natgillin/translations-raw huggingface dataset:
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.
CVMP stoga smatra da je na temelju tog ispitivanja moguće utvrditi razdoblje karencije od 108 sati (4,5 dana) za mlijeko goveda.
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.
Zbog nedostataka podataka za određene vrste, CVMP pristao je preporučiti primjenu razdoblja karencije za meso i iznutrice koje je predloženo za ovce i koze jer je režim doze (15 mg oksiklozanida po kg tjelesne mase) jedan za obje vrste te, kako je navedeno u stavku 29. EPMAR-a CVMP-a za oksiklozanid (EMEA/MRL/889/03-FINAL), farmakokinetika oksiklozanida smatra se sličnom u koza i ovaca.
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.
Lijek „Nilzan Drench Plus” primjenjivao se oralno u ovaca u jednoj preporučenoj dozi od 15 mg oksiklozanida po kg tjelesne mase i 7,5 mg levamisola po kg tjelesne mase.
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).
Uzimajući u obzir očuvanje dostupnosti lijeka, CVMP donio je pragmatičan pristup kojim se prihvaća ekstrapolacija razdoblja karencije mlijeka za ovce i koze u odnosu na razdoblje karencije za goveda, unatoč činjenici da je doza koja se primjenjuje u ovaca i koza (15 mg oksiklozanida po kg tjelesne mase) veća od doze koja se primjenjuje u goveda (10 mg oksiklozanida po kg tjelesne mase).
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.
Nijedna od statističkih metoda navedenih u napomeni CVMP-a sa smjernicama za utvrđivanja karencije za mlijeko (EMEA/CVMP/473/98) nije se smatrala primjerenom za analizu podataka zbog velikih koncentracija rezidua koje su bile ispod granice kvantifikacije.
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.
Utvrđen je rizik od razina rezidua koje premašuju najveću dopuštenu količinu rezidua nakon odobrenog razdoblja karencije na temelju dostavljenih podataka o izlučivanju rezidua u mlijeku, mesu i iznutricama.
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).
Ukupni omjer koristi i rizika za veterinarsko-medicinski proizvod Zanil i pridružena imena te njegove generičke lijekove ostaje pozitivan na temelju preporučenih izmjena informacija o VMP-u (vidjeti Prilog III.).
Four treated animals (two of each sex) were slaughtered at 5, 10 15 and 21 days after administration.
Četiri liječene životinje (po dvije svakog spola) zaklane su 5., 10., 15. i 21. dana nakon primjene.
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.
Ukratko, na temelju ispitivanja o izlučivanju rezidua u kojem je korišten kombinirani lijek „Nilzan Drench Plus“ i rezultata o izlučivanju rezidua predstavljenih u EPMAR-u CVMP-a za oksiklozanid (EMEA/MRL/889/03-FINAL) te uzimajući u obzir razdoblje karencije preporučene za goveda i procijenjeni poluvijek u masnoći, preporučuje se razdoblje karencije od 14 dana za meso i iznutrice ovaca.
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).
Preporučena doza za ovce i koze je 15 mg oksiklozanida po kg tjelesne mase (ekvivalentno 4,4 ml proizvoda po 10 kg tjelesne mase), pri čemu je maksimalna doza 0,68 g oksiklozanida po životinji (ekvivalentno 20 ml proizvoda po životinji).
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.
Od CVMP-a zatraženo je da pregleda sve dostupne podatke o izlučivanju rezidua za veterinarskomedicinski proizvod Zanil, pridružena imena te njegove generičke lijekove i preporuči razdoblja karencije za mlijeko, meso i iznutrice dobivene od liječenih goveda, ovaca i koza.
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.
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 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
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).
Preporučena doza za stoku je 10 mg oksiklozanida po kg tjelesne mase (ekvivalentno 3 ml proizvoda po 10 kg tjelesne mase), pri čemu je maksimalna doza 3,5 g oksiklozanida po životinji (ekvivalentno 105 ml proizvoda po životinji).
Residue depletion data in cattle milk
Podatci o izlučivanju rezidua u mlijeku goveda
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).
Dostavljeno je ispitivanje o izlučivanju rezidua u goveda u skladu s dobrom laboratorijskom praksom u kojem je korišten veterinarsko-medicinski proizvod „Zanil Fluke Drench“ pri preporučenoj dozi (10 mg oksiklozanida po kg tjelesne mase).
The recommended doses are 10 mg oxyclozanide per kg bw for cattle and 15 mg oxyclozanide per kg bw for sheep and goats.
Preporučene doze su 10 mg oksiklozanida po kg tjelesne mase za goveda i 15 mg oksiklozanida po kg tjelesne mase za ovce i koze.
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.
Odbor stoga smatra da je na temelju tog ispitivanja moguće utvrditi razdoblje karencije od 108 sati (4,5 dana) za mlijeko goveda.
The untreated control animals (one of each sex) were slaughtered at 5 and 21 days.
Neliječene životinje iz kontrolne skupine (po jedna svakog spola) zaklane su 5. i 21. dana.
• a cattle meat and offal withdrawal period of 13 days,
• razdoblje karencije za meso i iznutrice goveda iznosi 13 dana,
• 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;
• na temelju dostupnih podataka o izlučivanju rezidua, CVMP smatra da razdoblje karencije za mlijeko, meso i iznutrice liječenih goveda, ovaca i koza treba prilagoditi prema prijedlogu kako bi se osigurala sigurnost potrošača;
Belgium Chanelle Pharmaceuticals Manufacturing Ltd.
Nizozemska Chanelle Pharmaceuticals Manufacturing Ltd.
The untreated control animals (one of each sex) were slaughtered at 2 and 10 days.
Neliječene životinje iz kontrolne skupine (po jedna svakog spola) zaklane su 2. i 10. dana.
Therefore, on 1 September 2016, France initiated a procedure under Article 35 of Directive 2001/82/EC, for the veterinary medicinal products Zanil and associated names, and generic products thereof.
Direktive 2001/82/EZ za veterinarsko-medicinski proizvod Zanil i pridružena imena te njegove generičke lijekove.
After treatment the oxyclozanide residues in milk were below the MRL at all milkings.
Nakon liječenja, količina rezidua oksiklozanida u mlijeku bila je manja od najveće dopuštene količine rezidua prilikom svih mužnji.
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.
Prvo je ispitivanje provedeno 2000. godine uz veterinarsko-medicinski proizvod „Zanil Fluke Drench” u količini jedne maksimalne preporučene doze od 105 ml po životinji te u skladu s 48. smjernicom Međunarodne suradnja za harmonizaciju tehničkih zahtjeva za registraciju veterinarsko-medicinskih proizvoda (VICH)2.
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.
CVMP smatra da razdoblje karencije za mlijeko, meso i iznutrice liječenih goveda, ovaca i koza treba prilagoditi prema prijedlogu kako bi se osigurala sigurnost potrošača.
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.
Na temelju tog ispitivanja u kojem su rezidui u svim tkivima bili manji od najveće dopuštena količina rezidua 10. dana te podataka navedenih u EPMAR-u CVMP-a za oksiklozanid (EMEA/MRL/889/03-FINAL) o ukupnoj količini rezidua koja je bila manja od najveće dopuštene količine rezidua u svim tkivima 14. dan nakon primjene, zadržava se razdoblje karencije od 14 dana.
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.
Primijećeno je da se u 14radijski označenom ispitivanju C-oksiklozanida prijavljenom u odjeljku 25. Europskog javnog izvješća CVMP-a o procjeni najvećih dopuštenih količina rezidua (EPMAR) za oksiklozanid (EMEA/MRL/889/03-FINAL)1 navodi da je ukupna količina 14rezidua C-oksiklozanida bila manja od najveće dopuštene količine rezidua četrnaestog dana.
Two GLP-compliant residue depletion studies in cattle were submitted.
Dostavljena su dva ispitivanja o izlučivanju rezidua u goveda u skladu s dobrom laboratorijskom praksom.
Overall summary of the scientific evaluation of Zanil and associated names, and generic products thereof (see Annex I)
Cjelokupni sažetak znanstvene ocjene veterinarskomedicinskog proizvoda Zanil i pridruženih imena (vidi Prilog I.)
• the CVMP considered that the overall benefit-risk balance for the products under this procedure remains positive subject to amendments in the product information; the CVMP has recommended variations of the marketing authorisations for veterinary medicinal products Zanil and associated names, and generic products thereof remains positive (see Annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in Annex III.
CVMP preporučuje da varijacije odobrenja za stavljanje u promet veterinarsko-medicinskog proizvoda Zanil i pridruženih imena te njegove generičke lijekove ostanu pozitivne (vidjeti Prilog I.) kako bi se izmijenili sažetci opisa svojstava VMP-a, označivanje i upute o VMP-u u skladu s preporučenim izmjenama u informacijama o VMP-u kako je utvrđeno u Prilogu III.
• a sheep and goat meat and offal withdrawal period of 14 days,
• razdoblje karencije za meso i iznutrice ovce i koze iznosi 14 dana,
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.
VMP je primijenjen na 22 krave u količini od jedne maksimalne preporučene doze od 105 ml VMP-a po životinji te u skladu s 48. smjernicom Međunarodne suradnja za harmonizaciju tehničkih zahtjeva za registraciju veterinarsko-medicinskih proizvoda (VICH).
Residue depletion data in sheep and goat milk
Podatci o izlučivanju rezidua u mlijeku ovaca i koza
The highest residues levels (2 µg/kg i.e. 1/5 of the MRL) were observed in one cow at the second milking.
1/5 najveće dopuštene količine rezidua) primijećena je kod jedne krave pri drugoj mužnji.
INN
Down
Station Works Camlough Road Newry, Co. Down BT35 6JP
Down BT35 6JP
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.
Francuska je napomenula da su države članice diljem EUa/EGP-a uspostavile različita razdoblja karencije za mlijeko, meso i iznutrice nastalo od liječenih goveda i ovaca za Zanil i pridružena imena te njihove generičke proizvode.
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.
Uzimajući u obzir razloge za arbitražni postupak i dostupne podatke, CVMP smatra da razdoblje karencije za mlijeko, meso i iznutrice od liječenih goveda, ovaca i koza treba prilagoditi prema prijedlogu kako bi se osigurala sigurnost potrošača.
Whereas
Co.
Based on this, considering that in the study with the combination product ‘Nilzan Drench Plus', residues were also measured in the untreated control, the results seen in the ‘Nilzan Drench Plus' study at day 21 were considered to be outliers and excluded from the analysis.
Na temelju navedenog, uzimajući u obzir da su u ispitivanju nakon primjene kombiniranog VMP-a „Nilzan Drench Plus“ također izmjereni rezidui
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
Uzimajući u obzir nedostatke primijećene u ispitivanju VMP-a „Nilzan Drench Plus”, odnosno to što je korišteni lijek bio kombinirani lijek (oksiklozanid i levamisol) umjesto monolijeka Zanil (oksiklozanid) i abnormalne rezultate koji su primijećeni 21. dana, smatra se da je potrebno uvesti sigurnosni faktor od barem 30 % pri utvrđivanju razdoblja karencije.
Belgium Merial SAS 29 avenue Tony Garnier 69007 Lyon
Nizozemska Merial SAS 29 avenue Tony Garnier 69007 Lyon
No other residue depletion data in cattle milk were provided by the applicants/marketing authorisation holders.
Podnositelji zahtjeva/nositelji odobrenja za stavljanje u promet nisu dostavili druge podatke o izlučivanju rezidua u mlijeko goveda.
No other residue depletion data in sheep meat and offal were provided by the applicants/marketing authorisation holders.
Podnositelj zahtjeva/nositelj odobrenja za stavljanje u promet nije dostavio druge podatke o izlučivanju rezidua u meso i iznutrice ovaca.
No other residue depletion data in cattle meat and offal were provided by the applicants/marketing authorisation holders.
Podnositelj zahtjeva/nositelj odobrenja za stavljanje u promet nije dostavio druge podatke o izlučivanju rezidua u meso i iznutrice goveda.
1 CVMP European Public MRL Assessment Report for oxyclozanide (EMEA/MRL/889/03-FINAL) - link
1 CVMP European Public MRL Assessment Report for oxyclozanide (EMEA/MRL/889/03-FINAL) - link u životinja iz kontrolne skupine koje nisu liječene, rezultati primijećeni u ispitivanju VMP-a „Nilzan Drench Plus“ 21. dana smatraju se izuzetnima te su isključeni iz analize.
Some cases may require longer treatment.
Neki slučajevi mogu zahtijevati dulje liječenje.
Additional polar metabolites also exist.
Također postoje i dodatni polarni metaboliti.
Do not use in male breeding dogs.
Ne primjenjivati u muških rasplodnih pasa.
Date of last renewal: 10 April 2008
Datum posljednjeg produljenja odobrenja: 10. travnja 2008.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 30 tablets
SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA 30 tableta
Clomicalm should be used under veterinary supervision.
Clomicalm treba koristiti pod nadzorom veterinara.
In dogs, the volume of distribution (VDss) is 3.8 l/kg.
Kod pasa volumen distribucije (VDss) je 3,8 l/kg.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/ .
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
Shelf-life of the veterinary medicinal product as packaged for sale: 4 years
Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 4 godine.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Clomicalm contains:
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta Clomicalma sadrži:
The efficacy and safety of Clomicalm has not been established in dogs weighing less than 1.25 kg or under six months of age.
Neškodljivost i djelotvornost Clomicalma nije utvrđena u pasa koji teže manje od 1,25 kg ili u onih mlađih od šest mjeseci.
In cases showing no improvement after 2 months, treatment with Clomicalm should be ceased.
U slučaju da nema poboljšanja nakon dva mjeseca, liječenje Clomicalmom treba prekinuti.
MARKETING AUTHORISATION NUMBERS EU/2/98/007/001-003
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/98/007/001-003
Do not use after the expiry date which is stated on the label after EXP.
Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi poslije „EXP“.
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.
Klomipramin i njegovi metaboliti brzo se distribuiraju u tijelu miševa, kunića i štakora, s visokim koncentracijama u organima i tkivima (uključujući pluća, srce i mozak) i niskim koncentracijama koje zaostaju u krvi.
EXPIRY DATE EXP {month/year}
ROK VALJANOSTI EXP: {mjesec/godina}
The safety of the veterinary medicinal product has not been established in female dogs during pregnancy and lactation.
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena u ženki pasa tijekom graviditeta i laktacije.
One HDPE bottle with child resistant closure and sealing disk, containing 30 tablets and one silica gel desiccant sachet, packed within a cardboard box.
Jedna HDPE boca sa sigurnosnim zatvaračem za djecu i zapornim diskom koja sadrži 30 tableta i jednu vrećicu silikagela kao sredstvo za sušenje zapakiranu unutar kartonske kutije.
Laboratory animal studies in mice and rats have shown evidence of embryotoxic effects.
Laboratorijska ispitivanja na miševima i štakorima dokazala su embriotoksične učinke.
Pharmacotherapeutic group: Non-selective monoamine re-uptake inhibitors, ATCvet code: QN06AA04.
Farmakoterapijska grupa: Neselektivni inhibitori ponovne pohrane monoamina ATCvet kod: QN06AA04
Still higher doses (725 mg/kg) produced, in addition, convulsions and death.
Još više doze (725 mg/kg) uz to su uzrokovale konvulzije i smrt.
Simultaneous administration with cimetidine may lead to increased plasma levels of clomipramine.
Istodobna primjena s cimetidinom može uzrokovati povišene plazmatske razine klomipramina.
The active components in vivo are clomipramine and its major metabolite, desmethylclomipramine.
Djelatne komponente in vivo su klomipramin i njegov glavni metabolit, desmetilklomipramin.
It therefore possesses the properties of a serotonin re-uptake inhibitor and a tricyclic antidepressant.
Stoga posjeduje svojstva inhibitora ponovne pohrane serotonina i tricikličkog antidepresiva.
Clomicalm may be given with or without food.
Clomicalm se može dati s hranom ili bez nje.
Colloidal anhydrous silica Magnesium stearate
Koloidni bezvodni silikagel Magnezijev stearat
The major route of biotransformation of clomipramine is demethylation to desmethylclomipramine.
Glavni put biotransformacije klomipramina je demetilacija u desmetilklomipramin.
Clomipramine is extensively bound to plasma proteins (>97 %) in dogs.
Klomipramin se ekstenzivno veže za proteine plazme u pasa (> 97 %).
Clomicalm may very rarely cause vomiting, changes in appetite, lethargy or an elevation in liver enzymes, which is reversible when the product is discontinued.
Clomicalm može vrlo rijetko uzrokovati povraćanje, promjene apetita, letargiju ili povišenje jetrenih enzima, što je reverzibilno nakon prekida primjene proizvoda.
As an aid in the treatment of separation-related disorders in dogs manifested by destruction and inappropriate elimination (defaecation and urination) and only in combination with behavioural modification techniques.
Kao pomoć u liječenju poremećaja povezanih s razdvajanjem u pasa koji se očituju destrukcijom i neodgovarajućom eliminacijom (defekacijom i mokrenjem) i samo u kombinacijama s tehnikama bihevioralne modifikacije.
Any unused veterinary medicinal product or waste materials derived form such veterinary medicinal products should be disposed of in accordance with local requirements.
Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima.
Both clomipramine and desmethylclomipramine contribute to the effects of Clomicalm: clomipramine is a potent and selective 5-HT reuptake inhibitor while desmethylclomipramine is a potent and selective noradrenaline reuptake inhibitor.
klomipramin i desmetilklomipramin pridonose učincima Clomicalma: klomipramin je potentni i selektivni inhibitor ponovne pohrane 5-HT, dok je desmetilklomipramin potentni i selektivni inhibitor ponovne pohrane noradrenalina.
Clomipramine is well absorbed (>80%) from the gastrointestinal tract in dogs when administered orally but the systemic bioavailability for clomipramine and desmethylclomipramine is 22-26% due to extensive first pass metabolism by the liver.
Klomipramin se dobro apsorbira (> 80 %) iz probavnog sustava pasa kad se primjenjuje peroralno, ali je sistemska bioraspoloživost za klomipramin i desmetilklomipramin 22 - 26 % zbog ekstenzivnog metabolizma prvog prolaska kroz jetru.
The elimination t1/2 after intravenous administration of clomipramine hydrochloride in dogs was 6.4 hours for clomipramine and 3.6 hours for desmethylclomipramine.
Poluvrijeme eliminacije t1/2 nakon intravenske primjene klomipraminklorida u pasa iznosilo je 6,4 sati za klomipramin i 3,6 sati za desmetilklomipramin.
Do not use in case of known hypersensitivity to clomipramine and related tricyclic antidepressants.
Ne primjenjivati u slučaju poznate preosjetljivosti na klomipramin i srodne tricikličke antidepresive.