FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Valtropin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: The CHMP decided that, in accordance with EU requirements, Valtropin has been shown to have a comparable quality, safety and efficacy profile to Humatrope.
Slovenian: 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.
English: • children who are short because of Turner syndrome (a rare genetic disorder affecting girls), confirmed by chromosome analysis (DNA testing);
Slovenian: • otrok, ki so premajhne rasti zaradi Turnerjevega sindroma (redka prirojena bolezen, ki prizadene dekleta), potrjenega s kromosomsko analizo (analiza DNK);
English: Valtropin treatment should be supervised by a doctor experienced in the management of patients with growth disorders.
Slovenian: Zdravljenje z zdravilom Valtropin mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z motnjami rasti.
English: What benefit has Valtropin shown during the studies?
Slovenian: Kakšne koristi je zdravilo Valtropin izkazalo med študijami?
English: It promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates.
Slovenian: Ta hormon spodbuja rast v otroštvu in obdobju pubertete ter vpliva tudi na presnovo beljakovin, maščob in ogljikovih hidratov v telesu.
English: Valtropin must not be used for growth promotion in children with closed epiphyses (the state of the large bones when they have finished growing).
Slovenian: Zdravila Valtropin se ne sme uporabljati za spodbujanje rasti pri otrocih z zaprtimi epifizami (stanjem večjih kosti po končani rasti).
English: This was considered sufficient to demonstrate that the benefits of Valtropin are comparable to those of the reference medicine.
Slovenian: To je štelo kot zadosten dokaz, da so koristi zdravila Valtropin primerljive s koristmi referenčnega zdravila.
English: What is the risk associated with Valtropin?
Slovenian: Kakšna tveganja so povezana z zdravilom Valtropin?
English: 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.
Slovenian: 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.
English: Other information about Valtropin
Slovenian: Druge informacije o zdravilu Valtropin:
English: 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).
Slovenian: Zdravila Valtropin ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) somatropin ali katerokoli drugo sestavino zdravila (vehikel za zdravilo Valtropin vsebuje metakresol).
English: Valtropin replaces the natural hormone.
Slovenian: Zdravilo Valtropin je nadomestilo za naravni hormon.
English: Valtropin must not be used when the patient suffers from an active tumour, or a life-threatening illness.
Slovenian: Zdravila Valtropin ne smejo uporabljati bolniki, ki imajo aktiven tumor ali smrtno nevarno bolezen.
English: For the full list of all side effects reported with Valtropin, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Valtropin, glejte navodilo za uporabo.
English: The active substance in Valtropin, somatropin, is identical to human growth hormone.
Slovenian: Zdravilna učinkovina zdravila Valtropin, somatropin, je enaka človeškemu rastnemu hormonu.
English: • children before puberty, who fail to grow because of longstanding kidney disease (chronic renal insufficiency).
Slovenian: • otrok pred puberteto z zastojem v rasti zaradi dolgotrajne bolezni ledvic (kronično ledvično obolenje).
English: Valtropin is a powder and solvent that are made up into a solution for injection.
Slovenian: Zdravilo Valtropin je prašek in vehikel za pripravo raztopine za injiciranje.
English: Therefore, the CHMP's view was that, as for Humatrope, the benefit outweighs the identified risks.
Slovenian: Zaradi tega je CHMP menil, da so koristi zdravila Valtropin, tako kot pri zdravilu Humatrope, večje od z njim povezanih tveganj.
English: Valtropin was studied to show that it is comparable to the reference medicine, Humatrope.
Slovenian: Zdravilo Valtropin so proučevali, da bi dokazali, da je podobno referenčnemu zdravilu Humatrope.
English: The reference medicine for Valtropin is Humatrope.
Slovenian: Referenčno zdravilo za zdravilo Valtropin je zdravilo Humatrope.
English: Why has Valtropin been approved?
Slovenian: Zakaj je bilo zdravilo Valtropin odobreno?
English: Growth hormone is a substance secreted by a gland located at the base of the brain called the pituitary gland.
Slovenian: Rastni hormon je snov, ki jo izloča žleza, ki jo imenujemo hipofiza in se nahaja na možganskem dnu.
English: Valtropin contains the active substance somatropin.
Slovenian: Zdravilo Valtropin vsebuje zdravilno učinkovino somatropin.
English: Valtropin is a ‘biosimilar' medicine.
Slovenian: Zdravilo Valtropin je podobno biološko zdravilo.
English: The patient or caregiver can inject Valtropin after training by a doctor or a nurse.
Slovenian: 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.
English: 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.
Slovenian: Zdravnik za vsakega bolnika posebej izračuna odmerek na osnovi njegove telesne mase in zdravstvenega stanja.
English: What is Valtropin used for?
Slovenian: Za kaj se zdravilo Valtropin uporablja?
English: What is Valtropin?
Slovenian: Kaj je zdravilo Valtropin?
English: How is Valtropin used?
Slovenian: Kako se zdravilo Valtropin uporablja?
English: How does Valtropin work?
Slovenian: Kako zdravilo Valtropin deluje?
English: How has Valtropin been studied?
Slovenian: Kako je bilo zdravilo Valtropin raziskano?
English: The site of injection must be varied to avoid lipoatrophy (loss of fat below the skin).
Slovenian: Zaradi preprečevanja lipoatrofije (izguba maščobe pod kožo) je treba zdravilo injicirati vedno na drugem mestu.
English: • children from two years of age and adolescents who fail to grow because they lack growth hormone (replacement therapy);
Slovenian: Zdravilo Valtropin se uporablja za zdravljenje otrok v naslednjih primerih: • otrok, starih vsaj dve leti, in mladostnikov z motnjami v rasti zaradi pomanjkanja rastnega
English: (see section 5.1).
Slovenian: (Glejte poglavje 5.1)
English: This occurs in both men and women of all ages.
Slovenian: Pojavlja se tako pri moških kot pri ženskah vseh starosti.
English: These studies involved a total of 560 patients aged 17-83 years.
Slovenian: Ti študiji sta vključevali skupaj 560 bolnikov v starosti 17-83 let.
English: Therefore, it is important that you follow the advice given in section 3.
Slovenian: Zato je pomembno, da upoštevate navodila v poglavju 3.
English: The relevance for humans is unknown.
Slovenian: Pomen tega za ljudi ni poznan.
English: ATC code: M05BA04
Slovenian: Oznaka ATC: M05BA04
English: It will help if you make a note of what you experienced, when it started and how long it lasted.
Slovenian: Dobro je, da si zabeležite, kaj se vam je zgodilo, kdaj se je pojavilo in kako dolgo je trajalo.
English: - Do not take with coffee or tea.
Slovenian: - Ne vzemite s kavo ali čajem.
English: • Inability to stand or sit upright for at least 30 minutes.
Slovenian: • Nesposobnost stati ali sedeti vzravnano vsaj 30 minut.
English: *See section 4.2 and 4.4.
Slovenian: *Glejte poglavji 4.2 in 4.4.
English: If you think any of these apply to you, do not take the tablets.
Slovenian: Če mislite, da karkoli od naštetega velja za vas, tablet ne jemljite.
English: Talk to your doctor first and follow the advice given.
Slovenian: Najprej se pogovorite z zdravnikom in upoštevajte njegov nasvet.
English: The time to onset of symptoms varied from one day to several months after starting treatment.
Slovenian: Čas pojavnosti simptomov je segal od enega dneva do več mesecev po začetku zdravljenja.
English: Very rare: < 1/10,000, not known (cannot be estimated from the available data)
Slovenian: Zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov)
English: 14, 28, 56, 98, 112 and 50 x 1 (unit dose).
Slovenian: 14, 28, 56, 98, 112 in 50 x 1 (enkratni odmerek).
English: The incidence of new vertebral fractures was evaluated as a safety variable.
Slovenian: Pojavnost novih zlomov vretenc so ocenjevali kot varnostno spremenljivko.
English: Protein binding in human plasma is approximately 78%.
Slovenian: Vezava na plazemske proteine pri ljudeh je približno 78%.
English: - Do not take with juice or milk.
Slovenian: - Ne vzemite s sokom ali mlekom.
English: Conventional studies of general toxicity, genotoxicity and carcinogenicity did not reveal any special risks for humans.
Slovenian: V konvencionalnih študijah splošne toksičnosti, genotoksičnosti in kancerogenosti niso odkrili posebnih tveganj za ljudi.
English: These are usually slight and asymptomatic.
Slovenian: Ta so običajno majhna in asimtpomatska.
English: • Hypocalcaemia.
Slovenian: • Hipokalcemija.
English: Do not make yourself vomit, and do not lie down.
Slovenian: Ne poskušajte bruhati in ne ulezite se.
English: Early on, osteoporosis usually has no symptoms.
Slovenian: Na začetku osteoporoza običajno nima simptomov.
English: 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)
Slovenian: je CHMP priporočil naslednjo indikacijo, ki je usklajena s smernico o ocenjevanju zdravil za zdravljenje primarne osteoporoze (CHMP/EWP/552/95 Rev.2)
English: Total BMD also increased significantly.
Slovenian: Prav tako se je pomembno zvišala MGK celotnega telesa.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: 50 x 1 (unit dose) tablet
Slovenian: 50 x 1 (enkratni odmerek) tableta
English: A causal relationship cannot be excluded (see section 4.8).
Slovenian: Vzročne povezave ni mogoče izključiti (glejte poglavje 4.8).
English: It is therefore particularly important to ensure that patients taking glucocorticoids have an adequate calcium and vitamin D intake.
Slovenian: Zato je še posebno pomembno zagotoviti, da imajo bolniki, ki jemljejo glukokortikoide, ustrezen vnos kalcija in vitamina D.
English: Talk to your doctor if you suffer from cancer or if your teeth are in bad condition as this is a risk factor.
Slovenian: Posvetujte se z zdravnikom, če imate raka ali so vaši zobje v slabem stanju, ker je to dejavnik tveganja.
English: The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis.
Slovenian: Večina poročil se nanaša na bolnike z rakom, vendar pa so o takih primerih poročali tudi pri bolnikih, ki so se zdravili za osteoporozo.
English: If you have been told by your doctor that you have an intolerance to some sugars (for example lactose), contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje (na primer laktozo), se pred jemanjem tega zdravila posvetujte s svojim zdravnikom.
English: 3) Do not lie down - stay fully upright (sitting, standing or walking) - for at least 30 minutes after swallowing the tablet.
Slovenian: 3) Ne uležite se - ostanite v popolnoma pokončnem položaju (sedite, stojte ali hodite) - še najmanj 30 minut potem, ko ste pogoltnili tableto.
English: This might be a symptom of osteonecrosis (death of bone tissue).
Slovenian: To je lahko simptom osteonekroze (odmrtja kostnega tkiva).
English: The physician should therefore be alert to any signs or symptoms of possible oesophageal reaction.
Slovenian: Zdravnik mora biti zato pozoren na kakršnekoli znake ali simptome, ki opozarjajo na možno reakcijo v požiralniku.
English: Alendronate HEXAL should not be given to children and adolescents.
Slovenian: Zdravila Alendronat HEXAL se ne sme dajati otrokom in mladostnikom.
English: Long-term use of steroids is often associated with the development of osteoporosis accompanied by fractures.
Slovenian: Dolgotrajna uporaba steroidov je pogosto povezana z razvojem osteoporoze, ki jo spremljajo zlomi.
English: Please see package leaflet for further information.
Slovenian: Za dodatne informacije glejte priloženo navodilo.
English: Plasma concentrations fell by more than 95% within 6 hours following intravenous administration.
Slovenian: Plazemske koncentracije so v šestih urah po intravenski aplikaciji padle za več kot 95%.
English: Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss.
Slovenian: Čeprav so ti običajno boleči, pa lahko zlomi kosti v hrbtenici minejo neopaženo, dokler ne povzročijo znižanja telesne višine.
English: See also section 4.4 .
Slovenian: Glejte tudi poglavje 4.4.
English: - Do not take with mineral water (still or sparkling).
Slovenian: - Ne vzemite z mineralno vodo (z mehurčki ali brez).
English: In addition, BMD at the femoral neck and total body was maintained.
Slovenian: Poleg tega se je MGK vratu stegnenice in celotnega telesa vzdrževala.
English: The tablets are supplied in triplex blister (PVC/PE/PVDC/AL) packs containing 14, 28, 56, 98, 112 and 50 x 1 (unit dose).
Slovenian: Tablete so na voljo v pakiranjih s tremi pretisnimi omoti (PVC/PE/PVDC/AL), ki vsebujejo po 14, 28, 56, 98, 112 in 50 x 1 (enkratni odmerek) tablet.
English: In the two-year extensions of these studies the BMD in the spine and trochanter continued to increase.
Slovenian: V dvoletnem podaljšku teh študij se je MGK hrbtenice in trohantra še naprej zviševala.
English: No specific interaction studies have been carried out, but alendronate was used in clinical trials concomitantly with a number of other commonly prescribed medicines without any evidence of clinically unfavourable interactions.
Slovenian: Specifičnih študij interakcije niso izvedli, vendar pa so Alendronat HEXAL uporabljali v kliničnih preskušanjih sočasno s številnimi drugimi pogosto predpisanimi zdravili, pri čemer niso ugotovili nobenih kliničnih neželenih interakcij.
English: Studies in which rats were given high doses showed an increased incidence of incomplete foetal bone formation.
Slovenian: Študije, v katerih so podganam dajali visoke odmerke, so pokazale večjo pojavnost nepopolne tvorbe kosti pri plodu.
English: In postmarketing experience, these symptoms have rarely been seen and/or incapacitating (see section 4.8).
Slovenian: Po izdaji zdravila v promet so te učinke redko opazili in/ali so bili redko moteči (glejte poglavje 4.8).
English: For other populations, see summary of product characteristics for preparations that contain 5 mg alendronate.
Slovenian: Za druge skupine bolnikov glejte povzetek glavnih značilnosti zdravila za pripravke, ki vsebujejo 5 mg alendronske kisline.
English: If you take more Alendronate HEXAL than you should If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Alendronat HEXAL, kot bi smeli Če pomotoma vzamete preveč tablet, popijte poln kozarec mleka in nemudoma pokličite zdravnika.
English: Although no clinical information is available, it is likely that, as in animals, elimination of alendronate via the kidney will be reduced in patients with impaired renal function.
Slovenian: Čeprav kliničnih informacij ni na voljo, je možno, da se, tako kot pri živalih, izločanje alendronske kisline preko ledvic zmanjša pri bolnikih z motnjami v delovanju ledvic.
English: While on treatment, these patients should avoid invasive dental procedures if possible.
Slovenian: Ti bolniki bi se morali v času zdravljenja po možnosti izogibati invazivnim zobozdravstvenim posegom.
English: In addition, a statistically significant reduction in the incidence of hip fractures was confirmed (1.1 % versus 2.2 %, a reduction of 51 %).
Slovenian: Poleg tega je bilo potrjeno statistično pomembno zmanjšanje pojavnosti zlomov kolka (1,1% v primerjavi z 2,2%, zmanjšanje za
English: Broken bones can happen during normal, everyday activity, such as lifting, or from minor injury that would not generally break normal bone.
Slovenian: Do zlomov kosti lahko pride že med običajno vsakodnevno aktivnostjo, kot je dvigovanje, ali pri manjši poškodbi, ki običajno ne bi povzročila zloma normalne kosti.
English: Many of these patients were also receiving chemotherapy and corticosteroids.
Slovenian: Veliko število teh bolnikov je prejemalo tudi kemoterapijo in kortikosteroide.
English: On account of the risk of oesophageal irritation, vomiting should not be induced and the patient should be kept in an upright position.
Slovenian: Zaradi tveganja za draženje požiralnika se bruhanja ne sme izzvati, bolnik pa mora ostati v zravnanem položaju.
English: • FIT 2: A four-year study with 4432 patients who had a low bone mass but had not had any vertebral fracture at the start of the study.
Slovenian: • FIT 2: Štiriletna študija na 4432 bolnicah z nizko kostno maso, vendar na začetku študije brez zloma vretenca.
English: The following terms are used to describe how often side effects have been reported.
Slovenian: Pri opisu, kako pogosto so poročali o neželenih učinkih, se uporabljajo naslednji izrazi.
English: Do not take two tablets on the same day.
Slovenian: Ne vzemite dveh tablet na isti dan. Nadaljujte z jemanjem ene tablete na dan.
English: Biotransformation There is no evidence that alendronate is metabolised in animals or humans.
Slovenian: Biotransformacija Ni dokazov, da se alendronska kislina presnavlja pri živalih ali ljudeh.
English: The Applicant submitted an extensive review of the literature concerning the treatment of osteoporosis in men.
Slovenian: Vlagatelj je predložil obširen pregled literature na temo zdravljenja osteoporoze pri moških.
English: However, the incidence of reductions in serum calcium to <2.0 mmol/l and serum phosphate to ≤0.65 mmol/l was comparable in the two groups.
Slovenian: Vendar pa je bila pojavnost znižanja serumskega kalcija na < 2,0 mmol/l in serumskega fosfata na ≤ 0,65 mmol/l v obeh skupinah primerljiva.
English: Please read the package leaflet before use.
Slovenian: Pred uporabo preberite priloženo navodilo.
English: Alendronate belongs to a group of non-hormonal medicines called bisphosphonates.
Slovenian: Alendronat HEXAL spada v skupino nehormonskih zdravil, ki jih imenujemo difosfonati.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ALENDRONATE HEXAL AND ASSOCIATED NAMES (see Annex I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA ALENDRONATE HEXAL IN Z NJIM POVEZANIH IMEN (glejte Dodatek I)
English: 2) Do not chew the tablet or allow it to dissolve in your mouth.
Slovenian: 2) Tablete ne žvečite in ne raztapljajte v ustih.
English: Very rare (≤1/10,000): Isolated cases of severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Slovenian: Zelo redki (≤1/10.000): poročali so o posameznih primerih hudih kožnih reakcij, vključno s StevensJohnsonovim sindromom in toksično epidermalno nekrolizo.
English: The terminal half-life in humans is estimated to exceed ten years, reflecting release of alendronate from the skeleton.
Slovenian: Ocenjujejo, da je končni razpolovni čas pri ljudeh daljši od desetih let, kar odraža sproščanje alendronske kisline iz kosti.
English: Following a single intravenous dose of 10 mg, the renal clearance of alendronate was 71 ml/min, and systemic clearance did not exceed 200 ml/min.
Slovenian: Po enkratnem intravenskem odmerku 10 mg je bil ledvični očistek alendronske kisline 71 ml/min, sistemski očistek pa ni presegel 200 ml/min.
English: It is very important to follow instructions 1), 2), 3) and 4) to help the Alendronate HEXAL reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagusthe tube that connects your mouth with your stomach).
Slovenian: Zelo pomembno je, da upoštevate navodila 1), 2), 3) in 4), da bo lahko Alendronat HEXAL hitro prišel v želodec in da boste zmanjšali možnost draženja požiralnika (cevi, ki povezuje usta z želodcem).
English: Osteonecrosis of the jaw is generally associated with tooth extraction and/or local infection (including osteomyelistis).
Slovenian: Osteonekroza čeljusti se običajno povezuje s puljenjem zoba in/ali lokalno okužbo (vključno z osteomielitisom).
English: For post-menopausal women who are not receiving oestrogen treatment the recommended dose is one 10 mg tablet daily.
Slovenian: Za ženske po menopavzi, ki ne prejemajo zdravljenja z estrogeni, je priporočen odmerek ena 10 mg tableta dnevno.
English: Alendronate 10 mg and 5 mg were effective irrespective of the dose or duration of steroid use.
Slovenian: Alendronat HEXAL 10 mg in 5 mg sta bila učinkovita ne glede na odmerek ali trajanje jemanja steroidov.
English: The recommended dosage is 10 mg once daily.
Slovenian: Priporočen odmerek je 10 mg enkrat dnevno.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates.
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti, difosfonati.
English: The effects of alendronate on BMD and fracture incidence in post-menopausal women were studied in two initial efficacy studies of identical design (n=994), and in the Fracture Intervention Trial (FIT: n=6459).
Slovenian: Učinke Alendronata HEXAL na MGK in pojavnost zlomov pri ženskah po menopavzi so raziskovali v dveh začetnih enako zasnovanih študijah učinkovitosti (n=994) in v preskušanju FIT (Fracture Intervention Trial, n=6459).
English: As well as your treatment with Alendronate HEXAL, your doctor may suggest you make changes to your lifestyle to help your condition, such as:
Slovenian: Poleg zdravljenja z zdravilom Alendronat HEXAL vam lahko zdravnik predlaga spremembe v načinu življenja, ki pomagajo pri vaši bolezni.
English: No other clinically significant active substance interactions are expected.
Slovenian: Drugih klinično pomembnih interakcij zdravilne učinkovine ni pričakovati.
English: If you are being treated by a dentist or if you are going to have dental surgery, tell your dentist that you are taking Alendronate HEXAL.
Slovenian: Če se zdravite pri zobozdravniku ali boste imeli kirurški poseg na zobeh, povejte svojemu zobozdravniku, da jemljete zdravilo Alendronat HEXAL.
English: Do not take the tablets after the expiry date stated on the blister and the carton.
Slovenian: Tablet ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in na škatli.
English: Excipient: 103.95 mg lactose monohydrate per tablet For a full list of excipients see section 6.1.
Slovenian: Pomožna snov: 103,95 mg laktoze monohidrata na tableto Za celoten seznam pomožnih snovi glejte poglavje 6.1.