FrancophonIA/ELRC3.0 huggingface dataset:
English: Name and address of the manufacturers responsible for batch release
Slovenian: A. IZDELOVALCI ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije
English: Itraconazole Cmin ↓ 0.13 Itraconazole Cmax ↓ 0.62
Slovenian: Cmax itrakonazola ↓ 0,62
English: Nevirapine Cmin ↑ 1.22 (1.10-1.35) Nevirapine Cmax ↑ 1.13 (1.03-1.24)
Slovenian: AUC nevirapina ↑ 1,14 (1,05-1,24) Cmin nevirapina ↑ 1,22 (1,10-1,35) Cmax nevirapina ↑ 1,13 (1,03-1,24)
English: Each tablet contains 200 mg of nevirapine (as anhydrous)
Slovenian: Ena tableta vsebuje 200 mg nevirapina (v brezvodni obliki)
English: Stavudine: 30/40 mg BID
Slovenian: 30/40 mg 2-krat na dan
English: Nevirapine Cmin ↑ 1.32 (1.22-1.43) Nevirapine Cmax ↑ 1.17 (1.09-1.25)
Slovenian: AUC nevirapina ↑ 1,25 (1,17-1,34) Cmin nevirapina ↑ 1,32 (1,22-1,43) Cmax nevirapina ↑ 1.17 (1,09-1,25)
English: Package leaflet: Information for the patient Nevirapine Teva 200 mg tablets nevirapine
Slovenian: Navodilo za uporabo Nevirapin Teva 200 mg tablete nevirapin
English: Severe and life-threatening skin reactions have occurred in patients treated with nevirapine, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Slovenian: - hudi in življenjsko nevarni kožni izpuščaji (Stevens-Johnsonov sindrom/toksična epidermalna
English: Saquinavir/ritonavir and Nevirapine Teva can be coadministered without dose adjustments.
Slovenian: Sakvinavir z ritonavirjem in zdravilo Nevirapin Teva se lahko uporablja sočasno brez prilagajanja odmerkov.
English: NNRTIs Efavirenz 600 mg QD
Slovenian: 600 mg na dan
English: Consult your doctor if you have taken more Nevirapine Teva than you should.
Slovenian: nemudoma obvestite svojega zdravnika, ki vam bo svetoval, ali morate zdravilo Nevirapin Teva prenehati jemati.
English: Darunavir Cmin ↔ 1.02 (0.79-1.32) Darunavir Cmax ↑ 1.40 (1.14-1.73)
Slovenian: AUC darunavirja ↑ 1,24 (0,97-1,57) Cmin darunavirja ↔ 1,02 (0,79-1,32) Cmax darunavirja ↑ 1,40 (1,14-1,73)
English: Dose adjustment of Nevirapine Teva is not required when co-administered with lopinavir.
Slovenian: Teva ni potrebno prilagoditi, če se ga daje hkrati z lopinavirjem.
English: Patients with moderate to severe elevations (ASAT or ALAT > 5 ULN) should be permanently discontinued from nevirapine.
Slovenian: ALT > 5-kratna zgornja mejna normalna vrednost) pa je potrebno nevirapin trajno ukiniti.
English: It is very important that you take only one Nevirapine Teva tablet a day for the first 14 days (”lead-in” period) If you have any rash during this period, do not increase the dose but consult your doctor.
Slovenian: Če se v tem obdobju pojavi izpuščaj, ne povečujte odmerka, temveč se posvetujte z zdravnikom.
English: It is not recommended to coadminister fosamprenavir and Nevirapine Teva if fosamprenavir is not co-administered with ritonavir (see section 4.4).
Slovenian: Če fosamprenavirja ne dajemo hkrati z ritonavirjem, sočasna uporaba fosamprenavirja in zdravila Nevirapin Teva ni priporočena (glejte poglavje 4.4).
English: The patients studied were receiving antiretroviral therapy containing nevirapine 200 mg twice daily for at least 6 weeks prior to pharmacokinetic sampling, with a median duration of therapy of 3.4 years.
Slovenian: dvakrat na dan, najmanj 6 tednov pred jemanjem vzorcev za farmakokinetičnim vzorčenjem.
English: INTEGRASE INHIBITORS
Slovenian: Zaviralci integraze
English: Lopinavir Cmin ↓ 0.45 (0.25-0.82) Lopinavir Cmax ↓ 0.86 (0.64-1.16)
Slovenian: AUC lopinavirja ↓ 0,78 (0,56-1,09) Cmin lopinavirja ↓ 0,45 (0,25-0,82) Cmax lopinavirja ↓ 0,86 (0,64-1,16)
English: Enfuvirtide and Nevirapine Teva can be co-administered without dose adjustments.
Slovenian: Enfuvirtid in zdravilo Nevirapin Teva se lahko uporablja sočasno brez prilagajanja odmerkov.
English: Nevirapine Teva and emtricitabine may be co-administered without dose adjustments.
Slovenian: Zdravilo Nevirapin Teva in emtricitabin lahko dajemo sočasno brez prilagoditve odmerkov.
English: Didanosine Cmin ND Didanosine Cmax ↔ 0.98 (0.79-1.21)
Slovenian: Cmax didanozina ↔ 0,98 (0,79-1,21)
English: Compounds using this metabolic pathway may have decreased plasma concentrations when coadministered with nevirapine.
Slovenian: Pri sočasnem dajanju z nevirapinom se lahko v plazmi zmanjša koncentracija učinkovin z isto potjo presnavljanja.
English: It is not recommended to coadminister boceprevir and Nevirapine Teva (see section 4.4).
Slovenian: Sočasno dajanje boceprevirja in zdravila Nevirapin Teva ni priporočeno (glejte poglavje 4.4).
English: The concomitant administration of Nevirapine Teva with NNRTIs is not recommended (see section
Slovenian: Sočasno dajanje zdravila Nevirapin Teva in NNRTI ni priporočeno (glejte poglavje 4.4).
English: Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel: +372 6610801
Slovenian: Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
English: If a hypersensitivity reaction occurs, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lymphadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction, nevirapine must be permanently stopped and not be reintroduced (see section 4.3).
Slovenian: Če se pojavi preobčutljivostna reakcija z izpuščajem in hkratnimi splošnimi simptomi, kot so povišana temperatura, artralgija, mialgija in limfadenopatija, ter prizadetost visceralnih organov, npr. hepatitis,
English: DMPA and Nevirapine Teva can be coadministered without dose adjustments.
Slovenian: DMPA in zdravilo Nevirapin Teva se lahko uporablja sočasno brez prilaganja odmerkov.
English: NRTIs
Slovenian: Stavudin
English: Nevirapine pharmacokinetics in HIV-1 infected adults does not appear to change with age (range 19-68 years) or race (Black, Hispanic, or Caucasian).
Slovenian: Kaže, da se farmakokinetika nevirapina pri s HIV-1 okuženih odraslih s starostjo (v razponu od 19 do
English: It is not recommended to coadminister atazanavir/ritonavir and Nevirapine Teva (see section
Slovenian: Sočasno dajanja atazanavirja z ritonavirjem in zdravila Nevirapin
English: Liver test monitoring should be performed if the patient experiences signs or symptoms suggestive of hepatitis and/or hypersensitivity.
Slovenian: Če se pri bolniku pojavijo znaki ali simptomi, ki kažejo na hepatitis ali preobčutljivost ali oboje, je potrebno pregledati delovanje jeter.
English: Clarithromycin AUC ↓ 0.69 (0.62
Slovenian: Cmax klaritromicina ↓ 0,77 (0,69-0,86)
English: versus 0.9 %).
Slovenian: bolnikov ali 17 %).
English: You should continue to take Nevirapine Teva for as long as instructed by your doctor.
Slovenian: morate prenehati jemati zdravilo Nevirapin Teva in se nemudoma posvetovati s svojim zdravnikom.
English: Nevirapine Teva and abacavir may be co-administered without dose adjustments.
Slovenian: Zdravilo Nevirapin Teva in abakavir lahko dajemo sočasno brez prilagoditve odmerkov.
English: PIs
Slovenian: Zidovudin
English: In the case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Slovenian: Pri sočasnem protivirusnem zdravljenju zaradi hepatitisa B ali C
English: Atazanavir/ritonavir 300/100 mg QD 400/100 mg QD
Slovenian: PI (zaviralci proteaze) Atazanavir/ritonavir 300/100 mg na dan 400/100 mg na dan atazanavir/r 300/100 mg:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (CALENDAR PACK)
Slovenian: PRETISNI OMOT (KOLEDARSKO PAKIRANJE)
English: The interaction between nevirapine and the antithrombotic agent warfarin is complex, with the potential for both increases and decreases in coagulation time when used concomitantly.
Slovenian: Medsebojno delovanje nevirapina in antitrombotika varfarina je kompleksno.
English: Fosamprenavir/ritonavir and Nevirapine Teva can be coadministered without dose adjustments
Slovenian: Fosamprenavir z ritonavirjem in zdravilo Nevirapin Teva se lahko uporablja sočasno brez prilagajanja odmerkov.
English: Nevirapine Cmax ↓ 0.50 compared to historical controls.
Slovenian: Cmax nevirapina ↓ 0,50
English: Fatal cases of SJS, TEN and drug reaction with eosinophilia and systemic symptoms have been reported.
Slovenian: - medikamentna reakcija s sistemskimi simptomi (medikamentna reakcija z eozinofilijo in sistemskimi simptomi).
English: What Nevirapine Teva is and what it is used for What you need to know before you take Nevirapine Teva How to take Nevirapine Teva Possible side effects
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Nevirapin Teva 3.
English: No specific drug-drug interaction study has been performed.
Slovenian: Medsebojnega delovanja niso proučevali v specifičnih raziskavah.
English: Nevirapine concentrations in human cerebrospinal fluid
Slovenian: Fuzijski zaviralci (zaviralci spajanja)
English: It may be harmful to the teeth.
Slovenian: Lahko škodljivo vpliva na zobe.
English: Patients are not required to drink more fluid than they normally would.
Slovenian: Bolnikom ni treba piti več tekočine, kot jo zaužijejo ponavadi.
English: It is unlikely that this medicine would pass into the mother's milk.
Slovenian: Malo verjetno je, da bi to zdravilo prehajalo v materino mleko.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 August 2014
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 26 avgust 2014
English: These compounds can be absorbed in the blood.
Slovenian: Te sestavine se lahko absorbirajo v kri.
English: Carcinogenicity studies were performed in mice and rats.
Slovenian: Študije karcinogenosti so opravili na miših in podganah.
English: The serum phosphorus reduction was maintained over 55 weeks.
Slovenian: Znižanje fosforja v serumu se je ohranilo več kot 55 tednov.
English: - Push the tablet through the aluminium foil.
Slovenian: - Potisnite tableto skozi aluminijasto folijo.
English: The safety and efficacy of Velphoro in children and adolescents below the age of 18 years has not yet been established.
Slovenian: Varnost in učinkovitost zdravila Velphoro pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
English: Drug-drug interaction studies have only been performed in healthy volunteers.
Slovenian: Študije medsebojnega delovanja med zdravili so bile opravljene samo pri zdravih prostovoljcih.
English: Blood levels of radiolabelled iron were very low and confined to the erythrocytes.
Slovenian: Ravni radioaktivno označenega železa v krvi so bile zelo nizke in omejene na eritrocite.
English: See further information in section 4.4.
Slovenian: Za več informacij glejte poglavje 4.4.
English: Vitamin D and 1,25-dihydroxy Vitamin D levels remained unchanged.
Slovenian: Ravni vitamina D in 1,25­dihidroksi vitamina D so ostale nespremenjene.
English: There is no information on the effects of this medicine if taken during pregnancy or breastfeeding.
Slovenian: Ni podatkov o učinkih tega zdravila, če ga jemljete v času nosečnosti ali dojenja.
English: Do not stop taking the medicine before talking to your doctor or pharmacist as the phosphorus level in your blood may increase (see section 1).
Slovenian: Ne prenehajte jemati zdravila, dokler se ne posvetujete z zdravnikom ali s farmacevtom, saj se ravni fosforja v krvi lahko zvišajo (glejte poglavje 1).
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Slovenian: • Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1
English: Tablets must be chewed and not swallowed whole; tablets may be crushed.
Slovenian: Tablete je treba žvečiti in se jih ne sme pogoltniti celih; lahko se jih tudi zdrobi.
English: Only for the blister packs: - Separate the blister pack at perforations.
Slovenian: Samo za pakiranja s pretisnimi omoti: - Ločite pretisni omot na perforacijah.
English: Maximum tolerated daily dose
Slovenian: Največji dovoljen dnevni odmerek
English: Non-inferiority to sevelamer carbonate was determined at week 12.
Slovenian: Neinferiornost sevelamerijevega karbonata je bila ugotovljena v 12. tednu.
English: The absolute absorption studies in humans were not performed.
Slovenian: Študije absolutne absorpcije pri ljudeh niso bile izvedene.
English: In 2 Phase 1 studies, it was concluded that the potential for iron overload is minimal and no dose dependent effects were observed in healthy volunteers.
Slovenian: V dveh študijah faze 1 so ugotovili, da je možnost za prenasičenost z železom minimalna in da pri zdravih prostovoljcih niso opazili učinkov, odvisnih od odmerka.
English: Component of a multipack.
Slovenian: Del večjega pakiranja.
English: Therefore Velphoro is not recommended for use in children and adolescents.
Slovenian: Zato zdravilo Velphoro ni priporočeno za uporabo pri otrocih in mladostnikih.
English: Of the total number of subjects in clinical studies of Velphoro, 29.7% were aged 65 and over, while 8.7% were aged 75 and over.
Slovenian: Od skupnega števila bolnikov v kliničnih študijah zdravila Velphoro je bilo 29,7 % starih 65 let in več, medtem ko je bilo 8,7 % starih 75 let in več.
English: The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).
Slovenian: Neželeni učinki so po stopnji poročanja razvrščeni kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100).
English: Description of selected adverse reactions *Diarrhoea
Slovenian: Opis izbranih neželenih učinkov *Diareja
English: This medicine has no significant effect on your ability to drive or to use tools or machines.
Slovenian: To zdravilo ne vpliva bistveno na sposobnost vožnje ali uporabe orodij oz. strojev.
English: This is thought to be most likely an adaptive response to the pharmacological effect of the drug, and not clinically relevant.
Slovenian: Sklepajo, da je to najverjetneje prilagojevalni odziv na farmakološki učinek zdravila in ne šteje za klinično pomembnega.
English: Patients receiving Velphoro should adhere to their prescribed diets.
Slovenian: Bolniki, ki jemljejo zdravilo Velphoro, se morajo držati svoje predpisane diete.
English: Subjects were continued on their study medication from week 12 to week 55.
Slovenian: Preiskovanci so nadaljevali z jemanjem raziskovanega zdravila od 12. do 55. tedna.
English: The distribution studies in humans were not performed.
Slovenian: Študije porazdelitve pri ljudeh niso bile izvedene.
English: After first opening of the bottle the chewable tablets can be used for 90 days.
Slovenian: Po prvem odprtju plastenke lahko žvečljive tablete uporabljate še 90 dni.
English: The vast majority of these gastrointestinal disorders occurred early during treatment and abated with time with continued dosing.
Slovenian: Do velike večine teh gastrointestinalnih težav je prišlo na začetku zdravljenja in so se z nadaljevanjem jemanja sčasoma zmanjšale.
English: Since absorption of iron from Velphoro is minimal (see section 5.2), excretion of iron from Velphoro in breast milk is unlikely.
Slovenian: Ker je absorpcija železa iz zdravila Velphoro minimalna (glejte poglavje 5.2), je izločanje železa iz zdravila Velphoro v materino mleko malo verjetno.
English: Too much phosphorus in the blood can lead to calcium being deposited in tissues (calcification).
Slovenian: Preveč fosforja v krvi lahko povzroči nalaganje kalcija v tkivih (kalcifikacija).
English: This study was an open-label, randomised, activecontrolled (sevelamer carbonate), parallel group study for up to 55 weeks.
Slovenian: To je bila odprta, randomizirana, z učinkovino kontrolirana (sevelamerijev karbonat), vzporedna skupinska študija, ki je trajala do 55 tednov.
English: Clinical studies have demonstrated that the systemic absorption of iron from Velphoro is low.
Slovenian: Klinične študije so pokazale, da je sistemska absorpcija železa iz zdravila Velphoro nizka.
English: In patients, absorbed iron is expected to be also distributed to the target organs, i.e. liver, spleen and bone marrow, and utilized by incorporation into red blood cells.
Slovenian: Pri bolnikih je pričakovano, da se tudi absorbirano železo porazdeli v ciljne organe, tj. jetra, vranico in kostni mozeg, ter se porabi z vključitvijo v rdeče krvne celice.
English: If one or more doses are missed, the normal dose of the medicinal product should be resumed with the next meal.
Slovenian: Če se izpusti enega ali več odmerkov, je z naslednjim obrokom treba vzeti običajni odmerek zdravila.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se obrnite na predstavništvo imetnika dovoljenja za promet z zdravilom.
English: - Peel back the paper foil at the corner.
Slovenian: - Odlepite folijo na vogalu.
English: In vitro studies with the following active substances did not show any relevant interaction: acetylsalicylic acid, cephalexin, cinacalcet, ciprofloxacin, clopidogrel, enalapril, hydrochlorothiazide, metformin, metoprolol, nifedipine, pioglitazone and quinidine.
Slovenian: Študije in vitro z naslednjimi učinkovinami niso pokazale pomembnega medsebojnega delovanja: acetilsalicilna kislina, cefaleksin, cinakalcet, ciprofloksacin, klopidogrel, enalapril, hidroklorotiazid, metformin, metoprolol, nifedipin, pioglitazon in kinidin.
English: EU/1/14/943/002 90 chewable tablets
Slovenian: EU/1/14/943/002 90 žvečljivih tablet
English: Table 1 Adverse reactions detected in clinical trials System Organ Class
Slovenian: Tabela 1: Neželeni učinki, odkriti v kliničnih preskušanjih Organski sistem
English: Velphoro is almost not absorbed from the gastrointestinal tract.
Slovenian: Zdravilo Velphoro se skoraj ne absorbira iz gastrointestinalnega trakta.
English: There was no clear evidence of a carcinogenic effect in mice.
Slovenian: Pri miših ni bilo jasno opaznih karcinogenih učinkov.
English: Do not use this medicine after the expiry date stated on the carton, bottle or blister after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, plastenki ali pretisnem omotu poleg oznake »EXP«.
English: Diarrhoea occurred in 11.6% of patients in clinical trials.
Slovenian: V kliničnih preskušanjih se je diareja pojavila pri 11,6 % bolnikov.
English: Due to the insolubility and degradation characteristics of Velphoro, no classical pharmacokinetic studies can be carried out, e.g., determination of the distribution volume, area under the curve, mean residence time, etc.
Slovenian: Zaradi netopnosti in značilnosti razgradnje zdravila Velphoro ni mogoče izvesti klasičnih farmakokinetičnih študij, na primer določanja obsega porazdelitve, področja pod krivuljo, povprečnega časa prisotnosti itd.
English: Phosphate binding takes place by ligand exchange between hydroxyl groups and/or water and the phosphate ions throughout the physiological pH range of the gastrointestinal tract.
Slovenian: Vezava fosfata poteka z izmenjavo liganda med hidroksilnimi skupinami in/ali vodo ter fosfatnimi ioni v celotnem fiziološkem razponu pH v gastrointestinalnem traktu.
English: 92042 Paris la Défense Cedex France
Slovenian: 92042 Paris la Défense Cedex Francija
English: If you also have symptoms like increasing tiredness and breathlessness contact your doctor immediately (see section 2 “Warnings”).
Slovenian: Če imate tudi druge simptome, kot je povečana utrujenost in zadihanost, se nemudoma obrnite na svojega zdravnika (glejte poglavje 2 »Opozorila«).
English: Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharoza­izomaltaze ne smejo jemati tega zdravila.
English: If you are pregnant or breastfeeding, or you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: Do not take Velphoro:
Slovenian: Ne jemljite zdravila Velphoro:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Velphoro in one or more subsets of the paediatric population in the treatment of hyperphosphataemia (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Velphoro za eno ali več podskupin pediatrične populacije pri zdravljenju hiperfosfatemije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Effects seen in the rabbit embryo-foetal development toxicity study (skeletal variations and incomplete ossificaton) are related to exaggerated pharmacology, and likely not relevant for patients.
Slovenian: Učinki, ki so jih opazili pri kuncih v toksikološki študiji razvoja zarodka/ploda (skeletne spremembe in nepopolna okostenelost), so povezani s pretirano farmakologijo in verjetno niso relevantni za bolnike.
English: In order to maximise the adsorption of dietary phosphate, the total daily dose should be divided across the meals of the day.
Slovenian: Da bi povečali adsorpcijo prehranskega fosfata, je treba celotni dnevni odmerek razdeliti prek dnevnih obrokov.
English: - Take the tablet during a meal and chew it (if necessary, the tablet may be crushed to make this easier for you).
Slovenian: - Tableto vzemite med obrokom in jo prežvečite (da vam bo lažje, jo lahko tudi zdrobite).
English: Pharmacotherapeutic group: Drugs for treatment of hyperkalaemia and hyperphosphataemia; ATC code: V03AE05
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje hiperkaliemije in hiperfosfatemije; oznaka ATC: V03AE05
English: - The amount of tablets taken per day should be divided across the meals of the day.
Slovenian: - Količino tablet, ki jih morate vzeti na dan, porazdelite na dnevne obroke.
English: If you have missed a dose, just take the next dose at the usual time with a meal.
Slovenian: Če ste pozabili vzeti odmerek, vzemite naslednji odmerek kot običajno z obrokom.
English: • Haemochromatosis and any other iron accumulation disorders.
Slovenian: • Hemokromatoza in druge motnje kopičenja železa v telesu.
English: The current safety profile of Velphoro is based on a total of 778 patients on haemodialysis and 57 patients on peritoneal dialysis, who received Velphoro treatment of up to 55 weeks.
Slovenian: Trenutni varnostni profil za zdravilo Velphoro temelji na skupno 778 bolnikih na hemodializi ter 57 bolnikih na peritonealni dializi, ki so 55 tednov v sklopu zdravljenja prejemali zdravilo Velphoro.
English: No special dose and administration guidelines were applied to seniors in these studies and the dosing schedules were not associated with any significant concerns.
Slovenian: V teh študijah niso uporabljali nobenih posebnih smernic za odmerjanje in jemanje, pa tudi urnikom odmerjanja niso posvečali večjih skrbi.
English: Other reproduction toxicity studies showed no adverse effects.
Slovenian: Druge študije vpliva na sposobnost razmnoževanja niso pokazale neželenih učinkov.
English: It may also lead to calcium deposits in soft tissues and bone causing effects such as red eyes, itchy skin and bone pain.
Slovenian: Kalcij se lahko odlaga tudi v mehkih tkivih in kosteh, zaradi česar se lahko pojavijo znaki, kot so rdeče oči, srbeča koža in bolečine v kosteh.
English: - When taking Velphoro you should adhere to your recommended diet and treatments prescribed by your doctor such as calcium supplements, vitamin D3 or calcimimetics.
Slovenian: - Če jemljete zdravilo Velphoro, morate upoštevati priporočeno dieto in zdravljenja, ki vam jih je predpisal zdravnik, na primer dodajanje kalcija, vitamina D3 ali kalcimimetikov.