natgillin/translations-raw huggingface dataset:
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Sandimmun and Sandimmun Neoral in the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je treba uskladiti informacije o predpisovanju zdravil Sandimmun in Sandimmun Neoral v Evropski uniji (EU).
Sandimmun and Sandimmun Neoral are immunosuppressive medicines (medicines that reduce the activity of the immune system, the body's natural defences).
Sandimmun in Sandimmun Neoral sta imunosupresivni zdravili (zdravili, ki zmanjšata aktivnost imunskega sistema, tj. naravnega obrambnega sistema telesa).
• Endogenous uveitis (inflammation of the uvea, the middle layer of the eye);
• endogenega uveitisa (vnetja žilnice, tj. srednje plasti očesa);
Sandimmun and Sandimmun Neoral are used in patients who have had a transplant, to prevent rejection (when the immune system attacks the transplanted organ) and to treat or prevent graftversus-host disease (when the immune system of the transplanted organ attacks the patient's tissues).
Zdravili Sandimmun in Sandimmun Neoral se uporabljata pri bolnikih po presaditvi za preprečevanje zavrnitve (ko imunski sistem napade presajeni organ) in za zdravljenje ali preprečevanje reakcije presadka proti gostitelju (ko imunski sistem presajenega organa napade tkiva bolnika).
Information on how to switch between different ciclosporin medicines was also included in the product information of these medicines.
V informacije o zdravilu za ti dve zdravili so bile vključene tudi informacije v zvezi s prehodom med različnimi zdravili, ki vsebujejo ciklosporin.
On 27 June 2013, the European Medicines Agency completed a review of Sandimmun and Sandimmun Neoral.
Evropska agencija za zdravila je 27. junija 2013 zaključila pregled zdravil Sandimmun in Sandimmun Neoral.
• Nephrotic syndrome (a kidney disease);
• nefrotskega sindroma (ledvične bolezni);
• Solid organ transplantation (for the prevention and treatment of graft rejection);
• presaditev parenhimskih organov (za preprečevanje in zdravljenje zavrnitve presadka);
The active substance in Sandimmun and Sandimmun Neoral, ciclosporin, acts on some special cells in the immune system called T-cells that are responsible for attacking transplanted organs or, in autoimmune diseases, normal tissue.
Zdravilna učinkovina v zdravilih Sandimmun in Sandimmun Neoral, ciklosporin, deluje na nekatere posebne celice imunskega sistema, imenovane T-celice, ki so odgovorne za napadanje presajenih organov oziroma normalnega tkiva pri avtoimunskih boleznih.
Why were Sandimmun and Sandimmun Neoral reviewed?
Zakaj sta bili zdravili Sandimmun in Sandimmun Neoral pregledani?
Sandimmun is also available as a concentrate for solution for infusion (50
Zdravilo Sandimmun je na voljo tudi v obliki koncentrata za raztopino za infundiranje (50 mg/ml).
However, while Sandimmun is an oil-based formulation of ciclosporin, Sandimmun Neoral is a microemulsified formulation, which allows for a more uniform absorption of ciclosporin by the body.
Razlika je, da je zdravilo Sandimmun pripravek ciklosporina na oljni osnovi, zdravilo Sandimmun Neoral pa je pripravek v obliki mikroemulzije, ki omogoča enakomernejšo absorpcijo ciklosporina v telesu.
What are Sandimmun and Sandimmun Neoral?
Kaj sta zdravili Sandimmun in Sandimmun Neoral?
• Bone marrow transplantation (for the prevention of graft rejection and prevention or treatment of graft-versus-host disease).
• presaditev kostnega mozga (za preprečevanje zavrnitve presadka in preprečevanje ali zdravljenje reakcije presadka proti gostitelju).
• Severe psoriasis (a disease causing red, scaly patches on the skin);
• hude psoriaze (bolezni, ki povzroča rdeče luskaste zaplate na koži);
The CHMP agreed that Sandimmun and Sandimmun Neoral should not be used in patients who are hypersensitive (allergic) to the active substance.
CHMP se je strinjal, da se zdravili Sandimmun in Sandimmun Neoral ne smeta uporabljati pri bolnikih, ki so preobčutljivi za zdravilno učinkovino ali alergični nanjo.
• Severe atopic dermatitis (eczema, an itchy red rash of the skin).
• hudega atopijskega dermatitisa (ekcema, tj. srbečega rdečega izpuščaja na koži).
Sandimmun and Sandimmun Neoral should only be prescribed by, or in close collaboration with, a doctor experienced in the diseases that these medicines are used to treat.
Zdravili Sandimmun in Sandimmun Neoral lahko predpiše samo zdravnik, ki ima izkušnje z boleznimi, za zdravljenje katerih se uporabljata ti zdravili, oziroma se lahko predpišeta v tesnem sodelovanju z njim.
• Severe rheumatoid arthritis (a disease causing damage and inflammation in the joints);
• hudega revmatoidnega artritisa (bolezni, ki povzroča okvaro in vnetje sklepov);
They should also not be given in combination with a herbal medicine called St John's wort (used to treat depression) nor with medicines whose blood levels may be increased by ciclosporin and lead to serious side effects, such as dabigatran etexilate (used to prevent the formation of blood clots after surgery) or bosentan and aliskiren (used to treat high blood pressure).
Prav tako se ne smeta uporabljati v kombinaciji z zdravilom rastlinskega izvora, imenovanim šentjanževka (uporablja se za zdravljenje depresije), in z zdravili, katerih koncentracije v krvi bi se lahko zaradi ciklosporina zvišale in povzročile resne neželene učinke.
On 15 December 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Sandimmun and Sandimmun Neoral in the EU.
Da bi uskladili dovoljenja za promet z zdraviloma Sandimmun in Sandimmun Neoral v EU je Evropska komisija dne 15. decembra 2011 napotila zadevo na odbor CHMP.
Sandimmun and Sandimmun Neoral were identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) je ugotovila, da je za zdravili Sandimmun in Sandimmun Neoral potrebno usklajevanje.
As the medicine is no longer authorised in the EU no further action will be taken by the European Commission.
Ker zdravilo v EU ni več odobreno, Evropska komisija ne bo več nadalje ukrepala.
18 March 2018 EMA/286850/2018
18. marec 2018 EMA/286850/2018
Zinbryta is no longer available in hospitals and pharmacies in the EU.
Zdravilo Zinbryta ni več na voljo v bolnišnicah in lekarnah v EU.
The PRAC report will be sent to EMA's Committee for Medicinal Products for Human Use (CHMP).
Poročilo odbora PRAC bo poslano Odboru za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA.
Zinbryta is a medicine that was authorised in 2016 for treating relapsing forms of multiple sclerosis.
Zinbryta je zdravilo, ki je bilo odobreno leta 2016 za zdravljenje recidivnih oblik multiple skleroze.
Multiple sclerosis medicine no longer authorised and has been recalled from hospitals and pharmacies
Zdravilo za multiplo sklerozo ni več odobreno in je bilo odpoklicano iz bolnišnic in lekarn
Healthcare professionals should continue monitoring patients who have been treated with Zinbryta in line with recommendations issued in March 2018.
Zdravstveni delavci morajo še naprej spremljati bolnike, ki so se zdravili z zdravilom Zinbryta, v skladu s priporočili, izdanimi marca 2018.
Patients could be at risk from the start of treatment and for several months after stopping treatment, and it is not possible to predict which patients will be affected.
Bolniki so lahko ogroženi od začetka zdravljenja in še več mesecev po njegovi prekinitvi.
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the multiple sclerosis medicine Zinbryta (daclizumab beta) poses a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs.
Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC) pri agenciji EMA je potrdil, da zdravilo za multiplo sklerozo Zinbryta (daklizumab beta) pomeni tveganje za hude in potencialno smrtno nevarne imunske reakcije, ki prizadenejo možgane, jetra in druge organe.
To date over 10,000 patients have been treated with Zinbryta worldwide.
Do zdaj se je po svetu z njim zdravilo več kot 10 000 bolnikov.
There are no immediate consequences of the PRAC's review as Zinbryta is no longer authorised in the EU.
Neposrednih posledic pregleda PRAC ni, saj zdravilo Zinbryta v EU ni več odobreno.
The PRAC has now concluded its review of the available evidence on Zinbryta.
Odbor PRAC je zdaj zaključil pregled razpoložljivih dokazov o zdravilu Zinbryta.
The European Commission issued a legally binding decision to suspend the marketing authorisation on 8 March 2018.
Evropska komisija je 8. marca 2018 izdala pravno zavezujoč sklep za začasni preklic dovoljenja za promet z zdravilom.
The PRAC therefore confirmed its previous conclusions that risks of Zinbryta outweigh its benefits for patients with multiple sclerosis.
Odbor PRAC je zato potrdil svoje predhodne zaključke, da so tveganja zdravila Zinbryta pri bolnikih z multiplo sklerozo večja od njegovih koristi.
EMA review of Zinbryta confirms medicine's risks outweigh its benefits
Pregled zdravila Zinbryta, ki ga je opravila agencija EMA, potrjuje, da so tveganja zdravila večja od njegovih koristi
On 27 March 2018, the European Commission withdrew the marketing authorisation of the medicine at the request of the marketing authorisation holder Biogen Idec Ltd.
Evropska komisija je 27. marca 2018 na zahtevo imetnika dovoljenja za promet z zdravilom, družbe Biogen Idec Ltd, umaknila dovoljenje za promet z zdravilom.
On 6 March 2018, while the review was ongoing, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended suspension of the marketing authorisation of Zinbryta and a recall of the
Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC) pri agenciji EMA je 6. marca 2018, v času pregleda, priporočil začasni preklic dovoljenja za promet z zdravilom Zinbryta in odpoklic zdravila.
On 27 March 2018, the marketing authorisation was withdrawn at the request of Biogen Idec Ltd, the company that marketed the medicine.
Na zahtevo družbe Biogen Idec Ltd, ki je tržilo zdravilo, je bilo 27. marca 2018 dovoljenje za promet z zdravilom umaknjeno.
0.5 mL (0.5 mg/mL) 5 pre-filled syringes
0,5 ml (0,5 mg/ml) 5 napolnjenih injekcijskih brizg
0.5 mL (0.5 mg/mL) 1 pre-filled syringe
0,5 ml (0,5 mg/ml) 1 napolnjena injekcijska brizga
This summary was last updated in 03-2011.
Povzetek je bil nazadnje posodobljen 03-2011.
The European Commission granted a marketing authorisation valid throughout the European Union for Valtropin to BioPartners GmbH on 24 April 2006.
Evropska komisija je dovoljenje za promet z zdravilom Valtropin, veljavno po vsej Evropski uniji, odobrila družbi BioPartners GmbH dne 24. aprila 2006.
The full EPAR for Valtropin 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 Valtropin je na voljo na spletni strani Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The study lasted 12 months, and measured the children's height at the beginning and the end of the study, and the speed of growth during the study.
V raziskavi, ki je trajala 12 mesecev, so merili višino otrok na začetku in koncu raziskave ter hitrost rasti med raziskavo.
After 12 months, treatment with Valtropin and Humatrope brought about similar increases in height and speed of growth (speed of +11.4 and +10.5 cm per year, respectively).
Po 12 mesecih je zdravljenje z zdravilom Valtropin in zdravilom Humatrope izkazalo podobna povečanja telesne višine in hitrosti rasti (hitrost +11,4 oziroma +10,5 cm na leto).
This means that Valtropin is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU) and that Valtropin and the reference medicine contain the same active substance.
To pomeni, da je zdravilo Valtropin podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je v Evropski uniji (EU) že odobreno, in da zdravilo Valtropin in referenčno zdravilo vsebujeta enako zdravilno učinkovino.
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 Valtropin.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z zdravilom in priporočila glede pogojev uporabe zdravila Valtropin.
This is a summary of the European public assessment report (EPAR) for Valtropin.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Valtropin.
It is produced by a method known as ‘recombinant DNA technology': the hormone is made by a yeast that has received a gene (DNA) that makes it able to produce somatropin.
Proizvaja se po metodi, imenovani “tehnologija rekombinantne DNK”: hormon tvori kvasovka, ki je prejela gen (DNK), ki ji omogoča tvorbo somatropina.
For more information on biosimilar medicines, see the question-and-answer document here.
Za več informacij o podobnih bioloških zdravilih si oglejte dokument z vprašanji in odgovori , ki je na voljo tukaj.
Valtropin was compared with Humatrope in 149 children with a lack of growth hormone and who had not been treated before.
Valtropin so primerjali z zdravilom Humatrope pri 149 otrocih s pomanjkanjem rastnega hormona, ki predhodno še niso bili zdravljeni.
For more information about treatment with Valtropin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Valtropin preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali s farmacevtom.
Valtropin is also used to treat adults with pronounced growth hormone deficiency, which has started in adulthood or childhood and needs to be confirmed by testing before treatment (replacement therapy).
Zdravilo Valtropin se uporablja tudi za zdravljenje odraslih z dokazanim pomanjkanjem rastnega hormona, ki se je začelo v odrasli dobi ali otroštvu in mora biti potrjeno s testi pred začetkom zdravljenja (nadomestna terapija).
The CHMP decided that, in accordance with EU requirements, Valtropin has been shown to have a comparable quality, safety and efficacy profile to Humatrope.
CHMP je sklenil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Valtropin podoben profil kakovosti, varnosti in učinkovitosti kot zdravilo Humatrope.
• children who are short because of Turner syndrome (a rare genetic disorder affecting girls), confirmed by chromosome analysis (DNA testing);
• otrok, ki so premajhne rasti zaradi Turnerjevega sindroma (redka prirojena bolezen, ki prizadene dekleta), potrjenega s kromosomsko analizo (analiza DNK);
Valtropin treatment should be supervised by a doctor experienced in the management of patients with growth disorders.
Zdravljenje z zdravilom Valtropin mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z motnjami rasti.
What benefit has Valtropin shown during the studies?
Kakšne koristi je zdravilo Valtropin izkazalo med študijami?
It promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates.
Ta hormon spodbuja rast v otroštvu in obdobju pubertete ter vpliva tudi na presnovo beljakovin, maščob in ogljikovih hidratov v telesu.
Valtropin must not be used for growth promotion in children with closed epiphyses (the state of the large bones when they have finished growing).
Zdravila Valtropin se ne sme uporabljati za spodbujanje rasti pri otrocih z zaprtimi epifizami (stanjem večjih kosti po končani rasti).
This was considered sufficient to demonstrate that the benefits of Valtropin are comparable to those of the reference medicine.
To je štelo kot zadosten dokaz, da so koristi zdravila Valtropin primerljive s koristmi referenčnega zdravila.
What is the risk associated with Valtropin?
Kakšna tveganja so povezana z zdravilom Valtropin?
The most common side effects with Valtropin are reactions at the site of injection and hormonal changes, and, in adults, headache, paraesthesia (unusual sensation like pins and needles), arthralgia (joint pain) and joint disorders.
Najpogostejši neželeni učinki zdravila Valtropin so reakcije na mestu injiciranja in hormonske spremembe, pri odraslih pa glavobol, parestezija (nenavadni občutek zbadanja), artralgija (bolečine v sklepih) in težave s sklepi.
Other information about Valtropin
Druge informacije o zdravilu Valtropin:
Valtropin should not be used in people who may be hypersensitive (allergic) to somatropin or any of the other ingredients (the solvent for Valtropin contains metacresol).
Zdravila Valtropin ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) somatropin ali katerokoli drugo sestavino zdravila (vehikel za zdravilo Valtropin vsebuje metakresol).
Valtropin replaces the natural hormone.
Zdravilo Valtropin je nadomestilo za naravni hormon.
Valtropin must not be used when the patient suffers from an active tumour, or a life-threatening illness.
Zdravila Valtropin ne smejo uporabljati bolniki, ki imajo aktiven tumor ali smrtno nevarno bolezen.
For the full list of all side effects reported with Valtropin, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Valtropin, glejte navodilo za uporabo.
The active substance in Valtropin, somatropin, is identical to human growth hormone.
Zdravilna učinkovina zdravila Valtropin, somatropin, je enaka človeškemu rastnemu hormonu.
• children before puberty, who fail to grow because of longstanding kidney disease (chronic renal insufficiency).
• otrok pred puberteto z zastojem v rasti zaradi dolgotrajne bolezni ledvic (kronično ledvično obolenje).
Valtropin is a powder and solvent that are made up into a solution for injection.
Zdravilo Valtropin je prašek in vehikel za pripravo raztopine za injiciranje.
Therefore, the CHMP's view was that, as for Humatrope, the benefit outweighs the identified risks.
Zaradi tega je CHMP menil, da so koristi zdravila Valtropin, tako kot pri zdravilu Humatrope, večje od z njim povezanih tveganj.
Valtropin was studied to show that it is comparable to the reference medicine, Humatrope.
Zdravilo Valtropin so proučevali, da bi dokazali, da je podobno referenčnemu zdravilu Humatrope.
The reference medicine for Valtropin is Humatrope.
Referenčno zdravilo za zdravilo Valtropin je zdravilo Humatrope.
Why has Valtropin been approved?
Zakaj je bilo zdravilo Valtropin odobreno?
Growth hormone is a substance secreted by a gland located at the base of the brain called the pituitary gland.
Rastni hormon je snov, ki jo izloča žleza, ki jo imenujemo hipofiza in se nahaja na možganskem dnu.
Valtropin contains the active substance somatropin.
Zdravilo Valtropin vsebuje zdravilno učinkovino somatropin.
Valtropin is a ‘biosimilar' medicine.
Zdravilo Valtropin je podobno biološko zdravilo.
The patient or caregiver can inject Valtropin after training by a doctor or a nurse.
Zdravilo Valtropin se daje z injekcijo pod kožo, enkrat na dan. Bolnik ali negovalec lahko zdravilo Valtropin vbrizgata sama, če ju medicinska sestra ali zdravnik za to ustrezno usposobita.
The doctor calculates the dose for each patient individually, depending on the body weight and condition, and may need to adjust it over time, depending on changes in body weight and response.
Zdravnik za vsakega bolnika posebej izračuna odmerek na osnovi njegove telesne mase in zdravstvenega stanja.
What is Valtropin used for?
Za kaj se zdravilo Valtropin uporablja?
What is Valtropin?
Kaj je zdravilo Valtropin?
How is Valtropin used?
Kako se zdravilo Valtropin uporablja?
How does Valtropin work?
Kako zdravilo Valtropin deluje?
How has Valtropin been studied?
Kako je bilo zdravilo Valtropin raziskano?
The site of injection must be varied to avoid lipoatrophy (loss of fat below the skin).
Zaradi preprečevanja lipoatrofije (izguba maščobe pod kožo) je treba zdravilo injicirati vedno na drugem mestu.
• children from two years of age and adolescents who fail to grow because they lack growth hormone (replacement therapy);
Zdravilo Valtropin se uporablja za zdravljenje otrok v naslednjih primerih: • otrok, starih vsaj dve leti, in mladostnikov z motnjami v rasti zaradi pomanjkanja rastnega
(see section 5.1).
(Glejte poglavje 5.1)
This occurs in both men and women of all ages.
Pojavlja se tako pri moških kot pri ženskah vseh starosti.
These studies involved a total of 560 patients aged 17-83 years.
Ti študiji sta vključevali skupaj 560 bolnikov v starosti 17-83 let.
Therefore, it is important that you follow the advice given in section 3.
Zato je pomembno, da upoštevate navodila v poglavju 3.
The relevance for humans is unknown.
Pomen tega za ljudi ni poznan.
ATC code: M05BA04
Oznaka ATC: M05BA04
It will help if you make a note of what you experienced, when it started and how long it lasted.
Dobro je, da si zabeležite, kaj se vam je zgodilo, kdaj se je pojavilo in kako dolgo je trajalo.
- Do not take with coffee or tea.
- Ne vzemite s kavo ali čajem.
• Inability to stand or sit upright for at least 30 minutes.
• Nesposobnost stati ali sedeti vzravnano vsaj 30 minut.
*See section 4.2 and 4.4.
*Glejte poglavji 4.2 in 4.4.
If you think any of these apply to you, do not take the tablets.
Če mislite, da karkoli od naštetega velja za vas, tablet ne jemljite.
Talk to your doctor first and follow the advice given.
Najprej se pogovorite z zdravnikom in upoštevajte njegov nasvet.
The time to onset of symptoms varied from one day to several months after starting treatment.
Čas pojavnosti simptomov je segal od enega dneva do več mesecev po začetku zdravljenja.
Very rare: < 1/10,000, not known (cannot be estimated from the available data)
Zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov)
14, 28, 56, 98, 112 and 50 x 1 (unit dose).
14, 28, 56, 98, 112 in 50 x 1 (enkratni odmerek).
The incidence of new vertebral fractures was evaluated as a safety variable.
Pojavnost novih zlomov vretenc so ocenjevali kot varnostno spremenljivko.
Protein binding in human plasma is approximately 78%.
Vezava na plazemske proteine pri ljudeh je približno 78%.
- Do not take with juice or milk.
- Ne vzemite s sokom ali mlekom.
Conventional studies of general toxicity, genotoxicity and carcinogenicity did not reveal any special risks for humans.
V konvencionalnih študijah splošne toksičnosti, genotoksičnosti in kancerogenosti niso odkrili posebnih tveganj za ljudi.
These are usually slight and asymptomatic.
Ta so običajno majhna in asimtpomatska.
• Hypocalcaemia.
• Hipokalcemija.
Do not make yourself vomit, and do not lie down.
Ne poskušajte bruhati in ne ulezite se.
Early on, osteoporosis usually has no symptoms.
Na začetku osteoporoza običajno nima simptomov.
The CHMP has recommended the following indication, which is in accordance with the guideline on the evaluation of medicinal products in the treatment of primary osteoporosis (CHMP/EWP/552/95 Rev.2)
je CHMP priporočil naslednjo indikacijo, ki je usklajena s smernico o ocenjevanju zdravil za zdravljenje primarne osteoporoze (CHMP/EWP/552/95 Rev.2)
Total BMD also increased significantly.
Prav tako se je pomembno zvišala MGK celotnega telesa.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta.
50 x 1 (unit dose) tablet
50 x 1 (enkratni odmerek) tableta
A causal relationship cannot be excluded (see section 4.8).
Vzročne povezave ni mogoče izključiti (glejte poglavje 4.8).
It is therefore particularly important to ensure that patients taking glucocorticoids have an adequate calcium and vitamin D intake.
Zato je še posebno pomembno zagotoviti, da imajo bolniki, ki jemljejo glukokortikoide, ustrezen vnos kalcija in vitamina D.