natgillin/translations-raw huggingface dataset:
Optimark injections should not be repeated unless the interval between injections is at least 7 days. 
Ponovno injiciranje zdravila Optimark je dovoljeno šele po poteku vsaj 7 dni.
Acute toxicity symptoms are unlikely to occur in patients with normal renal function. 
Pri bolnikih z normalnim delovanjem ledvic ni verjetno, da bi prišlo do simptomov akutne toksičnosti.
The peel-off tracking label on the vials should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. 
Odluščljivo sledilno oznako na vialah pritrdite na kartoteko bolnika, da zagotovite natančno evidentiranje uporabljenega kontrastnega sredstva z gadolinijem.
Allergoid and other idiosyncratic reactions also may occur with gadoversetamide, which could become manifest in form of cardiovascular, respiratory and skin reactions. 
Alergoidne in druge idiosinkratične reakcije se lahko pojavijo tudi pri gadoversetamidu.
Prior to using the syringe, twist off grey tip cap and discard. 
Pred uporabo brizge odvijte sivo zaporko konice in jo zavrzite.
Each 30 ml syringe contains 9927 mg gadoversetamide. 
Ena 30 ml injekcijska brizga vsebuje 9.927 mg gadoversetamida.
ml/h/kg) and the two adult populations (82.1 ± 16.8 and 56.5 ± 9.7 ml/h/kg in the 19 to 64 and ≥ 65 
2 do 11 let (143 ± 27,9 ml/h/kg) kakor pri starostni skupini od 12 do 18 let (117 ± 26,1 ml/h/kg) ter dveh skupinah odraslih (82,1 ± 16,8 ml/h/kg pri starostni skupini od 19 do 64 let in 56,5 ± 9,7 ml/h/kg pri starostni skupini ≥ 65 let).
You must report any of the following symptoms immediately to the doctor or nurse/technologist, and get immediate treatment as they can be or can become very serious: side effects affecting the heart (fainting, extra heart beats, chest pain) or the respiratory system (shortness of breath, tightening of the airways, swollen or tight throat, itchy or runny nose, sneezing). 
neželeni učinki, ki vplivajo na srce (omedlevica, dodatni srčni utrip, bolečina v prsnem košu) ali dihala (kratka sapa, stiskanje dihalnih poti, oteklo ali stisnjeno grlo, srbeč nos ali izcedek iz nosu, kihanje).
Each 15 ml vial contains 4963.5 mg gadoversetamide. 
Ena 15 ml viala vsebuje 4.963,5 mg gadoversetamida.
15 ml (1, 10 vials) 
15 ml (1, 10 vial)
The peel-off tracking label on the pre-filled syringes should be stuck onto the patients record to enable accurate recording of the gadolinium contrast agent used. 
Odluščljivo sledilno oznako na napolnjenih injekcijskih brizgah pritrdite na kartoteko bolnika, da zagotovite natančno evidentiranje uporabljenega kontrastnega sredstva z gadolinijem.
Pre-filled syringes: 
Napolnjene injekcijske brizge:
Each 30 ml syringe contains 9927 mg gadoversetamide equivalent to 15 millimol. 
Ena 30 ml injekcijska brizga vsebuje 9.927 mg gadoversetamida, kar ustreza 15 milimolom.
Vomiting 
Bruhanje
Each 10 ml vial contains 3309 mg gadoversetamide. 
Ena 10 ml viala vsebuje 3.309 mg gadoversetamida.
Each 20 ml vial contains 6618 mg gadoversetamide equivalent to 10 millimol. 
Ena 20 ml viala vsebuje 6.618 mg gadoversetamida, kar ustreza 10 milimolom.
20 ml (1, 10 vials) 
20 ml (1, 10 vial)
• to any of the other ingredients of Optimark (see section 6), or 
• katero koli sestavino zdravila Optimark (glejte poglavje 6) ali • na druga kontrastna sredstva, ki vsebujejo gadolinij.
Each 20 ml vial contains 6618 mg gadoversetamide. 
Ena 20 ml viala vsebuje 6.618 mg gadoversetamida.
Each 15 ml vial contains 4963.5 mg gadoversetamide equivalent to 7.5 millimol. 
Ena 15 ml viala vsebuje 4.963,5 mg gadoversetamida, kar ustreza 7,5 milimolom.
- If you get any side effects talk to your doctor or pharmacist. 
- Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
Rare (may affect up to 1 in 1000 people) 
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
As with any paramagnetic contrast agent, enhancement of MRI with Optimark may impair the visualization of existing lesions. 
Posebna opozorila in previdnostni ukrepi Kot pri vseh drugih paramagnetnih kontrastnih sredstvih lahko krepitev kontrasta pri magnetnoresonančnem slikanju z zdravilom Optimark okvari vidnost obstoječih lezij.
NAME OF THE MEDICINAL PRODUCT Optimark 500 micromol/ml solution for injection in pre-filled syringe Optimark 500 micromol/ml solution for injection in vial 
Optimark 500 mikromolov/ml raztopina za injiciranje v napolnjeni injekcijski brizgi Optimark 500 mikromolov/ml raztopina za injiciranje v viali
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Text for the outer packaging of 10 ml, 15 ml and 20 ml vials 
PODATKI NA ZUNANJI OVOJNINI Besedilo za zunanjo ovojnino za 10-, 15- in 20-mililitrske viale
The risk for development of NSF in patients with moderate renal impairment (GFR 30-59 ml/min/1.73 m2) is unknown; therefore, Optimark should only be used after careful risk-benefit evaluation in patients with moderate renal impairment. 
Tveganje za nastanek NSF pri bolnikih z zmerno okvaro ledvic (GFR 30-59 ml/min/1,73 m2) ni znano; zato je treba zdravilo Optimark pri bolnikih z zmerno okvaro ledvic uporabljati le po skrbni analizi koristi in tveganj.
SPECIAL STORAGE CONDITIONS Keep the syringe in the outer carton in order to protect from light. 
POSEBNA NAVODILA ZA SHRANJEVANJE Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Text for the outer packaging of 10 ml, 15 ml, 20 ml and 30 ml pre-filled syringes 
PODATKI NA ZUNANJI OVOJNINI Besedilo za zunanjo ovojnino za 10-, 15-, 20- in 30-mililitrske napolnjene injekcijske brizge
Confusion and disorientation 
Anksioznost, motnje spanja, zmedenost in dezorientacija
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Text for the immediate packaging of 15 ml, 20 ml and 30 ml pre-filled syringes 
PODATKI NA PRIMARNI OVOJNINI Besedilo za primarno ovojnino za 15-, 20- in 30-mililitrske napolnjene injekcijske brizge
Breast-feeding should be discontinued for at least 24 hours after you receive Optimark. 
Po tem, ko prejmete zdravilo Optimark, je treba prenehati z dojenjem za vsaj 24 ur.
Optimark is supplied in pre-filled syringes made of polypropylene. 
Zdravilo Optimark je na voljo v polnjenih injekcijskih brizgah iz polipropilena.
30 ml (1, 10 syringes) 
30 ml (1, 10 brizg)
Final Study Report: 
Za elektronske kartoteke:
Optimark has been studied in children of 2 years and older with a similar safety profile as shown in the adult population. 
Varnostni profil je bil podoben kot pri odrasli populaciji.
Optimark 500 micromol/ml solution for injection in vial Gadoversetamide 
Optimark 500 mikromolov/ml raztopina za injiciranje v viali gadoversetamid
Each 15 ml syringe contains 4963.5 mg gadoversetamide equivalent to 7.5 millimol. 
Ena 15 ml injekcijska brizga vsebuje 4.963,5 mg gadoversetamida, kar ustreza 7,5 milimolom.
Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period (see section 4.3). 
Zdravilo Optimark je kontraindicirano pri bolnikih s hudo ledvično okvaro (stopnja glumeralne filtracije (GFR) < 30 ml/min/1,73 m²) in/ali akutno poškodbo ledvic in pri bolnikih, pri katerih so opravili presaditev jeter ali so v perioperativen obdobju presaditve jeter (glejte poglavje 4.3).
Each 20 ml syringe contains 6618 mg gadoversetamide equivalent to 10 millimol. 
Ena 20 ml injekcijska brizga vsebuje 6.618 mg gadoversetamida, kar ustreza 10 milimolom.
Each 15 ml syringe contains 4963.5 mg gadoversetamide. 
Ena 15 ml injekcijska brizga vsebuje 4.963,5 mg gadoversetamida.
Each 20 ml syringe contains 6618 mg gadoversetamide. 
Ena 20 ml injekcijska brizga vsebuje 6.618 mg gadoversetamida.
Each 10 ml vial contains 3309 mg gadoversetamide equivalent to 5 millimol. 
Ena 10 ml viala vsebuje 3.309 mg gadoversetamida, kar ustreza 5 milimolom.
15 ml (1, 10 syringes) 
15 ml (1, 10 brizg)
20 ml (1, 10 syringes) 
20 ml (1, 10 brizg)
Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73 m²) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period. 
Zdravilo Optimark je kontraindicirano pri bolnikih s hudo ledvično okvaro (stopnja glumeralne filtracije (GFR) < 30 ml/min/1,73 m²) in/ali akutno poškodbo ledvic in pri bolnikih, pri katerih so opravili presaditev jeter ali so v perioperativen obdobju presaditve jeter.
Sodium hydroxide and/or hydrochloric acid for pH adjustment Water for injections 
6.1 Seznam pomožnih snovi versetamid kalcijev hidroksid kalcijev klorid dihidrat natrijev hidroksid in/ali klorovodikova kislina za uravnavanje pH voda za injekcije
Each 10 ml syringe contains 3309 mg gadoversetamide. 
Ena 10 ml injekcijska brizga vsebuje 3.309 mg gadoversetamida.
Optimark 500 micromol/ml solution for injection in pre-filled syringe Gadoversetamide 
Optimark 500 mikromolov/ml raztopina za injiciranje v napolnjeni injekcijski brizgi gadoversetamid
Higher doses contain 1 mmol sodium or more, which should be taken into consideration for patients on a controlled sodium diet. 
Večji odmerki vsebujejo 1 mmol natrija ali več.
Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period. 
Zdravilo Optimark je kontraindicirano pri bolnikih s hudo ledvično okvaro (stopnja glumeralne filtracije (GFR) < 30 ml/min/1,73 m2) in/ali akutno poškodbo ledvic in pri bolnikih, pri katerih so opravili presaditev jeter ali so v perioperativen obdobju presaditve jeter.
1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol. 
1 ml vsebuje 330,9 mg gadoversetamida, kar ustreza 500 mikromolom.
Pre-filled syringe 
Žilne bolezni
Hypoaesthesia, Paraesthesia, Parosmia 
Omotica, hipestezija, parestezija, parozmija
Do not use Optimark if you are allergic 
Kaj morate vedeti, preden vam bodo dali zdravilo Optimark Ne uporabljajte zdravila Optimark če ste alergični na: • zdravilno učinkovino gadoversetamid ali
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Optimark 500 micromol/ml solution for injection in pre-filled syringe Gadoversetamide 
IME ZDRAVILA IN POT(I) UPORABE Optimark 500 mikromolov/ml raztopina za injiciranje v napolnjeni injekcijski brizgi gadoversetamid i.v.
Vial 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol. 
Viala 1 ml vsebuje 330,9 mg gadoversetamida, kar ustreza 500 mikromolom.
Optimark must not be administered with an autoinjector to children of 2 to 11 years. 
Otrokom, starih od 2 do 11 let, se zdravila Optimark ne sme dati z avtoinjektorjem.
Ear and Labyrinth Disorders 
vključno z motnjami labirinta
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Optimark 500 micromol/ml solution for injection in vial Gadoversetamide 
IME ZDRAVILA IN POT(I) UPORABE Optimark 500 mikromolov/ml raztopina za injiciranje v viali gadoversetamid i.v.
Chills, Pain, Face oedema, Asthenic conditions including asthenia, fatigue, and malaise, Fever, Oedema peripheral, 
Mrzlica, bolečina, ,edem obraza, astenična stanja vključno z astenijo,
Insertion of a flexible in-dwelling venous catheter is recommended, see section 4.4. 
Priporoča se vstavitev prožnega stalnega venskega katetra,
Cardiac Disorders 
Srčne bolezni
As with any paramagnetic contrast agent, enhancement of MRI with gadoversetamide may impair the visualization of existing lesions. 
4.4 Posebna opozorila in previdnostni ukrepi Kot pri vseh drugih paramagnetnih kontrastnih sredstvih lahko krepitev kontrasta pri magnetnoresonančnem slikanju z gadoversetamidom okvari vidnost obstoječih lezij.
Frequency Common (may affect up to 1 in 10 people) 
Pogosti (pojavijo se lahko pri največ 1 od
Each 10 ml syringe contains 3309 mg gadoversetamide equivalent to 5 millimol. 
Ena 10 ml injekcijska brizga vsebuje 3.309 mg gadoversetamida, kar ustreza 5 milimolom.
Optimark should only be used after careful risk/benefit evaluation in patients with moderate renal impairment (GFR 30-59 ml/min/1.73 m2) at a dose not exceeding 100 micromol/kg body weight. 
Pri bolnikih z zmerno ledvično okvaro (GFR 30-59 ml/min/1,73 m2) je uporaba zdravila Optimark dovoljena le po skrbni oceni razmerja med tveganjem in koristmi pri odmerku, ki ne preseže 100 mikromolov/kg telesne mase.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Text for the immediate packaging of 15 ml and 20 ml vials 
PODATKI NA PRIMARNI OVOJNINI Besedilo za primarno ovojnino za 15-, in 20-mililitrske viale
Calcium hydroxide 
Tinitus, vertigo
Pre-filled syringe 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol. 
Napolnjena injekcijska brizga 1 ml vsebuje 330,9 mg gadoversetamida, kar ustreza 500 mikromolom.
AUTHORISATION 
uporaba
hardening of the skin which may affect also soft tissue and internal organs (nephrogenic systemic fibrosis), feeling unwell 
zadebelitev kože, ki lahko vpliva tudi na mehka tviva in notranje organe
Dizziness, 
Ušesne bolezni,
Keep the vial in the outer carton in order to protect from light. 
Brizge shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Urticaria, Cold sweat, Erythema, Hyperhidrosis 
Urtikarija, hladen pot, eritem,
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Optimark and some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR <30ml/min/1.73m2) and/or acute kidney injury. 
Pri bolnikih s hudo akutno ali kronično ledvično okvaro (GFR < 30 ml/min/1,73m2) in/ali akutno poškodbo ledvic so poročali o nefrogeni sistemski fibrozi (NSF), povezani z uporabo zdravila
Pack sizes: 
100 bolnikov):
• Additional risk minimisation measures 
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
Not all pack-sizes may be marketed. 
10 x 30 ml Na trgu morda ni vseh navedenih pakiranj.
List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant(s) in the Member States 
Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila, predlagateljev v državah članicah
Oral drop solution Oral use 
100 microgram/ml peroralna raztopina Peroralna uporaba
This summary was last updated on 28 January 2013. 
Povzetek je bil nazadnje posodobljen dne 28/01/2013.
If damaged a new intraruminal device should be used. 
Če je poškodovan, je treba uporabiti nov intraruminalni sistem.
This improves energy production in the cow's body and reduces the level of ketones in the blood. 
Tako izboljša proizvodnjo energije v kravjem telesu in zniža raven ketonov v krvi.
Continuous release means that monensin is released slowly from the device. 
Kontinuirano sproščanje pomeni, da se monenzin iz sistema sprošča počasi.
Exposure to monensin may result in an allergic response in certain people. 
Izpostavljenost monenzinu lahko pri nekaterih ljudeh izzove alergijsko reakcijo.
It attaches to the surface of bacterial cells and interferes with the mechanism for transporting nutrients. 
Veže se na površino bakterijskih celic in ovira delovanje mehanizma za transport hranil.
Other information about Kexxtone: 
Druge informacije o zdravilu Kexxtone:
Kexxtone must not be used in animals weighing less than 300 kg. 
Zdravilo Kexxtone se ne sme uporabljati pri živalih s telesno maso manj kot 300 kg.
It is mainly active against Gram-positive bacteria. 
V glavnem učinkuje na grampozitivne bakterije.
The cumulative ketosis rate was 11.5% in the Kexxtone group compared with 25.6% in the placebo group. 
Kumulativna stopnja ketoze v skupini, ki je prejemala zdravilo Kexxtone, je bila 11,5 %, v primerjavi s 25,6 % v skupini s placebom.
The European Commission granted a marketing authorisation valid throughout the European Union, for Kexxtone on 28 January 2013. 
Evropska komisija je dovoljenje za promet z zdravilom Kexxtone, veljavno po vsej Evropski uniji, odobrila dne 28/01/2013.
People who are known to be hypersensitive (allergic) to monensin or any of the ingredients should avoid contact with the product. 
Ljudje z znano preobčutljivostjo (alergijo) na monenzin ali katero koli drugo sestavino zdravila naj se izogibajo stiku s sistemom.
Kexxtone has been studied in one main study involving 1,312 commercial dairy cows. 
Zdravilo Kexxtone je bilo raziskano v eni glavni študiji, ki je vključevala 1 312 krav molznic za prodajo.
Dogs, horses, other equines or guinea fowl must not be allowed access to Kexxtone as consumption of intraruminal device contents can be fatal in these species. 
Psi, konji, drugi kopitarji in pegatke ne smejo imeti dostopa do zdravila Kexxtone, saj lahko zaužitje vsebine intraruminalnega sistema pri teh živalskih vrstah povzroči smrt.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Kexxtone exceed the risks for the approved indication and recommended that Kexxtone be given a marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je sklenil, da koristi zdravila Kexxtone presegajo z njim povezana tveganja pri odobreni indikaciji, in priporočil, da se zanj odobri dovoljenje za promet.
The main measure of effectiveness was the cumulative rate of clinical ketosis in the cows over the 15 to 16 weeks after calving. 
Glavno merilo učinkovitosti je bila kumulativna stopnja klinične ketoze pri kravah v obdobju 15 do 16 tednov po telitvi.
Gloves should be removed and hands and exposed skin washed after handling the product. 
Po rokovanju s sistemom je treba odstraniti rokavice in si umiti roke ter izpostavljeno kožo.
Clinical ketosis was defined based on a minimum level of the substance ß-hydroxybutyrate in the blood in combination with one or more clinical signs of ketosis. 
Klinična ketoza je bila določena na podlagi najmanjše ravni ß-hidroksibutirata v krvi v kombinaciji z enim ali več kliničnimi znaki ketoze.
The person administering Kexxtone should wear gloves when handling the product, including when retrieving a regurgitated intraruminal device. 
Oseba, ki daje zdravilo Kexxtone, mora pri rokovanju s sistemom nositi rokavice, tudi pri odstranjevanju regurgitiranega intraruminalnega sistema.
What benefit has Kexxtone shown during the studies? 
Kakšne koristi je zdravilo Kexxtone izkazalo med študijami?
Accidental administration of more than one intraruminal device could result in side effects typical of monensin overdose, including decreased appetite, scouring (diarrhoea) and lethargy. 
Nenamerna uporaba več kot enega intraruminalnega sistema lahko povzroči neželene učinke, ki so običajni za prevelik odmerek monenzina, vključno z zmanjšanjem apetita, drisko (diarejo) in letargijo.
People should not eat, drink or smoke while handling Kexxtone. 
Med uporabo zdravila Kexxtone osebe ne smejo jesti, piti ali kaditi.
It is available as a continuous-release intraruminal device (a device administered through the animal's mouth and placed within the rumen, or first stomach, of cattle). 
Na voljo je v obliki intraruminalnega sistema s kontinuiranim sproščanjem (sistem, ki se vstavi živali skozi usta in namesti v vamp oziroma prvi del želodca goveda).
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption. 
Karenca je obdobje, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in se lahko meso ali mleko uporabi za prehrano ljudi.
Ketosis is a metabolic disturbance in which blood glucose levels are low and substances called ketones (such as acetoacetatic acid and β-hydroxybutyrate) accumulate in the blood. 
Ketoza je presnovna motnja, za katero je značilna nizka raven glukoze v krvi in kopičenje snovi, ki jih imenujemo ketoni (na primer acetoacetatna kislina in β-hidroksibutirat), v krvi.
A single intraruminal device is given to a dairy cow or heifer three to four weeks before the expected calving, using an appropriate administration tool. 
Pri kravi molznici oziroma telici se tri do štiri tedne pred pričakovano telitvijo uporabi en intraruminalni sistem, ki se ga da z ustreznim orodjem za dajanje.
The active substance in Kexxtone, monensin, is an antibiotic produced by natural fermentation. 
Zdravilna učinkovina v zdravilu Kexxtone, monenzin, je antibiotik, ki nastane z naravno fermentacijo.
Monensin changes the population of microbes in the rumen resulting in an increase of the bacteria that produce propionate, a substance used to make glucose. 
Monenzin spremeni mikrobno populacijo v vampu, pri čemer se poveča število bakterij, ki proizvajajo propionat - snov, ki sodeluje pri tvorjenju glukoze.
A single dose of Kexxtone was compared with a placebo (dummy treatment) given three to four weeks before the expected calving date. 
Enkratni odmerek zdravila Kexxtone so primerjali s placebom (zdravilom brez zdravilne učinkovine), ki so ga živalim dali tri do štiri tedne pred pričakovanim datumom telitve.
What is the risk associated with Kexxtone? 
Kakšna tveganja so povezana z zdravilom Kexxtone?
Treated cattle should be held in a confined area for one hour after administration to observe for failure to swallow or regurgitation. 
Zdravljeno govedo je treba eno uro po uporabi zdravila zadržati v zaprtem prostoru in opazovati, ali lahko požira oziroma ali pride do regurgitacije.
Kexxtone is used to reduce the incidence of ketosis in dairy cows and heifers which are expected to develop ketosis in the period around calving. 
Zdravilo Kexxtone se uporablja za zmanjšanje pojavnosti ketoze pri kravah molznicah in telicah, pri katerih se pričakuje razvoj ketoze v obdobju pred in po telitvi.
Kexxtone is a veterinary medicine that contains the active substance monensin. 
Kexxtone je zdravilo, ki vsebuje zdravilno učinkovino monenzin.
Why has Kexxtone been approved? 
Zakaj je bilo zdravilo Kexxtone odobreno?
Cattle should be re-checked for up to four days after dosing in case the intraruminal device has not been fully swallowed and has lodged in the oesophagus (the gullet or tube leading from the mouth to the rumen). 
Govedo je treba do štiri dni po odmerjanju pregledovati, saj se lahko zgodi, da žival intraruminalnega sistema ne požre v celoti in se ta zagozdi v požiralniku (oziroma cevi, ki povezuje usta in vamp).
If this occurs, the product should be re-administered if undamaged. 
Če ne požira ali če regurgitira, je treba ponovno dati zdravilo, če sistem ni poškodovan.
How does Kexxtone work? 
Kako zdravilo Kexxtone deluje?
What is Kexxtone used for? 
Za kaj se zdravilo Kexxtone uporablja?
How has Kexxtone been studied? 
Kako je bilo zdravilo Kexxtone raziskano?
What is Kexxtone? 
Kaj je zdravilo Kexxtone?
The withdrawal period for Kexxtone for cattle is zero days for meat and milk. 
Karenca za meso in mleko po uporabi zdravila Kexxtone je nič dni.
References: 1. 
Referenčna literatura: 1.
More about the procedures 
Več o postopkih
While the re-examination was ongoing, some Member States decided to suspend or limit the marketing or use of these medicines in their territories. 
V času, ko je potekal ponoven pregled, so se nekatere države članice odločile, da bodo začasno ustavile ali omejile trženje oziroma uporabo teh zdravil na svojih ozemljih.
* The CMDh is a medicines regulatory body representing the European Union (EU) Member States 
* CMDh je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU).
HES will be available in restricted patient populations 
HES bo na voljo za omejene populacije bolnikov
For the re-examination procedure the PRAC confirmed its previous position. 
Pri ponovnem pregledu mnenja je odbor PRAC potrdil svoje prvotno stališče.
These recommendations are based on a review of all available safety and efficacy data, including recent data4,5,6, from clinical studies, meta-analyses and post-marketing experience. 
Ta priporočila temeljijo na pregledu vseh razpoložljivih podatkov o varnosti in učinkovitosti, vključno z najnovejšimi podatki4,5,6 iz kliničnih študij, metaanaliz in izkušenj v obdobju trženja.