natgillin/translations-raw huggingface dataset:
Pramipexole Teva is a ‘generic medicine'.
Pramipexole Teva je „generično zdravilo“.
Because Pramipexole Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Ker je Pramipexole Teva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, se upošteva, da ima enake koristi in tveganja kot referenčno zdravilo.
What are the benefit and risk of Pramipexole Teva?
Kakšne so koristi in tveganja, povezani z zdravilom Pramipexole Teva?
Because Pramipexole Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine (i.e. that the two medicines produce the same levels of the active substance in the body).
Ker je zdravilo Pramipexole Teva generično zdravilo, so bile študije omejene na preskuse, s katerimi se dokazuje, da je biološko enakovredno referenčnemu zdravilu (tj. da zdravili dosegata enake ravni zdravilne učinkovine v telesu).
Pramipexole Teva is used to treat the symptoms of Parkinson's disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Zdravilo Pramipexole Teva se uporablja za zdravljenje simptomov Parkinsonove bolezni, napredujoče okvare možganov, ki povzroča tresenje, upočasnjeno izvajanje gibov in otrplost mišic.
Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson's disease, such as shaking, stiffness and slowness of movement.
Pramipeksol stimulira možgane enako kot dopamin, tako da lahko bolniki spet nadzirajo svoje gibe in kažejo manj znakov in simptomov Parkinsonove bolezni, kot so tresenje, otrplost mišic in upočasnjeno izvajanje gibov.
The Committee recommended that Pramipexole Teva be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Pramipexole Teva odobri dovoljenje za promet.
Therefore, the CHMP's view was that, as for Sifrol, the benefit outweighs the identified risk.
Zaradi tega je CHMP menil, da njegove koristi tako kot pri zdravilu Sifrol odtehtajo z njim povezana tveganja.
The active substance in Pramipexole Teva, pramipexole, is a dopamine agonist, which imitates the action of dopamine.
Zdravilna učinkovina zdravila Pramipexole Teva, pramipeksol, je agonist dopamina, ki posnema delovanje dopamina.
Pramipexole Teva is a medicine containing the active substance pramipexole base.
Pramipexole Teva je zdravilo, ki vsebuje zdravilno učinkovino pramipeksol.
Why has Pramipexole Teva been approved?
Zakaj je bilo zdravilo Pramipexole Teva odobreno?
The full EPAR for Pramipexole Teva can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pramipexole Teva je na voljo tukaj.
How has Pramipexole Teva been studied?
Kako je bilo zdravilo Pramipexole Teva raziskano?
How is Pramipexole Teva used?
Kako se zdravilo Pramipexole Teva uporablja?
What is Pramipexole Teva used for?
Za kaj se zdravilo Pramipexole Teva uporablja?
What is Pramipexole Teva?
Kaj je zdravilo Pramipexole Teva?
How does Pramipexole Teva work?
Kako zdravilo Pramipexole Teva deluje?
6 spare Insulin Release Units (IRUs)
6 rezervnih nastavkov za sproščanje insulina (Insulin Release Units, IRUs)
1 insulin inhaler
1 insulinski inhalator
Strength Pharmaceutical Form Route of Administration Packaging
Farmacevtska oblika Način uporabe zdravila Ovojnina
1 spare chamber
1 rezervna komora
Efficib is taken twice a day.
Zdravilo Efficib se jemlje dvakrat na dan.
Other information about Efficib
Druge informacije o zdravilu Efficib
The European Commission granted a marketing authorisation valid throughout the EU for Efficib on 16 July 2008.
Evropska komisija je dovoljenje za promet z zdravilom Efficib, veljavno po vsej Evropski uniji, odobrila dne 16. julija 2008.
The full EPAR for Efficib can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Efficib je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Efficib.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Efficib.
The results of three further studies were used to support the use of Efficib.
V podporo uporabi zdravila Efficib so bili uporabljeni rezultati treh nadaljnjih študij.
What benefit has Efficib shown during the studies?
Kakšne koristi je zdravilo Efficib izkazalo med študijami?
The most common side effect with Efficib (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
Najpogostejši neželeni učinek zdravila Efficib (opažen pri 1 do 10 bolnikih od 100) je navzeja (slabost).
For more information about treatment with Efficib, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Efficib preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Efficib sitagliptin / metformin hydrochloride
Efficib sitagliptin/metforminijev klorid
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Efficib.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Efficib, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The CHMP decided that Efficib's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Efficib večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The company also carried out additional studies to show that the active substances in Efficib are absorbed by the body in the same way as the two medicines given separately.
Družba je opravila še nadaljnje študije, da bi dokazala, da telo zdravilni učinkovini zdravila Efficib absorbira na enak način, kot če sta vzeti v obliki ločenih zdravil.
It must not be used in patients who have diabetic ketoacidosis or pre coma (dangerous conditions that can occur in diabetes), problems with the kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Prav tako se ne sme uporabljati pri bolnikih, ki imajo diabetično ketoacidozo, predkomo (nevarno stanje, ki se lahko pojavi pri sladkorni bolezni), težave z ledvicami in jetri, obolenja, ki lahko prizadenejo ledvice, ali obolenja, ki povzročajo zmanjšano oskrbo tkiv s kisikom, kot so srčno popuščanje, težave s pljuči ali nedavni srčni napad.
Efficib is a medicine that contains two active substances, sitagliptin and metformin hydrochloride.
Efficib je zdravilo, ki vsebuje dve zdravilni učinkovini, sitagliptin in metforminijev klorid.
Efficib must not be used in people who are hypersensitive (allergic) to sitagliptin, metformin or any of the other ingredients.
Zdravila Efficib ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) sitagliptin, metformin ali katero koli drugo sestavino zdravila.
What is the risk associated with Efficib?
Kakšna tveganja so povezana z zdravilom Efficib?
If Efficib is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Če se zdravilo Efficib jemlje skupaj s sulfonilsečnino ali insulinom, bo morda treba odmerek sulfonilsečnine ali insulina zmanjšati, da ne bi prišlo do hipoglikemije (nizke ravni sladkorja v krvi).
Efficib should be taken with food to avoid any stomach problems caused by metformin.
Zdravilo Efficib je treba jemati sočasno s hrano, da se preprečijo želodčne težave, ki jih povzroča metformin.
Efficib is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels.
Zdravilo Efficib se uporablja za zdravljenje bolnikov s sladkorno boleznijo tipa 2 za izboljšanje nadzora nad ravnmi glukoze (sladkorja) v krvi.
Why has Efficib been approved?
Zakaj je bilo zdravilo Efficib odobreno?
In the first of the three further studies, Efficib was more effective than metformin or sitagliptin alone.
V prvi od treh dodatnih študij je bilo zdravilo Efficib učinkovitejše od metformina ali sitagliptina, uporabljenih kot samostojni zdravili.
The first included 1,091 patients who were not satisfactorily controlled on diet and exercise alone and compared the effect of Efficib with that of metformin or sitagliptin alone.
V prvo je bilo vključenih 1 091 bolnikov, pri katerih zadosten nadzor ni bil dosežen zgolj z dieto in telesno vadbo, v njej pa so primerjali učinke zdravila Efficib z učinki metformina ali sitagliptina, uporabljenih kot samostojni zdravili.
For the full list of all side effects reported with Efficib, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Efficib, glejte navodilo za uporabo.
The active substances in Efficib, sitagliptin and metformin hydrochloride, each have a different mode of action.
Zdravilni učinkovini v zdravilu Efficib, sitagliptin in metforminijev klorid, imata različna načina delovanja.
The company presented the results of three studies of Januvia/Xelevia to support the use of Efficib in patients who were not satisfactorily controlled on their existing metformin treatment.
Družba je v podporo uporabi zdravila Efficib pri bolnikih, pri katerih obstoječe zdravljenje z metforminom ni zadostno za nadzor bolezni, predstavila rezultate treh študij z zdraviloma Januvia in Xelevia.
Efficib was more effective than metformin alone.
Zdravilo Efficib je bilo učinkovitejše od metformina, uporabljenega kot samostojno zdravilo.
How has Efficib been studied?
Kako je bilo zdravilo Efficib raziskano?
What is Efficib used for?
Za kaj se zdravilo Efficib uporablja ?
How does Efficib work?
Kako zdravilo Efficib deluje?
How is Efficib used?
Kako se zdravilo Efficib uporablja?
What is Efficib?
Kaj je zdravilo Efficib?
Octegra was initially approved in June 1999.
Zdravilo Octegra je bilo prvič odobreno junija 1999.
190 09 Pikermi- Attica- Athens Greece
190 09 Pikermi- Attica- Athens Grčija
4745-457 S. Mamede do Coronado
4745-457 S. Mamede do
- The Committee considered the Referral made under Article 6(12) of Commission Regulation (EC) No 1084/2003, for Octegra and associated names (See Annex 1).
- Odbor je preučil napotitev, pripravljeno v skladu s členom 6(12) Uredbe Komisije (ES) št. 1084/2003, za zdravilo Octegra in z njim povezana imena (glejte Dodatek I).
This procedure is a referral following a Mutual Recognition Procedure concerning the above variation application which was submitted for Octegra film-coated tablets to Germany as Reference Member State (RMS) and the Concerned Member States (CMS) AT, BE, EL, ES, FR, IT, LU, NL and PT on 5 December 2006.
Ta postopek je napotitev na podlagi postopka medsebojnega priznavanja v zvezi z zgornjo vlogo za spremembo, ki je bila za zdravilo Octegra - filmsko obložene tablete Nemčiji kot referenčni državi članici in zadevnim državam članicam AT, BE, EL, ES, FR, IT, LU, NL in PT predložena dne 5. decembra 2006.
Cornellá de LlobregatBarcelona
Cornellá de Llobregat - Barcelona Španija
Bialfar - Produtos Farmacêuticos, S.A.
PT - Portugalska Bialfar - Produtos Farmacêuticos, S.A.
Bayer Healthcare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Nemčija
The MRP variation application DE/H/156/01/II/34 concerned an extension of the indication to include the treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis.
Vloga za odobritev spremembe po postopku medsebojnega priznavanja DE/H/156/01/II/34 je zadevala razširitev indikacije, tako da bi vključevala zdravljenje blagih do zmernih pelvičnih vnetnih bolezni tj. okužb zgornjega genitalnega trakta, vključno s salpingitisom in endometritisom.
Octegra film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Octegra - filmsko obložene tablete vsebujejo 400 mg moksifloksacina v obliki klorida.
- The Committee considered that robust data is available showing the efficacy of Octegra in the indication “Treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis” , however due to emerging resistance of N. gonorrhoeae, moxifloxacin should not be used in empirical monotherapy, unless moxifloxacinresistant N. gonorrhoeae can be excluded.
- Odbor je sklenil, da so na voljo trdni podatki, ki dokazujejo učinkovitost zdravila Octegra pri indikaciji „zdravljenje blagih do zmernih pelvičnih vnetnih bolezni, tj. okužb zgornjega genitalnega trakta, vključno s salpingitisom in endometritisom“, vendar pa se moksifloksacin zaradi pojava odpornosti na N. gonorrhoeae ne sme uporabljati v empirični monoterapiji, razen če je mogoče izključiti N. gonorrhoeae, odporno na moksifloksacin.
Objections and concerns over the efficacy and safety of Octegra in the proposed indication were raised during the Mutual Recognition variation procedure.
Med postopkom medsebojnega priznavanja za prijavljeno spremembo so bili izraženi ugovori in pomisleki glede učinkovitosti in varnosti zdravila Octegra pri predlagani indikaciji.
Bayer HealthCare AG 51368 Leverkusen Germany
NL - Nizozemska Bayer Healthcare AG 51368 Leverkusen
OCTEGRA 400 mg, comprimé pelliculé
OCTEGRA 400 mg, comprimé pelliculé 400 mg
BE - Belgium THERABEL PHARMA S.A. Rue Egide Van Ophem 108
THERABEL PHARMA S.A. Rue Egide Van Ophem 108 1180 BRUXELLES Belgija
- The Committee, in view of the presented data on efficacy and safety, considered that the Benefit / Risk balance for Octegra and associated names in the “ The treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis” with the restrictions concerning empirical monotherapy was favourable; - The CHMP, as a consequence, recommended the amendment of the Summary of Product Characteristics sections 4.1, 4.2, 4.3, 4.4, 5.1 and 5.2 and Package Leaflet relevant sections as set out in Annex III for Octegra and associated names (see Annex I).
- CHMP je posledično priporočal dopolnitev poglavij 4.1, 4.2, 4.3, 4.4, 5.1 in 5.2 povzetka glavnih značilnosti zdravila ter ustreznih poglavij navodila za uporabo, kot je navedeno v Dodatku III za zdravilo Octegra in z njim povezana imena (glejte Dodatek I).
Saliva
Coronado
Germany1 CP-Pharma Handelsgesellschaft mbH Ostlandring 13
Nemčija1 CP-Pharma Handelsgesellschaft mbH
The residue depletion data concerning methylprednisolone can be summarised as follows:
Podatke o izločanju ostankov v zvezi z metilprednizolonom lahko povzamemo na naslednji način:
These veterinary medicinal products are also authorised for use in dogs and cats, but considering the scope of the referral, these target species were not assessed during this procedure.
Ta zdravila za uporabo v veterinarski medicini so odobrena tudi za uporabo pri psih in mačkah, vendar glede na namen napotitve ti ciljni vrsti v okviru tega postopka nista bili ocenjeni.
Zoetis France 23-25 Avenue du Dr Lannelongue 75014 Paris France
Francija Zoetis France 23-25 Avenue du Dr Lannelongue
However, the efficacy assessment does not fall within the scope of this referral procedure.
Vendar ta napotitveni postopek ne zajema ocene učinkovitosti.
In addition, the pharmacological ADI was exceeded up to 262 fold at day 7 and up to 2.8 fold at day 14.
Poleg tega je bil farmakološki dopustni dnevni vnos 7. dan presežen do 262-krat, 14. dan pa do 2,8-krat.
Therefore, on 2 May 2016, Germany initiated a procedure under Article 35 of Directive 2001/82/EC, for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection for intramuscular use in cattle.
Zato je Nemčija 2. maja 2016 sprožila postopek v skladu s členom 35 Direktive 2001/82/ES za zdravila za uporabo v veterinarski medicini, ki vsebujejo metilprednizolonhidrogensukcinat in so v obliki raztopine za injiciranje za intramuskularno uporabo pri govedu.
• After administration of 400 µg/kg bw for 5 consecutive days, residues in injection site muscle ranged from below LOQ (10 µg/kg) to 8393 µg/kg at day 7 after injection and at day 14 from below LOQ to 90 µg/kg.
• Po dajanju 400 µg/kg telesne mase 5 dni zaporedoma so bili ostanki v mišicah na mestu injiciranja 7. dan po injiciranju v razponu od pod mejo določljivosti (10 µg/kg) do 8 393 µg/kg, 14. dan po injiciranju pa v razponu od pod mejo določljivosti do 90 µg/kg.
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicant/marketing authorisation holder in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe in predlagatelja/imetnika dovoljenja za promet z zdravilom v državah članicah
Veterinary medicinal products containing methylprednisolone hydrogen succinate are used for treatment of inflammatory or allergic conditions and also for treatment and prevention of shock conditions.
Zdravila za uporabo v veterinarski medicini, ki vsebujejo metilprednozolonhidrogensukcinat, se uporabljajo za zdravljenje vnetnih ali alergijskih stanj ter za zdravljenje in preprečevanje šokovnih stanj.
Twenty-one days after administration residues at injection sites were below the LOQ in all animals.
Enaindvajset dni po dajanju so bili ostanki na mestih injiciranja pri vseh živalih pod mejo določljivosti.
Overall summary of the scientific evaluation of veterinary medicinal products containing methylprednisolone hydrogen succinate for use in target species cattle (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil za uporabo v veterinarski medicini, ki vsebujejo metilprednizolonhidrogensukcinat za uporabo pri ciljni vrsti govedo (glejte Prilogo I)
Methylprednisolone, a 6α-methyl derivative of prednisolone, is a synthetic corticosteroid, which is used in veterinary medicine as a free alcohol, and as various esters.
Metilprednizolon, 6α-metilni derivat prednizolona, je sintetični kortikosteroid, ki se uporablja v veterinarski medicini v obliki prostega alkohola in v obliki različnih estrov.
At the injection site, the MRL for muscle was exceeded more than 800 fold at day 7 and still 9 fold at day 14.
Na mestu injiciranja je bila najvišja mejna vrednost ostankov za mišice 7. dan presežena več kot 800-krat, 14. dan pa še vedno devetkrat.
Residues in muscle, liver, kidney and fat were already below LOQ (10 µg/kg) at the earliest slaughter time (day 7).
Ostanki v mišicah, jetrih, ledvicah in maščobi so bili že ob najzgodnejšem času zakola (7. dan) pod mejo določljivosti.
The only residue depletion study for methylprednisolone after intramuscular injection in cattle is cited in the CVMP EPMAR for methylprednisolone (EMEA/MRL/798/01-FINAL).
Edina študija o izločanju ostankov metilprednizolona po intramuskularnem injiciranju pri govedu je citirana v poročilu EPMAR odbora CVMP za metilprednizolon (EMEA/MRL/798/01-FINAL).
No information has been found in open databases (e.g. PubMed, Scopus, VetMed Resource, Web of Science) regarding pharmacokinetic and residue data of methylprednisolone hydrogen succinate in edible tissues and at the injection site of cattle.
V odprtih zbirkah podatkov (npr. PubMed, Scopus, VetMed Resource, Web of Science) ni nobenih informacij glede farmakokinetike in podatkov o ostankih metilprednizolonhidrogensukcinata v užitnih tkivih in na mestu injiciranja pri govedu.
Solupred 125 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Solupred 125 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung metilprednizolonhidrogensukcinat prašek in vehikel
The residue depletion data do not allow a statistically based determination of a withdrawal period.
Podatki o izločanju ostankov ne omogočajo določitve karence, ki bi temeljila na statističnih podatkih.
Furthermore, the data from the MRL file on methylprednisolone support the assumption that the potential consumer exposure from injection site residue will be above the pharmacological ADI, indicating a serious risk for consumer safety.
Poleg tega podatki dosjeja o najvišjih mejnih vrednostih ostankov za metilprednizolon podpirajo domnevo, da bo morebitna izpostavljenost potrošnikov ostankom na mestu injiciranja nad farmakološko dopustnim dnevnim vnosom, kar kaže na resno tveganje za varnost potrošnikov.
Methylprednisolone hydrogen succinate is an ester of the synthetic glucocorticoid methylprednisolone.
Metilprednizolonhidrogensukcinat je ester sintetičnega glukokortikoida metilprednizolona.
Taking all the information together, it cannot be confirmed from the available data that the withdrawal period of 6 days for cattle (meat and offal) for the reference product Solu-Medrol is safe for the consumer.
Z upoštevanjem vseh informacij iz razpoložljivih podatkov ni mogoče potrditi, da je šestdnevna karenca za govedo (meso in organe) za referenčno zdravilo Solu-Medrol varna za potrošnika.
Following a marketing authorisation application to the Federal Office of Consumer Protection and Food Safety of Germany, under Article 13(1) of Directive 2001/82/EC, i.e., a generic application, for the veterinary medicinal product Solupred 125 mg (applicant: CP-Pharma), it appeared that no productspecific residue data are available in support of the cattle meat and offal withdrawal periods of 6 days for the reference products Solu-Medrol 120 mg and Solu-Medrol 500 mg which are authorised in France for use in dogs, cats and cattle (marketing authorisation holder: Zoetis).
Po vložitvi vloge za pridobitev dovoljenja za promet z zdravilom pri nemškem zveznem uradu za varstvo potrošnikov in varnost hrane v skladu s členom 13(1) Direktive 2001/82/ES, tj. generične vloge, za zdravilo Solupred 125 mg za uporabo v veterinarski medicini (predlagatelj: CP-Pharma), se je izkazalo, da v podporo šestdnevni karenci za goveje meso in organe za referenčni zdravili Solu-Medrol 120 mg in Solu-Medrol 500 mg, ki imata dovoljenje za promet v Franciji za uporabo pri psih, mačkah in govedu (imetnik dovoljenja za promet z zdravilom: Zoetis), ni na voljo nobenih za zdravilo specifičnih podatkov o ostankih.
• the CVMP considered that a withdrawal period for meat and offal derived from treated cattle cannot be set; the CVMP has recommended the refusal of the granting of the marketing authorisation for the target species cattle and the variation of the existing marketing authorisations in order to remove any reference to the target species cattle for veterinary medicinal products containing methylprednisolone hydrogen succinate as referred in Annex I.
• odbor CVMP je menil, da ni mogoče določiti karence za meso in organe, pridobljene iz zdravljenega goveda; odbor CVMP je priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom za ciljno vrsto govedo in spremembo obstoječih dovoljenj za promet z zdravilom, tako da se črtajo vse navedbe za ciljno vrsto govedo, za zdravila za uporabo v veterinarski medicini, ki vsebujejo metilprednizolonhidrogensukcinat, kot je navedeno v Prilogi I.
Therefore, the Committee considers that the benefit-risk balance for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection for use in target species cattle is not favourable in the absence of adequate residue depletion data to justify a withdrawal period of 6 days for cattle (meat and offal).
Zato odbor meni, da razmerje med tveganji in koristmi zdravil za uporabo v veterinarski medicini, ki vsebujejo metilhidrogensukcinat in so v obliki raztopine za injiciranje za uporabo pri ciljni vrsti govedo, zaradi odsotnosti ustreznih podatkov o izločanju ostankov, ki bi utemeljilo šestdnevno karenco za govedo (meso in organe), ni ugodno.