FrancophonIA/ELRC3.0 huggingface dataset:
English: There were no significant differences in serum estradiol and estrone levels in patients treated with Livensa for up to 52 weeks compared to baseline.
Slovenian: ki so prejemale zdravljenje z zdravilom Livensa, po 52 tednih ni bilo pomembnih razlik v koncentracijah estradiola in estrona, v primerjavi z izhodiščno vrednostjo.
English: The appropriate use and restrictions associated with estrogen therapy should be considered before Livensa therapy is initiated and during routine re-evaluation of treatment.
Slovenian: Pred zdravljenjem z zdravilom Livensa in med rutinskimi ponovnimi ocenitvami zdravljenja je treba upoštevati ustrezno uporabo in omejitve, povezane z zdravljenjem z estrogenom.
English: The medical term for this condition is Hypoactive Sexual Desire Disorder, also known as
Slovenian: Medicinski izraz za to stanje je motnja hipoaktivne spolne želje ali HSDD (hypoactive sexual desire disorder).
English: On removal of an Livensa patch, testosterone serum concentrations return to near baseline values within 12 hours due to its short terminal exponential half-life (approximately 2 hours).
Slovenian: Po odstranitvi obliža Livensa se zaradi kratke končne eksponentne razpolovne dobe (približno 2 uri)
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: N Srednja vrednost (SEM)
English: Hirsutism Acne, alopecia Eczema, increased sweating, rosacea
Slovenian: Bolezni kože in podkožja hirsutizem akne, alopecije ekcem, povečano potenje, rozacea
English: ANNEX II A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: DODATEK II A. IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, androgens, ATC
Slovenian: Farmakoterapevtska skupina: spolni hormoni in zdravila za uravnavanje delovanja spolovil, androgeni, oznaka ATC: G03BA03.
English: Step 1 Tear open the sachet.
Slovenian: Kako nalepiti obliž 1. korak Odprite zaščitno vrečico.
English: Oedema (with or without congestive heart failure) may be a serious complication from high doses of testosterone or other anabolic steroids in patients with pre-existing cardiac, renal, or hepatic disease.
Slovenian: Pri bolnicah z že obstoječo srčno, ledvično ali jetrno boleznijo, je edem (s kongestivno srčno odpovedjo ali brez nje) lahko resen zaplet zaradi velikih odmerkov testosterona ali drugih anabolnih steroidov.
English: Breast cyst, clitoral engorgement, enlarged clitoris, genital pruritus, vaginal burning sensation
Slovenian: Motnje reprodukcije in dojk bolečine v dojkah cista na dojki, nabrekanje klitorisa, povečanje klitorisa, genitalni pruritus, občutek pečenja v vagini
English: The other ingredients are: Sorbitan oleate, 2-Ethylhexylacrylate - 1-Vinyl-2-pyrrolidone co-polymer.
Slovenian: Pomožne snovi so: sorbitanoleat, 2-etilheksilakrilat - 1-vinil-2-pirolidonski kopolimer.
English: Use your fingers to make sure the edges of the patch stick to the skin.
Slovenian: Potipajte robove in se prepričajte, da so prilepljeni na kožo.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 transdermalni obliž
English: Breast pain
Slovenian: - bolečina v prsnem košu
English: Apply the patch immediately after removing it from the sachet.
Slovenian: Namestite takoj, ko vzamete iz zaščitne vrečice.
English: Serum concentrations of testosterone attain steady-state by the application of the second patch when applied in a twice-a-week regimen.
Slovenian: Stanje dinamičnega ravnovesja koncentracije testosterona v serumu se pri apliciranju dvakrat tedensko doseže z aplikacijo drugega obliža.
English: Migraine
Slovenian: - migrena
English: Translucent polyethylene backing film printed with ink containing sunset yellow FCF (E110), latolrubine BK (E180) and copper phthalocyanine blue pigment.
Slovenian: Prosojna polietilenska zunanja folija, natisnjena s črnilom, ki vsebuje oranžno barvilo FCF (E 110), latolrubin BK (E 180) in modri pigment bakrovega ftalocianina.
English: 1 patch of 28 cm2 contains 8.4 mg of testosterone and provides 300 micrograms per 24 hours.
Slovenian: 1 obliž s površino 28 cm2 vsebuje 8,4 mg testosterona in sprosti 300 mikrogramov testosterona v 24 urah.
English: Change the patch only on these two days.
Slovenian: Obliž vsak teden zamenjajte ob istih dveh dnevih.
English: The transdermal patch should not be flushed down the toilet.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje Transdermalnega obliža ne odplaknite v stranišče.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije Warner Chilcott Deutschland GmbH
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN
English: DHT concentrations increased in parallel with testosterone concentrations during Livensa treatment.
Slovenian: Med zdravljenjem z zdravilom Livensa se koncentracije DHT povečajo skupaj s koncentracijami testosterona.
English: Severe skin erythema, local oedema and blistering may occur due to hypersensitivity to the patch at the site of application.
Slovenian: Zaradi preobčutljivosti na obliž se lahko na mestu aplikacije pojavijo hud kožni eritem, lokalni edem in mehurji.
English: If an area of the patch lifts, apply pressure to that area.
Slovenian: Če se del obliža odlepi, ta del pritisnite.
English: Patients with diabetes mellitus have not been studied.
Slovenian: Bolnic s sladkorno boleznijo niso preučevali.
English: Gastrointestinal disorders
Slovenian: Prosti testosteron
English: Siliconised polyester film
Slovenian: Zaščitna plast silikonizirana poliestrska folija
English: Grounds for one additional renewal
Slovenian: Podlaga za eno dodatno podaljšanje dovoljenja za promet z zdravilom
English: Diarrhoea, dry mouth, nausea
Slovenian: Bolezni prebavil bolečina v trebuhu driska, suha usta, navzea
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each patch of 28 cm2 contains 8.4 mg testosterone and provides 300 micrograms of testosterone per 24 hours.
Slovenian: Vsak obliž s površino 28 cm2 vsebuje 8,4 mg testosterona in sprosti 300 mikrogramov testosterona v 24 urah.
English: Livensa is intended for use by women up to the age of 60 years who: - have a low sexual desire which is causing distress or concern, and - have had both of their ovaries removed, and - have had their womb removed (hysterectomy), and - are receiving estrogen therapy.
Slovenian: imajo nizko spolno željo, ki povzroča stisko ali skrbi in so jim odstranili oba jajčnika in so jim odstranili maternico (histerektomija) in prejemajo zdravljenje z estrogenom.
English: What Livensa contains
Slovenian: DODATNE INFORMACIJE Kaj vsebuje zdravilo Livensa
English: A responder analysis of the pivotal phase II and III studies showed significant improvements in all three major clinical endpoints versus placebo in patients on concomitant transdermal and oral non-CEE estrogens.
Slovenian: in III. faze, je pri bolnicah, ki so sočasno prejemale transdermalne in druge peroralne estrogene kot CEE, pokazala pomembno izboljšanje v primerjavi s placebom pri vseh treh kliničnih končnih točkah.
English: Only one patch is to be worn at a time.
Slovenian: Hkrati se sme aplicirati le en obliž.
English: Diplopia, eye redness
Slovenian: Očesne bolezni diplopija, rdeče oko
English: Testosterone may induce virilising effects on the female foetus when administered to a pregnant woman.
Slovenian: Kadar ga uporabljajo nosečnice, testosteron lahko sproži virilizacijske učinke pri ženskem plodu.
English: Translucent polyethylene backing film sunset yellow FCF (E110) latolrubine BK (E180) copper phthalocyanine blue pigment.
Slovenian: Zunanja plast prosojna polietilenska zunanja folija Tiskarsko črnilo oranžno barvilo FCF (E 110) latolrubin BK (E 180) modri pigment bakrovega ftalocianina
English: Testosterone has a masculinising effect on female rat foetuses when dosed subcutaneously at 0.5 or 1 mg/day (as the propionate ester) to pregnant rats during organogenesis.
Slovenian: Testosteron ima maskulinizirajoči učinek na ženske plodove podgan pri subkutanem odmerjanju 0,5
English: Transdermal patch.
Slovenian: Transdermalna uporaba.
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: HOW TO STORE LIVENSA
Slovenian: SHRANJEVANJE ZDRAVILA LIVENSA
English: Anasarca, asthenia, chest tightness, chest discomfort
Slovenian: anasarka, astenija, stiskanje v prsih, občutek neugodja v prsnem košu
English: Livensa 300 micrograms/24 hours transdermal patch Testosterone
Slovenian: Livensa 300 mikrogramov/24 ur transdermalni obliž Testosteron
English: Eye disorders
Slovenian: - pordelost oči
English: 8 transdermal patches
Slovenian: 8 transdermalnih obližev 24 transdermalnih obližev
English: NAME OF THE MEDICINAL PRODUCT Livensa 300 micrograms/24 hours transdermal patch
Slovenian: IME ZDRAVILA Livensa 300 mikrogramov/24 ur transdermalni obliž
English: Hepatic impairment No studies have been conducted in patients with hepatic impairment.
Slovenian: Študij pri bolnikih z okvarjenim delovanjem jeter niso izvajali.
English: How to stick on the patch
Slovenian: Kam nalepiti obliž
English: Remove the patch.
Slovenian: Navodilo shranite.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Livensa 300 micrograms/24 hours transdermal patch Testosterone
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Livensa 300 mikrogramov/24 ur transdermalni obliž Testosteron
English: Therefore, based on the safety profile in Livensa, which requires the submission of 6 monthly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.
Slovenian: Zato je Odbor za zdravila za uporabo v humani medicini na podlagi varnostnega profila zdravila Livensa, za katerega je treba periodično poročilo o varnosti zdravila predložiti vsakih 6 mesecev,
English: Always use Livensa exactly as your doctor has told you.
Slovenian: Pri uporabi zdravila Livensa natančno upoštevajte zdravnikova navodila.
English: Breastfeeding Livensa must not be used by breast-feeding women.
Slovenian: Previdnostni ukrepi Zdravila Livensa se ne sme uporabljati pri ženskah po naravni menopavzi
English: Acrylic co-polymer adhesive containing 2-Ethylhexylacrylate - 1-Vinyl-2-pyrrolidone co-polymer.
Slovenian: Samolepilna matriksna plast, ki vsebuje zdravilo sorbitanoleat akrilno kopolimerno lepilo, ki vsebuje 2-etilheksilakrilat - 1-vinil-2-pirolidonski kopolimer
English: You should check with your doctor or pharmacist if you are not sure of the instructions or if you want any more information.
Slovenian: Če ste negotovi, da razumete navodila, ali če želite dodatne informacije, se posvetujte z zdravnikom ali s farmacevtom.
English: THE MARKETING AUTHORISATION HOLDER Medicinal product subject to medical prescription.
Slovenian: Izdaja zdravila je le na recept.
English: Warner Chilcott Deutschland GmbH Dr.-Otto-Röhm-Strasse 2-4 64331 Weiterstadt Germany
Slovenian: Dr.-Otto-Röhm-Strasse 2-4
English: Reproductive system and breast disorders
Slovenian: Infekcijske in parazitske bolezni sinuzitis
English: Baseline
Slovenian: Livensa.
English: The mode of administration of Livensa makes overdose unlikely.
Slovenian: 4.9 Preveliko odmerjanje Zaradi načina odmerjanja zdravila Livensa preveliko odmerjanje ni verjetno.
English: Information to appear on the inside of the flap
Slovenian: Podatki na notranji strani zavihka Kdaj namestiti obliž:
English: Special populations
Slovenian: Posebna opozorila
English: B. PACKAGE LEAFLET
Slovenian: DODATEK IV
English: Press the sticky side of the patch firmly into place for about 10 seconds.
Slovenian: 10 sekund močno pritisnite na kožo.
English: Where to stick the patch - Stick the patch onto your lower abdomen, below your waist.
Slovenian: Obliž nalepite na spodnji del trebuha, pod pas.
English: Application site reaction (erythema, itching)
Slovenian: DHT (ng/dl)
English: - Keep out of the reach and sight of children - Do not use Livensa after the expiry date which is stated on the carton and sachet after EXP.
Slovenian: Zdravila Livensa ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in zaščitni vrečici poleg oznake EXP/Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: Tabulated list of adverse reactions
Slovenian: Seznam neželenih učinkov v obliki razpredelnice
English: The significance of these data for the use of Livensa in patients is not known.
Slovenian: Livensa pri bolnicah ni znan.
English: Very common Common
Slovenian: Pogosti
English: Subgroup analyses suggested that the route and type of concomitant estrogen (transdermal oestradiol, oral conjugated equine estrogen (CEE), oral non-CEE) can influence patient response.
Slovenian: Analiza podskupin je nakazala, da lahko na odziv bolnic vpliva način uporabe in vrsta estrogena
English: NAME OF THE MEDICINAL PRODUCT Livensa 300 micrograms/24 hours transdermal patch Testosterone
Slovenian: NAVODILO ZA UPORABO Livensa 300 mikrogramov/24 ur transdermalni obliž Testosteron
English: please tell your doctor or pharmacist.
Slovenian: Zdravniku takoj povejte:
English: The CHMP decided that the MAH should continue to submit 6 monthly PSURs.
Slovenian: Odbor za zdravila za uporabo v humani medicini se je odločil, da naj imetnik dovoljenja za promet z zdravilom predloži periodično poročilo o varnosti zdravila vsakih 6 mesecev.
English: Livensa is not recommended in naturally
Slovenian: Uporaba zdravila Livensa se ne priporoča ženskam po naravni menopavzi.
English: Blood and lymphatic system
Slovenian: Bolezni krvi in limfatičnega nenormalni faktor strjevanja krvi
English: Arthritis
Slovenian: Dojenje
English: Abnormal clotting factor
Slovenian: - sinusitis (vnetje nosnih sinusov) - nenormalen faktor strjevanja krvi
English: Increased appetite
Slovenian: Presnovne in prehranske motnje povečanje apetita
English: NA NA NA NA
Slovenian: NA NA NA
English: Each pack contains the vial with concentrate.
Slovenian: Vsaka škatla vsebuje vialo s koncentratom.
English: Date of latest renewal: 20th November 2018
Slovenian: Datum prve odobritve: 16.01.2014 Datum zadnjega podaljšanja: 20. novembra 2018
English: Packs containing 1, 4 or 10 vials.
Slovenian: Pakiranje vsebuje 1, 4 ali 10 vial.
English: EXP Use immediately after dilution.
Slovenian: EXP Uporabite takoj po redčenju.
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention:
Slovenian: Neželeni učinki so razvrščeni glede na pogostnost, najprej najpogostejši, in to po naslednjem dogovoru:
English: The safety and efficacy of zoledronic acid in children aged 1 year to 17 years have not been established.
Slovenian: Varnost in učinkovitost zoledronske kisline pri otrocih starih 1 do 17 let nista bili dokazani.
English: Your doctor, pharmacist or nurse knows how to store Zoledronic Acid Accord properly (see section 6).
Slovenian: Vaš zdravnik, farmacevt ali medicinska sestra vedo, kako je treba zdravilo Zoledronska kislina Accord pravilno shranjevati (glejte poglavje 6).
English: Zoledronic Acid Accord can be given to people aged 65 years and over.
Slovenian: Zdravilo Zoledronska kislina Accord lahko dajemo ljudem, ki so stari 65 let ali več.
English: • Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
Slovenian: - Zdravnik vam bo priporočil, da pred vsako infuzijo spijete dovolj vode, kar bo pomagalo preprečiti dehidracijo.
English: NR NR NR 640
Slovenian: NR NR 640
English: Very common (may affect more than 1 in 10 people): • Low level of phosphate in the blood.
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 ljudi): nizka koncentracija fosfata v krvi.
English: If a lower dose of Zoledronic Acid Accord is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Slovenian: Če je potreben manjši odmerek zdravila Zoledronska kislina Accord, najprej odvzemite ustrezni volumen, kot je navedeno spodaj, in ga nato dodatno razredčite s 100 ml infuzijske raztopine.
English: NR NR 424
Slovenian: NR 424
English: • If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.
Slovenian: - Če imate težave z ledvicami, vam bo zdravnik dal manjši odmerek, ki bo odvisen od tega, kako hude so vaše težave z ledvicami.
English: Additional information on handling of Zoledronic Acid Accord, including guidance on preparation of reduced doses, is provided in section 4.2.
Slovenian: Nadaljnje informacije o ravnanju z zdravilom Zoledronska kislina Accord, vključno z navodili za pripravo nižjih odmerkov, so navedene v poglavju 4.2.
English: Other medicines and Zoledronic Acid Accord Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Zoledronska kislina Accord Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Chemical and physical in-use stability has been demonstrated for 36 hours at 2 - 8 °C.
Slovenian: - Kemijska in fizikalna stabilnost je bila dokazana med uporabo 36 ur pri 2-8 ° C.
English: In addition to being a potent inhibitor of bone resorption, zoledronic acid also possesses several anti-tumour properties that could contribute to its overall efficacy in the treatment of metastatic bone disease.
Slovenian: Poleg tega, da je zoledronska kislina močan inhibitor resorpcije kosti, ima tudi več protitumorskih lastnosti, ki bi lahko prispevale k njeni celotni učinkovitosti v zdravljenju metastatične bolezni kosti.
English: • A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Slovenian: okvara v delovanju ledvic, imenovana Fanconijev sindrom (običajno jo ugotovi zdravnik s pomočjo določenih preiskav urina).
English: For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Slovenian: Glede bolnikov, pri katerih so potrebni zobozdravstveni postopki, ni na voljo nikakršnih podatkov, ki bi kazali na to, ali prekinitev difosfonatnega zdravljenja zmanjša tveganje osteonekroze čeljustnic.
English: In long-term animal studies, zoledronic acid inhibits bone resorption without adversely affecting the formation, mineralization or mechanical properties of bone.
Slovenian: V dolgoročnih raziskavah na živalih zoledronska kislina zavira resorpcijo kosti, ne da bi neugodno vplivala na oblikovanje, mineralizacijo ali mehanske lastnosti kosti.
English: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1
Slovenian: Preglednica 6: Neželeni učinki, ki so jih opažali pri pediatričnih bolnikih s hudo obliko osteogenesis imperfecta1
English: * Includes vertebral and non-vertebral fractures ** Accounts for all skeletal events, the total number as well as time to each event during the trial NR-Not Reached
Slovenian: * zajema vertebralne in nevertebralne zlome; ** velja za vse skeletne dogodke, tako za njihovo celotno število kot za trajanje vsakega dogodka med preskušanjem;
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, S PROSTORNINO ALI ŠTEVILOM ENOT
English: • Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with Zoledronic Acid Accord.
Slovenian: Študije z več vrstami infuzijskih sistemov, izdelanih iz polivinilklorida, polietilena in polipropilena, niso pokazale nezdružljivosti z zdravilom Zoledronska kislina Accord.
English: Adverse reactions, such as dizziness and somnolence, may have influence on the ability to drive or use machines, therefore caution should be exercised with the use of Zoledronic Acid Accord along with driving and operating of machinery.
Slovenian: Neželeni učinki, kot na primer vrtoglavost in somnolenca, lahko vplivajo na sposobnost vožnje in upravljanja s stroji, zato je ob uporabi zdravila Zoledronska kislina Accord potrebna previdnost pri vožnji in upravljanju s stroji.
English: • If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic Acid Accord.
Slovenian: - Če prejemate zdravilo za zniževanje količine kalcija v krvi, boste običajno prejeli samo eno infuzijo zdravila Zoledronska kislina Accord.
English: For instructions on the dilution of zoledronic acid before administration, see section 6.6.
Slovenian: Za navodila glede redčenja zoledronske kisline pred dajanjem glejte poglavje 6.6.
English: Healthcare professionals are advised not to dispose of unused Zoledronic Acid Accord via the domestic sewage system.
Slovenian: Zdravstvenim delavcem svetujemo, da neporabljenega zdravila Zoledronska kislina Accord ne izlijejo v gospodinjske odplake.
English: Zoledronic acid treatment should be resumed at the same dose as that given prior to treatment interruption.
Slovenian: Zdravljenje z zoledronsko kislino je treba spet začeti z enakim odmerkom kot ga je bolnik prejemal pred prekinitvijo zdravljenja.
English: Treatment of TIH Adults and older people
Slovenian: Odrasli in starejši ljudje
English: Zoledronic acid shows no appreciable binding to plasma proteins and does not inhibit human P450 enzymes in vitro (see section 5.2), but no formal clinical interaction studies have been performed.
Slovenian: Zoledronska kislina ne kaže znatne vezave na plazemske beljakovine in ne zavira humanih encimov P450 in vitro (glejte poglavje 5.2), niso pa bile narejene formalne klinične študije medsebojnega delovanja.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate) Clear and colourless solution.
Slovenian: FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat) bistra in brezbarvna raztopina
English: Zoledronic acid is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
Slovenian: Zoledronske kisline ne priporočajo bolnikom, ki imajo že pred uvedbo zdravljenja težko ledvično okvaro, ki je za to skupino bolnikov opredeljena kot CLcr < 30 ml/min.
English: Hypophosphataemia 1 Adverse events occurring with frequencies < 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid (see section 4.8)
Slovenian: hipofosfatemija 1 Neželene učinke s pogostnostjo < 5 % so ocenili z medicinskega vidika in pokazalo se je, da se ujemajo z že ugotovljenim varnostnim profilom zoledronske kisline (glejte poglavje 4.8).
English: The study treatment period was 12 months preceded by a 4- to 9-week screening period during which vitamin D and elemental calcium supplements were taken for at least 2-weeks.
Slovenian: Obdobje zdravljenja v študiji je trajalo 12 mesecev, pred tem so imeli bolniki 4- do 9-tedensko obdobje presejanja (screening), v katerem so bolniki vsaj 2 tedna jemali vitamin D in nadomestke z elementarnim kalcijem.
English: Zoledronic acid should not be used during pregnancy.
Slovenian: Zoledronske kisline ne smete uporabljati med nosečnostjo.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference product containing zoledronic acid in all subsets of the paediatric population in the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje zoledronsko kislino, za vse podskupine pediatrične populacije glede zdravljenja tumorsko povzročene hiperkalciemije in preprečevanja z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).