FrancophonIA/ELRC3.0 huggingface dataset:
English: FORSTEO has been administered in single doses of up to 100 micrograms and in repeated doses of up to 60 micrograms/day for 6 weeks.
Croatian: FORSTEO se primjenjivao u jednokratnim dozama do 100 mikrograma i višekratnim dozama do 60 mikrograma na dan tijekom 6 tjedana.
English: • increase in an enzyme called alkaline phosphatase.
Croatian: • povišene razine enzima koji se zove alkalna fosfataza
English: In a large clinical trial, antibodies that cross-reacted with teriparatide were detected in 2.8 % of women receiving FORSTEO.
Croatian: U velikom kliničkom ispitivanju su protutijela koja su ukriženo reagirala s teriparatidom utvrđena u 2,8% žena koje primale FORSTEO.
English: • Check the FORSTEO label to make sure you have the correct medicine.
Croatian: • Provjerite naljepnicu na FORSTEO brizgalici kako biste se uvjerili da imate ispravan lijek te da rok valjanosti nije istekao.
English: Pharmaco-therapeutic group: Calcium homeostasis, parathyroid hormones and analogues, ATC code: H05 AA02.
Croatian: Farmakoterapijska skupina: Pripravci s utjecajem na mijenu kalcija, paratiroidni hormoni i njihovi analozi, ATK oznaka: H05 AA02.
English: Once the needle is removed from the skin, check to make sure the black injection button is all the way in.
Croatian: Nakon što iglu izvučete iz kože, provjerite je li crni gumb za injiciranje utisnut do kraja.
English: Uncommon: Weight increased, cardiac murmur, alkaline phosphatase increase *Serious cases of back cramp or pain have been reported within minutes of the injection.
Croatian: Manje često: porast tjelesne težine, srčani šum, porast alkalne fosfataze * Prijavljeni su ozbiljni slučajevi grča ili boli u leđima unutar nekoliko minuta nakon injekcije.
English: 3) Attach a new needle, pull off the large needle cover and save it.
Croatian: 3) Pričvrstite novu iglu, skinite veći pokrov igle i sačuvajte ga.
English: Because FORSTEO transiently increases serum calcium, FORSTEO should be used with caution in patients taking digitalis.
Croatian: S obzirom na to da FORSTEO prolazno povećava koncentraciju kalcija u serumu, treba ga primjenjivati uz oprez u bolesnika koji uzimaju digitalis.
English: If pregnancy occurs, FORSTEO should be discontinued.
Croatian: Dođe li do trudnoće, primjenu lijeka FORSTEO treba prekinuti.
English: The FORSTEO is designed to inject the full dose every time it is used according to the directions in the section Instructions for Use.
Croatian: FORSTEO je oblikovan tako da se cijela doza injicira svaki put kada se koristi prema uputama u odlomku
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL TEXT
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE TEKST NA NALJEPNICI
English: After each injection, the FORSTEO pen should be returned to the refrigerator.
Croatian: Nakon svake injekcije brizgalica s lijekom FORSTEO se mora vratiti u hladnjak.
English: Never store your pen with the needle attached.
Croatian: Nikada nemojte spremiti brizgalicu s pričvršćenom iglom.
English: Otherwise tell your doctor as soon as possible.
Croatian: Ako se ne povuku, obratite se liječniku što je prije moguće.
English: • if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness.
Croatian: • ako imate stalne mučnine, povraćate, imate zatvor, osjećate nedostatak energije ili slabost u mišićima.
English: 680 subjects were randomised to Forsteo and 680 subjects were randomised to oral risedronate 35 mg/week.
Croatian: 680 ispitanica bilo je randomizirano za primanje lijeka Forsteo, a 680 za liječenje peroralnim risedronatom u dozi od 35 mg na tjedan.
English: It is not known whether teriparatide is excreted in human milk.
Croatian: Nije poznato izlučuje li se teriparatid u majčino mlijeko.
English: Rats treated with near-life time daily injections had dose-dependent exaggerated bone formation and increased incidence of osteosarcoma most probably due to an epigenetic mechanism.
Croatian: Štakori koji su gotovo čitavog života svakodnevno primali injekcije imali su o dozi ovisnu, pojačanu formaciju kosti i povećanu incidenciju osteosarkoma, najverojatnije zbog epigenetičkog mehanizma.
English: Your pen contains 28 days of medicine.
Croatian: Brizgalica sadrži lijek za 28 dana liječenja.
English: Each pen contains 2.4 mL of solution enough for 28 doses.
Croatian: Jedna brizgalica sadrži 2,4 ml otopine, što je dovoljno za 28 doza.
English: OTHER Store in a refrigerator
Croatian: Čuvati u hladnjaku
English: If you use more FORSTEO than you should If, by mistake, you have used more FORSTEO than you should, contact your doctor or pharmacist.
Croatian: Ako ste greškom primijenili više lijeka FORSTEO nego što ste trebali, javite se svom liječniku ili ljekarniku.
English: The mean (median) vitamin D intake for the teriparatide arm was 1433 IU/day (1400 IU/day) and for the risedronate arm was 1191 IU/day (900 IU/day).
Croatian: Srednja vrijednost (medijan) unosa vitamina D u skupini koja je primala teriparatid iznosila je 1433 IU na dan (1400 IU na dan), dok je u skupini liječenoj risedronatom iznosila 1191 IU na dan (900 IU na dan).
English: Generally, antibodies were first detected following 12 months of treatment and diminished after withdrawal of therapy.
Croatian: Protutijela su u pravilu prvi puta utvrđena nakon 12 mjeseci liječenja, da bi nakon prekida liječenja došlo do njihova smanjenja.
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri primjeni
English: FORSTEO should not be used if the solution is cloudy, coloured or contains particles.
Croatian: FORSTEO se ne smije primijeniti ako je otopina zamućena, obojana ili sadrži čestice.
English: Common: Depression
Croatian: Često: depresija
English: Experience in the younger adult population, including premenopausal women, is limited (see section 5.1).
Croatian: Ograničena su iskustva primjene u populaciji mlađih odraslih bolesnika, uključujući žene u predmenopauzi (vidjeti dio 5.1).
English: • Ask your healthcare professional about options to dispose of the pen and the sharps container properly.
Croatian: • Pitajte zdravstvenog radnika na koje načine možete propisno zbrinuti brizgalicu i spremnik za oštre predmete.
English: FORSTEO contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation.
Croatian: FORSTEO sadrži djelatnu tvar teriparatid, koja se koristi za jačanje kostiju i smanjuje rizik od prijeloma tako što potiče stvaranje kosti.
English: • Patients with skeletal malignancies or bone metastases should be excluded from treatment with teriparatide.
Croatian: • Bolesnici s malignim bolestima skeleta ili koštanim metastazama moraju se isključiti iz terapije teriparatidom.
English: Some patients may have experienced allergic reactions soon after injection, consisting of breathlessness, swelling of the face, rash and chest pain (frequency is rare).
Croatian: U nekih su se bolesnika ubrzo nakon injekcije pojavile alergijske reakcije, koje su uključivale nedostatak zraka, oticanje lica, osip i bol u prsnom košu (rijetko).
English: The pens are available in cartons containing one or three pens.
Croatian: Brizgalice se isporučuju u kutijama koje sadrže 1 ili 3 brizgalice.
English: Lilly France S.A.S., rue du colonel Lilly, 67640 Fegersheim, France
Croatian: Lilly France S.A.S., Rue du Colonel Lilly, F-67640 Fegersheim, Francuska.
English: Overdose experience based on post-marketing spontaneous reports In post-marketing spontaneous reports, there have been cases of medication error where the entire contents (up to 800 mcg) of the teriparatide pen have been administered as a single dose.
Croatian: U spontanim prijavama nakon stavljanja lijeka u promet navode se slučajevi pogrešaka u primjeni lijeka, kada je cjelokupan sadržaj (do 800 mikrograma) brizgalice s teriparatidom primijenjen u jednoj dozi.
English: Each dose of 80 microliters contains 20 micrograms of teriparatide*.
Croatian: Jedna doza od 80 mikrolitara sadrži 20 mikrograma teriparatida*.
English: The recommended dose is 20 micrograms given once daily by injection under the skin (subcutaneous injection) in the thigh or abdomen.
Croatian: Preporučena doza iznosi 20 mikrograma jedanput na dan, a primjenjuje se injekcijom pod kožu (supkutanom injekcijom) u bedro ili trbuh.
English: • Prior external beam or implant radiation therapy to the skeleton
Croatian: • Prethodna teleradioterapija ili brahiradioterapija skeleta.
English: Gently hold a fold of skin from thigh or abdomen and insert needle straight into skin.
Croatian: Nježno držite nabor kože bedra ili trbuha i ubodite iglu ravno u kožu.
English: Store in a refrigerator (2°C - 8°C) at all times.
Croatian: Uvijek čuvati u hladnjaku (2°C - 8°C).
English: Pregnancy FORSTEO is contraindicated for use during pregnancy (see section 4.3).
Croatian: Primjena lijeka FORSTEO kontraindicirana je tijekom trudnoće (vidjeti dio 4.3).
English: Following cessation of FORSTEO therapy, patients may be continued on other osteoporosis therapies.
Croatian: Nakon završetka terapije lijekom FORSTEO bolesnici smiju nastaviti liječenje osteoporoze drugim lijekovima.
English: • The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.
Croatian: • Upute o rukovanju iglama ne predstavljaju zamjenu za lokalne propise ni upute zdravstvenih radnika ili ustanova.
English: In short-term clinical studies with FORSTEO, isolated episodes of transient orthostatic hypotension were observed.
Croatian: U kratkoročnim kliničkim ispitivanjima su u bolesnika koji su primali FORSTEO zabilježene izolirane epizode prolazne ortostatske hipotenzije.
English: The effects of overdose that might be expected include nausea, vomiting, dizziness, and headache.
Croatian: Očekivani učinci predoziranja mogu biti mučnina, povraćanje, omaglica i glavobolja.
English: The following convention has been used for the classification of the adverse reactions: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000) very rare (<1/10,000).
Croatian: Nuspojave su klasificirane prema učestalosti na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do
English: In patients with moderate renal impairment, FORSTEO should be used with caution.
Croatian: U bolesnika s umjerenim oštećenjem bubrega FORSTEO treba primjenjivati uz oprez.
English: In addition, 15 of 214 patients in the alendronate group (7.0 %) had experienced a non-vertebral fracture compared with 16 of 214 patients in the FORSTEO group (7.5 %) (p=0.84).
Croatian: Nadalje, nevertebralni prijelom je imalo 15 od 214 bolesnika iz skupine liječene alendronatom (7,0%) u usporedbi sa 16 od 214 bolesnika iz skupine koja je primala FORSTEO (7,5%) (p = 0,84).
English: Do not freeze FORSTEO.
Croatian: Ne zamrzavati FORSTEO.
English: New vertebral fracture (≥1) a
Croatian: Novi prijelom kralješka (≥ 1) a
English: Uncommon: Hypercalcaemia greater than 2.76 mmol/L, hyperuricemia Rare: Hypercalcaemia greater than 3.25 mmol/L
Croatian: Često: hiperkolesterolemija Manje često: hiperkalcijemija veća od 2,76 mmol/l, hiperuricemija
English: Elderly patients Dosage adjustment based on age is not required (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu s obzirom na dob (vidjeti dio 5.2).
English: Remember to use a new needle every time you inject to be sure your FORSTEO will work properly.
Croatian: Upamtite da morate koristiti novu iglu pri svakom injiciranju, kako biste bili sigurni da će FORSTEO
English: FORSTEO can be injected at meal times.
Croatian: FORSTEO možete injicirati u vrijeme obroka.
English: Teriparatide did not increase the incidence of any other type of neoplasia in rats.
Croatian: Teraparatid nije doveo do povećanja incidencije niti jednog drugog tipa neoplazmi u štakora.
English: When transient orthostatic hypotension occurred, it happened within the first several doses, was relieved by placing subjects in a reclining position, and did not preclude continued treatment.
Croatian: Prolazna bi se ortostatska hipotenzija razvila nakon primanja prvih nekoliko doza, a ublažila bi se spuštanjem bolesnika u ležeći položaj te nije spriječila nastavak liječenja.
English: At baseline, 35 % of patients had a vertebral fracture and 59 % had a non-vertebral fracture.
Croatian: Na početku ispitivanja je 35% bolesnika imalo prijelom kralješka, a 59% njih nevertebralni prijelom.
English: FORSTEO increases serum uric acid concentrations.
Croatian: FORSTEO povećava koncentraciju mokraćne kiseline u serumu.
English: Co-administration of raloxifene or hormone replacement therapy with FORSTEO did not alter the effects of FORSTEO on serum or urine calcium or on clinical adverse events.
Croatian: Istodobna primjena raloksifena ili hormonske nadomjesne terapije i lijeka FORSTEO nije promijenila učinke lijeka FORSTEO na koncentraciju kalcija u serumu ili mokraći niti na kliničke nuspojave.
English: Treatment of suspected overdose should include transitory discontinuation of FORSTEO, monitoring of serum calcium, and implementation of appropriate supportive measures, such as hydration.
Croatian: Liječenje u slučaju sumnje na predoziranje treba obuhvatiti privremeni prekid primjene lijeka FORSTEO, praćenje razine kalcija u serumu te primjerene suportivne mjere, poput hidratacije.
English: Inject dose
Croatian: Injiciranje doze
English: Uncommon: Injection site erythema, injection site reaction Rare: Possible allergic events soon after injection: acute dyspnoea, oro/facial oedema, generalised urticaria, chest pain, oedema (mainly peripheral).
Croatian: Manje često: eritem na mjestu injekcije, reakcija na mjestu injekcije Rijetko: moguće alergijske reakcije ubrzo nakon injiciranja: akutna zaduha, oro/facijalni edem, generalizirana urtikarija, bol u prsištu, edem (uglavnom periferni) Pretrage
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree”.
Croatian: FORSTEO sadrži natrij: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: If you are a woman of child-bearing potential, you should use effective methods of contraception during use of FORSTEO.
Croatian: Ako ste žena reproduktivne dobi, morate koristiti djelotvorne metode kontracepcije tijekom primjene lijeka FORSTEO.
English: • a hernia of the tube that carries food to your stomach
Croatian: • kila jednjaka (cijevi kojom se hrana prenosi u želudac)
English: Warnings and precautions FORSTEO may cause an increase in the amount of calcium in your blood or urine.
Croatian: FORSTEO može povećati količinu kalcija u krvi ili mokraći.
English: Major non-vertebral fragility fracturesc (hip, radius, humerus, ribs and pelvis)
Croatian: Veliki nevertebralni prijelomi zbog krhkostic (kuk, palčana kost, nadlaktična kost, rebra i zdjelica)
English: Pull off large needle cover and save it.
Croatian: Skinite veći pokrov igle i sačuvajte ga.
English: Pull off paper tab.
Croatian: Skinite papirnati pokrov.
English: • reduced kidney function, including renal failure
Croatian: • smanjena bubrežna funkcija, uključujući zatajenje bubrega
English: • Unexplained elevations of alkaline phosphatase
Croatian: • Nerazjašnjena povišenja vrijednosti alkalne fosfataze.
English: Prepare the injection site as directed by your doctor or pharmacist.
Croatian: Pripremite mjesto injiciranja prema uputama liječnika ili ljekarnika.
English: Each FORSTEO pack is provided with a user manual that fully describes the use of the pen.
Croatian: U svakom pakiranju lijeka FORSTEO priložen je priručnik za korisnike, u kojemu je detaljno opisana uporaba brizgalice.
English: All patients were offered 1000 mg calcium per day and 800 IU vitamin D per day.
Croatian: Svim je bolesnicima ponuđeno da uzimaju 1000 mg kalcija i 800 IU vitamina
English: The adverse reactions associated with the use of teriparatide in osteoporosis clinical trials and postmarketing exposure are summarised in the table below.
Croatian: Nuspojave povezane s primjenom teriparatida u kliničkim ispitivanjima liječenja osteoporoze te nakon stavljanja lijeka u promet sažeto su prikazane u sljedećoj tablici.
English: Talk to your doctor or pharmacist before or while using FORSTEO:
Croatian: Obratite se svom liječniku ili ljekarniku prije ili tijekom liječenja lijekom FORSTEO:
English: Method of administration FORSTEO should be administered once daily by subcutaneous injection in the thigh or abdomen.
Croatian: FORSTEO se primjenjuje jedanput dnevno supkutanom injekcijom u bedro ili abdomen.
English: Cases of fainting have been reported in association with teriparatide use.
Croatian: Prijavljeni su slučajevi nesvjestice povezani s primjenom teriparatida.
English: Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).
Croatian: Liječenje osteoporoze povezano s dugotrajnom terapijom sustavnim glukokortikoidima u žena i muškaraca s povećanim rizikom od prijeloma (vidjeti dio 5.1).
English: FORSTEO should be stored in a refrigerator (2°C to 8°C) at all times.
Croatian: FORSTEO se uvijek mora čuvati u hladnjaku (od 2°C do 8°C).
English: a The incidence of vertebral fractures was assessed in 448 placebo and 444 Forsteo patients who had baseline and follow-up spine radiographs.
Croatian: a Incidencija prijeloma kralježaka ocijenjena je u 448 bolesnica koje su primale placebo te 444 bolesnice koje su primale Forsteo, a u kojih je učinjena radiografska snimka kralježnice na početku te tijekom ispitivanja.
English: 1) If you have already injected, DO NOT inject yourself a second time on the same day.
Croatian: Ako ste si već dali injekciju, NEMOJTE si dati sljedeću injekciju istoga dana.
English: 2.4 mL solution in cartridge (siliconised Type I glass) with a plunger (halobutyl rubber), disc seal (polyisoprene/bromobutyl rubber laminate)/aluminium assembled into a disposable pen.
Croatian: 2,4 ml otopine u ulošku (silikonizirano staklo tipa I), s klipom (halobutilna guma) i čepom u obliku pločice (poliizoprenski/bromobutilni gumeni laminat)/aluminij, sklopljeni u brizgalicu za jednokratnu primjenu.
English: Some patients have experienced severe back cramps or pain which lead to hospitalisation.
Croatian: U nekih su se bolesnika pojavili jaki grčevi ili bolovi u leđima, koje je trebalo liječiti u bolnici.
English: Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1).
Croatian: Liječenje osteoporoze u žena u postmenopauzi i u muškaraca s povećanim rizikom od prijeloma (vidjeti dio 5.1).
English: The skeletal effects of FORSTEO depend upon the pattern of systemic exposure.
Croatian: na skelet ovise o obrascu sustavne izloženosti.
English: Transient events reported have included nausea, weakness/lethargy and hypotension.
Croatian: Zabilježeni učinci uključuju prolaznu mučninu, slabost/letargiju i hipotenziju.
English: • Wipe the outside of the FORSTEO with a damp cloth.
Croatian: • Obrišite FORSTEO izvana vlažnom krpicom.
English: The mean (median) cumulative dose of glucocorticoid was 474.3 (66.2) mg in the teriparatide arm and 898.0 (100.0) mg in the risedronate arm.
Croatian: Srednja vrijednost (medijan) ukupne doze glukokortikoida iznosila je 474,3 (66,2) mg u skupini koja je primala teriparatid te 898,0 (100,0) mg u skupini liječenoj risedronatom.
English: Women of childbearing potential / Contraception in females Women of childbearing potential should use effective methods of contraception during use of FORSTEO.
Croatian: Žene reproduktivne dobi / kontracepcija u žena Žene reproduktivne dobi moraju koristiti učinkovite metode kontracepcije tijekom primjene lijeka
English: Posology The recommended dose of FORSTEO is 20 micrograms administered once daily.
Croatian: Doziranje Preporučena doza lijeka FORSTEO iznosi 20 mikrograma jedanput na dan.
English: Do not use FORSTEO if solid particles appear or if the solution is cloudy or coloured.
Croatian: FORSTEO se ne smije primijeniti ako sadrži čvrste čestice ili je otopina zamućena ili obojana.
English: Glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, water for injections.
Croatian: Ledena acetatna kiselina, natrijev acetat (bezvodni), manitol, metakrezol, voda za injekcije.
English: If you have a bone disease, tell your doctor.
Croatian: Ako imate neku koštanu bolest, obavijestite o tome svog liječnika.
English: • Put used needles in a sharps container or a hard plastic container with a secure lid. Do not throw needles directly into your household waste.
Croatian: • Upotrijebljene igle odložite u spremnik za oštre predmete ili spremnik od tvrde plastike sa čvrsto zatvorenim poklopcem.
English: The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.
Croatian: Upute o rukovanju iglama ne predstavljaju zamjenu za lokalne propise niti upute zdravstvenih radnika ili ustanova.
English: No special caution is required for patients with mild renal impairment.
Croatian: Nisu potrebne posebne mjere opreza u bolesnika s blagim oštećenjem bubrega.
English: In some cases, no adverse events occurred as a result of the overdose.
Croatian: U nekim slučajevima predoziranje nije rezultiralo nuspojavama.
English: Hydrochloric acid solution and/or sodium hydroxide solution (for pH adjustment).
Croatian: Otopina kloridne kiseline i/ili otopina natrijevog hidroksida (za podešavanje pH).
English: Do not use this medicine after the expiry date which is stated on the carton and pen after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i brizgalici iza 'Rok valjanosti'.
English: MARKETING AUTHORISATION NUMBERS EU/1/03/247/001-002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/247/001-002
English: Large Needle Cover
Croatian: Veći pokrov igle
English: At baseline, the women had a mean age of 72.1 years and a median of 2 prevalent vertebral fractures; 57.9% of patients had received previous bisphosphonate therapy and 18.8% took concomitant glucocorticoids during the study.
Croatian: Srednja vrijednost dobi žena na početku ispitivanja iznosila je 72,1 godinu, a medijan postojećih prijeloma kralježaka iznosio je 2; 57,9% bolesnica prethodno je primalo terapiju bisfosfonatima, dok je njih 18,8% tijekom ispitivanja istodobno uzimalo glukokortikoide.
English: You should not receive more than one treatment course of 24 months over your lifetime.
Croatian: Tijekom života ne smijete primiti više od jednog 24-mjesečnog ciklusa liječenja.
English: Colourless, clear solution.
Croatian: Bezbojna, bistra otopina.
English: Each pen contains 28 doses of 20 micrograms (per 80 microliters).
Croatian: Jedna brizgalica sadrži 28 doza od 20 mikrograma (u 80 mikrolitara).
English: • heartburn (painful or burning sensation just below the breast bone)
Croatian: • žgaravica (bol ili pečenje neposredno ispod prsne kosti) • povraćanje
English: • increase in blood cholesterol levels
Croatian: • povišene razine kolesterola u krvi
English: Immune System Disorder
Croatian: Poremećaji imunološkog sustava
English: The effect of teriparatide on human foetal development has not been studied.
Croatian: Nije ispitivan učinak teriparatida na razvoj ljudskog fetusa.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.4 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: All patients were offered 1000 mg calcium per day and at least 400 IU vitamin D per day.
Croatian: Svim je bolesnicima ponuđeno da uzimaju 1000 mg kalcija i najmanje 400 IU vitamina
English: A new, sterile needle must be used for every injection.
Croatian: Za svaku se injekciju mora upotrijebiti nova sterilna igla.
English: Please also refer to the user manual for instructions on how to use the pen.
Croatian: Pročitajte i Priručnik za korisnike za upute o uporabi brizgalice.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/247/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/247/001