FrancophonIA/ELRC3.0 huggingface dataset:
English: • Healthcare professionals in the EU countries where flupirtine is marketed will receive a letter with detailed information on the appropriate actions to be taken, including when the medicine will become unavailable.
Slovenian: • Zdravstveni delavci v državah EU, kjer se flupirtin trži, bodo prejeli dopis s podrobnimi informacijami o ustreznih ukrepih, vključno s podatkom o tem, od kdaj zdravila ne bodo več na voljo.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 March 2018 EMA/153044/2018
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23.
English: • Patients with any questions should speak to their healthcare professional.
Slovenian: • Bolniki, ki imajo kakršna koli vprašanja, naj se posvetujejo z zdravstvenim delavcem.
English: • Healthcare professionals should consider alternative treatments for patients.
Slovenian: • Zdravstveni delavci morajo razmisliti o drugih možnostih zdravljenja za bolnike.
English: It also assessed cases of serious liver damage reported since the 2013 review.
Slovenian: Ocenjevali so tudi primere resnih poškodb jeter, o katerih so poročali od leta 2013.
English: • These medicines are being taken off the market in the EU because of a risk of serious liver injury.
Slovenian: • Ta zdravila se jemljejo s trga v EU zaradi tveganja za resno poškodbo jeter.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Slovenian: Pregled je najprej opravil Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj v zvezi z zdravili za uporabo v humani medicini, in podal več priporočil.
English: The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Slovenian: Skupina CMDh je organ, ki zastopa države članice EU ter Islandijo, Lihtenštajn in Norveško.
English: Since the CMDh adopted its position by consensus, it will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Slovenian: Skupina CMDh je soglasno sprejela svoje stališče, zato bodo morale države članice, v katerih so zdravila odobrena, v skladu z dogovorjeno časovnico neposredno izvajati ukrepe.
English: • Restrictions introduced in 2013, which included limiting flupirtine use to two weeks and regular monitoring of liver function tests, have not been sufficiently followed in clinical practice.
Slovenian: • Omejitve, uvedene leta 2013, ki so vključevale omejitev uporabe flupirtina na dva tedna in redno spremljanje delovanja jeter s preiskavami, se v klinični praksi niso dovolj upoštevale.
English: The review, carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), looked at the available data including studies evaluating whether the 2013 restrictions were followed in clinical practice.
Slovenian: V okviru pregleda, ki ga je opravil Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC) agencije EMA, so preučili razpoložljive podatke, vključno s študijami, ki so ocenjevale, ali se omejitve iz leta 2013 v klinični praksi upoštevajo.
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway.
Slovenian: Skupina CMDh je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU), Islandijo, Lihtenštajn in Norveško.
English: The CMDh agreed with the PRAC conclusion that the restrictions introduced in 2013 have not been sufficiently followed, and cases of serious liver injury, including liver failure, still occurred.
Slovenian: Skupina CMDh se je strinjala z zaključkom odbora PRAC, da omejitve, uvedene leta 2013, niso bile upoštevane v zadostni meri, primeri resnih poškodb jeter, vključno z jetrno odpovedjo, pa so se še vedno pojavljali.
English: • Strict measures to try to reduce this risk were introduced in 2013 but have not been put into practice widely enough, and liver injury has continued to be reported.
Slovenian: • Leta 2013 so uvedli stroge ukrepe, namenjene zmanjšanju tega tveganja, vendar se v praksi niso dovolj izvajali in še naprej so poročali o poškodbah jeter.
English: While the use of flupirtine-containing products has decreased, the measures implemented have not been effective at minimising the risk.
Slovenian: Uporaba zdravil, ki vsebujejo flupirtin, se je sicer zmanjšala, vendar uvedeni ukrepi niso zadoščali za zmanjšanje tveganja.
English: The EMA recommendation was the outcome of a review of flupirtine medicines which was started because liver problems continued to be reported even after measures were introduced in 2013 to manage this risk.
Slovenian: Priporočilo agencije EMA je bilo izid pregleda zdravil s flupirtinom, ki so ga sprožili, ker so tudi po uvedbi ukrepov za obvladovanje tveganja leta 2013 še naprej poročali o težavah z jetri.
English: • Flupirtine-containing medicines are being taken off the market in the EU because of the risk of serious liver injury.
Slovenian: • Zdravila, ki vsebujejo flupirtin, se jemljejo s trga v EU zaradi tveganja za resno poškodbo jeter.
English: Flupirtine works as a ‘selective neuronal potassium channel opener'.
Slovenian: Flupirtin deluje kot „selektivni odpiralec kalijevih kanalčkov v živčnih celicah“.
English: In order to protect public health, the CMDh endorsed the PRAC recommendation to withdraw the marketing authorisations of flupirtinecontaining medicines.
Slovenian: Skupina CMDh je zaradi zaščite javnega zdravja podprla priporočilo odbora PRAC za umik dovoljenj za promet z zdravili, ki vsebujejo flupirtin.
English: Serious liver problems continued to be reported despite previous restrictions in use
Slovenian: Kljub predhodnim omejitvam uporabe še naprej poročajo o resnih težavah z jetri
English: These measures had included limiting flupirtine use to no more than 2 weeks in patients with acute pain who could not use other painkillers, and carrying out weekly tests of liver function during treatment.
Slovenian: Ti ukrepi so vključevali omejitev uporabe flupirtina na največ dva tedna, in sicer pri bolnikih z akutno bolečino, ki ne smejo uporabljati drugih protibolečinskih zdravil, in izvajanje tedenskih preiskav delovanja jeter med zdravljenjem.
English: • Since 2013, cases of serious liver injury, including 23 cases of acute liver failure, some of which were fatal or led to transplantation have been reported following flupirtine use.2 The reactions are unpredictable and the exact mechanism by which flupirtine causes liver injury is not known.
Slovenian: • Od leta 2013 so po uporabi flupirtina poročali o primerih resne poškodbe jeter, vključno s 23 primeri akutne jetrne odpovedi, od katerih so bili nekateri smrtni ali pa so pripeljali do presaditve.2 Odziva na zdravilo ni mogoče napovedati in ni znano, po kakšnem sistemu flupirtin povzroča poškodbo jeter.
English: • Flupirtine-containing medicines have been used to treat acute (short-term) pain for up to two weeks in adults who cannot use other painkillers (such as non-steroidal anti-inflammatory drugs (NSAIDs) and weak opioids).
Slovenian: • Zdravila, ki vsebujejo flupirtin, se uporabljajo za zdravljenje akutne (kratkotrajne) bolečine v obdobju do dveh tednov pri odraslih, ki ne morejo uporabljati drugih protibolečinskih zdravil (kot so nesteroidna protivnetna zdravila in šibki opioidi).
English: In addition, no further measures to reduce the risk of liver problems could be identified.
Slovenian: Poleg tega ni bilo mogoče določiti nobenih nadaljnjih ukrepov za zmanjšanje tveganja za težave z jetri.
English: • Since 2013, cases of serious liver injury, including 23 cases of acute liver failure (sudden loss of liver function), some of which were fatal or led to transplantation have been reported following flupirtine use.
Slovenian: • Od leta 2013 so po uporabi flupirtina poročali o primerih resne poškodbe jeter, vključno s 23 primeri akutne jetrne odpovedi (nenadnega prenehanja delovanja jeter), od katerih so bili nekateri smrtni ali pa so pripeljali do presaditve.
English: Flupirtine is a medicine used to treat acute (short-lived) pain for up to 2 weeks, in patients who cannot use other painkillers such as opioids or nonsteroidal anti-inflammatory medicines (NSAIDs).
Slovenian: Flupirtin je zdravilo, ki se uporablja za zdravljenje akutne (kratkotrajne) bolečine v obdobju do dveh tednov pri bolnikih, ki ne morejo uporabljati drugih protibolečinskih zdravil, kot so opioidi ali nesteroidna protivnetna zdravila.
English: The CMDh1 has endorsed EMA's recommendation to withdraw the marketing authorisation for the pain medicine flupirtine, because of the risk of serious liver injury.
Slovenian: Skupina CMDh1 je zaradi tveganja za resno poškodbo jeter podprla priporočilo agencije EMA za umik dovoljenja za promet z zdravilom za protibolečinsko zdravilo flupirtin.
English: • In addition, no further measures to increase adherence to the restrictions nor adequately reduce the risk of liver problems could be identified.
Slovenian: • Poleg tega ni bilo mogoče določiti nobenih nadaljnjih ukrepov za povečanje upoštevanja omejitev ali za zmanjšanje tveganja za težave z jetri.
English: In addition, no further measures to increase adherence to the restrictions nor adequately reduce the risk of liver problems could be identified.
Slovenian: Poleg tega ni bilo mogoče določiti nobenih nadaljnjih ukrepov za povečanje upoštevanja omejitev ali za zmanjšanje tveganja za težave z jetri.
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe in imetnikov dovoljenja za promet v državah članicah
English: Freeze-Dried Powder
Slovenian: Liofiliziran prašek
English: Eepoprostenol 1.5 mg
Slovenian: Epoprostenol 1.5 mg
English: GlaxoSmithKline s.a. / n.v. Rue du Tilleul 13
Slovenian: GlaxoSmithKline s.a. / n.v.
English: Sterile freezedried powder for solution for infusion
Slovenian: Sterilen liofiliziran prašek za raztopino za infundiranje
English: Package size
Slovenian: Pot uporabe Ovojnina Vsebina Velikost pakiranja
English: Maximum efficacy is achieved within 48 hours.
Slovenian: Maksimalna učinkovitost je dosežena v 48 urah.
English: These changes do not affect the safety or efficacy of the veterinary medicinal product.
Slovenian: Te spremembe ne vplivajo na varnost ali učinkovitost zdravila.
English: All blisters in a box are the same size.
Slovenian: Vsi blistri v škatli so enake velikosti.
English: It is therefore recommended to treat the animals during the evening.
Slovenian: Zato je priporočljivo zdraviti živali zvečer.
English: This is not a sign of intoxication and disappears within minutes without treatment.
Slovenian: To ni znak zastrupitve in izgine v nekaj minutah brez zdravljenja.
English: In very rare cases temporary local hair loss may occur.
Slovenian: V zelo redkih primerih se lahko pojavi začasna lokalna izguba dlake.
English: *- Very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - Common (more than 1 but less than 10 animals in 100 animals) - Uncommon (more than 1 but less than 10 animals in 1,000 animals ) - Rare (more than 1 but less than 10 animals in 10,000 animals) - Very rare (less than 1 animal in 10,000 animals, including isolated reports).
Slovenian: * Zelo pogosti (neželeni učinki so se pojavili pri več kot 10 živalih v enem ciklusu zdravljenja) - Pogosti (pri več kot 1, vendar manj kot pri 10 živalih od 100 živali) - Občasni (pri več kot 1, vendar manj kot pri 10 živalih od 1000 živali) - Redki (pri več kot 1, vendar manj kot pri 10 živalih od 10.000 živali) - Zelo redki (pri manj kot 1 živali od 10.000 živali, vključno s posamičnimi poročili)
English: Do not administer orally or via any other route.
Slovenian: Ne dajajte ga peroralno ali na kakšen drug način.
English: Recently treated animals are not allowed to sleep with owners, especially children.
Slovenian: Pravkar zdravljene živali ne smejo spati z lastniki, še posebej ne z otroci.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable
Slovenian: PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Ni smiselno
English: Avoid direct contact with skin, eyes or mouth.
Slovenian: Izogibajte se direktnemu stiku s kožo, očmi ali usti.
English: These results are consistent with laboratory efficacy studies showing activity for up to 56 days post-treatment.
Slovenian: Ti rezultati so bili v skladu z laboratorijskimi študijami učinkovitosti, ki so pokazale delovanje do 56. dneva po zdravljenju.
English: Gamma-hexalactone
Slovenian: Gama-heksalakton
English: Metaflumizone (mg)
Slovenian: Metaflumizon (mg)
English: Wash hands thoroughly after use.
Slovenian: Po dajanju si dobro umijte roke.
English: Metaflumizone was still measurable in the hair 56 days following treatment.
Slovenian: Metaflumizon je bilo v dlaki možno izmeriti 56 dni po zdravljenju.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
English: Maximum concentrations in the hair were generally reached between 1 to 2 days post-treatment and gradually declined through 56 days posttreatment.
Slovenian: Maksimalna koncentracija v dlaki je dosežena med 1. in 2. dnevom po zdravljenju in se postopoma znižuje v 56 dnevih po zdravljenju.
English: Metaflumizone is a sodium channel antagonist and disrupts nerve function resulting in paralysis and death of insects.
Slovenian: Metaflumizon je antagonist natrijevih kanalov in prekine živčne funkcije, čemur sledi paraliza in smrt insektov.
English: For optimum control of flea problems in a multi-pet household, all pets in the household should be treated with a suitable insecticide.
Slovenian: Za optimalno kontrolo bolhavosti v gospodinjstvu z več živalmi, bi bilo treba vse živali v tem gospodinjstvu zdraviti s primernim insekticidom.
English: Synperonic NCA 830
Slovenian: Seznam pomožnih snovi Synperonic NCA 830
English: The recommended minimum dose is 40 mg metaflumizone/kg bodyweight, equivalent to 0.20ml/kg bodyweight.
Slovenian: Priporočen minimalen odmerek je 40 mg metaflumizona/kg telesne mase, kar ustreza 0,20 ml/kg telesne mase.
English: Metaflumizone is active against fleas due to non-systemic exposure of the parasites on the skin and hair.
Slovenian: Metaflumizon učinkuje proti bolham z nesistemsko izpostavitvijo parazitov na koži in dlaki.
English: Excipients For a full list of excipients, see section 6.1.
Slovenian: Pomožne snovi: Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
English: Children should not be allowed to play with treated animals until the application site is dry.
Slovenian: Otroci se ne smejo igrati z zdravljeno živaljo, dokler ni mesto nanosa suho.
English: In addition, it is recommended to treat the environment with a suitable insecticide.
Slovenian: Prav tako je priporočljivo s primernim insekticidom tretirati tudi okolje.
English: Treatment schedule:
Slovenian: Načrt zdravljenja:
English: Do not smoke, drink or eat while handling the product.
Slovenian: Med dajanjem zdravila je prepovedano kaditi, piti ali jesti.
English: The MAH must ensure that the system of pharmacovigilance, as described in Part I of the marketing authorisation application, is in place and functioning before and whilst the veterinary medicinal product is on the market.
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, predložen kot je opisan v delu I vloge za pridobitev dovoljenja za promet, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
English: Kent CT13 9NJ United Kingdom
Slovenian: Kent CT13 9NJ Združeno Kraljestvo
English: DATE ON WHICH THE PACKAGE INSERT WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/
English: Avoid direct contact with treated animals until the application site is dry.
Slovenian: Izogibajte se direktnemu stiku z zdravljeno živaljo, dokler ni mesto nanosa suho.
English: After topical administration at a single site on the cat's neck at the base of the skull, metaflumizone levels in plasma were too low to allow the calculation of standard pharmacokinetic parameters.
Slovenian: Po topikalnem dajanju na eno mesto vratu na zatilje glave mačke, so bile koncentracije metaflumizona v plazmi prenizke za izračun standardnih farmakokinetičnih parametrov.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years 6.4.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta.
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Slovenian: Skladno s sklepom mora imetnik dovoljenja za promet obvestiti Evropsko komisijo o načrtih trženja zdravila.
English: Do not apply the veterinary medicinal product to the surface of the cat's hair coat.
Slovenian: Zdravila ne nanašajte na površino dlake.
English: United Kingdom
Slovenian: Združeno Kraljestvo
English: Hold the pipette upright, bend the tip of the pipette to break the tip along the scored line.
Slovenian: Držite merilno kapalko pokonci ter upognite konico tako, da se le ta zlomi po zarezani črti.
English: Each unit dose (pipette) of ProMeris delivers:
Slovenian: Vsak odmerek (merilna kapalka) ProMeris-a vsebuje:
English: Treatment and prevention of flea infestations (Ctenocephalides canis and C. felis) in cats.
Slovenian: Zdravljenje in preprečevanje bolhavosti (Ctenocephalides canis in C. felis) pri mačkah.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/064/001-004
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/064/001-004
English: No adverse effects were observed in cats aged 8 weeks and older treated 7 times at two-week intervals with 3-5 times the recommended dose.
Slovenian: Pri mačkah, starih 8 tednov ali več, zdravljenih 7-krat v dvotedenskih intervalih s 3 - 5-kratnim priporočenim odmerkom ni bilo opaziti neželenih učinkov.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilna učinkovina:
English: For cutaneous use only.
Slovenian: Samo za demalno uporabo.
English: For optimal control of flea infestation, the veterinary medicinal product can be administered at 4 to 6 week intervals throughout the flea season or the treatment schedule can be based on the local epidemiological situation.
Slovenian: Za optimalno kontrolo bolhavosti lahko zdravilo nanašate v 4 do 6 tedenskih intervalih med sezono bolh, lahko pa načrt zdravljenja temelji na lokalni epidemiološki situaciji.
English: Consult your veterinarian before using the veterinary medicinal product on sick or debilitated cats.
Slovenian: Pred uporabo zdravila pri bolanih ali izčrpanih mačkah se posvetujte s svojim veterinarjem.
English: ProMeris for Large Cats (> 4 kg)* *Due to limited space on the packaging, the abbreviations "S" and "L", which represent "small" and "large", respectively, are used on the blister foil and applicator pipettes.
Slovenian: (> 4 kg)* * Zaradi omejenega prostora na ovojnini sta na foliji in merilnih kapalkah uporabljeni oznaki: S (za majhne mačke) in L (za velike mačke).
English: The veterinary medicinal product is packaged in individual-dose transparent plastic pipettes overpacked in an aluminium foil package.
Slovenian: Zdravilo je pakirano v prozorne plastične merilne kapalke z enkratnim odmerkom, ki so ovite v ovitek iz aluminijaste folije.
English: Special precautions for storage Do not store above 25°C
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte pri temperaturi nad 25 ºC
English: Wyeth Lederle Italia S.p.A. 18, Via Franco Gorgone 95121 Catania Italy
Slovenian: 18, Via Franco Gorgone 95121 Catania Italija
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris S
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris S
English: Cats over 8 weeks of age.
Slovenian: Mačke, starejše od 8 tednov.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Dosage:
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
English: WASTE MATERIALS, IF ANY
Slovenian: ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
English: Each strength of the veterinary medicinal product is available in boxes with 1 and in boxes with 2 blister cards of 3 pipettes.
Slovenian: Vsaka jakost zdravila je na voljo v škatlah z 1 in v škatlah z 2 blistroma s po 3 merilnimi kapalkami.
English: Marketing authorisation holder Pfizer Limited
Slovenian: Imetnik dovoljenja za promet Pfizer Limited
English: For animal treatment only - to be supplied only on veterinary prescription.
Slovenian: Samo za živali - na veterinarski recept.
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 160 mg
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 160 mg
English: The top of the tip will fold back against the pipette.
Slovenian: Vrh konice se bo upognil proti merilni kapalki.
English: Active substance: 320 mg metaflumizone
Slovenian: Zdravilna učinkovina: 320 mg metaflumizona
English: ProMeris for Small Cats (≤ 4 kg)
Slovenian: ProMeris za majhne mačke (≤ 4 kg)
English: In rare cases, transient irritation may occur at the site of the product application.
Slovenian: V redkih primerih se lahko pojavi prehodna iritacija na mestu nanosa zdravila.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris L
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris L
English: ProMeris for Small Cats ProMeris for Large Cats
Slovenian: ProMeris za majhne mačke ProMeris za velike mačke
English: Active substance: 160 mg metaflumizone
Slovenian: Zdravilna učinkovina: 160 mg metaflumizona
English: Care should be taken to ensure that the content of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.
Slovenian: Poskrbite, da vsebina pipete ali nanešen odmerek ne pride v stik z očmi ali usti zdravljene živali in/ali drugih živali.
English: Method of administration:
Slovenian: Način dajanja:
English: Each ml contains 200 mg metaflumizone.
Slovenian: 1 ml vsebuje 200 mg metaflumizona.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA
English: Carefully dispose of used pipettes immediately after use.
Slovenian: Takoj po uporabi prazno merilno kapalko previdno odstranite.
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: D. DRUGI POGOJI IN ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA
English: Not applicable.
Slovenian: Ni smiselno
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS , IF ANY
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
English: Do not store above 25 °C.Do not use after the expiry date stated on the carton after “EXP”.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po “EXP”.
English: TARGET SPECIES For cats over 8 weeks of age.
Slovenian: CILJNE ŽIVALSKE VRSTE Za mačke, starejše od 8 tednov.
English: 4.9 Amounts to be administered and administration route Dosage:
Slovenian: 4.9 Odmerjanje in pot uporabe Odmerki:
English: The application of the veterinary medicinal product may produce a local, temporary oily appearance and clumping or spiking of the fur at the application site.
Slovenian: Nanos zdravila lahko lokalno povzroči začasen masten izgled, vozlanje in zlepljanje dlake na mestu nanosa.