natgillin/translations-raw huggingface dataset:
6.5 Nature and contents of container and special requirement for use, administration or
6.5 Vrsta ovojnine in vsebina ter posebna oprema za uporabo, dajanje ali implantacijo Zdravilo MACI je poslano v posebej zasnovani sterilni zatesnjeni posodi iz prozornega polistirena.
<{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
<{MM/LLLL}> <{DD/MM/LLLL}> <{DD mesec LLLL}>
In these cases, the treatment should be immediately withdrawn.
V teh primerih je treba zdravljenje nemudoma ukiniti.
10 DATE OF REVISION OF THE TEXT
10 DATUM REVIZIJE BESEDILA
It is not associated with clinical signs.
Pojav ni povezan s kliničnimi znaki.
Each dose of 0.1 g contains:
Vsak odmerek 0,1 g vsebuje:
Date of first authorisation: 10/12/2019
Datum pridobitve dovoljenja za promet 10/12/2019:
Read carefully the user safety warnings before use.
Pred uporabo natančno preberite varnostna opozorila za uporabnika.
Avoid direct contact with the product.
Izogibajte se neposrednemu stiku z zdravilom.
In rare occasions, hypersensitivity reactions can occur.
V redkih primerih se lahko pojavijo preobčutljivostne reakcije.
The product has an expected positive effect on feed intake by stimulating the appetite but this effect was not measured in the pivotal field trial.
Zdravilo ima pričakovan pozitiven učinek na vnos hrane s spodbujanjem apetita, vendar ta učinek v ključnem terenskem preskušanju ni bil izmerjen.
This corresponds to a 3.8 cm line of ointment (see below).
To ustreza 3,8 cm dolgi črti mazila (glejte spodaj).
In case of an overdose, symptomatic/supportive treatment should be instituted if needed.
V primeru prevelikega odmerjanja moramo po potrebi uvesti simptomatsko/podporno terapijo.
The efficacy of the product was only demonstrated with a 14-day administration corresponding to the current recommendations (see section 4.9).
Učinkovitost zdravila je bila dokazana le za 14-dnevno dajanje, ki ustreza trenutnim priporočilom (glejte poglavje 4.9).
In the case of overdose, the same effects as those observed at the recommended therapeutic dose were noted but with a higher incidence.
Pri prevelikem odmerjanju so opazili enake učinke kot pri priporočenem terapevtskem odmerku, vendar z večjo pojavnostjo.
Limited data are available on the reproductive toxicity of mirtazapine.
Na voljo je malo podatkov o reproduktivni toksičnosti mirtazapina.
The effects of mirtazapine on glucose regulation have not been evaluated.
Učinki mirtazapina na regulacijo glukoze niso bili preučeni.
These adverse events, including local reactions, resolved at the end of treatment period with no specific treatment.
Opisani neželeni učinki, vključno z lokalnimi reakcijami, so po koncu obdobja zdravljenja izzveneli brez posebnega zdravljenja.
Care should be taken that other animals in the household do not come in contact with the application site until it is dry.
Paziti je treba, da druge živali v gospodinjstvu ne pridejo v stik z mestom nanosa, dokler to ni suho.
Alternate the daily application between the left and right ears.
Zdravilo izmenično nanašajte na levi in desni uhelj.
Given that pregnant women are considered a more sensitive population, it is recommended that pregnant women or women trying to conceive should avoid handling the product and avoid contact with treated animals throughout the treatment period.
Glede na to, da nosečnice veljajo za občutljivejšo populacijo, je priporočljivo, da se nosečnice in ženske, ki poskušajo zanositi, izogibajo ravnanju z zdravilom in stiku z zdravljenimi živalmi v celotnem obdobju zdravljenja.
The efficacy of the veterinary medicinal product has not been established in cats less than 3 years of age.
Učinkovitost zdravila ni bila ugotovljena pri mačkah, mlajših od 3 let.
The product can be absorbed via the cutaneous or oral route and can cause drowsiness or sedation.
Zdravilo se lahko absorbira po dermalni ali peroralni poti in lahko povzroči zaspanost ali sedacijo.
Do not use in breeding animals (see section 4.3).
Ne uporabite pri vzrejnih živalih (glejte poglavje 4.3).
Pharmacotherapeutic Group: Psychoanaleptics, antidepressants ATCvet code: QN06AX11
FARMAKOLOŠKE LASTNOSTI Farmakoterapevtska skupina: Psihoanaleptiki, antidepresivi Oznaka ATC vet: QN06AX11
Repetition of the treatment has not been investigated and as such should only be done after benefit-risk balance assessment by the veterinarian.
Ponavljanje zdravljenja ni bilo preučeno, zato se zanj odločamo le na podlagi ocene razmerja korist-tveganje odgovornega veterinarja.
In the case of use in cats with diabetes mellitus, glycaemia should be regularly monitored.
V primeru uporabe pri mačkah s sladkorno boleznijo moramo redno spremljati glikemijo.
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 veterinarian.
Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo, ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
The management of any chronic disease associated with weight loss should include providing appropriate nutrition and monitoring body weight and appetite.
Obvladovanje katere koli kronične bolezni, povezane s hujšanjem, mora vključevati zagotavljanje ustrezne prehrane ter spremljanje telesne mase in apetita.
Do not eat, drink or smoke while handling the veterinary medicinal product.
Med ravnanjem z zdravilom ne jejte, pijte ali kadite.
The veterinary medicinal product should not be applied on damaged skin.
Tega zdravila ne smemo nanašati na poškodovano kožo.
The plasma concentrations of mirtazapine may be also increased when used concomitantly with ketoconazole or cimetidine.
Plazemske koncentracije mirtazapina se lahko zvišajo tudi ob sočasni uporabi ketokonazola ali cimetidina.
Do not use in breeding animals.
Ne uporabite pri vzrejnih živalih.
Kidney disease may cause reduced clearance of mirtazapine, which may result in higher drug exposure.
Bolezen ledvic lahko povzroči zmanjšan očistek mirtazapina, kar lahko privede do večje izpostavljenosti zdravilu.
Non-greasy, homogeneous, white to off-white ointment.
Nemastno, homogeno, belo do umazano belo mazilo.
Depending on the severity of vomiting, dehydration or behavioural changes, administration of the product may be discontinued according to the benefit-risk assessment of the veterinarian.
Glede na resnost bruhanja, dehidracije ali vedenjskih sprememb lahko v skladu z oceno razmerja korist-tveganje odgovornega veterinarja, dajanje zdravila ukinemo.
The therapy with mirtazapine should not replace necessary diagnostics and/or treatment regimens needed to manage the underlying disease(s) causing unintended weight loss.
Terapija z mirtazapinom ne sme nadomestiti potrebnih diagnostičnih in/ali terapevtskih režimov, potrebnih za obvladovanje osnovnih bolezni, ki so vzrok nenamernega hujšanja.
Transdermal use.
Transdermalna uporaba.
It is therefore recommended to treat the animal in the evening.
Zato je priporočljivo, da zdravilo nanesete zvečer.
Do not use in animals less than 7.5 months of age or less than 2 kg body weight.
Ne uporabite pri živalih, mlajših od 7,5 meseca, ali tistih, ki tehtajo manj kot 2 kg.
Proper diagnosis and treatment of the underlying disease is key to managing weight loss, and treatment options are dependent on the severity of weight loss and underlying disease(s).
Pravilna diagnoza in zdravljenje osnovne bolezni sta ključnega pomena za obvladovanje hujšanja, možnosti zdravljenja pa so odvisne od resnosti izgube telesne mase in osnovne(ih) bolezni.
Mirtazapine may increase sedative properties of benzodiazepines and of other substances with sedative properties (antihistamines H1, opiates).
Mirtazapin lahko poveča sedativne lastnosti benzodiazepinov in drugih snovi s sedativnimi lastnostmi (antihistaminiki H1, opiati).
Shelf life after first opening the immediate packaging: 30 days.
Rok uporabnosti po prvem odpiranju stične ovojnine: 30 dni.
Step 1: Put on impermeable gloves.
1. korak: Nadenite si neprepustne rokavice.
The exact mechanism by which mirtazapine induces weight gain appears to be multifactorial.
Natančen mehanizem, s katerim mirtazapin povzroči povečanje telesne mase, se zdi večfaktorski.
Avoid hand to mouth and hand to eye contact until hands have been thoroughly washed.
Preprečite prenos zdravila z rokami v usta in z rokami v oči, dokler si temeljito ne umijete rok.
If a dose is missed, apply the veterinary medicinal product the following day and resume daily dosing.
Če odmerek izpustite, zdravilo nanesite naslednji dan in nato nadaljujte dnevno odmerjanje.
In these special cases, biochemical hepatic and renal parameters should be regularly monitored during the treatment.
V teh posebnih primerih moramo med zdravljenjem redno spremljati biokemične jetrne in ledvične parametre.
The efficacy and safety of the veterinary medicinal product has not been established in cats with severe renal disease and/or neoplasia.
Učinkovitost in varnost zdravila nista bili ugotovljeni pri mačkah s hudo ledvično boleznijo in/ali neoplazijo ledvic.
In the case of contact with eyes, rinse the eyes thoroughly with clean water.
V primeru stika z očmi temeljito sperite oči s čisto vodo.
The known symptoms of a mirtazapine overdose of > 2.5 mg/kg in cats include: vocalization and behavioural changes, vomiting, ataxia, restlessness, and tremors.
Znani simptomi prevelikega odmerjanja mirtazapina > 2,5 mg/kg pri mačkah so: oglašanje in vedenjske spremembe, bruhanje, ataksija, nemir in tresenje.
EU/2/19/247/001
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/19/247/001
The mean AUC0-24 was 100 ng*h/ml (± 51.7).
Povprečna vrednost AUC0-24 je bila 100 ng × h/ml (± 51,7).
In the case of hepatic disease, elevated hepatic enzyme levels may be observed.
V primeru bolezni jeter so lahko ravni jetrnih encimov povišane.
Mirtazapine is an α2-adrenergic receptor antagonist nor-adrenergic and serotonergic antidepressant drug.
Mirtazapin je antagonist adrenergičnih receptorjev α2, noradrenergični in serotoninergični antidepresiv.
When used in hypovolemic cats, supportive treatment (fluid therapy) should be implemented.
Pri uporabi pri hipovolemičnih mačkah moramo uvesti podporno zdravljenje (tekočinska terapija).
Each plastic bottle with a child resistant cap contains 1 tube (5 g).
Vsaka plastenka z zaporko, varno za otroke, vsebuje 1 tubo (5 g).
Do not use during pregnancy and lactation (see section 4.3).
Ne uporabite v obdobju brejosti in laktacije (glejte poglavje 4.3).
The median accumulation between first and 35th dose was 3.71X (based on AUC ratio) and 3.90X (based on Cmax ratio).
Mediana akumulacije med prvim in 35. odmerkom je bila 3,71krat (na podlagi razmerja AUC) in 3,90krat (na podlagi razmerja Cmax).
This veterinary medicinal product may cause eye and skin irritation.
To zdravilo lahko povzroči draženje oči in kože.
Mirtazapine is a potent antagonist of 5-HT2 and 5-HT3 receptors in the central nervous system (CNS), and a potent inhibitor of histamine H1 receptors.
Mirtazapin je močan antagonist receptorjev 5-HT2 in 5-HT3 v centralnem živčnem sistemu (CŽS) in močan zaviralec histaminskih receptorjev H1.
The mean terminal half-life of mirtazapine was 19.9 h (± 3.70) and the mean AUC0-24 was 400 ng*h/ml (±100).
Povprečna končna razpolovna doba mirtazapina je bila 19,9 h (± 3,70), srednja vrednost AUC0-24 pa 400 ng × h/ml
Treated animals should not be allowed to sleep with owners, especially children and pregnant women during all the period of the treatment.
V celotnem obdobju zdravljenja zdravljene živali ne smejo spati z lastniki, zlasti ne z otroci in nosečnicami.
Bioavailability following topical administration was 34% (6.5 to 89%) compared to oral administration during the first 24 hours and 65% (40.1 to 128.0%) based on AUC0-∞.
Biološka uporabnost po lokalnem dajanju je bila 34 % (od 6,5 do 89 %) vrednosti po peroralnem dajanju v prvih 24 urah in 65 % (od 40,1 do 128,0 %)
People with known hypersensitivity to mirtazapine should not handle the veterinary medicinal product.
Osebe z znano preobčutljivostjo za mirtazapin ne smejo rokovati s tem zdravilom.
The recommended fixed dose has been tested in cats weighing between 2.1 kg and 7.0 kg.
Priporočeni fiksni odmerek je bil testiran na mačkah s telesno maso med 2,1 kg in 7,0 kg.
If skin or eye irritation occurs or in case of accidental ingestion, seek immediately medical advice and show the label to the physician.
Če pride do draženja kože ali oči ali v primeru nenamernega zaužitja, se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
The efficacy and safety of the veterinary medicinal product has not been established in cats weighing less than 2.1 kg or more than 7.0 kg (see “Dosage for each species, route(s) and method of administration”).
Učinkovitost in varnost zdravila pri mačkah, težkih manj kot 2,1 kg ali več kot 7,0 kg, nista bili ugotovljeni (glejte poglavje „Odmerki za posamezne živalske vrste ter pot(i) in način uporabe zdravila“).
In case of oral ingestion, in addition to effects cited above (except local reactions), salivation and tremors may rarely occur.
V primeru zaužitja zdravila se lahko poleg zgoraj navedenih učinkov (razen lokalnih reakcij) v redkih primerih pojavita tudi povečano slinjenje in tresenje.
In the target animal safety study, where cats received a higher dose (2.8 to 5.4 mg) than the label dose (2 mg) once daily for 42 days, steady state was achieved within 14 days.
V študiji varnosti pri ciljnih živalih, kjer so mačke 42 dni enkrat dnevno prejemale večji odmerek (od 2,8 do 5,4 mg) od priporočenega (2 mg), je bilo stanje dinamičnega ravnovesja doseženo v 14 dneh.
This line coincides with the appropriate length of ointment to be applied:
Ta črta predstavlja ustrezno dolžino črte mazila, ki ga morate nanesti:
The line below coincides with the appropriate length of ointment to be applied:
Spodnja črta predstavlja ustrezno dolžino črte mazila, ki ga morate nanesti:
Step 3: Apply even pressure on tube and squeeze a 3.8 cm line of ointment onto your index finger using the measured line on the bottle or in this leaflet as a guide.
3. korak: Z enakomernim stiskanjem tube iztisnite 3,8 cm dolgo črto mazila na svoj kazalec.
In a crossover study conducted with the product at 0.5 mg/kg in eight cats to determine the relative bioavailability of oral and transdermal 2% mirtazapine, the mean terminal half-life (25.6 ± 5.5 hours) with topical administration was over 2X longer than the mean terminal half-life (8.63 ±3.9 hours) with oral administration.
V navzkrižni študiji, opravljeni z zdravilom v odmerku 0,5 mg/kg pri osmih mačkah z namenom določitve relativne biološke uporabnosti peroralnega in transdermalnega odmerka 2-odstotnega mirtazapina, je bila povprečna končna razpolovna doba (25,6 ± 5,5 ure) po lokalnem dajanju več kot 2krat daljša od povprečne končne razpolovne dobe (8,63 ± 3,9 ure) po peroralnem dajanju.
For bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions (see “other information”).
Za povečanje telesne mase pri mačkah, ki imajo slab apetit in hujšajo zaradi kroničnih bolezenskih stanj (glejte poglavje „Druge informacije“).
Application site reaction(s) (erythema, crust/scab, residue, scaling/dryness, flaking, head shaking, dermatitis or irritation, alopecia, and pruritus) and behavioural changes (increased vocalisation, hyperactivity, disoriented state or ataxia, lethargy/weakness, attention seeking and aggression) occurred very commonly in safety and clinical studies.
V varnostnih in kliničnih študijah so se zelo pogosto pojavljale reakcije na mestu aplikacije (eritem, krusta/krasta, ostanki, mekinasta koža/suhost, luščenje, tresenje glave, dermatitis ali draženje, alopecija in srbenje) in vedenjske spremembe (povečano oglašanje, hiperaktivnost, dezorientiranost ali ataksija, letargija/šibkost, iskanje pozornosti in agresivnost).
Step 4: Using your finger, gently rub ointment on inside surface of cat's ear (pinna) spreading it evenly over the surface.
4. korak: S prstom nežno vtrite mazilo v notranjo površino mačkinega uhlja
In the case of contact with the skin, wash thoroughly with soap and warm water.
V primeru stika s kožo prizadeti predel temeljito umijte z milom in toplo vodo.
Thoroughly wash hands immediately after administration of the veterinary medicinal product or in case of skin contact with the product or the treated cat.
Takoj po uporabi zdravila ali v primeru kožnega stika z zdravilom ali zdravljeno mačko si temeljito umijte roke.
After a single topical administration, the mean peak plasma concentration of 21.5 ng/ml (± 43.5) is reached in Tmax mean of 15.9 hours (1-48 hours).
Po enkratnem lokalnem dajanju dosežemo povprečno najvišjo koncentracijo v plazmi 21,5 ng/ml (± 43,5) pri srednji vrednosti Tmax 15,9 ure (1-48 ur).
THE WORDS “FOR ANIMAL TREATMENT ONLY”
BESEDILO „SAMO ZA ŽIVALI“ Samo za živali.
Mirtazapine-induced weight gain may be secondary to changes in leptin and the tumour necrosis factor (TNF).
Z mirtazapinom inducirano povečanje telesne mase je lahko posledica sprememb ravni leptina in faktorja tumorske nekroze (TNF).
Mirataz 20 mg/g transdermal ointment for cats
Mirataz 20 mg/g transdermalno mazilo za mačke
The veterinary medicinal product is a skin sensitiser.
Zdravilo povzroča preobčutljivost kože.
After administration of the product to 8 cats at a dose of 0.5 mg/kg once daily for 14 days, mean peak plasma concentration of 39.6 ng/ml (± 9.72) is reached in Tmax mean of 2.13 hours (1-4 hours).
Po dajanju zdravila 8 mačkam v odmerku 0,5 mg/kg enkrat dnevno 14 dni je bila dosežena povprečna najvišja koncentracija v plazmi 39,6 ng/ml (± 9,72) pri srednji vrednosti Tmax 2,13 ure (1-4 ure).
If desired, the inner surface of the cat's ear may be cleaned by wiping with a dry tissue or cloth immediately prior to the next scheduled dose.
Tik pred naslednjim načrtovanim odmerkom se lahko notranjo površino mačkinega uhlja očisti s suhim zložencem ali krpo.
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)
The veterinary medicinal product is applied topically to the inner pinna (inner surface of the ear) once daily for 14 days, at the dosage of 0.1 g ointment/cat (2 mg mirtazapine/cat).
Zdravilo se nanaša lokalno na notranjo površino uhlja, enkrat dnevno v obdobju 14 dni, v odmerku 0,1 g mazila/mačko (2 mg mirtazapina/mačko).
5 gram coated aluminium tube (coat: lacquer (internal)/ enamel (external) with a low-density polyethylene (LDPE) screw cap and crimp sealant.
Tuba s 5 g prevlečena z aluminijem (prevleka: lak (notranja stran)/emajl (zunanja stran)) z navojno zaporko iz polietilena z nizko gostoto (LDPE) in tesnilno maso pregiba.
Vomiting, polyuria associated with reduced urine specific gravity, elevated blood urea nitrogen (BUN) and dehydration were commonly observed in safety and clinical studies.
V varnostnih in kliničnih študijah so pogosto opazili bruhanje, poliurijo, povezano z zmanjšano specifično težo urina, zvišano raven dušika sečnine v krvi (BUN) in dehidracijo.
0.1 g contains 2 mg mirtazapine (as hemihydrate)
0,1 g vsebuje 2 mg mirtazapina (v obliki hemihidrata)
Transient increased hepatic alanine transferase can be observed uncommonly.
Občasno lahko opazimo prehodno povečano raven jetrne alanin-transferaze.
Mirataz 20 mg/g transdermal ointment for cats mirtazapine
Mirataz 20 mg/g transdermalno mazilo za mačke mirtazapin
The only effect tested under field practice was on bodyweight: client-owned cats presented with a weight loss ≥ 5%, deemed clinically significant by the investigator, gained a statistically significant (p<0.0001) amount of weight, after 14 days of product administration (3.39% weight gain or average of 130 grams) compared to those cats administered placebo (0.09% weight gain or average of 10 grams).
Edini učinek, preskušen v terenski praksi, je bil učinek na telesno maso: lastniške mačke, katerih izguba telesne mase je znašala ≥ 5 %, ki jo je raziskovalec ocenil kot klinično pomembno, so po 14 dneh uporabe zdravila pridobile statistično pomembno (p < 0,0001) telesno maso (3,39odstotno povečanje telesne mase ali povprečno 130 gramov) v primerjavi z mačkami, ki so prejemale placebo (0,09odstotno povečanje telesne mase ali povprečno 10 gramov).
The tube must be placed in the child-proof container after application, which must be closed immediately.
Tubo po nanosu zdravila vstavite v vsebnik z zaporko, varno za otroke, in vsebnik takoj zaprite.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Učinkovina:
EXP {month/year} Once opened use within 30 days.
Načeto zdravilo uporabite v 30 dneh.
If contact with your skin occurs wash with soap and water.
Če vaša koža pride v stik z zdravilom, prizadeti predel umijte z milom in vodo.
Impermeable disposable protective gloves should be provided at the point of sale with the product and must be worn when handling and administering the veterinary medicinal product.
Rokavice je treba nositi pri ravnanju z zdravilom in njegovem dajanju.
Do not leave the tube out of its child-proof container except during the application phase.
Ko tube ne uporabljate, je ne puščajte zunaj njenega vsebnika z zaporko, varno za otroke.
Children must not be present when applying the treatment to the cat.
Pri nanosu zdravila na mačko otroci ne smejo biti prisotni.
The efficacy and safety of the veterinary medicinal product has not been established in cats weighing less than 2.1 kg or more than 7.0 kg (see also section 4.9).
Učinkovitost in varnost zdravila pri mačkah, težkih manj kot 2,1 kg ali več kot 7,0 kg, nista bili ugotovljeni
Inhibition of 5-HT2 and histamine H1 receptors may account for the orexigenic effects of the molecule.
Oreksigen učinek molekule lahko povzroči zaviranje receptorjev 5-HT2 in histaminskih receptorjev H1.
Do not use in cats treated with cyproheptadine, tramadol or monoamine oxidase inhibitors (MAOIs) or treated with an MAOI within 14 days prior to treatment with the veterinary medicinal product as there may be an increased risk of serotonin syndrome (see “Contraindications”).
Ne uporabite pri mačkah, ki se zdravijo s ciproheptadinom, tramadolom ali zaviralci monoaminooksidaze (MAOI) ali so bile z MAOI zdravljene v zadnjih 14 dneh, ker lahko pride do povečanega tveganja za serotoninski sindrom (glejte poglavje „Kontraindikacije“).
Do not use in breeding, pregnant or lactating cats.
Ne uporabite pri vzrejnih živalih ali v obdobju brejosti in laktacije.
Step 2: Twist cap on tube counter clockwise to open.
2. korak: Odprite zaporko na tubi tako, da jo zavrtite v nasprotni smeri urinega kazalca.
Do not use in cats treated with monoamine oxidase inhibitors (MAOIs) or treated with an MAOI within 14 days prior to treatment with the veterinary medicinal product due to an increased risk of serotonin syndrome (see also “special warnings”).
Ne uporabite pri mačkah, ki se zdravijo z zaviralci monoaminooksidaze (MAOI) ali so bile z MAOI zdravljene v zadnjih 14 dneh, ker lahko pride do povečanega tveganja za serotoninski sindrom (glejte poglavje „Posebna opozorila“).
Marketing authorisation holder: Aniserve GmbH Geyerspergerstr.
IMETNIK DOVOLJENJA ZA PROMET Aniserve GmbH
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release
Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij Klifovet AG
The product may be harmful after ingestion.
Zdravilo ima lahko škodljive učinke pri zaužitju.