FrancophonIA/ELRC3.0 huggingface dataset:
English: Metabolites are excreted mainly in the urine and to a lesser extent in the faeces.
Croatian: Metaboliti se većinom izlučuju mokraćom te u manjoj mjeri stolicom.
English: For higher weight ranges, use Cepedex 0.5 mg/ml and its dosing tables.
Croatian: Za veće raspone težina, primijeniti Cepedex 0,5 mg/ml i pripadajuće tablice doziranja.
English: When dexmedetomidine is used as a premedicant in cats, vomiting, retching, pale mucous membranes, and low body temperature may occur.
Croatian: Kad se deksmedetomidin koristi za premedikaciju u mačaka, može doći do povraćanja, nagona na povraćanje, bljedila sluznica i niske tjelesne temperature.
English: Sedation may be reversed with atipamezole (see section 4.10).
Croatian: Sedacija se može prekinuti pomoću atipamezola (vidjeti dio 4.10).
English: In case of accidental oral intake or self-injection, seek medical advice immediately and show the package insert to the physician but DO NOT DRIVE as sedation and changes in blood pressure may occur.
Croatian: U slučaju nehotičnog gutanja ili samo injiciranja, odmah potražiti pomoć liječnika i pokazati mu uputu o VMP, ali NE UPRAVLJATI VOZILIMA, jer može doći do sedacije i promjena krvnog tlaka.
English: The peak sedative and analgesic effects are reached within 30 minutes after administration.
Croatian: Maksimalni sedativni i analgetski učinci postižu se unutar 30 minuta nakon primjene.
English: In cases of overdose, or if the effects of dexmedetomidine become potentially life-threatening, the appropriate antagonist is atipamezole, administered by intramuscular injection, at the following dose: 5 times the initial dose of dexmedetomidine in micrograms/kg bw.
Croatian: U slučajevima predoziranja ili ako učinci deksmedetomidina postanu potencijalno životno ugrožavajući, prikladni antagonist je atipamezol, primijenjen intramuskularnom injekcijom u sljedećoj dozi: peterostruka inicijalna doza deksmedetomidina u mikrogramima/kg tjelesne težine.
English: Dexmedetomidine 375 micrograms/m2
Croatian: Deksmedetomidin 375 mikrograma/m2
English: 1 ml contains: Dexmedetomidine hydrochloride
Croatian: 1 ml sadrži: Deksmedetomidin hidroklorid
English: Dexmedetomidine 300 micrograms/m2 intramuscularly
Croatian: Deksmedetomidin 300 mikrograma/m2 intramuskularno
English: Dexmedetomidine 40 micrograms/kg intramuscularly
Croatian: Deksmedetomidin 40 mikrograma/kg intramuskularno
English: Use of dexmedetomidine as a premedicant in dogs and cats significantly reduces the amount of induction medicinal product required for induction of anaesthesia.
Croatian: Primjena deksmedetomidina kao premedikacije u pasa i mačaka značajno smanjuje količinu VMP potrebnog za uvođenje u anesteziju.
English: Sodium chloride
Croatian: Deksmedetomidin hidroklorid
English: Dexmedetomidine 125 micrograms/m2
Croatian: Deksmedetomidin 125 mikrograma/m2
English: Intramuscularly: up to 500 micrograms/square metre body surface area.
Croatian: Intramuskularno: do 500 mikrograma/četvornom metru površine tijela.
English: Supraventricular and ventricular premature complexes, sinus pause and 3rd degree AV block may be observed in rare cases.
Croatian: U rijetkim slučajevima zabilježene su supraventrikularne i ventrikularne ekstrasistole, sinusne pauze i AV blok 3. stupnja.
English: When dexmedetomidine and butorphanol are used concomitantly in dogs, bradypnoea, tachypnoea, an irregular respiratory pattern (20-30 sec apnoea followed by several rapid breaths), hypoxaemia, muscle twitch or tremor or paddling, excitation, hypersalivation, retching, vomiting, urination, skin erythema, a sudden arousal, or prolonged sedation may occur.
Croatian: tahipneje, nepravilnog obrasca respiracije (apneja u trajanju 20-30 sekundi nakon koje slijedi nekoliko brzih udisaja), hipoksemije, mišićnih trzaja ili tremora, ili „veslanja“, ekscitacije, hipersalivacije, nagona na povraćanje, povraćanja, mokrenja, kožnog eritema, naglog buđenja ili prolongirane sedacije.
English: Shelf life of the veterinary medicinal product as packaged for sale: 4 years Shelf-life after first opening the immediate packaging: 56 days.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 4 godine.
English: Intravenously: up to 375 micrograms/square metre body surface area.
Croatian: Intravenski: do 375 mikrograma/četvornom metru površine tijela.
English: Dogs: intravenous or intramuscular use Cats: intramuscular use Read the package leaflet before use.
Croatian: Mačke: intramuskularna primjena Prije upotrebe pročitati uputu o VMP.
English: People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution.
Croatian: Osobe preosjetljive na djelatnu tvar ili na bilo koju od pomoćnih tvari trebaju oprezno primjenjivati ovaj veterinarsko-medicinski proizvod.
English: CP Pharma Handelsgesellschaft mbH Ostlandring 13, 31303 Burgdorf Germany
Croatian: CP Pharma Handelsgesellschaft mbH Ostlandring 13, 31303 Burgdorf
English: Dexmedetomidine 500 micrograms/m2*
Croatian: Deksmedetomidin 500 mikrograma/m2*
English: Cats: After administration of 40 micrograms dexmedetomidine/kg bw intramuscularly concurrently with 5 mg ketamine/kg bw to cats, the maximum concentration of dexmedetomidine increased twofold but there was no effect on Tmax.
Croatian: Mačke: Nakon istodobne intramuskularne primjene 40 mikrograma deksmedetomidina/kg tjelesne mase i 5 mg ketamina/kg tjelesne mase u mačaka, maksimalna se koncentracija deksmedetomidina povećala dva puta, ali nije bilo utjecaja na Tmax.
English: - Dogs: intravenous or intramuscular use - Cats: intramuscular use
Croatian: Psi: intravenska ili intramuskularna primjena
English: Excipient(s):
Croatian: Pomoćna(e) tvar(i):
English: In a clinical study, the requirement for propofol and thiopental was reduced by 30% and 60% respectively.
Croatian: U kliničkom ispitivanju potreba za propofolom je smanjena za 30%, a potreba za tiopentalom za 60%.
English: THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN"
Croatian: 14. RIJEČI “ČUVATI IZVAN POGLEDA
English: mbH Ostlandring 13, 31303 Burgdorf Deutschland
Croatian: mbH Ostlandring 13, 31303 Burgdorf
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I
English: When dexmedetomidine is used as a premedicant in dogs bradypnoea, tachypnoea and vomiting may occur.
Croatian: Kad se deksmedetomidin koristi za premedikaciju u pasa, može doći do bradipneje, tahipneje i povraćanja.
English: The dose for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume of 0.4 ml Cepedex/kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
Croatian: Doza za mačke je 40 mikrograma deksmedetomidin hidroklorida/kg tjelesne mase, jednako volumenu doze od 0,4 ml Cepedexa/kg tjelesne mase pri korištenju za neinvazivne, blago do umjereno bolne zahvate koji zahtijevaju obuzdavanje, sedaciju i analgeziju.
English: Premedication with dexmedetomidine will significantly reduce the dosage of the induction agent required and will reduce volatile anaesthetic requirements for maintenance anaesthesia.
Croatian: Premedikacija deksmedetomidinom značajno će smanjiti dozu pripravka potrebnog za uvođenje u anesteziju te će smanjiti potrebu za inhalacijskim anestetikom pri održavanju anestezije.
English: The dose for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume of 0.08 ml Cepedex/kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
Croatian: Mačke: Doza za mačke je 40 mikrograma deksmedetomidin hidroklorida/kg tjelesne mase, jednako volumenu doze 0,08 ml Cepedexa/kg tjelesne mase pri korištenju za neinvazivne, blago do umjereno bolne zahvate koji zahtijevaju obuzdavanje, sedaciju i analgeziju.
English: Colourless Type I glass vials of 5 ml, 10 ml and 20 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.
Croatian: I od 5, 10 i 20 ml zatvorene obloženim brombutilnim gumenim čepom i aluminijskim poklopcem u kartonskoj kutiji.
English: When dexmedetomidine is used for premedication in cats, the same dose is used.
Croatian: Ista doza se upotrebljava kad se u mačaka deksmedetomidin koristi za premedikaciju.
English: Colourless Type I glass vials of 5 ml and 10 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.
Croatian: I od 5 i 10 ml zatvorene obloženim brombutilnim gumenim čepom i aluminijskim poklopcem u kartonskoj kutiji.
English: Attention should be given during the administration of intravenous induction medicinal products to effect.
Croatian: Potreban je oprez za vrijeme intravenske primjene VMP za uvođenje u anesteziju.
English: Shelf-life after first opening the container: 56 days.
Croatian: Rok valjanosti nakon prvog otvaranja unutarnjeg pakovanja:56 dana.
English: When administering in conjunction with butorphanol (0.1 mg/kg) for deep sedation and analgesia, the intramuscular dose of dexmedetomidine is 300 micrograms/square metre body surface area.
Croatian: Kad se primjenjuje istodobno s butorfanolom (0,1 mg/kg) za duboku sedaciju i analgeziju,
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one-half the volume of Cepedex 0.5 mg/ml that was given to the cat.
Croatian: Volumen doze atipamezola pri koncentraciji od 5 mg/ml jest jedna polovina volumena Cepedexa 0,5 mg/ml primijenjenog na mački.
English: Blood pressure decreases to normal or below normal levels after an initial increase.
Croatian: Nakon inicijalnog povišenja krvnog tlaka, dolazi do normalizacije tlaka ili do hipotenzije.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vials of 5, 10 or 20 ml (0.5 mg/ml)
Croatian: Staklene bočice od 5, 10 ili 20 ml (0,5 mg/ml)
English: Cepedex 0.5 mg/ml solution for injection for dogs and cats dexmedetomidine hydrochloride
Croatian: Cepedex 0,5 mg/ml otopina za injekciju za pse i mačke deksmedetomidin hidroklorid
English: Cepedex 0.1 mg/ml solution for injection for dogs and cats dexmedetomidine hydrochloride
Croatian: Cepedex 0,1 mg/ml otopina za injekciju za pse i mačke deksmedetomidin hidroklorid
English: Premedication with dexmedetomidine will significantly reduce the dose of the induction agent required and will reduce volatile anaesthetic requirements for maintenance anaesthesia.
Croatian: Premedikacija s deksmedetomidinom značajno će smanjiti dozu pripravka koji se koristi za uvođenje u anesteziju i dozu inhalacijskih anestetika koji se koriste za održavanje anestezije.
English: Cepedex 0.1 mg/ml injection dexmedetomidine hydrochloride
Croatian: Cepedex 0,1 mg/ml injekcija deksmedetomidin hidroklorid
English: Sedation may be reversed with atipamezole (see section 12 overdose).
Croatian: Sedacija se može prekinuti pomoću atipamezola (vidjeti dio 12.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vials of 5 or 10 ml (0.1 mg/ml)
Croatian: Staklene bočice od 5 ili 10 ml (0,1 mg/ml)
English: 1 or 5 vials of 10 ml
Croatian: 1 bočica od 5 ml, 1 ili 5 bočica od 10 ml.
English: Cepedex 0.5 mg/ml solution for injection for dogs and cats
Croatian: Cepedex 0,5 mg/ml otopina za injekciju za pse i mačke
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one fifth (1/5) of the dose volume of Cepedex 0.1 mg/ml that was given to the dog, regardless of route of administration of Cepedex.
Croatian: Volumen doze atipamezola pri koncentraciji od 5 mg/ml iznosi jednu petinu (1/5) volumena doze Cepedexa 0,1 mg/ml koji je primijenjen na psu, neovisno o putu primjene Cepedexa.
English: The dose volume of atipamezole at the concentration of 5 mg/ml equals the dose volume of Cepedex 0.5 mg/ml that was given to the dog, regardless of route of administration of Cepedex.
Croatian: Volumen doze atipamezola pri koncentraciji od 5 mg/ml jednaka je dozi volumena doze Cepedexa 0,5 mg/ml primijenjenom na psu, neovisno o putu primjene Cepedexa.
English: Special warnings
Croatian: 12. POSEBNA UPOZORENJA
English: Cepedex 0.1 mg/ml solution for injection for dogs and cats
Croatian: Cepedex 0,1 mg/ml otopina za injekciju za pse i mačke
English: Cepedex 0.5 mg/ml injection dexmedetomidine hydrochloride
Croatian: Cepedex 0,5 mg/ml injekcija deksmedetomidin hidroklorid
English: SPECIAL WARNINGS
Croatian: Posebna upozorenja:
English: Equipment for manual ventilation should be available in case of respiratory depression or apnoea when dexmedetomidine and ketamine are used sequentially to induce anaesthesia in cats.
Croatian: Kad se deksmedetomidin i ketamin koriste sekvencijalno za uvođenje mačaka u anesteziju oprema za manualnu ventilaciju treba biti dostupna za slučaj depresije disanja ili apneje.
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one-tenth (1/10) the volume of Cepedex 0.1 mg/ml that was given to the cat.
Croatian: Volumen doze atipamezola pri koncentraciji od 5 mg/ml jednak je jednoj desetini (1/10) volumena Cepedexa 0,1
English: Read the package leaflet before use
Croatian: Prije upotrebe pročitati uputu o VMP.
English: Reduced heart rate and temporary AV-block can be seen after administration of dexmedetomidine.
Croatian: atipamezol se može primijeniti u preporučenoj dozi za poništavanje učinaka deksmedetomidina.
English: Corneal opacities may occur during sedation.
Croatian: Za vrijeme sedacije mogu nastati zamućenja rožnice.
English: WITHDRAWAL PERIOD(S) SPECIAL WARNINGS, IF NECESSARY
Croatian: 12. POSEBNO(A) UPOZORENJE(A)
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Croatian: METODE I NAČIN PRIMJENE
English: Take a tablet as soon as you remember and then continue as before.
Croatian: Uzmite tabletu čim se sjetite i potom nastavite kao prije.
English: You should talk to your doctor first.
Croatian: Trebali biste prvo razgovarati sa svojim liječnikom.
English: Your doctor will tell you how long you should continue to take Optruma.
Croatian: Vaš liječnik će Vam reći koliko dugo trebate uzimati Optrumu.
English: The highest overdose has been approximately 1.5 grams.
Croatian: Najveće predoziranje iznosilo je otprilike 1,5 grama.
English: In one of these trials the women had previously undergone hysterectomy.
Croatian: U jednom od tih ispitivanja žene su ranije imale histerektomiju.
English: The women were 2 to 8 years postmenopausal.
Croatian: Žene su bile u postmenopauzi od 2 do 8 godina.
English: The dose is one tablet a day.
Croatian: Doza je jedna tableta na dan.
English: These changes do not affect concentrations of free hormones.
Croatian: Te promjene ne utječu na koncentracije slobodnih hormona.
English: The duration of treatment in these studies ranged from 6 to 60 months.
Croatian: Dužina trajanja liječenja u tim ispitivanjima iznosila je od 6 do 60 mjeseci.
English: Do not take a double dose to make up for a forgotten tablet dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: One further change was seen which was not statistically significant (p > 0.05), but which did show a significant dose trend.
Croatian: Primijećena je još jedna promjena koja nije bila statistički značajna (p > 0,05), ali koja je pokazala značajnu ovisnost o dozi.
English: If you take more Optruma than you should
Croatian: Ako uzmete više Optrume nego što ste trebali
English: No other metabolites have been detected.
Croatian: Drugi metaboliti nisu otkriveni.
English: Raloxifene is strongly bound to plasma proteins (98-99 %).
Croatian: Raloksifen se snažno veže na proteine plazme (98-99 %).
English: They are packed in blisters or in plastic bottles.
Croatian: Pakirane su u blistere ili u plastične boce.
English: Each tablet contains lactose (149.40 mg).
Croatian: Jedna tableta sadrži laktozu (149,40 mg).
English: Like all medicines, this medicine can cause side effects although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave, iako se one neće javiti kod svakoga.
English: Teratology studies were conducted in rabbits and rats.
Croatian: Ispitivanja teratogenosti provedena su na kunićima i štakorima.
English: In accidental overdose in children younger than 2 years of age, the maximum reported dose has been 180 mg.
Croatian: Kod slučajnih predoziranja u djece mlađe od 2 godine najviša prijavljena doza bila je 180 mg.
English: Optruma may affect the development of the baby.
Croatian: Optruma može utjecati na razvoj djeteta.
English: A risk to the newborns/infants cannot be excluded.
Croatian: Nije moguće isključiti rizik za novorođenčad/dojenčad.
English: Tell your doctor or pharmacist.
Croatian: Recite svom liječniku ili ljekarniku.
English: • If there is still a possibility that you can get pregnant, Optruma could harm your unborn child.
Croatian: • Ako još postoji mogućnost da zatrudnite, Optruma može naškoditi Vašem nerođenom djetetu.
English: Mechanism of action and Pharmacodynamic effect
Croatian: Mehanizam djelovanja i farmakodinamički učinak
English: Renal insufficiency - Less than 6 % of the total dose is eliminated in urine.
Croatian: Renalna insuficijencija - manje od 6 % ukupne doze se eliminira urinom.
English: Optruma could harm your unborn child.
Croatian: Optruma može naškoditi Vašem nerođenom djetetu.
English: Other medicines and Optruma
Croatian: Drugi lijekovi i Optruma
English: Date of first authorisation: 5 August 1998 Date of latest renewal: 11 August 2008
Croatian: Datum prvog odobrenja: 5. kolovoza 1998.
English: iv) Histomorphometry (bone quality).
Croatian: iv) Histomorfometrija (kvaliteta kosti).
English: You should check with your doctor or pharmacist if you are not sure.
Croatian: Provjerite s liječnikom ili ljekarnikom ako niste sigurni.
English: iii) Calcium kinetics.
Croatian: iii) Kinetika kalcija.
English: This adverse reaction was most common in the first 6 months of treatment, and seldom occurred de novo after that time.
Croatian: Ta nuspojava najčešća je unutar prvih 6 mjeseci terapije i rijetko se događa de novo nakon tog perioda.
English: There is no evidence of endometrial proliferation.
Croatian: Nema dokaza o proliferaciji endometrija.
English: The volume of distribution is not dose dependent.
Croatian: Volumen distribucije nije ovisan o dozi.
English: Presystemic glucuronidation is extensive.
Croatian: Predsistemska glukuronidacija je opsežna.
English: A similar increase in BMD was seen in the treatment population who received Optruma for up to 7 years.
Croatian: Slično povećanje BMD-a uočeno je i u liječenoj skupini koja je dobivala Optrumu do 7 godina.
English: Forty five women with osteoporosis or 15 women with osteoporosis with an existing fracture would need to be treated with Optruma for 3 years to prevent one or more vertebral fractures.
Croatian: Četrdeset i pet žena s osteoporozom ili 15 žena s osteoporozom s postojećim prijelomom morale bi se liječiti Optrumom tijekom 3 godine da bi se spriječio nastanak jednog ili više prijeloma kralježaka.
English: What Optruma looks like and contents of the pack
Croatian: Kako Optruma izgleda i sadržaj pakiranja
English: The risk of a thromboembolic event was greatest in the first four months of therapy.
Croatian: Rizik od tromboembolijskog događaja bio je najveći u prva četiri mjeseca terapije.
English: Osteoporosis is a disease that causes your bones to become thin and fragile - this disease is especially common in women after the menopause.
Croatian: Osteoporoza je bolest koja uzrokuje da Vaše kosti postaju tanke i lomljive - ova je bolest posebno česta u žena nakon menopauze.
English: Cholecystectomy rates for raloxifene (2.3 %) were not statistically significantly different from placebo (2.0 %).
Croatian: Stope kolecistektomija za raloksifen (2,3 %) nisu bile statistički značajno različite od placeba (2,0 %).
English: There is no relevant use of Optruma in the paediatric population.
Croatian: Nema relevantne primjene Optrume u pedijatrijskoj populaciji.
English: In some clinical trials, daily doses were given up to 600 mg for 8 weeks and 120 mg, for 3 years.
Croatian: U nekim kliničkim ispitivanjima davane su dnevne doze do 600 mg tijekom 8 tjedana i 120 mg tijekom 3 godine.
English: Women with the highest baseline cholesterol levels had the greatest decreases.
Croatian: Žene s najvišom početnom vrijednošću kolesterola ujedno su imale i najveće sniženje vrijednosti.
English: Discontinuation should happen as soon as possible in case of the illness, or from 3 days before the immobilisation occurs.
Croatian: Do prekida liječenja mora doći što prije u slučaju bolesti ili 3 dana prije imobilizacije.
English: 3528 BJ Utrecht The Netherlands
Croatian: 3528 BJ Utrecht Nizozemska
English: • If you have had a cerebrovascular accident (e.g. stroke), or if your doctor has told you that you are at high risk of having one.
Croatian: • Ako ste imali cerebrovaskularni događaj (npr. moždani udar), ili ako Vam je liječnik rekao da imate visok rizik od takvog događaja.
English: This increase was generally a 2 % increase in BMD compared to placebo.
Croatian: To je uglavnom bilo povećanje od 2 % BMD-a u usporedbi s placebom.
English: The Cmax of digoxin increased by less than 5 %.
Croatian: Cmax digoksina povećana je za manje od 5 %.
English: Optruma tablets are packed either in PVC/PE/PCTFE blisters or in high density polyethylene bottles.
Croatian: Optruma tablete pakirane su ili u PVC/PE/PCTFE blistere ili u boce od polietilena visoke gustoće.
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000),
Croatian: (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko
English: Approximately 60 % of an oral dose is absorbed.
Croatian: Otprilike 60 % peroralne doze se apsorbira.
English: In rare cases, blood levels of liver enzymes may increase during treatment with Optruma.
Croatian: U rijetkim slučajevima, razine jetrenih enzima u krvi mogu porasti za vrijeme liječenja Optrumom.
English: The recommended dose is one tablet daily by oral administration, which may be taken at any time of the day without regard to meals.
Croatian: Preporučena doza je jedna tableta na dan primijenjena peroralno, a može se uzeti u bilo koje doba dana neovisno o obroku.
English: The majority of adverse reactions have not usually required cessation of therapy.
Croatian: Većina nuspojava obično nije zahtijevala prekid liječenja.
English: ii) Bone Mineral Density (BMD): The efficacy of Optruma once daily in postmenopausal women aged up to 60 years and with or without a uterus was established over a two-year treatment period.
Croatian: ii) Mineralna gustoća kosti (BMD): Djelotvornost Optrume primijenjene jednom dnevno u žena u postmenopauzi do 60 godina života s maternicom ili bez nje utvrđena je tijekom dvogodišnjeg liječenja.
English: • Swelling of hands, feet and legs (peripheral oedema)
Croatian: • otečene ruke, stopala i noge (periferni edem)
English: Do not take Optruma if you are breast-feeding as it might be excreted in mother's milk.
Croatian: Nemojte uzimati Optrumu ako dojite budući da se lijek može izlučivati u majčino mlijeko.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (ALL BLISTER PACKS):
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER (SVA BLISTER PAKIRANJA):
English: Eli Lilly and Company (Ireland) Limited Tel:
Croatian: Eli Lilly and Company (Ireland) Limited.
English: Very common: Increased blood pressure a a Term(s) included based on postmarketing experience.
Croatian: Vrlo često: povišen krvni tlaka a Uključeni pojmovi na temelju postmarketinškog iskustva.
English: Nearly 3,000 transvaginal ultrasound (TVUs) examinations were evaluated from 831 women in all dose groups.
Croatian: Ocijenjeno je približno 3000 transvaginalnih ultrazvučnih (TVUZV) pregleda u 831 žene iz svih skupina doziranja.
English: Absolute bioavailability of raloxifene is 2 %.
Croatian: Apsolutna bioraspoloživost raloksifena je 2 %.
English: No adverse effects on cognitive function have been seen.
Croatian: Nisu primijećeni štetni učinci na kognitivne funkcije.