FrancophonIA/ELRC3.0 huggingface dataset:
English: If signs of sulphonamide hypersensitivity occur, treatment should be discontinued.
Slovenian: Če se pojavijo znaki preobčutljivosti na sulfonamide, je treba zdravljenje ukiniti.
English: The mean percentage of unbound grapiprant was 4.35% and 5.01% at a grapiprant concentration of 200 ng/ml and 1000 ng/ml.
Slovenian: Povprečen odstotek nevezanega grapipranta je bil 4,35 % oziroma 5,01 % pri koncentraciji grapipranta 200 ng/ml oziroma 1000 ng/ml.
English: Do not use in case of hypersensitivity to the active substance or any of the excipients.
Slovenian: Ne uporabite v primerih preobčutljivosti na učinkovino ali na katero koli pomožno snov.
English: QM01AX92
Slovenian: Oznaka ATC vet: QM01AX92
English: Maximum grapiprant concentrations are observed in serum within one hour of dosing in the fasted state.
Slovenian: Najvišje koncentracije grapipranta v serumu nastopijo v eni uri po odmerjanju na tešče.
English: It is not known whether dogs with a history of hypersensitivity to sulphonamides will exhibit hypersensitivity to grapiprant.
Slovenian: Ni znano, ali psi z anamnezo preobčutljivosti na sulfonamide izkazujejo preobčutljivost na grapiprant.
English: Drug compatibility should be monitored in animals requiring adjunctive therapy.
Slovenian: Pri živalih, ki potrebujejo dodatno zdravljenje, je treba spremljati kompatibilnost zdravil.
English: Four metabolites are identified and the metabolic pathways include Ndeamination to form the major metabolite in faeces (7.2%) and urine (3.4%).
Slovenian: Ugotovljeni so štirje presnovki, presnovne poti pa vključujejo N-deaminacijo, pri kateri nastaja glavni presnovek v blatu (7,2 %) in urinu (3,4 %).
English: The concurrent use of grapiprant with other anti-inflammatory agents has not been studied and should be avoided.
Slovenian: Sočasna uporaba grapipranta z drugimi protivnetnimi zdravili ni bila proučena in se ji je treba izogibati.
English: Intake of the tablet with food reduces the oral bioavailability, i.e. the oral bioavailability of grapiprant when taken in the fasted state was 89% and when taken with food it was 33%, with mean Cmax and AUC grapiprant values reduced 4-fold and 2-fold, respectively.
Slovenian: Zaužitje tablete s hrano zmanjša peroralno biološko razpoložljivost, t. j. peroralna biološka razpoložljivost grapipranta je bila pri dajanju na tešče 89 %, pri dajanju s hrano pa 33 %, pri čemer sta se vrednosti Cmax in AUC grapipranta znižali za 4-krat oziroma 2-krat.
English: After a single oral dose of 2 mg grapiprant/kg, Cma x and AUC values of 1.21 µg/ml and 2.71 µg.h/ml were reached in the fasted state.
Slovenian: Po enkratnem peroralnem odmerku 2 mg grapipranta/kg v stanju teščosti sta bili doseženi vrednosti Cmax 1,21 µg/ml in AUC 2,71 µg.h/ml.
English: Do not use this veterinary medicinal product after the expiry date, which is stated on the carton and bottle after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in plastenki za oznako »EXP«.
English: Faecal excretion accounted for roughly 65% of the dose whereas approximately 20% of the dose was excreted through urine.
Slovenian: Približno 65 % odmerka se je izločilo z blatom, približno 20 % pa z urinom.
English: Dose range (mg/kg bw)
Slovenian: Razpon odmerka (mg/kg t. m.)
English: The pharmacological activity of the metabolites is not known.
Slovenian: Farmakološka aktivnost teh presnovkov ni znana.
English: In dogs, grapiprant is a major excretion product in bile, faeces and urine.
Slovenian: Pri psih je grapiprant glavni produkt izločanja v žolču, blatu in urinu.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 7 tablets
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 7 tablet
English: - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: - pogosti (pri več kot 1, toda manj kot 10 živalih od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živalih od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živalih od 10.000 zdravljenih živali)
English: Prior treatment with other anti-inflammatory substances may result in additional or increased severity of adverse effects and accordingly a treatment-free period with such drugs should be observed before the commencement of treatment with this veterinary medicinal product.
Slovenian: Predhodno zdravljenje z drugimi protivnetnimi zdravili lahko privede do dodatnih neželenih učinkov ali povečane resnosti neželenih učinkov, zato mora po zdravljenju s tovrstnimi zdravili in pred začetkom zdravljenja s tem zdravilom preteči interval brez zdravljenja.
English: The specific effects of the binding of prostaglandin E2 to the EP4 receptor include vasodilation, increased vascular permeability, angiogenesis and production of pro‐inflammatory mediators.
Slovenian: Specifični učinki vezave prostaglandina E2 na receptor EP4 vključujejo vazodilacijo, povečano žilno prepustnost, angiogenezo in tvorbo vnetnih mediatorjev.
English: Commonly used protein-bound veterinary medicinal products include cardiac, anticonvulsant and behavioural medications.
Slovenian: Pogosto uporabljana zdravila, ki se vežejo na beljakovine, vključujejo zdravila za srce, antiepileptike in zdravila za vedenjske motnje.
English: The concomitant use of protein-bound veterinary medicinal products with grapiprant has not been studied.
Slovenian: Sočasna uporaba grapipranta in zdravil, ki se vežejo na beljakovine, ni bila proučena.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/221/006 (100 mg, 30 tablets, 60 ml bottle)
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/17/221/006 (100 mg, 30 tablet, 60 ml plastenka)
English: Grapiprant is a methylbenzenesulfonamide.
Slovenian: Grapiprant je metilbenzensulfonamid.
English: Grapiprant is readily and rapidly absorbed from the gastrointestinal tract in dogs.
Slovenian: Grapiprant se zlahka in zelo hitro absorbira iz prebavil psov.
English: One white HDPE bottle with a child-resistant cap containing 7 or 30 tablets (20 mg, 60 mg or 100 mg tablets).
Slovenian: Ena bela plastenka iz HDPE z za otroke varno zaporko, ki vsebuje 7 ali 30 tablet (20 mg, 60 mg ali 100 mg tablete).
English: In clinical studies, the following mild and generally transient adverse reactions have been observed: vomiting, soft-formed faeces, diarrhoea and inappetence.
Slovenian: V kliničnih študijah so opazili naslednje blage in na splošno prehodne neželene učinke: bruhanje, zmehčano blato, diarejo in neješčnost.
English: 4.2 Indications for use, specifying the target species For the treatment of pain associated with mild to moderate osteoarthritis in dogs.
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Za zdravljenje bolečine, povezane z blagim do zmernim osteoartritisom pri psih.
English: INDICATION(S) For the treatment of pain associated with mild to moderate osteoarthritis in dogs.
Slovenian: INDIKACIJA(E) Za zdravljenje bolečine, povezane z blagim do zmernim osteoartritisom pri psih.
English: The majority of clinical cases assessed in the clinical field studies suffered from mild to moderate osteoarthritis based on the veterinary assessment.
Slovenian: Pri večini kliničnih primerov, ki so bili obravnavani v kliničnih terenskih študijah, je po veterinarski oceni šlo za blag do zmeren osteoartritis.
English: The treatment-free period should take into account the pharmacokinetic properties of the products used previously.
Slovenian: Dolžina intervala brez zdravljenja je odvisna od farmakokinetičnih lastnosti predhodno uporabljenih zdravil.
English: To achieve a substantiated response to treatment, use the veterinary medicinal product only in mild and moderate cases of osteoarthritis.
Slovenian: Da bi dosegli opazen odziv na zdravljenje, uporabljajte zdravilo samo v primerih blagega do zmernega osteoartritisa.
English: 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)
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali)
English: 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.
Slovenian: (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.
English: Grapiprant is primarily bound to serum proteins.
Slovenian: Grapiprant se primarno veže na beljakovine v serumu.
English: EU/2/17/221/001-006
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/17/221/001-006
English: Grapiprant is a selective antagonist of the EP4 receptor, a key prostaglandin E2 receptor that predominantly mediates prostaglandin E2‐elicited nociception.
Slovenian: Grapiprant je selektivni antagonist receptorja EP4, ključnega receptorja prostaglandina E2, ki pretežno posreduje nociocepcijo, ki jo izzove prostaglandin E2.
English: Pack sizes of 7 and 30 tablets per bottle.
Slovenian: Velikosti pakiranja: 7 in 30 tablet v plastenki.
English: 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.
Slovenian: 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.
English: PACKAGE SIZE 7 tablets
Slovenian: VELIKOST PAKIRANJA 7 tablet
English: Any remaining whole and half tablets should be discarded after 3 months following first opening.
Slovenian: Neporabljene cele tablete in polovice tablet je treba zavreči 3 mesece po prvem odprtju.
English: The following number of tablets should be given once daily:
Slovenian: Enkrat dnevno je treba dati naslednje število tablet: Telesna masa (kg)
English: 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.
Slovenian: Receptor EP4 je pomemben pri posredovanju bolečine in vnetja, saj je primarni mediator senzitizacije senzoričnih nevronov in vnetja, ki ju izzove prostaglandin E2.
English: Wash hands after handling of the veterinary medicinal product.
Slovenian: Po rokovanju s tem zdravilom si umijte roke.
English: Use with caution in dogs suffering from pre-existing liver, cardiovascular or renal dysfunctions or from gastrointestinal disease.
Slovenian: Uporabljajte previdno pri psih z obstoječimi okvarami jeter, srca in ožilja ali ledvic ali boleznimi prebavil.
English: Any half tablets should be stored in the bottle.
Slovenian: Neporabljene polovice tablet je treba shraniti v plastenki.
English: Pharmacotherapeutic group: Other anti-inflammatory and antirheumatic agents, non-steroids ATCvet code:
Slovenian: Farmakoterapevtska skupina: Druge nesteroidne protivnetne in protirevmatične učinkovine
English: Grapiprant does not accumulate in the dog after repeated administration.
Slovenian: Grapiprant se pri ponavljajočem se dajanju ne kopiči v psu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (20 ml, 35 ml and 60 ml bottles)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (20 ml, 35 ml in 60 ml plastenke)
English: Any remaining whole and half tablets should be discarded after 3 months following first opening of the bottle.
Slovenian: Neporabljene cele tablete in polovice tablet je treba zavreči 3 mesece po prvem odprtju plastenke.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Rp-Vet.
English: Shelf-life after first opening of the bottle: 3 months.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: 3 mesece.
English: In vitro protein binding of grapiprant indicates that grapiprant is primarily bound to dog serum albumin.
Slovenian: Vezava grapipranta na beljakovine in vitro kaže, da se grapiprant pri psih primarno veže na albumin v serumu.
English: 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.
Slovenian: 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.
English: Since clinical signs of canine osteoarthritis wax-and-wane, intermittent treatment may be beneficial in some dogs.
Slovenian: Zaradi izmenične krepitve in slabitve kliničnih znakov osteoartritisa pri psih je pri nekaterih psih lahko koristno občasno zdravljenje.
English: In case of accidental ingestion by children, mild and reversible gastrointestinal signs and nausea may be observed.
Slovenian: Če otrok nenamerno zaužije to zdravilo,se lahko pojavijo blagi prehodni gastrointestinalni znaki in slabost.
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Slovenian: PROIZVAJALČEVA ŠTEVILKA SERIJE Lot: {številka}
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: Induction sealed, white, round high density polyethylene (HDPE) bottles (20, 35, and 60 ml) with a threaded child-resistant cap with rayon coil.
Slovenian: 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.
English: Vomiting was observed very commonly, whereas soft-formed faeces, diarrhoea and inappetence were commonly observed.
Slovenian: Bruhanje so opazili zelo pogosto, zmehčano blato, diarejo in neješčnost pa pogosto.
English: PACKAGE SIZE 30 tablets
Slovenian: VELIKOST PAKIRANJA 30 tablet
English: Grapiprant is a non-steroidal, non-cyclooxygenase inhibiting anti-inflammatory drug in the piprant class.
Slovenian: Grapiprant je nesteroidno protivnetno zdravilo iz razreda piprantov, ki ne zavira ciklooksigenaze.
English: In very rare cases, haematemesis or haemorrhagic diarrhoea was reported following clinical use post authorisation in the USA.
Slovenian: Pri klinični uporabi po odobritvi v ZDA,so v zelo redkih primerih poročali o hematemezi ali hemoragični driski.
English: Two hydroxylated metabolites and one N-oxidated metabolite are also recovered in bile, faeces and/or urine.
Slovenian: V žolču, blatu in/ali urinu je mogoče odkriti še dva hidroksilirana presnovka in en N-oksidiran presnovek.
English: 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.
Slovenian: 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.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle (60 ml)
Slovenian: PODATKI, KI MORAJO BITI NAVEDENI NA STIČNI OVOJNINI Plastenka (60 ml)
English: EXPIRY DATE EXP {month/year} Once opened use by:
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: {mesec/leto}
English: 20 mg tablet
Slovenian: 20 mg tableta
English: Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany
Slovenian: 27472 Cuxhaven
English: Lactation:
Slovenian: Laktacija:
English: Do not use in pregnant, lactating or breeding animals.
Slovenian: Ne uporabite pri živalih v obdobju brejosti ali laktacije ali pri živalih, namenjenih za vzrejo.
English: ROUTE(S) OF ADMINISTRATION Oral use
Slovenian: NAČIN IN POT(I) UPORABE
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life after first opening the immediate packaging: 3 months.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta.
English: Grapiprant did not produce any signs of kidney or liver toxicity at daily overdoses of up to 15x the recommended dose.
Slovenian: Ob vsakodnevnem dajanju prevelikih odmerkov, ki so za do 15-krat presegli priporočen odmerek, grapiprant ni povzročil znakov toksičnosti za ledvice ali jetra.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Galliprant 20 mg tablets
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Galliprant 20 mg tablete
English: Galliprant 60 mg tablets
Slovenian: Galliprant 60 mg tablete
English: Grapiprant is mainly excreted via faeces.
Slovenian: Grapiprant se večinoma izloča z blatom.
English: CLINICAL PARTICULARS 4.1 Target species Dogs.
Slovenian: 4.1 Ciljne živalske vrste
English: In order to avoid any accidental ingestion, store tablets out of reach of animals.
Slovenian: Tablete shranjujte nedosegljive živalim, da se prepreči nenamerno zaužitje.
English: Galliprant 100 mg tablets grapiprant
Slovenian: Galliprant 100 mg tablete grapiprant
English: Tablet
Slovenian: ZDRAVILA
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Galliprant 100 mg tablets grapiprant
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Galliprant 100 mg tablete grapiprant
English: 100 mg tablet
Slovenian: 100 mg tableta
English: Galliprant 20 mg tablets Galliprant 60 mg tablets Galliprant 100 mg tablets grapiprant
Slovenian: Galliprant 20 mg tablete Galliprant 60 mg tablete Galliprant 100 mg tablete grapiprant
English: 4.11 Withdrawal period(s) Not applicable.
Slovenian: 4.11 Karenca Ni smiselno.
English: Grapiprant is primarily excreted via faeces.
Slovenian: Grapiprant se primarno izloča z blatom.
English: 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.
Slovenian: 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«.
English: 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.
Slovenian: 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«.
English: 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.
Slovenian: 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«.
English: 4.9 Amounts to be administered and administration route For oral use.
Slovenian: 4.9 Odmerjanje in pot uporabe
English: 60 mg tablet
Slovenian: 60 mg tableta
English: 100 mg grapiprant
Slovenian: 100 mg grapipranta
English: Do not use lactating animals as the safety of grapiprant has not been established during lactation.
Slovenian: Ne uporabite v obdobju brejosti, saj varnost grapipranta v tem obdobju ni bila ugotovljena.
English: PACKAGE LEAFLET: Galliprant 20 mg tablets for dogs Galliprant 60 mg tablets for dogs Galliprant 100 mg tablets for dogs
Slovenian: NAVODILO ZA UPORABO Galliprant 20 mg tablete za pse Galliprant 60 mg tablete za pse Galliprant 100 mg tablete za pse
English: Do not use in breeding animals as the safety of grapiprant has not been established or in dogs used for breeding.
Slovenian: Ne uporabite pri živalih, namenjenih za vzrejo, saj varnost grapipranta pri teh psih ni bila ugotovljena.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Po rokovanju s tem zdravilom si umijte roke.
English: Cellulose, microcrystalline Magnesium stearate Silica, colloidal anhydrous
Slovenian: 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
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS One tablet contains:
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUGIH SESTAVIN
English: 60 mg grapiprant/tablet
Slovenian: 20 mg grapipranta/tableto 60 mg grapipranta/tableto 100 mg grapipranta/tableto
English: Ελλάδa ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Slovenian: ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
English: Otherwise tell your doctor as soon as possible.
Slovenian: V nasprotnem primeru čim prej obvestite svojega zdravnika.
English: FORSTEO can be given with or without food.
Slovenian: Zdravilo FORSTEO se lahko daje z ali brez hrane.
English: The volume of distribution is approximately 1.7 L/kg.
Slovenian: Porazdelitev Volumen porazdelitve je približno 1,7 l/kg.
English: Date of first use:
Slovenian: Datum prve uporabe:
English: You can continue to take your dose as usual.
Slovenian: Lahko nadaljujete z dajanjem odmerka kot običajno.
English: Treatment should only be initiated if the benefit clearly outweighs risks in this population.
Slovenian: Zdravljenje mora biti uvedeno le, če korist jasno pretehta tveganja pri tej populaciji.
English: Instead, you MUST reset FORSTEO (see Troubleshooting Problem A).
Slovenian: Namesto tega, MORATE ponovno nastaviti FORSTEO (glejte Reševanje težav Problem A).
English: Date of the latest renewal: 13 February 2013
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 13. februar 2013
English: This disease is especially common in women after the menopause, but it can also occur in men.
Slovenian: Ta bolezen je posebno pogosta pri ženskah po menopavzi, vendar se lahko pojavi tudi pri moških.
English: • During injection, you may hear one or more clicks - this is a normal device operation.
Slovenian: • Med injiciranjem lahko slišite enega ali več klikov - to je običajno delovanje medicinskega pripomočka.
English: Cleaning and Storage
Slovenian: Čiščenje in shranjevanje
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 June 2003
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 10. junij 2003
English: Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours.
Slovenian: Tipično se je dogodek začel v 4 urah po odmerjanju in spontano izzvenel v nekaj minutah do nekaj urah.
English: Risk Factors
Slovenian: Dejavniki tveganja
English: The primary objective of the study was to collect safety data of FORSTEO.
Slovenian: Primarni cilj študije je bil zbrati podatke o varnosti zdravila FORSTEO.
English: A small air bubble will not affect your dose nor will it harm you.
Slovenian: Majhen zračni mehurček ne vplival na vaš odmerek in vas tudi ne bo poškodoval.
English: If you do not feel better, you should call a doctor before you continue treatment.
Slovenian: Če se ne počutite bolje, pred nadaljevanjem zdravljenja pokličite zdravnika.
English: Due to the differences in bone physiology in rats and humans, the clinical relevance of these findings is probably minor.
Slovenian: Zaradi razlik v fiziologiji kosti pri podganah in ljudeh je klinični pomen teh ugotovitev verjetno majhen.