natgillin/translations-raw huggingface dataset:
If you are breast-feeding, ask your doctor for advice before you are given {invented name}.
Če dojite, se posvetujte z zdravnikom preden vam dajo zdravilo {izmišljeno ime}.
Healthcare professionals are asked to report any suspected adverse reactions {via the national reporting system listed in Appendix V*}.
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V*.
Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of {invented name}.
Med injiciranjem zdravila {izmišljeno ime} in po njem bolnike pazljivo spremljajte za znake in simptome preobčutljivostnih reakcij.
4.6 Fertility, pregnancy and lactation [the wording below should be inserted in the relevant section]
4.6 Plodnost, nosečnost in dojenje [spodnje besedilo je treba vključiti v ustrezno poglavje]
[the wording below should be inserted in the relevant section]
[spodnje besedilo je treba vključiti v ustrezno poglavje]
Contraindications [the wording below should be inserted in the relevant section]
Kontraindikacije [spodnje besedilo je treba vključiti v ustrezno poglavje]
4.4 Special warnings and precautions for use [the wording below should be inserted in the relevant section]
4.4 Posebna opozorila in previdnostni ukrepi [spodnje besedilo je treba vključiti v ustrezno poglavje]
Possible side effects [the wording below should be inserted in the relevant section]
Možni neželeni učinki [spodnje besedilo je treba vključiti v ustrezno poglavje]
4.2 Posology and method of administration [the wording below should be inserted in the relevant section]
4.2 Odmerjanje in način uporabe [spodnje besedilo je treba vključiti v ustrezno poglavje]
A careful risk/benefit evaluation is therefore required before use during pregnancy and {invented name} should not be used during pregnancy unless clearly necessary (see section
Zdravila {izmišljeno ime} med nosečnostjo ne smete uporabljati, razen če je nujno potrebno (glejte poglavje 4.4).
PACKAGE LEAFLET
Priloga III
1 vial + 1 pre-filled syringe + 2 needles
1 viala +1 napolnjena brizga + 2 igli
Strength Pharmaceutical Form Route of Administration
Farmacevtska oblika Način uporabe zdravila
The risk to humans is not known.
Tveganje za človeka ni znano.
It may harm them,
Med znaki so lahko koprivnica,
Currently available data are described in section 4.8, 5.1 and 5.2.
Podatki, ki so trenutno na voljo, so opisani v poglavjih 4.8, 5.1 in 5.2.
Before starting, the hands should be washed.
Preden začnete, si je potrebno umiti roke.
The final content, format and distribution modalities of both documents should be agreed with the national competent authority in each Member State.
Glede končne vsebine, oblike in načina razdeljevanja obeh dokumentov se je treba dogovoriti s pristojnim nacionalnim organom v vsaki državi članici.
Use in small children
Uporaba pri majhnih otrocih
Your doctor will explain what might happen if you stop treatment and discuss other options with you.
Zdravnik vam bo pojasnil, kaj se lahko zgodi, če prekinete zdravljenje, in se bo z vami pogovoril o drugih možnostih.
Your dose will depend on your body weight.
Vaš odmerek bo odvisen od vaše telesne mase.
MARKETING AUTHORISATION NUMBER EU/1/12/775/001
ZDRAVILOM EU/1/12/775/001
The calculation of the correction factor 0.117 is related to the exact quantity of the product and not the nominal value of the product.
Uporaba korekcijskega faktorja 0,117 je povezana z natančno količino zdravila in ne z njegovo nominalno vrednostjo.
The results of standard coagulation tests are normal, as it is the quality of the clot that is affected.
Rezultati standardnih koagulacijskih testov so normalni, kajti prizadeta je kakovost strdka.
The potency of this medicinal product is expressed in international units (IU).
Jakost tega zdravila izražamo v mednarodnih enotah (i.e.).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Znotraj vsake skupine pogostnosti so neželeni učinki razvrščeni po padajoči resnosti.
• If you are allergic to catridecacog or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na katridekakog ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The Marketing Authorisation Holder must implement this educational plan nationally, prior to marketing.
Imetnik dovoljenja za promet mora izvesti ta načrt izobraževanja na nacionalni ravni pred prihodom zdravila na trg.
Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Skupine pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Pack size of 1.
Pakiranje z 1 kompletom.
Until further results are available, alternative treatment should be considered in such situations.
Dokler ne bodo na voljo dodatni rezultati, je treba v takih primerih razmisliti o uporabi drugega zdravila.
The injections are given once a month (every 28 ± 2 days).
Injekcije se dajejo enkrat na mesec (vsakih 28 ± 2 dni).
• Distribution and use of the patient brochure and the need to ensure that the patient has read and understood the brochure
• razdeljevanje in uporabo brošure za bolnike ter opozorilo, da je treba poskrbeti, da bolnik brošuro prebere in jo razume
3 of these patients discontinued the study due to the adverse reaction.
3 od teh bolnikov so končali študijo zaradi neželene reakcije.
The antibodies disappeared in the 6-month follow up.
Protitelesa so izginila med 6-mesečnim spremljanjem.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03 September 2012
Datum prve odobritve: 03. september 2012 Datum zadnjega podaljšanja:
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or within 60 days as a result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali v 60 dneh, kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
None of the reported cases have shown any signs of illness.
V nobenem od opisanih primerov ni bilo bolezenskih znakov.
NovoThirteen can be used for all age groups.
Zdravilo NovoThirteen se lahko uporablja pri vseh starostnih skupinah.
The specific activity of NovoThirteen is approximately 165 IU/mg protein.
Specifična aktivnost zdravila NovoThirteen je približno 165 i.e./mg beljakovine.
Your doctor may adapt the dose if this is deemed necessary.
Zdravnik lahko odmerek prilagodi, če je to potrebno.
The mean t½ of FXIII was approximately 15 days (range: 10 to 25 days).
FXIII je bil približno 15 dni (razpon: od 10 do 25 dni).
Also, on-demand treatment is followed in a noninterventional post-authorisation safety study (NN1841-3868).
Uporaba zdravila po potrebi se spremlja tudi v neintervencijski študiji o varnosti po pridobitvi dovoljenja za promet z zdravilom (NN1841-3868).
If you are pregnant or breast-feeding, or if you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Nosečnost in dojenje Če ste noseči ali dojite, ali menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
After dilution proceed to step H.
Po razredčenju nadaljujte s korakom H.
Animal reproductive or developmental toxicity studies have not been performed.
Študij reproduktivne in razvojne toksičnosti pri živalih niso izvedli.
• The importance of collecting safety data and how to enrol patients in the PASS and other registries
• pomen zbiranja podatkov o varnosti in navodila, kako vključiti bolnike v študijo o varnosti zdravila (PASS) in druge registre
Side effects in children:
Neželeni učinki pri otrocih:
Genotoxic potential or carcinogenicity has not been studied since rFXIII is an endogenous protein.
Genotoksičnosti in kancerogenosti niso raziskovali, ker je rFXIII endogena beljakovina.
If a larger dose is needed, repeat the procedure in a separate syringe until the required dose is reached.
Če je potreben večji odmerek, ponovite postopek z ločeno brizgo, dokler potrebni odmerek ni dosežen.
One continued to receive rFXIII and the antibodies decreased below detection limit.
Eden pa je še naprej prejemal rFXIII in koncentracija protiteles se je znižala pod mejo detekcije.
You should only use the prescribed dose calculated by your doctor from this formula considering that the usual dose and the concentration of NovoThirteen are different from those of the other products which contain factor XIII.
Uporabljati smete le predpisani odmerek, ki vam ga je zdravnik izračunal po tej formuli, kajti običajni odmerek in koncentracija zdravila NovoThirteen se razlikujeta od tistih pri drugih zdravilih, ki vsebujejo faktor XIII.
• If you experience an allergic reaction to NovoThirteen.
• če se vam pojavi alergična reakcija na zdravilo NovoThirteen.
4 patients received at least 2 doses of NovoThirteen.
Vsi 4 bolniki pa so prejeli vsaj 2 odmerka zdravila NovoThirteen.
Increased levels of activated NovoThirteen may increase the risk of thrombosis.
Povečanje količine aktiviranega zdravila NovoThirteen lahko poveča tveganje za trombozo.
• Headache (most common side effect)
• glavobol (najpogostejši neželeni učinek)
3 of the patients discontinued the study and returned to their previous treatment.
3 od teh bolnikov so prenehali sodelovati v študiji in prešli na svojo prejšnjo terapijo.
Remove the plastic caps from the 2 vials.
Odstranite plastična pokrovčka z obeh vial.
Pharmacotherapeutic group: Antihaemorrhagics, Blood Coagulation factor, ATC code: B02BD11.
Farmakoterapevtska skupina: antihemoragiki, krvni koagulacijski faktorji, oznaka ATC: B02BD11.
The side effects observed in children are the same as also observed in adults but the side effects may be more common in children than in adults.
Neželeni učinki, ki so jih opazili pri otrocih, so enaki tistim, ki so jih opazili pri odraslih, vendar pa so lahko neželeni učinki pri otrocih pogostejši kot pri odraslih.
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with NovoThirteen should be made taking into account the benefit of breast-feeding to the child and the benefit of NovoThirteen therapy to the mother.
Pri odločitvi za nadaljevanje ali prekinitev dojenja oz. za nadaljevanje ali prekinitev zdravljenja z zdravilom NovoThirteen je treba upoštevati korist dojenja za otroka in korist zdravljenja z zdravilom NovoThirteen za mater.
• Development of antibodies against factor XIII which have no influence on the effect of the drug.
• pojav protiteles proti koagulacijskem faktorju XIII, ki ne vplivajo na učinek zdravila
It is unknown whether rFXIII is excreted in human breast milk.
Ni znano, ali se rFXIII pri človeku izloča v materinem mleku.
The dilution should be performed in accordance with aseptic rules.
Razredčenje je treba opraviti v aseptičnih pogojih.
NovoThirteen should be injected at a rate not higher than 2 ml/minute.
Zdravilo NovoThirteen je treba injicirati s hitrostjo, ki ne presega 2 ml/minuto.
• Correct handling and the risks associated with mishandling
• pravilno ravnanje in tveganja, povezana z nepravilnim ravnanjem
Inject air into the vial by pushing the plunger until you feel a clear resistance.
S pritiskanjem bata potiskajte zrak v vialo, dokler ne začutite jasnega odpora.
If you stop using NovoThirteen, you are not protected against bleeding.
Če ste prenehali uporabljati zdravilo NovoThirteen Če prenehate uporabljati zdravilo NovoThirteen, niste več zaščiteni pred krvavitvami.
Both documents are to be used as part of an educational plan aiming to minimise risks of medication errors, risk of thromboembolic events due to increased levels of non-proteolytically activated rFXIII in connection with incorrect storage, and risk of off-label use for treatment of breakthrough bleeding.
Oba dokumenta je treba uporabiti v okviru načrta izobraževanja, katerega cilj je zmanjšati možnost napak pri uporabi zdravila, tveganje za trombembolične dogodke zaradi zvišane ravni neproteolitično aktiviranega rFXIII v povezavi z nepravilnim shranjevanjem ter tveganje za neodobreno uporabo za zdravljenje vmesnih krvavitev.
The reconstituted product must be handled in accordance with section 6.3.
S pripravljenim zdravilom je treba ravnati v skladu s poglavjem 6.3.
• The risks associated with incorrect storage and mishandling
• tveganja, povezana z nepravilnim shranjevanjem in ravnanjem
FXIII is a pro-enzyme (pro-transglutaminase), which is activated by thrombin in the presence of Ca2+.
FXIII je proencim (protransglutaminaza), ki ga aktivira trombin v prisotnosti Ca2+.
In this trial, the mean clearance in children was 0.15 ml/h/kg.
V tem preskušanju je bil povprečni očistek pri otrocih 0,15 ml/h/kg.
However, based on the therapeutic need the use of NovoThirteen may be considered during pregnancy.
Vendar lahko, glede na terapevtske potrebe, pride uporaba zdravila NovoThirteen med nosečnostjo v poštev.
• Contraindication of hypersensitivity
• kontraindikacijo zaradi preobčutljivosti
The excretion of rFXIII in milk has not been studied in animals.
Izločanje rFXIII v mleku pri živalih ni raziskano.
The dose volume for small children can then be calculated by using the below formula:
Velikost odmerka za majhne otroke je mogoče izračunati po naslednji formuli:
The patient brochure, to be distributed to patients by the prescribers, should contain the following key elements and item:
Brošura za bolnike, ki jo morajo zdravniki, ki predpisujejo zdravilo izročiti bolnikom, mora vsebovati naslednje ključne elemente in postavke:
NovoThirteen replaces the missing factor XIII and helps to stabilise the initial blood clot by producing a mesh around the clot.
Zdravilo NovoThirteen nadomesti manjkajoči faktor XIII in pomaga stabilizirati začetni krvni strdek, tako da okrog njega ustvari mrežico.
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 čezmerni farmakološki učinek (trombozo in smrt) pri manjših odmerkih kot v primeru uporabe vsake od učinkovin same zase.
These antibodies were seen at the start of treatment with NovoThirteen.
Ta protitelesa so ugotovili na začetku zdravljenja z zdravilom NovoThirteen.
Do not use this medicine after the expiry date which is stated on the label and the outer carton after ‘EXP.'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake "Uporabno do".
Analyses of data from paediatric patients included in clinical trials have not identified differences in treatment response according to age.
Pediatrična populacija Analize podatkov pediatričnih bolnikov, vključenih v klinična preskušanja, niso pokazale, da bi se odziv na zdravljenje razlikoval glede na starost.
Summary of the safety profile The most frequent adverse reaction is ‘headache' reported in 37% of patients.
Najpogosteje opisani neželeni učinek je »glavobol«, ki se je pojavil pri 37 % bolnikov.
Leucopenia and aggravated neutropenia
Pogosti levkopenija in poslabšanje nevtropenije
Inhibitors may be suspected in the event of lack of therapeutic response which is observed as bleeding or demonstrated by laboratory findings including FXIII activity that fails to reach expected levels.
Na zaviralce je mogoče posumiti, če ni terapevtskega odziva, kar se kaže s krvavitvami ali z laboratorijskimi izvidi, vključno z aktivnostjo FXIII, ki ne doseže pričakovane ravni.
• How to recognise the potential side effects (thrombosis and embolism)
• navodila, kako prepoznati možne neželene učinke (trombozo in embolijo)
This is in agreement with the elimination pharmacokinetics estimated from a clinical pharmacology trial in healthy subjects, which determined the half-life to be 11.8 days.
To se ujema z eliminacijsko farmakokinetiko, ocenjeno v preskušanju klinične farmakologije pri zdravih preiskovancih, ki je pokazalo razpolovni čas 11,8 dneva.
The on-demand treatment of acute bleeds or breakthrough bleeds with NovoThirteen was allowed per protocol in the late phase clinical development programme.
Zdravljenje akutnih krvavitev ali vmesnih krvavitev z uporabo zdravila NovoThirteen po potrebi je bilo dovoljeno v skladu s protokolom v poznejši fazi kliničnega razvoja.
The dosing scheme used was 35 IU/kg/month (every 28 days ± 2 days).
Uporabljena shema za odmerjanje je bila 35 i.e./kg/mesec (vsakih 28 dni ± 2 dni).
Patients known to have neutralising antibodies to FXIII should not be treated with NovoThirteen without close monitoring.
Bolnikov, za katere je znano, da imajo nevtralizirajoča protitelesa proti FXIII, se ne sme zdraviti z zdravilom NovoThirteen brez natančnega spremljanja.
The usual dose is 35 IU for each kilogram of body weight.
Običajen odmerek je 35 i.e. na kilogram telesne mase.
Tell your doctor if you are using, have recently used or might use any other medicines.
Druga zdravila in zdravilo NovoThirteen Obvestite zdravnika, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
In the reported cases of NovoThirteen overdose up to 2.3 times, no clinical symptoms have been observed.
V opisanih primerih prevelikega odmerjanja (do 2,3-krat) zdravila NovoThirteen niso opazili kliničnih simptomov.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3) as NovoThirteen has not been studied in pregnant animals.
Študije na živalih so nezadostne, kar zadeva toksične učinke na sposobnost razmnoževanja (glejte poglavje 5.3), ker zdravilo NovoThirteen ni raziskano pri brejih živalih.
Bring the powder and solvent vials to a temperature not above 25°C, by holding them in the hands until they feel as warm as your hands.
Vialo s praškom in vialo z vehiklom ogrejte na temperaturo do 25 °C, tako da ju držite v rokah dokler nista tako topli, kot vaše roke.
Based on the non-clinical study (see section 5.3) it is not recommended to combine NovoThirteen and recombinant activated FVII (rFVIIa).
Na podlagi neklinične študije (glejte poglavje 5.3) ni priporočljivo, da bi zdravilo NovoThirteen in rekombinantni aktivirani FVII (rFVIIa) uporabljali v kombinaciji.
What NovoThirteen is and what it is used for What you need to know before you use NovoThirteen How to use NovoThirteen
Kaj je zdravilo NovoThirteen in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo NovoThirteen Kako uporabljati zdravilo NovoThirteen
Antibodies were transient in all patients.
Pojav protiteles je bil pri vseh bolnikih prehoden.
In this last case your doctor will prescribe an alternative treatment to treat the bleeding.
V tem primeru vam bo zdravnik predpisal drugo zdravilo za zdravljenje krvavitve;
In patients below 6 years, no anti-rFXIII antibodies, no thromboembolic adverse events or other safety issues were reported.
Pri bolnikih, mlajših od 6 let, ni bilo opisanih protiteles proti rFXIII, trombemboličnih neželenih učinkov ali drugih težav z varnostjo zdravila.
Treatment should be initiated under the supervision of a doctor experienced in the treatment of rare bleeding disorders.
Zdravljenje je treba začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem redkih motenj strjevanja krvi.
If you use more NovoThirteen than you should
Če ste uporabili večji odmerek zdravila NovoThirteen, kot bi smeli
The active transglutaminase cross-links fibrin and other proteins resulting in increased mechanical strength and resistance to fibrinolysis of the fibrin clot and contributes to enhanced platelet and clot adhesion to the injured tissue.
Aktivna transglutaminaza navzkrižno veže fibrin in druge beljakovine in tako poveča mehanično odpornost fibrinskega strdka ter njegovo odpornost proti fibrinolizi in pripomore k povečanju adhezije trombocitov in strdka na poškodovano tkivo.
If allergic or anaphylactic-type reactions occur, the administration should be immediately discontinued and further treatment with NovoThirteen should not be given.
Če se pojavi alergijska ali anafilaktična reakcija, je treba uporabo zdravila nemudoma prekiniti in zdravljenja z zdravilom NovoThirteen se ne sme nadaljevati.
For more information see section ‘NovoThirteen user instructions - Instructions of how to dilute the reconstituted NovoThirteen'.
Za več informacij glejte poglavje "Navodila za uporabnika zdravila NovoThirteenNavodila za razredčenje pripravljenega zdravila NovoThirteen".
In all cases, the non-neutralising antibodies were found to be of no clinical significance.
V vseh primerih je bilo ugotovljeno, da nenevtralizirajoča protitelesa niso klinično pomembna.
All findings in the non-clinical safety programme have been related to expected exaggerated pharmacology (general thrombosis, ischaemic necrosis and ultimately mortality) of rFXIII and non-proteolytically activated recombinant FXIII at dose levels in excess (>48 fold) of the maximum recommended clinical dose of 35 IU/kg.
Vsi izsledki v nekliničnem programu varnosti so bili povezani s pričakovanim čezmernim farmakološkim učinkom (splošna tromboza, ishemična nekroza in navsezadnje smrt) rFXIII in neproteolitično aktiviranega rekombinantnega FXIII pri odmerkih, ki so presegali (> 48-krat) največji priporočeni klinični odmerek 35 i.e./kg.
If you forget an injection of NovoThirteen, talk to your doctor.
Če ste si pozabili dati injekcijo zdravila NovoThirteen, se posvetujte z zdravnikom.
Make sure not to aim the stream of solvent directly at the powder as this will cause foaming.
Pazite, da ne boste curka vehikla usmerili neposredno na prašek, ker bi s tem povzročili penjenje.
Considering that the posology and the FXIII concentration in NovoThirteen are different from those of the other FXIII containing products, careful attention should be paid to the calculation of the appropriate dose for the individual patient (see dose volume formula provided in section 4.2).
Glede na to, da se odmerjanje in koncentracija FXIII v zdravilu NovoThirteen razlikujeta od tistih pri drugih zdravilih, ki vsebujejo FXIII, je treba posebno pozornost nameniti izračunu ustreznega odmerka za posameznega bolnika (glejte formulo za velikost odmerka, ki je navedena v poglavju 4.2).
Following discontinuation of NovoThirteen the patient's neutrophil count returned to levels similar to those prior to treatment with NovoThirteen.
Po prenehanju uporabe zdravila NovoThirteen se mu je število nevtrofilcev vrnilo na raven, podobno tisti pred zdravljenjem z zdravilom NovoThirteen.
Please see NovoThirteen user instructions.
Prosimo, glejte Navodila za uporabnika zdravila NovoThirteen.
A stabilisation of the thrombus might occur, resulting in increased risk of vessel occlusions.
Pride lahko do stabilizacije tromba, s čimer se poveča tveganje za zaporo žile.
Based on FXIII activity measured by the Berichrom assay in patients with congenital FXIII deficiency, a geometric mean half-life of 11.8 days was estimated.
Na podlagi aktivnosti FXIII, izmerjene s preizkusom Berichrom pri bolnikih s prirojenim pomanjkanjem FXIII, je bil ocenjeni geometrični povprečni razpolovni čas 11,8 dneva.
There are no human data on potential effects on fertility.
O morebitnih vplivih zdravila na plodnost pri človeku ni podatkov.
If the caps are loose or missing, do not use the vials.
Če zaščitni pokrovček ne sedi trdno ali ga sploh ni, viale ne uporabite.