natgillin/translations-raw huggingface dataset:
For more information about treatment with Fluenz Tetra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Fluenz Tetra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Of these studies the main study involved over 2,000 children aged 2 to 17 years who were vaccinated with either Fluenz Tetra or one of two Fluenz vaccines containing either one of the two influenza B strains which are also contained in Fluenz Tetra. 
V glavni študiji je sodelovalo več kot 2 000 otrok, starih od 2 do 17 let, ki so bili cepljeni s cepivom Fluenz Tetra ali z enim od dveh cepiv Fluenz, ki vsebujeta enega od dveh sevov gripe B in ju vsebuje tudi cepivo Fluenz Tetra.
Influenza is mainly caused by two kinds of influenza virus, known as influenza A and B. Each of these circulates as different strains or subtypes, which change over time. 
Gripo običajno povzročata dve vrsti virusa, tj. virus gripe A in virus gripe B. Vsak od njiju kroži v obliki različnih sevov ali podtipov, ki se sčasoma spreminjajo.
For practical information about using Fluenz Tetra, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Fluenz Tetra naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Fluenz Tetra will contain live attenuated (weakened) influenza A and B virus strains (type A-H1N1, type A-H3N2, and two type B strains) based on the official recommendation for the annual flu season. 
Cepivo Fluenz Tetra bo vsebovalo žive oslabljene seve virusa gripe A in B (tip A-H1N1, tip A-H3N2 in oba seva B) na podlagi uradnega priporočila za vsakoletno sezono gripe.
The two A and two B strains in Fluenz Tetra will be updated with weakened virus strains for each season, according to WHO and European Union recommendations. 
Oba seva tipa A in oba seva tipa B v cepivu Fluenz Tetra bosta dopolnjena z oslabljenimi sevi virusa za vsako sezono v skladu s priporočili SZO in Evropske unije.
What is Fluenz Tetra and what is it used for? 
Kaj je zdravilo Fluenz Tetra in za kaj se uporablja?
The company provided three studies that compared Fluenz Tetra with Fluenz, an authorised influenza vaccine that contains three of the four strains of influenza in Fluenz Tetra and whose effectiveness is already established. 
Družba je predložila tri študije, v katerih so cepivo Fluenz Tetra primerjali s cepivom Fluenz, ki je odobreno za uporabo proti gripi in vsebuje tri od štirih sevov virusa gripe, ki so prisotni tudi v cepivu Fluenz Tetra, in katerega učinkovitost je bila že dokazana.
What benefits of Fluenz Tetra have been shown in studies? 
Kakšne koristi je zdravilo Fluenz Tetra izkazalo v študijah?
Fluenz Tetra influenza vaccine (live attenuated, nasal) 
Fluenz Tetra cepivo proti gripi (z živimi oslabljenimi virusi, nosno)
For the full list of all side effects reported with Fluenz Tetra, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Fluenz Tetra, glejte navodilo za uporabo.
What are the risks associated with Fluenz Tetra? 
Kakšna tveganja so povezana z zdravilom Fluenz Tetra?
The study showed that patients vaccinated with Fluenz Tetra had immune responses against each of the four vaccine virus strains that were comparable to the immune responses stimulated by the Fluenz vaccines. 
V njej so zabeležili, da so bili pri bolnikih, cepljenih s cepivom Fluenz Tetra, imunski odzivi proti vsakemu od štirih sevov virusa v cepivu primerljivi z imunskimi odzivi, ki jih je sprožilo cepivo Fluenz.
Why is Fluenz Tetra approved? 
Zakaj je bilo zdravilo Fluenz Tetra odobreno?
The CHMP considered that the immune response stimulated by Fluenz Tetra was similar to the immune response stimulated by Fluenz. 
Menil je, da je bil imunski odziv, ki ga je sprožilo cepivo Fluenz Tetra, podoben imunskemu odzivu, ki ga je sprožilo cepivo Fluenz.
The recommended dose is one nasal spray (0.1 ml) per nostril. 
Cepivo Fluenz Tetra je na voljo v obliki pršila za nos. Priporočeni odmerek je en vpih (0,1 ml) v vsako nosnico.
In addition, the CHMP considered the fact that the vaccine is given by nasal spray and not by injection and the fact that both influenza B viruses are included in the vaccine to be important advantages for children. 
Prav tako je menil, da sta za otroke pomembni prednosti, da se cepivo daje v obliki pršila za nos in ne z injiciranjem ter da cepivo vsebuje oba virusa gripe tipa B .
It is not intended to provide practical advice on how to use Fluenz Tetra. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Historically, seasonal flu vaccines have contained three strains of influenza: one influenza A-H1N1 virus, one influenza A-H3N2 virus, and one influenza B virus. 
V preteklosti so cepiva proti gripi vsebovala tri seve virusa gripe: en virus gripe A-H1N1, en virus gripe A-H3N2 in en virus gripe B. Vključitev obeh virusov gripe B v cepivo Fluenz Tetra lahko zagotovi zaščito proti virusu gripe B.
How does Fluenz Tetra work? 
Kako zdravilo Fluenz Tetra deluje?
How is Fluenz Tetra used? 
Kako se zdravilo Fluenz Tetra uporablja?
250 mg Tablet bottle 
250 mg tableta peroralna uporaba plastenka
22 May 2006 CHMP/477258/2006 
22. maj 2006 CHMP/477258/2006
The company responded to these points on 19 January 2006. 
Na ta vprašanja je podjetje odgovorilo dne 19. januarja 2006.
It is registered in the EU since 1996 through Mutual Recognition Procedure and national procedures. 
V EU je registriran od leta 1996 in sicer s postopkom medsebojnega priznavanja in z nacionalnimi postopki.
International Non-Proprietary Name (INN): atorvastatin 
Mednarodno nelastniško ime (INN): atorvastatin
The final opinion was converted into a Decision by the European Commission on 22 May 2006. 
Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 22. maja 2005.
The arbitration procedure was discussed and initiated by the CHMP at its plenary meeting in December 2005, and a Rapporteur (Dr Eric Abadie) and Co-Rapporteur (Dr Bengt Ljungberg) were appointed. 
Arbitražni postopek je CHMP obravnaval in začel na svojem plenarnem zasedanju decembra 2005, imenovana pa sta bila tudi poročevalec (dr. Eric Abadie) in soporočevalec (dr. Bengt Ljungberg).
* Notes: The information given in this document and Annexes reflect only the CHMP Opinion dated 23 March 
* Opombe: Informacije, podane v tem dokumentu in v Dodatkih odražajo samo mnenje CHMP z dne 23. marca
COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CHMP) OPINION FOLLOWING AN ARTICLE 6(12) REFERRAL 
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 6(12)
Based on the evaluation of the currently available data and the (Co-)Rapporteurs' assessment reports, the CHMP adopted an opinion on 23 March 2006 recommending the variation of the Marketing Authorisations for the addition of the following new indication: 
Na podlagi ovrednotenja trenutno razpoložljivih podatkov in poročil o oceni, ki sta jih podala poročevalec in soporočevalec, je CHMP dne 23. marca sprejel mnenje s katerim je priporočil dopolnitev dovoljenj za promet z zdravilom tako, da se doda naslednja indikacija:
The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the amended Summary of Product Characteristics in the Annex III. 
Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, skupaj z dopolnjenim Povzetkom glavnih značilnosti zdravila v Dodatku III.
Sortis and associated names contain atorvastatin, a HMG-CoA-reductase inhibitor (known as statin), which inhibits the synthesis of cholesterol. 
Sortis in z njim povezana imena vsebujejo atorvastatin, zaviralec HMG-CoA reduktaze (znan pod imenom statin), ki zavira sintezo holesterola.
This Referral procedure relates to a request for Arbritation concerning a type II variation for a new indication in the “Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors”. 
Ta napotitveni postopek se nanaša na zahtevo po arbitraži v zvezi s spremembo tipa II za novo indikacijo in sicer “preprečevanje kardiovaskularnih dogodkov pri bolnikih z ocenjenim visokim tveganjem za prvi kardiovaskularni dogodek, kot dopolnilo pri odpravljanju drugih dejavnikov tveganja.”.
“Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.” 
“Preprečevanje kardiovaskularnih dogodkov pri bolnikih z ocenjenim visokim tveganjem za prvi kardiovaskularni dogodek, kot dopolnilo pri odpravljanju drugih dejavnikov tveganja.”
Atorvastatin is currently indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. 
Atorvastatin je trenutno indiciran kot dopolnilo k prehrani za zniževanje zvišanega skupnega holesterola, holesterola-LDL, apolipoproteina B in trigliceridov pri bolnikih s primarno hiperholesterolemijo vključno z družinsko hiperholesterolemijo (heterozigotna različica) ali kombinirano (mešano) hiperlipidemijo (ki ustreza tipoma IIa in IIb po Fredricksonovi klasifikaciji), kadar je odziv na dieto in druge nefarmakološke ukrepe nezadosten.
Atorvastatin is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. 
Atorvastatin je indiciran tudi za zniževanje skupnega holesterola (total-C), holesterola LDL (LDL-C) pri bolnikih s homozigotno družinsko hiperholesterolemijo kot dopolnilo drugim terapijam za zniževanje lipidov (npr. LDL - afereza), ali kadar take terapije niso na voljo.
At the end of the MRP procedure there was a discrepancy between different Member States regarding the wording of the indication that adequately reflects the clinical data submitted by the company, and an official referral for arbitration according to Article 6(12) of Commission Regulation EC No 1084/2003, as amended, was notified by Spain to the CHMP on 1.12.2005. 
O uradni napotitvi na arbitražo v skladu s členom 6(12) Uredbe Komisije ES št. 1084/2003, kot je bila spremenjena, je Španija obvestila CHMP dne 1. decembra 2005.
The questions identified pertained to: i) the lack of a significant effect in favour of atorvastatin for the composite primary endpoint and several secondary endpoints in the female subgroup, ii) the exclusion of non-diabetic patients at high cardiovascular risk from the proposed indication, iii) the higher cardioprotective effect of atorvastatin when used in combination with particular antihipertensive therapies iv) the extent to which the claimed therapeutic indication could be applied to atorvastatin doses other than those tested in the pivotal trials 
ii) izključitev nediabetičnih bolnikov z visokim kardiovaskularnim tveganjem iz predlagane indikacije, iii) večji kardiozaščitni učinek atorvastatina, kadar je v kombinaciji z določenimi antihipertenzivnimi terapijami iv) obseg, do katerega je lahko zahtevana terapevtska indikacija veljavna tudi za odmerke atorvastatina, ki niso bili preizkušeni v osrednji raziskavi.
The consecutive treatment should be done at the same time each day. 
Zdravilo je treba dajati vsak dan ob istem času.
Do not use on an empty stomach. 
Ne uporabite na prazen želodec.
The apparent volume of distribution is 10 l/kg. 
Navidezna prostornina porazdelitve je 10 l/kg.
For a full list of excipients, see section 6.1 
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.emea.europa.eu/. 
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.emea.europa.eu/.
The terminal elimination half-life is 11.7 hours after intravenous administration and 30.84 hours after single oral administration. 
Končna razpolovna doba izločanja je 11,7 ure po intravenskem dajanju in 30,84 ure po enkratnem peroralnem odmerku.
Repetitive contact with the product may lead to skin allergies. 
Večkratni stik z zdravilom lahko povzroči kožne alergije.
The concentrations to inhibit 50 % and 90 % of the parasites, in an in vitro test system, are IC50 < 0.1 µg/ml and IC90 of 4.5 µg/ml respectively. 
Koncentraciji, potrebni za 50- in 90-odstotno zaviranje parazitov v preskusu in vitro sta: IC50 < 0,1 µg/ml in IC90 4,5 µg/ml.
The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required. 
Pomožne snovi, navedene v poglavju 6.1 SPC dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben.
Do not use in case of diarrhoea established for more than 24 hours and in weak animals. 
Ne uporabite v primerih driske, ki traja več kot 24 ur in pri oslabelih živalih.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements. 
Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi zahtevami.
Symptoms of toxicity include diarrhoea, visible blood in faeces, decline in milk consumption, dehydration, apathy and prostration. 
Simptomi toksičnosti so driska, vidne sledi krvi v iztrebkih, manjše uživanje mleka, dehidracija, apatija in izčrpanost.
(as lactate salt) 
(v obliki soli laktata)
HALOCUR should not enter water courses, as this may be dangerous for fish and other aquatic organisms. 
Zdravilo HALOCUR ne sme priti v vodotoke, ker je lahko nevaren za ribe in druge vodne organizme.
Wear protective gloves while handling the product. 
Pri uporabi zdravila uporabljajte zaščitne rokavice.
Once the first calf has been treated, all the forthcoming new-born calves must be systematically treated as long as the risk for diarrhoea due to C. parvum persists. 
Po dajanju zdravila prvemu teletu ga moramo sistematično dajati vsem naslednjim novorojenim teletom vse dokler traja nevarnost driske, ki jo povzroča C. parvum.
As symptoms of toxicity may occur at twice the therapeutic dose, it is necessary to apply the recommended dosage strictly. 
Ker se po dvakratnem terapevtskem odmerku lahko pojavijo znaki toksičnosti, moramo natančno upoštevati priporočeno odmerjanje.
Date of first authorisation: 29 October 2004 Date of last renewal: 23 November 2009 
Datum zadnjega podaljšanja dovoljenja za promet:: 23.11.2009
In both cases, the reduction of oocysts excretion has been demonstrated. 
V obeh primerih je dokazano zmanjšanje števila oocist v izločkih.
It is mainly active on the free stages of the parasite (sporozoïte, merozoïte). 
Pretežno je učinkovita proti prostim oblikam parazita (sporozoitom, merozoitom).
In case of skin and eye contact wash the exposed area thoroughly with clean water. 
V primeru nenamernega razlitja po koži ali stika z očmi, temeljito sperite izpostavljene dele telesa s čisto vodo.
Manufacturer responsible for batch release: Intervet Productions S.A. 
Proizvajalec, odgovoren za sproščanje serij: Intervet Productions S.A.
Antiparasitic agents/Agents acting against protozoa 
Antiparazitska zdravila/sredstva, ki delujejo proti protozojem
Administration should start in the first 24 to 48 hours of age. 
Zdravilo začnemo dajati prvih 24 do 48 ur po rojstvu.
Benzoic acid (E 210) 
benzojska kislina (E 210)
The bioavailability of the drug in the calf, following single oral administration, is about 80 %. 
Biološka uporabnost zdravila je pri teletih po enkratnem peroralnem odmerku približno 80 %.
Administration should start within 24 hours after the onset of diarrhoea. 
Zdravilo začnemo dajati v 24 urah po pojavu driske.
Disposal: read package leaflet. 
Odstranjevanje: preberite navodilo za uporabo..
Liver Kidney Muscle Fat 
Ledvice Mišice Maščoba
However, in order to make the HALOCUR treatment easier, a simplified dosage scheme is proposed: 
Za enostavnejše zdravljenje z zdravilom HALOCUR lahko uporabimo naslednjo shemo odmerjanja:
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE HDPE container (500 ml and 1000 ml presentations) 
PODATKI NA ZUNANJI OVOJNINI HDPE vsebnik (500 ml in 1000 ml plastenka)
For oral use in new born calves after feeding. 
Za peroralno dajanje novorojenom teletom po hranjenju.
6.2 Major incompatibilities 
6.2 Glavne inkompatibilnosti Niso znane.
The active substance in HALOCUR is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010: 
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Učinkovina v zdravilu HALOCUR je dovoljena učinkovina, kot je navedena v tabeli 1 priloge Uredbe Komisije (EU) št. 37/2010:
Should clinical signs of overdosing occur the treatment must be stopped immediately and the animal fed unmedicated milk or milk replacer. 
Če se pojavijo znaki, ki jih povzroča prevelik odmerek, moramo zdravljenje nemudoma prekiniti in žival hraniti z mlekom ali mlečnim nadomestkom brez dodanega zdravila.
The compound has a cryptosporidiostatic effect on Cryptosporidium parvum. 
Spojina ima kriptosporidiostatični učinek na Cryptosporidium parvum.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs 
PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
HALOCUR contains 0.5 mg/ml halofuginone base (as lactate salt). 
Zdravilo HALOCUR vsebuje 0,50 mg/ml halofuginona, baze (v obliki soli laktata).
Intervet International B.V. Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands 
Wim de Körverstraat 35NL-5831 AN Boxmeer
Oral solution Canary yellow homogenous clear solution. 
Kanarsko rumena homogena prozornaraztopina.
If eye irritation persists, seek medical advice. 
Če traja dražeč učinek na očeh dlje časa, se posvetujte z zdravnikom.
The plasmatic concentrations of halofuginone after repeated oral administrations are comparable to the pharmacokinetic pattern after single oral treatment. 
Po ponovnem peroralnem dajanju so koncentracije halofuginon v plazmi primerljive s farmakokinetičnim vzorcem po enkratnem peroralnem dajanju.
An increase in the level of diarrhoea has been observed in treated animals in very rare cases. 
Pri zdravljenih živalih se v zelo redkih primerih lahko poveča pojavnost driske.
For treatment of anorexic calves, the product should be administered in half a litre of an electrolyte solution. 
Anoreksičnim teletom dajemo zdravilo v polovici litra elektrolitske raztopine.
The active substance, halofuginone, is an antiprotozoal agent of the quinazolinone derivatives group (nitrogenous polyheterocycles). 
Zdravilna učinkovina halofuginon je antiprotozoik iz skupine derivatov kinazolinona (dušični poliheterocikli).
35 kg < calves ≤ 45 kg: 8 ml of HALOCUR once a day during 7 consecutive days 
• 35 kg < teleta ≤ 45 kg: 8 ml zdravila HALOCUR, 1-krat na dan, 7 zaporednih dni
Halofuginone Bovine 
Halofuginon Halofuginon Govedo
Pharmaco-logically active substance 
Farmakološko aktivna snov
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 
- pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
Halofuginone base (as lactate salt) 
Halofuginon, baza (v obliki soli laktata)
Administer after colostrum feeding, or after milk or milk replacer feeding only, using either a syringe or any appropriate device for oral administration. 
Zdravilo dajemo po hranjenju s kolostrumom, mlekom ali mlečnim nadomestkom z brizgo ali ustrezno napravo za peroralno dajanje.
Pharmacotherapeutic group: Quinazolinone derivate ATCvet code: QP51AX08 
Oznaka ATC vet: QP51AX08.
Halofuginone base 
halofuginon, baza
45 kg < calves < 60 kg: 12 ml of HALOCUR once a day during 7 consecutive days For smaller or higher weights, a precise calculation should be performed (2 ml/10 kg BW). 
• 45 kg < teleta < 60 kg: 12 ml zdravila HALOCUR, 1-krat na dan, 7 zaporednih dni Za teleta z manjšo ali večjo telesno maso je treba odmerek natančno izračunati (2 ml/10 kg TM).
Reduction of diarrhoea due to diagnosed Cryptosporidium parvum. 
Ublažitev driske pri diagnozi okužbe s Cryptosporidium parvum.
Benzoic acid (E 210) Tartrazine (E 102) Lactic acid (E 270) Water, purified 
mlečna kislina (E 270) voda, prečiščena
Read package leaflet before use. 
Pred uporabo preberite navodilo.
Prevention of diarrhoea due to diagnosed Cryptosporidium parvum, in farms with history of cryptosporidiosis. 
Preprečevanje driske pri diagnozi okužbe s Cryptosporidium parvum na farmah, na katerih se je že v preteklosti pojavila kriptosporidioza.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated ) 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali)
Not for use in animals from which milk is produced for human consumption. 
katerih mleko je namenjeno prehrani ljudi.
The dosage is: 100 µg of halofuginone base / kg body weight (BW) / once a day for 7 consecutive days, i.e. 2 ml of HALOCUR / 10 kg BW / once a day for 7 consecutive days. 
Odmerjanje: 100 µg halofuginon baze/kg telesne mase (TM), 1-krat na dan, 7 zaporednih dni, to je 2 ml zdravila HALOCUR/10 kgTM, 1-krat na dan, 7 zaporednih dni.
Unchanged Halofuginone is the major component in the tissues. 
Glavna sestavina v tkivih je nespremenjeni halofuginon.
New born calves. 
Novorojena teleta.
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years. 
Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta Rok uporabnosti po prvem odpiranju vsebnika: 6 mesecev.
Halofuginone lactate (RU 38788) is a salt whose antiprotozoal properties and efficacy against Cryptosporidium parvum have been demonstrated both in in vitro conditions and in artificial and natural infections. 
Halofuginon laktat (RU 38788) je sol, katere učinek proti protozojem in
Intervet Productions SA Rue de Lyons F-27460 Igoville France 
F-27460 Igoville
Avoid skin, eye or mucosal contact with the product. 
Pazite, da zdravilo ne pride v stik s kožo, očmi ali sluznico.
To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary. 
Zaradi natančnega odmerjanja je zdravilo treba dajati z brizgo ali ustrezno napravo za peroralno dajanje.
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE 
B. POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE Na veterinarski recept.
Marketing authorisation holder: Intervet International B.V. Wim de Körverstraat 35 
IMETNIK(I) DOVOLJENJ(A) ZA PROMET Intervet International B.V.
High-density polyethylene portable bottle of 500 ml containing 490 ml of the oral solution. 
Prenosna 500 ml plastenka iz polietilena visoke gostote s 490 ml peroralne raztopine.
HALOCUR 0.5 mg/ml oral solution for calves 
HALOCUR 0,5 mg/ml, peroralna raztopina za teleta