FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.>
Slovenian: Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke o tem zdravilu.
English: The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.>
Slovenian: Evropska agencija za zdravila bo vsaj enkrat letno ponovno pregledala nove podatke o tem zdravilu.
English: If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte <z>
 <zdravnikom> <ali><,> <farmacevtom> <ali medicinsko sestro>.
English: Talk to your doctor <or> <,> <pharmacist> <or nurse> before <taking> <using> X
Slovenian: Pred začetkom <jemanja> <uporabe> zdravila X se posvetujte <z> zdravnikom <ali><,> <farmacevtom> <ali medicinsko sestro>.
English: PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING>
Slovenian: PODATKI NA <ZUNANJI OVOJNINI> <IN> <PRIMARNI OVOJNINI> {VRSTA/TIP}
English: <Medicinal product subject to medical prescription.>
Slovenian: <Predpisovanje in izdaja zdravila je le na recept.>
English: The European Medicines Agency will review new information on this medicinal product at least every year and this SmPC will be updated as necessary.>
Slovenian: Evropska agencija za zdravila bo vsaj enkrat letno ponovno pregledala nove podatke o zdravilu.
English: The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary.>
Slovenian: Evropska agencija za zdravila bo vsako leto pregledala vse nove podatke, ki bodo na voljo.
English: Immediate Packaging
Slovenian: Pot uporabe Stična ovojnina Velikost Pakiranja
English: Zinbryta daclizumab
Slovenian: Zinbryta daklizumab
English: The recommended dose is 150 mg once a month by injection under the skin.
Slovenian: Priporočeni odmerek je 150 mg enkrat na mesec z injekcijo pod kožo.
English: The full EPAR for Zinbryta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zinbryta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Zinbryta.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zinbryta.
English: Treatment is associated with adverse effects on the liver and an increased risk of infections but the CHMP considered these could be managed with regular monitoring.
Slovenian: Zdravljenje je povezano z neželenimi učinki na jetra in povečanim tveganjem za okužbe, vendar je odbor CHMP menil, da se jih lahko nadzoruje z rednim spremljanjem.
English: What measures are being taken to ensure the safe and effective use of Zinbryta?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zinbryta?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zinbryta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Zinbryta večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The most common side effects with Zinbryta (which may affect more than 1 in 100 people) are rash, increased liver enzymes in the blood, depression, inflamed and sore nose and throat, influenza and upper respiratory tract infection such as colds and lymphadenopathy (swollen glands).
Slovenian: Najpogostejši neželeni učinki zdravila Zinbryta (ki lahko prizadenejo več kot 1 osebo od 100) so izpuščaj, povečana raven jetrnih encimov v krvi, depresija, vnet in boleč nos in žrelo, gripa in vnetje zgornjih dihal, kot so prehladi in limfadenopatija (otekle bezgavke).
English: Zinbryta has been found to be effective in studies carried out over up to 3 years.
Slovenian: Zdravilo Zinbryta se je izkazalo kot učinkovito v študijah, ki so jih izvajali v obdobju do 3 let.
English: Zinbryta works in a different way to existing treatments and has the advantage that it is given just once a month.
Slovenian: Zdravilo Zinbryta deluje na drugačen način kot obstoječa zdravila in njegova prednost je, da se daje samo enkrat na mesec.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zinbryta have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito uporabo zdravila Zinbryta, so prav tako vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The company that markets Zinbryta will issue educational materials for healthcare professionals and for patients about liver damage and how to prevent or reduce the damage.
Slovenian: Družba, ki trži zdravilo Zinbryta, bo izdala izobraževalno gradivo za zdravstvene delavce in bolnike o poškodbi jeter ter o tem, kako preprečiti ali omiliti poškodbo.
English: Daclizumab may also have other effects that reduce the immune system's damaging effects on nerve cells.
Slovenian: Daklizumab ima lahko tudi druge učinke, ki zmanjšajo škodljive učinke imunskega sistema na živčne celice.
English: attacking and damaging nerve cells.
Slovenian: poškodovale živčne celice.
English: Other information about Zinbryta
Slovenian: Druge informacije o zdravilu Zinbryta
English: Patients receiving Zinbryta 150 mg every 4 weeks had on average 0.21 relapses over a year compared with 0.46 in those receiving placebo.
Slovenian: Bolniki, ki so prejemali 150 mg zdravila Zinbryta vsake 4 tedne, so imeli na leto v povprečju 0,21 recidiva, v primerjavi z 0,46 recidiva pri tistih, ki so prejemali placebo.
English: Patients should be trained to give themselves the injection using either a prefilled syringe or an injection pen device.
Slovenian: Bolnike je treba naučiti, da si zdravilo injicirajo sami s pomočjo napolnjene injekcijske brizge ali injekcijskega peresnika.
English: In another study involving 1,841 patients, patients receiving Zinbryta 150 mg every 4 weeks had on average 0.22 relapses over a year compared with 0.39 in those receiving interferon beta-1a, another medicine used for multiple sclerosis.
Slovenian: V drugi študiji, ki je vključevala 1 841 bolnikov, so bolniki, ki so prejemali 150 mg zdravila Zinbryta vsake 4 tedne, imeli na leto povprečno 0,22 recidiva, v primerjavi z 0,39 recidiva pri tistih, ki so prejemali interferon beta-1a, drugo zdravilo za zdravljenje multiple skleroze.
English: By attaching to the T cells, daclizumab blocks interleukin-2, so preventing T cells from
Slovenian: Z vezavo na celice T daklizumab zavira interlevkin-2 in s tem preprečuje, da bi celice T napadale in
English: In one study involving 600 patients, Zinbryta was found to be more effective than placebo (a dummy treatment) at reducing relapses of the condition.
Slovenian: V eni študiji, ki je vključevala 600 bolnikov, se je zdravilo Zinbryta izkazalo učinkovitejše od placeba (zdravila brez zdravilne učinkovine) pri zmanjševanju recidivov bolezni.
English: The most common serious side effects of Zinbryta are liver damage and severe skin reactions.
Slovenian: Najpogostejši resni neželeni učinki zdravila Zinbryta sta poškodba jeter in hude kožne reakcije.
English: For more information about treatment with Zinbryta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Zinbryta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Zinbryta and what is it used for?
Slovenian: Kaj je zdravilo Zinbryta in za kaj se uporablja?
English: What benefits of Zinbryta have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Zinbryta izkazalo v študijah?
English: What are the risks associated with Zinbryta?
Slovenian: Kakšna tveganja so povezana z zdravilom Zinbryta?
English: In multiple sclerosis, the body's immune (defence) system incorrectly attacks and damages the protective sheath around the nerve cells in the central nervous system (the brain and spinal cord).
Slovenian: Pri multipli sklerozi imunski (obrambni) sistem telesa nepravilno napade in poškoduje zaščitno ovojnico okoli živčnih celic v osrednjem živčnem sistemu (možganih in hrbtenjači).
English: For the full list of restrictions and of all side effects reported with Zinbryta, see the package leaflet.
Slovenian: Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Zinbryta, glejte navodilo za uporabo.
English: Why is Zinbryta approved?
Slovenian: Zakaj je bilo zdravilo Zinbryta odobreno?
English: Zinbryta is a medicine used to treat adults with the relapsing forms of multiple sclerosis.
Slovenian: Zdravilo Zinbryta se uporablja za zdravljenje odraslih z recidivno obliko multiple skleroze.
English: It is not intended to provide practical advice on how to use Zinbryta.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: For practical information about using Zinbryta, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Zinbryta naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Zinbryta can only be obtained with a prescription and treatment should be started by a doctor with experience in managing multiple sclerosis.
Slovenian: Izdaja zdravila Zinbryta je le na recept, zdravljenje pa mora uvesti zdravnik z izkušnjami z zdravljenjem multiple skleroze.
English: How is Zinbryta used?
Slovenian: Kako se zdravilo Zinbryta uporablja?
English: How does Zinbryta work?
Slovenian: Kako zdravilo Zinbryta deluje?
English: These cells form part of the body's immune system and they are activated by interleukin-2, a signalling protein in the body.
Slovenian: Zdravilna učinkovina v zdravilu Zinbryta, daklizumab, je monoklonsko protitelo, ki napada celice T. Te celice oblikujejo del imunskega sistema telesa in se aktivirajo s pomočjo interlevkina-2, signalne beljakovine v telesu.
English: Zinbryta contains the active substance daclizumab.
Slovenian: Zdravilo Zinbryta vsebuje zdravilno učinkovino daklizumab.
English: Zinbryta has been found effective for treating relapsing multiple sclerosis in two main studies involving over 2,400 patients.
Slovenian: V dveh glavnih študijah, ki sta vključevali več kot 2 400 bolnikov, se je zdravilo Zinbryta izkazalo kot učinkovito za zdravljenje recidivne multiple skleroze.
English: Once removed from the refrigerator:
Slovenian: Po odstranitvi iz hladilnika:
English: Dosing recommendations for elderly patients are the same as for adult patients.
Slovenian: Priporočila za odmerjanje so pri starejših bolnikih enaka kot pri odraslih bolnikih.
English: A risk to breastfed newborns/infants cannot be excluded.
Slovenian: Tveganja za dojene novorojence/dojenčke ni mogoče izključiti.
English: Not known: frequency cannot be estimated from the available data • Allergic reactions (including anaphylactic reactions)
Slovenian: Neznana: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov • Alergijske reakcije (vključno z anafilaktičnimi reakcijami)
English: Before you are given Parsabiv, tell your doctor if you have or have ever had:
Slovenian: Preden boste dobili zdravilo Parsabiv, morate svojemu zdravniku povedati, če imate ali ste kdaj imeli:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 November 2016
Slovenian: Datum prve odobritve: 11. november 2016
English: Body weight, gender, age, race
Slovenian: Telesna masa, spol, starost, rasa
English: The safety and efficacy of etelcalcetide in children and adolescents less than 18 years has not yet been established.
Slovenian: Varnost in učinkovitost etelkalcetida pri otrocih in mladostnikih, mlajših od 18 let, še nista dokazani.
English: Tell your doctor if you are taking cinacalcet or have recently taken cinacalcet.
Slovenian: Obvestite zdravnika, če jemljete cinakalcet ali ste pred kratkim jemali cinakalcet.
English: The extent and duration of the reduction in PTH increased with increasing dose.
Slovenian: Izrazitost in trajanje znižanja PTH sta se s povečevanjem odmerka povečevala.
English: 6 See section 4.4.
Slovenian: 6 Glejte poglavje 4.4.
English: Additional recommendations related to the management of low calcium are provided in the table below.
Slovenian: Dodatna priporočila v zvezi z obravnavo nizkega kalcija so navedena v spodnji tabeli.
English: The inter-subject variability of the system clearance in the patient population is approximately
Slovenian: Interindividualna variabilnost sistemskega očistka v populaciji bolnikov je približno
English: Demographic and baseline characteristics between the two groups in each study were similar.
Slovenian: Demografske in izhodiščne značilnosti med skupinama so bile v obeh študijah podobne.
English: Dose adjustment may be necessary at any time during treatment including the maintenance phase.
Slovenian: Prilagoditev odmerka je lahko potrebna kadar koli med zdravljenjem, tudi med obdobjem vzdrževalnega zdravljenja.
English: Pack sizes of 1, 6, 12 and 42 vials.
Slovenian: Velikosti pakiranj z 1, 6, 12 in 42 vialami.
English: 80.3% of these had pre-existing antibodies.
Slovenian: 80,3 % teh bolnikov je imelo protitelesa že prej.
English: It is not known whether Parsabiv is safe and effective in children less than 18 years of age as it has not been studied in these patients.
Slovenian: Ni znano, ali je zdravilo Parsabiv varno in učinkovito pri otrocih, mlajših od 18 let, ker pri teh bolnikih ni raziskano.
English: Parsabiv should not be administered more frequently than 3 times per week.
Slovenian: Zdravila Parsabiv se ne sme uporabljati pogosteje kot 3-krat na teden.
English: Adverse reactions are listed below using 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).
Slovenian: Neželeni učinki so navedeni spodaj upoštevaje naslednji dogovor: zelo pogosti (≥ 1/10), pogosti (od ≥ 1/100 do < 1/10), občasni (od ≥ 1/1.000 do < 1/100), redki (od ≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Do not use Parsabiv if you are allergic to etelcalcetide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Parsabiv, če ste alergični na etelkalcetid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: No special temperature storage requirements are needed.
Slovenian: Posebnih zahtev glede temperature med shranjevanjem ni.
English: Demographics and other baseline characteristics were similar to the placebo-controlled studies.
Slovenian: Demografske in druge izhodiščne značilnosti so bile podobne kot v študijah, kontroliranih s placebom.
English: The mean age of patients across the 2 studies was 58.2 (range 21 to 93) years.
Slovenian: Povprečna starost bolnikov v obeh študijah je bila 58,2 leta (razpon: od 21 do 93).
English: Other laboratory assays may have different cut-offs for the lower limit of the normal range.
Slovenian: Drugi laboratorijski testi imajo lahko drugačne meje spodnje vrednosti normalnega območja.
English: The dose may be increased up to 15 mg or lowered down to 2.5 mg depending on your response.
Slovenian: Odmerek je mogoče povečati do 15 mg ali ga zmanjšati do 2,5 mg, odvisno od vašega odziva.
English: Do not use this medicine if you notice it has particles or it has changed colour.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da zdravilo vsebuje delce, ali je spremenjene barve.
English: All effects were reversible upon cessation of treatment.
Slovenian: Vsi učinki so bili po prenehanju dajanja zdravila reverzibilni.
English: a p < 0.001 versus placebo b p = 0.003 versus placebo
Slovenian: a p < 0,001 v primerjavi s placebom b p = 0,003 v primerjavi s placebom
English: Hypersensitivity reactions1 (including anaphylaxis)
Slovenian: Neznana preobčutljivostne reakcije1 (vključno z anafilaksijo)
English: Etelcalcetide was efficiently removed with a haemodialysis clearance value of 7.66 L/hour.
Slovenian: Etelkalcetid se je učinkovito odstranil s hemodializnim očistkom 7,66 l/uro.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including those medicines obtained without a prescription, or any other medicines that lower serum calcium.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali, ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili brez recepta, ali katera koli druga zdravila, ki znižujejo kalcij v serumu.
English: Do not use Parsabiv if you have very low levels of calcium in your blood.
Slovenian: Ne uporabljajte zdravila Parsabiv, če imate zelo nizko koncentracijo kalcija v krvi.
English: The predominant biotransformation product (albumin bound) was minimally active in vitro.
Slovenian: Glavni produkt biotransformacije (vezan na albumin) je bil in vitro minimalno aktiven.
English: 6.6 Special precautions for disposal and other handling For single use only.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Samo za enkratno uporabo.
English: Overdose of etelcalcetide may lead to hypocalcaemia with or without clinical symptoms and may require treatment.
Slovenian: Preveliko odmerjanje etelkalcetida lahko povzroči hipokalciemijo s kliničnimi simptomi ali brez njih in lahko zahteva zdravljenje.
English: • Disturbances in the heart's electrical activity seen as QT prolongation on electrocardiogram
Slovenian: • Motnje v električni aktivnosti srca, ki so na elektrokardiogramu vidne kot podaljšanje intervala
English: Headache Paraesthesia3
Slovenian: Pogosti glavobol parestezije3
English: • Low blood pressure
Slovenian: • Nizek krvni tlak
English: • If removed from the original carton Parsabiv is stable for a maximum of 4 hours if protected from direct sunlight.
Slovenian: • Potem ko zdravilo Parsabiv vzamete iz originalne škatle, je stabilno največ 4 ure, če je zaščiteno pred neposredno sončno svetlobo.
English: The average duration of haemodialysis prior to study entry was 5.4 years and 68% of patients were receiving vitamin D sterols at study entry, with 83% receiving phosphate binders.
Slovenian: Povprečno trajanje hemodialize pred vključitvijo v študijo je bilo 5,4 let in 68 % bolnikov je ob vključitvi v študijo prejemalo sterole vitamina D, 83 % pa jih je prejemalo vezalce fosfatov.
English: Other medicines and Parsabiv
Slovenian: Druga zdravila in zdravilo Parsabiv
English: In clinical studies, 7.1% of patients with SHPT treated with Parsabiv for up to 6 months tested positive for binding antibodies.
Slovenian: V kliničnih študijah je imelo 7,1 % bolnikov s SHPT, zdravljenih z zdravilom Parsabiv do 6 mesecev, pozitiven izvid preiskave za vezavna protitelesa.
English: What Parsabiv is and what it is used for
Slovenian: Kaj je zdravilo Parsabiv in za kaj ga uporabljamo
English: Keep in the original carton in order to protect from light.
Slovenian: Shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
English: Once the maintenance phase has been established for a patient, corrected serum calcium should be measured approximately every 4 weeks.
Slovenian: Ko je pri bolniku dosežena vzdrževalna faza, je treba korigirani kalcij v serumu meriti na približno vsake 4 tedne.
English: It is not known whether Parsabiv can harm your unborn baby.
Slovenian: Ni znano, ali lahko zdravilo Parsabiv škoduje nerojenemu otroku.
English: However certain symptoms of low calcium levels (such as fits or convulsions) can affect your ability to drive or operate machinery.
Slovenian: Toda nekateri simptomi nizke koncentracije kalcija (na primer napadi krčev ali konvulzije) lahko prizadenejo vašo sposobnost za upravljanje vozil in strojev.
English: Parsabiv may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate (see section 5.1).
Slovenian: Zdravilo Parsabiv je mogoče uporabiti v terapevtski shemi, ki vključuje vezalce fosfatov in/ali sterole vitamina D, kot je primerno (glejte poglavje 5.1).
English: No statistically significant difference between the two groups was observed for the secondary endpoint evaluating the mean number of days of vomiting or nausea per week in the first 8 weeks.
Slovenian: Med skupinama ni bilo statistično značilne razlike pri sekundarnem opazovanem dogodku, ki je ocenjeval povprečno število dni bruhanja ali navzee na teden v prvih 8 tednih.
English: Open-label extension study
Slovenian: Odprta podaljšana študija
English: As a precautionary measure, it is preferable to avoid the use of Parsabiv during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Parsabiv bolje izogibati.
English: Both studies demonstrated that Parsabiv reduced PTH, while lowering calcium, phosphate and Ca x P. Results of all primary and secondary endpoints were statistically significant and the results were consistent across both studies as shown in table 2.
Slovenian: Obe študiji sta dokazali, da zdravilo Parsabiv zniža PTH ob hkratnem znižanju kalcija, fosfata in Ca x P. Rezultati vseh primarnih in sekundarnih opazovanih dogodkov so bili statistično značilni in so se med obema študijama ujemali, kot prikazuje preglednica 2.
English: However, certain potential manifestations of hypocalcaemia may affect the ability to drive and use machines (see section 4.4).
Slovenian: Toda določene možne posledice hipokalciemije lahko poslabšajo sposobnost vožnje in upravljanja strojev (glejte poglavje 4.4).
English: 3 Paraesthesia includes preferred terms of paraesthesia and hypoaesthesia.
Slovenian: 3 Parestezije vključujejo prednostna izraza parestezije in hipestezija.
English: In the population pharmacokinetics model, volume of distribution at steady-state was approximately 796 L. Etelcalcetide is predominately bound to plasma albumin by reversible covalent binding.
Slovenian: V populacijskem farmakokinetičnem modelu je bil volumen porazdelitve v stanju dinamičnega ravnovesja približno 796 l. Etelkalcetid je pretežno vezan na plazemski albumin z reverzibilno kovalentno vezavo.
English: Corrected serum calcium value or clinical symptoms of hypocalcaemia*:
Slovenian: Vrednost korigiranega kalcija v serumu ali klinični simptomi hipokalciemije*:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Parsabiv in one or more subsets of the paediatric population in the treatment of hyperparathyroidism (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Parsabiv za eno ali več podskupin pediatrične populacije za zdravljenje hiperparatiroidizma (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: • Parsabiv is stable for a maximum of 7 cumulative days if stored in the original carton.
Slovenian: • Zdravilo Parsabiv je stabilno največ 7 dni skupaj, če je shranjeno v originalni škatli.
English: No evidence of altered pharmacokinetic profile, clinical response or safety profile was associated with pre-existing or developing anti-etelcalcetide antibodies.
Slovenian: Ugotovili niso nobenih znakov spremenjenega farmakokinetičnega profila, kliničnega odziva ali varnostnih značilnosti, povezanih z že prej obstoječimi ali novonastalimi protitelesi proti etelkalcetidu.
English: Parsabiv has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Parsabiv nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.