FrancophonIA/ELRC3.0 huggingface dataset:
English: Breast-feeding should be discontinued during treatment with pazopanib.
Slovenian: V primeru pojava nefrotskega sindroma je treba zdravljenje s pazopanibom prekiniti.
English: Votrient 200 mg film-coated tablets Votrient 400 mg film-coated tablets pazopanib
Slovenian: Votrient 200 mg filmsko obložene tablete Votrient 400 mg filmsko obložene tablete pazopanib
English: (CYP3A4 and CYP2C8 substrate) once weekly resulted in a mean increase of 26% and 31% in paclitaxel AUC and Cmax, respectively.
Slovenian: Pri sočasni uporabi pazopaniba v odmerku 800 mg enkrat na dan in paklitaksela v odmerku 80 mg/m (substrat za CYP3A4 in CYP2C8) enkrat na teden, se je srednja vrednost AUC paklitaksela povečala za 26 %, Cmax paklitaksela pa za 31 %.
English: Investigations
Slovenian: Ukrepanje
English: You will be checked for any lung problems while you are taking Votrient.
Slovenian: Med zdravljenjem z zdravilom Votrient vas bodo pregledovali glede morebitnih težav s pljuči.
English: P value = 0.245 (2-sided)
Slovenian: ROg = razmerje ogroženosti, PFS = preživetje brez napredovanja a vrednost p = 0,245 (2-stranska)
English: Photosensitivity reaction
Slovenian: Trajanje odziva
English: Hepatic effects
Slovenian: Hemoragični dogodki
English: Uncommon Retinal detachment† 1 (<1%) Retinal tear†
Slovenian: Očesne bolezni pogosti zamegljen vid občasni odstop mrežnice† 1 (< 1 %) pretrganje mrežnice† 1 (< 1 %) sprememba barve trepalnic
English: All patients should be observed closely for signs and symptoms of thyroid dysfunction on pazopanib treatment.
Slovenian: Med zdravljenjem s pazopanibom je treba vse bolnike skrbno nadzirati glede pojava znakov ali simptomov zmanjšanega delovanja ščitnice.
English: Votrient can have side effects that may affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Nekateri neželeni učinki zdravila Votrient lahko vplivajo na sposobnost upravljanja vozil in strojev.
English: How to store Votrient
Slovenian: Shranjevanje zdravila Votrient
English: Pazopanib should be used with caution in patients with significant risk of haemorrhage.
Slovenian: Pri bolnikih s pomembnim tveganjem za pojav krvavitev je treba pazopanib uporabljati previdno.
English: Myocardial dysfunction occurred in 13% (47/362) of subjects in the pazopanib arm compared to 11% (42/369) of subjects in the sunitinib arm. Congestive heart failure was observed in 0.5% of subjects in each treatment arm. Congestive heart failure was reported in 3 out of 240 subjects (1%) in the Phase III VEG110727 STS study.
Slovenian: Moteno delovanje miokarda se je pojavilo pri 13 % preiskovancev (47/362), ki so prejemali pazopanib, in pri 11 % preiskovancev (42/369), ki so prejemali sunitinib.
English: Talk to your doctor before taking Votrient: - if you have heart disease.
Slovenian: Med zdravljenjem z zdravilom Votrient vas bo zdravnik nadzoroval glede pojava težav s srcem.
English: Hyperbilirubinaemia 38 (3%) Hepatic function abnormal
Slovenian: Bolezni jeter, žolčnika in žolčevodov pogosti hiperbilirubinemija 38 (3 %) nenormalno delovanje jeter hepatotoksičnost občasni zlatenica z zdravilom povzročena okvara jeter odpoved jeter
English: If you take too many tablets, contact a doctor or pharmacist for advice.
Slovenian: Če ste vzeli večji odmerek zdravila Votrient, kot bi smeli Če ste vzeli večje število tablet, kot bi smeli, se posvetujte z zdravnikom ali farmacevtom.
English: A similar proportion of patients in each arm were treatment-naïve and cytokine pre-treated (53% and 47% in pazopanib arm, 54% and 46% in placebo arm).
Slovenian: V obeh skupinah je bil delež bolnikov, ki se predhodno še niso zdravili, podoben deležu bolnikov, ki so se že zdravili s citokini (v skupini, ki je prejemala pazopanib se 53 % bolnikov predhodno še ni zdravilo, 47 % bolnikov pa se je predhodno že zdravilo s citokini, v skupini, ki je prejemala placebo pa se predhodno še ni zdravilo 54 % bolnikov, s citokini pa se je predhodno zdravilo 46 % bolnikov).
English: Titanium dioxide (E171)
Slovenian: Obloga tablete hipromeloza makrogol 400 polisorbat 80 titanov dioksid (E171)
English: A reduced pazopanib dose of 200 mg once daily is recommended in patients with moderate hepatic impairment (elevation of bilirubin >1.5 to 3 x ULN regardless of the ALT value) (see sections 4.2 and 5.2).
Slovenian: Za bolnike z blagimi nepravilnostmi serumskih jetrnih testov (bodisi z normalnim bilirubinom in kakršnim koli zvišanjem ALT bodisi z zvišanjem bilirubina do 1,5-kratne ZMN ne glede na vrednost ALT) je priporočeni odmerek 800 mg pazopaniba enkrat na dan. Za bolnike z zmerno okvaro jeter (zvišanje bilirubina na > 1,5- do 3-kratno ZMN ne glede na vrednost ALT) je priporočljiv manjši odmerek pazopaniba 200 mg enkrat na dan (glejte poglavji 4.2 in 5.2).
English: Figure 3 Kaplan-Meier Curve for progression-free survival by independent assessment for the cytokine pre-treated population (VEG105192)
Slovenian: Slika 3 Kaplan-Meierjeva krivulja časa preživetja brez napredovanja bolezni na osnovi neodvisne presoje za bolnike, ki so se predhodno že zdravili s citokini (VEG105192)
English: Uncommon Tumour pain
Slovenian: občasni tumorska bolečina
English: Uncommon Hypertensive crisis Haemorrhage
Slovenian: Psihiatrične motnje pogosti nespečnost
English: ILD, which can be fatal, has been reported in association with pazopanib (see section 4.8).
Slovenian: V povezavi s pazopanibom je bila opisana IBP, ki se lahko konča smrtno (glejte poglavje 4.8).
English: Uncommon Rhinorrhoea Pulmonary haemorrhage
Slovenian: Globoka venska tromboza in pljučna embolija
English: Don't breast-feed while taking Votrient.
Slovenian: Med zdravljenjem z zdravilom Votrient ne smete dojiti.
English: Votrient 200 mg film-coated tablets pazopanib
Slovenian: Votrient 200 mg filmsko obložene tablete pazopanib
English: Very common Hair colour change 404 (35%) 1 (<1%) Palmar-plantar erythrodysaesthesia syndrome
Slovenian: Bolezni kože in podkožja zelo pogosti sprememba barve las hipopigmentacija kože 80 (21 %) eksfoliativni izpuščaj pogosti alopecija spremembe na koži c suha koža čezmerno znojenje spremembe na nohtih 13 (3 %) srbenje eritem občasni kožni ulkus izpuščaj papulozni izpuščaj fotosenzibilnostna reakcija 1 (< 1 %) sindrom palmarnoplantarne eritrodisestezije
English: Cerebral infarction 1 (<1%)
Slovenian: Zelo pogosti proteinurija občasni krvavitev v sečilih 1 (< 1 %)
English: Votrient can increase your likelihood of having a stroke.
Slovenian: Zdravilo Votrient lahko poveča tveganje za možgansko kap.
English: Votrient 400 mg film-coated tablets pazopanib
Slovenian: Votrient 400 mg filmsko obložene tablete pazopanib
English: In clinical studies with pazopanib, events of hypothyroidism have occurred (see section 4.8).
Slovenian: V kliničnih študijah s pazopanibom so poročali o primerih zmanjšanega delovanja ščitnice (glejte poglavje 4.8).
English: The risks and benefits of pazopanib should be considered before beginning therapy in patients who have pre-existing cardiac dysfunction.
Slovenian: Pred začetkom zdravljenja bolnikov s predobstoječimi motnjami delovanja srca je treba upoštevati tveganja in koristi pazopaniba.
English: Reproductive system and breast disorders
Slovenian: Infekcijske in parazitske bolezni pogosti okužba dlesni
English: Pazopanib should be used with caution in patients at risk for GI perforation or fistula.
Slovenian: Pri bolnikih s tveganjem za pojav perforacije ali fistule v gastrointestinalnem traktu je treba pazopanib uporabljati previdno.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni jeter, žolčnika in žolčevodov občasni nenormalno delovanje jeter
English: Frequent bowel movements
Slovenian: Zmerna okvara jeter
English: Do not drink grapefruit juice while you are being treated with Votrient as this may increase the chance of side effects.
Slovenian: Med zdravljenjem z zdravilom Votrient ne smete uživati soka grenivke.
English: * - treatment-naïve and cytokine pre-treated populations
Slovenian: * - Predhodno še nezdravljeni bolniki in bolniki, ki so se predhodno že zdravili s citokini.
English: Uncommon Oropharyngeal pain 3 (<1%) Bronchial haemorrhage 2 (<1%) Rhinorrhoea
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti epistaksa disfonija dispneja hemoptiza občasni rinoreja pljučna krvavitev 2 (< 1 %) pnevmotoraks redki intersticijska bolezen pljuč/pnevmonitis†
English: Lung inflammation
Slovenian: Krvni strdki
English: Common Dehydration Uncommon Hypomagnesaemia
Slovenian: Bolezni endokrinega sistema pogosti hipotiroidizem 18
English: You will be checked for thyroid hormone levels while you are taking Votrient.
Slovenian: Med zdravljenjem z zdravilom Votrient bo zdravnik spremljal vrednost ščitničnih hormonov.
English: Do not break or crush the tablets as this affects the way the medicine is absorbed and may increase the chance of side effects.
Slovenian: To lahko vpliva na absorpcijo zdravila iz črevesa in poveča tveganje za pojav neželenih učinkov.
English: Of note, patients with adipocytic sarcoma were excluded from the pivotal Phase III study as in a preliminary Phase II study (VEG20002) activity (PFS at week 12) observed with pazopanib in adipocytic did not meet the prerequisite rate to allow further clinical testing.
Slovenian: (preživetje brez napredovanja po 12 tednih) pri adipocitnem sarkomu ni izpolnilo vnaprej zahtevanega deleža, ki bi dopuščal nadaljnje klinično preizkušanje.
English: Rare
Slovenian: Blaga
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Slovenian: Izgled zdravila Votrient in vsebina pakiranja
English: Decreased corpora lutea, increased cysts and ovarian atrophy have also been noted in rodents.
Slovenian: Pri glodavcih so opazili tudi zmanjšanje rumenih telesc, pogostejše ciste in atrofije jajčnikov.
English: (Invented) name Pharmaceutical form Route of administration
Slovenian: (Izmišljeno) ime Farmacevtska oblika Pot uporabe
English: 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Slovenian: 2 matriksa 4,8 x 4,8 cm
English: Continue with the remaining steps.
Slovenian: Nadaljujte s preostalimi koraki.
English: ● At the request of the European Medicines Agency;
Slovenian: ● na zahtevo Evropske agencije za zdravila;
English: Get ready:
Slovenian: Pripravite se:
English: >48 hours
Slovenian: > 48 ur
English: In children less than one year of age, the blood system is still developing.
Slovenian: Pri otrocih, mlajših od enega leta, se krvni sistem še vedno razvija.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če ni uporabljeno takoj, so čas in pogoji shranjevanja odgovornost uporabnika.
English: Your doctor or nurse will give more information about this.
Slovenian: Zdravnik ali medicinska sestra vam bosta o tem dala več informacij.
English: Higher scores indicate better quality of life.
Slovenian: Višje ocene pomenijo boljšo kakovost življenja.
English: Loss of efficacy was reported in 1 out of 398 patients.
Slovenian: O izgubi učinkovitosti so poročali pri 1 od 398 bolnikov.
English: ● Let the skin dry for about 10 seconds.
Slovenian: ● Pustite približno 10 sekund, da se koža posuši.
English: In some cases, this can cause damage to the kidneys and other organs.
Slovenian: V nekaterih primerih lahko to poškoduje ledvice in druge organe.
English: Please see below recommended features:
Slovenian: Za njihove priporočene lastnosti glejte spodaj:
English: Children below the age of 1 year
Slovenian: Otroci, mlajši od 1 leta
English: <24 hours 24-48 hours
Slovenian: < 24 ur 24-48 ur
English: ● Wash your hands well with soap and water.
Slovenian: ● Roke si dobro umijte z milom in vodo.
English: Clinically meaningful difference: Total score: 7 points; Physical Health: 10 points.
Slovenian: Klinično pomembna razlika: celotna ocena: 7 točk; telesno zdravje: 10 točk.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Slovenian: Ker študij kompatibilnosti ni na voljo, se zdravila ne sme mešati z drugimi zdravili.
English: ● Only use the vial once.
Slovenian: ● Vialo uporabite le enkrat.
English: No dose adjustment is required for this demographic factor.
Slovenian: Prilagoditev odmerka glede na ta demografski dejavnik ni potrebna.
English: Do not use if they appear damaged or if they have been dropped.
Slovenian: Ne uporabite ga, če je videti poškodovan, ali če je kam padel.
English: Use of aPCC should be avoided unless no other treatment options/alternatives are available.
Slovenian: Uporabi aPCC se je treba izogniti, razen če ni na voljo nobenih drugih alternativ/možnosti zdravljenja.
English: Use aPCC only if no other treatment can be used.
Slovenian: aPCC uporabljajte le, če ni mogoče uporabiti nobenega drugega zdravljenja.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 2018
Slovenian: Datum prve odobritve: 23. februar 2018
English: In case of clinical signs of loss of efficacy, a change of treatment should be considered.
Slovenian: V primeru znakov izgube učinkovitosti je treba razmisliti o spremembi zdravljenja.
English: ● if you are allergic to emicizumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: ● če ste alergični na emicizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: - upright and stable during use.
Slovenian: - biti pokončen in stabilen med uporabo.
English: Injecting into a muscle could cause discomfort.
Slovenian: Injiciranje v mišico lahko povzroči neugodje.
English: Includes all instances of aPCC treatment excluding those in the first 7 days and those that occurred 30 days after the discontinuation of Hemlibra.
Slovenian: Vključuje vse primere zdravljenja z aPCC, razen tistih v prvih 7 dneh in tistih, ki so se zgodili 30 dni po prekinitvi zdravila Hemlibra.
English: Human IgG is known to be present in human milk.
Slovenian: Znano je, da je človeški IgG pri človeku prisoten v materinem mleku.
English: Based on limited data, there is no evidence to suggest a difference in efficacy or safety in patients aged 65 years or above.
Slovenian: Na podlagi majhnega števila podatkov ni dokazov o različni učinkovitosti in varnosti pri bolnikih, starih 65 let ali več.
English: The loading dose regimen is the same, irrespective of the maintenance dose regimen.
Slovenian: Shema polnilnih odmerkov je enaka, ne glede na shemo vzdrževalnega odmerka.
English: Examples:
Slovenian: Primeri:
English: If you stop using Hemlibra, you may no longer be protected against bleeding.
Slovenian: Če prenehate uporabljati zdravilo Hemlibra, morda ne boste več zaščiteni pred krvavitvami.
English: If your child is less than one year old, your doctor may prescribe Hemlibra only after carefully weighing the expected benefits and risks of using this product.
Slovenian: Če je vaš otrok star manj kot eno leto, mu lahko zdravnik zdravilo Hemlibra predpiše le, ko skrbno pretehta pričakovane koristi in tveganja uporabe tega zdravila.
English: Each time you use Hemlibra, record the name and batch number of the medicine.
Slovenian: Vsakič, ko uporabite zdravilo Hemlibra, zabeležite ime in številko serije zdravila.
English: Monoclonal antibodies are a type of protein that recognise and bind to a target in the body.
Slovenian: Monoklonska protitelesa so vrsta beljakovin, ki v telesu prepoznajo določen cilj in se vežejo nanj.
English: * An instance of aPCC treatment is defined as all doses of aPCC received by a patient, for any reason, until there was a 36-hour treatment-free break.
Slovenian: * Primer zdravljenja z aPCC je opredeljen kot vsi odmerki aPCC, ki jih je bolnik prejel iz kakršnega koli razloga, do 36-urnega obdobja brez zdravljenja.
English: The vials should never be exposed to temperatures above 30 °C.
Slovenian: Viale ne smejo biti nikoli izpostavljene temperaturam nad 30 °C.
English: Delayed or missed doses
Slovenian: Zapozneli ali izpuščeni odmerki
English: Pharmacotherapeutic group: antihemorrhagics, other systemic hemostatics; ATC code: B02BX06
Slovenian: Farmakoterapevtska skupina: antihemoragiki, drugi hemostatiki za sistemsko zdravljenje; oznaka ATC: B02BX06
English: ● Do not throw away any used sharps disposal container in your household waste unless your local guidelines permit this.
Slovenian: ● Ne zavrzite odrabljenega vsebnika za ostre odpadke med gospodinjske odpadke, razen če vaše lokalne smernice to dovoljujejo.
English: ● If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Slovenian: ● Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden uporabite to zdravilo.
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
English: If aPCC is required, talk to your doctor in case you feel you need a total of more than 50 units/kg of aPCC.
Slovenian: Če je aPCC potreben, se posvetujte z zdravnikom, če menite, da potrebujete skupaj več kot 50 enot aPCC na kilogram.
English: Calculated ABR
Slovenian: Izračunani ABR
English: Analyses are based on data from individuals who provided responses at both baseline and Week 25 assessments.
Slovenian: Analize temeljijo na podatkih posameznikov z odzivi na podlagi ocen v izhodišču in v 25. tednu.
English: For more information, see in section 6 “What is needed for Hemlibra administration and is not contained in this pack”.
Slovenian: Za več informacij glejte poglavje 6, "Kaj je potrebno za dajanje zdravila Hemlibra in ni priloženo v tem pakiranju".
English: ● Remove syringe cap (if required).
Slovenian: ● Odstranite pokrovček brizge (če je potrebno).
English: Of all instances of aPCC treatment, 68 % consisted of only one infusion < 100 U/kg.
Slovenian: Med vsemi zdravljenji z aPCC jih je 68 % obsegalo le eno infuzijo < 100 e./kg.
English: Store in a refrigerator (2°C to 8°C).
Slovenian: Shranjujte v hladilniku (od 2 do 8 °C).
English: Evidence of improvement was seen within one week following discontinuation of aPCC and interruption of Hemlibra.
Slovenian: Dokaze o izboljšanju so opazili v enem tednu po prenehanju uporabe aPCC in prekinitvi zdravljenja z zdravilom
English: Pinching the skin is important to ensure that you inject under the skin (into fatty tissue) but not any deeper (into muscle).
Slovenian: Stisk kože v gubo je pomemben, da zagotovite injiciranje pod kožo (v maščobno tkivo), ne pa globlje (v mišico).
English: Do not save unused medicine in the vial for later use.
Slovenian: Neporabljenega zdravila v viali ne shranjujte za poznejšo uporabo.
English: Hemlibra is intended for long-term prophylactic treatment.
Slovenian: Zdravilo Hemlibra je namenjeno za dolgotrajno profilaktično zdravljenje.
English: The dose and duration of treatment with bypassing agents will depend on the location and extent of bleeding, and the patient's clinical condition.
Slovenian: Odmerek in trajanje zdravljenja z obvodnimi zdravili sta odvisna od mesta in obsežnosti krvavitve ter bolnikovega kliničnega stanja.
English: No patients with such characteristics were enrolled in clinical trials.
Slovenian: Bolniki s takšnimi značilnostmi niso bili vključeni v klinična preskušanja.
English: Chromogenic factor VIII activity tests may be manufactured with either human or bovine coagulation proteins.
Slovenian: Kromogeni testi aktivnosti faktorja VIII so lahko izdelani s človeškimi ali govejimi koagulacijskimi beljakovinami.
English: Factor VIII (FVIII) prophylaxis may be continued for the first 7 days of Hemlibra treatment.
Slovenian: Profilaksa s faktorjem VIII (FVIII) se lahko nadaljuje še prvih 7 dni zdravljenja z zdravilom Hemlibra.
English: This is because Hemlibra in the blood may interfere with some laboratory tests, leading to inaccurate results.
Slovenian: Zdravilo Hemlibra v krvi namreč lahko zmoti nekatere laboratorijske preiskave in povzroči netočne rezultate.
English: ● Once the syringe has been filled with the medicine, the injection must be given immediately.
Slovenian: ● Ko je brizga napolnjena z zdravilom, je treba injekcijo dati takoj.
English: No fertility data are available in humans.
Slovenian: Podatkov o plodnosti pri človeku ni na voljo.
English: Be cautious if you are at high risk for this condition (have had this condition in the past, or a member of your family have suffered from it), or if you are taking medicines that can increase the risk of developing this condition, such as ciclosporin, quinine or tacrolimus.
Slovenian: Bodite previdni, če imate za to stanje veliko tveganje (če ste ga v preteklosti že imeli ali ga je imel/ima vaš družinski član) ali če uporabljate zdravila, ki lahko povečajo tveganje za razvoj tega stanja, kot so ciklosporin, kinin ali takrolimus.
English: If you inject Hemlibra yourself or if your caregiver injects it, you or your caregiver must carefully read and follow the instructions in section 7, “Instructions for use”.
Slovenian: Če si zdravilo Hemlibra injicirate sami ali vam ga injicira skrbnik, morate vi ali vaš skrbnik skrbno prebrati in upoštevati navodila v poglavju 7, "Navodila za uporabo".
English: ● 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 as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: ● 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 kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: ● Once you have been trained, you should be able to inject this medicine at home, by yourself or with the help of a caregiver.
Slovenian: ● Ko boste usposobljeni, boste lahko zdravilo injicirali doma, bodisi sami bodisi s pomočjo skrbnika.
English: Haem-A-QoL at week 25
Slovenian: Ocene Haem-A-QoL v 25. tednu
English: There are no data in patients over 77 years old.
Slovenian: Za bolnike, starejše od 77 let, ni podatkov.
English: ● Thigh (front and middle).
Slovenian: ● stegno (sprednji in srednji del),
English: IgG antibodies are mainly catabolised by lysosomal proteolysis and then eliminated from or reused by the body.
Slovenian: Protitelesa IgG se v glavnem katabolizirajo z lizosomsko proteolizo in jih telo nato izloči ali ponovno uporabi.
English: The patient dose (in mg) and volume (in mL) should be calculated as follows:
Slovenian: Bolnikov odmerek (v mg) in volumen (v ml) zdravila je treba izračunati takole:
English: ● Hold plunger firmly to ensure it does not pull back in.
Slovenian: ● Močno primite bat, da zagotovite, da ga ne povleče nazaj noter.
English: Parameters
Slovenian: Parametri
English: In healthy subjects, the absolute bioavailability following subcutaneous administration of 1 mg/kg was between 80.4% and 93.1% depending on the injection site.
Slovenian: Pri zdravih preiskovancih je bila absolutna biološka uporabnost po subkutani uporabi 1 mg/kg med 80,4 % in 93,1 %, odvisno od mesta injiciranja.
English: Clinical experience indicates a drug interaction exists with emicizumab and aPCC (see sections 4.4 and 4.8).
Slovenian: Klinične izkušnje kažejo, da obstaja medsebojno delovanje med emicizumabom in aPCC (glejte poglavji 4.4 in 4.8).
English: ● If you do not hear a click, look to see that the needle is fully covered by the safety shield.
Slovenian: ● Če ne zaslišite klika, preverite, ali varnostni ščitnik povsem pokriva iglo.
English: Important information after the injection:
Slovenian: Pomembne informacije po injiciranju zdravila:
English: ● Do not inject yourself or someone else unless you have been shown how to by your healthcare provider.
Slovenian: ● Ne injicirajte zdravila sebi ali komu drugemu, dokler vam zdravnik ne pokaže, kako to naredite.