natgillin/translations-raw huggingface dataset:
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.
Blagi pad serumskih vrijednosti albumina i ukupnih proteina, najčešće unutar granica referentnih vrijednosti, opažen je u pasa liječenih grapiprantom, ali to nije bilo povezano ni s kakvim klinički značajnim zapažanjima ili događajima.
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.
4.7 Primjena tijekom graviditeta, laktacije ili nesenja Ne primjenjivati na gravidnim i rasplodnim životinjama te onima koje doje jer sigurnost primjene grapipranta tijekom graviditeta i laktacije ili na rasplodnim psima još nije utvrđena.
Grapiprant is primarily bound to serum proteins.
Grapiprant se prvenstveno vezuje na serumske proteine.
The mean percentage of unbound grapiprant was 4.35% and 5.01% at a grapiprant concentration of 200 ng/ml and 1000 ng/ml.
Srednja vrijednost postotka nevezanog grapipranta iznosila je 4,35% i 5,01% pri koncentracijama grapipranta od 200 ng/mL odnosno 1000 ng/mL.
SPECIAL STORAGE CONDITIONS Do not store above 30 °C.
11. POSEBNI UVJETI ČUVANJA Nemojte čuvati pri temperaturi iznad 30 C.
4.11 Withdrawal period(s) Not applicable.
4.11 Karencija(e) Nije primjenjivo.
Use with caution in dogs suffering from pre-existing liver, cardiovascular or renal dysfunctions or from gastrointestinal disease.
Primjenjivati s oprezom u pasa koji od ranije boluju od poremećaja funkcije jetre, kardiovaskularnog sustava ili bubrega ili koji boluju od gastrointestinalnih bolesti.
Maximum grapiprant concentrations are observed in serum within one hour of dosing in the fasted state.
Maksimalna koncentracija grapipranta u serumu zabilježena je unutar jednog sata nakon doziranja natašte.
26 Rue de la Chapelle 68330 Huningue France
Elanco France S.A.S. 26 Rue de la Chapelle 68330 Huningue Francuska
Grapiprant is readily and rapidly absorbed from the gastrointestinal tract in dogs.
Grapiprant se jednostavno i brzo apsorbira iz gastrointestinalnog trakta pasa.
Grapiprant is a methylbenzenesulfonamide.
Grapiprant je metilbenzensulfonamid.
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.
U dva klinička terenska ispitivanja sveukupna stopa uspješnosti temeljena na CBPI-upitniku (Canine Brief Pain Inventory, kako ga je ispunio vlasnik), 28 dana nakon početka liječenja iznosila je 51,3% (120/235) u skupini Galliprant i 35,5% (82/231) u skupini placebo.
Any remaining whole and half tablets should be discarded after 3 months following first opening of the bottle.
Sve preostale tablete, bilo cijele ili prepolovljene, treba baciti 3 mjeseca nakon prvog otvaranja bočice.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary 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
4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno U zdravih pasa liječenih grapiprantom kroz 9 uzastopnih mjeseci opaženi su blaga i prolazna mekano formirana ili sluzava stolica, ponekad krvava i povraćanje pri dnevnom predoziranju s otprilike
Two hydroxylated metabolites and one N-oxidated metabolite are also recovered in bile, faeces and/or urine.
Utvrđena su također dva hidroksilirana i jedan N-oksidirani metabolit u žuči, fecesu i/ili urinu.
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.
Specifični učinci vezivanja prostaglandina E2 na receptore EP4 uključuju vazodilataciju, povećanu vaskularnu permeabilnost, angiogenezu i stvaranje proinflamatornih medijatora.
In case of accidental ingestion by children, mild and reversible gastrointestinal signs and nausea may be observed.
U slučaju da ga djeca nehotice progutaju, mogu se primijetiti blagi i reverzibilni gastrointestinalni znakovi i mučnina.
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.
Nakon jedne peroralne doze od 2 mg grapipranta/kg, dostignuta je vrijednost Cma x i AUC od 1,21 µg/mL, odnosno 2,71 µg h/mL natašte.
One white HDPE bottle with a child-resistant cap containing 7 or 30 tablets (20 mg, 60 mg or 100 mg tablets).
Bijela bočica od HDPE sa zatvaračem koji djeca ne mogu otvoriti koja sadržava 7 ili 30 tableta (tablete od 20 mg, 60 mg ili 100 mg).
Any remaining whole and half tablets should be discarded after 3 months following first opening.
Sve preostale tablete, bilo cijele ili prepolovljene, treba baciti 3 mjeseca od prvog otvaranja.
Do not use in case of hypersensitivity to the active substance or any of the excipients.
Ne primjenjivati u slučaju preosjetljivosti na djelatnu tvar ili na bilo koju od pomoćnih tvari.
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.
Uzimanje tablete s hranom smanjuje bioraspoloživost nakon peroralne primjene, tj. bioraspoloživost nakon peroralne primjene grapipranta natašte bila je 89%, a kada je uzimana s hranom bila je 33%, što znači da su srednje vrijednosti Cmax i AUC grapipranta bile 4 puta, odnosno 2 puta niže.
In vitro protein binding of grapiprant indicates that grapiprant is primarily bound to dog serum albumin.
Vezivanje grapipranta na proteine in vitro pokazuje da se grapiprant u pasa prvenstveno vezuje na serumske albumine.
The concurrent use of grapiprant with other anti-inflammatory agents has not been studied and should be avoided.
Istovremena primjena grapipranta i drugih protuupalnih tvari nije ispitana i potrebno ju je izbjegavati.
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 receptora EP4, ključnog receptora za prostaglandin E2 koji je glavni medijator nocicepcije pobuđene prostaglandinom E2.
Faecal excretion accounted for roughly 65% of the dose whereas approximately 20% of the dose was excreted through urine.
primijenjene doze, dok se otprilike 20% te doze izluči urinom.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (20 ml, 35 ml and 60 ml bottles)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija (bočice od 20 mL, 35 mL i 60 mL)
MARKETING AUTHORISATION NUMBER(S) EU/2/17/221/006 (100 mg, 30 tablets, 60 ml bottle)
EU/2/17/221/006 (100 mg, 30 tableta, bočica od 60 mL)
The concomitant use of protein-bound veterinary medicinal products with grapiprant has not been studied.
Istovremena primjena veterinarsko-medicinskih proizvoda koji se vezuju na proteine s grapiprantom nije ispitana.
Commonly used protein-bound veterinary medicinal products include cardiac, anticonvulsant and behavioural medications.
Uobičajeno korišteni veterinarsko-medicinski proizvodi koju se vezuju na proteine uključuju kardiološke, antikonvulzivne i lijekove koji djeluju na ponašanje.
EU/2/17/221/001-006
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/17/221/001-006
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle (60 ml)
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Bočica (60 mL)
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
U slučaju da se nehotice proguta, odmah treba potražiti pomoć liječnika i pokazati mu uputu o VMP ili etiketu.
INDICATION(S) For the treatment of pain associated with mild to moderate osteoarthritis in dogs.
INDIKACIJA(E) Za liječenje boli povezane s blagim do umjerenim osteoartritisom pasa.
Store out of reach of animals.
Čuvati izvan dosega životinja.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life after first opening the immediate packaging: 3 months.
Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 3 godine.
It is not known whether dogs with a history of hypersensitivity to sulphonamides will exhibit hypersensitivity to grapiprant.
Nije poznato hoće li psi koji u anamnezi imaju preosjetljivost na sulfonamide biti preosjetljivi i na grapiprant.
Wash hands after handling of the veterinary medicinal product.
Nakon rukovanja veterinarsko-medicinskim proizvodom treba oprati ruke.
The majority of clinical cases assessed in the clinical field studies suffered from mild to moderate osteoarthritis based on the veterinary assessment.
U većini kliničkih slučajeva, procijenjenih u kliničkim terenskim ispitivanjima, životinje su bolovale, prema procjeni veterinara, od blagog do umjerenog osteoartritisa.
In clinical studies, the following mild and generally transient adverse reactions have been observed: vomiting, soft-formed faeces, diarrhoea and inappetence.
U kliničkim ispitivanjima primijećene su sljedeće blage i uglavnom prolazne nuspojave: povraćanje, mekano formirana stolica, dijareja i inapetencija.
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 važan je u medijaciji boli i upale jer je on primarni medijator prostaglandinom E2 pobuđene senzibilizacije osjetnih neurona i prostaglandinom E2 pobuđene upale.
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 veterinary medicinal products should be observed before the commencement of treatment with this veterinary medicinal product.
Prethodna primjena drugih tvari s protuupalnim djelovanjem može imati za posljedicu dodatne ili pojačane nuspojave te je, sukladno tome, prije početka liječenja ovim veterinarsko-medicinskim proizvodom potrebno osigurati razdoblje bez primjene takvih lijekova.
100 mg For the full list of excipients, see section 6.1.
Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
Grapiprant is a non-steroidal, non-cyclooxygenase inhibiting anti-inflammatory drug in the piprant class.
Grapiprant je nesteroidni protuupalni lijek iz razreda pripranta koji ne inhibira ciklooksigenazu.
In dogs, grapiprant is a major excretion product in bile, faeces and urine.
U pasa, grapiprant se najvećim dijelom izlučuje sa žuči, fecesom i urinom.
Induction sealed, white, round high density polyethylene (HDPE) bottles (20, 35, and 60 ml) with a threaded child-resistant cap with rayon coil.
Zapečaćene bijele okrugle bočice od polietilena visoke gustoće (HDPE) (od 20 mL, 35 mL i 60 mL) s navojnim zatvaračem s oprugom od rajona koji djeca ne mogu otvoriti.
- 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).
- česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja)
No gender related differences in absorption are observed.
Nisu primijećene razlike u apsorpciji s obzirom na spol životinje.
Cellulose, microcrystalline Magnesium stearate Silica, colloidal anhydrous
Magnezijev stearat Silika, koloidna, bezvodna
Vomiting was observed very commonly, whereas soft-formed faeces, diarrhoea and inappetence were commonly observed.
Povraćanje je primijećeno vrlo često, dok su mekano formirana stolica, dijareja i inapetencija primijećeni često.
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)
Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojave tijekom trajanja jednog liječenja)
EXPIRY DATE EXP {month/year} Once opened use by:
ROK VALJANOSTI EXP {mjesec/godina} Jednom otvoren upotrijebiti do:
Grapiprant is primarily excreted via faeces.
Grapiprant se primarno izlučuje fecesom.
Do not use in pregnant animals as the safety of grapiprant has not been established during pregnancy.
Ne primjenjivati na gravidnim životinjama jer sigurnost primjene grapipranta tijekom graviditeta još nije ispitana.
Manufacturer responsible for batch release:
Njemačka Proizvođač odgovoran za puštanje serije u promet:
The treatment-free period, should take into account the pharmacokinetic properties of the products used previously.
Pri određivanju tog razdoblja bez terapije treba uzeti u obzir farmakokinetička svojstva prethodno primjenjivanih veterinarsko medicinskih proizvoda.
Since clinical signs of canine osteoarthritis wax-and-wane, intermittent treatment may be beneficial in some dogs.
Budući da jačina znakova osteoartritisa u pasa oscilira (periodično se pojačavaju i slabe), neki psi mogu imati koristi od intermitentne terapije.
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.
U zdravih pasa liječenih grapiprantom kroz 9 uzastopnih mjeseci primijećena je prolazna mekano formirana ili sluzava stolica, ponekad krvava, i povraćanje pri dnevnom predoziranju s otprilike
Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany
27472 Cuxhaven
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
DODATAK II A. PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
20 mg tablet
20 mg tableta
Lactation:
Laktacija:
4.9 Amounts to be administered and administration route For oral use.
4.9 Količine koje se primjenjuju i put primjene
Tablet
OBLIK tableta
CLINICAL PARTICULARS 4.1 Target species Dogs.
4.1 Ciljne vrste životinja
SPECIAL STORAGE PRECAUTIONS
POSEBNI UVJETI ČUVANJA
Grapiprant is mainly excreted via faeces.
Grapiprant se uglavnom izlučuje izmetom.
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) - 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).
Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojave tijekom trajanja jednog liječenja) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja)
EXPIRY DATE EXP {month/year} Once opened use by: …
ROK VALJANOSTI EXP {mjesec/godina} Jednom otvoren VMP upotrijebiti do: ...
NAME OF THE VETERINARY MEDICINAL PRODUCT Galliprant 20 mg tablets
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Galliprant 20 mg tablete
Galliprant 60 mg tablets
Galliprant 60 mg tablete
Grapiprant did not produce any signs of kidney or liver toxicity at daily overdoses of up to 15x the recommended dose.
Pri dnevnom predoziranju, dozama do 15 puta višima od preporučene dnevne doze grapiprant nije izazvao znakove toksičnosti za bubrege ili jetru.
In very rare cases, haematemesis or haemorrhagic diarrhoea was reported following clinical use post authorisation in the USA.
Nakon odobrenja veterinarsko-medicinskog proizvoda u SAD-u, u vrlo rijetkim slučajevima nakon kliničke primjene prijavljena je hematemeza ili hemoragični proljev.
Galliprant 100 mg tablets grapiprant
Galliprant 100 mg tablete grapiprant
100 mg tablet
100 mg tableta
Do not use in pregnant, lactating or breeding animals.
Ne primjenjivati na gravidnim i rasplodnim životinjama te onima koje doje
NAME OF THE VETERINARY MEDICINAL PRODUCT Galliprant 100 mg tablets grapiprant
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Galliprant 100 mg tablete grapiprant
Galliprant 20 mg tablets Galliprant 60 mg tablets Galliprant 100 mg tablets grapiprant
Galliprant 20 mg tablete Galliprant 60 mg tablete Galliprant 100 mg tablete grapiprant
Pork liver powder Lactose monohydrate Sodium starch glycolate Type A Sodium laurilsulfate Copovidone
Svinjska jetra u prahu Laktoza monohidrat
Do not use in breeding animals as the safety of grapiprant has not been established or in dogs used for breeding.
Ne primjenjivati na rasplodnim životinjama jer sigurnost primjene grapipranta na rasplodnim psima još nije ispitana.
Do not use lactating animals as the safety of grapiprant has not been established during lactation.
Ne primjenjivati na životinjama koje doje jer sigurnost primjene grapipranta tijekom laktacije još nije ispitana.
60 mg tablet
60 mg tableta
PACKAGE LEAFLET: Galliprant 20 mg tablets for dogs Galliprant 60 mg tablets for dogs Galliprant 100 mg tablets for dogs
UPUTA O VMP: Galliprant 20 mg tablete za pse Galliprant 60 mg tablete za pse Galliprant 100 mg tablete za pse
4.4 Special warnings for each target species
. Vidi odjeljak 4.7. 4.4 Posebna upozorenja za svaku od ciljnih vrsta životinja
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.
Tableta od 60 mg: bikonveksna ovalna tableta sa smeđim mrljama, na jednoj strani s razdjelnim urezom koji razdvaja utisnuti broj „60“ na jednoj polovici i slova „MG“ na drugoj polovici; na drugoj strani utisnuto je slovo „G“.
Pharmacotherapeutic group: Other anti-inflammatory and antirheumatic agents, non-steroids ATCvet code:
druge protuupalne i antireumatske nesteroidne tvari,
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.
Tableta od 100 mg: bikonveksna ovalna tableta sa smeđim mrljama, na jednoj strani s razdjelnim urezom koji razdvaja utisnuti broj „100“ na jednoj polovici i slova „MG“ na drugoj polovici; na drugoj strani utisnuto je slovo „G“.
PACKAGE SIZE 7 tablets
7 tableta 30 tableta
100 mg grapiprant
SASTAV DJELATNIH TVARI 100 mg grapiprant
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.
Tableta od 20 mg: bikonveksna ovalna tableta sa smeđim mrljama, na jednoj strani s razdjelnim urezom koji razdvaja utisnuti broj „20“ na jednoj polovici i slova „MG“ na drugoj polovici; na drugoj strani utisnuto je slovo „G“.
Oral use.
Nije primjenjivo.
The following number of tablets should be given once daily:
Broj tableta koji je potrebno dati jedanput dnevno: Tjelesna težina (kg)
ROUTE(S) OF ADMINISTRATION Oral use
PUT(EVI) PRIMJENE Kroz usta
Body weight (kg)
Broj tableta koji je potreban dati jedanput dnevno: Tjelesna težina (kg)
STATEMENT OF ACTIVE SUBSTANCE(S) 20 mg grapiprant/tablet
SASTAV DJELATNIH TVARI 20 mg grapiprant/tableta 60 mg grapiprant/tableta 100 mg grapiprant/tableta
60 mg grapiprant
20 mg grapiprant 60 mg grapiprant 100 mg grapiprant
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
12. BROJ PROIZVODNE SERIJE PROIZVOĐAČA
Name and address of the manufacturer responsible for batch release
NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET Elanco GmbH
Date of first use:
Datum prve uporabe:
The volume of distribution is approximately 1.7 L/kg.
Volumen distribucije iznosi približno 1,7 l/kg.
FORSTEO can be given with or without food.
FORSTEO se može primjenjivati s hranom ili bez nje.
Each pen should be properly disposed of after 28 days, even if it is not completely empty.
Svaku brizgalicu morate na odgovarajući način zbrinuti nakon 28 dana, čak i ako nije potpuno prazna.
To reset the FORSTEO, follow the steps below.
Što se nalazi u ovoj uputi: Što je FORSTEO i za što se koristi
• During injection, you may hear one or more clicks - this is a normal device operation.
• Za vrijeme injiciranja, možda ćete čuti jedan ili više klikova - to je normalan način rada injektora.
- The FORSTEO appears damaged
- FORSTEO izgleda oštećeno
A small air bubble will not affect your dose nor will it harm you.
Mali mjehurić zraka neće utjecati na dozu i neće Vam naškoditi.
Date of the latest renewal: 13 February 2013
Datum posljednje obnove odobrenja: 13. veljače 2013.
Instead, you MUST reset FORSTEO (see Troubleshooting Problem A).
Umjesto toga, MORATE ponovno namjestiti FORSTEO (pogledajte Rješavanje problema, Problem A).
This disease is especially common in women after the menopause, but it can also occur in men.
Ta je bolest osobito česta u žena nakon menopauze, no može se javiti i u muškaraca.
After completing the injection:
Nakon davanja injekcije:
If you do not feel better, you should call a doctor before you continue treatment.
Ako se ne osjećate bolje, nazovite liječnika prije nego nastavite liječenje.
Risk Factors
Faktori rizika
Each pen should be used by only one patient.
Svaku brizgalicu smije koristiti samo jedan bolesnik.
To prevent one or more new vertebral fractures, 11 women had to be treated for a median of 19 months.
Kako bi se spriječio jedan ili više novih prijeloma kralježaka, 11 žena je trebalo liječiti tijekom medijana od 19 mjeseci.
(metastasised) to your bones.
(metastazirao) u kosti.
• Write down your first injection date on a calendar.
• Zapišite datum prve injekcije u kalendar.
What FORSTEO is and what it is used for
Što je FORSTEO i za što se koristi
Other Important Notes
Ostale važne napomene
If you forget or cannot take FORSTEO at your usual time, take it as soon as possible on that day.
Ako ste zaboravili ili ne možete primijeniti FORSTEO u uobičajeno vrijeme, primijenite ga što prije istoga dana.
You can continue to take your dose as usual.
Možete nastaviti s primjenom doze kao inače.
Therefore, FORSTEO should be used with caution.
Stoga FORSTEO treba primjenjivati uz oprez.
• if you have ever been diagnosed with bone cancer or other cancers that have spread
• ako Vam je ikada dijagnostiticiran rak kosti ili neka druga vrsta raka koji se proširio
Sixty-nine percent of patients completed the 18-month primary phase.
69% bolesnika je završilo 18-mjesečnu primarnu fazu ispitivanja.
Due to the differences in bone physiology in rats and humans, the clinical relevance of these findings is probably minor.
S obzirom na razlike u fiziologiji kosti između štakora i ljudi, klinička je važnost ovih nalaza vjerojatno neznatna.
• neuralgic pain in the leg
• neuralgična bol u nozi
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.
Ovo pokazuje da ste potrošili količinu lijeka koja se može precizno injicirati, iako još možete vidjeti preostali lijek u ulošku.
The primary objective of the study was to collect safety data of FORSTEO.
Primarni cilj tog ispitivanja bio je prikupiti podatke o sigurnosti primjene lijeka FORSTEO.
• Pregnancy and breast-feeding (see sections 4.4 and 4.6)
• Trudnoća i dojenje (vidjeti dijelove 4.4 i 4.6).
E. What should I do if I cannot pull out the black injection button?
Što trebam napraviti ako ne mogu izvući crni gumb za injiciranje?
• if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6).
• ako ste alergični na teriparatid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
Multiple vertebral fractures (≥2) a
Višestruki prijelomi kralježaka (≥ 2) a