natgillin/translations-raw huggingface dataset:
Overall Survival Number of deaths, N (%) Median OS (months)a [95% CI]b Hazard ratio [95% CI] P-valuec
Preživetje brez napredovanja bolezni Število napredovanj bolezni ali smrti, N (%) Mediana PFS (meseci)a [95-% CI]b Razmerje ogroženosti [95-% CI] Vrednost pc
* Common terminology criteria for adverse events Table 4 - Dose reductions according to body surface area (BSA)
* enotna razvrstitev meril neželenih dogodkov (CTCAE - Common Terminology Criteria for Adverse Events)
NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg film-coated tablets Lonsurf 20 mg/8.19 mg film-coated tablets
Lonsurf 15 mg/6,14 mg filmsko obložene tablete Lonsurf 20 mg/8,19 mg filmsko obložene tablete
Pleural effusion Rhinorrhoea Dysphonia Oropharyngeal pain Epistaxis
Jetrna okvara • Blaga jetrna okvara
Tipiracil hydrochloride was a substrate for OCT2 and MATE1, therefore, the concentration might be increased when Lonsurf is administered concomitantly with inhibitors of OCT2 or MATE1.
Tipiracilijev klorid je substrat prenašalca za organske katione OCT2 (OCT2 - Organic Cation Transporter 2) in prenašalca za ekstruzijo več zdravil in toksinov (MATE1 - MultiDrug and Toxin Extrusion 2), zato se lahko njegova koncentracija ob sočasni uporabi zdravila Lonsurf in inhibitorjev OCT2 in MATE1 poveča.
Lonsurf 20 mg/8.19 mg film-coated tablets
Lonsurf 20 mg/8,19 mg filmsko obložene tablete
Special populations
Etnične skupine
Figure 1- Kaplan-Meier curves of overall survival in patients with metastatic colorectal cancer
Slika 1 - Kaplan-Meierjeva krivulja celokupnega preživetja pri bolnikih z metastatskim kolorektalnim rakom
Based on the mechanism of action, trifluridine is suspected to cause congenital malformations when administered during pregnancy.
Podatkov o uporabi zdravila Lonsurf pri nosečnicah ni. Glede na mehanizem delovanja trifluridina obstaja sum, da povzroča prirojene nepravilnosti, če ga jemljejo nosečnice.
• Week 4 - No medicine You will then start again with another cycle of 4 weeks following the above pattern.
Potem boste začeli naslednji 4-tedenski cikel zdravljenja po zgornji shemi.
Cancer pain
Rak želodca
Skin exfoliation Urticaria
PODATKI NA ZUNANJI OVOJNINI ŠKATLA
There is no need for a starting dose adjustment in patients with mild hepatic impairment (see section
Pri bolnikih z blago jetrno okvaro ni priporočil glede prilagajanja začetnega odmerka (glejte poglavje
The median time to PS ≥ 2 for the Lonsurf group and placebo group was 5.7 months and 4.0 months, respectively, with a hazard ratio of 0.66 (95% CI: [0.56, 0.78]), p < 0.0001.
Zdravljenje z zdravilom Lonsurf in BSC je povzročilo statistično značilno podaljšanje PS < 2 v primerjavi s placebom in z BSC. Mediana vrednost časa do PS ≥ 2 je bila v skupini, zdravljeni z zdravilom Lonsurf, 5,7 meseca in v placebo skupini 4,0 mesece z razmerjem ogroženosti 0,66 (95-% CI [od 0,56 do 0,78]), p < 0,0001.
Figure 2 - Kaplan-Meier curves of progression-free survival in patients with metastatic colorectal cancer
Slika 2 - Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni pri bolnikih z metastatskim kolorektalnim rakom
INFORMATION IN BRAILLE Lonsurf 20 mg/8.19 mg
Lonsurf 20 mg/8.19 mg
• swelling in your hands or legs or feet
• otekanje dlani ali nog ali stopal
Following a single dose of Lonsurf (35 mg/m2) in patients with advanced solid tumours, the mean times to peak plasma concentrations (tmax) of trifluridine and tipiracil hydrochloride were around 2 hours and 3 hours, respectively.
Po enkratnem odmerku zdravila Lonsurf (35 mg/m2) pri bolnikih z napredovalimi solidnimi tumorji je bil srednji čas do največje plazemske koncentracije (tmax) trifluridina okoli 2 uri, tipiracilijevega klorida pa 3 ure.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg trifluridine and 6.14 mg of tipiracil (as hydrochloride).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 15 mg trifluridina in 6,14 mg tipiracila (v obliki klorida).
Figure 3- Kaplan-Meier curves of overall survival in patients with metastatic gastric cancer
Slika 3 - Kaplan-Meierjevi krivulji celokupnega preživetja pri bolnikih z metastatskim rakom želodca
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg trifluridine and 8.19 mg of tipiracil (as hydrochloride).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 20 mg trifluridina in 8,19 mg tipiracila (v obliki klorida).
Hazard ratio for progression or death, 0.57 (95% CI, 0.47-0.70) P<0.0001 (1-sided and 2-sided)
Razmerje ogroženosti za napredovanje bolezni in smrt, 0,57 (95% CI, p < 0,0001 (enostranska in dvostranska)
They are classified according to System Organ Class (SOC) and the appropriate Medical Dictionary for Regulatory (MedDRA) term is used to describe a certain drug reaction and its synonyms and related conditions.
Za opis določenega učinka, njegovih sinonimov in povezanih stanj so uporabljeni najustreznejši izrazi iz Medicinskega slovarja za regulatorne aktivnosti (MedDRA - Medical Dictionary for Regulatory Activities).
Figure 4 - Kaplan-Meier curves of progression-free survival in patients with metastatic gastric cancer
Slika 4 - Kaplan-Meierjevi krivulji preživetja brez napredovanja bolezni pri bolnikih z metastatskim rakom želodca
• rash, itchy or flaky skin
• izpuščaj, srbeča ali luskasta koža.
Reproductive system and breast disorders
Motnje reprodukcije in dojk motnje menstruacije
EU/1/16/1096/005 40 film-coated tablets
EU/1/16/1096/004 20 filmsko obloženih tablet EU/1/16/1096/005 40 filmsko obloženih tablet EU/1/16/1096/006 60 filmsko obloženih tablet
Mucosal inflammation Malaise
Psihiatrične motnje anksioznost nespečnost
mild (CrCl = 60 to 89 mL/min) or moderate (CrCl = 30 to 59 mL/min) renal impairment subgroups.
Globalna pojavnost neželenih dogodkov (AEs - Adverse Events) je podobna v podskupinah z normalno ledvično funkcijo (očistek kreatinina ≥ 90 ml/min), blago (očistek kreatinina od 60 do 89 ml/min) ali zmerno ledvično okvaro (očistek kreatinina od 30 do 59 ml/min).
NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg film-coated tablets trifluridine/tipiracil
Lonsurf 15 mg/6,14 mg filmsko obložene tablete trifluridin/tipiracil
Reproductive toxicity
Toksičnost za prebavila
NAME OF THE MEDICINAL PRODUCT Lonsurf 20 mg/8.19 mg film-coated tablets trifluridine/tipiracil
Lonsurf 20 mg/8,19 mg filmsko obložene tablete trifluridin/tipiracil
Renal failure Cystitis noninfective Micturition disorder Haematuria Leukocyturia
Bolezni sečil proteinurija ledvična odpoved neinfektivni cistitis motnje mikcije hematurija levkociturija
• If you experience any side effects, talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
- Film coating: hypromellose, macrogol (8000), titanium dioxide (E171), iron oxide red (E172) and magnesium stearate.
• Druge sestavine so: - jedro tablete: laktoza monohidrat, predgelirani koruzni škrob in stearinska kislina; - filmska obloga: hipromeloza, makrogol (8000), titanov dioksid (E171) in magnezijev stearat; - črnilo: šelak, rdeči železov oksid (E172), rumeni železov oksid (E172), titanov dioksid (E171), indigotin (E132), karnauba vosek in smukec.
• redness, itching of the eye, eye infections, watery eyes
• rdeče, srbeče oko, vnetje oči, solzne oči
• kidney failure
Ledvična okvara
- Printing ink: shellac, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine aluminium lake (E132), carnauba wax and talc.
• Druge sestavine so: - jedro tablete: laktoza monohidrat, predgelirani koruzni škrob in stearinska kislina; - filmska obloga: hipromeloza, makrogol (8000), titanov dioksid (E171), rdeči železov oksid (E172) in magnezijev stearat; - črnilo: šelak, rdeči železov oksid (E172), rumeni železov oksid (E172), titanov dioksid (E171), indigotin (E132), karnauba vosek in smukec.
• bloating, passing gas, indigestion
• občutek napihnjenosti, vetrovi, prebavne motnje
≥ 1.5 × 109/L
 1,5  109/l trombociti
No adjustment of the starting dose is recommended in patients with mild hepatic impairment (see section 5.2).
Pri bolnikih z blago jetrno okvaro prilagajanje začetnega odmerka ni potrebno (glejte poglavje 4.2).
Enterocolitis haemorrhagic Gastrointestinal haemorrhage Pancreatitis acute Ascites
Bolezni jeter, žolčnika in žolčevodov hiperbilirubinemija hepatotoksičnost razširitev žolčnih vodov
15 mg/6.14 mg 20 mg/8.19 mg Level 1 dose reduction: From 35 mg/m2 to 30 mg/m2 30 mg/m2
1. raven zmanjšanja odmerka: s 35 mg/m2 na 30 mg/m2 30 mg/m2
Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.
Zdravilo Lonsurf je indicirano v monoterapiji za zdravljenje odraslih bolnikov z metastatskim kolorektalnim rakom (KRR), ki so bili predhodno že zdravljeni ali niso primerni za zdravljenja, ki so na voljo.
Impaired gastric emptying Abdominal distension Anal inflammation Mouth ulceration Dyspepsia
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja pljučna embolijab plevralni izliv izcedek iz nosu disfonija orofaringealna bolečina epistaksa kašelj
Bone marrow suppression
• odpoved ledvic
• feeling generally out of sorts (malaise)
• občutek splošnega slabega počutja
A dry residue may also be observed.
Opazen je lahko tudi suh ostanek.
In these cases do not treat more frequently than once a fortnight.
V takih primerih ne zdravite pogosteje kot enkrat na 14 dni.
Recently treated animals should not be allowed to sleep with the owners, especially children.
Pravkar zdravljene živali ne smejo spati z lastniki, še posebej ne z otroki.
These signs are transient and reversible if prompt and appropriate treatment is administered.
Ti znaki so prehodni in reverzibilni, če se zagotovi takojšnje in ustrezno zdravljenje.
Children should not have access to used pipettes.
Otroci ne smejo imeti dostopa do uporabljenih pipet.
Used pipettes should be disposed of immediately.
Uporabljene pipete je treba odstraniti takoj.
Both components were still measurable in the hair 56 days following treatment.
Oba je bilo v dlaki možno izmeriti 56 dni po zdravljenju.
Where possible, treatment should not be discontinued until skin scrapings are negative on at least two monthly occasions.
Če je možno, zdravljenja ne prekinite, dokler niso kožni ostružki negativni vsaj dva meseca.
This is not a sign of intoxication and disappears within minutes without treatment.
To ni znak zastrupitve in brez zdravljenja izgine v nekaj minutah.
Kills most ticks within 48 hours.
Večino klopov pobije v 48 urah.
Children should not have contact with the product or with animals during treatment.
Otroci ne smejo imeti stika z zdravilom ali z živalmi med zdravljenjem.
If the dog requires shampooing, it is better to do so before applying the veterinary medicinal product.
Če je psa potrebno skopati s šamponom, je to bolje opraviti pred dajanjem zdravila.
Signs are usually transitory and generally resolved without treatment within 24 hours.
Znaki so ponavadi prehodni in običajno izginejo brez zdravljenja v 24 urah.
Maximum concentrations in the hair were generally reached between 2 to 7 days post treatment and gradually declined through 56 days post treatment.
Maksimalna koncentracija v dlaki je dosežena med 2. in 7. dnevom po zdravljenju in se postopoma znižuje v 56 dnevih po zdravljenju.
For dogs more than 50 kg, use a combination of two pipettes that most closely matches the body weight.
Pri psih, težjih od 50 kg, uporabite kombinacijo dveh merilnih kapalk, ki najbolj ustrezata njihovi telesni masi.
In very rare cases temporary local hair loss may occur.
V zelo redkih primerih se lahko pojavi začasna izguba dlake.
In addition it is recommended to treat the environment with a suitable insecticide.
Prav tako je s primernim insekticidom priporočljivo tretirati tudi okolje.
In cases of frequent water exposure the duration of activity may be reduced.
V primeru pogostega izpostavljanja vodi se lahko skrajša čas učinkovanja zdravila.
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/
This product contains amitraz, which can lead to adverse neurological effects in humans and especially in children.
Zdravilo vsebuje amitraz, ki lahko povzroči neželene nevrološke učinke pri ljudeh, še posebej pri otrocih.
Do not administer to cats.
Ne dajajte mačkam.
As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
Ker je demodikoza večfaktorska bolezen, je priporočljivo primerno zdraviti tudi osnovno bolezen.
Do not administer to sick or debilitated dogs or dogs suffering from heat stress.
Ne dajajte bolnim ali slabotnim psom, ali psom, prizadetim zaradi vročinskega stresa.
To minimise the potential for inhalation, it is recommended that the product is applied in open air or in well ventilated rooms.
Da se zmanjša možnost inhalacije, je priporočljivo zdravilo dajati v odprtem prostoru ali v dobro prezračevanem prostoru.
Amitraz is a formamidine acaricide.
Amitraz je formamidinski akaricid.
The veterinary medicinal product should not enter watercourses, as this may be dangerous for fish and other aquatic organisms.
Zdravilo za uporabo v veterinarski medicini ne sme priti v vodotoke, ker je lahko nevarno za ribe in druge vodne organizme.
This product may cause skin sensitisation and allergic reactions in humans.
Zdravilo lahko draži kožo in povzroči alergične reakcije pri ljudeh.
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances
KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilne učinkovine
The risk of experiencing adverse effects may however increase when overdosing, so animals should always be treated with the correct pipette size according to body weight.
Vendar pa se tveganje za pojav neželenih učinkov pri prevelikem odmerjanju poveča, zato je treba živali vedno zdraviti z ustrezno velikostjo pipete glede na njihovo telesno maso.
Dogs should be prevented from accessing streams and rivers for the 24-hour period following treatment.
Psi ne smejo imeti dostopa do potokov in rek 24 ur po zdravljenju.
For treatment of demodicosis, the product should be administered at monthly intervals until clinical signs resolve.
Za zdravljenje demodikoze dajajte zdravilo v mesečnih intervalih dokler klinični znaki ne izginejo.
Do not allow puppies to lick the application site of their mothers when it is still wet.
Ne dovolite mladičem, da bi lizali mesto nanosa na materi, dokler je to še mokro.
Dogs over 8 weeks of age
Psi, starejši od 8 tednov
ProMeris Duo contains components that, on very rare occasions, can cause respiratory irritation in certain people.
ProMeris Duo vsebuje snovi, ki lahko v redkih primerih pri določenih ljudeh povzročijo draženje dihal.
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”.
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 merilne kapalke ali nanešen odmerek ne pride v stik z očmi ali usti zdravljene živali in/ali drugih živali.
It acts at octopamine receptor sites in ectoparasites giving rise to increased nervous activity and death of insects.
Učinkuje na mestu oktopaminskih receptorjev v ektoparazitih, s čimer poveča živčno aktivnost in s tem smrt insektov.
Most of these signs are due to alpha-2adreno-receptor agonist effects.
Večina teh znakov je posledica agonističnih učinkov na alfa-2adrenergične-receptorje.
Known side-effects of amitraz and metabolites are sedation, lethargy, CNS depression, hyperglycaemia, bradycardia and slow, shallow breathing.
Znani stranski učinki amitraza in metabolitov so sedacija, letargija, depresija CŽS, hiperglikemija, bradikardija in počasno, plitko dihanje.
Shelf life of the veterinary medicinal product as package for sale:2 years.
Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti.
Stored pipettes must be kept in the intact foil package.
Shranjene pipete je treba hraniti v nepoškodovanem pakiranju iz folije.
TARGET SPECIES For dogs over 8 weeks of age.
CILJNE ŽIVALSKE VRSTE Za pse, starejše od 8 tednov.
This product may cause mild eye irritation.
Zdravilo lahko povzroči blažje iritacije oči.
For the treatment and prevention of infestations by fleas and ticks, and treatment of demodicosis and lice.
Zdravljenje in preprečevanje bolhavosti in klopavosti, ter zdravljenje demodikoze in ušivosti.
After topical administration at a single site at the base of the skull, both metaflumizone and amitraz levels in plasma were too low to allow the calculation of standard pharmacokinetic parameters.
Po topikalnem dajanju na eno mesto na zatilju so bili nivoji metaflumizona in amitraza v plazmi prenizki, da bi omogočali izračun standardnih farmakokinetičnih parametrov.
Avoid direct contact with treated animals until the application site is dry.
Izogibajte se direktnim stikom z živaljo, dokler ni mesto nanosa suho.
This is normal and will generally resolve within a few days after administration, though may persist longer on rare occasions.
To je normalno in izgine v nekaj dneh po dajanju, v redkih primerih lahko ostane dlje časa.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients N, N-Diethyl-m-toluamide 1-Methoxy-2-propyl-acetate Dimethyl sulfoxide
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi N, N-dietil-m-toluamid 1-metoksi-2-propil-acetat Dimetilsulfoksid 1, 8-Cineol
Do not store above 25 °C.
Ne shranjujte pri temperaturi nad 25 ºC.
Do not apply the medicine to the surface of the dog's hair coat.
Zdravila ne nanašajte na površino dlake.
For treatment of biting lice a single dose should be sufficient.
Za zdravljenje ušivosti zadostuje en odmerek.
Amitraz is a monoamine oxidase inhibitor (MOAI); therefore, people taking MOAI-containing medication should take particular care when handling this product.
Amitraz je inhibitor monoamino-oksidaze (MOAI); zato morajo ljudje, ki delajo z zdravilom, ravnati pazljivo.
If symptoms are severe or persist the alpha-2-adreno-receptor antagonist atipamezole hydrochloride may be used at a dose of 0.2 mg/kg bodyweight by intramuscular injection to reverse these side-effects.
Če so simptomi hudi ali trajajo dlje časa, lahko uporabite antagonist alfa-2-adrenergičnih-receptorjev, atipamezolijev klorid, v odmerku 0,2 mg/kg telesne mase intramuskularno, da stranski učinki izginejo.
No adverse effects were observed in healthy dogs and puppies aged 8 weeks and older treated 7 times at two-week intervals with 3-5 times the recommended dose.
Pri zdravih psih in mladičkih, starih 8 tednov ali več, zdravljenih 7-krat v dvotedenskih intervalih s 35-kratnim priporočenim odmerkom ni bilo opaziti neželenih učinkov.
For optimal control of flea and/or tick infestation the product should be administered at monthly intervals throughout the flea and/or tick season, or the treatment schedule can be based on the local epidemiological situation.
Za optimalno kontrolo bolhavosti in/ali klopavosti lahko med sezono bolh in/ali klopov zdravilo nanašate v mesečnih intervalih, lahko pa načrt zdravljenja temelji na lokalni epidemiološki situaciji.
For further information see package leaflet.
Za nadaljnje informacije glejte navodilo za uporabo.
In very rare cases, pemphigus foliaceous-like cutaneous signs have been reported.
V zelo redkih primerih so poročali o kožnih spremembah, podobnih tistim, ki so značilne za pemphigus foliaceous.
België/Belgique/Belgien Pfizer Animal Health s.a., Tél/Tel.
Pfizer Animal Health s.a., Tél/Tel.
MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/001-010
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/065/001-010
Metaflumizone and amitraz are combined in the final formulation to provide a broad spectrum of activity against both fleas and ticks, respectively, due to non-systemic exposure of the parasites on the skin and hair.
Kombinacija metaflumizona in amitraza zagotovlja širok spekter delovanja proti bolham in klopom z nesistemsko izpostavitvijo parazitov na koži in dlaki.
SPECIAL STORAGE CONDITIONS Do not store above 25°C
POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte pri temperaturi nad 25 ºC
Treatment with other products containing amitraz is not recommended whilst the dog is being treated with ProMeris Duo Spot-On for Dogs.
Zdravljenje z drugimi zdravili, ki vsebujejo amitraz v obdobju, ko psa zdravite z zdravilom ProMeris Duo kožni nanos za pse, ni priporočljivo.
For the treatment and prevention of infestations by fleas (Ctenocephalides canis and C. felis), and ticks (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulatus and Dermacentor variabilis), and treatment of demodicosis (caused by Demodex spp.)
Zdravljenje in preprečevanje bolhavosti (Ctenocephalides canis in C. felis) in klopavosti (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulatus in Dermacentor variabilis) ter zdravljenje demodikoze (ki jo povzroča Demodex spp.)
After topical administration at a single site at the base of the skull, both metaflumizone and amitraz were rapidly distributed throughout the surface of the skin.
Po topikalnem nanosu na eno mesto na zatilju se metaflumizon in amitraz hitro razporedita po površini kože.
The recommended minimum dose is 20 mg/kg bodyweight for each of metaflumizone and amitraz, equivalent to 0.133ml/kg bodyweight.
Priporočen minimalni odmerek za metaflumizon in za amitraz je 20 mg/kg telesne mase, kar ustreza 0,133 ml/kg telesne mase.
EXPIRY DATE EXP {month/year}
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {month/year}
If pemphigus-like signs occur, further use of the product should be avoided.
V primeru pojava sprememb, podobnih tistim, ki so značilne za pemphigus foliaceous, se izognite nadaljnji uporabi zdravila.
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).
EXPIRY DATE EXP {month/year}>
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {month/year}>
Each ml contains 150 mg metaflumizone and 150 mg amitraz.
1 ml vsebuje 150 mg metaflumizona in 150 mg amitraza.
The veterinary medicinal product is packaged in individual-dose transparent plastic pipettes over packed in an aluminium foil package.
Zdravilo je pakirano v prozorne plastične merilne kapalke z enkratnim odmerkom, ki so ovite z ovitkom iz aluminijaste folije.
BATCH NUMBER LOT {number}
ŠTEVILKA SERIJE LOT {number}
for Small Dogs (≤ 5 kg) for Medium Sized Dogs - (5.1 - 10.0 kg) for Medium/Large Sized Dogs (10.1 - 25.0 kg) for Large Dogs (25.1 - 40.0 kg) for Extra Large Dogs (40.1 - 50.0 kg)
za majhne pse (≤ 5 kg) za srednje pse - (5,1 - 10,0 kg) za srednje/velike pse (10,1 - 25,0 kg) za velike pse (25,1 - 40,0 kg) za zelo velike pse (40,1 - 50,0 kg)
The following table defines the size of pipette to be used according to the weight of the dog.
Sledeča tabela prikazuje prikazuje ustrezno velikost merilne kapalke glede na telesno maso psov.
For the treatment and prevention of infestations by fleas (Ctenocephalides canis and C. felis) and ticks (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulates and Dermacentor variabilis), and treatment of demodicosis (caused by Demodex spp.)
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Zdravljenje in preprečevanje bolhavosti (Ctenocephalides canis in C. felis) in klopavosti (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulatus in Dermacentor variabilis) ter zdravljenje demodikoze (ki jo povzroča Demodex spp.)
In rare cases, transient irritation may occur at the site of product application.
V redkih primerih se lahko pojavi prehodna iritacija na mestu nanosa.