 
Pri odločitvi za nadaljevanje ali prekinitev dojenja oz. za nadaljevanje ali prekinitev zdravljenja z zdravilom NovoSeven je treba upoštevati korist dojenja za otroka in korist zdravljenja z zdravilom NovoSeven za žensko.
In each of these situations, the potential benefit of treatment with NovoSeven should be weighed against the risk of these complications. 
V takšnih okoliščinah morate možno korist zdravljenja z zdravilom NovoSeven pretehtati v primerjavi s tveganjem za te zaplete.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). 
Študije na živalih niso pokazale neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje
Thromboembolic events may lead to cardiac arrest. 
Trombembolični dogodki lahko povzročijo zastoj srca.
• Changes in some liver and blood tests. 
• spremembe izvidov nekaterih preiskav jeter in krvi
Usually severe bleeds are treated at the hospital and you can give yourself the first NovoSeven dose on the way there. 
Zdravljenje hudih krvavitev ponavadi poteka v bolnišnici in prvi odmerek zdravila NovoSeven si lahko sami injicirate na poti tja.
Serious bleeding episodes 
Resne krvavitve
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Druga zdravila in zdravilo NovoSeven Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleeding disorders. 
Zdravljenje je treba začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem hemofilije in/ali drugih motenj strjevanja krvi.
Read all of this leaflet carefully before you are given this injection because it contains important information for you. 
Preden dobite injekcijo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
• If the CVAD line needs to be flushed before or after NovoSeven injection, use sodium chloride 9 mg/ml solution for injection. 
• Če je treba linijo CVD pred injiciranjem zdravila NovoSeven ali po injiciranju sprati, uporabite raztopino 9 mg/ml natrijevega klorida za injekcije.
Safely dispose of the used materials. 
Uporabljeni material varno zavrzite.
The equipment in this package is designed to reconstitute and inject NovoSeven. 
Oprema v tem pakiranju je namenjena za pripravo in injiciranje zdravila NovoSeven.
Do not use NovoSeven at the same time as prothrombin complex concentrates or rFXIII. 
Zdravila NovoSeven ne uporabljajte sočasno s koncentrati protrombinskega kompleksa ali rFXIII.
A theoretical risk for the development of systemic activation of the coagulation system in patients suffering from underlying diseases predisposing them to DIC cannot be totally excluded. 
Teoretičnega tveganja za razvoj sistemske aktivacije koagulacijskega sistema pri bolnikih z osnovnimi boleznimi, ki povečujejo nagnjenost k DIK, ni mogoče povsem izključiti.
It is important that the dosage regimen of NovoSevenis compliant with the recommended dosage as stated in section 4.2. 
Pomembno je, da shema odmerjanja zdravila NovoSeven upošteva odmerna priporočila, navedena v poglavju 4.2.
It is unknown whether rFVIIa is excreted in human breast milk. 
Ni znano, ali se rFVIIa pri človeku izloča v materino mleko.
Mild to moderate bleeding episodes (including home therapy) Early intervention has been shown to be efficacious in the treatment of mild to moderate joint, muscle and mucocutaneous bleeds. 
Blage do zmerne krvavitve (vključno z zdravljenjem na domu) Izkazalo se je, da je zgodnje ukrepanje učinkovito pri zdravljenju blagih do zmernih sklepnih, mišičnih in mukokutanih krvavitev.
• In case of a severe bleed you should contact your doctor. 
• V primeru hude krvavitve se morate posvetovati z zdravnikom.
Safety and efficacy of NovoSeven have not been established outside the approved indications and therefore NovoSeven should not be used. 
Ker varnost in učinkovitost zdravila NovoSeven izven odobrenih indikacij nista bili dokazani, se ga izven indikacij naj ne uporablja.
The following dose varies according to the type and severity of the haemorrhage. 
Naslednji odmerek se razlikuje glede na vrsto in resnost krvavitve.
An observational registry (F7HAEM-3521) covered 133 subjects with Glanzmann's thrombasthenia treated with NovoSeven. 
Opazovalni register (F7HAEM-3521) je zajel 133 oseb z Glanzmannovo trombastenijo, ki so se zdravili z zdravilom NovoSeven.
Some needleless connectors with an internal spike are incompatible with the pre-filled syringe. 
Nekateri brezigelni konektorji, ki imajo notranjo konico, niso združljivi z napolnjeno injekcijsko brizgo.
• Allergic, hypersensitivity or anaphylactic reactions. 
• Alergijske, preobčutljivostne ali anafilaktične reakcije.
Contents of the pack and other information What NovoSeven contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo NovoSeven
If your dose requires more than one vial, repeat steps A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose. 
Če za svoj odmerek potrebujete več kot eno vialo, ponovite korake od A do J z dodatnimi vialami, nastavki za vialo in napolnjenimi injekcijskimi brizgami, dokler ne dosežete potrebnega odmerka.
If you have Glanzmann's thrombasthenia: 
Če imate Glanzmannovo trombastenijo:
• If you recently had a crush injury 
• če ste nedavno imeli poškodbo z zmečkanino,
- Disseminated intravascular coagulation (see section 4.4) 
- diseminirana intravaskularna koagulacija (glejte poglavje 4.4)
• If, at any point, there is too much air in the syringe, inject the air back into the vial. 
• Če je kadar koli v injekcijski brizgi preveč zraka, potisnite zrak nazaj v vialo.
If you cannot use it at once, see section 5 How to store NovoSeven on the other side of this leaflet. 
Če ga ne morete uporabiti takoj, glejte poglavje 5, Shranjevanje zdravila NovoSeven, na drugi strani tega navodila.
There are no clinical data available on interaction between rFVIIa and rFXIII. 
Kliničnih podatkov o medsebojnem delovanju rFVIIa in rFXIII ni na voljo.
Dose and frequency of injections for prophylaxis should be based on clinical response and adapted to each individual. 
Odmerek in pogostnost injiciranja za profilakso morata temeljiti na kliničnem odzivu in morata biti prilagojena posamezniku.
- Coagulopathy 
- koagulopatija
A potential synergistic effect of combined treatment with rFXIII and rFVIIa in an advanced cardiovascular model in cynomolgus monkey resulted in exaggerated pharmacology (thrombosis and death) at a lower dose level than when administering the individual compounds. 
Možni sinergistični učinek kombiniranega zdravljenja z rFXIII in rFVIIa v naprednem srčno-žilnem modelu pri opicah cynomolgus je povzročil čezmeren farmakološki učinek (trombozo in smrt) pri manjših odmerkih kot v primeru uporabe vsake od učinkovin same zase.
Patients should be informed of the early signs of hypersensitivity reactions. 
Bolnika morate seznaniti z zgodnimi znaki preobčutljivostnih reakcij.
It is used in certain groups of people: 
Uporablja se pri ljudeh, ki imajo:
Caution: The pre-filled syringe is made of glass and is designed to be compatible with standard luer-lock connections. 
Opozorilo: Napolnjena injekcijska brizga je izdelana iz stekla in pripravljena tako, da je združljiva s povezavami, ki imajo nastavek luer.
Use a disposable syringe of an appropriate size and a vial adapter, transfer needle (20 - 26G) or other suitable device. 
Uporabite primerno veliko brizgo za enkratno uporabo ter nastavek za vialo, iglo za prenos (20-26 G) ali drug ustrezen pripomoček.
Four cases of overdose have been reported in patients with haemophilia in 16 years. 
Pri bolnikih s hemofilijo so bili v 16. letih opisani štirje primeri prevelikega odmerjanja.
In case the factor VIIa activity fails to reach the expected level or bleeding is not controlled after treatment with the recommended doses, antibody formation may be suspected and analysis for antibodies should be performed. 
Če aktivnost faktorja VIIa ne uspe doseči pričakovane ravni ali krvavitev po zdravljenju s priporočenimi odmerki ni obvladana, obstaja sum na tvorbo protiteles in opraviti je treba preiskavo nanje.
The usual dose is 90 micrograms for every 1 kilogram you weigh; you can repeat the injection every 2-3 hours until bleeding is controlled. 
Običajni odmerek je 90 mikrogramov na vsak kilogram telesne mase; injekcijo lahko ponovite na 2 do 3 ure, dokler krvavitev ni obvladana.
• Do not throw it out with the ordinary household waste. 
• Ničesar od tega ne smete odvreči med običajne gospodinjske odpadke.
Therefore, higher doses of rFVIIa may be needed in paediatric patients to achieve similar plasma concentrations as in adult patients (see section 
Pediatrični bolniki utegnejo zato potrebovati večje odmerke rFVIIa za doseganje podobne koncentracije v plazmi, kot je dosežena pri odraslih bolnikih (glejte poglavje 5.2).
It works in all types of bleeds, including joint bleeds. 
Deluje pri vseh vrstah krvavitev, vključno s krvavitvami v sklepe.
Pooling of vials (hospital use only): 
Združevanje vsebine vial (le za bolnišnično uporabo):
- Pruritus and urticaria 
- srbenje in urtikarija
• The active substance is recombinant coagulation factor VIIa (activated eptacog alfa). 
• Učinkovina je rekombinantni koagulacijski faktor VIIa (aktivirani eptakog alfa).
• Do not touch the rubber stopper with your fingers as this can transfer germs. 
• Ne dotikajte se gumijastega zamaška s prsti, ker lahko tako prenesete klice.
• Repeat the above procedure with the remaining vials with reconstituted product, to obtain the desired volume in the syringe. 
• Zgoraj navedeni postopek ponovite s preostalimi vialami pripravljenega zdravila, da boste v brizgo dobili želeno količino.
The initial dose interval should be 2 - 3 hours. 
Začetni odmerni interval mora biti od 2 do 3 ure.
Patients/carers should inform the physician/supervising hospital at the earliest possible opportunity about all usages of NovoSeven. 
Bolniki oz. tisti, ki zanje skrbijo, morajo zdravnika oz. nadzorno bolnišnico obvestiti o vseh uporabah zdravila NovoSeven, čim prej je mogoče.
The shelf life for the product packed for sale is 3 years when the product is stored below 25°C. 
Rok uporabnosti zdravila, pakiranega za prodajo, je 3 leta, če je zdravilo shranjeno pri temperaturi do 25 °C.
NovoSeven is used to treat bleeding, and to prevent excessive bleeding after surgery or other important treatments. 
Zdravilo NovoSeven se uporablja za zdravljenje krvavitev in preprečevanje čezmernih krvavitev po operaciji ali drugih pomembnih zdravljenjih.
• All steps should be completed under controlled and validated aseptic conditions by adequately trained staff. 
• Vse korake mora izvesti ustrezno usposobljeno osebje v nadzorovanih in preverjenih aseptičnih pogojih.
Simultaneous use of prothrombin complex concentrates, activated or not, should be avoided. 
Izogibati se je treba sočasni uporabi koncentratov protrombinskega kompleksa, tako aktiviranih kot neaktiviranih.
In some cases, the antibodies showed inhibitory effect in vitro. 
V nekaterih primerih so imela ta protitelesa zaviralen učinek in vitro.
• If you have an increased risk of blood clots (thrombosis) 
• če imate večje tveganje za krvne strdke (tromboza),
If the entire dose is not required, use the scale on the syringe to see how much mixed solution is withdrawn. 
Če ni potreben celotni odmerek, uporabite merilo na brizgi, da boste videli, koliko pripravljene raztopine ste izvlekli.
See overleaf for detailed instructions. 
Glejte na drugo stran lista za podrobna navodila.
Such situations may include patients with advanced atherosclerotic disease, crush injury, septicaemia or DIC. 
Takšne okoliščine lahko vključujejo bolnike z napredovano aterosklerotično boleznijo, zmečkaninami, septikemijo ali DIK.
Based on a non-clinical study (see section 5.3) it is not recommended to combine rFVIIa and rFXIII. 
Na podlagi predklinične študije (glejte poglavje 5.3) rFVIIa in rFXIII ni priporočljivo uporabljati v kombinaciji.
You will also need an administration set (tubing and butterfly needle, sterile alcohol swabs, gauze pads and plasters). 
Potrebovali boste tudi komplet za injiciranje (cevko in iglo z metuljčkom, sterilne alkoholne zložence, vpojno gazo in obliže).
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu/.
The recommended route of administration is bolus injection as lack of efficacy may appear in connection with continuous infusion. 
Priporočeni način uporabe je bolusna injekcija, ker se ob stalni infuziji lahko pojavi neučinkovitost.
Plunger rod: made of polypropylene. 
Nosilec bata: izdelan iz polipropilena.
Injecting the solution via a central venous access device (CVAD) such as a central venous catheter or a subcutaneous port: 
Injiciranje raztopine skozi centralni venski dostop (CVD), na primer skozi centralni venski kateter ali subkutani nastavek:
Although NovoSeven will be stable for 24 hours after it has been mixed, you should use it at once to avoid infection. 
Čeprav je zdravilo NovoSeven stabilno 24 ur po pripravi, ga uporabite takoj, da boste preprečili možnost okužbe.
Initially 2 - 3 hours to obtain haemostasis. 
Uvodoma na 2 do 3 ure, da se zagotovi hemostaza.
Experience with concomitant administration of anti-fibrinolytics and rFVIIa treatment is however limited. 
Vendar so izkušnje s sočasno uporabo antifibrinolitikov in rFVIIa omejene.
• If you have just had surgery 
• če ste bili pred kratkim operirani,
In the same registry 3 out of 91 surgical patients experienced thromboembolic events. 
V istem registru so se trombembolični dogodki pojavili pri 3 od 91 bolnikov, ki so potrebovali kirurško zdravljenje.
NovoSeven was used in 157 surgical procedures, at a median dose of 92 µg/kg (up to 270 µg/kg). 
Zdravilo NovoSeven so uporabili pri 157 kirurških posegih v medianem odmerku 92 µg/kg (do 270 µg/kg).
If allergic or anaphylactic-type reactions occur, the administration should be discontinued immediately. 
Če se pojavi alergijska ali anafilaktična reakcija, morate uporabo zdravila nemudoma prekiniti.