natgillin/translations-raw huggingface dataset:
*- 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). 
* 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)
Do not administer orally or via any other route. 
Ne dajajte ga peroralno ali na kakšen drug način.
Recently treated animals are not allowed to sleep with owners, especially children. 
Pravkar zdravljene živali ne smejo spati z lastniki, še posebej ne z otroci.
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable 
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Ni smiselno
Avoid direct contact with skin, eyes or mouth. 
Izogibajte se direktnemu stiku s kožo, očmi ali usti.
These results are consistent with laboratory efficacy studies showing activity for up to 56 days post-treatment. 
Ti rezultati so bili v skladu z laboratorijskimi študijami učinkovitosti, ki so pokazale delovanje do 56. dneva po zdravljenju.
Gamma-hexalactone 
Gama-heksalakton
Wash hands thoroughly after use. 
Po dajanju si dobro umijte roke.
Metaflumizone was still measurable in the hair 56 days following treatment. 
Metaflumizon je bilo v dlaki možno izmeriti 56 dni po zdravljenju.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu 
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/.
Maximum concentrations in the hair were generally reached between 1 to 2 days post-treatment and gradually declined through 56 days posttreatment. 
Maksimalna koncentracija v dlaki je dosežena med 1. in 2. dnevom po zdravljenju in se postopoma znižuje v 56 dnevih po zdravljenju.
Metaflumizone is a sodium channel antagonist and disrupts nerve function resulting in paralysis and death of insects. 
Metaflumizon je antagonist natrijevih kanalov in prekine živčne funkcije, čemur sledi paraliza in smrt insektov.
For optimum control of flea problems in a multi-pet household, all pets in the household should be treated with a suitable insecticide. 
Za optimalno kontrolo bolhavosti v gospodinjstvu z več živalmi, bi bilo treba vse živali v tem gospodinjstvu zdraviti s primernim insekticidom.
Synperonic NCA 830 
Seznam pomožnih snovi Synperonic NCA 830
The recommended minimum dose is 40 mg metaflumizone/kg bodyweight, equivalent to 0.20ml/kg bodyweight. 
Priporočen minimalen odmerek je 40 mg metaflumizona/kg telesne mase, kar ustreza 0,20 ml/kg telesne mase.
Metaflumizone is active against fleas due to non-systemic exposure of the parasites on the skin and hair. 
Metaflumizon učinkuje proti bolham z nesistemsko izpostavitvijo parazitov na koži in dlaki.
Excipients For a full list of excipients, see section 6.1. 
Pomožne snovi: Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
Children should not be allowed to play with treated animals until the application site is dry. 
Otroci se ne smejo igrati z zdravljeno živaljo, dokler ni mesto nanosa suho.
In addition, it is recommended to treat the environment with a suitable insecticide. 
Prav tako je priporočljivo s primernim insekticidom tretirati tudi okolje.
Treatment schedule: 
Načrt zdravljenja:
Do not smoke, drink or eat while handling the product. 
Med dajanjem zdravila je prepovedano kaditi, piti ali jesti.
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. 
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.
Kent CT13 9NJ United Kingdom 
Kent CT13 9NJ Združeno Kraljestvo
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 
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/
Avoid direct contact with treated animals until the application site is dry. 
Izogibajte se direktnemu stiku z zdravljeno živaljo, dokler ni mesto nanosa suho.
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. 
Po topikalnem dajanju na eno mesto vratu na zatilje glave mačke, so bile koncentracije metaflumizona v plazmi prenizke za izračun standardnih farmakokinetičnih parametrov.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years 6.4. 
Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision. 
Skladno s sklepom mora imetnik dovoljenja za promet obvestiti Evropsko komisijo o načrtih trženja zdravila.
Do not apply the veterinary medicinal product to the surface of the cat's hair coat. 
Zdravila ne nanašajte na površino dlake.
United Kingdom 
Združeno Kraljestvo
Hold the pipette upright, bend the tip of the pipette to break the tip along the scored line. 
Držite merilno kapalko pokonci ter upognite konico tako, da se le ta zlomi po zarezani črti.
Each unit dose (pipette) of ProMeris delivers: 
Vsak odmerek (merilna kapalka) ProMeris-a vsebuje:
Treatment and prevention of flea infestations (Ctenocephalides canis and C. felis) in cats. 
Zdravljenje in preprečevanje bolhavosti (Ctenocephalides canis in C. felis) pri mačkah.
MARKETING AUTHORISATION NUMBER(S) EU/2/06/064/001-004 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/064/001-004
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. 
Pri mačkah, starih 8 tednov ali več, zdravljenih 7-krat v dvotedenskih intervalih s 3 - 5-kratnim priporočenim odmerkom ni bilo opaziti neželenih učinkov.
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilna učinkovina:
For cutaneous use only. 
Samo za demalno uporabo.
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. 
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.
Consult your veterinarian before using the veterinary medicinal product on sick or debilitated cats. 
Pred uporabo zdravila pri bolanih ali izčrpanih mačkah se posvetujte s svojim veterinarjem.
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. 
(> 4 kg)* * Zaradi omejenega prostora na ovojnini sta na foliji in merilnih kapalkah uporabljeni oznaki: S (za majhne mačke) in L (za velike mačke).
The veterinary medicinal product is packaged in individual-dose transparent plastic pipettes overpacked in an aluminium foil package. 
Zdravilo je pakirano v prozorne plastične merilne kapalke z enkratnim odmerkom, ki so ovite v ovitek iz aluminijaste folije.
Special precautions for storage Do not store above 25°C 
POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte pri temperaturi nad 25 ºC
Wyeth Lederle Italia S.p.A. 18, Via Franco Gorgone 95121 Catania Italy 
18, Via Franco Gorgone 95121 Catania Italija
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris S 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris S
Cats over 8 weeks of age. 
Mačke, starejše od 8 tednov.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Dosage: 
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
WASTE MATERIALS, IF ANY 
ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
Each strength of the veterinary medicinal product is available in boxes with 1 and in boxes with 2 blister cards of 3 pipettes. 
Vsaka jakost zdravila je na voljo v škatlah z 1 in v škatlah z 2 blistroma s po 3 merilnimi kapalkami.
Marketing authorisation holder Pfizer Limited 
Imetnik dovoljenja za promet Pfizer Limited
For animal treatment only - to be supplied only on veterinary prescription. 
Samo za živali - na veterinarski recept.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 160 mg 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 160 mg
The top of the tip will fold back against the pipette. 
Vrh konice se bo upognil proti merilni kapalki.
Active substance: 320 mg metaflumizone 
Zdravilna učinkovina: 320 mg metaflumizona
ProMeris for Small Cats (≤ 4 kg) 
ProMeris za majhne mačke (≤ 4 kg)
In rare cases, transient irritation may occur at the site of the product application. 
V redkih primerih se lahko pojavi prehodna iritacija na mestu nanosa zdravila.
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris L 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris L
ProMeris for Small Cats ProMeris for Large Cats 
ProMeris za majhne mačke ProMeris za velike mačke
Active substance: 160 mg metaflumizone 
Zdravilna učinkovina: 160 mg metaflumizona
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. 
Poskrbite, da vsebina pipete ali nanešen odmerek ne pride v stik z očmi ali usti zdravljene živali in/ali drugih živali.
Method of administration: 
Način dajanja:
Each ml contains 200 mg metaflumizone. 
1 ml vsebuje 200 mg metaflumizona.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR 
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA
Carefully dispose of used pipettes immediately after use. 
Takoj po uporabi prazno merilno kapalko previdno odstranite.
D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
D. DRUGI POGOJI IN ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA
Not applicable. 
Ni smiselno
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS , IF ANY 
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
Do not store above 25 °C.Do not use after the expiry date stated on the carton after “EXP”. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po “EXP”.
TARGET SPECIES For cats over 8 weeks of age. 
CILJNE ŽIVALSKE VRSTE Za mačke, starejše od 8 tednov.
4.9 Amounts to be administered and administration route Dosage: 
4.9 Odmerjanje in pot uporabe Odmerki:
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. 
Nanos zdravila lahko lokalno povzroči začasen masten izgled, vozlanje in zlepljanje dlake na mestu nanosa.
The solvent in ProMeris may stain certain materials including leather, fabrics, plastics and finished surfaces. 
Topilo v zdravilu Promeris lahko pusti madeže na nekaterih materialih, vključno z usnjem, tkaninami,
In sick or debilitated animals, use only according to the benefit/risk assessment by the responsible veterinarian. 
Pri bolnih ali izčrpanih živalih uporabite le v skladu z oceno razmerja koristi/tveganja odgovornega veterinarja.
After topical administration at a single site on the cat's neck at the base of the skull, metaflumizone is rapidly distributed throughout the surface of the skin. 
Po topikalnem nanosu na eno mesto vratu na zatilje glave mačke se metaflumizon hitro razporedi po površini kože.
Remove the pipette from the package. 
Odstranite merilno kapalko iz ovojnine.
In case of accidental spillage onto skin, wash off immediately with soap and water. 
Če zdravilo pride v stik s kožo, jo takoj dobro sperite z milom in vodo.
Apply the content of the pipette to a single spot on the skin of the cat's neck at the base of the skull. 
Nanesite vsebino merilne kapalke na eno mesto kože vratu na zatilju glave mačke.
In sick or debilitated animals use only according to the benefit/risk assessment. 
Pri bolnih ali izčrpanih živalih uporabite zdravilo le v skladu z oceno razmerja koristi/tveganja.
Pharmacotherapeutic group: ATC Vet Code QP 53AX25 
Farmakoterapevtska skupina: Oznaka ATC vet QP 53AX25 Metaflumizon je ektoparazitik, ki po sestavi spada v skupino semikarbazonov.
BATCH NUMBER Lot {number} 
ŠTEVILKA SERIJE LOT {številka}
BATCH NUMBER LOT {number} 
ŠTEVILKA SERIJE Lot {številka}
It is important to apply the dose to an area where the animal cannot lick it off. Do not allow animals to groom each other following treatment. 
Odmerek nanesite na mesto, kjer ga žival ne more polizati.
MARKETING AUTHORISATION NUMBER(S) EU/2/06/064/001 - 1 blister card of 3 pipettes of 0.80 ml EU/2/06/064/002 - 2 blister cards of 3 pipettes of 0.80 ml 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/064/001 - 1 blister s 3 merilnimi kapalkamipo 0,80 ml EU/2/06/064/002 - 2 blistra s 3 merilnimi kapalkami po 0,80 ml
4.2 Indications for use, specifying the target species Treatment and prevention of flea infestations (Ctenocephalides canis and C. felis) in cats. 
INDIKACIJA(E) Zdravljenje in preprečevanje bolhavosti (Ctenocephalides canis in C. felis) pri mačkah.
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
DRUGI POGOJI IN ZAHTEVE KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 0.80 ml pipette delivers: 
Vsaka 0,80 ml pipeta vsebuje:
NAME OF THE MARKETING AUTHORISATION HOLDER PFIZER 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM PFIZER
The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD). 
Zdravilo se lahko uporablja za zdravljenje in preprečevanje alergijskih dermatitisov zaradi bolhavosti (FAD) pri mačkah.
METHOD AND ROUTE(S) OF ADMINISTRATION For cutaneous use only. 
NAČIN IN POT(I) UPORABE
The following table defines the size of pipette to be used according to the weight of the cat. 
Sledeča tabela prikazuje ustrezno velikost merilne kapalke glede na telesno maso mačke.
PHARMACEUTICAL FORM Spot-on solution A clear, yellow to amber solution 
FARMACEVTSKA OBLIKA Kožni nanos, raztopina Bistra, rumena do jantarna raztopina.
The following table defines the size of pipette to be used according to the weight of the cat 
Sledeča tabela prikazuje ustrezno velikost merilne kapalke glede na telesno maso mačke
If the veterinary medicinal product accidentally gets into eyes, flush the eyes thoroughly with water. 
Če zdravilo pride v stik z očmi, jih dobro sperite z veliko količino čiste vode.
TARGET SPECIES Cats above 8 weeks of age. 
CILJNE ŽIVALSKE VRSTE Mačke, starejše od 8 tednov.
Correct application will minimise licking of the application site. 
Pravilen nanos zmanjša možnost lizanja mesta nanosa.
This is normal and will generally resolve within 1 - 4 days after administration. 
Opazen je lahko tudi suh ostanek, ki se razgradi v 1 - 4 dneh po dajanju.
Part the fur on the cat's neck at the base of the skull until the skin is visible. 
Razprite dlako na vratu na zatilju glave, dokler ni vidna koža.
MARKETING AUTHORISATION NUMBER(S) EU/2/06/064/003 - 1 blister card of 3 pipettes of 1.60 ml EU/2/06/064/004 - 2 blister cards of 3 pipettes of 1.60 ml 
EU/2/06/064/003 - 1 blister s 3 merilnimi kapalkami po 1,60 ml EU/2/06/064/004 - 2 blistra s 3 merilnimi kapalkami po 1,60 ml
Name and address of the manufacturer responsible for batch release 
Ime in naslov izdelovalca(izdelovalcev) zdravila, odgovornega (odgovornih) za sprostitev serije
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box for 1 blister card -Carton box for 2 blister cards 
PODATKI NA ZUNANJI OVOJNINI Kartonasta škatla z 1 blistrom - Kartonasta škatla z 2 blistroma
The veterinary medicinal product will prevent flea infestation for up to 6 weeks following a single administration depending on the level of environmental rechallenge. 
Zdravilo po enkratnem dajanju ščiti pred bolhami do 6 tednov, odvisno od ponovne infestacije iz okolja.
Do not administer to kittens under 8 weeks of age. 
KONTRAINDIKACIJE Ne dajajte mačkam, mlajšim od 8 tednov.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Active Substance 
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI
Box of 1 or 2 blister card of 3 x 0.80 ml pipettes Box of 1 or 2 blister card of 3 x 1.60 ml pipettes 
Škatla z 1 ali 2 blistroma s 3 x 0,80 ml merilnimi kapalkami Škatla z 1 ali 2 blistroma s 3 x 1,60 ml merilnimi kapalkami
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 1.60 ml pipette delivers: 
Vsaka 1,60 ml pipeta vsebuje:
4.6 Adverse reactions (frequency* and seriousness) 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
ProMeris for Small Cats (≤ 4 kg)* 
ProMeris za majhne mačke (≤ 4 kg)* ProMeris za velike mačke
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris 320 mg Spot-on for large cats {> 4 kg} 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris 320 mg kožni nanos za velike mačke {> 4 kg}
Box of 1 blister card of 3 x 0.80 ml pipettes Box of 2 blister cards of 3 x 0.80 ml pipettes 
VELIKOST PAKIRANJA Škatla z 1 blistrom s 3 x 0,80 ml merilnimi kapalkami Škatla z 2 blistroma s 3 x 0,80 ml merilnimi kapalkami
Box of 1 blister card of 3 x 1.60 ml pipettes Box of 2 blister cards of 3 x 1.60 ml pipettes 
VELIKOST PAKIRANJA Škatla z 1 blistrom s 3 x 1,60 ml merilnimi kapalkami Škatla z 2 blistroma s 3 x 1,60 ml merilnimi kapalkami
C. STATEMENT OF THE MRLs Not applicable 
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
INDICATION(S) For the treatment and prevention of infestations by fleas. 
Za zdravljenje in preprečevanje bolhavosti.
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris 160 mg Spot-on for small cats ProMeris 320 mg Spot-on for large cats 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris 160 mg kožni nanos za majhne mačke ProMeris 320 mg kožni nanos za velike mačke
STATEMENT OF THE MRLs 
( MRL)
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box for 1 blister card 
PODATKI NA ZUNANJI OVOJNINI Kartonasta škatla z 1 blistrom Kartonasta škatla z 2 blistroma
For use only under the supervision of a veterinary surgeon. 
NASVET O PRAVILNI UPORABI ZDRAVILA Uporabljajte samo pod nadzorom veterinarja
4.7 Use during pregnancy, lactation or lay 
Uporaba v obdobju brejosti, laktacije ali nesnosti Lahko se uporablja v obdobju brejosti in laktacije.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROSTITEV SERIJE
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children. 
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris 160 mg Spot-on for small cats {< 4 kg} 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris 160 mg kožni nanos za majhne mačke {≤ 4 kg}
Allow the application site to dry before permitting contact with such materials. 
plastiko in lakiranimi površinami, zato zagotovite, da se mesto nanosa posuši, preden pride v stik s takimi površinami.
PACKAGE LEAFLET ProMeris Spot-on for cats 
NAVODILO ZA UPORABO ProMeris kožni nanos za mačke
Hypersalivation may occur if the animal licks the application site immediately after treatment. 
NEŽELENI UČINKI* Če žival takoj po nanosu liže mesto nanosa, se lahko pojavi pretirano slinjenje.
Place the tip of the pipette on the skin and squeeze the pipette to empty the entire contents. 
Merilno kapalko stisnite, dokler popolnoma ne izpraznite njene vsebine.
It is supplied in units of 3 pipettes per cardboard card and one or two cards per cardboard box. 
V enem blistru so 3 merilne kapalke, v eni škatli sta 1 ali 2 blistra.
Avoid contact with the eyes of the cat and avoid oral ingestion by the animal. 
Preprečite, da bi zdravilo prišlo v stik z očmi mačke, ali da bi ga žival pojedla..
CONTRAINDICATIONS 
Posebna opozorila
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription. 
B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom 
Pfizer Limited Ramsgate Road Sandwich
PHARMACEUTICAL FORM Spot-on solution 
FARMACEVTSKA OBLIKA Kožni nanos, raztopina
Weight Of Cat (kg) 
(kg)
MINIMUM PARTICULARS TO APPEAR ON PIPETTES for small cats 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the CHMP concludes that: 
Odbor CHMP zato v skladu s členoma 31 in 32 Direktive 2001/83/ES zaključuje naslednje:
In view of the elements described above, BfArM considered that there was a need to take action at EU level. 
Glede na navedeno je inštitut BfArM ocenil, da je treba ukrepati na ravni EU.
Conclusions 
Zaključki
Three bioequivalence trials, two performed in 2013 and one performed in 2014, were inspected. 
Pregledana so bila tri preskušanja bioekvivalence, dve, opravljeni leta 2013, in eno, opravljeno leta 2014.
• The Committee reviewed all available data and information provided by the MAHs/applicants, as well as information provided by Alkem Laboratories; 
• Odbor je pregledal vse razpoložljive podatke in informacije, ki so jih zagotovili imetniki dovoljenj za promet z zdravilom/predlagatelji, ter informacije, ki jih je predložila družba Alkem Laboratories;
The findings of the above mentioned inspection cast doubts on the reliability of the data of bioequivalence studies conducted between 2013 and 2014 at the site inspected. 
Izsledki navedenega inšpekcijskega pregleda vzbujajo dvome o zanesljivosti podatkov iz študij bioekvivalence, opravljenih leta 2013 in 2014 na pregledani lokaciji.
It has been highlighted that all the CAPAs agreed after the BfArM/IGZ inspection have been either implemented (for critical observations) or committed to (for other observations). 
Poudarjeno je bilo, da so bili vsi dogovorjeni korektivni in preventivni ukrepi po inšpekcijskem pregledu inštituta BfArM/inšpektorata IGZ bodisi izvedeni (za kritične napake) bodisi je bila zanje prevzeta obveznost izvedbe (za druge napake).
There was one general quality management system implemented at the site which included a quality assurance unit which was responsible for the clinical and the bioanalytical parts of the trial and which reported to the CEO of the facility. 
Na lokaciji se je izvajal en splošni sistem vodenja kakovosti, ki je vključeval enoto za zagotavljanje kakovosti, odgovorno za klinični in bioanalitski del preskušanja, ki je poročala izvršnemu direktorju obrata.
The conditions imposed to lift the suspension of the marketing authorisation are set out in section 4 of this report. 
Pogoji za preklic začasnega umika dovoljenja za promet z zdravilom so navedeni v razdelku 4 tega poročila.