natgillin/translations-raw huggingface dataset:
Tabulated list of adverse reactions A tabulated list of frequencies was defined using the following convention: very common (≥1/10); common
Neželeni učinki v obliki preglednice so bili razvrščeni po naslednjem pogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki
This summary was last updated in 06-2008.
Povzetek je bil nazadnje posodobljen 07-2008.
The marketing authorisation was renewed on 29 July 2003 and on 29 July 2008.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 29. julija 2003 in 29. julija 2008.
Neither the patients nor the doctors knew which treatment each patient was taking until the end of the study.
Niti zdravniki niti bolniki do konca študije niso vedeli, katero zdravljenje bolniki prejemajo.
This helps weight reduction.
To pomaga pri zmanjševanju telesne mase.
It is available as turquoise capsules (120 mg).
Na voljo je v kapsulah turkizne barve (120 mg).
The food in the diet should be spread over three main meals.
Dietna prehrana mora biti porazdeljena med tri glavne obroke.
These symptoms generally occur at the beginning of treatment, and go away after some time.
Našteti simptomi se večinoma pojavijo na začetku zdravljenja in sčasoma izginejo.
The European Commission granted a marketing authorisation valid throughout the European Union for Xenical to Roche Registration Limited on 29 July 1998.
Evropska komisija je dovoljenje za promet z zdravilom Xenical, veljavno po vsej Evropski uniji, odobrila družbi Roche Registration Limited dne 29. julija 1998.
In all studies, the main measure of effectiveness was the change in weight.
V vseh študijah je bilo glavno merilo učinkovitosti sprememba telesne mase.
The patient should be on a diet in which about 30% of the calories come from fat, and which is rich in fruit and vegetables.
Bolnik mora biti na dieti, v kateri okoli 30 % kalorij izvira iz maščob in ki je bogata s sadjem in zelenjavo.
The effects of Xenical were first tested in experimental models before being studied in humans.
Učinki zdravila Xenical so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The body cannot use this dietary fat for energy or convert it into fat tissue.
Tega deleža maščob telo ne more uporabiti kot vira energije ali ga pretvoriti v maščobno tkivo.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) XENICAL EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) XENICAL Povzetek EPAR za javnost
When these enzymes are blocked, they cannot digest some fats in the diet, and this allows about 30% of the fat eaten in the meal to pass through the gut undigested.
Če so ti encimi blokirani, potem ne morejo razkrojiti nekaterih maščob, zaradi česar se približno 30 % maščob, zaužitih z hrano, izloči skozi črevo neprebavljenih.
Xenical is given as one capsule taken with water just before, during, or up to one hour after each main meal.
Bolnik zaužije eno kapsulo zdravila Xenical z vodo tik pred ali med vsakim glavnim obrokom ali do eno uro po njem.
What benefit has Xenical shown during the studies?
Kakšne koristi je zdravilo Xenical izkazalo med študijami?
The Committee recommended that Xenical be given marketing authorisation.
Zato je priporočil, da se za zdravilo Xenical odobri dovoljenje za promet.
If a meal is missed or contains no fat, Xenical should not be taken.
Če bolnik obrok izpusti ali če ta ne vsebuje maščob, naj bolnik zdravila Xenical ne vzame.
Xenical has been studied in seven main studies involving over 3,000 overweight or obese patients.
Zdravilo Xenical so preučevali v sedmih glavnih študijah, ki so vključevale več kot 3000 bolnikov s prekomerno telesno maso ali debelih bolnikov.
Xenical was more effective than placebo in producing a reduction in weight.
Zdravilo Xenical je bilo učinkovitejše od placeba pri zmanjševanju telesne mase.
Xenical should not be used in people who may be hypersensitive (allergic) to orlistat or any of the other ingredients.
Zdravila Xenical ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) orlistat ali katero koli drugo sestavino zdravila.
When the results from all seven shorter studies were taken together, patients taking 120 mg Xenical three times a day had an average fall of 6.1 kg in body weight after a year, compared with 2.6 kg in those taking placebo.
Ko so povzeli rezultate vseh sedmih krajših študij, so ugotovili, da so bolniki, ki so prejemali zdravilo Xenical 120 mg trikrat dnevno, v povprečju izgubili 6,1 kg telesne mase v letu dni, v primerjavi z 2,6 kg pri bolnikih, ki so prejemali placebo.
The most common side effects with Xenical (seen in more than 1 patient in 10) are influenza (flu), hypoglycaemia (low blood sugar levels), headache, upper respiratory infection (colds), oily spotting from the rectum, abdominal (tummy) pain or discomfort, flatus (gas) with discharge, faecal urgency (urgent need to open the bowels), fatty or oily stools, flatulence (gas), liquid stools, oily evacuation (faeces) and increased defecation.
Najpogostejši neželeni učinki zdravila Xenical (opaženi pri več kot 1 bolniku od 10) so gripa, hipoglikemija (nizke ravni sladkorja v krvi), glavobol, okužbe zgornjih dihal (prehladi), oljnati madeži iz danke, bolečina ali neugodje v trebuhu, napenjanje z izcedkom, siljenje na blato (nujna potreba po izpraznitvi črevesa), mastno ali oljnato blato, napenjanje (vetrovi), tekoče blato, oljnat izcedek (blato) in pogostnejše iztrebljanje.
Xenical is a medicine containing the active substance orlistat.
Xenical je zdravilo, ki vsebuje zdravilno učinkovino orlistat.
Orlistat blocks gastrointestinal lipases (enzymes that digest fat).
Orlistat blokira lipaze v prebavilih (encime, ki presnavljajo maščobe).
The proportion of patients losing 10% or more of their body weight was 20% in the patients taking this dose of Xenical and 8% in those taking placebo.
Delež bolnikov, ki so izgubili 10 % ali več svoje telesne mase, je bil 20 % pri bolnikih, ki so prejemali odmerek zdravila Xenical, in 8 % pri bolnikih, ki so prejemali placebo.
The active ingredient in Xenical, orlistat, is an anti-obesity medicine, which does not affect appetite.
Zdravilna učinkovina v zdravilu Xenical, orlistat, je zdravilo proti debelosti, ki ne vpliva na tek.
At the end of the four-year study, 21% of the patients treated with Xenical had lost more than 10% of their body weight, compared with 10% of the patients who received placebo.
Na koncu štiriletne študije je 21 % bolnikov, ki so bili zdravljeni z zdravilom Xenical, izgubilo več kot 10 % svoje telesne mase v primerjavi z 10 % bolnikov, ki so prejemali placebo.
What is the risk associated with Xenical?
Kakšna tveganja so povezana z zdravilom Xenical?
Why has Xenical been approved?
Zakaj je bilo zdravilo Xenical odobreno?
For the full description of all side effects reported with Xenical, see the Package Leaflet.
Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Xenical, glejte navodilo za uporabo.
It should also not be used in people with a long-term malabsorption disease (where nutrients from the food are not easily absorbed during digestion), with cholestasis (a liver disorder) or who are breast-feeding.
Zdravila prav tako ne smejo uporabljati osebe z dolgotrajno malabsorpcijsko boleznijo (slabo absorpcijo hranilnih snovi iz hrane med prebavljanjem), osebe s holestazo (motnjo delovanja jeter) ali doječe matere.
The studies lasted from one to two years and compared three different doses of Xenical with placebo (a dummy treatment), in combination with dieting.
V teh študijah, ki so potekale od enega do dveh let, so primerjali tri različne odmerke zdravila Xenical s placebom (zdravilom brez zdravilne učinkovine) v kombinaciji z dieto.
Xenical is used together with dieting for the treatment of obese (very overweight) patients with a body mass index (BMI) greater than or equal to 30 kg per square metre, or overweight patients (BMI greater than or equal to 28 kg/m2) who are at risk of illness because of their weight.
Zdravilo Xenical se hkrati z dieto uporablja za zdravljenje debelosti (izrazito prevelike telesne mase) pri bolnikih z indeksom telesne mase (ITM) 30 kg na kvadratni meter ali več ter pri bolnikih s preveliko telesno maso (ITM večji od ali enak 28 kg/m²), katerih zdravje je ogroženo zaradi njihove teže.
The Committee for Medicinal Products for Human Use (CHMP) decided that Xenical's benefits are greater than its risks in conjunction with a mildly hypocalorific diet for the treatment of obese patients with a BMI greater or equal to 30 kg/m2, or overweight patients (BMI ≥ 28 kg/m2) with associated risk factors.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Xenical v kombinaciji z zmerno nizkokalorično dieto za zdravljenje debelosti pri bolnikih z indeksom telesne mase 30 kg/m² ali več ali pri bolnikih s preveliko telesno maso (ITM ≥ 28 kg/m2) in hkratnimi ogrožajočimi dejavniki večje od z njim povezanih tveganj.
The full EPAR for Xenical can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Xenical je na voljo tukaj.
Other information about Xenical:
Druge informacije o zdravilu Xenical?
What is Xenical used for?
Za kaj se zdravilo Xenical uporablja?
How has Xenical been studied?
Kako je bilo zdravilo Xenical raziskano?
How is Xenical used?
Kako se zdravilo Xenical uporablja?
Treatment with Xenical should be stopped after 12 weeks if patients have been unable to lose at least 5% of their body weight since the start of treatment.
Če se telesna masa bolnika po 12 tednih ne zmanjša vsaj za 5 % izhodiščne telesne mase, je treba zdravljenje z zdravilom Xenical ukiniti.
obese patients compared the effects of Xenical and placebo over four years, in combination with diet and exercise.
V dodatni daljši študiji, ki je obsegala več kot 3000 debelih bolnikov in je trajala štiri leta, so primerjali učinke zdravila Xenical in placeba v kombinaciji z dieto in telesno aktivnostjo.
What is Xenical?
Kaj je zdravilo Xenical?
How does Xenical work?
Kako zdravilo Xenical deluje?
DO NOT USE EXCESSIVE FORCE.
NE UPORABLJAJTE PRETIRANE SILE.
These are generally transient.
Ti učinki so običajno prehodni.
ATC vet code: QA16QA06
Oznaka ATC vet: QA16QA06
Follow instructions carefully.
Skrbno upoštevajte navodila.
Elanco France S.A.S 26 Rue de la Chapelle 68330 Huningue France
Elanco France S.A.S 26 Rue de la Chapelle 68330 Huningue Francija
If resistance is encountered, withdraw the tool slightly and repeat the procedure.
Če se pojavi upor, orodje nekoliko izvlecite in ponovite postopek.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Če opazite kakršnekoli stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo, ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
Anti-infectious agent/antibiotic
Sredstvo proti okužbam/antibiotik.
Date of last renewal: 06/12/2017
Datum zadnjega podaljšanja dovoljenja za promet: 06/12/2017
Due to the risk of bolus regurgitation, do not allow these species access to areas where treated cattle have been kept.
Zaradi možnosti regurgitacije bolusa ne pustite, da imajo te živalske vrste dostop do območja, kjer se nahaja zdravljeno govedo.
Any unused veterinary medicinal product, waste materials derived from such veterinary medicinal products or regurgitated intraruminal devices should be disposed of in accordance with local requirements.
Vsako neporabljeno zdravilo za uporabo v veterinarski medicini, odpadne snovi, ki nastanejo iz teh zdravil, ali regurgitirane intraruminalne sisteme je treba odstraniti v skladu z lokalnimi zahtevami.
Pharmacotherapeutic group: Other alimentary tract and metabolism products: drugs for prevention and/or treatment of acetonemia.
Farmakoterapevtska skupina: Druga zdravila za bolezni prebavil in presnove: zdravila za preprečevanje in/ali zdravljenje acetonemije.
Intraruminal use.
Intraruminalna uporaba.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28/01/2013
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 28/01/2013
Keep the foil tightly closed.
Folijo shranjujte tesno zaprto.
Do not use in animals weighing less than 300 kg bodyweight.
KONTRAINDIKACIJE Ne uporabite pri živalih s telesno maso manj kot 300 kg.
They are the product of natural fermentation products produced by Streptomyces cinnamonensis.
Ti so rezultat naravnih produktov fermentacije bakterije Streptomyces cinnamonensis.
Manufacturer responsible for batch release: Eli Lilly and Company Ltd Speke Operations
Proizvajalec, odgovoren za sproščanje serij: Eli Lilly and Company Ltd Speke Operations
Monensin is a member of the pharmacotherapeutic group of polyether ionophores, specifically the carboxylic subgroup.
Monenzin je del farmakoterapevtske skupine polieter ionoforov, natančneje karboksilne podskupine.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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).
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - 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) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri)
Kexxtone delivers an approximate average dose of 335 mg of monensin per day for approximately 95 days.
Zdravilo Kexxtone dovaja približen povprečen odmerek 335 mg monenzina na dan približno 95 dni.
Identification of animals for treatment should be at veterinary discretion.
Določitev živali za zdravljenje je v presoji veterinarja.
Exposure to the active substance may elicit an allergic response in susceptible individuals.
Izpostavljenost učinkovini lahko pri občutljivih posameznikih izzove alergijsko reakcijo.
Do not eat, drink or smoke when handling the veterinary medicinal product.
Med dajanjem zdravila za uporabo v veterinarski medicini ne jejte, pijte ali kadite.
People with known hypersensitivity to monensin or any of the excipients should avoid contact with the veterinary medicinal product.
Osebe z znano preobčutljivostjo na monenzin ali na katero koli pomožno snov naj se izogibajo stiku z zdravilom.
10 μg/kg 50 μg/kg 10 μg/kg 2 μg/kg
10 μg/kg 50 μg/kg 10 μg/kg 2 μg/kg mišice maščoba jetra ledvice mleko
Monensin is released from the intraruminal device at an approximate average dose of 335 mg/day.
Monenzin se sprošča iz intraruminalnega sistema s približnim povprečnim odmerkom 335 mg/dan.
Ingestion or oral exposure to monensin can be fatal in dogs, horses, other equines or guinea fowl.
Zaužitje ali oralna izpostavljenost monenzinu je lahko smrtno nevarna za pse, konje, druge kopitarje ali pegatke.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
BESEDILO »SAMO ZA ŽIVALI« IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN
Accidental administration of more than one intraruminal device could result in some adverse reactions which are typical of monensin overdose, including decreased appetite, scouring and lethargy.
Nenamerna uporaba več kot enega intraruminalnega sistema lahko povzroči nekatere neželene učinke, ki so običajni za prevelik odmerek monenzina, vključno z zmanjšanjem apetita, diarejo in letargijo.
Each intraruminal device contains 12 subunits each containing 2.7 g monensin (equivalent to 2.9 g monensin sodium).
Vsak intraruminalni sistem vsebuje 12 podenot, od katerih vsaka vsebuje 2,7 g monenzina (kar ustreza 2,9 g monenzin natrija).
TARGET SPECIES Cattle (dairy cows and heifers)
CILJNE ŽIVALSKE VRSTE Govedo (krave molznice in telice).
Risk factors may include a history of energy-deficiency-related diseases, high body condition score and parity.
Dejavniki tveganja lahko vključujejo anamnezo bolezni, povezane z negativno energetsko bilanco, visoko oceno telesne kondicije in plodnost.
In very rare cases, oesophagus obstruction has been observed.
V zelo redkih primerih so opazili obstrukcijo požiralnika.
Signs of lodging may include bloat which may be followed by coughing, drooling, inappetence and unthriftiness.
Znak zagozditve je lahko napihnjenost, ki ji lahko sledi kašelj, slinjenje, neješčnost in hiranje.
Each intraruminal device has an individual number along the device body.
Vsak intraruminalni sistem ima individualno številko vzdolž telesa sistema.
Monensin is mainly active against Gram-positive bacteria.
Monenzin v glavnem učinkuje na grampozitivne bakterije.
As a result of the change in population of bacteria within the rumen, efficiency of energy metabolism is improved.
Zaradi spremenjene populacije bakterij v vampu se poveča učinek energetske presnove.
6 months Do not use this veterinary medicinal product after the expiry date which is stated on the package after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini za oznako »EXP«.
Restrain the animal with its head and neck stretched forward.
Žival pridržite tako, da ima glavo in vrat iztegnjena naprej.
Standing to one side of the animal, restrain it with its head and neck stretched forward and held firmly against your side.
Stojte ob strani živali in jo pridržite tako, da ima glavo in vrat iztegnjena naprej ter trdno uprta ob vaš bok.
Thus, the ultimate effect of monensin within the rumen is to shift the microbial population resulting in a decrease of the bacteria that produce acetate and butyrate and increasing the bacteria that produce propionate, the gluconeogenic precursor.
Zato je končni učinek monenzina v vampu sprememba mikrobne populacije - zmanjšanje števila bakterij, ki proizvajajo acetat in butirat, ter povečanje števila bakterij, ki proizvajajo propionat, ki je glukoneogeni prekurzor.
SPECIAL STORAGE CONDITIONS Keep the foil tightly closed.
POSEBNA NAVODILA ZA SHRANJEVANJE Folijo shranjujte tesno zaprto.
Do not allow dogs, horses, other equines or guinea fowl access to veterinary medicinal products containing monensin.
Psi, konji, drugi kopitarji ali pegatke ne smejo imeti dostopa do zdravil za uporabo v veterinarski medicini, ki vsebujejo monenzin.
Gram-negative bacteria have complex outer cell membranes, resulting in inherent resistance to the action of ionophores.
Gramnegativne bakterije imajo kompleksne zunanje celične membrane, zato so same po sebi odporne na delovanje ionoforov.
Grasp the animal with one hand in the corner of the animal's mouth.
Žival z eno roko primite za ustne kotičke.
In rare cases, digestive signs (e.g. diarrhoea, ruminant stomach disorder) have been observed.
V redkih primerih so opazili prebavne znake (npr. diarejo, motnje v vampu).
Such restraint must limit forward/backward motion and allow the animal's head to be held in the forward extended position and without pressure on the neck to prevent choking.
Preprečiti je treba premikanje naprej in nazaj ter omogočiti čim boljšo iztegnitev glave naprej brez pritiska na vrat, da ne pride do dušenja.
Hold treated cattle in a confined area for 1 hour after administration to observe for failure to swallow or regurgitation.
Zdravljeno govedo po uporabi zdravila za eno uro zadržite v zaprtem prostoru in opazujte, ali lahko požira oziroma ali pride do regurgitacije.
Intraruminal administration of monensin is followed by extensive first pass metabolism which results in low concentrations of monensin in the systemic circulation.
Po intraruminalni uporabi monenzina se pojavi obsežna presnova prvega prehoda, kar se odraža v nizki koncentraciji monenzina v sistemskem obtoku.
None known.
Jih ni.
PACKAGE SIZE 1 intraruminal device 3 intraruminal devices 5 intraruminal devices
VELIKOST PAKIRANJA 1 intraruminalni sistem 3 intraruminalni sistemi 5 intraruminalnih sistemov
Cattle (dairy cows and heifers)
Govedo (krave molznice in telice).
In the event of early regurgitation, identify the animal by matching the animal ID number with the number on the intraruminal device.
V primeru zgodnje regurgitacije določite žival tako, da primerjate identifikacijsko številko živali s številko intraruminalnega sistema.
In the event of early regurgitation, identify the animal by matching the animal ID number with the number on the intraruminal device and re-administer an undamaged intraruminal device (See section
V primeru zgodnje regurgitacije določite žival tako, da primerjate identifikacijsko številko živali s številko intraruminalnega sistema in živali ponovno dajte nepoškodovan intraruminalni sistem (glejte poglavje 4.5).
Shelf life after first opening the immediate packaging: 6 months
Rok uporabnosti po prvem odpiranju stične ovojnine: 6 mesecev.
The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of Monensin in Kexxtone in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 37/2010 as follows:
Kexxtone v tabelo 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010: Farmakološko aktivna snov
4.2 Indications for use, specifying the target species For the reduction in the incidence of ketosis in the peri-parturient dairy cow/heifer which is expected to develop ketosis.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Za zmanjšanje pojavnosti ketoze pri kravah molznicah in telicah v obporodnem obdobju, pri katerih se pričakuje razvoj ketoze.
32.4 g (equivalent to 35.2 g monensin sodium)
32,4 g (kar ustreza 35,2 g monenzin natrija)
When the tablet-subunits inside the intraruminal device are in contact with rumen fluid at the orifice of the device, a gel is formed and is slowly released from the intraruminal device.
Ko so tablete-podenote intraruminalnega sistema na ustju sistema v stiku z vampovim sokom, nastane gel, ki se počasi sprošča iz intraruminalnega sistema.
Aluminium foil bag containing 1, 3 or 5 intraruminal device(s).
Vrečka iz aluminijeve folije, ki vsebuje 1, 3 ali 5 intraruminalnih sistemov.
Other precautions
Ostali previdnostni ukrepi
A cylindrical orange polypropylene intraruminal device uniquely identified with a number, fitted with wings, consisting of a core which presents as a stack of 12 subunits.
Cilindričen oranžen polipropilenski intraruminalni sistem, označen z individualno številko in opremljen s krilci, ki ga sestavlja sredica s svežnjem 12 podenot.
As the animal swallows the administration tool will move easily over the base of the tongue.
Ko žival požira, se orodje za dajanje z lahkoto premika po korenu jezika.
This should be recorded with the corresponding animal identification number so that, should an intraruminal device be regurgitated, the animal can be identified.
To številko je treba zabeležiti skupaj z ustrezno identifikacijsko številko živali, tako da je mogoče žival, ki intraruminalni sistem regurgitira, identificirati.
When the animal swallows, eject the intraruminal device from the administration tool.
Ko žival požira, potisnite intraruminalni sistem iz orodja za dajanje.
A single intraruminal device is to be administered to a dairy cow/heifer 3-4 weeks prior to expected calving, using an appropriate administration tool.
Z ustreznim orodjem za dajanje dajte kravi molznici/telici en intraruminalni sistem 3-4 tedne pred pričakovano telitvijo.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PROZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
B. POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE Rp-Vet.