natgillin/translations-raw huggingface dataset:
Regular monitoring should be undertaken by the veterinarian.
Pri dolgotrajnem zdravljenju lahko po vidnem kliničnem odgovoru odmerek Onsiorja prilagodimo na najnižji učinkovit individualen odmerek, pri tem pa upoštevamo, da se stopnja bolečine in vnetja, povezani s kroničnim osteoartritisom, lahko spreminja Potreben je reden nadzor s strani veterinarja.
In healthy young dogs aged 5-6 months, oral robenacoxib administered at high overdoses (4, 6, or 10 mg/ kg/ day for 6 months) did not produce any signs of toxicity, including no evidence of any gastrointestinal, kidney or liver toxicity and no effect on bleeding time.
Pri zdravih psih, starih 5- 6 mesecev, se po 6 mesecih peroralnega prejemanja prevelikih odmerkov robenakoksiba (4, 6 ali 10 mg/ kg/ dan) niso pojavili znaki toksičnosti na prebavilih, ledvicah ali jetrih ter ni bilo vpliva na čas krvavitve.
Robenacoxib also had no detrimental effects on cartilages or joints.
Robenakoksib tudi ni imel škodljivih vplivov na hrustance in sklepe.
9 4.11 Withdrawal period
9 Pri občutljivih ali ogroženih psih je lahko prevelik odmerek, tako kot pri drugih NSAR, toksičen za prebavila, ledvica ali jetra.
Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class.
Robenakoksib je nesteroidno antirevmatično zdravilo (NSAR), ki pripada skupini koksibov.
COX-2 is the inducible form of the enzyme and is responsible for the production of mediators including PGE2 which induce pain, inflammation or fever.
COX- 2 je inducibilna oblika encima, ki je odgovorna za sintezo mediatorjev, vključno s PGE2, ki inducirajo bolečino, vnetje ali povišano telesno temperaturo.
In an in vitro whole blood assay in dogs, robenacoxib was approximately 140 fold selective for COX- 2 (IC50 0.04 µM) as compared to COX-1 (IC50 7.9 µM).
Raziskave celokupne krvi pri psih in vitro so pokazale, da deluje robenakoksib približno 140 krat bolj selektivno na COX- 2 (IC50 0, 04 µM) kot na COX- 1 (IC50 7, 9 µM).
Robenacoxib tablets are therefore COX-1 sparing at recommended doses in dogs.
Pri psih so peroralni odmerki robenakoksiba od 0, 5 do 4 mg/ kg telesne mase povzročili vidno inhibicijo COX- 2 aktivnosti, medtem ko na COX- 1 aktivnost niso vplivali, kar pomeni, da so robenakoksib tablete v priporočenih odmerkih za COX- 1 pri psih manj škodljive.
Robenacoxib had analgesic and anti-inflammatory actions in an inflammation model in dogs with single oral doses ranging from 0.5 to 8 mg/ kg, with an ID50 of 0.8 mg/ kg and a rapid onset of action (0.5 h).
Pri vnetnem modelu pri psih so enkratni peroralni odmerki robenakoksiba od 0, 5 do 8 mg/ kg telesne mase z ID50 0, 8 mg/ kg učinkovali hitro protibolečinsko in protivnetno (0, 5 h).
In clinical trials robenacoxib reduced the lameness and inflammation of dogs with chronic osteoarthritis and reduced pain and inflammation after orthopaedic or soft tissue surgery in dogs.
V kliničnih poskusih je robenakoksib zmanjšal šepavost in vnetje pri psih s kroničnim osteoartritisom ter zmanjšal bolečino in vnetje pri psih po ortopedskih operativnih posegih in operativnih posegih na mehkih tkivih.
Absorption After oral administration of robenacoxib flavoured tablets at 1 mg/ kg without food, peak blood concentrations are attained rapidly with a Tmax of 0.5 h, a Cmax of 1124 ng/ ml and an AUC of 1249 ng. h/ ml.
Absorpcija Po peroralnem vnosu aromatiziranih tablet robenakoksiba v priporočenem odmerku 1 mg/ kg telesne mase brez hrane je bila maksimalna koncentracija v plazmi (Cmax 1124 ng/ ml) dosežena v 0, 5 ure (Tmax), površina pod krivuljo koncentracije v plazmi v odvisnosti od časa (AUC) je znašala 1249 ng. h/ ml.
Co-administration of robenacoxib non-flavoured tablets with food produced no delay in Tmax, but slightly lower values for Cmax (832 ng/ ml) and AUC (782 ng. h/ ml).
Vnos nearomatiziranih tablet robenakoksiba s hrano ni povzročilo nobenih sprememb pri Tmax (0, 5 h), pač pa malo nižjo koncentracijo Cmax (832 ng/ ml) in AUC (782 ng. h/ ml).
The systemic bioavailability of robenacoxib tablets in dogs was 62% with food and 84% without food.
Sistemska biorazpoložljivost tablet robenakoksiba pri psih je bila s hrano 62% in brez hrane 84%.
Distribution Robenacoxib has a relatively small volume of distribution (Vss 240 ml/ kg) and is highly bound to plasma proteins (> 99%).
Porazdelitev Robenakoksib ima razmeroma majhno prostornino porazdelitve (Vss 240 ml/ kg) in se zelo dobro veže na plazemske proteine (> 99%).
Biotransformation Robenacoxib is extensively metabolised by the liver in dogs.
Presnavljanje Robenakoksib se pri psih presnavlja večinoma v jetrih.
Apart from one lactam metabolite, the identity of other metabolites is not known in dogs.
Identiteta presnovkov pri psih, razen enega izmed laktamskih, ni znana.
After oral administration of the tablets, the terminal half-life in blood was 1.2 h.
Po peroralnem vnosu tablet je končni razpolovni čas 1, 2 h.
Robenacoxib is excreted predominately via the biliary route (∼ 65%) and the remainder via the kidneys.
Pretežno se izloča z žolčem (∼65%), preostali del pa preko ledvic.
Repeated oral administration of robenacoxib to dogs at dosages of 2 -10 mg/ kg for 6 months produced no change in the blood profile, with neither accumulation of robenacoxib nor enzyme induction.
Ponavljajoče se 6 mesecev trajajoče peroralno prejemanje robenakoksiba v priporočenih odmerkih 2- 10 mg/ kg telesne mase pri psih ni povzročilo sprememb v krvni sliki, akumulacije robenakoksiba ali indukcije encimov.
The pharmacokinetics of robenacoxib do not differ between male and female dogs, and are linear over the range 0.5-8 mg/ kg.
Farmakokinetika robenakoksiba se med psicami in psi ne razlikuje ter je pri odmerkih od 0, 5- 8 mg/ kg telesne mase linearna.
Yeast powder Cellulose, microcrystalline Flavour, artificial beef Cellulose, powdered Povidone (K-30) Crospovidone Silica, colloidal anhydrous Magnesium stearate
Kvas v prahu Mikrokristalna celuloza Umetna goveja aroma Celuloza, uprašena Povidon (K- 30) Krospovidon Brezvodni koloidni silicijev dioksid Magnezijev stearat
Cardboard box containing 1, 2, 4 or 10 Alu/ Alu blisters.
Kartonske škatle vsebujejo 1, 2, 4 ali 10 aluminijasto/ aluminijastih pretisnih omotov.
11 10 DATE OF REVISION OF THE TEXT
DATUM REVIZIJE BESEDILA
Onsior 20 mg/ ml solution for injection for cats and dogs
Onsior 20 mg/ ml raztopina za injiciranje za mačke in pse
Robenacoxib
Zdravilna učinkovina:
20 mg
Robenakoksib 20 mg
Sodium metabisulphite (E 223):
Natrijev metabisulfit (E 223):
Clear, colourless to slightly coloured (pink) liquid
Bistra, brezbarvna do rahlo obarvana (roza) tekočina
For the treatment of pain and inflammation associated with soft tissue surgery in cats.
Za zdravljenje bolečine in vnetja v povezavi z operativnimi posegi na mehkih tkivih pri mačkah.
Special precautions for use in animals The safety of the veterinary medicinal product has not been established in cats less than 4 months of age and in dogs less than 2 months of age, or in cats or dogs less than 2.5 kg body weight.
Varnost zdravila ni bila dokazana za mačke, mlajše od 4 mesecev in pse, mlajše od 2 mesecev oziroma za mačke ali pse, lažje od 2, 5 kg telesne mase.
Use in animals with impaired cardiac, renal or hepatic function or that are dehydrated, hypovolaemic or hypotensive may involve additional risks.
13 Uporaba pri živalih z oslabljenim srčnim, ledvičnim ali jetrnim delovanjem oziroma pri dehidriranih, hipovolemičnih ali hipotenzivnih živalih predstavlja dodatno tveganje.
If use cannot be avoided, these animals require careful monitoring and fluid therapy.
Če se uporabi v takih primerih ne morete izogniti, potrebujejo živali strog veterinarski nadzor in tekočinsko terapijo.
13 Use this veterinary medicinal product under strict veterinary monitoring in cases at risk of gastrointestinal ulceration, or if the animal previously displayed intolerance to other NSAIDs.
Pri živalih s tveganjem za nastanek razjed v prebavilih oziroma z znano preobčutljivostjo na druge NSAR uporabite to zdravilo pod strogim veterinarskim nadzorom.
Wash hands and exposed skin immediately after use of the product
Umijte si roke in izpostavljeno kožo takoj po uporabi zdravila.
In case of accidental ingestion or self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega zaužitja ali samo- injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
For pregnant women, particularly near term pregnant women, accidental injection and prolonged dermal exposure increases the risk for premature closure of the ductus arteriosus in the foetus.
Pri nosečnicah, zlasti blizu porodnega termina, nenamerno injiciranje in dolgotrajno izpostavljanje kože poveča tveganje za predčasno zaprtje duktusa arteriozusa pri plodu.
4..6 Adverse reactions (frequency and seriousness)*
4. 6 Neželeni učinki (pogostost in resnost) *
Gastrointestinal adverse events (such as vomiting) were very commonly reported, but most cases were mild and recovered without treatment.
Neželeni učinki na prebavilih (kot je bruhanje) so bili opisani zelo pogosto, vendar so bili v večini primerov blagi in so se popravili brez zdravljenja.
Diarrhoea or vomiting with blood were uncommon..
Driska in bruhanje s prisotnostjo krvi sta bila manj pogosta.
Slight pain at injection was very commonly reported.
Rahla bolečina ob injiciranju je bila opisana zelo pogosto.
Moderate or severe pain at injection was commonly reported.
Zmerna ali huda bolečina ob injiciranju je bila opisana pogosto.
Gastrointestinal adverse events (such as vomiting) were commonly reported but most cases were mild and recovered without treatment.
Neželeni učinki na prebavilih (kot je bruhanje) so bili opisani pogosto, vendar so bili v večini primerov blagi in so se popravili brez zdravljenja.
Slight pain at injection was commonly reported.
Rahla bolečina ob injiciranju je bila opisana pogosto.
Moderate or severe pain at injection was uncommon.
Zmerna ali huda bolečina ob injiciranju je bila manj pogosta.
Do not use in pregnant and lactating animals because the safety of robenacoxib has not been established during pregnancy and lactation or in cats and dogs used for breeding.
Ne uporabite pri mačkah in psicah v obdobju brejosti in laktacije oziroma pri mačkah in psicah, namenjenih za razplod, ker varnost robenakoksiba pri teh živalih ni bila ugotovljena.
As anaesthetics may affect renal perfusion, the use of parenteral fluid therapy during surgery should be considered to decrease potential renal complications when using NSAIDs peri-operatively.
14 Ker lahko anestetiki vplivajo na ledvični pretok, je potrebno pri perioperativni uporabi NSAR premisliti o uporabi parenteralne tekočinske terapije med operativnim posegom za zmanjšanje potencialnih ledvičnih komplikacij.
14 Concurrent use of other active substances that have a high degree of protein binding may compete with robenacoxib for binding and thus lead to toxic effects.
Ob sočasni uporabi drugih zdravilnih učinkovin, ki se dobro vežejo na plazemske proteine, lahko pride do tekmovalnosti z robenakoksibom pri vezavi in posledično do toksičnih učinkov.
Administer subcutaneously to cats or dogs approximately 30 minutes before the start of surgery, for example around the time of induction of general anaesthesia, at a dose of 1 ml per 10 kg of body weight (2 mg/ kg).
Dajte subkutano mačkam ali psom, približno 30 minut pred začetkom operativnega posega, npr. v času uvajanja splošne anestezije, v odmerku 1 ml na 10 kg telesne mase (2 mg/ kg).
In healthy young dogs aged 6 months, once daily subcutaneous administration of robenacoxib at doses of 2 (recommended therapeutic dose; RTD), 6 (3 times RTD), and 20 mg/ kg (10 times RTD) for 9 administrations over a 5 week period (3 cycles of 3 consecutive once daily injections) did not produce any signs of toxicity, including no gastrointestinal, kidney or liver toxicity and no effect on bleeding time.
Pri zdravih psih, starih 6 mesecev, se po 5 tednih subkutanega prejemanja 9 odmerkov (3 ciklov 3 zaporednih injekcij enkrat dnevno) robenakoksiba v odmerkih 2 mg/ kg (priporočen terapevtski odmerek; PTO), 6 mg/ kg (3 kratni PTO) in 20 mg/ kg (10 kratni PTO) znaki toksičnosti na prebavilih, ledvicah ali jetrih niso pojavili in ni bilo vpliva na čas krvavitve.
Reversible inflammation at the injection site was noted in all groups (including controls) and was more severe in the 6 and 20 mg/ kg dose groups.
Na vbodnih mestih je bilo pri vseh skupinah, vključno s kontrolnimi, opaziti vnetje (močneje pri skupinah z odmerkoma 6 mg/ kg in 20 mg/ kg), ki je bilo reverzibilno.
In healthy young cats aged 10 months, once daily subcutaneous administration of robenacoxib at doses of 4 mg/ kg (twice RTD) for 2 consecutive days and 10 mg/ kg (5 times RTD) for 3 consecutive days did not produce any signs of toxicity, including no signs of gastrointestinal, kidney or liver toxicity and no effect on bleeding time.
Pri zdravih mačkah, starih 10 mesecev, se po 2 zaporednih dnevih subkutanega prejemanja robenakoksiba v odmerku 4 mg/ kg (2 kratnega PTO) enkrat dnevno in po 3 zaporednih dnevih subkutanega prejemanja robenakoksiba v odmerku 10 mg/ kg (5 kratnega PTO) enkrat dnevno, znaki toksičnosti na prebavilih, ledvicah ali jetrih niso pojavili in ni bilo vpliva na čas krvavitve.
Reversible, minimal injection site reactions were noted in both dose groups.
Pri obeh skupinah je bilo opaziti minimalno reakcijo na vbodnem mestu, ki je bila reverzibilna.
As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised animals.
Pri občutljivih ali ogroženih živalih je lahko prevelik odmerek, tako kot pri drugih NSAR, toksičen za prebavila, ledvica ali jetra.
Anti-inflammatory and antirheumatic products, non-steroids, coxibs.
Protivnetna in antirevmatična zdravila, nesteroidi, koksibi.
In cats, using an in vitro whole blood assay, robenacoxib was approximately 500 fold selective for COX-2 (IC50 0.058 µM) as compared to COX-1 (IC50 28.9 µM).
15 Raziskave celokupne krvi in vitro pri mačkah so pokazale, da deluje robenakoksib 500 krat bolj selektivno na COX- 2 (IC50 0, 058 µM) kot na COX- 1 (IC50 28, 9 µM).
In vivo, robenacoxib solution for injection produced marked inhibition of COX-2 activity and had no effect on COX-1 activity.
In vivo so priporočeni odmerki robenakoksib raztopine za injiciranje povzročili vidno inhibicijo COX- 2 aktivnosti, medtem ko na COX- 1 aktivnost niso vplivali.
At the recommended dosage (2 mg/ kg), analgesic, anti-inflammatory and anti-pyretic effects were demonstrated in an inflammation model, and in clinical trials, robenacoxib reduced pain and inflammation in cats undergoing soft tissue surgery.
V priporočenem odmerku 2 mg/ kg so bili pri vnetnem modelu vidni analgetični, protivnetni in antipiretični učinki, v kliničnih poskusih pa je robenakoksib zmanjšal bolečino in vnetje pri mačkah podvrženim operativnim posegom na mehkih tkivih.
15 In dogs, robenacoxib was in vitro approximately 140 fold selective for COX-2 (IC50 0.04 µM) as compared to COX-1 (IC50 7.9 µM).
Pri psih je robenakoksib in vitro deloval 140 krat bolj selektivno na COX- 2 (IC50 0, 04 µM) kot na COX- 1 (IC50 7, 9 µM).
In vivo, robenacoxib solution for injection produced marked inhibition of COX-2 activity and had no effect on COX-1 activity.
In vivo je robenakoksib raztopina za injiciranje povzročila vidno inhibicijo COX- 2 aktivnosti, medtem ko na COX- 1 aktivnost ni vplivala.
At dosages ranging from 0.25 to 4 mg/ kg, robenacoxib had analgesic, anti-inflammatory and anti-pyretic effects in an inflammation model with a rapid onset of action (1 h).
V odmerkih od 0, 25 do 4 mg/ kg je robenakoksib pri vnetnem modelu učinkoval hitro (1 h) protibolečinsko, protivnetno in antipiretično.
In clinical trials at the recommended dose (2 mg/ kg), robenacoxib reduced pain and inflammation in dogs undergoing orthopaedic or soft tissue surgery.
5. 2 Farmakokinetični podatki
Absorption Peak blood concentrations of robenacoxib are attained rapidly after subcutaneous injection in cats and dogs.
Absorpcija Po subkutanem injiciranju robenakoksiba so bile pri mačkah in pri psih maksimalne koncentracije v plazmi hitro dosežene.
After a dosage of 2 mg/ kg a Tmax of 1 h (cats and dogs), a Cmax of 1464 ng/ ml (cats) and 615 ng/ ml (dogs), and an AUC of 3128 ng. h/ ml (cats) and 2180 ng. h/ ml (dogs) is obtained.
Pri odmerku 2 mg/ kg je bila maksimalna koncentracija v plazmi (Cmax 1464 ng/ ml pri mačkah in 615 ng/ ml pri psih) dosežena v 1 uri (Tmax), površina pod krivuljo koncentracije v plazmi v odvisnosti od časa (AUC) pa je znašala pri mačkah 3128 ng. h/ ml in pri psih 2180 ng. h/ ml.
After a subcutaneous administration of 1 mg/ kg the systemic bioavailability is 69% in cats and 88% in dogs.
Po subkutanem injiciranju robenakoksiba 1 mg/ kg je bila sistemska biorazpoložljivost pri mačkah 69% in pri psih 88%.
Distribution Robenacoxib has a relatively small volume of distribution (Vss of 190 ml/ kg in cats and 240 ml/ kg in dogs) and is highly bound to plasma proteins (> 99%).
Porazdelitev Robenakoksib ima razmeroma majhno prostornino porazdelitve (Vss 190 ml/ kg pri mačkah in Vss 240 ml/ kg pri psih) in se zelo dobro veže na plazemske proteine (> 99%).
Biotransformation Robenacoxib is extensively metabolised by the liver in cats and dogs.
Presnavljanje Robenakoksib se pri mačkah in psih presnavlja večinoma v jetrih.
Apart from one lactam metabolite, the identity of other metabolites is not known in cats or dogs.
Identiteta presnovkov pri mačkah in psih, razen enega izmed laktamskih, ni znana.
Elimination After intravenous administration robenacoxib was rapidly cleared from blood (CL of 0.44 L/ kg/ h in cats and 0.81 L/ kg/ h in dogs) with an elimination t1/ 2 of 1.1 h in cats and 0.8 h in dogs.
Izločanje Robenakoksib se po intravenozni aplikaciji hitro izloča iz plazme, njegov plazemski očistek je pri mačkah CL 0, 44 L/ kg/ h in pri psih 0, 81 L/ kg/ h, razpolovni čas t1/ 2 1, 1 h pri mačkah in 0, 7 h pri psih.
After subcutaneous administration, the terminal half-life from blood was 1.1 h in cats and 1.2 h in dogs.
Po subkutanem injiciranju je končni razpolovni čas 1, 1 h pri mačkah in 1, 2 h pri psih.
Robenacoxib persists longer and in higher concentrations at sites of inflammation than in blood.
Na vnetnih mestih ostaja robenakoksib dlje časa in v višjih koncentracijah kot v plazmi.
Robenacoxib is excreted predominately via the biliary route in cats (∼ 70%) and dogs (∼ 65%) and the remainder via the kidneys.
Pretežno se izloča z žolčem pri mačkah (∼70%) in pri psih (∼65%), preostali del pa preko ledvic.
Repeated subcutaneous administration at dosages of 2 -20 mg/ kg produced no change in the blood profile, with neither bioaccumulation of robenacoxib nor enzyme induction.
Ponavljajoče se subkutano injiciranje odmerkov 2- 20 mg/ kg ni povzročilo sprememb v krvni sliki, bioakumulacije robenakoksiba oziroma indukcije encimov.
The pharmacokinetics of robenacoxib injection do not differ between male and female cats and dogs, and are linear over the range of 0.25-4 mg/ kg in dogs.
Farmakokinetika injiciranega robenakoksiba se med mačkami in psi ženskega in moškega spola ne razlikuje ter je pri psih pri odmerkih 0, 25- 4 mg/ kg linearna.
Macrogol 400 Ethanol, anhydrous Poloxamer 188 Citric acid monohydrate Sodium metabisulphite (E 223) Sodium hydroxide Water for injections
Makrogol 400 Etanol, brezvodni Poloksamer 188 Citronska kislina monohidrat Natrijev metabisulfit (E 223) Natrijev hidroksid Voda za injekcije
6.2 Incompatibilities
16 6. 2 Inkompatibilnosti
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Zaradi odsotnosti študij o kompatibilnosti se naj to zdravilo ne meša z drugimi zdravili.
Shelf life after first broaching of the vial:
Rok uporabnosti po prvem odpiranju viale:
Keep the vial in the outer carton.
Hranite vialo v zunanji ovojnini.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalcev zdravila, odgovornih za sproščanje serije
26 Rue de la Chapelle F-68330 Huningue France.
26 Rue de la Chapelle F- 68330 Huningue Francija
Vericore Ltd., Kinnoull Road Kingsway West Dundee DD2 3XR United Kingdom
Vericore Ltd., Kinnoull Road Kingsway West Dundee DD2 3XR Velika Britanija
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
21 PODATKI NA ZUNANJI OVOJNINI
NATURE/ TYPE:
VRSTA/ TIP:
Cardboard box
Kartonska škatla
Each tablet contains 6 mg Robenacoxib
Vsaka tableta vsebuje 6 mg robenakoksiba
7 tablets 14 tablets 70 tablets
7 tablet 14 tablet 70 tablet
EXP {month/ year}
Uporabno do {mesec/ leto}
Store below 30°C
Shranjujte pri temperaturi do 30°C
Read Package leaflet.
Preberite navodilo za uporabo.
Frimley Business Park Frimley/ Camberley, Surrey, GU16 7SR United Kingdom
Frimley Business Park Frimley/ Camberley, Surrey, GU16 7SR Velika Britanija
EU/ 2/ 08/ 089/ 001 (7 tablets) EU/ 2/ 08/ 089/ 002 (14 tablets) EU/ 2/ 08/ 089/ 003 (70 tablets)
EU/ 2/ 08/ 089/ 001 (7 tablet) EU/ 2/ 08/ 089/ 002 (14 tablet) EU/ 2/ 08/ 089/ 003 (70 tablet)
Blister foil
Pretisni omot
24 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
24 PODATKI NA ZUNANJI OVOJNINI
Onsior 5 mg tablets for dogs Robenacoxib
Onsior 5 mg tablete za pse Robenakoksib
Each tablet contains 5 mg Robenacoxib
Vsaka tableta vsebuje 5 mg robenakoksiba
7 tablets 14 tablets 28 tablets 70 tablets
7 tablet 14 tablet 28 tablet 70 tablet
Read Package leaflet
Preberite navodilo za uporabo.
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
BESEDILO "ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ”
EU/ 2/ 08/ 089/ 004 (7 tablets) EU/ 2/ 08/ 089/ 005 (14 tablets) EU/ 2/ 08/ 089/ 006 (28 tablets) EU/ 2/ 08/ 089/ 007 (70 tablets)
EU/ 2/ 08/ 089/ 004 (7 tablet) EU/ 2/ 08/ 089/ 005 (14 tablet) EU/ 2/ 08/ 089/ 006 (28 tablet) EU/ 2/ 08/ 089/ 007 (70 tablet)
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
26 PODATKI NA ZUNANJI OVOJNINI
Onsior 10 mg tablets for dogs Robenacoxib
Onsior 10 mg tablete za pse Robenakoksib
Each tablet contains 10 mg Robenacoxib
Vsaka tableta vsebuje 10 mg robenakoksiba
EU/ 2/ 08/ 089/ 008 (7 tablets) EU/ 2/ 08/ 089/ 009 (14 tablets) EU/ 2/ 08/ 089/ 010 (28 tablets) EU/ 2/ 08/ 089/ 011 (70 tablets)
EU/ 2/ 08/ 089/ 008 (7 tablet) EU/ 2/ 08/ 089/ 009 (14 tablet) EU/ 2/ 08/ 089/ 010 (28 tablet) EU/ 2/ 08/ 089/ 011 (70 tablet)
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
28 PODATKI NA ZUNANJI OVOJNINI
Onsior 20 mg tablets for dogs Robenacoxib
Onsior 20 mg tablete za pse Robenakoksib
Each tablet contains 20 mg Robenacoxib
Vsaka tableta vsebuje 20 mg robenakoksiba
EU/ 2/ 08/ 089/ 012 (7 tablets) EU/ 2/ 08/ 089/ 013 (14 tablets) EU/ 2/ 08/ 089/ 014 (28 tablets) EU/ 2/ 08/ 089/ 015 (70 tablets)
EU/ 2/ 08/ 089/ 012 (7 tablet) EU/ 2/ 08/ 089/ 013 (14 tablet) EU/ 2/ 08/ 089/ 014 (28 tablet) EU/ 2/ 08/ 089/ 015 (70 tablet)
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
30 PODATKI NA ZUNANJI OVOJNINI
Onsior 40 mg tablets for dogs Robenacoxib
Onsior 40 mg tablete za pse Robenakoksib
Each tablet contains 40 mg Robenacoxib
Vsaka tableta vsebuje 40 mg robenakoksiba
EU/ 2/ 08/ 089/ 016 (7 tablets) EU/ 2/ 08/ 089/ 017 (14 tablets) EU/ 2/ 08/ 089/ 018 (28 tablets) EU/ 2/ 08/ 089/ 019 (70 tablets)
EU/ 2/ 08/ 089/ 016 (7 tablet) EU/ 2/ 08/ 089/ 017 (14 tablet) EU/ 2/ 08/ 089/ 018 (28 tablet) EU/ 2/ 08/ 089/ 019 (70 tablet)
35 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
35 PODATKI, KIMORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
36 PODATKI NA ZUNANJI OVOJNINI
Onsior 20 mg/ ml solution for injection for cats and dogs Robenacoxib
Onsior 20 mg/ ml raztopina za injiciranje za mačke in pse Robenakoksib
20 mg/ ml Robenacoxib 1 mg/ ml Sodium metabisulphite (E 223)
20 mg/ ml robenakoksiba 1 mg/ ml natrijevega metabisulfita (E 223)
EXP {month/ year} Once broached, use within 28 days by …
Uporabno do {mesec/ leto} Odprto zdravilo uporabite v 28 dneh do …
EXP {month/ year} Once broached, use by …
Uporabno do{ mesec/ leto} Odprto zdravilo uporabite do …
40 PACKAGE LEAFLET FOR:
40 NAVODILO ZA UPORABO ZA: