FrancophonIA/ELRC3.0 huggingface dataset:
English: Urticaria
Slovenian: Driska
English: Alternative therapies should be considered when treating patients with neutropenia and ABSSSI (see section 5.1).
Slovenian: Pri bolnikih z nevtropenijo ter akutnimi bakterijskimi okužbami kože in mehkih tkiv je treba razmisliti o drugih možnostih zdravljenja (glejte poglavje 5.1).
English: For administration, the reconstituted solution must be further diluted in 250 mL of sodium chloride 0.9% solution for injection.
Slovenian: Za uporabo pri bolniku je treba rekonstituirano raztopino dodatno razredčiti v 250 ml 0,9-odstotne raztopine natrijevega klorida za injiciranje.
English: White to off-white powder.
Slovenian: bel do skoraj bel prašek
English: The safety profile was similar when comparing patients receiving intravenous tedizolid phosphate alone to patients who received oral administration alone, except for a higher reported rate of gastrointestinal disorders associated with oral administration.
Slovenian: Varnostni profil je bil podoben pri bolnikih, ki so tedizolid fosfat prejemali kot samostojno zdravljenje intravensko, in tistih, ki so zdravilo prejemali kot samostojno zdravljenje peroralno.
English: Hepatic impairment No dosage adjustment is required (see section 5.2).
Slovenian: Okvara jeter Prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: Crospovidone Magnesium stearate
Slovenian: Jedro tablete mikrokristalna celuloza manitol povidon krospovidon magnezijev stearat
English: Each vial of powder contains disodium tedizolid phosphate which is equal to 200 mg of tedizolid phosphate.
Slovenian: Ena viala vsebuje dinatrijev tedizolid fosfat, kolikor ga ustreza 200 mg tedizolid fosfata.
English: In a clinical study comparing the single dose (2 mg) pharmacokinetics of midazolam (CYP3A4 substrate) alone or in combination with tedizolid phosphate (once-daily 200 mg oral dose for 10 days), midazolam AUC and Cmax when co-administered with tedizolid phosphate were 81% and 83% of midazolam AUC and Cmax when administered alone, respectively.
Slovenian: V klinični študiji, v kateri so primerjali farmakokinetiko enkratnih odmerkov (2 mg) midazolama (substrat CYP3A4) samega ali v kombinaciji s tedizolid fosfatom (200-mg peroralni odmerek enkrat dnevno 10 dni), sta, v primeru sočasne uporabe s tedizolid fosfatom, AUC in Cmax midazolama znašala 81 % oziroma 83 % vrednosti AUC in Cmax v primeru uporabe samega midazolama.
English: If a dose is missed, it should be taken as soon as possible anytime up to 8 hours prior to the next scheduled dose.
Slovenian: Če bolnik izpusti odmerek, ga mora vzeti čim prej, in sicer kadar koli do 8 ur pred naslednjim načrtovanim odmerkom.
English: Sivextro 200 mg film-coated tablets tedizolid phosphate
Slovenian: Sivextro 200 mg filmsko obložene tablete tedizolid fosfat
English: If in any doubt, contact your pharmacist for advice.
Slovenian: Če ste v dvomih, se posvetujte s farmacevtom.
English: The mechanism of action is different from that of non-oxazolidinone class antibacterial medicinal products; therefore, cross-resistance between tedizolid and other classes of antibacterial medicinal products is unlikely.
Slovenian: Verjetnost navzkrižne odpornosti med tedizolidom in drugimi skupinami protibakterijskih zdravil je zato majhna.
English: • Abnormal sense of taste
Slovenian: • nenormalno okušanje
English: Sivextro 200 mg powder for concentrate for solution for infusion tedizolid phosphate
Slovenian: Sivextro 200 mg prašek za koncentrat za raztopino za infundiranje tedizolid fosfat
English: • Vaginal infection, inflammation or itching
Slovenian: • okužba, vnetje ali srbenje nožnice
English: Vulvovaginal mycotic infection Fungal infection Vulvovaginal candidiasis Abscess
Slovenian: Infekcijske in parazitske bolezni vulvovaginalna glivična okužba glivična okužba vulvovaginalna kandidiaza absces kolitis zaradi okužbe s Clostridioides difficile dermatofitija oralna kandidiaza okužba dihal
English: In a clinical study comparing the single dose (10 mg) pharmacokinetics of rosuvastatin (Breast Cancer Resistant Protein [BCRP] substrate) alone or in combination with tedizolid phosphate (once-daily 200 mg oral dose), rosuvastatin AUC and Cmax increased by approximately 70% and 55%, respectively, when coadministered with tedizolid phosphate.
Slovenian: V klinični študiji, v kateri so primerjali farmakokinetiko enkratnih odmerkov (10 mg) rosuvastatina (substrat proteina odpornosti pri raku dojke [BCRP - Breast Cancer Resistance Protein]) samega ali v kombinaciji s tedizolid fosfatom (200-mg peroralni odmerek enkrat dnevno), sta se, v primeru sočasne uporabe s tedizolid fosfatom, AUC in Cmax rosuvastatina zvišala; AUC za približno 70 % in Cmax za približno 55 %.
English: Talk to a doctor if you do not feel better, or if you feel worse after 6 days.
Slovenian: Če se v 6 dneh znaki vaše bolezni ne izboljšajo ali se še poslabšajo, se posvetujte z zdravnikom.
English: In a clinical study comparing the single dose (10 mg) pharmacokinetics of rosuvastatin (BCRP substrate) alone or in combination with the oral administration of tedizolid phosphate 200 mg, rosuvastatin AUC and Cmax increased by approximately 70% and 55%, respectively, when coadministered with Sivextro.
Slovenian: V klinični študiji, v kateri so primerjali farmakokinetiko enkratnih odmerkov (10 mg) rosuvastatina (substrat BCRP) samega ali v kombinaciji s peroralno obliko tedizolid fosfata v odmerku 200 mg, sta se, v primeru sočasne uporabe z zdravilom Sivextro, AUC in Cmax rosuvastatina zvišala; AUC za približno 70 % in Cmax za približno 55 %.
English: Infusion related reaction Peripheral oedema
Slovenian: bolečina na mestu infundiranja razdražljivost pireksija z infuzijo povezana reakcija periferni edem
English: • Swollen or enlarged lymph nodes
Slovenian: • zatečene ali povečane bezgavke
English: The reconstituted solution should be inspected visually for particulate matter prior to administration.
Slovenian: Rekonstituirano raztopino je treba pred uporabo pregledati in se prepričati, da ne vsebuje nobenih delcev.
English: Peripheral neuropathy, as well as optic neuropathy sometimes progressing to loss of vision, have been reported in patients treated with another member of the oxazolidinone class with treatment durations exceeding that recommended for tedizolid phosphate.
Slovenian: Med zdravljenjem z drugim zdravilom iz skupine oksazolidinonov v daljšem obdobju od priporočenega za tedizolid fosfat so poročali o periferni nevropatiji kot tudi o nevropatiji očesnega živca, ki je nekajkrat napredovala v izgubo vida.
English: Diabetes mellitus inadequate control
Slovenian: Bolezni imunskega sistema preobčutljivost za zdravilo
English: Talk to your doctor or nurse before being given Sivextro if any of the following apply to you: - are suffering from diarrhoea, or have suffered from diarrhoea whilst (or up to 2 months after) being treated with antibiotics in the past.
Slovenian: Preden prejmete zdravilo Sivextro se posvetujte z zdravnikom ali medicinsko sestro, če kar koli od naštetega velja za vas: - če imate drisko ali ste v preteklosti imeli drisko med uporabo antibiotikov (ali do 2 meseca po uporabi); - če ste alergični na druga zdravila, ki spadajo v skupino "oksazolidinonov" (npr. linezolid, cikloserin); - če jemljete zdravila za zdravljenje depresije, ki se imenujejo triciklični antidepresivi, antidepresivi vrste SSRI (selektivni zaviralci ponovnega privzema serotonina) ali zaviralci MAO (zaviralci monoaminooksidaze), za primere glejte Druga zdravila in zdravilo Sivextro; - če jemljete zdravila proti migreni, ki se imenujejo "triptani," za primere glejte Druga zdravila in zdravilo Sivextro.
English: Sivextro 200 mg powder for concentrate tedizolid phosphate
Slovenian: Sivextro 200 mg prašek za koncentrat tedizolid fosfat i.v.
English: Reproductive system and breast disorders
Slovenian: Motnje reprodukcije in dojk vulvovaginalni pruritus
English: Decreased platelets, decreased haemoglobin and decreased neutrophils have been observed in a few subjects during treatment with tedizolid phosphate.
Slovenian: Med zdravljenjem s tedizolid fosfatom so pri nekaj preiskovancih opazili zmanjšano število trombocitov, znižano raven hemoglobina in zmanjšano število nevtrofilcev.
English: Bradycardia
Slovenian: Laktacidoza
English: Certain side effects have been observed with another member of the oxazolidinone class when administered over a duration exceeding that recommended for Sivextro.
Slovenian: Pri drugem zdravilu iz skupine oksazolidinonov, ko so ga uporabljali v daljšem časovnem obdobju od priporočenega za zdravilo Sivextro, so opazili nekatere neželene učinke.
English: In rats, decreased foetal weights and increased skeletal variations including reduced ossification of the sternabrae, vertebrae, and skull were observed at the high dose of 15 mg/kg/day (6-fold the estimated human exposure based on AUCs) and were associated with maternal toxicity (reduced maternal body weights).
Slovenian: Pri podganah so pri velikem odmerku 15 mg/kg/dan (6-kratnik ocenjene ravni izpostavljenosti pri človeku, ki temelji na vrednostih AUC) opazili zmanjšano maso plodu in povečane variacije skeleta, vključno z zmanjšano okostenelostjo prsnice, vretenc in lobanje.
English: A second resistance mechanism is encoded by a plasmid-borne and transposon associated chloramphenicol-florfenicol resistance (cfr) gene, conferring resistance in staphylococci and enterococci to oxazolidinones, phenicols, lincosamides, pleuromutilins, streptogramin A and 16-membered macrolides.
Slovenian: Drugi mehanizem odpornosti temelji na genu za odpornost na kloramfenikol/florfenikol (cfr), ki ga prenašajo plazmidi in je povezan s transpozoni.
English: • bleeding or bruising easily
Slovenian: • nagnjenost h krvavitvam ali podplutbam,
English: Infusion
Slovenian: Infundiranje
English: Nasal dryness Pulmonary congestion
Slovenian: Žilne bolezni zardevanje vročinski oblivi
English: Serotonergic agents
Slovenian: Serotoninergične učinkovine
English: Povidone
Slovenian: Redčenje
English: Following single oral administration of
Slovenian: Po enkratnem peroralnem odmerku s
English: Clostridioides difficile colitis Dermatophytosis Oral candidiasis Respiratory tract infection
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj suhost nosne sluznice pljučna kongestija
English: Hepatic impairment
Slovenian: Očesne bolezni zamegljen vid
English: How to store Sivextro
Slovenian: Shranjevanje zdravila Sivextro
English: Contact your doctor straight away if you suffer from diarrhoea during or after your treatment.
Slovenian: Če med zdravljenjem ali po njem dobite drisko, o tem nemudoma obvestite zdravnika.
English: • Infusion site pain or swelling.
Slovenian: • bolečina ali oteklina na mestu infundiranja
English: The following quality, efficacy and safety issues were addressed:
Slovenian: Obravnavana so bila naslednja vprašanja kakovosti, učinkovitosti in varnosti:
English: Section on contraindications remained unchanged.
Slovenian: Poglavje o kontraindikacijah ostaja nespremenjeno.
English: Ms Eeva Liisa Kärkkäinen
Slovenian: ga. Eeva Liisa Kärkkäinen
English: The tubes are packed in boxes containing 10, 20, 30, 40, 60,
Slovenian: Vsebniki so pakirani v škatle, ki vsebujejo po 10, 20, 30, 40, 60, 80, 100 in
English: 1800 VILVOORDE Belgium
Slovenian: 1800 VILVOORDE Belgija
English: The mineral component of bones and teeth contains 99% of the body's calcium.
Slovenian: Mineralne sestavine kosti in zob vsebujejo 99 % kalcija v telesu.
English: Undesirable effects
Slovenian: 4.7 Neželeni učinki
English: Emelet Postacím: 1525 Budapest, Pf. 118 Hungary
Slovenian: Emelet Postacím: 1525 Budapest, Pf. 118 Madžarska
English: uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000) or very rare (<1/10,000), including isolated reports.
Slovenian: Pogostnost je opredeljena kot: občasni (>1/1.000, <1/100), redki (>1/10.000, <1/1.000) ali zelo redki (<1/10.000), vključno s posameznimi primeri.
English: Ms Margarida Moraes
Slovenian: ga. Margarida Moraes
English: Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: Physicochemical and biological aspects relevant to the uniform clinical performance of the product have been investigated and are controlled in a satisfactory way.
Slovenian: Fizikalno-kemijski in biološki vidiki, ki zadevajo enotno klinično učinkovitost zdravila, so bili zadovoljivo raziskani in so zadovoljivo nadzorovani.
English: Mr Carlo Candiani
Slovenian: g. Carlo Candiani
English: Sodium hydrogen carbonate
Slovenian: natrijev hidrogenkarbonat
English: Wimblehurst Road, Horsham,
Slovenian: Wimblehurst Road, Horsham, West
English: During pregnancy, the daily intake of calcium should not exceed 1500 mg.
Slovenian: V času nosečnosti dnevni vnos kalcija ne sme biti večji od 1500 mg.
English: To be completed nationally.
Slovenian: Izpolni država članica.
English: Attn: Mr Pieter De Pourcq
Slovenian: Vročiti: g. Pieter De Pourcq
English: The remaining 1% is present in the intra- and extracellular fluids.
Slovenian: Preostali 1 % se nahaja v znotraj- in zunajcelični tekočini.
English: Attn: Dr Jacinta Keogh-Bennett
Slovenian: Vročiti: Dr. Jacinta Keogh-Bennett
English: In the case of an intoxication, treatment should be stopped immediately and the fluid deficiency should be corrected.
Slovenian: V primeru zastrupitve je zdravljenje potrebno takoj prekiniti in nadomestiti pomanjkanje tekočin.
English: It was agreed that the wording indication would address the following three conditions: a generally worded indication for prevention and treatment of calcium deficiency, which covers situations of expected/potential increased calcium demand.
Slovenian: Dosežen je bil sporazum, da se besedilo indikacij nanaša na naslednja tri stanja: splošno indikacijo za preprečevanje in zdravljenje pomanjkanja kalcija, ki pokrije tudi stanja pričakovane/potencialne povečane potrebe po kalciju.
English: The quality of this product is considered to be acceptable when used in accordance with the conditions defined in the SPC.
Slovenian: Kakovost tega zdravila je bila ocenjena za sprejemljivo, če se uporablja skladno s pogoji, opredeljenimi v Povzetku glavnih značilnosti zdravila (SPC).
English: The effervescent tablets should be dissolved in a glass of water (approx. 200 ml) and drunk immediately.
Slovenian: Šumeče tablete je potrebno raztopiti v kozarcu vode (približno v 200 ml) in jo takoj popiti.
English: 6.6 instructions for use and handling
Slovenian: 6.6 Navodila za pripravo in ravnanje z zdravilom
English: Calcium is an essential mineral, necessary for bone formation and maintenance, for electrolyte equilibrium in the body and for the proper functioning of numerous regulatory mechanisms.
Slovenian: Kalcij je esencialni mineral, ki je nujno potreben za tvorbo in vzdrževanje kosti, ravnovesje elektrolitov v telesu in za ustrezno delovanje številnih regulatornih mehanizmov.
English: If necessary, the calcium dose should be reduced or therapy should be discontinued.
Slovenian: Če je potrebno, moramo odmerek kalcija zmanjšati ali zdravljenje prekiniti.
English: Largo U. Boccioni, 1 21040 Origgio (VA), Italy
Slovenian: Largo U. Boccioni, 1 21040 Origgio (VA), Italija
English: Attn: P. Miko
Slovenian: Vročiti: P. Miko
English: About 50% of the total blood-calcium content is in the physiologically active ionised form, with approximately 5% being complexed to citrate, phosphate or other anions.
Slovenian: Okoli 50 % celokupnega kalcija v krvi je v fiziološko aktivni ionizirani obliki, medtem ko je približno 5 % kalcija v kompleksih s citratnimi, fosfatnimi ali drugimi anioni.
English: For excipients, see section 6.1.
Slovenian: Za pomožne snovi glejte poglavje 6.1.
English: Novartis Santé Familiale S.A.S., 14 Bld Richelieu 92845 Rueil Malmaison Cedex,
Slovenian: Novartis Santé Familiale S.A.S., 14 Bld Richelieu 92845 Rueil Malmaison Cedex, Francija
English: GmbH, Bahnhofbichl 13 6391 Fieberbrunn/Tirol,
Slovenian: GmbH, Bahnhofbichl 13 6391 Fieberbrunn/Tirol, Avstrija
English: Patients with rare hereditary problems of fructose intolerance or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za fruktozo ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Adverse reactions are listed below, by system organ class and frequency.
Slovenian: Neželeni učinki so navedeni spodaj glede na organski sistem in pogostnost.
English: West Sussex RH12 5AB
Slovenian: Sussex RH12 5AB
English: Attn: Mr Torbjörn Sonck &
Slovenian: Vročiti: g. Torbjörn Sonck &
English: Varnavas Hadjipanayis Ltd. 7A Androcleous Str. 1060 Nicosia
Slovenian: Varnavas Hadjipanayis Ltd. 7A Androcleous Str. 1060 Nicosia Ciper.
English: There have been literature reports alluding to possible increased absorption of aluminium with citrate salts.
Slovenian: V literaturi so na voljo poročila, ki kažejo na možnost povečanja absorpcije aluminija ob prisotnosti soli citrata.
English: Classification and terminology were amended according to the MedDRA system organ class.
Slovenian: Klasifikacija in izrazoslovje sta bila dopolnjena v skladu z razvrščanjem po razredih organskih sistemov
English: Attn: A. Catasus
Slovenian: Vročiti: A. Catasus
English: Treatment of overdose:
Slovenian: Zdravljenje prevelikega odmerjanja:
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, NAČINOV UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: ATC codes: Calcium carbonate (A 12 AA 04), Calcium lactate gluconate (A 12 AA 06)
Slovenian: Oznaki ATC: kalcijev karbonat (A 12 AA 04), kalcijev laktat glukonat (A 12 AA 06)
English: 4.2 Posology and method of administration Adults: 500 - 1500 mg per day Children: 500 - 1000 mg per day
Slovenian: Odrasli: 500 - 1500 mg na dan Otroci: 500 - 1000 mg na dan
English: Urinary excretion depends on glomerular filtration and tubular reabsorption.
Slovenian: Izločanje s sečem je odvisno od glomerularne filtracije in tubularne reabsorpcije.
English: mmol of calcium).
Slovenian: mmol kalcija).
English: Safety issues
Slovenian: Vprašanja o varnosti
English: Successful treatment of rickets and osteomalacia will require adequate supply and action of vitamin D and sufficient supply of calcium to allow normal bone mineralisation.
Slovenian: Uspešno zdravljenje rahitisa in osteomalacije bo zahtevalo zadosten vnos in delovanje vitamina D ter zadosten vnos kalcija za normalno mineralizacijo kosti.
English: Av. Poeta Mistral n°2-2°, 1069-172 Lisboa, Portugal
Slovenian: 2°, 1069-172 Lisboa, Portugalska
English: Attn: J. Grevsen
Slovenian: Vročiti: J. Grevsen
English: Based on the documentation submitted by the Marketing Authorisation Holders and the scientific discussion within the Committee, the CHMP considered that the benefit/risk ratio of Calcium Sandoz 500 mg and 1000 mg effervescent tablets is positive for the agreed and harmonised indications.
Slovenian: Odbor za zdravila za uporabo v humani medicini na podlagi dokumentacije, ki so jo predložili imetniki dovoljenja za promet, in znanstvene razprave znotraj Odbora meni, da je razmerje med koristmi in tveganji za zdravilo Calcium Sandoz 500 mg in 1000 mg šumeče tablete pozitivno za dogovorjene in usklajene indikacije.
English: Based on the available information and a literature search, there does not seem to be any major safety issue associated with the administration of calcium in oral use.
Slovenian: Na podlagi dostopnih podatkov in pregleda literature ni mogoče najti večjih zadržkov glede varnosti, ki bi bili povezani z uporabo kalcija peroralno.
English: Attn: Ms Maria do Céu Correia &
Slovenian: Vročiti: ga. Maria do Céu Correia &
English: Benefit/Risk considerations
Slovenian: Pomisleki pri razmerju med koristmi in tveganji
English: Attn: Ms Maria Carla Baggio &
Slovenian: Vročiti: ga. Maria Carla Baggio &
English: Novartis (Hellas) AEBE 12o Km National Road No1, 14451 Metamorfosis Attikis,
Slovenian: Novartis (Hellas) AEBE -12o Km National Road No1,14451
English: The Netherlands Novartis Consumer Health B.V, Claudius Prinsenlaan 140
Slovenian: Novartis Consumer Health B.V, Claudius Prinsenlaan 140
English: For this reason, tetracycline preparations should be administered at least two hours before or four to six hours after oral intake of calcium.
Slovenian: Tetracikline je potrebno zato jemati najmanj 2 uri pred ali 4 do 6 ur po peroralnem vnosu kalcija.
English: Minor wording modification was introduced to section on pregnancy and lactation in order to add clarity and to put it in line with the guideline on summary of product characteristics.
Slovenian: V poglavju o nosečnosti in dojenju je bilo v manjši meri spremenjeno besedilo, da bi bilo slednje jasnejše in da bi se uskladilo s smernicami Povzetka glavnih značilnosti zdravila.
English: Postboks 237 Økern 0510 Oslo, Norway
Slovenian: Postboks 237 Økern 0510 Oslo, Norveška Vročiti: J. Lam
English: - Prevention and treatment of calcium deficiency - Calcium supplement as an adjunct to specific therapy in the prevention and treatment of osteoporosis - Rickets and osteomalacia, in addition to vitamin D3 therapy
Slovenian: - dodatek kalcija kot dopolnilo specifični terapiji pri preprečevanju in zdravljenju osteoporoze - pri rahitisu in osteomalaciji kot dodatek zdravljenju z vitaminom D3
English: Calcium Sandoz is therefore contraindicated in patients with hypersensitivity to the active substances or to any of the excipients of the effervescent tablet; diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria; nephrocalcinosis and nephrolithiasis.
Slovenian: Zdravilo Calcium Sandoz je torej kontraindicirano pri bolnikih s preobčutljivostjo za zdravilni učinkovini ali katerokoli pomožno snov šumečih tablet; boleznih in/ali stanjih, ki imajo za posledico hiperkalciemijo in/ali hiperkalciurijo; pri nefrokalcinozi in nefrolitiazi.
English: The active ingredients of the medicinal products, Calcium Sandoz 500 mg and 1000 mg effervescent tablets (calcium lactate gluconate and calcium carbonate), have demonstrated efficacy and an acceptable level of safety during decades of human use in a large number and variety of products in numerous countries.
Slovenian: Zdravilni učinkovini zdravil Calcium Sandoz 500 mg in 1000 mg šumeče tablete (kalcijev laktat glukonat in kalcijev karbonat) sta pokazali učinkovitost in sprejemljivo raven varnosti skozi desetletja uporabe pri človeku za veliko število in številne različice zdravila v številnih državah.
English: PHARMACEUTICAL FORM
Slovenian: FarmaceVTSKA OBLIKA
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
English: During high dose therapy and especially during concomitant treatment with vitamin D, there is a risk of hypercalcaemia with subsequent kidney function impairment.
Slovenian: Med zdravljenjem z velikimi odmerki in posebej ob sočasnem zdravljenju z vitaminom D obstaja tveganje za pojav hiperkalciemije, ki ima lahko za posledico motnje v delovanju ledvic.
English: Czech Republic Novartis s.r.o.
Slovenian: Češka republika Novartis s.r.o.
English: Section on undesirable effects was amended according to last post marketing surveillance information, and brought also in line with the guideline on summary of product characteristics.
Slovenian: Poglavje o neželenih učinkih je bilo dopolnjeno na podlagi zadnjih podatkov, pridobljenih v okviru postmarketinškega nadzora, in usklajeno s smernicami Povzetka glavnih značilnosti zdravila.
English: Osteoporosis, where the role of calcium supplementation is well established.
Slovenian: Osteoporoza, kjer je pomen dopolnjevanja vnosa kalcija dobro uveljavljen.
English: Attn: G. Tseriotis
Slovenian: Vročiti: G. Tseriotis