FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP concluded that for the determination of the withdrawal period, the worst-case scenario must be taken into account, i.e. consideration should be given to residues in low yielding animals.
Slovenian: Odbor CVMP je sklenil, da je treba za določitev karence upoštevati najslabši scenarij, zato je treba upoštevati ostanke pri živalih z majhno mlečnostjo.
English: The first study was conducted in 2000 with the veterinary medicinal product ‘Zanil Fluke Drench' at the single maximum recommended dose volume of 105 ml of product per animal and in accordance with the VICH Guideline 482.
Slovenian: Prva študija je bila izvedena leta 2000 z zdravilom za uporabo v veterinarski medicini „Zanil Fluke Drench“ z največjim priporočenim odmerkom 105 ml zdravila na žival in v skladu s smernico VICH 482.
English: In these 3 cows the maximum levels were 11.4, 20.26 and 23.2 µg/kg at 24 and 48 hours after administration and residue levels decreased to below the MRL by the 6th, 7th or 8th milking after administration, although the last
Slovenian: Pri teh treh kravah so bile največje vrednosti 11,4, 20,26, 23,2 µg/kg po 24 oz. 48 urah po dajanju,
English: The study was conducted in 2000 with sixteen treated animals (8 males and 8 females) and a control group consisting of four untreated animals (two males and two females).
Slovenian: Študija je bila izvedena leta 2000 na šestnajstih zdravljenih živalih (8 samcih in 8 samicah) in kontrolni skupini, sestavljeni iz štirih nezdravljenih živali (2 samca in 2 samici).
English: 5831 AN Boxmeer
Slovenian: Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
English: 2 VICH topic GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker-residue-depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009) - link sample presented a level of 10.09 µg/kg, close to the MRL (of 10 µg/kg) at the 8th milking after administration.
Slovenian: 2 VICH topic GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker-residue-depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009) - link nato so se ravni ostankov znižale pod mejno vrednost ostankov po 6., 7. ali 8. molži po dajanju zdravila, čeprav je imel zadnji vzorec raven 10,09 µg/kg, blizu mejne vrednosti ostankov (10 µg/kg) pri 8. molži po dajanju zdravila.
English: Oral suspension Cattle, sheep, goats
Slovenian: govedo, ovce, koze
English: Therefore, based on the pharmacokinetic similarities between sheep and other ruminants the withdrawal period of 14 days recommended for sheep meat and offal can also be applied for goat meat and offal.
Slovenian: Zato se na podlagi farmakokinetičnih podobnosti med ovcami in drugimi prežvekovalci lahko tudi za kozje meso in organe uporablja 14-dnevna karenca, priporočena za ovčje meso in organe.
English: A GLP-compliant residue depletion study in sheep was submitted, conducted with the veterinary medicinal product ‘Nilzan Drench Plus', a combination product containing oxyclozanide (3.1% w/v) and levamisole (1.5% w/v).
Slovenian: Predložena je bila študija o izločanju ostankov pri ovcah za veterinarsko zdravilo „Nilzan Drench Plus“, kombinirano zdravilo, ki vsebuje oksiklozanid (3,1 % m/v) in levamisol (1,5 % m/v).
English: A risk of residue levels exceeding the MRLs after some of the approved withdrawal periods was identified based on the milk, meat and offal residue depletion data provided.
Slovenian: Tveganje, da ravni ostankov presežejo mejne vrednosti ostankov po odobrenih karencah, je bilo ugotovljeno na podlagi podatkov o izločanju ostankov iz mleka, mesa in organov.
English: The product was administered to 22 cows at the single maximum recommended dose volume of 105 ml of product per animal and in accordance with the VICH Guideline 48.
Slovenian: Zdravilo so dajali 22 kravam z enkratnim največjim priporočenim volumnom odmerjanja 105 ml zdravila na žival in v skladu s smernico VICH 48.
English: Therefore, the Committee considered that based on the available data, a safe withdrawal period of 108 hours (4.5 days) for cattle milk could be derived.
Slovenian: Zato je odbor menil, da bi na podlagi razpoložljivih podatkov lahko izpeljali varno karenco za kravje mleko 108 ur (4,5 dni).
English: Merial Animal Health Limited,
Slovenian: Merial Animal Health Limited, PO Box 327
English: The concentration of oxyclozanide residues in liver, kidney and muscle were below the respective maximum residue limits (MRLs) at 7 days after administration, whilst residues in fat were well below the MRL at 10 days after administration.
Slovenian: Koncentracije ostankov oksiklozanida v jetrih, ledvicah in mišicah so bile pod ustreznimi najvišjimi mejnimi vrednostmi ostankov (MRL, maximum residue limits) 7 dni po uporabi, medtem ko so bili ostanki v maščobi znatno pod mejno vrednostjo ostankov 10 dni po uporabi.
English: The study was conducted in 2000 with sixteen treated animals (8 males and 8 females) and a control group consisting of four untreated animals per group (two males and two females).
Slovenian: Študija je bila izvedena leta 2000 na šestnajstih zdravljenih živalih (8 samcih in 8 samicah) in kontrolni skupini, sestavljeni iz štirih nezdravljenih živali na skupino (2 samca in 2 samici).
English: France noted that for Zanil and associated names, and generic products thereof the Member States across the EU/EEA have established different withdrawal periods for milk, meat and offal derived from treated cattle and sheep.
Slovenian: Francija je ugotovila, da so za zdravilo Zanil in povezana imena ter njegova generična zdravila države članice v EU/EGP določile različne karence za mleko, meso in organe zdravljenega goveda in ovac.
English: Thus, the alternative method as per CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)4 was followed.
Slovenian: Zato se je upoštevala alternativna metoda v skladu s sporočilom odbora CVMP glede priporočil o pristopu k uskladitvi karenc (EMEA/CVMP/036/95)4.
English: Samples from three of the four treated animals were above the limit of quantification (one of which was above the MRL for fat (20 μg/kg)), and the sample from one of the control animals was also above the MRL.
Slovenian: Koncentracije oksiklozanida so bile v vzorcih treh od štirih zdravljenih živali nad mejo določljivosti (v eni živali je bila koncentracija nad mejno vrednostjo ostanka za maščobo (20 μg/kg)), prav tako pa je bil tudi vzorec iz ene od kontrolnih živali nad mejno vrednostjo ostankov.
English: This half-life was calculated to be approximately 1.1 days based on the pivotal cattle study (reported above).
Slovenian: V ključni študiji na govedu (navedeni zgoraj) je bilo izračunano, da je ta razpolovni čas približno 1,1 dni.
English: The overall benefit-risk balance for the veterinary medicinal products Zanil and associated names, and generic products thereof remains positive subject to the recommended changes in the product information (see Annex III).
Slovenian: Skupno razmerje med koristmi in tveganjem za zdravilo Zanil in povezana imena za uporabo v veterinarski medicini ter njegova generična zdravila ob upoštevanju priporočenih sprememb informacij o zdravilu (glejte Prilogo III) ostaja pozitivno.
English: Four treated animals (two of each sex) were slaughtered at 2, 4, 7 and 10 days after administration.
Slovenian: Štiri zdravljene živali (dve vsakega spola) so bile zaklane 2, 4, 7 in 10 dni po uporabi zdravila.
English: The product ‘Nilzan Drench Plus' was administered orally to sheep at the single recommended dose of 15 mg oxyclozanide per kg body weight and 7.5 mg levamisole per kg body weight.
Slovenian: Zdravilo „Nilzan Drench Plus“ je bilo peroralno dajano ovcam v enotnem priporočenem odmerku 15 mg oksiklozanida na kg telesne mase in 7,5 mg levamisola na kg telesne mase.
English: It was noted that a 14C-oxyclozanide radiolabelled study reported in paragraph 25 of the CVMP European Public MRL Assessment Report (EPMAR) for oxyclozanide (EMEA/MRL/889/03-FINAL)1 indicates that all total 14C-oxyclozanide residues were below the MRL at fourteen days and that they did not increase thereafter.
Slovenian: Ugotovljeno je bilo, da študija s 14C radioaktivno označenim oksiklozanidom, o kateri so poročali v odstavku 25 evropskega javnega poročila o oceni mejnih vrednosti ostankov (EPMAR) za oksiklozanid (EMEA/MRL/889/03-FINAL),1 kaže, da so bile vse koncentracije skupnih ostankov 14C-oksiklozanida pod mejno vrednostjo ostankov v štirinajstih dneh in da se po tem niso zvišale.
English: None of the statistical methods described in the CVMP note for guidance for the determination of withdrawal periods for milk (EMEA/CVMP/473/98) were considered appropriate for analysis of the data due to the large number of residue concentrations below the LOQ.
Slovenian: Nobena od statističnih metod, navedenih v sporočilu odbora CVMP glede priporočil za določanje karence za mleko (EMEA/CVMP/473/98), se ni štela za primerno za analizo podatkov, zaradi velikega števila rezultatov s koncentracijami ostankov pod mejo določljivosti.
English: • a cattle milk withdrawal period of 108 hours (4.5 days),
Slovenian: • karenco za kravje mleko 108 ur (4,5 dni),
English: In the absence of species specific data, the CVMP agreed to recommend application of the meat and offal withdrawal period proposed for sheep in goats because the dose regimen (15 mg oxyclozanide per kg body weight) is the same in both species and, as reported in paragraph 29 of the CVMP EPMAR for oxyclozanide (EMEA/MRL/889/03-FINAL) the pharmacokinetics of oxyclozanide is considered to be similar in sheep and goats.
Slovenian: V odsotnosti podatkov, specifičnih za živalsko vrsto, je odbor CVMP menil, da priporoči uporabo karence za meso in organe, predlagane za ovce pri kozah, ker je shema odmerjanja (15 mg oksiklozanida na kg telesne mase) enaka pri obeh živalskih vrstah in je farmakokinetika oksiklozanida podobna pri ovcah in kozah, kot je navedeno v odstavku 29 dokumenta EPMAR odbora CVMP za oksiklozanid (EMEA/MRL/889/03-FINAL).
English: The concentration of oxyclozanide residues in liver, kidney, muscle and fat were below the respective MRLs and lower limit of quantification at 10 and 15 days after administration.
Slovenian: Koncentracija ostankov oksiklozanida v jetrih, ledvicah, mišicah in maščobi je bila pod ustreznimi mejnimi vrednostmi ostanka 10 dni po uporabi in pod spodnjo mejo določljivosti 15 dni po uporabi.
English: Goats:
Slovenian: Koze:
English: • on the basis of the available residue depletion data, the CVMP considered the withdrawal periods for milk, meat and offal derived from treated cattle, sheep and goats should be amended to provide assurance for consumer safety;
Slovenian: • na podlagi razpoložljivih podatkov o izločanju ostankov je odbor CVMP menil, da je treba karence za mleko, meso in organe, pridobljene iz zdravljene govedi, ovac in koz, spremeniti zaradi zagotovitve varnosti potrošnikov;
English: Four treated animals (two of each sex) were slaughtered at 5, 10 15 and 21 days after administration.
Slovenian: Štiri zdravljene živali (dve vsakega spola) so bile zaklane 5, 10, 15 in 21 dni po uporabi zdravila.
English: For goats the meat and offal withdrawal period is 14 days and milk withdrawal period is zero days.
Slovenian: Karence za kozje meso in organe so 14 dni, za mleko pa 0 dni.
English: The CVMP therefore considered that, based on this study, a safe withdrawal period of 108 hours (4.5 days) could be derived for cattle milk.
Slovenian: Zato je odbor menil, da bi lahko na podlagi te študije, bila varna karenca za kravje mleko 108 ur (4,5 dni).
English: 3 CVMP note for guidance for the determination of withdrawal periods for milk (EMEA/CVMP/473/98) - link 4 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link
Slovenian: 3 CVMP note for guidance for the determination of withdrawal periods for milk (EMEA/CVMP/473/98) - link 4 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link koze (15 mg oksiklozanida na kg telesne mase) večji od odmerka za govedo (10 mg oksiklozanida na kg telesne mase).
English: The recommended doses are 10 mg oxyclozanide per kg bw for cattle and 15 mg oxyclozanide per kg bw for sheep and goats.
Slovenian: Priporočeni odmerki so 10 mg oksiklozanida na kg telesne mase za govedo in 15 mg oksiklozanida na kg telesne mase za ovce in koze.
English: Two GLP-compliant residue depletion studies in cattle were submitted.
Slovenian: Predloženi sta bili dve študiji o izločanju ostankov pri govedu, skladni z dobro laboratorijsko prakso.
English: Based on this study, in which residues in all tissues were below the MRL at day 10, and on the data reported in the CVMP EPMAR for oxyclozanide (EMEA/MRL/889/03-FINAL), where total residues were below the MRLs in all tissues at the 14 day timepoint, a withdrawal period of 14 days is retained.
Slovenian: Na podlagi te študije, v kateri so bili 10. dan ostanki v vseh tkivih pod mejno vrednostjo ostankov, in podatki, navedenimi v dokumentu EPMAR odbora CVMP za oksiklozanid (EMEA/MRL/889/03-FINAL), kjer so bili skupni ostanki pod mejnimi vrednostmi ostankov v vseh tkivih po 14 dneh, se določi karenca 14 dni.
English: • a sheep and goat milk withdrawal period of 7 days.
Slovenian: • karenco za ovčje in kozje mleko 7 dni.
English: The CVMP was requested to review all available residue depletion data for the veterinary medicinal product Zanil and associated names, and generic products thereof and recommend withdrawal periods for milk, meat and offal derived from treated cattle, sheep and goats.
Slovenian: Odbor CVMP je bil zaprošen, naj pregleda vse razpoložljive podatke o izločanju ostankov za zdravilo Zanil in povezana imena za uporabo v veterinarski medicini ter njegova generična zdravila in priporoči karenco za mleko, meso in organe, pridobljene iz zdravljenega goveda, ovac in koz.
English: The untreated control animals (one of each sex) were slaughtered at 5 and 21 days.
Slovenian: Nezdravljene kontrolne živali (po ena vsakega spola) so bile zaklane 5. in 21. dan.
English: The untreated control animals (one of each sex) were slaughtered at 2 and 10 days.
Slovenian: Nezdravljene kontrolne živali (po ena vsakega spola) so bile zaklane 2. in 10. dan.
English: Belgium Intervet International B.V. Wim de Körverstraat 35
Slovenian: Intervet International B.V.
English: 4.11 Withdrawal period(s) Cattle:
Slovenian: 4.11 Karenca Govedo:
English: For sheep and goats the recommended dose is 15 mg oxyclozanide per kg body weight (equivalent to 4.4 ml of product per 10 kg body weight) with a maximum dose of 0.68 g of oxyclozanide per animal (equivalent to 20 ml of product per animal).
Slovenian: Pri ovcah in kozah je priporočeni odmerek 15 mg oksiklozanida na kg telesne mase (kar ustreza 4,4 ml zdravila na 10 kg telesne mase), največji odmerek pa je 0,68 g oksiklozanida na kg telesne mase (kar ustreza 20 ml zdravila na žival).
English: For cattle the recommended dose is 10 mg oxyclozanide per kg body weight (equivalent to 3 ml of product per 10 kg body weight) with a maximum dose of 3.5 g of oxyclozanide per animal (equivalent to 105 ml of product per animal).
Slovenian: Za govedo je priporočeni odmerek 10 mg oksiklozanida na kg telesne mase (kar ustreza 3 ml zdravila na 10 kg telesne mase), največji odmerek pa je 3,5 g oksiklozanida na žival (kar ustreza 105 ml zdravila na žival).
English: In summary, based on the residue depletion study performed with the ‘Nilzan Drench Plus' combination product, considering the residue depletion results presented in the CVMP EPMAR for oxyclozanide (EMEA/MRL/889/03-FINAL), and taking account of the withdrawal period recommended in cattle and the estimated half-life in fat a withdrawal period of 14 days for sheep meat and offal is recommended.
Slovenian: Tako na podlagi študije izločanja ostankov, izvedene s kombiniranim zdravilom „Nilzan Drench Plus“, z upoštevanjem rezultatov izločanja ostankov, predstavljenih v dokumentu EPMAR odbora CVMP za oksiklozanid (EMEA/MRL/889/03-FINAL) in karence, priporočene za govedo, ter ocenjene razpolovne dobe v maščobah, se priporoča karenca 14 dni za ovčje meso in organe.
English: • a sheep and goat meat and offal withdrawal period of 14 days,
Slovenian: • karenco za meso in organe ovac in koz 14 dni,
English: Evaluation and conclusions on the benefit-risk balance Having considered the grounds for referral and the available data, the CVMP concluded that the withdrawal periods for milk, meat and offal derived from treated cattle, sheep and goats should be amended as recommended to provide assurance for consumer safety.
Slovenian: Vrednotenje in zaključki o razmerju med tveganji in koristmi Po proučitvi razlogov za napotitev in razpoložljivih podatkov je odbor CVMP menil, da je treba zaradi zagotovitve varnosti potrošnikov karence za mleko, meso in organe, pridobljene iz zdravljene govedi, ovac in koz, spremeniti, kot je predlagano.
English: Residue depletion data in sheep and goat milk
Slovenian: Podatki o izločanju ostankov za ovčje in kozje mleko
English: • a cattle meat and offal withdrawal period of 13 days,
Slovenian: • karenco za meso in organe goveda 13 dni,
English: A GLP-compliant residue depletion study in cattle was submitted, conducted with the veterinary medicinal product ‘Zanil Fluke Drench' at the recommended dose (10 mg oxyclozanide per kg body weight).
Slovenian: Predložena je bila študija o izločanju ostankov veterinarskega zdravila „Zanil Fluke Drench“ pri govedu, ki je bila izvedena v skladu z načeli dobre laboratorijske prakse in s priporočenim odmerkom (10 mg oksiklozanida na kg telesne mase).
English: Residues levels were also below the MRLs (and limit of quantification) in liver, kidney and muscle on day 21.
Slovenian: Koncentracije ostankov v jetrih, ledvicah in mišicah so bile pod mejno vrednostjo ostanka (in mejo določljivosti) tudi 21. dan.
English: Residue depletion in cattle meat and offal
Slovenian: Izločanje ostankov za goveje meso in organe
English: In view of deficiencies noted in the ‘Nilzan Drench Plus' study, namely the fact that the product used was a combination product (oxyclozanide and levamisole) instead of the mono-product Zanil
Slovenian: Glede na pomanjkljivosti, ugotovljene v študiji „Nilzan Drench Plus“, zlasti dejstvo, da je bilo uporabljeno kombinirano zdravilo (oksiklozanid in levamisol) namesto monoterapevtskega zdravila Zanil (oksiklozanid) in da so bili nenormalni rezultati pridobljeni na 21. dan, je za določitev karence primerna uporaba varnostnega faktorja vsaj 30 %.
English: Residue depletion in sheep meat and offal
Slovenian: Izločanje ostankov za meso in organe ovac
English: With a view to preserving product availability the CVMP adopted a pragmatic approach, accepting extrapolation of the milk withdrawal period from cattle to sheep and goats , despite the fact that the dose for sheep and goats (15 mg oxyclozanide per kg body weight) is higher than that for bovine animals (10 mg oxyclozanide per kg body weight).
Slovenian: Da bi ohranili razpoložljivost zdravil, je odbor CVMP sprejel pragmatičen pristop in sprejel ekstrapolacijo karence za mleko iz goveda na ovce in koze, kljub dejstvu, da je odmerek za ovce in
English: Oxyclozanide is a salicylanilide anthelmintic, used for the treatment of fasciolosis in cattle, sheep and goats and also for elimination of gravid tapeworm segments (Moniezia spp).
Slovenian: Zdravilo Zanil in povezana imena za uporabo v veterinarski medicini ter njegova generična zdravila so peroralne suspenzije, ki vsebujejo 34 mg oksiklozanida na ml. Oksiklozanid je salicilanilidni antihelmintik, ki se uporablja za zdravljenje fascioloze pri govedu, ovcah in kozah ter za odstranjevanje odrivkov gravidnih trakulj (Moniezia spp).
English: No other residue depletion data in sheep meat and offal were provided by the applicants/marketing authorisation holders.
Slovenian: Predlagatelji/imetniki dovoljenj za promet niso predložili drugih podatkov o izločanju ostankov za ovčje meso in organe.
English: Belgium Merial SAS 29 avenue Tony Garnier 69007 Lyon
Slovenian: Portugalska Merial SAS 29 avenue Tony Garnier 69007 Lyon
English: The CVMP considered that the withdrawal periods for milk, meat and offal derived from treated cattle, sheep and goats should be amended as proposed to provide assurance for consumer safety.
Slovenian: Ukrepi za obvladovanje ali zmanjšanje tveganja Odbor CVMP je menil, da je treba zaradi zagotovitve varnosti potrošnikov karence za mleko, meso in organe, pridobljene iz zdravljene govedi, ovac in koz, spremeniti, kot je predlagano.
English: No other residue depletion data in cattle meat and offal were provided by the applicants/marketing authorisation holders.
Slovenian: Predlagatelji/imetniki dovoljenj za promet niso predložili drugih podatkov o izločanju ostankov za goveje meso in organe.
English: No residue depletion data in goat meat and offal were provided by the applicants/marketing authorisation holders.
Slovenian: Predlagatelji/imetniki dovoljenj za promet niso predložili podatkov o izločanju ostankov za kozje meso in organe.
English: No other residue depletion data in cattle milk were provided by the applicants/marketing authorisation holders.
Slovenian: Predlagatelji/imetniki dovoljenj za promet niso predložili drugih podatkov o izločanju ostankov za kravje mleko.
English: No residue depletion data in sheep and goat milk were provided by the applicants/marketing authorisation holders.
Slovenian: Predlagatelji/imetniki dovoljenj za promet niso predložili drugih podatkov o izločanju ostankov za ovčje in kozje mleko.
English: There is no specific antidote.
Slovenian: Ni specifičnega protistrupa.
English: 6 Adverse reactions (frequency and seriousness)
Slovenian: 4.6 Neželeni učinki (pogostost in resnost)
English: Additional polar metabolites also exist.
Slovenian: Obstajajo tudi njegovi polarni metaboliti.
English: Date of last renewal: 10 April 2008
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 10. april 2008
English: MARKETING AUTHORISATION NUMBERS EU/2/98/007/001-003
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/98/007/001-003
English: Do not use after the expiry date which is stated on the label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki za oznako »EXP«.
English: In dogs, the volume of distribution (VDss) is 3.8 l/kg.
Slovenian: Pri psih znaša distribucijski volumen (VDss) 3,8 l/kg.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation 1 April 1998
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 1. april 1998
English: MARKETING AUTHORISATION NUMBER EU/2/98/007/001 (5 mg, 30 tablets) EU/2/98/007/002 (20 mg, 30 tablets) EU/2/98/007/003 (80 mg, 30 tablets)
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/98/007/001 (5 mg, 30 tablet) EU/2/98/007/002 (20 mg, 30 tablet) EU/2/98/007/003 (80 mg, 30 tablet)
English: Clomipramine and its metabolites are rapidly distributed in the body in mice, rabbits, and rats with high concentrations being achieved in organs and tissues (including the lungs, heart and brain) and low concentrations remaining in the blood.
Slovenian: Klomipramin in njegovi metaboliti se pri miših, kuncih in podganah hitro porazdelijo po organizmu in dosežejo visoke koncentracije v tkivih in organih (vključno s pljuči, srcem in možgani), nizke pa v krvi.
English: Shelf-life of the veterinary medicinal product as packaged for sale: 4 years
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 4 leta.
English: Clomicalm should be used under veterinary supervision.
Slovenian: Zdravilo Clomicalm uporabite pod nadzorom veterinarja.
English: SPECIAL STORAGE CONDITIONS Store in the original container.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalnem vsebniku.
English: Do not use in case of known hypersensitivity to clomipramine and related tricyclic antidepressants.
Slovenian: Ne uporabite v primerih preobčutljivosti na klomipramin in podobne triciklične antidepresive.