natgillin/translations-raw huggingface dataset:
INDICATION(S) For the treatment of pain associated with mild to moderate osteoarthritis in dogs.
INDIKACIJA(E) Za zdravljenje bolečine, povezane z blagim do zmernim osteoartritisom pri psih.
The majority of clinical cases assessed in the clinical field studies suffered from mild to moderate osteoarthritis based on the veterinary assessment.
Pri večini kliničnih primerov, ki so bili obravnavani v kliničnih terenskih študijah, je po veterinarski oceni šlo za blag do zmeren osteoartritis.
The treatment-free period should take into account the pharmacokinetic properties of the products used previously.
Dolžina intervala brez zdravljenja je odvisna od farmakokinetičnih lastnosti predhodno uporabljenih zdravil.
To achieve a substantiated response to treatment, use the veterinary medicinal product only in mild and moderate cases of osteoarthritis.
Da bi dosegli opazen odziv na zdravljenje, uporabljajte zdravilo samo v primerih blagega do zmernega osteoartritisa.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions during the course of one treatment)
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali)
From the two clinical field studies, the overall success rates based on CBPI (Canine Brief Pain Inventory, as completed by the owner) at 28 days after the start of the treatment, were 51.3% (120/235) for Galliprant and 35.5% (82/231) for the placebo group.
(Canine Brief Pain Inventory, ki ga je izpolnil lastnik psa) 28 dni po začetku zdravljenja 51,3 % (120/235) za skupino, zdravljeno z zdravilom Galliprant, in 35,5 % (82/231) za skupino, zdravljeno s placebom.
Grapiprant is primarily bound to serum proteins.
Grapiprant se primarno veže na beljakovine v serumu.
EU/2/17/221/001-006
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/17/221/001-006
Grapiprant is a selective antagonist of the EP4 receptor, a key prostaglandin E2 receptor that predominantly mediates prostaglandin E2‐elicited nociception.
Grapiprant je selektivni antagonist receptorja EP4, ključnega receptorja prostaglandina E2, ki pretežno posreduje nociocepcijo, ki jo izzove prostaglandin E2.
Pack sizes of 7 and 30 tablets per bottle.
Velikosti pakiranja: 7 in 30 tablet v plastenki.
Mild decreases in serum albumin and total protein, most often within the reference range, have been observed in dogs treated with grapiprant but were not associated with any clinically significant observations or events.
Pri psih, zdravljenih z grapiprantom, so opazili blaga znižanja albumina in skupnih beljakovin v serumu, najpogosteje v referenčnem razponu, ki pa niso bila povezana s klinično pomembnimi opažanji ali dogodki.
PACKAGE SIZE 7 tablets
VELIKOST PAKIRANJA 7 tablet
Any remaining whole and half tablets should be discarded after 3 months following first opening.
Neporabljene cele tablete in polovice tablet je treba zavreči 3 mesece po prvem odprtju.
The following number of tablets should be given once daily:
Enkrat dnevno je treba dati naslednje število tablet: Telesna masa (kg)
The EP4 receptor is important in mediating pain and inflammation as it is the primary mediator of the prostaglandin E2-elicited sensitization of sensory neurons and prostaglandin E2-elicited inflammation.
Receptor EP4 je pomemben pri posredovanju bolečine in vnetja, saj je primarni mediator senzitizacije senzoričnih nevronov in vnetja, ki ju izzove prostaglandin E2.
Wash hands after handling of the veterinary medicinal product.
Po rokovanju s tem zdravilom si umijte roke.
Use with caution in dogs suffering from pre-existing liver, cardiovascular or renal dysfunctions or from gastrointestinal disease.
Uporabljajte previdno pri psih z obstoječimi okvarami jeter, srca in ožilja ali ledvic ali boleznimi prebavil.
Any half tablets should be stored in the bottle.
Neporabljene polovice tablet je treba shraniti v plastenki.
Pharmacotherapeutic group: Other anti-inflammatory and antirheumatic agents, non-steroids ATCvet code:
Farmakoterapevtska skupina: Druge nesteroidne protivnetne in protirevmatične učinkovine
Grapiprant does not accumulate in the dog after repeated administration.
Grapiprant se pri ponavljajočem se dajanju ne kopiči v psu.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (20 ml, 35 ml and 60 ml bottles)
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (20 ml, 35 ml in 60 ml plastenke)
Any remaining whole and half tablets should be discarded after 3 months following first opening of the bottle.
Neporabljene cele tablete in polovice tablet je treba zavreči 3 mesece po prvem odprtju plastenke.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Rp-Vet.
Shelf-life after first opening of the bottle: 3 months.
Rok uporabnosti po prvem odpiranju stične ovojnine: 3 mesece.
In vitro protein binding of grapiprant indicates that grapiprant is primarily bound to dog serum albumin.
Vezava grapipranta na beljakovine in vitro kaže, da se grapiprant pri psih primarno veže na albumin v serumu.
In healthy dogs treated with grapiprant for 9 consecutive months, mild and transient soft-formed or mucous faeces, occasionally bloody, and vomiting were observed at daily overdoses of approximately 2.5x and 15x the recommended dose.
Pri zdravih psih, ki so 9 mesecev zaporedoma prejemali prevelike odmerke grapipranta, ki so presegali največji priporočen odmerek za približno 2,5-krat in 15-krat, so opazili blag in prehoden pojav zmehčanega ali sluzastega blata, ki je bilo občasno krvavo, ter bruhanje.
Since clinical signs of canine osteoarthritis wax-and-wane, intermittent treatment may be beneficial in some dogs.
Zaradi izmenične krepitve in slabitve kliničnih znakov osteoartritisa pri psih je pri nekaterih psih lahko koristno občasno zdravljenje.
In case of accidental ingestion by children, mild and reversible gastrointestinal signs and nausea may be observed.
Če otrok nenamerno zaužije to zdravilo,se lahko pojavijo blagi prehodni gastrointestinalni znaki in slabost.
MANUFACTURER'S BATCH NUMBER Lot {number}
PROIZVAJALČEVA ŠTEVILKA SERIJE Lot: {številka}
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains:
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Induction sealed, white, round high density polyethylene (HDPE) bottles (20, 35, and 60 ml) with a threaded child-resistant cap with rayon coil.
Indukcijsko zatesnjene, bele okrogle plastenke iz polietilena velike gostote (HDPE) (20, 35 in 60 ml) z za otroke varno navojno zaporko, z zvitkom iz rajona.
Vomiting was observed very commonly, whereas soft-formed faeces, diarrhoea and inappetence were commonly observed.
Bruhanje so opazili zelo pogosto, zmehčano blato, diarejo in neješčnost pa pogosto.
PACKAGE SIZE 30 tablets
VELIKOST PAKIRANJA 30 tablet
Grapiprant is a non-steroidal, non-cyclooxygenase inhibiting anti-inflammatory drug in the piprant class.
Grapiprant je nesteroidno protivnetno zdravilo iz razreda piprantov, ki ne zavira ciklooksigenaze.
In very rare cases, haematemesis or haemorrhagic diarrhoea was reported following clinical use post authorisation in the USA.
Pri klinični uporabi po odobritvi v ZDA,so v zelo redkih primerih poročali o hematemezi ali hemoragični driski.
Two hydroxylated metabolites and one N-oxidated metabolite are also recovered in bile, faeces and/or urine.
V žolču, blatu in/ali urinu je mogoče odkriti še dva hidroksilirana presnovka in en N-oksidiran presnovek.
4.7 Use during pregnancy, lactation or lay Do not use in pregnant, lactating or breeding animals as the safety of grapiprant has not been established during pregnancy and lactation or in dogs used for breeding.
Ne uporabite pri živalih v obdobju brejosti ali laktacije ali pri živalih, namenjenih za vzrejo, saj varnost grapipranta v obdobju brejosti in laktacije ali pri psih, namenjenih za vzrejo, ni bila ugotovljena.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle (60 ml)
PODATKI, KI MORAJO BITI NAVEDENI NA STIČNI OVOJNINI Plastenka (60 ml)
EXPIRY DATE EXP {month/year} Once opened use by:
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: {mesec/leto}
Do not use in pregnant, lactating or breeding animals.
Ne uporabite pri živalih v obdobju brejosti ali laktacije ali pri živalih, namenjenih za vzrejo.
ROUTE(S) OF ADMINISTRATION Oral use
NAČIN IN POT(I) UPORABE
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.