natgillin/translations-raw huggingface dataset:
Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life after first opening the immediate packaging: 3 months. 
Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta.
Grapiprant did not produce any signs of kidney or liver toxicity at daily overdoses of up to 15x the recommended dose. 
Ob vsakodnevnem dajanju prevelikih odmerkov, ki so za do 15-krat presegli priporočen odmerek, grapiprant ni povzročil znakov toksičnosti za ledvice ali jetra.
NAME OF THE VETERINARY MEDICINAL PRODUCT Galliprant 20 mg tablets 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Galliprant 20 mg tablete
Grapiprant is mainly excreted via faeces. 
Grapiprant se večinoma izloča z blatom.
CLINICAL PARTICULARS 4.1 Target species Dogs. 
4.1 Ciljne živalske vrste
In order to avoid any accidental ingestion, store tablets out of reach of animals. 
Tablete shranjujte nedosegljive živalim, da se prepreči nenamerno zaužitje.
Tablet 
ZDRAVILA
NAME OF THE VETERINARY MEDICINAL PRODUCT Galliprant 100 mg tablets grapiprant 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Galliprant 100 mg tablete grapiprant
4.11 Withdrawal period(s) Not applicable. 
4.11 Karenca Ni smiselno.
Grapiprant is primarily excreted via faeces. 
Grapiprant se primarno izloča z blatom.
100 mg tablet: A brown speckled, biconvex oval tablet with a score on one face separating the debossed number ‘100' on one half and the letters ‘MG' on the other half; the letter ‘G' is debossed on the other face. 
100 mg tableta: bikonveksna ovalna tableta z rjavimi lisami, z zarezo na eni strani, ki deli tableto na dve polovici - na površini ene je vtisnjena številka »100«, na površini druge pa črki »MG«; na drugi strani tablete je vtisnjena črka »G«.
60 mg tablet: A brown speckled, biconvex oval tablet with a score on one face separating the debossed number ‘60' on one half and the letters ‘MG' on the other half; the letter ‘G' is debossed on the other face. 
60 mg tableta: bikonveksna ovalna tableta z rjavimi lisami, z zarezo na eni strani, ki deli tableto na dve polovici - na površini ene je vtisnjena številka »60«, na površini druge pa črki »MG«; na drugi strani tablete je vtisnjena črka »G«.
20 mg tablet: A brown speckled, biconvex oval tablet with a score on one face separating the debossed number ‘20' on one half and the letters ‘MG' on the other half; the letter ‘G' is debossed on the other face. 
20 mg tableta: bikonveksna ovalna tableta z rjavimi lisami, z zarezo na eni strani, ki deli tableto na dve polovici - na površini ene je vtisnjena številka »20«, na površini druge pa črki »MG«; na drugi strani tablete je vtisnjena črka »G«.
4.9 Amounts to be administered and administration route For oral use. 
4.9 Odmerjanje in pot uporabe
100 mg grapiprant 
100 mg grapipranta
Do not use lactating animals as the safety of grapiprant has not been established during lactation. 
Ne uporabite v obdobju brejosti, saj varnost grapipranta v tem obdobju ni bila ugotovljena.
PACKAGE LEAFLET: Galliprant 20 mg tablets for dogs Galliprant 60 mg tablets for dogs Galliprant 100 mg tablets for dogs 
NAVODILO ZA UPORABO Galliprant 20 mg tablete za pse Galliprant 60 mg tablete za pse Galliprant 100 mg tablete za pse
Do not use in breeding animals as the safety of grapiprant has not been established or in dogs used for breeding. 
Ne uporabite pri živalih, namenjenih za vzrejo, saj varnost grapipranta pri teh psih ni bila ugotovljena.
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: Po rokovanju s tem zdravilom si umijte roke.
Cellulose, microcrystalline Magnesium stearate Silica, colloidal anhydrous 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi prašičja jetra v prahu laktoza monohidrat natrijev karboksimetilškrob (vrsta A) natrijev lavrilsulfat kopovidon celuloza, mikrokristalna magnezijev stearat silicijev dioksid, koloidni, brezvodni
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS One tablet contains: 
NAVEDBA UČINKOVIN(E) IN DRUGIH SESTAVIN
60 mg grapiprant/tablet 
20 mg grapipranta/tableto 60 mg grapipranta/tableto 100 mg grapipranta/tableto
Otherwise tell your doctor as soon as possible. 
V nasprotnem primeru čim prej obvestite svojega zdravnika.
FORSTEO can be given with or without food. 
Zdravilo FORSTEO se lahko daje z ali brez hrane.
The volume of distribution is approximately 1.7 L/kg. 
Porazdelitev Volumen porazdelitve je približno 1,7 l/kg.
You can continue to take your dose as usual. 
Lahko nadaljujete z dajanjem odmerka kot običajno.
Treatment should only be initiated if the benefit clearly outweighs risks in this population. 
Zdravljenje mora biti uvedeno le, če korist jasno pretehta tveganja pri tej populaciji.
Instead, you MUST reset FORSTEO (see Troubleshooting Problem A). 
Namesto tega, MORATE ponovno nastaviti FORSTEO (glejte Reševanje težav Problem A).
Date of the latest renewal: 13 February 2013 
Datum zadnjega podaljšanja dovoljenja za promet: 13. februar 2013
This disease is especially common in women after the menopause, but it can also occur in men. 
Ta bolezen je posebno pogosta pri ženskah po menopavzi, vendar se lahko pojavi tudi pri moških.
• During injection, you may hear one or more clicks - this is a normal device operation. 
• Med injiciranjem lahko slišite enega ali več klikov - to je običajno delovanje medicinskega pripomočka.
Cleaning and Storage 
Čiščenje in shranjevanje
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 June 2003 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 10. junij 2003
Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours. 
Tipično se je dogodek začel v 4 urah po odmerjanju in spontano izzvenel v nekaj minutah do nekaj urah.
Risk Factors 
Dejavniki tveganja
The primary objective of the study was to collect safety data of FORSTEO. 
Primarni cilj študije je bil zbrati podatke o varnosti zdravila FORSTEO.
A small air bubble will not affect your dose nor will it harm you. 
Majhen zračni mehurček ne vplival na vaš odmerek in vas tudi ne bo poškodoval.
If you do not feel better, you should call a doctor before you continue treatment. 
Če se ne počutite bolje, pred nadaljevanjem zdravljenja pokličite zdravnika.
Due to the differences in bone physiology in rats and humans, the clinical relevance of these findings is probably minor. 
Zaradi razlik v fiziologiji kosti pri podganah in ljudeh je klinični pomen teh ugotovitev verjetno majhen.
You should NOT see any of the yellow shaft. 
Rumenega valja NE smete videti.
How do I reset my FORSTEO? 
Kako naj ponovno nastavim moj FORSTEO?
These may be signs there is too much calcium in your blood. 
To so lahko znaki, da je v vaši krvi preveč kalcija.
No differences in FORSTEO pharmacokinetics were detected with regard to age (range 31 to 85 years). 
V farmakokinetiki zdravila FORSTEO niso zaznali razlik glede na starost (razpon od 31 do 85 let).
Other Important Notes 
Druga pomembna opozorila
1,013 (74.5%) patients completed the 24-month follow-up. 
1.013 (74,5 %) bolnic je zaključilo 24-mesečno obdobje spremljanja.
No clinically significant interactions were noted. 
Zabeležili niso nobenih klinično pomembnih medsebojnih delovanj.
Sixty-nine percent of patients completed the 18-month primary phase. 
Devetinšestdeset odstotkov bolnikov je zaključilo 18-mesečno začetno fazo.
D. I cannot get the needle off. 
D. Ne morem odstraniti igle.
Each pen should be properly disposed of after 28 days, even if it is not completely empty. 
Injekcijski peresnik po 28 dneh ustrezno zavrzite, tudi če ni popolnoma prazen.
This indicates that you have now used all the medicine that can be injected accurately even though you may still see some medicine left in the cartridge. 
To kaže, da ste sedaj uporabili celotno zdravilo, ki se ga lahko natančno injicira, čeprav v vložku zdravila morda še vidite nekaj preostalega zdravila.
Always wash your hands before every injection. 
Pred vsakim injiciranjem si vedno umijte roke.
• Pregnancy and breast-feeding (see sections 4.4 and 4.6) 
• Nosečnost in dojenje (glejte poglavji 4.4 in 4.6)
B. How can I tell if my FORSTEO works? 
B. Kako naj vem, da moj FORSTEO deluje?
Osteoporosis is a disease that causes your bones to become thin and fragile. 
Osteoporoza je bolezen, ki povzroči, da vaše kosti postanejo tanjše in krhke.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V.* S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
Do not use FORSTEO if it is, or has been, frozen. 
Zdravila FORSTEO ne uporabite, če je, ali je bil, zamrznjen.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, because occasionally they may interact (e.g. digoxin/digitalis, a medicine used to treat heart disease). 
Obvestite svojega zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli zdravilo, ker lahko občasno delujejo medsebojno (npr. digoksin/digitalis, zdravilo za zdravljenje bolezni srca).
E. What should I do if I cannot pull out the black injection button? 
E. Kaj naj naredim, če ne morem potegniti ven črnega gumba za injiciranje?
Patients must be trained to use the proper injection techniques (see section 6.6). 
Bolnike moramo usposobiti za uporabo pravilnih tehnik injiciranja (glejte poglavje 6.6).
This study included postmenopausal women (N=277), premenopausal women (N=67), and men (N=83). 
Ta študija je vključevala ženske po menopavzi (N=277), ženske pred menopavzo (N=67) in moške (N=83).
Routine calcium monitoring during therapy is not required. 
Rutinsko spremljanje kalcija med zdravljenjem ni potrebno.
Ask your doctor or pharmacist which needle gauge and length are best for you. 
Vprašajte svojega zdravnika ali farmacevta kateri premer igle in dolžina sta za vas najprimernejša.
If you feel dizzy you should not drive or use machines until you feel better. 
Če ste omotični, ne vozite ali upravljajte strojev, dokler se ne počutite bolje.
Other in-use storage times and conditions are the responsibility of the user. 
Za drugačen čas in pogoje shranjevanja med uporabo zdravila je odgovoren uporabnik.
Other medicines and FORSTEO 
Druga zdravila in FORSTEO
6) Point the needle down into an empty container. 
6) Usmerite iglo navzdol v prazen vsebnik.
Your doctor will advise you and decide how long you should be treated with FORSTEO. 
Vaš zdravnik vam bo svetoval in se odločil, kako dolgo se morate zdraviti z zdravilom FORSTEO.
If the yellow shaft does not show, you have completed the injection steps correctly. 
Če rumenega valja ne vidite, ste pravilno zaključili korake injiciranja.
Warnings and precautions FORSTEO may cause an increase in the amount of calcium in your blood or urine. 
Opozorila in previdnostni ukrepi Zdravilo FORSTEO lahko poviša količino kalcija v vaši krvi ali urinu.
Fracture Incidence in Postmenopausal Women: Placebo (N = 544) (%) 
Incidenca zlomov pri ženskah po menopavzi: Placebo (N = 544) (%)
• if you suffer from high calcium levels (pre-existing hypercalcaemia). 
• če imate visoke ravni kalcija (že obstoječo hiperkalciemijo).
Your doctor may advise you to take FORSTEO with calcium and vitamin D. Your doctor will tell you how much you should take each day. 
Vaš zdravnik vam bo morda ob uporabi zdravila FORSTEO svetoval jemanje kalcija in vitamina D. Povedal vam bo tudi, kolikšen odmerek vzemite vsak dan.
To help you remember to take your medicine, inject it at about the same time each day. 
Da se laže spomnite uporabiti svoje zdravilo, si ga injicirajte vsak dan ob približno isti uri.
This leaflet is available in all EU/EEA languages on the European Medicines Agency web site. 
To navodilo za uporabo je na voljo v vseh uradnih jezikih EU/EGP na spletni strani Evropske agencije za zdravila.
FORSTEO should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition. 
Zdravilo FORSTEO je treba pri bolnikih z aktivno ali nedavno urolitiazo uporabljati previdno zaradi možnosti poslabšanja tega stanja.
You can prevent this problem by always using a NEW needle for each injection, and by pushing the black injection button all the way in and counting to 5 s-l-o-w-l-y. 
Ta problem lahko preprečite s tem, da za vsako injiciranje vedno uporabite NOVO iglo, da črni gumb za injiciranje pritisnete popolnoma noter in da p-o-č-a-s-i štejete do 5.
Younger adult population 
Populacija mladih odraslih
The pivotal study included 1637 postmenopausal women (mean age 69.5 years). 
Ključna študija je vključevala 1637 žensk po menopavzi (povprečna starost 69,5 let).
FORSTEO should not be used in growing adults. 
Zdravila FORSTEO se ne sme uporabljati pri odraslih v dobi rasti.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
Imetnik dovoljenja za promet bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Osteoporosis is also common in patients receiving corticosteroids. 
Osteoporoza je pogosta tudi pri bolnikih, ki prejemajo kortikosteroide.
During this observational period, other osteoporosis treatments were allowed and additional assessment of vertebral fractures was performed. 
V tem opazovalnem obdobju so dovolili druga zdravljenja osteoporoze, opravljeno pa je bilo tudi dodatno vrednotenje zlomov vretenc.
• Write down your first injection date on a calendar. 
• Na koledar si vpišite datum vašega prvega injiciranja.
It is not known whether teriparatide is excreted in human milk. 
Ni znano, ali se teriparatid izloča v materino mleko.
Serum calcium concentrations reach a maximum between 4 and 6 hours and return to baseline by 16 to 24 hours after each dose of teriparatide. 
Serumske koncentracije kalcija so dosegale najvišje vrednosti po 4 do 6 urah in se povrnile na izhodiščno vrednost po 16 do 24 urah po vsakem odmerku teriparatida.
Uncommon: Hypercalcaemia greater than 2.76 mmol/L, hyperuricemia Rare: Hypercalcaemia greater than 3.25 mmol/L 
Občasno: hiperkalcemija, višja od 2,76 mmol/l, hiperurikemija Redko: hiperkalcemija, višja od 3,25 mmol/l
• The FORSTEO contains 28 days of medicine. 
• Zdravilo FORSTEO vsebuje zdravilo za 28 dni zdravljenja.
Some patients have experienced severe back cramps or pain which lead to hospitalisation. 
Pri nekaterih bolnikih je prišlo do hudih krčev v hrbtu ali bolečine, ki je vodila v hospitalizacijo
There is no specific antidote for FORSTEO. 
Za zdravilo FORSTEO ni specifičnega antidota.
There were no important effects observed in pregnant rats or mice administered teriparatide at daily doses of 30 to 1000 µg/kg. 
Niso opazili nobenih pomembnih učinkov pri brejih podganah ali miših, ki so jim dajali teriparatid v dnevnih odmerkih 30 do 1000 µg/kg.
Animal studies have shown that severely reduced hepatic blood flow decreases exposure of PTH to the principal cleavage system (Kupffer cells) and consequently clearance of PTH(1-84). 
Študije na živalih so pokazale, da hudo zmanjšan pretok krvi skozi jetra zniža izpostavitev paratirodnega hormona poglavitnemu sistemu razgradnje (Kupfferjeve celice) in posledično očistek paratiroidnega hormona (1-84).
Inject FORSTEO each day for as long as your doctor prescribes it for you. 
Zdravilo FORSTEO si vbrizgajte vsak dan, tako dolgo, kolikor vam vaš zdravnik predpiše.
• if you have certain bone diseases. 
• če imate določena obolenja kosti.
• a hernia of the tube that carries food to your stomach 
• slabost (bruhanje) • hernija v predelu, ki prinaša hrano v vaš želodec
At baseline, 35 % of patients had a vertebral fracture and 59 % had a non-vertebral fracture. 
V osnovnem stanju je imelo 35 % bolnikov vretenčni zlom in 59 % nevretenčni zlom.
The FORSTEO is designed to inject the full dose every time it is used according to the directions in the section Instructions for Use. 
FORSTEO je oblikovan za injiciranje celotnega odmerka vsakič, ko je uporabljen v skladu z navodili v poglavju Navodila za uporabo.
Boehringer-Ingelheim RCV GmbH & Co KG, Dr.-Boehringer-Gasse 5-11, 1121 Vienna, Austria 
Ime in naslov izdelovalca biološke učinkovine Boehringer-Ingelheim RCV GmbH & Co KG, Dr.-Boehringer-Gasse 5-11, 1121 Vienna, Avstrija
• low haemoglobin or red blood cell count (anaemia) 
• nizek hemoglobin ali nizko število rdečih krvnih celic (anemija)
The embryotoxicity observed in rabbits may be related to their much greater sensitivity to the effects of PTH on blood ionised calcium compared with rodents. 
Embriotoksičnost, ki so jo opazili pri kuncih je morda povezana z njihovo večjo občutljivostjo za učinke paratiroidnega hormona na ioniziran kalcij v krvi v primerjavi z glodalci.
• if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na (preobčutljivi za) teriparatid ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.*
However, the hyperuricemia did not result in an increase in gout, arthralgia, or urolithiasis. 
Vendar pa hiperurikemija ni povzročila povišanja pojavnosti protina, artralgij ali urolitiaze.
Dosage adjustment based on age is not required. 
Prilagajanje odmerka glede na starost ni potrebno.
Serum and urine calcium 
Serumski in urinski kalcij
If you become dizzy (light-headed) after your injection, you should sit or lie down until you feel better. 
Če po injiciranju postanete omotični (zmedeni), sedite ali se uležite, dokler se ne počutite bolje.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
• Preobčutljivost na učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1.
Some patients get dizzy or get a fast heartbeat after the first few doses. 
Nekateri bolniki postanejo omotični ali imajo po prvih nekaj odmerkih hitrejši utrip srca.
In rare cases, serious and potentially life-threatening allergic reactions including anaphylaxis can occur. 
V redkih primerih lahko pride do resnih in potencialno življenjsko nevarnih alergijskih reakcij, vključno z anafilakso.
Teriparatide did not increase the incidence of any other type of neoplasia in rats. 
Teriparatid ni povečal incidenco kateregakoli drugega tipa novotvorb pri podganah.
The effect of teriparatide on human foetal development has not been studied. 
Učinka teriparatida na razvoj humanega ploda niso preučevali.
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. 
Izkušnje s prevelikim odmerjanjem na podlagi spontanih poročil po uvedbi zdravila na trg V spontanih poročilih po uvedbi zdravila na trg so poročali o primerih napačnega odmerjanja, ko so dali vso vsebino (do 800 mcg) peresnika s teriparatidom kot enkratni odmerek.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.4 mL 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2,4 ml
In a study of 15 healthy subjects administered digoxin daily to steady state, a single FORSTEO dose did not alter the cardiac effect of digoxin. 
V študiji 15 zdravih oseb, ki so dnevno prejemali digoksin do stanja dinamičnega ravnovesja, enkratni odmerek zdravila FORSTEO ni spremenil učinka digoksina na srce.
• Patients with skeletal malignancies or bone metastases should be excluded from treatment with teriparatide. 
• Bolniki s skeletnimi malignostmi ali kostnimi metastazami morajo biti izključeni iz zdravljenja s teriparatidom
437 patients (mean age 58.7 years) were enrolled in a clinical trial for men with hypogonadal (defined as low morning free testosterone or an elevated FSH or LH) or idiopathic osteoporosis. 
437 bolnikov (povprečna starost 58,7 let) je bilo vključenih v klinično preskušanje za moške s hipogonadalno (definirano kot nizek jutranji prosti testosteron ali povišan FSH ali LH) ali idiopatsko osteoporozo.
Until further clinical data become available, the recommended treatment time of 24 months should not be exceeded. 
Dokler ni na voljo nadaljnjih kliničnih podatkov, priporočenega časa zdravljenja 24 mesecev ne smemo preseči.
Treatment of suspected overdose should include transitory discontinuation of FORSTEO, monitoring of serum calcium, and implementation of appropriate supportive measures, such as hydration. 
Zdravljenje domnevnega prevelikega odmerjanja naj vključuje prehodno ukinitev zdravila FORSTEO, spremljanje serumskih koncentracij kalcija in uporabo ustreznih podpornih ukrepov, kot je hidracija.
* Needles not included. 
*Igle niso priložene.
Remember to use a new needle every time you inject to be sure your FORSTEO will work properly. 
Ne pozabite uporabiti za vsako injiciranje novo iglo za zagotovitev, da vaš FORSTEO deluje pravilno.
Do not share your pen or your needles as this may risk transmission of infectious agents. 
Vašega peresnika ali igel ne delite z drugimi, ker s tem tvegate prenos povzročiteljev okužb.
• Dispose of the device 28 days after first use. 
• Medicinski pripomoček zavrzite 28 dni po prvi uporabi.
• The FORSTEO is not recommended for use by the blind or visually impaired persons without the assistance of a person trained in the proper use of the device. 
• Injekcijskega peresnika FORSTEO ne priporočamo uporabljati slepim ali slabovidnim osebam, ki so brez pomoči ali osebe, usposobljene za pravilno uporabo medicinskega pripomočka.
Elderly patients Dosage adjustment based on age is not required (see section 5.2). 
Starejši bolniki Prilagoditev odmerjanja glede na starost ni potrebna (glejte poglavje 5.2).
If you are considering stopping FORSTEO treatment, please discuss this with your doctor. 
Če razmišljate o prenehanju jemanja zdravila FORSTEO, se o tem posvetujte s svojim zdravnikom.
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. 
Kadar se je pojavila prehodna ortostatska hipotenzija, ki se je pojavljala v času prvih nekaj odmerkov, so jo olajšali z namestitvijo osebe v ležeč položaj in ni preprečila nadaljnjega zdravljenja.
Before you use your new pen, please read the section Instructions for use completely. 
Pred uporabo vašega novega injekcijskega peresnika, prosimo preberite poglavje Navodila za uporabo v celoti.
Experience in the younger adult population, including premenopausal women, is limited (see section 5.1). 
Izkušnje pri populaciji mladih odraslih, vključno z ženskami pred menopavzo, so omejene (glejte poglavje 5.1).
However, no significant effect on fracture rates was demonstrated. 
Vendar pa niso dokazali nobenega značilnega učinka na stopnjo zlomov.
Children and adolescents FORSTEO should not be used in children and adolescents (less than 18 years). 
Zdravila FORSTEO se ne sme uporabljati pri otrocih in mladostnikih (mlajših od 18 let).
However, sporadic case reports have suggested that hypercalcaemia may predispose patients to digitalis toxicity. 
Vendar pa so sporadična poročila o primerih bolnikov nakazala, da hiperkalciemija lahko naredi bolnike bolj dovzetne za toksičnost digitalisa.
The effects of overdose that might be expected include delayed hypercalcaemia and risk of orthostatic hypotension. 
Učinki prevelikega odmerjanja, ki jih lahko pričakujemo, vključujejo podaljšano hiperkalciemijo in tveganje za ortostatsko hipotenzijo.