natgillin/translations-raw huggingface dataset:
The full EPAR for Azomyr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Azomyr je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Azomyr on 15 January 2001. 
Evropska komisija je dovoljenje za promet z zdravilom Azomyr, veljavno po vsej Evropski uniji, odobrila dne 15. januarja 2001.
This is a summary of the European public assessment report (EPAR) for Azomyr. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Azomyr.
For more information about treatment with Azomyr, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Azomyr preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
What benefit has Azomyr shown during the studies? 
Kakšne koristi je zdravilo Azomyr izkazalo med študijami?
In all studies, the effectiveness of Azomyr was compared with that of placebo (a dummy treatment). 
V vseh študijah so učinkovitost zdravila Azomyr primerjali s placebom (zdravilom brez zdravilne učinkovine).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Azomyr. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Azomyr, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Other information about Azomyr 
Druge informacije o zdravilu Azomyr:
Azomyr has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma). 
Zdravilo Azomyr so raziskali v osmih študijah, v katerih je sodelovalo približno 4 800 odraslih in mladostnikov z alergijskim rinitisom (vključno s štirimi študijami sezonskega alergijskega rinitisa in dvema študijama pri bolnikih, ki so imeli tudi astmo).
Azomyr is a medicine containing the active substance desloratadine. 
Azomyr je zdravilo, ki vsebuje zdravilno učinkovino desloratadin.
In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Azomyr was 58 and 67%, compared with 40 and 33% in placebo-treated patients. 
V dveh študijah pri bolnikih z urtikarijo se je jakost simptomov po šestih tednih zdravljenja z zdravilom Azomyr zmanjšala za 58 % in 67 % v primerjavi s 40 % in 33 % pri bolnikih, ki so prejemali placebo.
Azomyr must not be used in people who are hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients. 
Zdravila Azomyr ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) desloratadin, loratadin ali katero koli drugo sestavino zdravila.
What is the risk associated with Azomyr? 
Kakšna tveganja so povezana z zdravilom Azomyr?
Azomyr has also been studied in 416 patients with urticaria. 
Zdravilo Azomyr so proučevali tudi pri 416 bolnikih s kronično idiopatsko urtikarijo.
The Committee recommended that Azomyr be given marketing authorisation. 
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Azomyr.
The active substance in Azomyr, desloratadine, is an antihistamine. 
Zdravilna učinkovina zdravila Azomyr desloratadin je antihistaminik.
For the full list of all side effects reported with Azomyr, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Azomyr, glejte navodilo za uporabo.
Azomyr is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives). 
Zdravilo Azomyr se uporablja za lajšanje simptomov alergijskega rinitisa (vnetja nosne votline, ki ga povzroči alergija, na primer seneni nahod ali alergija na pršice) ali urtikarije (bolezni kože, ki jo povzroča alergija in katere simptomi vključujejo srbenje in izpuščaje).
Why has Azomyr been approved? 
Zakaj je bilo zdravilo Azomyr odobreno?
In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with 5 mg Azomyr led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo. 
Dvotedensko zdravljenje z zdravilom Azomyr 5 mg je pri alergijskem rinitisu v vseh študijah privedlo do zmanjšanja števila simptomov za povprečno 25 do 32 %, v primerjavi z 12- do 26-odstotnim zmanjšanjem pri bolnikih, ki so prejemali placebo.
For children from six to 11 years of age, the dose is 2.5 mg once a day, taken either as 5 ml of the syrup or oral solution, or as one 2.5 mg orodispersible tablet. 
Otroci, stari od 6 do 11 let, pa prejemajo odmerek 2,5 mg enkrat dnevno v obliki 5 ml sirupa ali peroralne raztopine oziroma z eno 2,5miligramsko orodisperzibilno tableto.
The Committee for Medicinal Products for Human Use (CHMP) decided that Azomyr's benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria. 
CHMP je zaključil, da so koristi zdravila Azomyr pri lajšanju simptomov alergijskega rinitisa ali urtikarije večje od z njim povezanih tveganj.
The effectiveness of Azomyr was measured by looking at the change in the symptoms (nasal discharge, itching, sneezing and congestion) before and after two or four weeks of treatment. 
Učinkovitost zdravila Azomyr so merili s spremembo simptomov (izcedek iz nosu, srbenje, kihanje, zamašenost nosu), ki so jih opazovali pred zdravljenjem in 2 do 4 tedne po zaključku zdravljenja.
It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally attaches itself. 
Desloratadin deluje kot zaviralec receptorjev, na katere se običajno veže histamin tj. snov v telesu, ki povzroča alergijske simptome.
How has Azomyr been studied? 
Kako je bilo zdravilo Azomyr raziskano?
What is Azomyr? 
Kaj je zdravilo Azomyr?
What is Azomyr used for? 
Za kaj se zdravilo Azomyr uporablja?
How does Azomyr work? 
Kako zdravilo Azomyr deluje?
How is Azomyr used? 
Kako se zdravilo Azomyr uporablja?
Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the Member States 
Dodatek I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
These pain improvements were maintained at all subsequent evaluations. 
To izboljšanje bolečine se je ohranilo na vseh nadaljnjih ocenah.
In rare cases allergic reactions may be severe. 
V redkih primerih so alergijske reakcije lahko hude.
The European Medicines Agency has deferred the obligation to submit the final results of this study. 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev končnih rezultatov te študije.
• in patients with advanced cancer: development of another form of cancer. 
• pri bolnikih z napredovanim rakom: razvoj druge oblike raka.
Date of latest renewal: 4 April 2016 
Datum zadnjega podaljšanja: 4. april 2016
The median time to surgery was 261 days. 
Mediana čas do kirurškega posega je bil 261 dni.
None of the adverse events was considered serious. 
Noben od teh neželenih dogodkov ni bil ocenjen za resnega.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 July 2011 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 13. julij 2011
Pack sizes of one, three or four. 
Velikost pakiranj po ena, tri ali štiri.
• excessive sweating, 
• čezmerno znojenje,
Clinical characteristics of these cases were similar between treatment groups. 
Klinične značilnosti teh primerov so bile med zdravljenimi skupinami podobne.
Based on best response 
Na podlagi najboljšega odziva 190
Within these active-controlled clinical trials, safety was evaluated in 5,931 patients. 
V okviru teh kliničnih študij, kontroliranih z učinkovino, so varnost ocenjevali pri 5.931 bolnikih.
The median duration of response was not estimable (four patients experienced disease progressions following an objective response). 
Mediana trajanje odziva ni bilo ocenljivo (štirim bolnikom je bolezen napredovala po objektivnem odzivu).
The overall incidence of clinically significant hypocalcaemia was 9%. 
Celotna incidenca klinično pomembne hipokalciemije je bila 9 %.
This includes medicines obtained without a prescription. 
To vključuje zdravila, ki ste jih dobili brez recepta.
Events have occurred during treatment and up to 9 months after treatment was discontinued (see section 4.4). 
Dogodki so se pojavili med zdravljenjem in do 9 mesecev po prenehanju zdravljenja (glejte poglavje 4.4).
1 CI = Exact Confidence Interval 
1 IZ = eksaktni interval zaupanja
Increasing body weight was associated with decreases in systemic exposure, and vice versa. 
Povečevanje telesne mase je bilo povezano z zmanjšanjem sistemske izpostavljenosti in obratno.
Number of patients with an objective response 
Število bolnikov z objektivnim odzivom
It is important to tell your doctor if you are pregnant, think you may be pregnant, or plan to get pregnant. 
Pomembno je, da zdravniku poveste, če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev.
Problems with your mouth, teeth or jaw 
Težave z usti, zobmi ali čeljustjo
Upon enrolment of 305 patients in studies 5 and 6 a retrospective independent review of radiographic imaging data was performed. 
Potem, ko je bilo v študiji 5 in 6 vključenih 305 bolnikov, je bil opravljen retrospektiven, neodvisen pregled podatkov radiografskih slikanj.
No overall differences in safety or efficacy were observed between geriatric patients and younger patients. 
V celoti niso ugotovili razlik v varnosti in učinkovitosti med geriatričnimi bolniki in mlajšimi.
Of the remaining 15 patients, 10 (67%) radiographic measurements showed no progression of the target lesion. 
Pri preostalih 15 bolnikih 10 (67 %) radiografskih meritev ni pokazalo napredovanja ciljne lezije.
RANKL exists as a transmembrane or soluble protein. 
RANKL obstaja kot transmembranska ali topna beljakovina.
For instructions for use, handling and disposal see section 6.6. 
Za navodila glede uporabe, ravnanja z zdravilom in odstranjevanja glejte poglavje 6.6.
Efficacy results from study 4 are presented in figure 2 and table 3. 
Rezultati učinkovitosti iz študije 4 so prikazani na sliki 2 in preglednici 3.
An investigator assessment reported that all 18 adolescent patients had a best response of stable disease or better (complete response in 2 patients, partial response in 8 patients, and stable disease in 8 patients). 
Ocena raziskovalcev je navajala, da je imelo vseh 18 mladostnikov kot najboljši odziv stabilno bolezen ali boljši (popolni odziv pri 2 bolnikih, delni odziv pri 8 bolnikih in stabilna bolezen pri 8 bolnikih).
• The entire contents of the vial should be injected. 
• Injicirajte celotno vsebino viale.
One hundred and ninety had at least 1 evaluable time point response and were included in the analysis (table 4). 
Stodevetdeset jih je imelo vsaj 1 ocenljivo časovno točko odziva in so bili vključeni v analizo (preglednica 4).
Patients with rare hereditary problems of fructose intolerance should not take this medicinal product. 
Bolniki z redko prirojeno motnjo intolerance za fruktozo ne smejo uporabljati tega zdravila.
Each pack contains one, three or four single use vials. 
Eno pakiranje vsebuje eno, tri ali štiri viale za enkratno uporabo.
Overall safety profile is consistent in all approved indications for XGEVA. 
Celoten varnostni profil je skladen med vsemi odobrenimi indikacijami za zdravilo XGEVA.
N = number of subjects randomised 
N = Število randomiziranih preiskovancev
• Before receiving treatment, tell your doctor/nurse (healthcare professional) if you have any problems with your mouth or teeth. 
• Preden dobite zdravilo, morate zdravniku ali medicinski sestri (zdravstvenemu delavcu) povedati, če imate kakšne težave v ustih ali z zobmi.
Based on these limited data, the adverse event profile appeared to be similar to adults. 
Na podlagi teh omejenih podatkov se zdijo značilnosti neželenih dogodkov podobne kot pri odraslih.
22.14 (14.26, NE) 
22,14 (14,26, NO)
It is important to try to prevent osteonecrosis of the jaw developing as it may be a painful condition that can be difficult to treat. 
Pomembno si je prizadevati, da bi preprečili nastanek osteonekroze čeljustnice, ker gre za stanje, ki lahko boli in ga je težko zdraviti.
Following subcutaneous administration, bioavailability was 62%. 
Po subkutani uporabi je bila biološka uporabnost 62 %.
All 20 patients (100%) with histology assessments responded. 
Odzvalo se je vseh 20 bolnikov (100 %), ki so imeli opravljeno histološko oceno.
22.8 (14.7, NE) 
22,8 (14,7, NO)
Between weeks 9 and 49, median trough levels varied by less than 9%. 
Med 9. in 49. tednom je mediana najnižja koncentracija variirala za manj kot 9 %.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine, since it contains sorbitol (E420). 
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se z njim posvetujte, preden vzamete to zdravilo, ker vsebuje sorbitol (E420).
Patients should be monitored for radiological signs of malignancy, new radiolucency or osteolysis. 
Bolnike je treba kontrolirati glede radioloških znakov malignosti, nove radiolucentnosti ali osteolize.
The primary and secondary endpoints evaluated the occurrence of one or more skeletal related events (SREs). 
Primarni in sekundarni opazovani dogodek sta ocenjevala pojav enega ali več skeletnih dogodkov (SRE - Skeletal Related Events).
Patients with giant cell tumour of bone should be evaluated at regular intervals to determine whether they continue to benefit from treatment. 
Bolnike z gigantocelularnim kostnim tumorjem je treba v rednih presledkih ocenjevati, da bi ugotovili, ali jim zdravljenje še koristi.
RANKL is essential for the formation, function and survival of osteoclasts, the sole cell type responsible for bone resorption. 
RANKL je nujen za nastajanje, delovanje in preživetje osteoklastov, edine vrste celic, odgovorne za resorpcijo kosti.
Low calcium in the blood may also lead to a change in heart rhythm called QT prolongation, which is seen by electrocardiogram (ECG). 
Nizek kalcij v krvi lahko povzroči spremembo srčnega ritma, imenovano podaljšanje QT, ki je vidna na elektrokardiogramu (EKG).
Response criteria included elimination of giant cells based on histopathology or lack of progression by radiography. 
Merila odziva so vključevala odpravo celic velikank na podlagi histopatološkega pregleda ali odsotnost radiografskega napredovanja.
Study 2** 
Študija 2**
The median time to response was 3.1 months (95% CI: 2.89, 3.65). 
Mediani čas do odziva je bil 3,1 meseca (95 % IZ: 2,89, 3,65).
Number of patients evaluable for response 
Število bolnikov, pri katerih je bilo mogoče oceniti odziv
• a bisphosphonate 
• z bisfosfonatom.
Kaplan-Meier plots of time to first on-study SRE 
Kaplan-Meierjevi prikazi časa do prvega SRE med študijo
Secondary outcome measures included superiority of time to first SRE, superiority of time to first and subsequent SRE, and overall survival. 
Med sekundarnimi merami izida so bili superiornost časa do prvega skeletnega dogodka, superiornost časa do prvega in nadaljnjih skeletnih dogodkih in celokupno preživetje.
• low phosphate levels in the blood (hypophosphataemia), 
• nizka koncentracija fosfata v krvi (hipofosfatemija),
NR 33.2 
ND 33,2
HCM = hypercalcaemia of malignancy 
HCM (hypercalcaemia of malignancy) = hiperkalciemija zaradi malignoma
Difference in median time (months) 
Razlika v mediana času (meseci)
Regular monitoring of calcium levels is especially important in these patients. 
Pri takšnih bolnikih so redne kontrole koncentracije kalcija posebej pomembne.
If you are being treated for giant cell tumour of bone, you will receive an additional dose 1 week and 2 weeks after the first dose. 
Če se zdravite zaradi gigantocelularnega kostnega tumorja, boste dobili dodaten odmerek 1 teden in 2 tedna po prvem odmerku.
• removal of a tooth, 
• izdrtje zoba,
Osteonecrosis of the jaw can also occur after stopping treatment. 
Osteonekroza čeljustnice se lahko pojavi tudi po končanju zdravljenja.
• While being treated, you should maintain good oral hygiene and receive routine dental check-ups. 
• Med zdravljenjem morate vzdrževati dobro ustno higieno in opravljati redne zobozdravniške preglede.
Consequently, osteolysis is reduced and proliferative tumour stroma is replaced with non-proliferative, differentiated, densely woven new bone. 
Posledično se osteoliza zmanjša in proliferacijsko tumorsko stromo nadomesti neproliferacijsko, diferencirano, gosto novo kostno tkivo.
XGEVA is a clear, colourless to slightly yellow solution. 
Zdravilo XGEVA je bistra, brezbarvna do rahlo rumena raztopina.
XGEVA has no or negligible influence on the ability to drive and use machines. 
Zdravilo XGEVA nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
There is no experience with overdose in clinical studies. 
Izkušenj s prevelikim odmerjanjem iz kliničnih študij ni.
Any effects of XGEVA are likely to be greater during the second and third trimesters of pregnancy since monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester. 
Za vse učinke zdravila XGEVA je verjetno, da so večji v drugem ali tretjem trimesečju nosečnosti, kajti monoklonska protitelesa prehajajo skozi placento linearno, kot napreduje nosečnost, s tem da jih največja količina preide v tretjem trimesečju.
No dose adjustment is required in elderly patients. 
Starejšim bolnikom odmerka ni treba prilagoditi.
In patients whose disease is controlled by XGEVA, the effect of interruption or cessation of treatment has not been evaluated, however limited data in these patients does not indicate a rebound effect upon cessation of treatment. 
Pri bolnikih, ki imajo bolezen z zdravilom XGEVA obvladano, niso ocenili učinka prekinitve ali prenehanja zdravljenja, toda omejeni podatki pri teh bolnikih ne kažejo povratnega učinka po prenehanju zdravljenja.
It is especially important that you tell your doctor if you are being treated with 
Posebej pomembno je, da zdravniku poveste, če se zdravite:
If hypocalcaemia occurs while receiving XGEVA, additional calcium supplementation and additional monitoring may be necessary. 
Če se med prejemanjem zdravila XGEVA pojavi hipokalciemija, je lahko potrebno dodatno dodajanje kalcija in dodatne kontrole.
1 single use vial 3 single use vials 4 single use vials 
1 viala za enkratno uporabo 3 viale za enkratno uporabo 4 viale za enkratno uporabo
Severe, untreated hypocalcaemia (see section 4.4). 
Huda, nezdravljena hipokalciemija (glejte poglavje 4.4).
Calcium and vitamin D supplementation 
Dodajanje kalcija in vitamina D
What XGEVA is and what it is used for 
Kaj je zdravilo XGEVA in za kaj ga uporabljamo
Its metabolism and elimination are expected to follow the immunoglobulin clearance pathways, resulting in degradation to small peptides and individual amino acids. 
Pričakovati je, da njegova presnova in izločanje potekata po poteh očistka imunoglobulinov, ki vodijo v razgradnjo do majhnih peptidov in posameznih aminokislin.
Monitoring of calcium levels should be conducted (i) prior to the initial dose of XGEVA, (ii) within two weeks after the initial dose, (iii) if suspected symptoms of hypocalcaemia occur (see section 4.8 for symptoms). 
Kontrolo koncentracije kalcija je treba izvesti (i) pred prvim odmerkom zdravila XGEVA, (ii) v dveh tednih po prvem odmerku, (iii) če se pojavijo simptomi, sumljivi za hipokalciemijo (za simptome glejte poglavje 4.8).
Within each frequency grouping and system organ class, adverse reactions are presented in order of decreasing seriousness. 
V vsaki skupini pogostnosti in vsakem organskem sistemu so neželeni učinki navedeni po padajoči resnosti.
Tell your doctor if you have or have had severe kidney problems, kidney failure or have needed dialysis, which may increase your risk of getting low blood calcium, especially if you do not take calcium supplements. 
Zdravniku morate tudi povedati, če imate ali ste kdaj imeli hude težave z ledvicami, ledvično odpoved ali ste potrebovali dializo; vse to lahko poveča vaše tveganje za pojav nizke koncentracije kalcija v krvi, še posebej, če ne jemljete dodatkov kalcija.
• poor oral hygiene, periodontal disease, poorly fitting dentures, pre-existing dental disease, invasive dental procedures (e.g. tooth extractions). 
• slabo ustno higieno, periodontalno bolezen, slabo prilegajoče se zobne proteze, že obstoječo zobno bolezen, invazivne zobozdravstvene posege (npr. ekstrakcije zob).
Once your vial has been left to reach room temperature (up to 25°C), it must be used within 30 days. 
Ko viala enkrat doseže sobno temperaturo (do 25 °C), jo morate uporabiti v 30 dneh.
Proportion of subjects without SRE 
Delež bolnikov brez SRE
Of the 35 patients included in the efficacy analysis, 85.7% (95% CI: 69.7, 95.2) had a treatment response to XGEVA. 
Od 35 bolnikov, vključenih v analizo učinkovitosti, se jih je 85,7 % (95 % IZ: 69,7, 95,2) odzvalo na zdravljenje z zdravilom XGEVA.
No dose adjustment is required in patients with renal impairment (see section 4.4 for recommendations relating to monitoring of calcium, 4.8 and 5.2). 
Bolnikom z okvaro ledvic odmerka ni treba prilagoditi (glejte poglavje 4.4 za priporočila o kontrolah kalcija, 4.8 in 5.2).
In studies of denosumab (60 mg, n = 55 and 120 mg, n = 32) in patients without advanced cancer but with varying degrees of renal function, including patients on dialysis, the degree of renal impairment had no effect on the pharmacokinetics of denosumab; thus dose adjustment for renal impairment is not required. 
V študijah z denosumabom (60 mg, n = 55, in 120 mg, n = 32) pri bolnikih brez napredovalega raka, a z različno stopnjo delovanja ledvic, vključno z bolniki na dializi, stopnja okvare ledvic ni vplivala na farmakokinetiko denosumaba, zato bolnikom z okvaro ledvic odmerka ni treba prilagoditi.
After treatment is discontinued, monitor patients for signs and symptoms of hypercalcaemia, consider periodic assessment of serum calcium and re-evaluate the patient's calcium and vitamin D supplementation requirements (see section 4.8). 
Po prenehanju zdravljenja spremljajte bolnike glede znakov in simptomov hiperkalciemije, razmislite o rednem preverjanju serumskega kalcija ter ponovno opredelite bolnikove potrebe po dodajanju kalcija in vitamina D (glejte poglavje 4.8).
Effect on pain 
Vpliv na bolečino
• allergic reactions (e.g. wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin). 
• alergijske reakcije (npr. piskajoče dihanje ali oteženo dihanje; oteklost obraza, ustnic, jezika, grla ali drugih delov telesa; izpuščaj, srbenje ali koprivnica na koži).
The non-linearity is likely due to a saturable target-mediated elimination pathway of importance at low concentrations. 
Nelinearnost je verjetno posledica saturabilne, s ciljem posredovane poti odstranjevanja, ki je pomembna pri nizkih koncentracijah.
Examples of clinical manifestations of severe symptomatic hypocalcaemia have included QT interval prolongation, tetany, seizures and altered mental status (including coma) (see section 4.4). 
Med kliničnimi manifestacijami hude simptomatske hipokalciemije so bili podaljšanje intervala QT, tetanija, konvulzije in spremenjeno duševno stanje (vključno s komo) (glejte poglavje 4.4).