FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with moderate or severe renal impairment or with end-stage renal disease (ESRD), the recommended dose of Galvus is 50 mg once daily (see also sections 4.4, 5.1 and 5.2).
Slovenian: Pri bolnikih z zmerno ali hudo okvaro ledvic ali s končno ledvično odpovedjo (ESRD - end-stage renal disease) je priporočeni odmerek zdravila Galvus 50 mg enkrat na dan (glejte tudi poglavja 4.4, 5.1 in 5.2).
English: Galvus 50 mg tablets are available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks comprising 3 cartons, each containing 112 tablets.
Slovenian: Tablete Galvus 50 mg so na voljo v pakiranjih po 7, 14, 28, 30, 56, 60, 90, 112, 180 ali 336 tablet in v skupnem pakiranju, ki obsega 3 škatle, od katerih vsaka vsebuje 112 tablet.
English: • Uncommon (may affect up to 1 in 100 people): Tiredness
Slovenian: • občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): utrujenost
English: • 100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Galvus alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulphonylurea, or with insulin.
Slovenian: • 100 mg na dan, ki ga vzamete v odmerkih 50 mg zjutraj in 50 mg zvečer, če jemljete zdravilo Galvus samostojno, skupaj z drugim zdravilom, ki se imenuje metformin ali glitazon, v kombinaciji z metforminom in sulfonilureo ali z insulinom,
English: Some symptoms need immediate medical attention: You should stop taking Galvus and see your doctor immediately if you experience the following side effects:
Slovenian: Pri nekaterih simptomih je potrebna takojšnja zdravniška pomoč: V primeru, da pride do naslednjih neželenih učinkov, morate prenehati jemati zdravilo Galvus in takoj obiskati zdravnika:
English: Galvus should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN) (see also sections 4.4 and 5.2).
Slovenian: Zdravila Galvus ne smejo uporabljati bolniki z okvaro jeter, vključno z bolniki, ki imajo pred zdravljenjem vrednosti alanin-aminotransferaze (ALT) ali aspartat-aminotransferaze (AST) nad 3-kratno zgornjo mejo normalnih vrednosti (upper limit of normal - ULN) (glejte poglavji 4.4 in 5.2).
English: Galvus contains lactose (milk sugar).
Slovenian: Zdravilo Galvus vsebuje laktozo Zdravilo Galvus vsebuje laktozo (mlečni sladkor).
English: How Galvus works
Slovenian: Kako zdravilo Galvus deluje
English: • Frequency not known (cannot be estimated from the available data): Itchy rash, inflammation of the pancreas, localised peeling of skin or blisters, muscle pain
Slovenian: • neznana pogostnost (je ni mogoče oceniti iz razpoložljivih podatkov): srbeč izpuščaj, vnetje trebušne slinavke, lokalizirano luščenje kože ali mehurji, bolečina v mišicah.
English: If you take too many Galvus tablets, or if someone else has taken your medicine, talk to your doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Galvus, kot bi smeli Če ste vzeli preveč tablet zdravila Galvus ali če je kdo drug vzel vaše zdravilo, se takoj obrnite na zdravnika.
English: Liver function should be monitored during treatment with Galvus at three-month intervals during the first year and periodically thereafter.
Slovenian: Delovanje jeter je treba v prvem letu zdravljenja z zdravilom Galvus spremljati vsake 3 mesece in občasno tudi kasneje.
English: Table 8 Key efficacy results of vildagliptin in placebo-controlled monotherapy trials and in add-on combination therapy trials (primary efficacy ITT population)
Slovenian: Preglednica 8 Ključni rezultati učinkovitosti vildagliptina v preskušanjih, kontroliranih s placebom, in sicer z monoterapijo oziroma s kombinacijo z dodanim zdravilom (primarna ITT populacija za oceno učinkovitosti)
English: Children and adolescents The use of Galvus in children and adolescents up to 18 years of age is not recommended.
Slovenian: Otroci in mladostniki Pri otrocih in mladostnikih do 18. leta starosti uporaba zdravila Galvus ni priporočena.
English: • 50 mg daily taken as one dose in the morning if you are taking Galvus with another medicine called a sulphonylurea.
Slovenian: • 50 mg na dan, ki ga vzamete v enem odmerku zjutraj, če jemljete zdravilo Galvus skupaj z drugim zdravilom, ki se imenuje sulfonilurea,
English: If you stop taking Galvus
Slovenian: Če ste prenehali jemati zdravilo Galvus
English: • if you are on dialysis.
Slovenian: • če se zdravite z dializo,
English: Do not take Galvus:
Slovenian: Ne jemljite zdravila Galvus
English: Galvus 50 mg tablets
Slovenian: Galvus 50 mg tablete
English: Liver function tests should be performed prior to the initiation of treatment with Galvus in order to know the patient's baseline value.
Slovenian: Pred začetkom zdravljenja z zdravilom Galvus je treba opraviti pregled jetrnih testov za določitev bolnikovih izhodiščnih vrednosti.
English: Galvus should not be used during breast-feeding.
Slovenian: Zdravila Galvus se med dojenjem ne sme uporabljati.
English: What Galvus looks like and contents of the pack Galvus 50 mg tablets are round, white to light yellowish and flat, with “NVR” on one side and “FB” on the other.
Slovenian: Tablete Galvus 50 mg so okrogle, ploščate, bele do svetlo rumenkaste barve, z napisom “NVR” na eni strani in “FB” na drugi.
English: It is not known if Galvus passes into breast milk.
Slovenian: Ni znano, ali zdravilo Glavus prehaja v materino mleko.
English: Galvus 50 mg tablets vildagliptin
Slovenian: Galvus 50 mg tablete vildagliptin
English: Galvus is not recommended for use in children and adolescents (< 18 years).
Slovenian: Uporaba zdravila Galvus pri otrocih in mladostnikih (< 18 let) ni priporočljiva.
English: Due to lack of human data, Galvus should not be used during pregnancy.
Slovenian: Zaradi nezadostnih podatkov o uporabi med nosečnostjo pri ljudeh zdravila Galvus ne smete uporabljati pri nosečnicah.
English: Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Galvus.
Slovenian: Bolniki, pri katerih pride do ikterusa ali drugih znakov, ki nakazujejo moteno delovanje jeter, morajo prekiniti zdravljenje z zdravilom Galvus.
English: • Very rare (may affect up to 1 in 10,000 people): Sore throat, runny nose
Slovenian: • zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): boleče grlo, nahod
English: Some patients have had the following side effects while taking Galvus and insulin (with or without metformin):
Slovenian: Pri nekaterih bolnikih je med jemanjem zdravila Galvus in uporabo insulina (z metforminom ali brez njega) prišlo do naslednjih neželenih učinkov:
English: In the pioglitazone add-on study, the absolute weight increases with placebo, Galvus 100 mg daily were 1.4 and 2.7 kg, respectively.
Slovenian: V študiji s pioglitazonom in dodanim zdravilom je prišlo do povečanja telesne mase in sicer pri placebu za 1,4 kg, pri zdravilu Galvus v odmerku 100 mg dnevno pa za 2,7 kg.
English: If a dose of Galvus is missed, it should be taken as soon as the patient remembers.
Slovenian: Če bolnik izpusti odmerek zdravila Galvus, naj ga vzame takoj, ko se spomni.
English: You are also advised to pay particular attention to new onset of blisters or ulcers while taking Galvus.
Slovenian: Svetujemo vam tudi, da ste v času jemanja zdravila Galvus posebno pozorni na pojavljanje novega mehurčastega izpuščaja ali novih razjed.
English: Galvus should not be used in patients with hepatic impairment, including patients with pre-treatment ALT or AST > 3x ULN (see also sections 4.2 and 5.2).
Slovenian: Zdravilo Galvus se ne sme uporabljati pri bolnikih z okvaro jeter, vključno z bolniki, ki imajo pred zdravljenjem vrednosti ALT ali AST nad 3-kratno zgornjo mejo normalnih vrednosti (glejte tudi poglavji 4.2 in 5.2).
English: How to take Galvus
Slovenian: Kako jemati zdravilo Galvus
English: Therefore Galvus should be used with caution in these patients (see also sections 4.2, 5.1 and 5.2).
Slovenian: Pri bolnikih z ESRD na hemodializi so izkušnje omejene, zato je treba zdravilo Galvus pri teh bolnikih uporabljati previdno (glejte tudi poglavja 4.2, 5.1 in 5.2).
English: A test to determine your liver function will be performed before the start of Galvus treatment, at three-month intervals for the first year and periodically thereafter.
Slovenian: Pred začetkom zdravljenja z zdravilom Galvus boste opravili preiskavo delovanja jeter, med zdravljenjem pa boste v prvem letu opravljali kontrolne preiskave na tri mesece in kasneje v rednih časovnih intervalihTo je potrebno za čimprejšnje odkrivanje znakov zvišanih vrednosti jetrnih encimov.
English: You should not use Galvus during pregnancy.
Slovenian: Med nosečnostjo zdravila Galvus ne smete uporabljati.
English: Table 6 Adverse reactions reported in patients who received Galvus 100 mg daily in combination with insulin (with or without metformin) in double-blind studies (N=371)
Slovenian: Preglednica 6 Neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali 100 mg zdravila Galvus dnevno v kombinaciji z insulinom (z metforminom ali brez njega) v dvojno slepih študijah (N=371)
English: Table 5 Adverse reactions reported in patients who received Galvus 50 mg twice daily in combination with metformin and a sulphonylurea (N=157)
Slovenian: Preglednica 5 Neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali 50 mg zdravila Galvus dvakrat dnevno v kombinaciji z metforminom in sulfonilureo (N=157)
English: However, the magnitude of change is not clinically significant, so that Galvus can be given with or without food.
Slovenian: Zaradi uživanja vildagliptina skupaj s hrano se je znižala Cmax (19 %), vendar velikost te spremembe ni klinično pomembna, zato se lahko zdravilo Galvus uživa s hrano ali brez nje.
English: Adverse reactions reported in patients who received Galvus in double-blind studies as monotherapy and add-on therapies are listed below for each indication by system organ class and absolute frequency.
Slovenian: V spodnjih preglednicah so po organskih sistemih in po absolutni pogostnosti za vsako indikacijo navedeni neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali zdravilo Galvus v dvojno slepih študijah kot monoterapijo ali v shemah zdravljenja z dodatno terapijo.
English: Some patients have had the following side effects while taking Galvus alone:
Slovenian: Nekateri bolniki so imeli naslednje neželene učinke, če so jemali zdravilo Galvus samo:
English: Some patients have had the following side effects while taking Galvus, metformin and a sulphonylurea:
Slovenian: Pri nekaterih bolnikih je med jemanjem zdravila Galvus, metformina in sulfoniluree prišlo do naslednjih neželenih učinkov:
English: Table 1 Adverse reactions reported in patients who received Galvus 100 mg daily in combination with metformin in double-blind studies (N=208)
Slovenian: Preglednica 1 Neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali zdravilo Galvus v odmerku 100 mg dnevno v kombinaciji z metforminom v dvojno slepih študijah (N=208)
English: Galvus works by making the pancreas produce more insulin and less glucagon.
Slovenian: Zdravilo Galvus deluje tako, da spodbuja trebušno slinavko, da tvori več insulina in manj glukagona, kar pomaga uravnavati koncentracijo sladkorja v krvi.
English: Table 4 Adverse reactions reported in patients who received Galvus 100 mg daily as monotherapy in double-blind studies (N=1,855)
Slovenian: Preglednica 4 Neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali zdravilo Galvus v odmerku 100 mg dnevno kot monoterapijo v dvojno slepih študijah (N=1.855)
English: Table 2 Adverse reactions reported in patients who received Galvus 50 mg in combination with a sulphonylurea in double-blind studies (N=170)
Slovenian: Preglednica 2 Neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali zdravilo Galvus v odmerku 50 mg dnevno v kombinaciji s sulfonilureo v dvojno slepih študijah (N=170)
English: Some patients have had the following side effects while taking Galvus and a glitazone:
Slovenian: Nekateri bolniki so imeli naslednje neželene učinke, če so jemali zdravilo Galvus skupaj z glitazonom:
English: Table 3 Adverse reactions reported in patients who received Galvus 100 mg daily in combination with a thiazolidinedione in double-blind studies (N=158)
Slovenian: Preglednica 3 Neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali zdravilo Galvus v odmerku 100 mg dnevno v kombinaciji s tiazolidindionom v dvojno slepih študijah (N=158)
English: Some patients have had the following side effects while taking Galvus and a sulphonylurea:
Slovenian: Nekateri bolniki so imeli naslednje neželene učinke, če so jemali zdravilo Galvus skupaj s sulfonilureo:
English: • Uncommon: Diarrhoea, flatulence
Slovenian: • občasni: driska, vetrovi.
English: Nasopharyngitis Metabolism and nutrition disorders Uncommon
Slovenian: Infekcijske in parazitske bolezni zelo redki nazofaringitis Presnovne in prehranske motnje pogosti hipoglikemija
English: Some patients have had the following side effects while taking Galvus and metformin:
Slovenian: Nekateri bolniki so imeli naslednje neželene učinke, če so jemali zdravilo Galvus skupaj z metforminom:
English: Talk to your doctor, pharmacist or nurse before taking Galvus
Slovenian: Pred začetkom jemanja zdravila Galvus se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: How to store Galvus
Slovenian: Shranjevanje zdravila Galvus
English: ATC vet code: QP54AA55.
Slovenian: oznaka ATC vet: QP54AA55
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/02/2017.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 09/02/2017
English: Clear, colourless to yellow solution.
Slovenian: Čista, brezbarvna do rumena raztopina.
English: During clinical field testing, no interactions between this veterinary medicinal product and routinely used veterinary medicinal products were observed.
Slovenian: Pri testiranju na terenu niso opazili nikakršnega medsebojnega delovanja med tem zdravilom in drugimi rutinsko uporabljenimi zdravili.
English: Stronghold Plus should not enter water courses as this may be dangerous to aquatic organisms.
Slovenian: Stronghold Plus ne sme priti v vodotoke, ker je lahko nevaren za ribe in druge vodne organizme.
English: The need for and frequency of re-treatment should be in accordance with the advice of the prescribing veterinarian.
Slovenian: Pogostnost zdravljenja in ponovno zdravljenje mora biti v skladu z navodili veterinarja.
English: Used pipettes should be disposed of immediately.
Slovenian: Uporabljene tube odvrzite takoj.
English: People with sensitive skin or known allergy to veterinary medicinal products of this type should handle the veterinary medicinal product with caution.
Slovenian: Osebe z občutljivo kožo ali znano alergijo na tovrstna zdravila naj s tem zdravilom ravnajo previdno.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/204/001-006
Slovenian: EU/2/16/204/001-006
English: - The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Slovenian: - Zdravilo se lahko uporabljakot del strategije zdravljenja alergijskega dermatitisa, ki ga povzročajo bolhe (flea allergy dermatitis (FAD).
English: Following topical administration of the Stronghold Plus both selamectin and sarolaner are well absorbed with bioavailability mean values of 40.5% and 57.9%, respectively and distribute systemically.
Slovenian: Po lokalem nanosu Stronghold Plus se oba selamektin in sarolaner dobro resorbirata in dosežeta povprečno biološko razpoložljivost 40,5% in 57,9% ter se sistemsko porazdelita.
English: Avoid eye contact including hand-to-eye-contact.
Slovenian: Izogibajte se stiku z očmi vključno s stikom oči z rok.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the blister after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na blistru.
English: Use of this veterinary medicinal product is indicated in cats aged at least 8 weeks old and weighing at least 1.25 kg bodyweight.
Slovenian: Zdravilo lahko dajemo mačkam, ki so stare vsaj 8 tednov ali tehtajo vsaj 1,25 kg.
English: Appropriate combination of pipettes
Slovenian: Ustrezna kombinacija tub.
English: No clinically significant adverse reactions were observed in kittens from 8 weeks of age treated with up to 5 times the maximum recommended dose of the product for up to 8 consecutive treatments at 28 day intervals, apart from a single cat administered 5 times the maximum dose that displayed transient hypersensitivity to touch, piloerection, mydriasis and mild tremor which resolved without treatment.
Slovenian: Nobenih klinično pomembnih neželenih učinkov niso opazili pri mačjih mladičih starih najmanj 8 tednov zdravljenih s petkratnim priporočenim maksimalnim odmerkom, v osmih zaporednih zdravljenjih z 28 dnevnimi intervali, z izjemo ene mačke, ki ji je bil dan 5 kratni maksimalni odmerek in je kazala prehodne znake preobčutljivost na dotik, naježeno dlako, midrijazo in rahlo tresenje in so izzveneli brez zdravljenja.
English: The product may cause eye irritation.
Slovenian: Izdelek lahko draži oči.
English: Stronghold Plus 60 mg/10 mg (green cap)
Slovenian: Stronghold Plus 60 mg/10 mg (zelen pokrovček)
English: Interactions with other medicinal products and other forms of interactions:
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Niso znane.
English: While the safety of sarolaner has not been evaluated in breeding, pregnant or lactating cats, laboratory studies with sarolaner in rats and rabbits have not produced any evidence of teratogenic effects.
Slovenian: Medtem, ko varnost sarolanerja ni bila ugotovljena pri vzrejnih in brejih mačkah ter mačkah v laktaciji pa z laboratorijskimi študijami na podganah in kuncih niso bili dokazani teratogeni učinki.
English: 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).
Slovenian: Najpogostejši neželeni učinek je v skupini naveden prvi, 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 živali od 100 zdravljenih živali) - občasni (pri več kot 1 toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1 toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključujoč posamezne primere).
English: Stronghold Plus should be administered as a single spot-on (topical) application in accordance with the following table (corresponding to a minimum of 6 mg/kg selamectin and 1 mg/kg sarolaner).
Slovenian: Stronghold Plus se daje kot enkratni kožni nanos (lokalno), v skladu s tabelo (ki zagotavlja najmanj 6 mg selamektina na kg telesne mase in 1 mg sarolanerja na kg telesne mase):
English: Stronghold Plus 30 mg/5 mg (orange cap)
Slovenian: Stronghold Plus 30 mg/5 mg (oranžen pokrovček)
English: Sarolaner is active against adult fleas (Ctenocephalides spp.)
Slovenian: Sarolaner deluje na odrasle bolhe (Ctenocephalides spp.)
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each unit dose (pipette) delivers: Active substances: Stronghold Plus spot-on solution
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Vsaka odmerna enota (merilna kapalka) zdravila vsebuje: Zdravilna učinkovina:
English: It is recommended, in accordance with good veterinary practice, that all animals 6 months of age or more, living in countries where a vector exists should be tested for existing adult heartworm infection before beginning preventive use with the veterinary medicinal product.
Slovenian: Kljub temu se priporoča (v skladu z dobro veterinarsko prakso), da vse živali stare 6 mesecev in več, ki živijo v državah, kjer obstaja prenašalec mikrofilarij, pred pričetkom zatiranja s tem zdravilom, testiramo na prisotnost infestacije z odraslimi oblikami Dirofilarie immitis.
English: Stronghold Plus ≤2.5 kg Stronghold Plus >2.5-5 kg Stronghold Plus >5-10 kg
Slovenian: Stronghold Plus >2,5-5 kg Stronghold Plus >5-10 kg
English: Stronghold Plus spot-on solution for cats Stronghold Plus spot-on solution for cats Stronghold Plus spot-on solution for cats
Slovenian: Stronghold Plus kožni nanos, raztopina za mačke Stronghold Plus kožni nanos, raztopina za mačke Stronghold Plus kožni nanos, raztopina za mačke
English: Apply the tip of the pipette directly to the skin, without massaging.
Slovenian: Konico tube z zdravilom namestimo neposredno na kožo in ne masiramo.
English: Cats ≤2.5 kg
Slovenian: Stronghold Plus ≤2,5 kg
English: For optimal control of tick and fleas infestations, the veterinary medicinal product should be administered at monthly intervals and continued throughout the flea and/or tick season based on local epidemiological situations.
Slovenian: Za optimalni nadzor nad infestacijami z bolhami in klopi, zdravilo dajemo v mesečnih intervalih skozi celo sezono bolh in klopov v skladu z lokalno epidemiološko situacijo.
English: The product is available in packs of three pipettes (all pipette sizes) and six pipettes (all pipette sizes).
Slovenian: Zdravilo se nahaja v ovojnini s tremi tubami (vse velikosti tub), s šestimi tubami (vse velikosti tub).
English: Keep the product in the original packaging until use, in order to prevent children from getting direct access to the product.
Slovenian: Da bi preprečili otrokom dostop do izdelka, izdelek do uporabe hranite v originalni ovojnini.
English: The product is available in packs of three pipettes (all pipette sizes) and six pipettes (all pipette sizes) placed in cardboard boxes.
Slovenian: Zdravilo je na voljo v pakiranju s tremi merilnimi kapalkami (vse velikosti merilnih kapalk), s šestimi merilnimi kapalkami (vse velikosti merilnih kapalk).
English: Strength and number of pipettes to be administered Stronghold Plus 15 mg/2.5 mg (yellow cap)
Slovenian: Moč in število merilnih kapalk, ki jih moramo dati Stronghold Plus 15 mg/2,5 mg (rumen pokrovček)
English: Excipients: 0.2 mg/ml butylated hydroxytoluene.
Slovenian: Pomožne snovi: 0,2% butilhidroksitoluen.
English: For ticks (I. ricinus), the onset of efficacy is within 24 hours of attachment for one month after product application.
Slovenian: Pri klopih (I.ricinus), začne zdravilo učinkovati znotraj 24 ur po pritrditvi in deluje en mesec.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each unit dose (pipette) delivers: Active substances: Stronghold Plus spot-on solution
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka odmerna enota (merilna kapalka) zdravila vsebuje: Učinkovina(e):
English: Treatment of roundworm and hookworm infections A single dose of the product should be administered.
Slovenian: Zdravljenje infestacij z valjastimi in kavljastimi črvi Za zdravljenje zadostuje enkraten odmerek.
English: Medicines should not be disposed of via wastewater.
Slovenian: Ne odvrzite zdravila v odpadno vodo, ali med gospodinjske odpadke.
English: These measures should help to protect the environment.
Slovenian: Ti ukrepi pomagajo varovati okolje Selamektin lahko negativno učinkuje na vodne organizme.
English: BLISTER
Slovenian: raztopina
English: NAME OF THE MARKETING AUTHORISATION HOLDER Zoetis Belgium SA
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Zoetis Belgium SA
English: DATE OF REVISION OF THE TEXT
Slovenian: DATUM REVIZIJE BESEDILA {DD/MM/LLLL}
English: Total volume of unit dose (ml)
Slovenian: Vsebnost tube (ml)
English: 3 pipettes 6 pipettes
Slovenian: VELIKOST PAKIRANJA 3 merilne kapalke 6 merilnih kapalk
English: Butylated hydroxytoluene
Slovenian: Raztopina kožnih kapljic.
English: The pipette should be removed from the protective package immediately prior to administration.
Slovenian: Tub vzamete iz zaščitne ovojnine tik pred nanosom.