FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetic parameters display variable dependency on dose and vary slightly between the first and the second three week treatment periods of a complete treatment schedule.
Slovenian: Farmakokinetični parametri kažejo na spremenljivo odvisnost od odmerka ter se med prvim in drugim tritedenskim obdobjem celotnega režima zdravljenja rahlo spreminjajo.
English: Typically, these findings normalised, or appeared to be reversing, within two weeks following the end of treatment.
Slovenian: Po navadi so se ti izvidi normalizirali ali so kazali na reverzibilnost v dveh tednih po zaključku zdravljenja.
English: In clinical trials, treated animals rapidly regained weight following cessation of treatment when diet was not restricted.
Slovenian: V kliničnih preskušanjih so zdravljene živali po prekinitvi zdravljenja hitro pridobile telesno težo, če se prehrana ni omejila.
English: This is related to the mode of action of the product and should not be considered as an adverse reaction unless it becomes very significant.
Slovenian: To je povezano z načinom delovanja zdravila in ni neželeni učinek, razen če postane zelo izrazit.
English: Mitratapide and its metabolites bind very extensively (> 99 %) to plasma proteins and distribute to the tissues.
Slovenian: Mitratapid in njegovi presnovki se večinoma (> 99 %) vežejo na beljakovine v plazmi in porazdelijo v tkivih.
English: Mitratapide therapy should be restricted to one treatment course for an individual dog.
Slovenian: Zdravljenje z mitratapidom je treba pri posameznem psu omejiti na en cikel.
English: Do not use in dogs in which overweight or obesity is caused by a concomitant systemic disease such as hypothyroidism or hyperadrenocorticism.
Slovenian: Ne uporabite pri psih, pri katerih čezmerno težo ali adipoznost povzroča sočasna sistemska bolezen, kot je hipotiroidizem ali hiperadrenokorticizem.
English: Fill the syringe by pulling the plunger until it reaches the mark on the dosing pipette corresponding to the correct body weight of the dog.
Slovenian: Brizgo napolnite z vlečenjem bata, dokler ne doseže oznake na pipeti za odmerjanje, ki ustreza telesni teži psa.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Janssen Pharmaceutica N.V.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Janssen Pharmaceutica N.V.
English: This is related to the mode of action of the product and should not be considered as a side effect, unless it becomes very significant (this is when your dog stops eating for two consecutive days).
Slovenian: To je povezano z načinom delovanja zdravila in ni neželeni učinek, razen če postane zelo izrazit (to pomeni, da pes v dveh zaporednih dneh odklanja hrano);
English: Butylated hydroxyanisole (E 320) 2 mg/ml For a full list of excipients, see section 6.1
Slovenian: Butiliran hidroksianizol (E 320) 2 mg/ml Celoten seznam pomožnih snovi, glejte razdelek 6.1.
English: Therefore, for dogs receiving treatments in addition to the product, drug interactions should be monitored closely.
Slovenian: Zato je treba pri psih, ki poleg zdravljenja s tem zdravilom prejemajo tudi druga zdravila, skrbno spremljati njihove interakcije.
English: Day 22-35
Slovenian: 22.-35. dan
English: If accidental eye contact occurs, flush immediately with copious amounts of water.
Slovenian: Če pride do naključnega stika z očmi, takoj sperite z veliko količino vode.
English: The use in dogs for breeding purposes has not been evaluated.
Slovenian: Uporabe pri psih za namene razmnoževanja niso ocenili.
English: Placebo vomiting : occasional ( 3x) vomiting : repeated (> 3 x) diarrhoea / soft stools anorexia / decreased appetite lethargy / weakness * data from 360 dogs over the whole treatment period.
Slovenian: Placebo bruhanje: občasno (≤ 3-krat) bruhanje: ponavljajoče (> 3-krat) driska/mehko blato anoreksija/zmanjšan tek letargija/šibkost * Podatki za 360 psov za celotno obdobje zdravljenja.
English: Do not use after the expiry date stated on the label and carton (EXP.).
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki in škatli (EXP).
English: Following oral administration, the bioavailability of mitratapide (parent compound and metabolites) is in the range from 55 to 69%, the volume of distribution is approximately 5 l/kg.
Slovenian: Po peroralni uporabi je biološka uporabnost mitratapida (izvirne spojine in presnovkov) med 55 in 69 %, volumen distribucije pa približno 5 l/kg.
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli resne neželene učinke ali druge učinke, ki niso omenjeni v teh navodilih, obvestite svojega veterinarja.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Slovenian: BESEDILO "SAMO ZA ŽIVALI" IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
English: Butylated hydroxyanisole
Slovenian: Butiliran hidroksianizol
English: • if your dog is hypersensitive (allergic) to mitratapide or to any of the other ingredients.
Slovenian: • je preobčutljiv za (alergičen na) mitratapid ali katero koli sestavino;
English: A colourless to slightly yellow solution.
Slovenian: Brezbarvna do rahlo rumena raztopina.
English: Mitratapide 5 mg/ml
Slovenian: Mitratapid 5 mg/ml
English: Accumulation of triglycerides inside the enterocytes may be followed by decreased appetite.
Slovenian: Akumulaciji trigliceridov v enterocitih lahko sledi zmanjšan tek.
English: Sucralose
Slovenian: Sukraloza
English: In order to allow proper dosing, the dog should be weighed on day 1 and day 35 (this is at the start of each treatment period).
Slovenian: Da bi omogočili ustrezno odmerjanje, je treba psa stehtati prvi in 35. dan (na začetku vsakega obdobja zdravljenja).
English: Percentages of dogs per weight loss category for mitratapide versus placebo:
Slovenian: Odstotki psov na kategorijo izgube telesne teže za mitratapid v primerjavi s placebom:
English: US field trial pooled data weight loss category placebo mitratapide placebo mitratapide placebo mitratapide
Slovenian: Kategorija izgube telesne teže placebo mitratapid placebo mitratapid placebo mitratapid
English: Laboratory animals and dogs rapidly absorb orally administered mitratapide.
Slovenian: Pri laboratorijskih živalih in psih se peroralni odmerek mitratapida hitro absorbira.
English: The terminal plasma half-life is 6.3 hours for mitratapide, 9.8 hours and 11.7 hours for the sulphoxides, respectively, and 44.7 hours for the sulphone metabolite.
Slovenian: Končni razpolovni čas v plazmi za mitratapid je 6,3 ure, za sulfokside 9,8 in 11,7 ure ter 44,7 ure za presnovek sulfona.
English: Administration of mitratapide to dogs results in reduced uptake of dietary lipids, dose dependent decreases in serum cholesterol and triglyceride and an increased presence of triglyceride containing droplets in enterocytes.
Slovenian: Uporaba mitratapida pri psih povzroči zmanjšan privzem dietnih lipidov, zmanjšanje vrednosti holesterola in trigliceridov v serumu, odvisno od odmerka, in povečano prisotnost trigliceridov, ki vsebujejo kapljice v enterocitih.
English: Your veterinary surgeon should monitor closely the intake of any other medicines in addition to the product.
Slovenian: Veterinar mora skrbno spremljati sočasen vnos katerega koli drugega zdravila.
English: The pipette should be washed and dried and the cap should be screwed back on tightly.
Slovenian: Pipeto je treba oprati in posušiti ter spet tesno priviti pokrovček.
English: PACKAGE SIZE 120 ml
Slovenian: VELIKOST PAKIRANJA 120 ml
English: Shelf-life after first opening the container: 3 months.
Slovenian: Rok uporabnosti po prvem odpiranju vsebnika: 3 mesece.
English: In case of accidental overdosing, symptomatic therapy should be administered.
Slovenian: Če pride do naključnega prevelikega odmerjanja, je treba uvesti simptomatsko zdravljenje.
English: Where treatment is interrupted due to vomiting, it is recommended that when treatment is resumed, the product should be administered after a meal.
Slovenian: Kadar se zdravljenje prekine zaradi bruhanja, se priporoča, da se ob ponovnem začetku zdravljenja zdravilo daje po obroku.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE LABEL AMBER GLASS BOTTLE 120 and 210 ml
Slovenian: PODATKI, KI MORAJO BITI NAVEDENI NA STIČNI OVOJNINI NALEPKA NA RUMENORJAVI 120- IN 210-MILILITRSKI STEKLENIČKI
English: Therefore, administer the product with the syringe onto a portion of the food.
Slovenian: Zato zdravilo z brizgo nakapajte na del hrane.
English: In fed dogs, a single dose of 0.63 mg mitratapide/kg bodyweight results in maximum concentrations of the parent substance in plasma of on average 0.012 g/ml attained 3.5 hours after dosing; the sulphoxide metabolites reach maximum concentration of on average 0.0136 g/ml and 0.0168 g/ml, respectively after 6.5 hours and 8.5 hours; the sulphone metabolite reaches 0.0092 g/ml after 17.5 hours.
Slovenian: Pri hranjenih psih je enkratni odmerek 0,63 mg mitratapida/kg telesne teže povzročil največje koncentracije izvirne snovi v plazmi, katerih povprečje je 0,012 µg/ml, doseženo 3,5 ure po odmerjanju; presnovka sulfoksida največjo koncentracijo dosežeta po 6,5 ure, ko je njeno povprečje 0,0136 µg/ml, in 8,5 ure, ko je njeno povprečje 0,168 µg/ml; presnovek sulfona po 17,5 ure doseže koncentracijo 0,0092 µg/ml.
English: In most of the cases, these side effects are mild and do not last very long.
Slovenian: V večini primerov so ti neželeni učinki blagi in kratkotrajni.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/063/001-3
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/063/001-3
English: The absorption of lipid soluble drugs used concomitantly with mitratapide has not been investigated.
Slovenian: Absorpcije zdravil, topnih v lipidih, ki so se uporabila sočasno z mitratapidom, niso raziskali.
English: D. STATEMENT OF THE MRLs Not applicable.
Slovenian: D NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Navedba ni smiselna.
English: Do not use in dogs during pregnancy and lactation.
Slovenian: Ne uporabite pri psih med brejostjo in laktacijo.
English: Introducing appropriate lifestyle changes (e.g. increased exercise), in conjunction with this weight management programme, may provide additional benefits.
Slovenian: Dodatne koristi se lahko v kombinaciji s programom za obravnavo telesne teže dosežejo z uvajanjem ustreznih sprememb življenjskega sloga (npr. povečana telesna aktivnost).
English: In case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: Ob nenamerni samoaplikaciji se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
English: It is assumed that these effects are mediated by MTP inhibition at the level of the enterocyte.
Slovenian: Domnevajo, da je za te učinke odgovorno zaviranje MTP na stopnji enterocitov.
English: In order to allow proper dosing, the dog should be weighed on day 1 and on day 35 (i.e. at the start of each treatment period).
Slovenian: NASVET O PRAVILNI UPORABI ZDRAVILA Da bi omogočili ustrezno odmerjanje, je treba psa stehtati prvi dan in 35. dan (tj. na začetku vsakega obdobja zdravljenja).
English: Do not use in dogs with impaired liver function.
Slovenian: Ne uporabite pri psih s poslabšanim delovanjem jeter.
English: No drug interactions were observed in studies where Yarvitan was administered concomitantly with NSAIDs (carprofen, meloxicam) or ACE inhibitors (enalapril, benazepril).
Slovenian: V študijah, v katerih so zdravilo Yarvitan uporabili sočasno z nesteroidnimi protivnetnimi zdravili (karprofen, meloksikam) ali zaviralci ACE (enalapril, benazepril), niso opazili nobenih interakcij.
English: The usual dose is once daily 0.63 mg mitratapide/kg bodyweight (1 ml of the product per 8 kg).
Slovenian: Navadni odmerek je 0,63 mg mitratapida/kg telesne teže (1 ml zdravila na 8 kg) enkrat dnevno.
English: Use the dosing pipette as provided with the product.
Slovenian: Uporabite pipeto za odmerjanje, kot je navedeno v navodilih zdravila.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Slovenian: NAČIN IN POT(I) UPORABE Peroralno.
English: The following adverse reactions were observed during the clinical trials (pooled data*):
Slovenian: Med kliničnimi preskušanji (skupni podatki*) so ugotovili naslednje neželene učinke:
English: Yarvitan is a colourless to slightly yellow solution.
Slovenian: Yarvitan je brezbarvna do rahlo rumena raztopina.
English: • if overweight or obesity in your dog is caused by a concomitant systemic disease such as hypothyroidism (this is due to a malfunction of the thyroid gland) or hyperadrenocorticism.
Slovenian: • čezmerno težo ali adipoznost povzroča sočasna sistemska bolezen, kot je hipotiroidizem (ki je posledica okvarjenega delovanja ščitnice) ali hiperadrenokorticizem (ki je posledica okvarjenega delovanja nadledvične žleze).
English: After each dose, the pipette should be washed and dried and the bottle cap screwed back on tightly.
Slovenian: Po vsakem odmerjanju je treba pipeto oprati in posušiti ter spet tesno priviti pokrovček.
English: Administer orally once daily at 0.63 mg mitratapide/kg bodyweight (1 ml of the product per 8 kg) given for 2 periods of 21 days with 14 days without treatment in between.
Slovenian: Odmerjajte enkrat dnevno 0,63 mg mitratapida/kg telesne teže peroralno (1 ml zdravila na 8 kg) v dveh obdobjih po 21 dni, z vmesnim presledkom brez zdravljenja, ki traja 14 dni.
English: • up to 36 kg for the 55 ml bottle
Slovenian: • do 36 kg za 55-mililitrsko stekleničko;
English: The dosing pipette has a gradation in body weight:
Slovenian: Pipeta za odmerjanje ima lestvico, prilagojeno telesni teži:
English: Once opened, use within 3 months.
Slovenian: Odprto zdravilo uporabite v 3 mesecih.
English: At the end of a three week dosing period, mitratapide attains average steady-state concentrations of 0.0068 g/ml, the sulphoxide metabolites 0.0089 g/ml and 0.0167 g/ml, respectively, the sulphone 0.0471 g/ml.
Slovenian: Na koncu tritedenskega odmerjanja mitratapid doseže povprečne koncentracije dinamičnega ravnovesja 0,0068 µg/ml, presnovka sulfoksida 0,0089 µg/ml in 0,0167 µg/ml ter presnovek sulfona 0,0471 µg/ml.
English: Thereafter, your dog should follow a nutrition programme.
Slovenian: Potem se mora pes držati diete.
English: Vomiting, diarrhoea or softened stools may occur during treatment.
Slovenian: Med zdravljenjem se lahko pojavijo bruhanje, driska ali zmehčano blato.
English: Pack sizes - amber glass bottles containing : 55ml:  10 kg bodyweight, 120ml:  22 kg bodyweight, 210ml:  40 kg bodyweight.
Slovenian: Velikosti pakiranja - rumenorjave stekleničke, ki vsebujejo: 55 ml: ≤ 10 kg telesne teže, 120 ml: ≤ 22 kg telesne teže, 210 ml: ≤ 40 kg telesne teže.
English: To be used as part of an overall weight management programme which also includes appropriate dietary changes.
Slovenian: Uporablja se kot del skupne obravnave telesne teže, ki vključuje tudi spremembe prehrane.
English: Always administer Yarvitan exactly as your veterinary surgeon has instructed you.
Slovenian: Zdravilo Yarvitan vedno uporabljajte skladno z navodili veterinarja.
English: The treatment is part of an overall weight management programme which also includes a nutrition programme.
Slovenian: Zdravljenje je del skupne obravnave telesne teže, ki vključuje tudi spremembe prehrane.
English: MANUFACTURER'S BATCH NUMBER Lot:
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA Serija:
English: The following clinical signs were observed after 3 or 5 times overdosing in dogs: softened or liquid faeces, vomiting, salivation, anorexia, severe weight loss, emaciated appearance, dehydration and pale mucosae.
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Pri psih so po 3- do 5-kratnem prevelikem odmerjanju opazili naslednje klinične znake: zmehčano ali tekoče blato, bruhanje, slinjenje, anoreksija, huda izguba telesne teže, videz izčrpanosti, dehidracija in blede sluznice.
English: • up to 36 kg for the 120 ml bottle
Slovenian: • do 36 kg za 120-mililitrsko stekleničko;
English: INDICATION(S) As an aid in the management of overweight and obesity in adult dogs.
Slovenian: INDIKACIJA(E) Kot pripomoček pri obravnavi čezmerne teže in adipoznosti pri odraslih psih.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega za sprostitev serije
English: Excipient(s):
Slovenian: Pomožna(e) snov(i):
English: • up to 48 kg for the 210 ml bottle
Slovenian: • do 48 kg za 210-mililitrsko stekleničko.
English: 6.5 Nature and composition of immediate packaging 55, 120 or 210 ml amber glass bottle (type III) with a child resistant polypropylene closure and dosing pipette.
Slovenian: 55-, 120- ali 210-mililitrska rumenorjava steklenička (tipa III) s propilensko zaporko, varno za otroke, in pipeto za odmerjanje.
English: Yarvitan is indicated as an aid in the management of overweight and obesity in adult dogs.
Slovenian: Yarvitan je indiciran kot pripomoček pri obravnavi čezmerne teže in adipoznosti pri odraslih psih.
English: If vomiting, significantly reduced appetite or diarrhoea repeatedly occurs, treatment should be interrupted and the advice of a veterinarian should be sought.
Slovenian: Če se ponavljajo bruhanje, opazno zmanjšan tek ali driska, je treba zdravljenje prekiniti in se posvetovati z veterinarjem.
English: In order to avoid rebound weight gain, it is necessary to continue the feeding for maintenance regimen after the end of treatment with the product.
Slovenian: Da bi se izognili ponovnemu pridobivanju telesne teže, je pomembno, da psa po koncu zdravljenja hranite po vzdrževalnem režimu.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Slovenian: BESEDILO "SAMO ZA ŽIVALI" Samo za živali.
English: • softened stools
Slovenian: • zmehčano blato.
English: Loss of appetite may occur during treatment.
Slovenian: Med zdravljenjem se lahko pojavi izguba teka.
English: Read all of this leaflet carefully before you start administering the medicine to your dog:
Slovenian: Preden svojemu psu daste to zdravilo, natančno preberite navodilo:
English: In laboratory studies, decreases in serum albumin, globulin, total protein, calcium and alkaline phosphatase and increases in ALT and AST were detected following administration of the product at the recommended treatment dose.
Slovenian: V laboratorijskih študijah so po uporabi zdravila pri priporočenem odmerku opazili zmanjšanje vrednosti albumina, globulina, skupnih beljakovin, kalcija in alkalne fosfataze v serumu ter povečanje vrednosti ALT in AST.
English: A decreased appetite may occur during treatment.
Slovenian: Med zdravljenjem se lahko pojavi zmanjšanje teka.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Mitratapide 5 mg/ml
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Mitratapid 5 mg/ml
English: MARKETING AUTHORISATION NUMBER(S) EU/0/00/000/001
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/0/00/000/001
English: The dosing pipettes provided with the product show graduations corresponding to the correct body weight of the dog.
Slovenian: Pipete za odmerjanje, priložene zdravilu, imajo lestvico, prilagojeno ustrezni telesni teži psa.
English: You should check with your veterinary surgeon if you are unsure.
Slovenian: Če ste negotovi, se posvetujte z veterinarjem.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Yarvitan 5 mg/ml oral solution for dogs Mitratapide
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Yarvitan 5 mg/ml peroralna raztopina za pse Mitratapid
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Varnost zdravila med brejostjo in laktacijo ni bila dokazana.
English: In case an adverse reaction repeatedly occurs or in case the dog stops eating for two consecutive days, treatment should be interrupted and the advice of a veterinarian should be sought.
Slovenian: Če se neželeni učinek ponavlja ali če pes dva zaporedna dneva odklanja hrano, je treba zdravljenje prekiniti in se posvetovati z veterinarjem.
English: • vomiting
Slovenian: • bruhanje;
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Mitratapide 5 mg/ml
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGE(IH) SESTAVIN(E) Mitratapid 5 mg/ml
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Mitratapide 5 mg/ml
Slovenian: KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Mitratapid 5 mg/ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Yarvitan 5 mg/ml oral solution for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Yarvitan 5 mg/ml peroralna raztopina za pse
English: Do not administer Yarvitan:
Slovenian: Zdravila Yarvitan pri psu ne uporabljajte, če:
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
English: PACKAGE SIZE 55 ml:  10 kg BW 120 ml:  22 kg BW 210 ml:  40 kg BW
Slovenian: 120 ml: ≤ 22 kg telesne teže; 210 ml: ≤ 40 kg telesne teže.
English: • diarrhoea
Slovenian: • driska;
English: In case vomiting, diarrhoea, softening stools repeatedly occurs or in case the dog stops eating for two consecutive days, stop the administration of Yarvitan to your dog and seek the advice of your veterinary surgeon as soon as possible.
Slovenian: Če se bruhanje, driska, zmehčano blato ponavljajo ali če pes v dveh zaporednih dneh odklanja hrano, je treba zdravljenje psa z zdravilom Yarvitan prekiniti in se čim prej posvetovati z veterinarjem.
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Slovenian: BESEDILO "ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM"
English: Shelf-life of the veterinary medicinal product as packaged for sale: 3 years Shelf-life after first opening the immediate packaging: 3 months 6.4 Special precautions for storage
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 3 leti.
English: • if your dog has impaired liver function.
Slovenian: • ima poslabšano delovanje jeter;
English: ROUTE(S) OF ADMINISTRATION Oral use.
Slovenian: POT(I) UPORABE ZDRAVILA Peroralno.
English: After multiple dosing, the highest concentrations are present in the adrenal glands, liver, jejunum and kidney, but there is no exposure in the brain, excluding any central effect of the product.
Slovenian: Po večkratnem odmerjanju so največje koncentracije v nadledvični žlezi, jetrih, jejunumu in ledvicah.
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children.
Slovenian: BESEDILO "ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM" Zdravilo shranjujte nedosegljivo otrokom.
English: EU field trial
Slovenian: Terensko preskušanje v ZDA
English: MARKETING AUTHORISATION NUMBER(S) EU/0/00/000/002
Slovenian: ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVILA EU/0/00/000/002
English: In case a side effect repeatedly occurs or in case the dog stops eating for two consecutive days, stop the administration of Yarvitan to your dog and seek the advice of your veterinary surgeon as soon as possible.
Slovenian: Če se neželeni učinki ponavljajo ali če pes dva zaporedna dneva odklanja hrano, je treba zdravljenje psa z zdravilom Yarvitan prekiniti in se čim prej posvetovati z veterinarjem.
English: Tell your veterinary surgeon if you notice any of the following:
Slovenian: Če opazite katerega od spodnjih neželenih učinkov, obvestite svojega veterinarja:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA
English: PACKAGE LEAFLET Yarvitan 5 mg/ml oral solution for dogs
Slovenian: NAVODILO ZA UPORABO Yarvitan 5 mg/ml peroralna raztopina za pse
English: This is called ‘myeloablation'.
Slovenian: To se imenuje „mieloablacija“.