FrancophonIA/ELRC3.0 huggingface dataset:
English: The risk of severe oesophageal adverse experiences appears to be greater in patients who do not comply with the dosing instruction and/or who continue to take oral bisphosphonates after developing symptoms suggestive of oesophageal irritation.
Slovenian: Kaže, da je tveganje za resne neželene učinke na požiralniku večje pri bolnikih, ki ne upoštevajo navodil o odmerjanju in/ali nadaljujejo z jemanjem peroralnih difosfonatov tudi po pojavu simptomov, ki kažejo na draženje požiralnika.
English: In humans, the efficacy of both daily and intermittent administration with a dose-free interval of 9-10 weeks of ibandronic acid was confirmed in a clinical trial (MF 4411), in which ibandronic acid demonstrated anti-fracture efficacy.
Slovenian: Pri ljudeh je bila učinkovitost dnevnega in intermitentnega dajanja ibandronske kisline z 9- do 10-tedenskim premorom brez odmerjanja potrjena v kliničnem preskušanju (MF 4411), s katerim so dokazali učinkovitost ibandronske kisline proti zlomom.
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
English: The earlier a woman reaches the menopause, the greater her risk of fractures in osteoporosis.
Slovenian: Pri ženskah, ki v menopavzo preidejo bolj zgodaj, je tveganje za zlome pri osteoporozi večje.
English: Once monthly tablet.
Slovenian: Tableta za odmerjanje enkrat mesečno.
English: StevensJohnson syndrome†, erythema multiforme†, dermatitis bullous†
Slovenian: StevensJohnsonov sindrom†, multiformni eritem†, bulozni dermatitis†
English: They include a decreased number of implantation sites, interference with natural delivery (dystocia), and an increase in visceral variations (renal pelvis ureter syndrome).
Slovenian: Vključujejo zmanjšano število vsaditvenih mest, motnje naravnega poroda (distocija) in povečano število visceralnih sprememb (ledvični pieloureterni sindrom).
English: The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at lumbar spine of 2 to 5 SD below the premenopausal mean (T-score) in at least one vertebra [L1-L4], and who had one to four prevalent vertebral fractures.
Slovenian: Študija je vključevala ženske, stare od 55 do 80 let, ki so bile vsaj 5 let v postmenopavzi ter so imele pri vsaj enem vretencu MKG ledvene hrbtenice 2 do 5 SD pod povprečno vrednostjo pred menopavzo (T-vrednost) (L1-L4) in enega do štiri predhodne zlome vretenc.
English: • if you have or ever had low calcium in your blood.
Slovenian: - če imate ali ste kadar koli imeli nizke koncentracije kalcija v krvi
English: Patients with a previous history of gastrointestinal disease including patients with peptic ulcer without recent bleeding or hospitalisation, and patients with dyspepsia or reflux controlled by medication were included in the once monthly treatment study.
Slovenian: Bolniki z anamnezo bolezni prebavil, vključno s peptično razjedo brez nedavne krvavitve ali hospitalizacije, dispepsijo ali refluksom, nadzorovanim z zdravili, so bili vključeni v študijo z odmerjanjem enkrat mesečno.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletnem mestu Evropske agencije za zdravila (EMA): http://www.ema.europa.eu/
English: Hypocalcaemia
Slovenian: Hipokalciemija
English: Existing hypocalcaemia must be corrected before starting Ibandronic Acid Teva therapy.
Slovenian: Obstoječo hipokalciemijo je treba popraviti pred začetkom zdravljenja z zdravilom Ibandronska kislina Teva.
English: - a type of antibiotic injection called “aminoglycoside” such as gentamicin.
Slovenian: - antibiotik v obliki injekcije iz skupine aminoglikozidov, kot je gentamicin.
English: If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Ibandronic Acid Teva.
Slovenian: Če vam zdravijo zobe ali boste imeli operacijo (npr. izdrtje zoba), o tem obvestite zdravnika, zobozdravniku pa povejte, da se zdravite z zdravilom Ibandronska kislina Teva.
English: Ibandronic Acid Teva with food and drink
Slovenian: Zdravilo Ibandronska kislina Teva s hrano in pijačo
English: Elderly population (see section 4.2)
Slovenian: Starejša populacija (glejte poglavje 4.2)
English: Mean relative changes from baseline % [95 % CI]
Slovenian: povprečna relativna sprememba od izhodiščne vrednosti % [95-odstotni interval zaupanja]
English: Ibandronic Acid Teva is less effective if it's taken with food.
Slovenian: Zdravilo Ibandronska kislina Teva je manj učinkovito, če ga vzamete s hrano.
English: Most cases did not lead to cessation of therapy.
Slovenian: V večini primerov prekinitev zdravljenja ni bila potrebna.
English: Influenza-like illness
Slovenian: Bolezen, podobna gripi
English: Temporary interruption of Ibandronic Acid Teva treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Slovenian: Razmisliti je treba o začasni prekinitvi zdravljenja z zdravilom Ibandronska kislina Teva, dokler se stanje ne popravi in zmanjša vpliv ostalih dejavnikov tveganja, če je to mogoče.
English: - Take your Ibandronic Acid Teva tablet at least 6 hours after you last had anything to eat or drink except water.
Slovenian: - Vzemite tableto Ibandronska kislina Teva vsaj 6 ur po tem, ko ste nazadnje jedli ali pili, razen vode.
English: Ibandronic Acid Teva is indicated in adults for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Slovenian: Zdravilo Ibandronska kislina Teva je pri odraslih indicirano za preprečevanje z okostjem povezanih dogodkov (patološki zlomi, zapleti, pri katerih je potrebno obsevanje, ali kirurški poseg) pri bolnikih z rakom dojke in metastazami v kosteh.
English: Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of Ibandronic Acid Teva.
Slovenian: Jemanje zdravil, ki zmanjšajo izločanje želodčne kisline, kot sta cimetidin in ranitidin, lahko rahlo povečajo učinek zdravila Ibandronska kislina Teva.
English: You should wait until the next scheduled dose is due and take it as normal; then, continue taking one tablet once a month on the scheduled days you've marked on your calendar.
Slovenian: Počakajte do naslednjega odmerka in ga vzemite kot običajno, nato jemanje tablet nadaljujte enkrat na mesec na izbrane dni, ki ste si jih označili na koledarju.
English: The pain reduction was consistently below baseline throughout the entire study and accompanied by a significantly reduced use of analgesics compared to placebo.
Slovenian: Zmanjšanje bolečin je bilo skozi vso raziskavo pod izhodiščno vrednostjo v primerjavi s placebom, pomembno pa je bila zmanjšana tudi uporaba analgetikov.
English: Ibandronic Acid Teva is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called bone “metastases”).
Slovenian: Zdravilo Ibandronska kislina Teva se uporablja pri odraslih in vam ga bodo predpisali, če imate raka dojke, ki se je razširil na kosti (metastaze v kosteh).
English: • inflammation of the duodenum (first section of the bowel) causing stomach pain
Slovenian: • vnetje dvanajstnika (začetnega dela črevesa), ki povzroča bolečino v trebuhu,
English: This reduction in urinary CTx levels was significantly correlated with the primary efficacy endpoint SMPR (Kendall-tau-b (p<0.001)).
Slovenian: Znižanje koncentracij CTx v seču je bilo pomembno v korelaciji s primarnim ciljem raziskave učinkovitosti stopnjo hitrosti obolevnosti okostja (Kendall-tau-b (p < 0,001)).
English: Month 1 __/__/__
Slovenian: Mesec 1 __/__/__
English: Ibandronic Acid Teva therapy should only be initiated by physicians experienced in the treatment of cancer.
Slovenian: Zdravljenje z zdravilom Ibandronska kislina Teva sme uvesti samo zdravnik, ki ima izkušnje pri zdravljenju raka.
English: Daily treatment with 2.5 mg resulted in progressive increases in BMD at vertebral and nonvertebral sites of the skeleton.
Slovenian: Zdravljenje z 2,5 mg dnevno je povzročilo progresivno povečanje MKG vretenc in nevretenčnih delov okostja.
English: Do not take Ibandronic Acid Teva with food or any other drinks except water as Ibandronic Acid Teva is less effective if it is taken with food or drink (see section 3).
Slovenian: Ne jemljite zdravila Ibandronska kislina Teva s hrano ali katero koli drugo pijačo razen vodo, ker lahko jemanje zdravila s hrano ali pijačo povzroči, da je zdravilo Ibandronska kislina Teva manj učinkovito (glejte poglavje 3).
English: If there is concern regarding potentially high levels of calcium in the tap water (hard water), it is advised to use bottled water with a low mineral content.
Slovenian: Če obstaja skrb, da je v vodi iz pipe visok delež kalcija (trda voda), je priporočljivo uporabljati ustekleničeno vodo z nizko vsebnostjo mineralov.
English: Opadry white YS-1-7003: Titanium dioxide (E 171) Hypromellose Macrogol 400
Slovenian: Opadry white YS-1-7003: titanov dioksid (E171) hipromeloza makrogol 400 polisorbat 80
English: There was also a 38% reduction in the risk of developing an SRE for ibandronic acid treated patients when compared with placebo (relative risk 0.62, p=0.003).
Slovenian: V primerjavi s placebom je bilo tveganje za nastanek z okostjem povezanih dogodkov pri bolnikih, zdravljenih z ibandronsko kislino, za 38 % manjše (relativno tveganje 0,62; p = 0,003).
English: • itching, swelling of your face, lips, tongue and throat, with difficulty breathing.
Slovenian: • srbenje, otekanje obraza, ustnic, jezika in žrela s težkim dihanjem.
English: Influenza-like illness includes events reported as acute phase reaction or symptoms including myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite, or bone pain.
Slovenian: Gripi podobna bolezen vključuje neželene učinke, o katerih so poročali kot o reakciji akutne faze ali simptomih, vključno z mialgijo, artralgijo, povišano telesno temperaturo, mrzlico, utrujenostjo, slabostjo, izgubo apetita ali bolečino v kosteh.
English: The recommended dose is one 150 mg film-coated tablet once a month.
Slovenian: Priporočeni odmerek je ena 150 mg filmsko obložena tableta enkrat mesečno.
English: You may have early signs of a possible unusual fracture of the thigh bone.
Slovenian: Lahko imate zgodnje znake možnega neobičajnega zloma stegnenice.
English: (duodenum) that is bleeding, or that your stomach is inflamed (gastritis)
Slovenian: krvavi ali da je želodec vnet (gastritis).
English: Secondary efficacy endpoints
Slovenian: Sekundarni cilji raziskave učinkovitosti
English: Take Ibandronic Acid Teva with at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements (e.g. products containing calcium (milk), aluminium, magnesium and iron) except water.
Slovenian: Vzemite zdravilo Ibandronska kislina Teva vsaj 6 ur po vašem zadnjem zaužitem obroku, pijači, katerem koli zdravilu ali dodatku (to so zdravila, ki vsebujejo kalcij (mleko), aluminij, magnezij in železo), razen vodi.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema anemija
English: You can drive and use machines as it's expected that Ibandronic Acid Teva has no or negligible effect on your ability to drive and use machines.
Slovenian: Lahko vozite in upravljate s stroji, ker pričakujemo, da zdravilo Ibandronska kislina Teva nima ali ima zanemarljiv učinek na vašo sposobnost za vožnjo in upravljanje strojev.
English: If you take more Ibandronic Acid Teva than you should If you take too many tablets talk to a doctor or go to hospital straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Ibandronska kislina Teva, kot bi smeli Če ste pomotoma zaužili preveč tablet, se posvetujte z zdravnikom ali pojdite takoj v bolnišnico.
English: Protein binding in human plasma is approximately 87% at therapeutic concentrations, and thus interaction with other medicinal products, due to displacement is unlikely.
Slovenian: Vezava na beljakovine v plazmi pri ljudeh je pri terapevtskih koncentracijah približno 87-odstotna, zato so medsebojna delovanja z drugimi zdravili zaradi izpodrivanja malo verjetna.
English: Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a full glass of water and/or if you lie down within an hour of taking Ibandronic Acid Teva.
Slovenian: Lahko pride do draženja, vnetja ali razjede požiralnika (ezofagusa), pogosto s simptomi, kot so huda bolečina v prsih, huda bolečina pri požiranju hrane in/ali pitju pijače, huda slabost ali bruhanje, še posebej, če ne popijete polnega kozarca vode in/ali če se uležete prej kot v eni uri po zaužitju zdravila Ibandronska kislina Teva.
English: - Take your Ibandronic Acid Teva tablet after you first get up for the day, and before you have anything to eat or drink (on an empty stomach)
Slovenian: - Vzemite tableto Ibandronska kislina Teva takoj, ko zjutraj vstanete, in preden kaj pojeste ali popijete (torej na prazen želodec).
English: Ibandronic Acid Teva is prescribed to you to treat postmenopausal osteoporosis because you have an increased risk of fractures.
Slovenian: Zdravilo Ibandronska kislina Teva vam je zdravnik predpisal za zdravljenje postmenopavzne osteoporoze, ker imate povečano tveganje za zlome.
English: Do not lie down.
Slovenian: Ne prisilite se k bruhanju in ne ulezite se.
English: They include a decreased number of implantation sites, interference with natural delivery (dystocia), an increase in visceral variations (renal pelvis ureter syndrome) and teeth abnormalities in F1 offspring in rats.
Slovenian: Vključujejo zmanjšano število vsaditvenih mest, motnje naravnega poroda (distocija), povečano število visceralnih sprememb (pieloureterni sindrom) in nepravilnosti zob pri potomcih podgan F1.
English: Further, as protein binding of ibandronic acid is approximately 87% at therapeutic concentrations, hypoproteinaemia in severe liver disease is unlikely to lead to clinically significant increases in free plasma concentration.
Slovenian: Vezava ibandronske kisline na beljakovine je pri terapevtskih koncentracijah približno 87-odstotna, zato hipoproteinemija pri bolnikih s hudo okvaro jeter verjetno ne bo povzročila klinično pomembnega povišanja koncentracije proste učinkovine v plazmi.
English: Ibandronic acid selectively inhibits osteoclast activity, reducing bone resorption and thereby reducing skeletal complications of the malignant disease.
Slovenian: Ibandronska kislina selektivno zavira osteoklastno aktivnost, zmanjšuje resorpcijo kosti in tako zmanjšuje zaplete pri okostju zaradi maligne bolezni.
English: The usual dose of Ibandronic Acid Teva is one tablet once a month.
Slovenian: Običajni odmerek zdravila Ibandronska kislina Teva je ena tableta enkrat mesečno.
English: Method of administration For oral use.
Slovenian: Način uporabe Za peroralno uporabo.
English: This includes any possible side effects not listed in this leaflet.
Slovenian: če opazite neželene učinke, ki niso navedeni v tem navodilu.
English: Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause.
Slovenian: Osteoporoza je bolezen, zaradi katere postanejo kosti tanjše in šibkejše, in se pogosto pojavlja pri ženskah po menopavzi.
English: This includes: - eating a balanced diet rich in calcium and vitamin D, - walking or any other weight-bearing exercise, - not smoking; and not drinking too much alcohol.
Slovenian: - uravnoteženo prehrano, bogato s kalcijem in vitaminom D, - hojo ali druge telesne dejavnosti z obremenitvijo, - nekajenje in zmerno pitje alkohola.
English: The pharmacokinetics of ibandronic acid in these patients is unknown, and ibandronic acid should not be used under these circumstances.
Slovenian: Ker je farmakokinetika ibandronske kisline pri tej skupini bolnikov neznana, se ibandronska kislina pri njih ne sme uporabljati.
English: If you develop these symptoms, stop taking Ibandronic Acid Teva and tell your doctor straight away (see sections 3 and 4).
Slovenian: Če se pojavijo ti simptomi, prenehajte z jemanjem zdravila Ibandronska kislina Teva in takoj obvestite svojega zdravnika (glejte poglavji 3 in 4).
English: Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1).
Slovenian: 4.1 Terapevtske indikacije Zdravljenje osteoporoze pri ženskah po menopavzi, ki imajo povečano tveganje za zlome (glejte poglavje 5.1).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletnem mestu Evropske agencije za zdravila (EMA), http://www.ema.europa.eu/.
English: In reproductive studies in rats by the oral route effects on fertility consisted of increased preimplantation losses at dose levels of 1 mg/kg/day and higher.
Slovenian: V študijah vplivov na sposobnost razmnoževanja pri podganah s peroralnim dajanjem je vpliv na plodnost predstavljala povečana izguba pred vgnezditvijo pri odmerkih 1 mg/kg/dan ali večjih.
English: ONJ can also occur after stopping treatment.
Slovenian: Osteonekroza čeljustnic se lahko pojavi tudi po končanem zdravljenju.
English: Toxic effects, e.g signs of renal damage, were observed in dogs only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Slovenian: Toksične učinke, na primer znake poškodbe ledvic, so opazili pri psih samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri ljudeh, kar kaže na majhen pomen za klinično uporabo.
English: Table 2 Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Slovenian: Preglednica 2: rezultati učinkovitosti (bolnice z rakom dojke z metastatično boleznijo kosti)
English: Increases at the hip compared to baseline were 2.8 % at the femoral neck, 3.4 % at the total hip, and 5.5 % at the trochanter.
Slovenian: V primerjavi z izhodiščno vrednostjo je bil porast mineralne kostne gostote za stegnenični vrat 2,8 %, za kolk 3,4 % in za trohanter 5,5 %.
English: Ibandronic acid 2.5 mg administered daily, showed a statistically significant and medically relevant reduction in the incidence of new vertebral fractures.
Slovenian: Dajanje 2,5 mg ibandronske kisline dnevno je povzročilo statistično in klinično pomembno zmanjšanje incidence novih zlomov vretenc.
English: Effects in non-clinical studies were observed only at exposures sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Slovenian: V predkliničnih študijah so opazili učinke samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri ljudeh, kar kaže na majhen pomen za klinično uporabo.
English: • flatulence (farting, feeling bloated)
Slovenian: • napenjanje (vetrovi, občutek napihnjenosti),
English: Mutagenicity/Carcinogenicity
Slovenian: Mutagenost/kancerogenost
English: Elderly population (> 65 years) No dose adjustment is necessary (see section 5.2).
Slovenian: Starejša populacija (> 65 let) Prilagajanje odmerkov ni potrebno (glejte poglavje 5.2).
English: - Supplements containing calcium, magnesium, iron or aluminium, as they could possibly influence the effects of Ibandronic Acid Teva.
Slovenian: - prehranska dopolnila, ki vsebujejo kalcij, magnezij, železo ali aluminij, ker bi lahko vplivali na učinek zdravila Ibandronska kislina Teva.
English: If you develop these symptoms, stop taking Ibandronic Acid Teva and tell your doctor straight away (see section 3).
Slovenian: Če se pri vas pojavijo ti simptomi, prenehajte jemati zdravilo Ibandronska kislina Teva in takoj obvestite svojega zdravnika (glejte poglavje 3).
English: Incidence of clinical vertebral fracture 6.97 % (4.67, 9.27) BMD - mean change relative to baseline lumbar spine at year 3
Slovenian: zmanjšanje relativnega tveganja za klinične zlome vretenc incidenca kliničnih zlomov vretenc 6,97 % (4,67; 9,27) MKG - povprečna sprememba glede na izhodiščno vrednost za ledveno hrbtenico po treh letih
English: Caution is advised when bisphosphonates are administered with aminoglycosides, since both substances can lower serum calcium levels for prolonged periods.
Slovenian: Pri sočasnem jemanju difosfonatov z aminoglikozidi je potrebna previdnost, ker lahko obe učinkovini znižata koncentracijo kalcija v serumu za daljše obdobje.
English: The unabsorbed fraction of ibandronic acid is eliminated unchanged in the faeces.
Slovenian: Neabsorbirani delež ibandronske kisline se nespremenjen izloči z blatom.
English: For patients with severe renal impairment (CLcr <30 mL/min) the recommended dose is one 50 mg film-coated tablet once weekly.
Slovenian: Pri bolnikih s hudo ledvično okvaro (CLcr < 30 ml/min) je priporočeni odmerek ena 50 mg filmsko obložena tableta enkrat tedensko.
English: It is not known whether ibandronic acid is excreted in human milk.
Slovenian: Ni znano, ali se pri ljudeh ibandronska kislina izloča v materino mleko.
English: Also some other medicines can affect the way Ibandronic Acid Teva works.
Slovenian: Prav tako lahko druga zdravila vplivajo na delovanje zdravila Ibandronska kislina Teva.
English: SRE relative risk p=0.003
Slovenian: relativno tveganje za dogodke, povezane z okostjem p = 0,003
English: During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Slovenian: Bolnikom je treba svetovati, naj v času zdravljenja z difosfonati sporočijo kakršne koli bolečine v stegnu, kolku ali dimljah, vsakega bolnika z navedenimi simptomi pa je treba pregledati glede nepopolnega zloma stegnenice.
English: Table 3 Secondary Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Slovenian: Preglednica 3: sekundarni rezultati učinkovitosti (bolnice z rakom dojke z metastatično boleznijo kosti)
English: In vivo, ibandronic acid prevents experimentally-induced bone destruction caused by cessation of gonadal function, retinoids, tumours or tumour extracts.
Slovenian: In vivo ibandronska kislina preprečuje eksperimentalno povzročeno razgradnjo kosti zaradi prekinitve gonadne funkcije, retinoidov, tumorjev ali ekstraktov tumorjev.
English: Marketing Authorisation Holder and Manufacturer
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec
English: Ibandronic acid was taken 60 minutes before the first food or drink of the day (post-dose fasting period).
Slovenian: Ibandronsko kislino so bolniki vzeli 60 minut pred prvim dnevnim obrokom hrane ali pijače (z obdobjem postenja tudi po odmerku).
English: Patients with hepatic impairment (see section 4.2)
Slovenian: Bolniki z okvaro jeter (glejte poglavje 4.2)
English: Tests for genotoxicity revealed no evidence of genetic activity for ibandronic acid.
Slovenian: Testi genotoksičnosti niso pokazali genetske aktivnosti ibandronske kisline.
English: Protein binding in human plasma is approximately 85 %-87 % (determined in vitro at therapeutic concentrations), and thus there is a low potential for interaction with other medicinal products due to displacement.
Slovenian: Vezava ibandronske kisline na beljakovine v plazmi je približno 85- do 87-odstotna (določeno in vitro pri terapevtskih koncentracijah), zato obstaja majhna možnost za delovanje z drugimi zdravili zaradi izpodrivanja.
English: Name and address of the manufacturers responsible for batch release
Slovenian: Ime in naslov izdelovalca odgovornega za sproščanje serij
English: The tablet should preferably be taken on the same date each month.
Slovenian: Priporoča se, da bolnik jemlje tablete vsak mesec na isti datum.