natgillin/translations-raw huggingface dataset:
Laboratory studies (in rats and rabbits) on the effect of spinosad and milbemycin oxime have neither produced any evidence of teratogenic, foetotoxic or maternotoxic effects, nor any effect on the reproductive capacity in males and females. 
Laboratorijski pokusi o utjecaju spinosada i milbemicin oksima (na miševima i kunićima) nisu dali nikakav dokaz teratogenog, fetotoksičnog niti maternotoksičnog učinka, kao ni utjecaj na reproduktivnu sposobnost kod mužjaka ili ženki.
Vomiting was seen in both treated and control dogs with similar frequencies. 
Na liječenim i kontrolnim psima povraćanje je primijećeno sa sličnom učestalošću.
Dogs living in heartworm endemic areas: 
Psi koji žive u endemičnim područjima bolesti srčanog crva:
Milbemycin oxime 
Milbemicin oksim
This product should therefore only be used during pregnancy and lactation according to the benefit-risk assessment of the responsible veterinarian. 
Stoga se ovaj proizvod smije primijeniti za vrijeme graviditeta i laktacije samo nakon procjene odnosa koristi/rizika od strane odgovornog veterinara.
For the prevention of lungworm disease by reducing the level of infection with immature adult (L5) Angiostrongylus vasorum larvae and the concurrent treatment and prevention of flea infestation, the veterinary medicinal product must be given at regular monthly intervals during the time of the year when snails/slugs and fleas are present. 
Za prevenciju bolesti plućnog oblića smanjenjem razine infestacije ličinkama nezrelih odraslih jedinki (L5) Angiostrongylus vasorum i usporedno liječenje i prevenciju infestacije buhama, veterinarskomedicinski proizvod mora se primijeniti u redovnim mjesečnim intervalima, u dijelu godine kad se pojave puževi/golaći i buhe.
and adult Ancylostoma caninum), roundworms (immature adult L5, and adult Toxocara canis and adult Toxascaris leonina) and whipworm (adult Trichuris vulpis). 
L5, odrasle jedinke Toxocara canis i odrasle jedinke Toxascaris leonina) i bičastim crvom (odrasle jedinke Trichuris vulpis).
Fleas from pets often infest the animal's basket, bedding and regular resting areas such as carpets and soft furnishings. 
Buhe kućnih ljubimaca često infestiraju košaru za spavanje, krevetninu i uobičajena područja za odmor, kao što su tepisi i presvlake.
Treatment and prevention of flea infestation when concurrent prevention of heartworm disease, angiostrongylosis and/or concurrent treatment of nematode infections is indicated. 
Za liječenje i prevenciju infestacija buhama, kada je indicirana istovremena prevencija dirofilarioze, tj. bolesti srčanog crva, angiostrongiloze i/ili liječenje gastrointestinalnih infestacija uzrokovanih oblićima.
In adult dogs, after repeated oral administration of spinosad and milbemycin oxime for six consecutive months, increases in elimination half-lives were observed up to month 3. 
Kod odraslih pasa, nakon ponovljene peroralne primjene spinosada i milbemicin oksima tijekom šest uzastopnih mjeseci primijećeno je povećanje poluvremena eliminacije do 3 mjeseca.
spinosad/milbemycin oxime 
spinosad / milbemicin oksim
spinosad / milbemycin oxime 
spinosad/milbemicin oksim
Accurate dosing is not possible in dogs weighing less than 3.9 kg. 
Precizno doziranje nije moguće kod pasa lakšim od 3,9 kg stoga se tim psima ne preporučuje primjena ovog veterinarsko-medicinskog proizvoda.
Trifexis 1620 mg/27 mg tablets: 
Trifexis 1620 mg/27 mg tablete:
Spinosad comprises spinosyn A and spinosyn D. The insecticidal activity of spinosad is characterised by nervous excitation leading to muscle contractions and tremors, prostration, paralysis and rapid death of the flea. 
Insekticidna aktivnost spinosada karakterizirana je ekscitacijom živaca koja vodi do mišićnih kontrakcija, tremora, prostracije, paralize i brze smrti buha.
Monthly repeated oral administration of spinosad and milbemycin oxime over six months revealed evidence of spinosad and milbemycin oxime accumulation in juvenile dogs. 
Ponovljena mjesečna peroralna primjena spinosada i milbemicin oksima tijekom šest mjeseci otkrila je nakupljanje spinosada i milbemicin oksima kod mladih pasa.
Dosage: 
Doziranje:
Trifexis 665 mg/11.1 mg spinosad 665 mg/milbemycin oxime 11.1 mg 
Trifexis 665 mg/11,1 mg spinosad 665 mg/milbemicin oksim 11,1 mg
Postmarketing reports for spinosad indicate that in very rare cases, blindness, impaired vision and other eye disorders were observed. 
Izvještaji za spinosad, nakon stavljanja veterinarsko-medicinskog proizvoda u promet, pokazuju da su u vrlo rijetkim slučajevima primijećeni sljepilo, oštećenje vida i ostali poremećaji vida.
The tablets are a mottled tan to brown colour, and are round and chewable. 
Išarane tablete tamnožute do smeđe boje, okrugle, za žvakanje.
The oral administration of spinosad and milbemycin oxime combination tablets at mean cumulative monthly doses of up to 255 mg spinosad and 4.2 mg milbemycin oxime per kg body weight (up to 3.6 times the maximum recommended dose) for 6 consecutive dosing periods in young dogs was well tolerated. 
Peroralnu primjenu kombinacije spinosada i milbemicin oksima u tabletama u srednjim kumulativnim mjesečnim dozama do 255 mg spinosada i 4,2 mg milbemicin oksima po kg tjelesne težine (do 3,6 puta veća doza od doze liječenja) u 6 uzastopnih doznih perioda mladi su psi dobro podnosili.
Trifexis 1620 mg/27 mg spinosad 1620 mg/milbemycin oxime 27.0 mg 
Trifexis 1620 mg/27 mg spinosad 1620 mg/milbemicin oksim 27,0 mg
The safe use of the maximum recommended dose (70mg/kg spinosad and 1.18mg/kg milbemycin oxime) given as capsules has been demonstrated for 12 months. 
Sigurna primjena najviše preporučene doze (70 mg/kg spinosada i 1,18 mg/kg milbemicin oksima) dane u kapsulama dokazana je nakon 12 mjeseci.
For the prevention of heartworm disease and the concurrent treatment and prevention of flea infestations, the veterinary medicinal product must be given at regular monthly intervals during the time of the year when mosquitoes and fleas are present. 
Radi prevencije bolesti srčanog crva i istovremenog liječenja i prevencije infestacije buhama, ovaj veterinarsko-medicinski proizvod mora se davati u redovnim mjesečnim intervalima, u godišnje doba kada su prisutni komarci i buhe.
4347 and no dimples 
4347 i bez rupica
spinosad 270 mg/milbemycin oxime 4.5 mg spinosad 425 mg/milbemycin oxime 7.1 mg spinosad 665 mg/milbemycin oxime 11.1 mg spinosad 1040 mg/milbemycin oxime 17.4 mg spinosad 1620 mg/milbemycin oxime 27 mg 
spinosad 270 mg/milbemicin oksim 4,5 mg spinosad 425 mg/milbemicin oksim 7,1 mg spinosad 665 mg/milbemicin oksim 11,1 mg spinosad 1040 mg/milbemicin oksim 17,4 mg spinosad 1620 mg/milbemicin oksim 27 mg
Trifexis 665 mg/11.1 mg tablets: 
Trifexis 665 mg/11,1 mg tablete:
The excretion of milbemycin oxime in lactating dogs (bitches) has not been tested and the safety for suckling puppies has not been established. 
Izlučivanje milbemicin oksima kod kuja koje doje nije ispitano te nije utvrđena neškodljivost za štence koji sišu.
6.5 Nature and composition of immediate packaging Blister packs (of 1, 3 or 6 chewable tablets) in a carton. 
Blister pakovanje (s 1, 3 ili 6 tableta za žvakanje) u kutiji.
In juvenile dogs, repeated oral administration of spinosad and milbemycin oxime over six months resulted in the trough plasma concentrations of spinosad and milbemycin increasing throughout the study. 
Kod mladih pasa, ponovljena peroralna primjena spinosada i milbemicin oksima tijekom šest mjeseci rezultirala je povećanjem najniže koncentracije spinosada i milbemicin oksima tijekom cijelog trajanja ispitivanja.
In case of adverse reactions consult your veterinarian. 
U slučaju nuspojava, molimo obavijestite svog veterinara.
4349 and 4 dimples 
4349 i 4 rupice
EU/2/13/155/001 (1 tablet, 270 mg/4.5 mg) EU/2/13/155/002 (1 x 3 tablets, 270 mg/4.5 mg) EU/2/13/155/003 (1 x 6 tablets, 270 mg/4.5 mg) EU/2/13/155/004 (1 tablet, 425 mg/7.1 mg) EU/2/13/155/005 (1 x 3 tablets, 425 mg/7.1 mg) EU/2/13/155/006 (1 x 6 tablets, 425 mg/7.1 mg) 
EU/2/13/155/001 (1 tableta, 270 mg/4,5 mg) EU/2/13/155/002 (1 x 3 tablete, 270 mg/4,5 mg) EU/2/13/155/003 (1x 6 tableta, 270 mg/4,5 mg) EU/2/13/155/004 (1 tableta, 425 mg/7,1 mg) EU/2/13/155/005 (1 x 3 tablete, 425 mg/7,1 mg) EU/2/13/155/006 (1x 6 tableta, 425 mg/7,1 mg)
Trifexis 1040 mg/17.4 mg spinosad 1040 mg/milbemycin oxime 17.4 mg 
Trifexis 1040 mg/17,4 mg spinosad 1040 mg/milbemicin oksim 17,4 mg
It is recommended that lungworm prevention should be continued until at least 1 month after the last exposure to slugs and snails, but not for more than 6 consecutive months using Trifexis in any one year. 
Preporučuje se nastavak prevencije plućnog oblića do najmanje 1 mjesec nakon posljednjeg izlaganja puževima i golaćima, ali se Trifexis ne smije primjenjivati više od 6 mjeseci zaredom, u jednoj godini.
Post-marketing reports following the concomitant use of spinosad with ivermectin indicate that dogs have experienced trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation. 
Izvještaji nakon stavljanja VMP u promet nakon istovremene primjene spinosada i ivermektina pokazuju da je u pasa uočeno drhtanje/trzanje, salivacija/slinjenje, epileptički napadaji, ataksija, midrijaza, sljepilo i gubitak orijentacije.
Trifexis 1040 mg/17.4 mg tablets: 
Trifexis 1040 mg/17,4 mg tablete:
For the treatment and prevention of flea (Ctenocephalides felis) infestations in dogs where one or more of the following indications are required concurrently: - prevention of heartworm disease (L3, L4 Dirofilaria immitis), - prevention of angiostrongylosis by reducing the level of infection with immature adult (L5) 
Za liječenje i prevenciju infestacija buhama (Ctenocephalides felis) kod pasa, kada se pojavi jedna ili više istovremenih indikacija: - za prevenciju bolesti srčanog crva (L3, L4, Dirofilaria immitis).
4333 and 2 dimples 
4333 i 2 rupice
Post-marketing reports: following the concomitant use of spinosad with ivermectin indicate that dogs have experienced trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation. 
Izvještaji nakon stavljanja VMP u promet, nakon istovremene primjene spinosada i ivermektina pokazuju da je u pasa uočeno drhtanje/trzanje, salivacija/slinjenje, epileptički napadaji, ataksija, midrijaza, sljepilo i gubitak orijentacije.
As the safety of this veterinary medicinal product in male dogs used for breeding has not been determined, it should only be used according to the benefit-risk assessment by the responsible veterinarian 
Budući da neškodljivost ovog veterinarsko-medicinskog proizvoda nije potvrđena u pasa za rasplod, isti se smije primijeniti samo nakon procjene odnosa koristi/rizika od strane odgovornog veterinara.
EU/2/13/155/001 (1 tablet, 270 mg/4.5 mg) EU/2/13/155/002 (1 x 3 tablets, 270 mg/4.5 mg) EU/2/13/155/003 (1 x 6 tablets, 270 mg/4.5 mg) EU/2/13/155/004 (1 tablet, 425 mg/7.1 mg) EU/2/13/155/005 (1 x 3 tablets, 425 mg/7.1 mg) EU/2/13/155/006 (1 x 6 tablets, 425 mg/7.1 mg) EU/2/13/155/007 (1 tablet, 665 mg/11.1 mg) EU/2/13/155/008 (1 x 3 tablets, 665 mg/11.1 mg) EU/2/13/155/009 (1 x 6 tablets, 665 mg/11.1 mg) EU/2/13/155/010 (1 tablet, 1040 mg/17.4 mg) EU/2/13/155/011 (1 x 3 tablets, 1040 mg/17.4 mg) EU/2/13/155/012 (1 x 6 tablets, 1040 mg/17.4 mg) EU/2/13/155/013 (1 tablet, 1620 mg/27.0 mg) EU/2/13/155/014 (1 x 3 tablets, 1620 mg/27.0 mg) EU/2/13/155/015 (1 x 6 tablets, 1620 mg/27.0 mg) 
EU/2/13/155/001 (1 tableta, 270 mg/4,5 mg) EU/2/13/155/002 (1 x 3 tablete, 270 mg/4,5 mg) EU/2/13/155/003 (1x 6 tableta, 270 mg/4,5 mg) EU/2/13/155/004 (1 tableta, 425 mg/7,1 mg) EU/2/13/155/005 (1 x 3 tablete, 425 mg/7,1 mg) EU/2/13/155/006 (1x 6 tableta, 425 mg/7,1 mg) EU/2/13/155/007 (1 tableta, 665 mg/11,1 mg) EU/2/13/155/008 (1 x 3 tablete, 665 mg/11,1 mg) EU/2/13/155/009 (1x 6 tableta, 665 mg/11,1 mg) EU/2/13/155/010 (1 tableta, 1040 mg/17,4 mg) EU/2/13/155/011 (1 x 3 tablete, 1040 mg/17,4 mg) EU/2/13/155/012 (1x 6 tableta, 1040 mg/17,4 mg) EU/2/13/155/013 (1 tableta, 1620 mg/27,0 mg) EU/2/13/155/014 (1 x 3 tablete, 1620 mg/27,0 mg) EU/2/13/155/015 (1x 6 tableta, 1620 mg/27,0 mg)
Angiostrongylus vasorum, - treatment of gastrointestinal nematode infections caused by hookworm (L4, immature adult (L5) 
- za prevenciju angiostrongiloze, smanjenjem infestacije s nezrelim odraslim (L5) Angiostrongylus vasorum, - za liječenje gastrointestinalne infestacije nematodima, uzrokovane: kukastim crvom (L4, nezrele odrasle jedinke (L5) i odrasle jedinke Ancylostoma caninum), glistama pasa (nezrele odrasle jedinke
Trifexis 425 mg/7.1 mg spinosad 425 mg/milbemycin oxime 7.1 mg 
Trifexis 425 mg/7,1 mg spinosad 425 mg/milbemicin oksim 7,1 mg
PACKAGE SIZE 1 chewable tablet 3 chewable tablets 6 chewable tablets 
VELIČINA PAKOVANJA 1 tableta za žvakanje
Trifexis 425 mg/7.1 mg tablets: 
Trifexis 425 mg/7,1 mg tablete:
EU/2/13/155/007 (1 tablet, 665 mg/11.1 mg) EU/2/13/155/008 (1 x 3 tablets, 665 mg/11.1 mg) EU/2/13/155/009 (1 x 6 tablets, 665 mg/11.1 mg) EU/2/13/155/010 (1 tablet, 1040 mg/17.4 mg) EU/2/13/155/011 (1 x 3 tablets, 1040 mg/17.4 mg) EU/2/13/155/012 (1 x 6 tablets, 1040 mg/17.4 mg) EU/2/13/155/013 (1 tablet, 1620 mg/27.0 mg) EU/2/13/155/014 (1 x 3 tablets, 1620 mg/27.0 mg) EU/2/13/155/015 (1 x 6 tablets, 1620 mg/27.0 mg) 
EU/2/13/155/007 (1 tableta, 665 mg/11,1 mg) EU/2/13/155/008 (1 x 3 tablete, 665 mg/11,1 mg) EU/2/13/155/009 (1x 6 tableta, 665 mg/11,1 mg) EU/2/13/155/010 (1 tableta, 1040 mg/17,4 mg) EU/2/13/155/011 (1 x 3 tablete, 1040 mg/17,4 mg) EU/2/13/155/012 (1x 6 tableta, 1040 mg/17,4 mg) EU/2/13/155/013 (1 tableta, 1620 mg/27,0 mg) EU/2/13/155/014 (1 x 3 tablete, 1620 mg/27,0 mg) EU/2/13/155/015 (1x 6 tableta, 1620 mg/27,0 mg)
PACKAGE LEAFLET FOR: Trifexis 270 mg/4.5 mg chewable tablets for dogs Trifexis 425 mg/7.1 mg chewable tablets for dogs Trifexis 665 mg/11.1 mg chewable tablets for dogs Trifexis 1040 mg/17.4 mg chewable tablets for dogs Trifexis 1620 mg/27 mg chewable tablets for dogs 
UPUTA O VMP ZA: Trifexis 270 mg/4,5 mg tablete za žvakanje za pse Trifexis 425 mg/7,1 mg tablete za žvakanje za pse Trifexis 665 mg/11,1 mg tablete za žvakanje za pse Trifexis 1040 mg/17,4 mg tablete za žvakanje za pse Trifexis 1620 mg/27 mg tablete za žvakanje za pse
Trifexis 270 mg/4.5 mg spinosad 270 mg/milbemycin oxime 4.5 mg 
Trifexis 270 mg/4,5 mg spinosad 270 mg/milbemicin oksim 4,5 mg
Spinosad and milbemycin oxime have been shown to be substrates for P-glycoprotein (P-gp) and therefore could interact with other P-gp substrates (for example, digoxin, doxorubicin) or other macrocyclic lactones. 
Pokazalo se da su spinosad i milbemicin oksim supstrati P-glikoproteina (Pgp) i stoga mogu uzajamno djelovati s drugim
Trifexis 270 mg/4.5 mg tablets: 
Trifexis 270 mg/4,5 mg tablete:
4336 and 5 dimples 
4336 i 5 rupica
4346 and 3 dimples 
4346 i 3 rupice
It is recommended that heartworm prevention treatment should be continued at regular monthly intervals until at least 1 month after the last exposure to mosquitoes, but not for more than 6 consecutive months using Trifexis in any one year. 
Preporučuje se nastavak prevencije bolesti srčanog crva u redovnim mjesečnim intervalima sve do 1 mjesec nakon posljednjeg izlaganja komarcima, ali Trifexis se ne smije davati dulje od 6 mjeseci uzastopno, unutar jedne godine.
In pregnant and lactating dogs (bitches), the safety of this veterinary medicinal product has not been sufficiently established. 
Neškodljivost ovog veterinarsko-medicinskog proizvoda kod gravidnih i kuja koje doje nije dovoljno utvrđena.
Trifexis 270 mg/4.5 mg chewable tablets for dogs (3.9 - 6.0 kg) Trifexis 425 mg/7.1 mg chewable tablets for dogs (6.1 - 9.4 kg) Trifexis 665 mg/11.1 mg chewable tablets for dogs (9.5 - 14.7 kg) Trifexis 1040 mg/17.4 mg chewable tablets for dogs (14.8 - 23.1 kg) Trifexis 1620 mg/27 mg chewable tablets for dogs (23.2 - 36.0 kg) 
Trifexis 270 mg/4,5 mg tablete za žvakanje za pse (3,9 - 6,0 kg) Trifexis 425 mg/7,1 mg tablete za žvakanje za pse (6,1 - 9,4 kg) Trifexis 665 mg/11,1 mg tablete za žvakanje za pse (9,5 - 14,7 kg) Trifexis 1040 mg/17,4 mg tablete za žvakanje za pse (14,8 - 23,1 kg) Trifexis 1620 mg/27 mg tablete za žvakanje za pse (23,2 - 36,0 kg)
Trifexis 270 mg/4.5 mg for dogs (3.9 - 6.0 kg) Trifexis 425 mg/7.1 mg for dogs (6.1 - 9.4 kg) Trifexis 665 mg/11.1 mg for dogs (9.5 - 14.7 kg) Trifexis 1040 mg/17.4 mg for dogs (14.8 - 23.1 kg) Trifexis 1620 mg/27 mg for dogs (23.2 - 36.0 kg) 
Trifexis 270 mg/4,5 mg za pse (3,9 - 6,0 kg) Trifexis 425 mg/7,1 mg za pse (6,1 - 9,4 kg) Trifexis 665 mg/11,1 mg za pse (9,5 - 14,7 kg) Trifexis 1040 mg/17,4 mg za pse (14,8 - 23,1 kg) Trifexis 1620 mg/27 mg za pse (23,2 - 36,0 kg)
Heartworm prevention treatment should be continued monthly, with the last administration being given one month after the dog has left the region, but not for more than 6 consecutive months using Trifexis in any one year. 
Prevencija bolesti srčanog crva mora se nastaviti na mjesečnoj bazi, a posljednja primjena treba biti mjesec dana nakon što je pas napustio takvo područje, ali Trifexis se ne smije davati dulje od 6 mjeseci uzastopno unutar jedne godine.
In another study, after repeated monthly oral administration of 70 mg spinosad and 1.18 mg milbemycin oxime/kg bodyweight to fed adult dogs for twelve consecutive months, steady state for systemic exposure (AUC) was reached in month 3. 
U drugom ispitivanju, nakon ponovljenog mjesečnog oralnog davanja 70 mg spinosada i 1,18 mg milbemicin oksima/kg tjelesne težine uhranjenim odraslim psima tijekom dvanaest mjeseci, postignuto je stabilno stanje sustavne izloženosti (AUC) u 3. mjesecu za.
In another study, after repeated monthly oral administration of 70 mg spinosad and 1.18 mg milbemycin oxime/kg bodyweight to fed juvenile dogs for twelve consecutive months, steady state for systemic exposure (AUC) was reached by month 7. 
U drugom ispitivanju, nakon ponovljenog mjesečnog oralnog davanja 70 mg spinosada i 1,18 mg milbemicin oksima/kg tjelesne težine uhranjenim mladim psima tijekom dvanaest mjeseci zaredom, postignuto je stabilno stanje sustavne izloženosti (AUC) do 7. mjeseca.
In another study, after repeated oral administration of 70 mg spinosad and 1.18 mg milbemycin oxime/kg bodyweight to fed juvenile dogs for twelve consecutive months, steady state for systemic exposure (AUC) was reached by month 7. 
U drugom ispitivanju, nakon ponovljenog peroralnog davanja 70 mg spinosada i 1,18 mg milbemicin oksima/kg tjelesne težine, uhranjenim mladim psima tijekom dvanaest mjeseci zaredom, postignuto je stabilno stanje sustavne izloženosti (AUC) do 7. mjeseca.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children. 
14. RIJEČI „ČUVATI IZVAN POGLEDA
Date of first authorisation: 15 July 2016 
Datum prvog odobrenja: 15. srpnja 2016.
What to do if you forget to take a tablet. 
Što trebate učiniti ako ste zaboravili uzeti tabletu.
(See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.) 
(Vidjeti dijelove 4.2, 4.4, 4.5 i 5.1 za dostupne podatke o ispitivanim kombinacijama).
- You can take the tablet at any time of the day. 
- Tabletu možete uzeti u bilo koje doba dana.
Qtern is taken orally once daily. 
Qtern se uzima peroralno jedanput na dan.
Some symptoms need immediate medical attention: 
Neki simptomi zahtijevaju hitnu liječničku pomoć:
The safety and efficacy of this medicinal product in children and adolescents aged 0 to < 18 years have not yet been established. 
Sigurnost i djelotvornost ovog lijeka kod djece i adolescenata u dobi od 0 do < 18 godina nisu još ustanovljene.
Taking this medicine - Swallow the tablet whole with half a glass of water. 
Uzimanje lijeka - Tabletu progutajte cijelu, s pola čaše vode.
Fournier's gangrene has to be treated immediately. 
Fournierovu gangrenu potrebno je odmah liječiti.
What Qtern is and what it is used for 
Što je Qtern i za što se koristi
Tablet is to be swallowed whole. 
Tabletu treba progutati cijelu.
- Do not take a double dose of Qtern to make up for a forgotten dose. 
- Nemojte uzeti dvostruku dozu lijeka Qtern da biste nadoknadili zaboravljenu dozu.
EU/1/16/1108/001 14 film-coated tablets EU/1/16/1108/002 28 film-coated tablets EU/1/16/1108/003 98 film-coated tablets EU/1/16/1108/004 30 film-coated tablets 
EU/1/16/1108/001 14 filmom obloženih tableta EU/1/16/1108/002 28 filmom obloženih tableta EU/1/16/1108/003 98 filmom obloženih tableta EU/1/16/1108/004 30 filmom obloženih tableta
There is no restriction based solely on age. 
Nema ograničenja isključivo na temelju dobi.
Qtern is not recommended during pregnancy and your doctor will ask you to stop taking this medicine if you become pregnant. 
Qtern se ne preporučuje tijekom trudnoće i Vaš će liječnik zatražiti da prestanete uzimati ovaj lijek ako zatrudnite.
The increased/decreased risk was not statistically significant in any of the organ systems. 
Niti povećan niti smanjen rizik nije ni u jednom organskom sustavu bio statistički značajan.
Study CV181168 
Ispitivanje CV181168
For more information, see section “Other medicines and Qtern” below. 
Za više informacija vidjeti dio „Drugi lijekovi i Qtern” u nastavku.
It may be taken at any time of day with or without food. 
Može se uzeti u bilo koje doba dana, s hranom ili bez nje.
Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above. 
Liječnik će Vam reći kako liječiti niske razine šećera u krvi i što učiniti ako se pojavi neki od gore navedenih znakova.
Your doctor may ask you to stop taking Qtern until you recover to prevent dehydration. 
Vaš liječnik može zatražiti da prestanete uzimati Qtern dok se ne oporavite kako biste spriječili dehidraciju.
Your doctor will advise you of the signs and symptoms of heart failure. 
Liječnik će Vas upozoriti na znakove i simptome zatajenja srca.
Your doctor may decide to temporarily or permanently stop your treatment with Qtern. 
Vaš liječnik može odlučiti privremeno ili trajno prekinuti Vaše liječenje lijekom Qtern.
PA/Alu/PVC-Alu blister 
PA/Al/PVC-Al blister.
See section 4.4 
Vidjeti dio 4.4
What Qtern looks like and contents of the pack 
Kako Qtern izgleda i sadržaj pakiranja
Talk to your doctor about the best way to control your blood sugar while you are pregnant. 
Razgovarajte sa svojim liječnikom o najboljem načinu kontrole razine šećera u krvi tijekom trudnoće.
If you take more Qtern tablets than you should, talk to a doctor or go to a hospital straight away. 
Ako uzmete više Qtern tableta nego što ste trebali, odmah se obratite liječniku ili otiđite u bolnicu.
There are insufficient data to draw conclusions regarding exposure in patients > 70 years old. 
Nema dovoljno podataka da bi se donijeli zaključci o izloženosti kod bolesnika starijih od 70 godina.
Qtern is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients. 
Primjena lijeka Qtern ne preporučuje se kod djece i adolescenata mlađih od 18 godina jer lijek nije ispitivan kod tih bolesnika.
This is a rare but serious and potentially life-threatening event that requires urgent surgical intervention and antibiotic treatment. 
To je rijedak, no ozbiljan i potencijalno po život opasan događaj koji zahtijeva hitnu kiruršku intervenciju i liječenje antibioticima.
What Qtern is and what it is used for What you need to know before you take Qtern How to take Qtern 
Što je Qtern i za što se koristi Što morate znati prije nego počnete uzimati Qtern Kako uzimati Qtern
Therefore, Qtern should not be used during pregnancy. 
Stoga, Qtern se ne smije upotrebljavati tijekom trudnoće.
Especially tell your doctor: - if you are taking a medicine used to increase the amount of water you pass out of the body (diuretic). 
Posebno je važno da obavijestite svog liječnika: - ako uzimate lijek koji se koristi za povećavanje količinu vode koju izlučujete iz tijela (diuretik).
Necrotising fasciitis of the perineum (Fournier's gangrene) 
Nekrotizirajući fasciitis perineuma (Fournierova gangrena)
Additional analysis did not indicate a differential effect among NYHA classes. 
Dodatna analiza nije ukazala na razliku u učinku kod različitih NYHA stupnjeva.