natgillin/translations-raw huggingface dataset:
NovoThirteen has been shown to have the same pharmacodynamic properties in plasma as endogenous FXIII.
Zdravilo NovoThirteen ima v plazmi enake farmakodinamične lastnosti kot endogeni FXIII.
Non-neutralising antibodies have been seen in 4 of the 82 exposed patients with congenital FXIII deficiency.
Nenevtralizirajoča protitelesa so opazili pri 4 od 82 izpostavljenih bolnikov s prirojenim pomanjkanjem FXIII.
It is not recommended to use NovoThirteen and recombinant coagulation factor VIIa (another blood clotting factor) together.
Zdravila NovoThirteen ni priporočljivo uporabljati skupaj z rekombinantnim koagulacijskim faktorjem VIIa (to je drug faktor strjevanja krvi).
• Appropriate diagnostic procedures to confirm FXIII A-subunit deficiency
• ustrezne diagnostične postopke za potrditev pomanjkanja podenote A FXIII
In case of predisposition to conditions of thrombosis, caution should be exercised due to the fibrinstabilising effect of NovoThirteen.
V primeru nagnjenosti k trombotičnim stanjem je potrebna previdnost, kajti zdravilo NovoThirteen stabilizira fibrin.
• Increased amount of small protein fragments caused by break down of blood clots
• bolečine v nogah in rokah • večja količina drobnih beljakovinskih delcev, nastalih zaradi razgradnje krvnih strdkov
One patient was treated on demand in a phase 3b extension study (F13CD-3720).
En bolnik je bil zdravljen z uporabo zdravila po potrebi v fazi 3b podaljšane študije (F13CD-3720).
In clinical trials, NovoThirteen has been administered to 82 patients with congenital factor XIII Asubunit deficiency (3112 doses of NovoThirteen).
V kliničnih preskušanjih je zdravilo NovoThirteen prejemalo 82 bolnikov s prirojenim pomanjkanjem podenote A faktorja XIII (3112 odmerkov zdravila NovoThirteen).
Take care not to touch the spike on the vial adapter.
Pazite, da se ne dotaknete konice nastavka za vialo.
Clean the rubber stoppers on the vials with alcohol swabs and allow them to dry before use.
Gumijasta zamaška na vialah očistite z alkoholnima zložencema, in pustite, da se pred uporabo posušita.
In this trial the mean volume of distribution at steady state was 47 ml/kg, mean residence time was 15.5 days and mean clearance was 0.13 ml/kg.
V tem preskušanju je bil povprečni volumen porazdelitve v stanju dinamičnega ravnovesja 47 ml/kg, povprečni rezidenčni čas 15,5 dneva in povprečni očistek 0,13 ml/kg.
The suggested dose of 35 IU/kg has shown to be appropriate to provide haemostatic coverage in this young population.
Ugotovljeno je, da priporočeni odmerek 35 i.e./kg v tej mladi populaciji zagotovi ustrezno hemostatsko kritje.
The four events of non-neutralising antibodies occurred in patients below the age of 18 (age 8, 8, 14 and 16).
V vseh štirih primerih so se pojavila pri bolnikih, mlajših od 18 let (leta 8, 8, 14 in 16).
NovoThirteen has no influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo NovoThirteen nima vpliva na sposobnost vožnje in upravljanja strojev.
• Warning and precautions regarding anaphylaxis
• opozorila in previdnostne ukrepe glede anafilakse
Frequency descriptions of all adverse reactions identified from 82 patients with congenital FXIII deficiency exposed in clinical trials are presented in the below table by system organ class.
Opis pogostnosti vseh neželenih učinkov, ugotovljenih pri 82 bolnikih s prirojenim pomanjkanjem FXIII, izpostavljenih v kliničnih preskušanjih, je naveden v spodnji preglednici po organskih sistemih.
Do not stop using NovoThirteen without talking to your doctor.
Ne prenehajte uporabljati zdravila NovoThirteen, ne da bi se prej posvetovali z zdravnikom.
• What to do in the event of incorrect storage, thrombosis or embolism
• kako ukrepati v primeru nepravilnega shranjevanja, tromboze ali embolije • navodilo za uporabo
If you are not sure, ask your doctor before using this medicine.
Če ste negotovi, se pred uporabo tega zdravila posvetujte z zdravnikom.
21 patients were between the age of 6 to less than 18 years old and 6 patients were less than 6 years old (total of 986 exposures of NovoThirteen in paediatric subjects (less than 18 years old).
21 bolnikov je bilo starih več kot 6 in manj kot 18 let ter 6 bolnikov je bilo starih manj kot 6 let (skupaj 986 izpostavljenosti zdravilu NovoThirteen pri pediatričnih bolnikih, mlajših od 18 let).
The dose volume in millilitres should be calculated based on body weight for each patient using the following formula: Dose volume in ml = 0.042 x subject bw (kg) if bw > 24 kg or dose volume in ml = 0.117 x bw (kg) if bw < 24 kg).
Velikost odmerka v mililitrih je treba za vsakega bolnika izračunati glede na telesno maso po naslednji formuli: velikost odmerka v ml = 0,042 x bolnikova telesna masa (v kg), če je telesna masa > 24 kg ali velikost odmerka v ml = 0,117 x telesna masa (kg), če je telesna masa < 24 kg).
There are no clinical data on the use of NovoThirteen in pregnant women.
Kliničnih podatkov o uporabi zdravila NovoThirteen pri nosečnicah ni.
Gently swirl the vial until all the powder is dissolved.
Previdno vrtite vialo, dokler se ves prašek ne raztopi.
Patients should be informed of the early signs of hypersensitivity reactions (including hives, generalised urticaria, tightness of the chest, wheezing, hypotension) and anaphylaxis.
Bolnike je treba seznaniti z zgodnimi znaki preobčutljivostnih reakcij (vključno s koprivnico, generalizirano urtikarijo, tiščanjem v prsih, piskajočim dihanjem, hipotenzijo) in anafilaksijo.
Following reconstitution the product should be administered separately and not mixed with infusion solutions nor be given in a drip.
Po pripravi je treba zdravilo aplicirati ločeno in se ga ne sme mešati z raztopinami za infundiranje ali dajati v kapalni infuziji.
Based on the actual concentration of NovoThirteen, the volume (in millilitres) to be administered to patients weighing at least 24 kg can be calculated from the formula below:
Glede na dejansko koncentracijo zdravila NovoThirteen je mogoče volumen (v mililitrih) za bolnike, ki so težki najmanj 24 kg, izračunati po naslednji formuli:
In clinical studies, adverse reactions were more frequently reported in patients aged from 6 to less than 18 years old than in adults.
Neželeni učinki so se v kliničnih študijah pogosteje pojavljali pri bolnikih, starih med 6 in 18 let, kot pri odraslih bolnikih.
NovoThirteen contains the active substance catridecacog, which is identical to human coagulation factor XIII, an enzyme necessary for blood clotting.
Zdravilo NovoThirteen vsebuje učinkovino katridekakog, ki je enaka človeškemu koagulacijskemu faktorju XIII - encimu, ki je potreben za pravilno strjevanje krvi.
Safely dispose of the syringe, vial adapter, infusion set and vials.
Varno zavrzite brizgo, nastavek za vialo, infuzijski komplet in viali.
The mean rate of treatment-requiring bleeds was determined to 0.138 per subject year.
Ugotovljeni povprečni delež krvavitev, ki zahtevajo zdravljenje, je bil 0,138 na preiskovanca na leto.
Follow the injection procedure as instructed by your doctor.
Pri tem se držite navodil za injiciranje, ki ste jih dobili od zdravnika.
At present there are no markers that can quantitatively assess the in vivo pharmacodynamics of FXIII.
Farmakodinamični učinki Trenutno ni na voljo označevalcev za kvantitativno oceno farmakodinamike FXIII in vivo.
If you forget to use NovoThirteen
Če ste pozabili uporabiti zdravilo NovoThirteen
3 patients (14%) aged between 6 and 18 years experienced serious adverse reactions in comparison to 0 patients over 18 years that experienced serious adverse reactions.
Pri 3 bolnikih (14 %), starih med 6 in 18 let, so se pojavili resni neželeni učinki, pri bolnikih, starejših od 18 let, pa se resni neželeni učinki niso pojavili pri nobenem bolniku.
After dilution proceed to the step ‘Injecting the solution'.
Po razredčenju nadaljujte s korakom "Injiciranje raztopine".
Side effects include:
Neželeni učinki so:
Non-neutralising antibodies Fibrin D-dimer increased
Preiskave Pogosti Pogosti nenevtralizirajoča protitelesa zvišanje fibrinskega D-dimera
Ensure that the plunger is pushed all the way in before turning the syringe upside down (it may have been pushed out by the pressure in the vial).
Preden obrnete brizgo na glavo, poskrbite, da bo bat potisnjen do konca (morda ga je pritisk v viali nekoliko iztisnil).
The recommended dose is 35 IU/kg body weight (bw) once monthly (every 28 days ± 2 days), administered as an intravenous bolus injection.
Priporočeni odmerek je 35 i.e./kg telesne mase enkrat na mesec (vsakih 28 ± 2 dni) v intravenski bolusni injekciji.
General instructions for dilution
Splošna navodila za razredčenje
One patient with pre-existing neutropenia experienced a mild aggravation of neutropenia and leucopenia during treatment with NovoThirteen.
Enemu bolniku s predhodno nevtropenijo sta se nevtropenija in levkopenija med zdravljenjem z zdravilom NovoThirteen rahlo poslabšali.
Powder: Sodium chloride, sucrose, polysorbate 20, L-histidine, hydrochloric acid, sodium hydroxide Solvent: water for injections
Prašek: natrijev klorid, saharoza, polisorbat 20, L-histidin, klorovodikova kislina, natrijev hidroksid Vehikel: voda za injekcije
For storage conditions of the reconstituted medicinal product, see section 6.3.
Za pogoje shranjevanja pripravljenega zdravila glejte poglavje 6.3.
NovoThirteen may not be effective in patients with hepatic impairment if the hepatic impairment is severe enough to result in decreased levels of FXIII B-subunits.
Zdravilo NovoThirteen pri bolnikih z okvaro jeter morda ne bo učinkovito, če je okvara jeter tako huda, da zmanjša koncentracijo podenot B FXIII.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
EXP After reconstitution, use the medicine immediately due to the risk of microbiological contamination.
Uporabno do: Po pripravi zdravilo uporabite takoj zaradi tveganja za mikrobiološko kontaminacijo.
The signs may include: hives, itching, swelling, difficulty breathing, low blood pressure (signs include paleness and coldness of skin, rapid heartbeat), feeling dizzy and sweating.
srbečica, otekanje, težave pri dihanju, nizek krvni tlak (bledost in hladnost kože, pospešen srčni utrip), vrtoglavica in potenje.
• The risks of off-label use within FXIII congenital deficiency
• tveganja neodobrene uporabe v okviru prirojenega pomanjkanja FXIII
Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
L-histidin klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
In the primary endpoint analysis covering the referred period, the age-adjusted rate (number per subject year) of treatment-requiring bleeds during the rFXIII treatment period was 0.048/year (95% CI: 0.009 - 0.250; model-based estimate corresponding to the mean age of 26.4 years for the 41 patients).
V analizi primarnega opazovanega dogodka, ki je zajela omenjeno obdobje, je bil za starost korigirani delež (število na preiskovanca na leto) krvavitev, ki so med obdobjem prejemanja rFXIII zahtevale zdravljenje, 0,048/leto (95 % interval zaupanja: od 0,009 do 0,250; ocene na podlagi modela ustrezajo povprečni starosti 26,4 leta za 41 bolnikov).
The powder is white and the solvent is clear and colourless.
Prašek je bele barve, vehikel pa je bister in brezbarven.
The congenital factor XIII A-subunit deficiency should be confirmed by appropriate diagnostic procedures including factor XIII activity and immunoassay and if applicable genotyping.
Prirojeno pomanjkanje podenote A faktorja XIII je treba potrditi z ustreznimi diagnostičnimi postopki, vključno z merjenjem aktivnosti faktorja XIII in imunološkim preizkusom ter z genotipizacijo, če pride v poštev.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Hold the syringe with the vial upside down and pull the plunger to draw up the amount calculated for the injection.
Držite brizgo in vialo skupaj obrnjeni na glavo in potegnite bat, tako da boste potegnili količino, izračunano za injekcijo.
In case of any questions ask your doctor or nurse.
Če imate kakšno vprašanje, se obrnite na zdravnika ali medicinsko sestro.
• Summary of Product Characteristics.
• povzetek glavnih značilnosti zdravila
• If you have or have ever had a higher risk of blood clots forming (thrombosis), as NovoThirteen may increase the severity of a pre-existing blood clot.
• če imate ali ste kdaj imeli večje tveganje za nastanek krvnih strdkov (tromboza), kajti zdravilo
The product is now ready for injection.
Zdravilo je sedaj pripravljeno za injiciranje.
In a post-authorisation safety study transient non-neutralising antibodies were seen in a child with congenital FXIII deficiency after several years of treatment with NovoThirteen.
V študiji o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom so pri otroku s prirojenim pomanjkanjem FXIII po večletnem zdravljenju z zdravilom NovoThirteen poročali o prehodnem pojavu nenevtralizirajočih protiteles.
No dose adjustment is required when NovoThirteen is used in paediatric patients and the dose of 35 IU/kg body weight should be used (see section 5.2 ‘Paediatric population').
Pediatričnim bolnikom odmerka zdravila NovoThirteen ni treba prilagoditi, uporabiti pa je treba odmerek 35 i.e./kg telesne mase (glejte poglavje 5.2, "Pediatrična populacija").
How to store NovoThirteen Contents of the pack and other information.
Shranjevanje zdravila NovoThirteen Vsebina pakiranja in dodatne informacije
Reconstituted NovoThirteen is a clear, colourless solution.
Pripravljeno zdravilo NovoThirteen je bistra, brezbarvna raztopina.
Congenital FXIII B-subunit deficiency
Prirojeno pomanjkanje podenote B FXIII
Based on the concentration of NovoThirteen solution, the dose volume to be injected (in millilitres) can be calculated from this formula:
Glede na koncentracijo raztopine NovoThirteen je mogoče velikost odmerka, ki ga je treba injicirati (v mililitrih) izračunati po formuli:
NovoThirteen (A-subunit) binds to free human FXIII B-subunit resulting in a heterotetramer [rA2B2] with a similar half-life to endogenous [A2B2].
Zdravilo NovoThirteen (podenota A) se veže na prosto podenoto B človeškega FXIII; nastane heterotetramer [rA2B2], ki ima podoben razpolovni čas kot endogeni [A2B2].
As NovoThirteen contains a recombinant protein it may cause allergic reactions including anaphylactic reactions.
Alergijske reakcije Zdravilo NovoThirteen vsebuje rekombinantno beljakovino, zato lahko povzroči alergijske reakcije,
Children above 6 years were investigated through the pivotal phase 3 trial (F13CD-1725) and the extension study (F13CD-3720) assessing the safety of monthly replacement therapy with NovoThirteen.
Otroke, starejše od 6 let, so preučili v ključnem preskušanju 3. faze (F13CD-1725) in v podaljšani študiji (F13CD-3720), v kateri je bila ocenjena varnost mesečnega nadomestnega zdravljenja z zdravilom NovoThirteen.
Twenty-one children between the age of 6 to less than 18 years old and six children less than 6 years old have been treated with NovoThirteen for a total of 986 exposures.
Z zdravilom NovoThirteen je bilo zdravljenih enaindvajset otrok, starih med 6 in 18 let, in šest otrok, mlajših od 6 let, tako da je skupno število izpostavljenosti 986.
Monitoring NovoThirteen activity levels using a standard FXIII activity assay is recommended.
Raven aktivnosti zdravila NovoThirteen je priporočljivo nadzorovati s standardnim preizkusom aktivnosti FXIII.
• Indication of the product
• indikacijo za uporabo zdravila
The 6 patients below 6 years were investigated through a single dose pharmacokinetic phase 3b trial (F13CD-3760) and then, included in the long-term follow-up trial (F13CD-3835) assessing the safety and the efficacy of monthly replacement therapy with NovoThirteen.
Šest bolnikov, mlajših od 6 let, so preučili v farmakokinetičnem preskušanju faze 3b s posameznim odmerkom (F13CD-3760) in so jih nato vključili v dolgoročno spremljevalno preskušanje (F13CD3835), v katerem je bila ocenjena varnost in učinkovitost mesečnega nadomestnega zdravljenja z zdravilom NovoThirteen.
Bring the powder and solvent vials to a temperature not above 25°C by holding them in the hands.
Vialo s praškom in vialo z vehiklom ogrejte na temperaturo do 25 °C, tako da ju držite v rokah.
The half-life of NovoThirteen was assessed in the F13CD-1725 trial from a limited blood sampling scheme at 1 hour, 14 and 28 days post dose.
5.2 Farmakokinetične lastnosti Razpolovni čas zdravila NovoThirteen je bil določen v preskušanju F13CD-1725 iz omejenega števila vzorcev krvi, vzetih po shemi: 1 ura, 14 in 28 dni po odmerku.
After reconstitution, the medicinal product should be used immediately due to the risk of microbiological contamination.
2 leti Po pripravi je treba zdravilo zaradi tveganja za mikrobiološko kontaminacijo uporabiti takoj.
The medicinal product contains less than 1 mmol sodium (23 mg) per injection, indicating that it is essentially ‘sodium free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na injekcijo, kar v bistvu pomeni »brez natrija«.
• How to safely store, handle, reconstitute and administer the product
• navodila za varno shranjevanje in ravnanje z zdravilom, pripravo in dajanje zdravila
Long term prophylactic treatment of bleeding in patients with congenital factor XIII A-subunit deficiency.
Dolgoročno profilaktično zdravljenje krvavitev pri bolnikih s prirojenim pomanjkanjem podenote A faktorja XIII (FXIII).
The FXIII B-subunit acts as a carrier molecule for the FXIII A-subunit in circulation, and is present in excess in plasma.
Podenota B FXIII v obtoku deluje kot nosilna molekula podenote A in je v plazmi prisotna v presežku.
Powder (2500 IU) in a vial (glass type I) with rubber stopper (chlorobutyl) and 3.2 ml solvent in a vial (glass type I) with rubber stopper (bromobutyl) and a vial adapter for reconstitution.
Prašek (2500 i.e.) v viali (steklo tipa I) z zamaškom (klorobutil) in 3,2 ml vehikla v viali (steklo tipa I) z zamaškom (bromobutil) in nastavek za vialo za pripravo zdravila.
Remove the protective paper from the vial adapter without taking the vial adapter out of the protective cap.
Z nastavka za vialo odstranite zaščitni papir, vendar nastavka ne vzemite iz zaščitnega pokrovčka.
There is limited information on overdose with NovoThirteen.
Informacij o prevelikem odmerjanju zdravila NovoThirteen je malo.
Upon activation, the FXIII A-subunit dissociates from the FXIII B-subunit and thereby exposes the active site of the FXIII A-subunit.
Po aktivaciji se podenota A FXIII loči od podenote B in tako izpostavi aktivno mesto podenote A.
Incorrect storage of the product after reconstitution must be avoided as it may result in loss of sterility and in increased levels of non-proteolytically activated NovoThirteen.
Pripravljeno zdravilo je treba shranjevati pravilno, ker sicer lahko postane nesterilno, poleg tega pa se poveča količina neproteolitično aktiviranega zdravila NovoThirteen.
The crude bleeding rates in the two trials, F13CD-1725 and F13CD-3720, not adjusted for age, were 0.138 and 0.043 respectively, corresponding to a total of 13 bleeds over 223 subject-years and a pooled rate of 0.058.
Groba, za starost nekorigirana deleža krvavitev v preskušanjih F13CD-1725 in F13CD-3720 sta bila 0,138 v prvem in 0,043 v drugem; to ustreza skupnemu številu 13 krvavitev v 223 preiskovanec-letih in kumulativnemu deležu 0,058.
The product is now ready for injection in the vein.
Zdravilo je zdaj pripravljeno za injiciranje v veno.
No effects on reproductive organs were noted in the repeated dose toxicity studies.
V študijah toksičnosti ponavljajočih se odmerkov niso ugotovili učinkov na reproduktivne organe.
How to use NovoThirteen
Kako uporabljati zdravilo NovoThirteen
The active substance is produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
Učinkovina je pridobljena iz kvasovk (Saccharomyces cerevisiae) s tehnologijo rekombinantne DNA
• The other ingredients are for the powder sodium chloride, sucrose and polysorbate 20, L-histidine, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH adjustment) and for the solvent water for injections.
• Druge sestavine zdravila v prašku so natrijev klorid, saharoza, polisorbat 20, L-histidin, klorovodikova kislina (za uravnavanje pH) ter natrijev hidroksid (za uravnavanje pH).
Any residual material of the diluted product has to be discarded immediately.
Ves morebitni preostanek razredčenega zdravila morate takoj zavreči.
The dose volume for the reconstituted NovoThirteen diluted with 6 ml sodium chloride 0.9%, solution for injection can be calculated from this formula:
Velikost odmerka pripravljenega zdravila NovoThirteen, razredčenega s 6,0 ml 0,9 % raztopine natrijevega klorida za injiciranje, je mogoče izračunati po naslednji formuli:
A clot solubility assay is widely used as an indicator of FXIII deficiency, but the assay is qualitative, and when performed correctly the test is positive only when the FXIII activity in the sample is close to zero.
Vendar je ta preizkus kvalitativen in če je opravljen pravilno, je pozitiven le v primerih, ko je aktivnost FXIII v vzorcu skoraj nična.
No clinical findings were associated with these antibodies.
Pojav teh protiteles ni bil povezan s kliničnimi ugotovitvami.
There are no clinical data available on interaction between NovoThirteen and other medicinal products.
O medsebojnem delovanju zdravila NovoThirteen in drugih zdravil ni kliničnih podatkov.
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)
Hold the syringe slightly tilted with the vial facing downwards.
Držite brizgo rahlo nagnjeno, tako da je vstavljena viala spodaj.
• If you experience bleeding during your treatment with NovoThirteen occurring spontaneously and/or requiring treatment.
Nemudoma se posvetujte z zdravnikom: • če se vam med zdravljenjem z zdravilom NovoThirteen pojavi spontana krvavitev in/ali krvavitev zahteva zdravljenje.
Check the injection solution for particulate matter and for discolouration.
Preverite, da raztopina za injiciranje ne vsebuje delcev in da ni obarvana.
To reconstitute and administer this product the following tools are needed: a 10 ml syringe or a syringe of a convenient size according to injection volume, alcohol swabs, the included vial adapter and an infusion set (tubing, butterfly needle).
Za pripravo in dajanje tega zdravila boste potrebovali: eno 10-ml brizgo (ali brizgo primerne velikosti glede na količino, ki jo morate injicirati), alkoholne zložence, priloženi nastavek za vialo in infuzijski komplet (cevke, iglo z metuljčkom).
Your treatment with NovoThirteen should be initiated by a doctor experienced in the treatment of rare bleeding disorders.
Vaše zdravljenje mora predpisati zdravnik, ki ima izkušnje z zdravljenjem redkih motenj strjevanja krvi.
The Marketing Authorisation Holder (MAH) shall ensure that, at launch, a letter is sent to all expected and actual prescribers of NovoThirteen with an Educational Pack containing the following: Physician brochure Patient brochure
Imetnik dovoljenja za promet bo zagotovil, da bo ob prihodu zdravila na trg vsem zdravnikom, ki predpisujejo zdravilo NovoThirteen in za katere se pričakuje, da ga bodo predpisovali, poslano pismo z izobraževalnim kompletom.
To dilute the reconstituted NovoThirteen the following tools are needed: a vial containing sodium chloride 0.9%, solution for injection, a 10 ml syringe and alcohol swabs.
Za razredčenje pripravljenega zdravila NovoThirteen so potrebni naslednji pripomočki: viala, ki vsebuje 0,9 % raztopino natrijevega klorida za injiciranje, 10-ml brizga in alkoholni zloženci.
No effects on reproductive organs have been seen in non-clinical studies.
Plodnost V nekliničnih študijah niso ugotovili vplivov na reproduktivne organe.