natgillin/translations-raw huggingface dataset:
Some dogs and cats may also vomit at the time of recovery. 
Nekateri psi in mačke lahko bruhajo tudi ob prenehanju delovanja.
Brady- and tachyarrhythmias have been reported and include profound sinus bradycardia, 1st and 2nd degree AV block and sinus arrest. 
Poročali so o bradi- in tahiaritmijah, med katere spadajo izrazita sinusna bradikardija, AV-blok prve in druge stopnje ter sinusni zastoj.
When dexmedetomidine is used for premedication in cats, the same dose is used. 
Pri uporabi deksmedetomidina za premedikacijo mačk se uporablja isti odmerek.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
Do not use this veterinary medicinal product after the expiry date which is stated on the package after EXP. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP. Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.
The peak sedative and analgesic effects are reached within 30 minutes after administration. 
Največji sedativni in analgetični učinek je dosežen v 30 minutah po dajanju zdravila.
Avoid skin, eye or mucosal contact; the use of impermeable gloves is advisable. 
Izogibajte se stiku s kožo, očmi ali sluznico.
The apparent volume of distribution (Vd) is 2.2 l/kg and the elimination half-life t1/2) is one hour. 
Navidezni volumen porazdelitve (Vd) je 2,2 l/kg, razpolovni čas izločanja (t1/2) pa ena ura.
Dexmedetomidine has a high clearance and its elimination depends on the hepatic blood flow. 
Očistek deksmedetomidina je visok in njegovo izločanje je odvisno od krvnega pretoka v jetrih.
Attention should be given during the administration of intravenous induction medicinal products to effect. 
Med dajanjem intravenskega indukcijskega zdravila do doseženega učinka morate biti pozorni.
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. 
Mačke: Po intramuskularnem dajanju 40 mikrogramov deksmedetomidina/kg telesne mase skupaj s 5 mg ketamina/kg telesne mase se je najvišja koncentracija deksmedetomidina dvakratno povečala, vendar ni bilo učinka na Tmax.
1 vial of 20 ml 
1 viala z 20 ml
As in dogs dexmedetomidine has a high clearance in cats and its elimination depends on the hepatic blood flow. 
Kot pri psih je očistek deksmedetomidina visok, njegovo izločanje pa je odvisno od krvnega pretoka v jetrih.
The veterinary medicinal product is intended for: - Dogs: intravenous or intramuscular use - Cats: intramuscular use 
To zdravilo za uporabo v veterinarski medicini je namenjeno za: - psi: intravensko ali intramuskularno uporabo - mačke: intramuskularno uporabo.
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. 
Pri sočasni uporabi deksmedetomidina in butorfanola se pri psih lahko pojavijo upočasnjeno ali pospešeno dihanje, nepravilni dihalni vzorci (20-30 sekund apneje, ki jim sledi nekaj hitrih vdihov), hipoksemija, trzanje mišic ali drhtenje ali brcanje, razdraženje, povečano izločanje sline, bljuvanje, bruhanje, uriniranje, kožni eritem, nenadno prebujanje ali dolgotrajna sedacija.
Cepedex contains dexmedetomidine as the active substance, which produces sedation and analgesia in dogs and cats. 
Zdravilo Cepedex kot zdravilno učinkovino vsebuje deksmedetomidin, ki pri psih in mačkah deluje kot sedativ in analgetik.
Premedication with dexmedetomidine will significantly reduce the dose of the induction agent required and will reduce volatile anaesthetic requirements for maintenance anaesthesia. 
Premedikacija z deksmedetomidinom bistveno zmanjša odmerke sredstva za indukcijo in zmanjša odmerke hlapnega anestetika za vzdrževanje anestezije.
Rare instances of pulmonary oedema have been reported. 
V redkih primerih so poročali o pljučnem edemu.
Sick and debilitated dogs and cats should only be premedicated with dexmedetomidine before induction and maintenance of general anaesthesia based on a risk-benefit assessment. 
Pri bolnih ali oslabljenih psih in mačkah se lahko uporabi deksmedetomidinom za premedikacijo pred uvajanjem in vzdrževanjem splošne anestezije šele po oceni koristi in tveganja postopka.
Expected respiratory events are bradypnoea, intermittent respiratory patterns, hypoventilation, and apnoea. 
Pri dihanju lahko pričakujemo upočasnjeno dihanje, pretrgane dihalne vzorce, hipoventilacijo in apnejo.
Anaesthesia can be induced 10 minutes after premedication by intramuscular administration of a target dose of 5 mg ketamine/ kg bw or by intravenous administration of propofol to effect. 
10 minut po premedikaciji se lahko začne anestezija z intramuskularnim odmerkom 5 mg ketamina/kg telesne mase ali intravenskim odmerkom propofola, dokler ni dosežen učinek.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (0.1 mg/ml) 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (0,1 mg/ml)
As a lipophilic compound, dexmedetomidine is well absorbed after intramuscular administration. 
Deksmedetomidin se kot lipofilna spojina po intramuskularnem dajanju dobro absorbira.
Atipamezole should not be administered prior to 30 minutes following ketamine administration. 
Atipamezola se ne daje pred potekom 30 minut po dajanju ketamina.
Intramuscular dosing at 40 micrograms/kg (followed by ketamine or propofol) frequently resulted in sinus bradycardia and sinus arrhythmia, occasionally resulted in 1st degree atrioventricular block, and rarely resulted in supraventricular premature depolarizations, atrial bigeminy, sinus pauses, 2nd degree atrioventricular block, or escape beats/rhythms. 
Intramuskularno dajanje v odmerku 40 mikrogramov/kg (ki mu sledi ketamin ali propofol) je pogosto povzročilo sinusno bradikardijo in sinusno aritmijo, občasno izraženo v prvi stopnji atrioventrikularnega bloka, ter redko supraventrikularno prezgodnjo depolarizacijo, atrijsko bigemijo, sinusni premor, drugo stopnjo atrioventrikularnega bloka ali manjkajoč utrip/ritem.
The safety of dexmedetomidine has not been established during pregnancy and lactation in the target species. 
Varnost deksemedetomidina v obdobju brejosti in laktacije pri ciljnih živalskih vrstah ni bila ugotovljena.
Sedation may be reversed with atipamezole (see section 12 on overdose). 
Učinki sedacije se lahko izničijo z atipamezolom (glejte poglavje 12 o prevelikem odmerjanju).
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (0.5 mg/ml) 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (0,5 mg/ml)
Marketing authorisation holder and manufacturer responsible for batch release: CP Pharma Handelsgesellschaft mbH 
Ime in naslov izdelovalca zdravila, odgovornega za sproščanje serij CP Pharma Handelsgesellschaft mbH Ostlandring 13
Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats. 
Neinvazivni, blago do zmerno boleči postopki in pregledi psov in mačk, pri katerih so potrebni mirovanje,
Dog Weight 
Psi Masa
- Dogs: intravenous or intramuscular use - Cats: intramuscular use 
Psi: intravenska ali intramuskularna uporaba Mačke: intramuskularna uporaba
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJE
THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN" 
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ”
Dexmedetomidine 375 micrograms/m2 
Deksmedetomidin 375 mikrogramov/m2
Sedation may be reversed with atipamezole (see section 12 overdose). 
Učinki sedacije se lahko izničijo z atipamezolom (glejte poglavje 12 Preveliko odmerjanje).
Dexmedetomidine 300 micrograms/m2 intramuscularly 
Deksmedetomidin 300 mikrogramov/m2 intramsukularno
Dexmedetomidine 125 micrograms/m2 
Deksmedetomidin 125 mikrogramov/m2
When dexmedetomidine is used as a premedicant in cats, vomiting, retching, pale mucous membranes, and low body temperature may occur. 
Pri uporabi deksmedetomidina za premedikacijo mačk lahko pride do bruhanja, poskusov bljuvanja, bledih mukoznih membran in nizke telesne temperature.
Dexmedetomidine 500 micrograms/m2* 
Deksmedetomidin 500 mikrogramov/m2*
Dosing for cats is presented in the following table. 
Naslednja preglednica prikazuje odmerjanje za mačke.
Dexmedetomidine 40 micrograms/kg intramuscularly 
Deksmedetomidin 40 mikrogramov/kg intramuskularno
Cats: After a 40 micrograms/kg bw intramuscular dose the Cmax is 17 ng/ml. 
Mačke: Po intramuskularnem odmerku 40 mikrogramov/kg telesne mase je najvišja koncentracija (Cmax) 17 nanogramov/ml.
EXP {month/year} Once broached use by 
EXP {mesec/leto}
Supraventricular and ventricular premature complexes, sinus pause and 3rd degree AV block may be observed in rare cases. 
V redkih primerih lahko opazimo prezgodnje supraventrikularne in ventrikularne komplekse, sinusno prekinitev in AV-blok tretje stopnje.
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. 
5-mililitrske in 10-mililitrske viale iz brezbarvnega stekla tipa I, zaprte s prevlečenim gumijastim zamaškom iz bromobutilne gume in aluminijasto zaporko, v kartonski škatli.
Corneal opacities may occur during sedation (see also section 4.5). 
Med sedacijo lahko roženica postane motna (gl. tudi točko 4.5).
1 ml contains: Dexmedetomidine hydrochloride 
1 ml vsebuje: deksmedetomidinijev klorid
1 vial of 5 ml 
1 viala s 5 ml
Shelf life of the veterinary medicinal product as packaged for sale: 4 years Shelf-life after first opening the immediate packaging: 56 days. 
Rok uporabnosti zdravila v pakiranju za prodajo: 4 leti.
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. 
5-, 10- in 20-mililitrske viale iz brezbarvnega stekla tipa I, zaprte s prevlečenim gumijastim zamaškom iz bromobutilne gume in aluminijasto zaporko, v kartonski škatli.
1 or 5 vials of 10 ml 
1 viala ali 5 vial z 10 ml
Sodium chloride 
deksmedetomidinijev klorid
The expected sedative and analgesic effects are reached within 15 minutes after administration and are maintained up to 60 minutes after administration. 
Pričakovani sedativni in analgetični učinki se pojavijo v 15 minutah po dajanju.
In cases of overdose, or if the effects of dexmedetomidine become potentially life- threatening, the appropriate dose of atipamezole is 10 times the initial dose of dexmedetomidine (micrograms/ kg bw or micrograms/ square meter body surface area). 
Psi: V primeru prevelikega odmerjanja, ali če postanejo učinki deksmedetomidina potencialno nevarni za življenje, je treba uporabiti odmerek atipamezola, ki je 10-krat večji od prvotnega odmerka deksmedetomidina (v mikrogramih/kg telesne mase ali mikrogramih/kvadratni meter telesne površine).
The corresponding doses based on body weight are presented in the following tables. 
Preglednica spodaj prikazuje ustrezne odmerke na podlagi telesne mase.
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. 
Odmerek za mačke je 40 mikrogramov deksmedetomidinijevega klorida/kg telesne mase, kar ustreza prostorninskemu odmerku 0,08 ml zdravila Cepedex/kg telesne mase pri uporabi za neinvazivne, blago do zmerno boleče postopke in preglede mačk, pri katerih so potrebni mirovanje, sedacija in analgezija.
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. 
Volumen odmerka atipamezola pri koncentraciji 5 mg/ml ustreza volumnu odmerka zdravila Cepedex 0,5 mg/ml, ki je bil dan psu, ne glede na način dajanja zdravila Cepedex.
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. 
Odmerek za mačke je 40 mikrogramov deksmedetomidinijevega klorida/kg telesne mase, kar ustreza prostorninskemu odmerku 0,4 ml zdravila Cepedex/kg telesne mase pri uporabi za neinvazivne, blago do zmerno boleče postopke in preglede mačk, pri katerih so potrebni mirovanje, sedacija in analgezija.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS, IF ANY 
ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ALI ODPADNIH SNOVI, ČE
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. 
Mačke: V primeru prevelikega odmerjanja, ali če postanejo učinki deksmedetomidina potencialno nevarni za življenje, je treba uporabiti atipamezol v obliki intramuskularne injekcije v naslednjem odmerku: 5-kratni prvotni odmerek deksmedetomidina v mikrogramih/kg telesne mase.
The veterinary medicinal product is intended for: 
Načeto zdravilo uporabite do:
For higher weight ranges, use Cepedex 0.5 mg/ml and its dosing tables. 
Za večje razpone telesne teže uporabite zdravilo Cepedex 0,5 mg/ml in pripadajoče odmerne preglednice.
A prolonged elimination half-life is therefore expected with overdoses or when dexmedetomidine is coadministered with other substances, which affect hepatic circulation. 
V primeru prevelikih odmerkov ali pri uporabi deksmedetomidina z drugimi snovmi, ki vplivajo na jetrni krvni obtok, lahko pričakujemo podaljšan razpolovni čas izločanja.
Reduced heart rate and temporary AV-block can be seen after administration of dexmedetomidine. 
Po uporabi deksmedetomidina lahko opazimo upočasnjeno delovanje srca in začasni AV-blok.
Cepedex 0.1 mg/ml injection dexmedetomidine hydrochloride 
Cepedex 0,1 mg/ml injekcija deksmedetomidinijev klorid
Cepedex 0.5 mg/ml solution for injection for dogs and cats dexmedetomidine hydrochloride 
Cepedex 0,5 mg/ml raztopina za injiciranje za pse in mačke deksmedetomidinijev klorid
Cepedex 0.1 mg/ml solution for injection for dogs and cats dexmedetomidine hydrochloride 
Cepedex 0,1 mg/ml raztopina za injiciranje za pse in mačke deksmedetomidinijev klorid
The safety of dexmedetomidine has not been established in males intended for breeding. 
Pri samcih za razplod varnost deksmedetomidina ni bila dokazana.
When dexmedetomidine is used as a premedicant in dogs bradypnoea, tachypnoea and vomiting may occur. 
Pri uporabi deksmedetomidina za premedikacijo psov lahko pride do bradipneje, tahipneje in bruhanja.
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. 
Volumen odmerka atipamezola pri koncentraciji 5 mg/ml ustreza polovici volumna zdravila Cepedex 0,5 mg/ml, ki je bil dan mački.
Propyl parahydroxybenzoate 
2,0 mg propilparahidroksibenzoat
This veterinary medicinal product does not require any special storage conditions. 
Za shranjevanje ni posebnih navodil.
Cepedex 0.5 mg/ml injection dexmedetomidine hydrochloride 
Cepedex 0,5 mg/ml injekcija deksmedetomidinijev klorid
The dose volume of atipamezole at the concentration of 5 mg/ml is one-half (1/2) the volume of Cepedex 0.5 mg/ml that was given to the cat. 
Volumen odmerka atipamezola pri koncentraciji 5 mg/ml ustreza eni polovici (1/2) volumna zdravila Cepedex 0,5 mg/ml, ki je bil dan mački.
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. 
Volumen odmerka atipamezola pri koncentraciji 5 mg/ml ustreza eni desetini (1/10) volumna zdravila Cepedex 0,1 mg/ml, ki je bil dan mački.
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. 
Pri zaporedni uporabi deksmedetomidina in ketamina za anestezijo pri mačkah lahko pride do dihalnega zastoja ali prenehanja dihanja, zato imejte pri roki opremo za ročno ventilacijo.
Cepedex 0.5 mg/ml solution for injection for dogs and cats 
Cepedex 0,5 mg/ml raztopina za injiciranje za pse in mačke
Cepedex 0.1 mg/ml solution for injection for dogs and cats. 
Cepedex 0,1 mg/ml raztopina za injiciranje za pse in mačke.
Dexmedetomidine also induces a number of other α2-adrenoceptor mediated effects, which include piloerection, depression of motor and secretory functions of the gastrointestinal tract, diuresis and hyperglycaemia. 
Mednje spadajo piloerekcija, upadanje motoričnih in sekretornih funkcij prebavil, diureza in hiperglikemija.
Cepedex 0.1 mg/ml solution for injection for dogs and cats 
Cepedex 0,1 mg/ml raztopina za injiciranje za pse in mačke
After concurrent exposure to an overdose of dexmedetomidine (3 times the recommended dose) and 15 mg ketamine/ kg, atipamezole can be administered at the recommended dose level for reversal of effects induced by dexmedetomidine. 
15 mg ketamina/kg se lahko da atipamezol v priporočenem odmerku za izničenje učinkov deksmedetomidina.
In a clinical study, the requirement for propofol and thiopental was reduced by 30% and 60% respectively. 
30 %, po tiopentalu pa za 60 %.
Special precautions to be taken by the person administering the veterinary medicinal product to animals 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Deksmedetomidin je sedativ in uspavalo.
(equivalent to dexmedetomidine 
(ki ustreza 0, 42 mg deksmedetomidina)
Corneal opacities may occur during sedation. 
Med sedacijo lahko pride do motnosti roženice.
Intramuscularly: up to 500 micrograms/square metre body surface area. 
(v mikrogramih/kg telesne mase ali mikrogramih/kvadratni meter telesne površine).
Take a tablet as soon as you remember and then continue as before. 
Vzemite tableto takoj, ko se spomnite, in potem nadaljujte enako kot prej.
4.8 Undesirable effects a. Summary of the safety profile 
4.8 Neželeni učinki a) Povzetek varnostnega profila
The highest overdose has been approximately 1.5 grams. 
Največji preveliki odmerek je bil približno 1,5 grama.
Do not take a double dose to make up for a forgotten tablet dose. 
Ne vzemite dvojnega odmerka, da bi nadoknadili pozabljeni odmerek.
These changes do not affect concentrations of free hormones. 
Te spremembe pa ne vplivajo na koncentracije prostih hormonov.
Due to the nature of this disease process, Optruma is intended for long term use. 
Zaradi narave tega bolezenskega procesa je zdravilo Optruma namenjeno dolgotrajni uporabi.
The women were 2 to 8 years postmenopausal. 
Ženske so bile v menopavzi 2 do 8 let.
Raloxifene is strongly bound to plasma proteins (98-99 %). 
Raloksifen se močno veže na plazemske beljakovine (98-99 %).
No other metabolites have been detected. 
Našli niso nobenih drugih metabolitov.
• Flu syndrome 
• Sindrom gripe
The volume of distribution is not dose dependent. 
Njegov volumen porazdelitve ni odvisen od odmerka.
The majority of adverse reactions have not usually required cessation of therapy. 
Večina neželenih učinkov običajno ni zahtevala prekinitve terapije.
• Increased blood pressure 
• Zvišan krvni tlak
Each tablet contains lactose (149.40 mg). 
Ena tableta vsebuje laktozo (149,40 mg).
de la Industria 30, 28108 Alcobendas (Madrid), Spain. 
de la Industria 30, 28108 Alcobendas (Madrid), Španija.
This adverse reaction was most common in the first 6 months of treatment, and seldom occurred de novo after that time. 
Ta neželeni učinek je bil najpogostejši v prvih 6 mesecih zdravljenja in se je kasneje le redko pojavil prvič.
Mechanism of action and Pharmacodynamic effect 
Mehanizem delovanja in farmakodinamični učinki
This increase was generally a 2 % increase in BMD compared to placebo. 
Na splošno je šlo za 2-odstotno povečanje BMD v primerjavi s placebom.
Your doctor will tell you how long you should continue to take Optruma. 
Vaš zdravnik vam bo povedal, kako dolgo naj bi jemali zdravilo Optruma.
- The other ingredients are: 
- Pomožne snovi so:
The Cmax of digoxin increased by less than 5 %. 
Cmax digoksina se je povečala za manj kot 5 %.
A similar increase in BMD was seen in the treatment population who received Optruma for up to 7 years. 
Podobno povečanje BMD so ugotovili pri zdravljeni populaciji, ki je prejemala zdravilo Optruma do 7 let.
The doctor may also advise you to take calcium and vitamin D supplements. 
Morda vam bo tudi svetoval, da jemljite dodatke kalcija in vitamina D.
Renal insufficiency - Less than 6 % of the total dose is eliminated in urine. 
Ledvična insuficienca - Manj kot 6 % celotnega odmerka se izloči z urinom.
• 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. 
• Če ste že imeli cerebrovaskularni dogodek (npr. kap) ali če vam je vaš zdravnik povedal, da imate visoko tveganje za tak dogodek.
There is no evidence of endometrial proliferation. 
Ni nobenih dokazov o proliferaciji endometrija.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: 
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na lokalno predstavništvo imetnika dovoljenja za promet z zdravilom:
One further change was seen which was not statistically significant (p > 0.05), but which did show a significant dose trend. 
Opažena je bila še ena sprememba, katere pojavnost ni bila statistično značilna (p > 0,05), bila pa je v precejšnji meri odvisna od odmerka zdravila.
Approximately 60 % of an oral dose is absorbed. 
Absorbira se približno 60 % peroralnega odmerka.
Date of first authorisation: 5 August 1998 Date of latest renewal: 11 August 2008 
Datum zadnjega podaljšanja dovoljenja za promet: 11. avgust 2008
e) Effects on cognitive function 
e) Vplivi na kognitivno funkcijo
In some clinical trials, daily doses were given up to 600 mg for 8 weeks and 120 mg, for 3 years. 
V nekaterih kliničnih študijah so dajali dnevne odmerke do 600 mg v času 8 tednov in 120 mg v času 3 let.
You should talk to your doctor first. 
Predhodno se posvetujte s svojim zdravnikom.
They are packed in blisters or in plastic bottles. 
Pakirane so v pretisnih omotih ali plastičnih stekleničkah.
In accidental overdose in children younger than 2 years of age, the maximum reported dose has been 180 mg. 
V naključnem prevelikem odmerjanju pri otrocih, mlajših od 2 let, so poročali o maksimalnem odmerku 180 mg.
• If you are receiving oral oestrogen therapy. 
• Če prejemate peroralno estrogensko terapijo.
The bottles contain 100 tablets. 
Stekleničke vsebujejo po 100 tablet.
This must be investigated by your doctor. 
V tem primeru vas mora pregledati vaš zdravnik.
(listed in section 6). 
(glejte poglavje 5.1).
Pharmacotherapeutic group: Selective Oestrogen Receptor Modulator, ATC code: G03XC01. 
Farmakoterapevtska skupina: selektivni modulatorji estrogenskega receptorja, oznaka ATC: G03XC01.
If this medicinal product is used mistakenly during pregnancy or the patient becomes pregnant while taking it, the patient should be informed of the potential hazard to the foetus (see section 5.3). 
Če ženska to zdravilo pomotoma vzame med nosečnostjo ali če bolnica zanosi med jemanjem tega zdravila, jo je treba obvestiti o možni nevarnosti za plod (glejte poglavje 5.3).
What Optruma is and what it is used for 
Kaj je zdravilo Optruma in za kaj ga uporabljamo
Optruma may affect the development of the baby. 
Zdravilo Optruma lahko vpliva na dojenčkov razvoj.
During the whole length of the study concomitant use of other bone-active medications was permitted. 
Med celotnim trajanjem študije je bila dovoljena sočasna uporaba drugih zdravil, ki učinkujejo na kosti.
Optruma tablets are packed either in PVC/PE/PCTFE blisters or in high density polyethylene bottles. 
Tablete Optruma so pakirane v pretisne omote PVC/PE/PCTFE ali v stekleničke iz polietilena visoke gostote.