natgillin/translations-raw huggingface dataset:
The vaccine contains inactivated (killed) bluetongue virus.
Cepivo vsebuje inaktivirane (uničene) viruse modrikastega jezika.
Protection lasts for one year for both serotype 1 and 8.
Zaščita traja eno leto za serotipa 1 in 8.
For more information about using Zulvac BTV, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe cepiva Zulvac BTV glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
The vaccine is given as two injections under the skin for sheep and in the muscle for cattle.
Cepivo se daje v obliki dveh injekcij v podkožje pri ovcah in v mišico pri govedu.
In most cases the reactions are diffuse swellings at the injection site which last no longer than one week.
V večini primerov je eden od neželenih učinkov difuzna oteklina na mestu injiciranja, ki ne traja več kot sedem dni.
Zulvac BTV is a vaccine.
Zdravilo Zulvac BTV je cepivo.
The most common side effects with Zulvac BTV in cattle (which may affect more than 1 in 10 animals) are local reactions at the injection site and a short-lived increase in body temperature, up to 2.7˚C, during the 2 days after vaccination.
Najpogostejši neželeni učinki zdravila Zulvac BTV pri govedu (ki lahko prizadenejo več kot 1 žival od 10) so lokalne reakcije na mestu injiciranja in kratkotrajno zvišanje telesne temperature do 2,7 °C v dveh dneh po cepljenju.
The first injection is given from 6 weeks of age for sheep and from 12 weeks of age for cattle; and a second injection is given 3 weeks later.
Prva injekcija se daje od 6 tednov starosti za ovce in od starosti 12 tednov za govedo.
When used in sheep the vaccine contains one of the following three vaccine strains: BTV serotype 1, BTV serotype 4 and BTV serotype 8.When used in cattle the vaccine contains either BTV serotype 1 or BTV serotype 8.
Za ovce se uporablja cepivo, ki vsebuje enega od naslednjih treh sevov cepiva: serotip 1 (BTV-1), serotip 4 (BTV-4) in serotip 8 (BTV-8).Če se uporablja pri govedu, cepivo vsebuje bodisi serotip 1 ali serotip 8.
The most common side effects with Zulvac BTV in sheep (which may affect more than 1 in 10 animals) are a short-lived increase in body temperature, up to 1.6˚C, during the 2 days after vaccination and local reactions at the injection site.
Najpogostejši neželeni učinki cepiva Zulvac BTV pri ovcah (ki lahko prizadenejo več kot 1 žival od 10) so prehodno povišanje telesne temperature (do največ 1,6 ˚C) v dveh dneh po cepljenju in lokalne reakcije na mestu injiciranja.
An overview of Zulvac BTV and why it is authorised in the EU
Pregled zdravila Zulvac BTV in zakaj je odobreno v EU
Zulvac BTV is a vaccine used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges.
Zdravilo Zulvac BTV je cepivo, ki se uporablja pri ovcah in govedu za zaščito pred boleznijo modrikastega jezika, tj. okužbo, ki jo prenašajo trzače, povzroča pa jo virus modrikastega jezika.
A laboratory study with lambs vaccinated with serotype 4 showed the vaccine to reduce levels of serotype 4 in the blood for at least 12 months whilst studies with serotype 1 and 8 showed absence of the respective serotypes after one year.
Laboratorijske študije z jagnjeti, cepljenimi s serotipom 4, so pokazale, da je cepivo za najmanj 12 mesecev znižalo ravni serotipa 4 v krvi, medtem ko so študije s serotipoma 1 in 8 pokazale, da posamezna serotipa po enem letu nista bila več prisotna.
Why is Zulvac BTV authorised in the EU?
Zakaj je zdravilo Zulvac BTV odobreno v EU?
Further laboratory studies showed protection lasts for one year for each serotype.
Dodatne laboratorijske študije so pokazale, da zaščita pri vsakem serotipu traja eno leto.
What is Zulvac BTV and what is it used for?
Kaj je zdravilo Zulvac BTV in za kaj se uporablja?
What benefits of Zulvac BTV have been shown in studies?
Kakšne koristi je zdravilo Zulvac BTV izkazalo v študijah?
For cattle protection starts 15 days after the initial course of two injections for serotype 1 whilst protection starts 25 days after the initial course of two injections for serotype 8.
Pri govedu se zaščita pojavi 15 dni po začetnem sklopu dveh injekcij za serotip 1, medtem ko se za serotip 8 zaščita pojavi 25 dni po začetnem sklopu dveh injekcij.
Further laboratory studies showed protection lasts for one year for the respective serotypes.
Dodatne laboratorijske študije so pokazale, da zaščita pri zadevnih serotipih traja eno leto.
What are the risks associated with Zulvac BTV?
Kakšna tveganja so povezana z zdravilom Zulvac BTV?
Zulvac BTV contains bluetongue virus that has been inactivated so that it cannot cause the disease.
Cepivo Zulvac BTV vsebuje inaktivirani virus bolezni modrikastega jezika, ki ne povzroča bolezni.
Laboratory studies were conducted with the individual serotypes 1, 4 and 8 as well as with the combination of 1 and 8 in sheep which showed that protection starts three weeks after completion of the initial course of two injections for each serotype.
Laboratorijske študije so bile opravljene s posameznimi serotipi 1, 4 in 8 ter s kombinacijo vseh treh serotipov pri ovcah ter so pokazale, da se je zaščita pojavila tri tedne po zaključenem začetnem sklopu dveh injekcij za vsak serotip.
When it is given to sheep or cattle, their immune system recognises
Ko ovce ali govedo prejmejo cepivo, imunski sistem prepozna virus kot „tujek“ in začne proti njemu tvoriti protitelesa.
Other information about Zulvac BTV?
Druge informacije o zdravilu Zulvac BTV
Laboratory studies were conducted with the individual serotypes 1 and 8 in cattle which showed that protection starts 15 days after completion on the initial vaccination course of two injections for serotype 1 and 25 days after completion of the initial vaccination course for serotype 8.
Pri govedu so bile izvedene laboratorijske študije s posameznimi serotipi 1 in 8, ki so pokazale, da se je zaščita pojavila 15 dni po zaključenem začetnem sklopu dveh injekcij za serotip 1 in 25 dni po zaključku začetnega cepljenja za serotip 8.
For sheep protection starts 3 weeks after the initial course of two injections and lasts for one year.
Zaščita je učinkovita od tretjega tedna po prvem sklopu z dvema injekcijama in traja eno leto.
Zulvac BTV contains bluetongue virus of one type selected from serotypes 1, 4 and 8.
Cepivo Zulvac BTV vsebuje enega od serotipov bolezni modrikastega jezika, in sicer 1, 4 ali 8.
How does Zulvac BTV work?
Kako zdravilo Zulvac BTV deluje?
How is Zulvac BTV used?
Kako se zdravilo Zulvac BTV uporablja?
• the CHMP reviewed the available data submitted by the Applicant
• odbor CHMP je pregledal razpoložljive podatke, ki jih je predložil predlagatelj,
Overall summary of the scientific evaluation of Simvastatin Vale and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Simvastatin Vale in povezanih imen (glejte Prilogo I)
The CHMP noted that the proposed formulations are largely identical qualitatively and quantitatively and are manufactured according to the same process.
Odbor CHMP je zabeležil, da so predlagane oblike kvalitativno in kvantitativno v glavnem identične in da so proizvedene z enakim postopkom.
Finally, the CHMP considered the bioanalytical method used to be sufficiently validated and in line with the bioequivalence guideline.
Nazadnje je odbor CHMP menil, da je bila uporabljena bioanalitična metoda zadovoljivo potrjena in v skladu s smernicami biološke enakovrednosti.
The CHMP also evaluated the in vitro dissolution data, noting that both products showed rapid and high dissolution levels at pH 7 and that solubility was therefore unlikely to be a limiting factor.
Odbor je prav tako ocenil podatke raztapljanja in vitro ter zabeležil, da sta obe zdravili pokazali hitre in visoke stopnje raztapljanja pri pH 7 in da topnost zato najverjetneje ne bo omejitveni dejavnik.
The CHMP considered that the pharmacokinetics of simvastatin are fully linear across the therapeutic dose range, that simvastatin is well absorbed and that no significant differences in absorption between the proposed and the reference product could be identified.
Odbor CHMP je menil, da je farmakokinetika simvastatina popolnoma linearna v razponu terapevtskih odmerkov, da se simvastatin dobro absorbira in da ni bilo mogoče opredeliti nobene pomembne razlike v absorpciji med predlaganim in referenčnim zdravilom.
While the CHMP agreed that there was a deviation from the CHMP Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr), which states that for substances with linear pharmacokinetics, bioequivalence should in general be established with the highest strengths, it considered that this deviation should be considered in light of the available data and therefore assessed the Applicant dossier to determine the clinical relevance of the deviation.
Čeprav se je odbor CHMP strinjal, da je prišlo do odklona od Smernic CHMP o raziskavah biološke enakovrednosti (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr), v katerih je navedeno, da je treba za snovi z linearno farmakokinetiko biološko enakovrednost v splošnem dokazati za največje jakosti, je odbor menil, da je treba ta odklon upoštevati v okviru razpoložljivih podatkov, in zato ocenil vlagateljevo dokumentacijo, da bi določil klinični pomen odklona.
• the CHMP considered that both strengths of the proposed product can be considered bioequivalent to the reference product the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Simvastatin Vale and associated names (see Annex I).
• odbor CHMP je menil, da sta obe jakosti predlaganega zdravila biološko enakovredni referenčnemu zdravilu, je odbor CHMP priporočil odobritev dovoljenja za promet z zdravilom, za katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostajajo enaki kot zadnje različice, pripravljene med postopkom usklajevalne skupine, kot je navedeno v Prilogi III za zdravilo Simvastatin Vale in povezana imena (glejte Prilogo I).
• the CHMP considered that the available data allowed extrapolation of the demonstrated bioequivalence from the 20 mg/5 ml strength to the 40 mg/5 ml strength
• odbor CHMP je menil, da razpoložljivi podatki omogočajo ekstrapolacijo dokazane biološke enakovrednosti z jakosti 20 mg/5 ml na jakost 40 mg/5 ml,
The marketing authorisation application for a generic simvastatin oral suspension to be marketed as Simvastatin Vale 20 mg/5 ml and 40 mg/5 ml and indicated in the treatment of hypercholesterolemia and cardiovascular disease prevention was supported by a single bioequivalence study comparing the 20 mg/5 ml oral suspension to the 20 mg immediate release tablet of the reference product.
Vloga za pridobitev dovoljenja za promet s peroralno raztopino generičnega simvastatina, ki naj bi se tržila kot zdravilo Simvastatin Vale 20 mg/5 ml in 40 mg/5 ml ter bila indicirana za zdravljenje hiperholesterolemije in preprečevanje srčno-žilnih bolezni, je podprta z eno študijo biološke enakovrednosti, v kateri so primerjali peroralno raztopino 20 mg/5 ml z 20-mg tableto s takojšnjim sproščanjem referenčnega zdravila.
In conclusion, the CHMP was of the opinion that the benefit-risk ratio of Simvastatin Vale and associated names is favourable.
Odbor CHMP je prav tako menil, da je razmerje med koristmi in tveganji zdravila Simvastatin Vale in povezanih imen pozitivno.
Following potential serious risks to public health raised regarding the evidence of bioequivalence for the higher 40 mg/5 ml strength, a referral under Article 29(4) of Directive 2001/83/EC was triggered, requesting the CHMP to give its opinion on whether Simvastatin is bioequivalent to the reference product.
Po potencialno resnem tveganju za javno zdravje, ki se je pojavilo v zvezi z dokazom biološke enakovrednosti za večjo jakost 40 mg/5 ml, je bil v okviru člena 29(4) Direktive 2001/83/ES sprožen napotitveni postopek, ki odbor CHMP poziva, da poda svoje mnenje o tem, ali je zdravilo Simvastatin biološko enakovredno referenčnemu zdravilu.
Overall, having considering the totality of the available evidence, the CHMP concluded that while a deviation from the current bioequivalence guideline is acknowledged, no potential serious risk to public health was identified, that extrapolation of the demonstrated bioequivalence from the 20 mg/5 ml strength to the 40 mg/5 ml strength is possible and that both strengths of the proposed product can therefore be considered bioequivalent to the reference product.
Glede na skupek razpoložljivih dokazov je odbor CHMP v splošnem zaključil, da kljub zabeleženemu odklonu od trenutnih smernic biološke enakovrednosti resnega tveganja za javno zdravje ni, da je ekstrapolacija dokazane biološke enakovrednosti z jakosti 20 mg/5 ml na jakost 40 mg/5 ml mogoča in da sta obe jakosti predlaganega zdravila zato biološko enakovredni referenčnemu zdravilu.
EU (MA) number Invented name
EU številka Izmišljeno ime
Packaging Package size
Ovojnina Velikost pakiranja
You will therefore need regular blood tests to determine the correct daily dose.
Zato boste potrebovali redne krvne preiskave za določanje pravilnega dnevnega odmerka.
Children and Adult
Otroci in odrasli
There is no evidence of development of tolerance.
Ni dokazov, da bi se razvijala toleranca.
However, Cystadane should not be used during pregnancy unless clearly necessary.
Kljub temu naj se zdravilo Cystadane med nosečnostjo ne uporablja, če ni nujno potrebno.
A standard battery of genotoxicity test reveals no specific hazard for humans.
Standardna baterija testov za genotoksičnosti ne kaže posebnega tveganja za človeka.
For specific recommendations, see section 4.4.
Za natančna priporočila glejte poglavje 4.4.
If you forget to take a dose take it as soon as you remember it and continue the next dose as planned.
Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite, nato pa z naslednjim odmerkom nadaljujte tako, kot je načrtovano.
Your doctor will decide if you can use this medicine during pregnancy and breast-feeding.
Zdravnik bo odločil, ali smete med nosečnostjo in dojenjem jemati to zdravilo.
You should take Cystadane orally (by mouth).
Zdravilo Cystadane morate jemati peroralno (skozi usta).
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Pogostnosti so definirane kot: zelo pogoste (≥ 1/10), pogoste (≥ 1/100 do < 1/10), občasne (≥ 1/1.000 do < 1/100), redke (≥ 1/10.000 do < 1/1.000), zelo redke (< 1/10.000).
Animal reproduction studies have not been conducted.
Študij razmnoževanja pri živalih niso opravili.
Do not store above 25C.
Shranjujte pri temperaturi do 25C.
As a result, plasma levels of homocysteine should decrease in these patients, to 20-30 % of pre-treatment levels.
Posledično naj bi se plazemska koncentracija homocisteina pri teh bolnikih znižala na 20-30 % ravni pred zdravljenjem.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
The steady-state response usually occurs within a month.
Odziv v stanju dinamičnega ravnovesja se običajno pojavi v enem mesecu.
In that case your doctor will monitor your methionine level in your body and may review your diet.
V takem primeru bo zdravnik spremljal koncentracijo metionina v vašem telesu in še enkrat pretehtal vašo dieto.
Your doctor may adapt the dose depending on your laboratory values.
Zdravnik bo morda odmerek prilagodil glede na vrednosti laboratorijskih preiskav.
Date of first authorisation: 15 February 2007 Date of latest renewal: 21 November 2016
Datum zadnjega podaljšanja: 21 november 2016
Do not stop the treatment without consulting your doctor.
Ne prenehajte z zdravljenjem brez predhodnega posvetovanja z zdravnikom.
Methionine levels should be closely monitored in these patients.
Pri teh bolnikih je treba ravni metionina pozorno spremljati.
• 5,10-methylene-tetrahydrofolate reductase (MTHFR),
• 5,10-metilentetrahidrofolat reduktaze (MTHFR),
Your treatment with Cystadane may need to be interrupted.
Mogoče bo treba vaše zdravljenje z zdravilom Cystadane prekiniti.
The aim of treatment is to keep plasma levels of total homocysteine below 15 µM or as low as possible.
Cilj zdravljenja je obdržati koncentracijo celotnega homocisteina v plazmi pod 15 µM ali tako nizko, kolikor je mogoče.
• take the correct measuring spoon:
• Vzemite pravilno merilno žličko:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Če ste noseči ali dojite, menite, da ste noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Complete recovery was seen after treatment discontinuation (see section 4.4).
Po prekinitvi zdravljenja je prišlo do popolnega okrevanja (glejte poglavje 4.4).
Betaine anhydrous was rapidly distributed into a relatively large volume (V/F = 1.3 l/kg).
Brezvodni betain se je hitro porazdelil po razmeroma velikem prostoru (V/F = 1,3 l/kg).
If methionine increases particularly above the first safety threshold of 700 µmol/L, patient should be monitored more frequently and compliance with diet should be checked.
Če se raven metionina poveča, zlasti če se poveča nad prvo varnostno mejo 700 µmol/l, je treba bolnika spremljati pogosteje in ugotoviti, ali se drži diete.
What Cystadane is and what it is used for
Kaj je zdravilo Cystadane in za kaj ga uporabljamo
• cystathionine beta-synthase (CBS),
• cistationin beta-sintaze (CBS),
- There is no other ingredient.
- Zdravilo ne vsebuje drugih sestavin.
The extent of this effect was dependent on the absolute degree of hyperhomocysteinemia, being higher in severe hyperhomocysteinemia.
Obseg tega učinka je bil odvisen od absolutne stopnje hiperhomocisteinemije in je bil večji pri težki hiperhomocisteinemiji.
The pharmacokinetic data of homocystinuric patients on long-term betaine anhydrous supplementation are very similar to those of healthy volunteers.
Farmakokinetični podatki bolnikov s homocistinurijo, ki dolgoročno prejemajo dodatek brezvodnega betaina, so zelo podobni kot pri zdravih prostovoljcih.
In a few cases, increased plasma methionine levels were associated with cerebral oedema (see sections 4.4 and 4.8).
V nekaj primerih so bili povišani nivoji metionina v plazmi povezani s cerebralnim edemom (glejte točki 4.4 in 4.8).
• take the correct number of spoonfuls of powder from the bottle
• Vzemite pravilno število žličk praška iz steklenice.
Very common: blood methionine increased*
Zelo pogosta: zvišan metionin v krvi*
Other medicines and Cystadane
Druga zdravila in zdravilo Cystadane
Uncommon: anorexia
Občasna: anoreksija
After a repeated dose regiment of 100 mg/kg/day for 5 days, the distribution half life was prolonged significantly (up to 36 h), indicating saturable transport and redistribution processes.
Po shemi ponavljajočih se odmerkov po 100 mg/kg/dan 5 dni se je razpolovni čas porazdelitve signifikantno podaljšal (do 36 ur), kar kaže na to, da se procesi transporta in ponovne porazdelitve nasitijo.
The available clinical data do not allow correlating posology and clinical efficacy.
Klinični podatki, ki so na voljo, ne omogočajo koreliranja odmerjanja in klinične učinkovitosti.
Methionine is present in regular food protein (e.g. meat, fish, milk, cheese, eggs).
Metionin je aminokislina, prisotna v običajnih beljakovinah v hrani (npr. mesu, ribah, siru, jajcih).
Fertility No data is available.
Plodnost Podatki niso na voljo.
Adjunctive treatment of homocystinuria, involving deficiencies or defects in:
Dodatno zdravljenje homocistinurije, ki obsega pomanjkanje ali napake:
• cobalamin cofactor metabolism (cbl).
• presnove kofaktorjev kobalamina (cbl).
It is recommended to measure plasma methionine level at start of treatment and about annually or biannually thereafter.
Priporočljivo je izmeriti raven metionina na začetku zdravljenja in nato približno enkrat na leto ali enkrat na dve leti.
To measure the dose:
Odmerek odmerite takole:
If you take more Cystadane than you should If you accidentally take too much Cystadane, talk to a doctor or pharmacist immediately.
Če ste vzeli večji odmerek zdravila Cystadane, kot bi smeli Če po nesreči vzamete preveč zdravila Cystadane, se takoj pogovorite z zdravnikom ali farmacevtom.
The bottle should be lightly shaken before opening.
Steklenico je treba pred odpiranjem rahlo pretresti.
In paediatric patients less than 10 years of age, the usual effective dose regimen is 100 mg/kg/day given in 2 doses daily; increasing the frequency above twice daily and/or the dose above 150 mg/kg/day does not improve the homocysteine-lowering effect.
Pri pediatričnih bolnikih, mlajših od 10 let, je običajna učinkovita shema odmerjanja 100 mg/kg/dan, danih v 2 odmerkih na dan; če zdravilo dajemo pogosteje kot dvakrat na dan in/ali zvečamo odmerek nad 150 mg/kg/dan, se učinkovitost zdravila glede zniževanja homocisteina ne izboljša.
Uncommon: urinary incontinence
Občasna: inkontinenca urina
After a repeated dose regimen of 100 mg/kg/day for 5 days, the absorption kinetics did not change.
Po shemi ponavljajočih se odmerkov po 100 mg/kg/dan 5 dni se kinetika absorpcije ni spremenila.
In some patients doses above 200 mg/ kg/day were needed to reach therapeutic goals.
Pri nekaterih bolnikih so za doseganje terapevtskih ciljev bili potrebni odmerki nad 200 mg/kg/dan.
The most commonly side effect when taking Cystadane which may affect more than 1 in 10 people (frequency very common) is elevated levels of methionine in the blood.
Najpogostejši neželeni učinek pri jemanju zdravila Cystadane, ki se lahko pojavi pri več kot 1 od 10 bolnikov (zelo pogosto) je zvišana raven metionina v krvi.
In order to reduce methionine levels, modification of diet as well as dose reduction of Cystadane or temporal interruption of Cystadane treatment should be considered.
Za zmanjšanje ravni metionina je treba razmisliti o spremembi diete in zmanjšanju odmerka zdravila Cystadane ali začasni prekinitvi zdravljenja z zdravilom Cystadane.
Reported adverse reactions are listed below, by system organ class and by frequency.
V nadaljevanju so neželeni učinki, o katerih so poročali, navedeni po organskih sistemih in po pogostnosti.
The use of this medicine will be supervised by a doctor experienced in the treatment of patients with homocystinuria.
Uporabo tega zdravila bo nadzoroval zdravnik, izkušen v zdravljenju bolnikov s homocistinurijo.
In most cases, adding betaine anhydrous resulted in a further reduction in plasma homocysteine level.
Pri večini primerov je imel dodatek brezvodnega betaina za posledico nadaljnje znižanje ravni homocisteina v plazmi.
Monitoring betaine plasma concentrations does not help to define the efficacy of treatment, since these concentrations do not directly correspond to the flux through the cytosolic betaine homocysteine methyl transferase pathway.
Spremljanje koncentracije betaina v plazmi ne pomaga pri opredeljevanju učinkovitosti zdravljenja, ker se te koncentracije ne ujemajo neposredno s tokom skozi citosolno betainsko-homocisteinsko metiltransferazno presnovno pot.
Pharmacotherapeutic group: Other alimentary tract and metabolism products, ATC code: A16AA06.
Farmakoterapevtska skupina: Druga zdravila za zdravljenje bolezni prebavil in presnove, oznaka ATC: A16A A06.