natgillin/translations-raw huggingface dataset:
The higher cough rate observed with TOBI Podhaler may be due to a higher powder deposition in the throat in comparison to nebuliser products. 
Večja stopnja kašlja pri zdravilu TOBI Podhaler je morda posledica večjega odlaganja praška v grlu v primerjavi z zdravili v obliki nebulatorja.
The difference is even more pronounced in the adult cystic fibrosis patient population (14% difference in overall discontinuations and 8% - in discontinuations due to AEs). 
Razlika je še izrazitejša v populaciji odraslih bolnikov s cistično fibrozo (razlika 14 % v skupni stopnji prekinitve zdravljenja in 8 % v stopnji prekinitve zdravljenja zaradi neželenih učinkov).
A higher percentage of TIP- than TIS-treated patients reported AEs (90.3% versus 84.2%, p<0.05). 
O neželenih učinkih je poročal večji odstotek bolnikov, zdravljenih s TIP, kot bolnikov, zdravljenih s TIS (90,3 % v primerjavi s 84,2 %, p<0,05).
This is particularly illustrated by the differences in the discontinuation rates due to AEs (13% for the inhalation powder vs. 8% for the nebuliser solution), development of cough as an adverse drug related event (25% for the inhalation powder vs. 4% for the nebuliser solution) and dysphonia rates (13% for the inhalation powder vs. 4% for the nebuliser solution). 
To še zlasti dokazujejo razlike v stopnji prekinitve zdravljenja zaradi neželenih učinkov (13 % pri prašku za inhalacijo v primerjavi z 8 % pri inhalacijski raztopini za nebulator), v pojavnosti kašlja kot neželenega učinka zdravila (25 % pri prašku za inhalacijo v primerjavi s 4 % pri inhalacijski raztopini za nebulator) in pojavnosti disfonije (13 % pri prašku za inhalacijo v primerjavi s 4 % pri inhalacijski raztopini za nebulator).
• The Committee was of the view that the data support the claim for clinical superiority of Tobramycin VVB versus TOBI Podhaler based on greater safety in a substantial portion of the target population, as per Article 8(3)(c) of Regulation (EC) No 141/2000 read in combination with Article 3(3)(d)(2) of Regulation (EC) No 847/2000; 
• Odbor je bil mnenja, da podatki podpirajo trditev o klinični superiornosti zdravila Tobramycin VVB v primerjavi z zdravilom TOBI Podhaler na podlagi večje varnosti pri znatnem deležu ciljne populacije v skladu s členom 8(3)(c) Uredbe (ES) št. 141/2000 v povezavi s členom 3(3)(d)(2) Uredbe (ES) št. 847/2000;
In the light of the above, to further justify why the applicant considers Tobramycin VVB clinically superior in a substantial portion of the target population to the orphan-designated medicinal product TOBI Podhaler. 
V luči zgoraj navedenega naj predlagatelj nadalje utemelji, zakaj meni, da je zdravilo Tobramycin VVB klinično superiorno pri znatnem deležu ciljne populacije v primerjavi z zdravilom siroto TOBI Podhaler.
Other treatment-related AEs more commonly reported in the TIP group were dysphonia (13.6% vs 3.8%) and dysgeusia (3.9% vs 0.5%). 
Druga neželena učinka, povezana z zdravljenjem, o katerih so pogosto poročali v skupini TIP, sta bila disfonija (13,6 % v primerjavi s 3,8 %) in disgevzija (3,9 % v primerjavi z 0,5 %).
Having established that there is a portion of the target population who cannot use powder inhalator due to the development of intolerance and that for these patients the tobramycin nebuliser solution is a safer alternative, in order for a conclusion on clinical superiority to be drawn CHMP needed to assess whether these patients correspond to a substantial portion of the target population. 
Ko je odbor CHMP ugotovil, da obstaja delež ciljne populacije, ki ne more uporabljati praška za inhalacijo zaradi pojava intolerance in pri katerem je inhalacijska raztopina tobramicina za nebulator varna alternativa, in da bi lahko izpeljal zaključek o klinični superiornosti, je moral oceniti, ali ti bolniki ustrezajo znatnemu deležu ciljne populacije.
The smallest difference was observed in the adult population (45% powder inhalation vs 34% nebuliser solution). 
Najmanjšo razliko so opazili pri odrasli populaciji (45 % pri prašku za inhalacijo v primerjavi s 34 % pri inhalacijski raztopini za nebulator).
The Applicant's claim for clinical superiority based on greater safety (tolerability) of tobramycin nebulizer solution (TIS) over tobramycin inhalation powder (TIP) in a substantial portion of the target population relies on clinical data generated by the open-label EAGER study1 and its post hoc analyses2. 
Predlagateljeva trditev o klinični superiornosti v smislu večje varnosti (prenašanja) inhalacijske raztopine tobramicina za nebulator (TIS) v primerjavi s praškom tobramicina za inhaliranje (TIP) pri znatnem deležu ciljne populacije se opira na klinične podatke iz odprte študije EAGER1 in njenih naknadnih analiz2.
• The Committee therefore considered that, in the context of Article 8(3) of Regulation (EC) No 141/2000, clinical superiority of Tobramycin VVB over TOBI Podhaler in a substantial portion of the target population can be established. 
• Odbor je zato menil, da je v kontekstu člena 8(3) Uredbe (ES) št. 141/2000 moč ugotoviti klinično superiornost zdravila Tobramycin VVB v primerjavi z zdravilom TOBI Podhaler pri znatnem deležu ciljne populacije.
The most common reasons for discontinuation were adverse events (AEs) - 40 (13.0%) of TIP as compared to 17 (8.1%) TIS-treated patients. 
Najpogostejši razlog za prekinitev zdravljenja so bili neželeni učinki (NU) - 40 (13,0 %) pri bolnikih, zdravljenih s TIP, in 17 (8,1 %) pri bolnikih, zdravljenih s TIS.
Therefore the CHMP concluded that the clinical relevance of the abovementioned differences between Tobramycin VVB and TOBI Podhaler demonstrates the clinical superiority of Tobramycin VVB over TOBI Podhaler based on greater safety in a substantial portion of the target population. 
Zato je zaključil, da klinični pomen zgoraj navedenih razlik med zdraviloma Tobramycin VVB in TOBI Podhaler dokazuje klinično superiornost zdravila Tobramycin VVB v primerjavi z zdravilom TOBI Podhaler na podlagi večje varnosti pri znatnem deležu ciljne populacije.
Poland considered that the clinical superiority of Tobramycin VVB vs. the orphan-designated medicinal product TOBI Podhaler 28 mg inhalation powder (hereinafter “TOBI Podhaler”) was not demonstrated, therefore derogation as per Article 8(3) of Regulation (EC) No 141/2000 was not fulfilled and a marketing authorisation as proposed by the RMS could not be granted. 
Poljska je bila mnenja, da klinična superiornost zdravila Tombramycin VVB v primerjavi z zdravilom siroto TOBI Podhaler 28 mg prašek za inhalacijo (v nadaljevanju „TOBI Podhaler“) ni bila dokazana, zato odstopanje v skladu s členom 8(3) Uredbe (ES) št. 141/2000 ni bilo izpolnjeno in dovoljenja za promet z zdravilom, kot je predlagala referenčna država članica, ni mogoče izdati.
The applicant of Tobramycin VVB has applied for a derogation from the market exclusivity of TOBI Podhaler 28 mg inhalation powder claiming that Tobramycin VVB 300 mg/5 ml nebuliser solution is clinically superior to the authorised orphan medicinal product (TOBI Podhaler 28 mg inhalation powder) in terms of providing greater safety in a substantial portion of the target population. 
Predlagatelj za zdravilo Tobramycin VVB je zaprosil za odstopanje od tržne ekskluzivnosti zdravila TOBI Podhaler 28 mg prašek za inhaliranje s trditvijo, da je zdravilo Tobramycin VVB 300 mg/5 ml inhalacijska raztopina za nebulator klinično superiornejša od odobrenega zdravila sirote (TOBI Podhaler 28 mg prašek za inhalacijo) v smislu večje varnosti pri znatnem deležu ciljne populacije.
In the EAGER study, cough described as an adverse drug related event was observed in 25% of patients on the inhalation powder vs. 4% of patients on the nebuliser solution. 
V študiji EAGER so kašelj, opisan kot neželeni učinek zdravila, opazili pri 25 % bolnikov, ki so prejemali prašek za inhalacijo, in pri 4 % bolnikov, ki so prejemali inhalacijsko raztopino za nebulator.
Fewer adolescents and adults on TIS discontinued study medication as a result of AEs, compared with those on TIP (9.1% on TIS discontinued vs 17.3% on TIP). 
Zaradi neželenih učinkov je jemanje študijskega zdravila prekinilo manj mladostnikov in odraslih, ki so prejemali TIS, v primerjavi s tistimi, ki so prejemali TIP (jemanje je prekinilo 9,1 % bolnikov s TIS in 17,3 % s TIP).
The importance of cough as AE for a powder formulation was already acknowledged during the assessment of TOBI Podhaler, and it is recommended that alternative treatment with the nebuliser solution is considered for patients using TOBI Podhaler who experience continued therapy-induced cough. 
Pomen kašlja kot neželenega učinka pri formulaciji s praškom je bil priznan že med ocenjevanjem zdravila TOBI Podhaler, zato se priporoča, da se pri bolnikih, ki uporabljajo zdravilo TOBI Podhaler, pri katerih se stalno pojavlja kašelj kot posledica zdravljenja, razmisli o alternativnem zdravljenju z inhalacijsko raztopino za nebulator.
The medicinal product TOBI Podhaler 28 mg inhalation powder is covered by an orphan designation in the condition treatment of P. aeruginosa lung infection in cystic fibrosis (orphan designation EU/3/03/140). 
Zdravilo TOBI Podhaler 28 mg prašek za inhalacijo je določeno kot zdravilo sirota pri stanju zdravljenje okužbe pljuč z bakterijo P. aeruginosa pri cistični fibrozi (določitev zdravila sirote EU/3/03/140).
The proposed therapeutic indication for Tobramycin VVB 300 mg/5 ml nebuliser solution is the same as for TOBI Podhaler (EU/1/10/652, Tobramycin, inhalation powder) and identical to that of TOBI 300 mg/5ml nebuliser solution: “suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis.” 
Predlagana terapevtska indikacija za zdravilo Tobramycin VVB 300 mg/5 ml inhalacijska raztopina za nebulator je enaka kot za zdravilo TOBI Podhaler (EU/1/10/652, tobramicin, prašek za inhaliranje) in identična kot pri zdravilu TOBI 300 mg/5 ml inhalacijska raztopina za nebulator: „supresivno zdravljenje kronične okužbe pljuč z bakterijo Pseudomonas aeruginosa pri odraslih in otrocih, starih 6 let ali več, ki imajo cistično fibrozo.“
Notification of a referral for arbitration, under Article 29(4) of Directive 2001/83/EC, to the CHMP was made by the Reference Member State Lithuania on 14 October 2015 based on concerns raised by the Concerned Member State Poland. 
14. oktobra 2015 je referenčna država članica, Litva, odboru CHMP poslala obvestilo o napotitvi v arbitražo v skladu s členom 29(4) Direktive 2001/83/ES na podlagi pomislekov zadevne države članice Poljske.
The differences in terms of safety (in terms of tolerability) observed in the EAGER trial between the nebuliser solution and the inhalation powder, favouring the nebuliser solution regarding the occurrence of cough and discontinuation of treatment, are relevant and support the claim of greater safety (in terms of tolerability), as per article Article 8(3)(c) of Regulation (EC) No 141/2000, of Tobramycin VVB in those patients who develop intolerance to TOBI Podhaler. 
Razlike v smislu varnosti (v smislu prenašanja), med inhalacijsko raztopino za nebulator in praškom za inhalacijo, opažene v preskušanju EAGER, ki glede na pojavnost kašlja in prekinitev zdravljenja dajejo prednost inhalacijski raztopini za nebulator, so pomembne in v skladu s členom 8(3)(c) Uredbe (ES) št. 141/2000 podpirajo trditev o večji varnosti (v smislu prenašanja) zdravila Tobramycin VVB pri bolnikih, pri katerih je pojavi intoleranca za zdravilo TOBI Podhaler.
Overall, in the context of the claim of clinical superiority based on a greater safety according to Article 8(3)(c) of Regulation (EC) No 141/2000 read in combination with Article 3(3)(d)(2) of Regulation (EC) No 847/2000, CHMP considered that a substantial portion of the target population experiences greater safety (in terms of tolerability) with Tobramycin VVB in terms of the incidence of cough and treatment discontinuation, as compared to TOBI Podhaler. 
Skupaj je odbor CHMP, v smislu trditve o klinični superiornosti na podlagi večje varnosti v skladu s členom 8(3)(c) Uredbe ES št. 141/2000 v povezavi s členom 3(3)(d)(2) Uredbe (ES) št. 847/200, menil, da je znaten delež ciljne populacije deležen večje varnosti (v smislu prenašanja) z zdravilom Tobramycin VVB v smislu pojavnosti kašlja in prekinitve zdravljenja kot z zdravilom TOBI Podhaler.
UAB “VVB” submitted on 2 May 2014 a marketing authorisation application for Tobramycin VVB 300 mg/5 ml nebuliser solution (hereinafter “Tobramycin VVB”) as an abridged application in accordance with Article 10(3) of Directive 2001/83/EC, referring to Nebcin solution for injection (PL 13621/0059) for the purpose of the data exclusivity, and to TOBI 300 mg/5 ml nebuliser solution (hereinafter “TOBI”; PL 00101/0935) for the purpose of the SmPC/clinical comparator. 
Družba UAB “VVB” je 2. maja 2014 predložila skrajšano vlogo za pridobitev dovoljenja za promet z zdravilom Tobramycin VVB 300 mg/5 ml inhalacijska raztopina za nebulator (v nadaljevanju „Tobramycin VVB“) v skladu s členom 10(3) Direktive 2001/83/ES, ki se nanaša na referenčno zdravilo Nebcin raztopina za injiciranje (PL 13621/0059) za namen ekskluzivnosti podatkov in na referenčno zdravilo TOBI 300 mg/5 ml inhalacijska raztopina za nebulator (v nadaljevanju „TOBI“;
RMS and CMSs agreed that Tobramycin VVB is comparable to TOBI 300 mg/5 ml nebuliser solution and therefore available efficacy and safety data for TOBI can be extrapolated to Tobramycin VVB. 
Referenčna država članica in zadevne države članice so se strinjale, da je zdravilo Tobramycin VVB primerljivo z zdravilom TOBI 300 mg/5 ml inhalacijska raztopina za nebulator, zato se razpoložljivi podatki o učinkovitosti in varnosti zdravila TOBI lahko ekstrapolirajo na zdravilo Tobramycin VVB.
For these patients, tobramycin nebuliser solution is an alternative. 
Ti bolniki imajo drugo možnost, inhalacijsko raztopino tobramicina za nebulator.
The post hoc subgroup analysis of EAGER trial data confirmed the 
Naknadna analiza podskupin podatkov iz preskušanja EAGER je potrdila razlike v stopnjah pojavnosti kašlja v vseh starostnih skupinah.
3 inhalers with 60 actuations 
3 inhalatorji s 60 sprožitvami
This summary was last updated in September 2013. 
Povzetek je bil nazadnje posodobljen septembra 2013.
It is available as chewable tablets in five strengths (90 mg, 140 mg, 180 mg, 270 mg, 425 mg) for dogs and cats and in three additional strengths for larger dogs (665 mg, 1040 mg and 1620 mg). 
Na voljo je v obliki žvečljivih tablet v petih različnih jakostih za pse in mačke (90 mg, 140 mg, 180 mg, 270 mg, 425 mg) in v treh dodatnih jakostih za večje pse (665 mg, 1 040 mg in 1 620 mg).
Comfortis is given as a single dose which can be repeated every month. 
Zdravilo se daje kot enojni odmerek, kar se lahko ponovi vsak mesec.
People who give the medicine should wash their hands after handling Comfortis. 
Osebe, ki dajejo zdravilo, naj si po uporabi zdravila Comfortis umijejo roke.
Other information about Comfortis: 
Druge informacije o zdravilu Comfortis:
The European Commission granted a marketing authorisation valid throughout the European Union, for Comfortis on 11/02/2011. 
Evropska komisija je dovoljenje za promet z zdravilom Comfortis, veljavno po vsej Evropski uniji, odobrila dne 11. februarja 2011.
The studies also showed that the preventive effect of spinosad against new flea infestations (which results from its residual insecticidal activity) lasts for up to 4 weeks. 
Študije so tudi pokazale, da preprečevalni učinek spinosada pred ponovno infestacijo z bolhami (ki je posledica rezidualne insekticidne aktivnosti) traja do štiri tedne.
Use of Comfortis tablets in dogs or cats which have epilepsy may involve additional risks. 
Uporaba tablet zdravila Comfortis pri psih ali mačkah, ki imajo epilepsijo, lahko vključuje dodatna tveganja.
The CVMP concluded that the benefits of Comfortis outweigh the risks when used for the approved indications and recommended that Comfortis be given a marketing authorisation. 
CVMP je zaključil, da so koristi zdravila Comfortis večje od z njim povezanih tveganj, kadar se uporablja za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
What benefit has Comfortis shown during the studies? 
Kakšne koristi je zdravilo Comfortis izkazalo med študijami?
Comfortis is a veterinary medicine that contains spinosad. 
Comfortis je zdravilo za uporabo v veterinarski medicini, ki vsebuje spinosad.
The studies involved dogs and cats of different age groups, genders, breeds and weights. 
V študije so bili vključeni psi in mačke različnih starostnih skupin, spolov, pasem in telesne mase.
Accidental ingestion, including by children, may cause adverse reactions. 
Nenamerno zaužitje, tudi pri otrocih, lahko povzroči neželene učinke.
The active substance in Comfortis, spinosad, is an insecticide which works by interfering with certain receptors (nicotinic acetylcholine receptors) in the fleas' nervous system, which results in their subsequent paralysis and death. 
Zdravilna učinkovina v zdravilu Comfortis, spinosad, je insekticid, ki deluje tako, da ovira nekatere receptorje (nikotinske receptorje acetilholina) v živčnem sistemu bolh, kar pri njih posledično povzroči paralizo in smrt.
Similarly Comfortis tablets should be given with a meal or immediately after feeding in cats. 
Podobno je treba tudi pri mačkah tablete zdravila Comfortis dajati skupaj s hrano ali nemudoma po njihovem hranjenju.
What is the risk associated with Comfortis? 
Kakšna tveganja so povezana z zdravilom Comfortis?
Comfortis tablets are not recommended for use in dogs weighing less than 1.3 kg or in cats weighing less than 1.2 kg (as accurate dosing of the product in such small dogs or cats is not possible and they may be accidentally overdosed). 
Uporaba tablet zdravila Comfortis ni priporočljiva pri psih, ki tehtajo manj kot 1,3 kg, in mačkah, ki tehtajo manj kot 1,2 kg (natančno odmerjanje zdravila pri tako majhnih psih in mačkah namreč ni mogoče, zato lahko nenamerno pride do prevelikega odmerka).
Comfortis has been studied in laboratory animals, as well as in dogs or cats that were treated in various veterinary practices and clinics across Europe (“clinical studies”). 
Zdravilo Comfortis so proučevali na laboratorijskih živalih ter psih in mačkah, ki so bili zdravljeni v različnih veterinarskih ambulantah in klinikah po Evropi („klinične študije“).
The effectiveness of the product was measured by looking at the number of fleas that were alive at various times after treatment. 
Učinkovitost zdravila je bila merjenja s preverjanjem števila živih bolh v različnih obdobjih po uporabi zdravila.
The most common side effect is vomiting, which is mild and transient in most dogs and cats. 
Najpogostejši neželeni učinek je bruhanje, ki je pri večini psov in mačk blago in prehodno.
The clinical studies, carried out for between one and three months, showed that Comfortis is as effective as the comparator medicine in the treatment of flea infestations in dogs and cats. 
Klinične študije, ki so trajale od enega do treh mesecev, so pokazale, da je zdravilo Comfortis enako učinkovito kot primerjalno zdravilo pri zdravljenju infestacije z bolhami pri psih in mačkah.
Comfortis tablets must not be used in dogs or cats aged less than 14 weeks, or in dogs or cats that are hypersensitive (allergic) to spinosad or any of the other ingredients in the tablets. 
Tablete zdravila Comfortis se ne smejo uporabljati pri psih in mačkah, mlajših od 14 tednov, ali psih in mačkah, ki so preobčutljivi za (alergični na) spinosad ali katero koli drugo sestavino v tabletah.
Comfortis can also be used as part of a treatment strategy for flea allergic dermatitis (an allergic reaction to flea bites). 
Lahko se uporablja tudi kot del strategije zdravljenja alergijskega dermatitisa, ki ga povzročajo bolhe (alergijske reakcije na ugrize bolh).
Why has Comfortis been approved? 
Zakaj je bilo zdravilo Comfortis odobreno?
In the clinical studies, Comfortis was compared with a veterinary medicine authorised in the EU for the treatment and prevention of flea infestations (selamectin, a ‘spot-on' applied to the skin of the dog or cat). 
V kliničnih študijah so zdravilo Comfortis primerjali z veterinarskim zdravilom, odobrenim v EU za zdravljenje in preprečevanje infestacije z bolhami (selamektin, zdravilo za kožni nanos za pse ali mačke).
The medicine starts killing fleas on the dog or cat 30 minutes after giving the tablet(s) and it remains active for up to four weeks. 
Zdravilo začne bolhe pri psih ali mačkah uničevati v 30 minutah po zaužitju tablete in učinkuje do štiri tedne.
In case of accidental ingestion, medical advice should be sought immediately and the package leaflet or the label shown to the doctor. 
V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
Comfortis is used to treat and prevent flea infestations in dogs and cats. 
Zdravilo Comfortis se uporablja za zdravljenje in preprečevanje infestacije z bolhami pri psih in mačkah.
Studies also showed that the frequency and severity of flea allergy dermatitis (an allergic reaction to flea bites) is significantly decreased in dogs and cats treated with Comfortis and so its use as part of a treatment strategy for the control of this condition is justified. 
Pri psih in mačkah, zdravljenih z zdravilom Comfortis, so študije pokazale tudi bistveno zmanjšano pogostnost in resnost alergijskega dermatitisa, ki ga povzročajo bolhe (alergijske reakcije na ugrize bolh), zato je uporaba tega zdravila kot dela strategije zdravljenja za nadzor tega obolenja upravičena.
The appropriate strength tablet(s) should be used according to the dog's or cat's weight (the dose differs between dogs and cats). 
Uporabiti je treba ustrezno jakost tablet glede na maso psa ali mačke (odmerek se razlikuje glede na to, ali se daje psom ali mačkam).
How has Comfortis been studied? 
Kako je bilo zdravilo Comfortis raziskano?
Laboratory studies were carried out to look at the effectiveness of Comfortis in killing the fleas on dogs and cats with existing flea infestations, and at the speed of killing fleas on the treated animals. 
V laboratorijskih študijah so proučevali učinkovitost zdravila Comfortis pri uničevanju bolh na psih in mačkah z obstoječo infestacijo z bolhami ter hitrost uničevanja bolh pri zdravljenih živalih.
For a full list of all side effects reported with Comfortis, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Comfortis, glejte navodilo za uporabo.
Comparative studies on fed/fasted dogs indicated that Comfortis tablets should be given with a meal to increase the amount of the active substance absorbed by the dog. 
Primerjalne študije na psih, ki so zaužili hrano, in teščih psih so pokazale, da je tablete zdravila Comfortis treba jemati s hrano, saj se tako poveča količina zdravilne učinkovine, ki jo pes absorbira.
Other common side effects in cats include diarrhoea and loss of appetite. 
Druga pogosta neželena učinka zdravila pri mačkah sta driska in izguba teka.
What is Comfortis used for? 
Za kaj se zdravilo Comfortis uporablja?
The results of laboratory studies demonstrated that the product was effective at killing the fleas on dogs or cats with existing flea infestations within 24 hours after treatment. 
Rezultati laboratorijskih študij so pokazali, da zdravilo v 24 urah po nanosu zdravila učinkovito uniči bolhe pri psih ali mačkah z obstoječo infestacijo z bolhami.
The safety for suckling puppies or kittens has not been sufficiently established, therefore Comfortis should only be used in breeding, pregnant or lactating dogs or cats if the veterinary surgeon has specifically recommended it. 
Ker dokazi o varnosti za pasje ali mačje mladiče, ki se dojijo, niso zadostni, se lahko zdravilo Comfortis pri psih in mačkah za razplod oziroma brejih ali doječih psicah in mačkah uporablja samo po izrecnem priporočilu veterinarja.
How does Comfortis work? 
Kako zdravilo Comfortis deluje?
The safety of Comfortis has not been sufficiently established in dogs or cats that are pregnant or breeding (male or female). 
Varnost zdravila Comfortis ni bila ustrezno proučena pri brejih psicah ali mačkah ali psih in mačkah za razplod (samcih ali samicah).
What is Comfortis? 
Kaj je zdravilo Comfortis?