natgillin/translations-raw huggingface dataset:
Exforge 5 mg/80 mg film-coated tablets amlodipine/valsartan
Exforge 5 mg/80 mg filmsko obložene tablete amlodipin/valsartan
How to store Exforge
Shranjevanje zdravila Exforge
Exforge 5 mg/160 mg film-coated tablets amlodipine/valsartan
Exforge 5 mg/160 mg filmsko obložene tablete amlodipin/valsartan
* Mostly consistent with cholestasis
* o tem so najpogosteje poročali v povezavi s holestazo Dodatne informacije o kombinaciji
EU/1/06/370/001 7 film-coated tablets EU/1/06/370/002 14 film-coated tablets EU/1/06/370/003 28 film-coated tablets EU/1/06/370/004 30 film-coated tablets EU/1/06/370/005 56 film-coated tablets EU/1/06/370/006 90 film-coated tablets EU/1/06/370/007 98 film-coated tablets EU/1/06/370/008 280 film-coated tablets EU/1/06/370/025 56x1 film-coated tablet (unit dose) EU/1/06/370/026 98x1 film-coated tablet (unit dose) EU/1/06/370/027 280x1 film-coated tablet (unit dose)
EU/1/06/370/001 7 filmsko obloženih tablet EU/1/06/370/002 14 filmsko obloženih tablet EU/1/06/370/003 28 filmsko obloženih tablet EU/1/06/370/004 30 filmsko obloženih tablet EU/1/06/370/005 56 filmsko obloženih tablet EU/1/06/370/006 90 filmsko obloženih tablet EU/1/06/370/007 98 filmsko obloženih tablet EU/1/06/370/008 280 filmsko obloženih tablet EU/1/06/370/025 56x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/370/026 98x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/370/027 280x1 filmsko obložena tableta (za enkratni odmerek)
Myalgia
Obloga
EU/1/06/370/017 7 film-coated tablets EU/1/06/370/018 14 film-coated tablets EU/1/06/370/019 28 film-coated tablets EU/1/06/370/020 30 film-coated tablets EU/1/06/370/021 56 film-coated tablets EU/1/06/370/022 90 film-coated tablets EU/1/06/370/023 98 film-coated tablets EU/1/06/370/024 280 film-coated tablets EU/1/06/370/031 56x1 film-coated tablet (unit dose) EU/1/06/370/032 98x1 film-coated tablet (unit dose) EU/1/06/370/033 280x1 film-coated tablet (unit dose)
EU/1/06/370/017 7 filmsko obloženih tablet EU/1/06/370/018 14 filmsko obloženih tablet EU/1/06/370/019 28 filmsko obloženih tablet EU/1/06/370/020 30 filmsko obloženih tablet EU/1/06/370/021 56 filmsko obloženih tablet EU/1/06/370/022 90 filmsko obloženih tablet EU/1/06/370/023 98 filmsko obloženih tablet EU/1/06/370/024 280 filmsko obloženih tablet EU/1/06/370/031 56x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/370/032 98x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/370/033 280x1 filmsko obložena tableta (za enkratni odmerek)
EU/1/06/370/009 7 film-coated tablets EU/1/06/370/010 14 film-coated tablets EU/1/06/370/011 28 film-coated tablets EU/1/06/370/012 30 film-coated tablets EU/1/06/370/013 56 film-coated tablets EU/1/06/370/014 90 film-coated tablets EU/1/06/370/015 98 film-coated tablets EU/1/06/370/016 280 film-coated tablets EU/1/06/370/028 56x1 film-coated tablet (unit dose) EU/1/06/370/029 98x1 film-coated tablet (unit dose) EU/1/06/370/030 280x1 film-coated tablet (unit dose)
EU/1/06/370/009 7 filmsko obloženih tablet EU/1/06/370/010 14 filmsko obloženih tablet EU/1/06/370/011 28 filmsko obloženih tablet EU/1/06/370/012 30 filmsko obloženih tablet EU/1/06/370/013 56 filmsko obloženih tablet EU/1/06/370/014 90 filmsko obloženih tablet EU/1/06/370/015 98 filmsko obloženih tablet EU/1/06/370/016 280 filmsko obloženih tablet EU/1/06/370/028 56x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/370/029 98x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/370/030 280x1 filmsko obložena tableta (za enkratni odmerek)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Izgled zdravila Exforge in vsebina pakiranja
If any of the following happen, tell your doctor straight away:
Če se karkoli od naštetega pri vas pojavi v hudi obliki, morate to povedati zdravniku.
This summary was last updated in 02-2012.
Povzetek je bil nazadnje posodobljen 01-2016.
The full EPAR for Clopidogrel Acino 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 Klopidogrel Acino je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
• patients who have recently had a myocardial infarction (heart attack).
• ki so nedavno doživeli miokardni infarkt (srčni napad).
For more information about treatment with Clopidogrel Acino, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Klopidogrel Acino preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This is a summary of the European public assessment report (EPAR) for Clopidogrel Acino.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Klopidogrel Acino.
This means that Clopidogrel Acino is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
• patients with peripheral arterial disease (problems with blood flow in the arteries);
• ki imajo periferno arterijsko bolezen (težave s pretokom krvi v arterijah);
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Acino on 28 July 2009.
Evropska komisija je dovoljenje za promet z zdravilom Klopidogrel Acino, veljavno po vsej Evropski uniji, izdala 28. julija 2009.
This is then followed by the standard 75 mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
Temu sledi običajni 75-miligramski odmerek enkrat na dan najmanj štiri tedne (pri miokardnem infarktu z dvigom spojnice ST) ali največ 12 mesecev (pri nestabilni angini pektoris ali miokardnem infarktu brez zobca Q).
The standard dose of Clopidogrel Acino is one 75 mg tablet once a day.
Običajni odmerek zdravila Klopidogrel Acino je ena 75-miligramska tableta enkrat na dan.
EPAR summary for the public clopidogrel
Povzetek EPAR za javnost
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 Clopidogrel Acino.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What are the benefits and risks of Clopidogrel Acino?
Kakšne so koristi in tveganja, povezani z zdravilom Klopidogrel Acino?
Clopidogrel Acino can be started between a few days and 35 days after the attack;
Zdravilo Klopidogrel Acino se lahko začne jemati od nekaj dni po napadu do 35 dni po njem;
Because Clopidogrel Acino is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as those of the reference medicine.
Ker je zdravilo Klopidogrel Acino generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The Committee recommended that Clopidogrel Acino be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Klopidogrel Acino izda dovoljenje za promet.
Other information about Clopidogrel Acino
Druge informacije o zdravilu Klopidogrel Acino
Clopidogrel Acino is a ‘generic medicine'.
Klopidogrel Acino je „generično zdravilo“.
The CHMP concluded that, in accordance with EU requirements, Clopidogrel Acino has been shown to have comparable quality and to be bioequivalent to Plavix.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Klopidogrel Acino primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
Clopidogrel Acino can be started between seven days and six months after the stroke;
Zdravilo Klopidogrel Acino se lahko začne jemati od sedem dni po napadu in do šest mesecev po njem;
• patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
• ki so nedavno utrpeli ishemično kap (kap zaradi neoskrbe določenega dela možganov s krvjo).
Because Clopidogrel Acino is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Ker je zdravilo Klopidogrel Acino generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
In acute coronary syndrome, Clopidogrel Acino is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Pri akutnem koronarnem sindromu se zdravljenje na splošno začne z udarnim odmerkom štirih 75-miligramskih tablet.
Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Plavix odtehtajo znana tveganja.
Clopidogrel Acino is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Zdravilo Klopidogrel Acino se uporablja za preprečevanje težav, ki jih povzročajo krvni strdki pri odraslih:
Clopidogrel Acino is a medicine that contains the active substance clopidogrel.
Klopidogrel Acino je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
The active substance in Clopidogrel Acino, clopidogrel, is an inhibitor of platelet aggregation.
Zdravilna učinkovina zdravila Klopidogrel Acino, klopidogrel, je zaviralec agregacije trombocitov.
• patients who have a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
• ki imajo akutni koronarni sindrom, pri katerem se mora zdravilo dajati skupaj z aspirinom (drugim zdravilom za preprečevanje krvnih strdkov).
Why has Clopidogrel Acino been approved?
Zakaj je bilo zdravilo Klopidogrel Acino odobreno?
How has Clopidogrel Acino been studied?
Kako je bilo zdravilo Klopidogrel Acino raziskano?
How does Clopidogrel Acino work?
Kako zdravilo Klopidogrel Acino deluje?
What is Clopidogrel Acino used for?
Za kaj se zdravilo Klopidogrel Acino uporablja?
What is Clopidogrel Acino?
Kaj je zdravilo Klopidogrel Acino?
How is Clopidogrel Acino used?
Kako se zdravilo Klopidogrel Acino uporablja?
It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘non-Q-wave' myocardial infarction.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom zajema tudi srčni napad in nestabilno angino pektoris (hudo obliko bolečine v prsih).
The European Commission granted a marketing authorisation valid throughout the European Union for Cholib on 26 August 2013.
Evropska komisija je dovoljenje za promet z zdravilom Cholib, veljavno po vsej Evropski uniji, odobrila 26. avgusta 2013.
The recommended dose is one tablet a day to be swallowed whole with a glass of water.
Priporočeni odmerek je ena tableta na dan, ki jo je treba pogoltniti celo s kozarcem vode.
The full EPAR for Cholib 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 Cholib je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Cholib
Druge informacije o zdravilu Cholib
The Committee also noted that the combination of fenofibrate and simvastatin is already being used in clinical practice.
Prav tako je odbor upošteval, da se kombinacija fenofibrata in simvastatina že uporablja v klinični praksi.
This is a summary of the European public assessment report (EPAR) for Cholib.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cholib.
A risk management plan has been developed to ensure that Cholib is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Cholib je bil pripravljen načrt obvladovanja tveganj.
Fenofibrate is a ‘PPARα agonist'.
Fenofibrat je „agonist receptorja PPARα“.
Cholib can only be obtained with a prescription and is available as tablets (145/20 mg and 145/40 mg).
Izdaja zdravila Cholib je le na recept, na voljo pa je v obliki tablet (145/20 mg in 145/40 mg).
The Committee therefore concluded that Cholib's benefits are greater than its risks and recommended that it be approved for use in the EU.
CHMP je zato zaključil, da so koristi zdravila Cholib večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Cholib?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila
What are the risks associated with Cholib?
Kakšna tveganja so povezana z zdravilom Cholib?
What benefits of Cholib have been shown in studies?
Kakšne koristi je zdravilo Cholib izkazalo v študijah?
What is Cholib and what is it used for?
Kaj je zdravilo Cholib in za kaj se uporablja?
With regard to the safety of Cholib, the side effects reported in the studies were consistent with what is known about the two active substances and there were no major concerns.
Kar se tiče varnosti zdravila Cholib, so bili neželeni učinki, o katerih so poročali v študijah, skladni s tem, kar je že znano o obeh zdravilnih učinkovinah, zato ni bilo nobenih večjih zadržkov.
It is not intended to provide practical advice on how to use Cholib.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
It must also not be used in pregnant or breast-feeding women, in people known to have light-induced reactions to fibrates or ketoprofen, or those who have liver or gallbladder disease, pancreatitis, or moderately or severely reduced kidney function, or who have previously had muscle problems while taking statins or fibrates.
Prav tako ga ne smejo uporabljati ženske, ki so noseče ali dojijo, osebe z znano dovzetnostjo za s svetlobo povzročene reakcije na fibrate ali ketoprofen, osebe z boleznijo jeter ali žolčnika, pankreatitisom ali zmerno ali hudo okvaro delovanja ledvic, in osebe, ki so v preteklosti med jemanjem statinov ali fibratov imele težave z mišicami.
This means that it activates a type of receptor called the ‘peroxisome proliferator-activated receptor alpha' (PPARα), which is involved in breaking down fats from diet, especially triglycerides.
To pomeni, da aktivira vrsto receptorja, imenovanega „s peroksisomskim proliferatorjem aktiviran receptor tipa alfa“ (PPARα), ki sodeluje pri razgradnji maščob iz hrane, še zlasti trigliceridov.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cholib, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Cholib vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Before starting treatment with Cholib, possible causes of the abnormal levels of blood fats should be adequately treated and patients should be placed on a standard fat-lowering diet.
Pred začetkom zdravljenja z zdravilom Cholib je treba možne vzroke za nenormalne ravni maščob v krvi že ustrezno zdraviti in pri bolnikih uvesti standardno dieto za zniževanje ravni maščob.
Why is Cholib approved?
Zakaj je bilo zdravilo Cholib odobreno?
In a main study comparing Cholib 145/20 mg with simvastatin 40 mg in 1,050 patients not adequately treated with 20 mg simvastatin alone, triglyceride levels decreased by around 36% with Cholib after 12 weeks compared with 12% with simvastatin.
V glavni študiji, v kateri so zdravilo Cholib 145/20 mg primerjali s simvastatinom 40 mg pri 1 050 bolnikih, pri katerih monoterapija z 20 mg simvastatina ni bila dovolj učinkovita, je po 12 tednih zdravilo Cholib znižalo ravni trigliceridov za približno 36 %, simvastatin pa za 12 %.
Cholib must not be used in people who are hypersensitive (allergic) to peanuts, soya lecithin or any of the ingredients of the medicine.
Zdravila Cholib ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) arašide, sojin lecitin ali katero koli drugo sestavino zdravila.
The cholesterol drawn out of the blood in this way is the ‘bad' cholesterol.
Holesterol, ki se na tak način odstrani iz krvi, je „slabi“ holesterol.
The second active substance, simvastatin, belongs to the group called ‘statins'.
Druga zdravilna učinkovina, simvastatin, spada v skupino zdravil, ki jih imenujemo „statini“.
For more information about treatment with Cholib, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Cholib preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
As the liver needs cholesterol to produce bile, the reduced blood cholesterol level causes the liver cells to produce receptors that draw cholesterol from the blood, reducing its level even further.
Ker jetra potrebujejo holesterol za proizvajanje žolča, nižja raven holesterola v krvi povzroči, da jetrne celice začnejo proizvajati receptorje, ki črpajo holesterol iz krvi in tako še bolj znižajo njegovo raven.
It showed that Cholib led to a greater reduction in triglyceride levels (33% versus 7%) and to higher levels of good cholesterol (6% increase versus a 1% decrease).
Rezultati so pokazali, da je zdravilo Cholib v večji meri znižalo ravni trigliceridov (za 33 % v primerjavi s 7 %) in zvišalo ravni dobrega holesterola (zvišanje za 6 % v primerjavi z znižanjem za 1 %).
The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the combination of fenofibrate and simvastatin has been shown to be effective at improving blood fat levels.
Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da je bilo dokazano, da kombinacija fenofibrata in simvastatina učinkovito zniža ravni maščob v krvi.
For practical information about using Cholib, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Cholib naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The active substances in Cholib, fenofibrate and simvastatin, work in different ways and their actions have a complementary effect.
Zdravilni učinkovini v zdravilu Cholib, fenofibrat in simvastatin, delujeta na različna načina, njuni učinki pa se med seboj dopolnjujejo.
Cholib is to be used in adults at high risk of heart disease whose levels of ‘bad' cholesterol (LDL cholesterol) are already being controlled with the corresponding dose of simvastatin alone.
Zdravilo Cholib je namenjeno uporabi pri odraslih z velikim tveganjem za bolezni srca, pri katerih so ravni „slabega“ holesterola (holesterola LDL) že obvladane z ustreznim odmerkom samega simvastatina.
Two further studies compared Cholib with other statins (atorvastatin and pravastatin) and showed Cholib to be more effective than those statins given alone.
V nadaljnjih dveh študijah so zdravilo Cholib primerjali z drugimi statini (atorvastatinom in pravastatinom) in ugotovili, da je bilo zdravilo Cholib učinkovitejše od samih statinov.
In addition, levels of good cholesterol increased by around 7% with Cholib compared with around 2% with simvastatin.
Poleg tega je zdravilo Cholib zvišalo ravni dobrega holesterola za približno 7 %, simvastatin pa za približno 2 %.
Another study compared Cholib 145/40 mg with simvastatin 40 mg in 450 patients not adequately treated with 40 mg simvastatin alone.
V drugi študiji so primerjali zdravilo Cholib 145/40 mg in simvastatin 40 mg pri 450 bolnikih, pri katerih monoterapija s 40 mg simvastatina ni bila dovolj učinkovita.
When these receptors are activated, the breakdown of fats speeds up, which helps clear the blood of ‘bad' cholesterol and triglycerides.
Aktiviranje teh receptorjev pospeši razgradnjo maščob, kar pomaga pri odstranjevanju „slabega“ holesterola in trigliceridov iz krvi.
It contains two active substances, fenofibrate and simvastatin, and is used together with a low fat diet and exercise with the aim of reducing patients' levels of triglycerides (a type of fat) and increasing their levels of ‘good' cholesterol (HDL cholesterol).
Vsebuje dve zdravilni učinkovini, fenofibrat in simvastatin, ter se uporablja v kombinaciji s prehrano z majhnim vnosom maščob in telesno vadbo za zniževanje ravni trigliceridov (vrsta maščobe) ter zviševanje ravni „dobrega“ holesterola (holesterola HDL) pri bolnikih.
The most common side effects with Cholib are raised blood creatinine levels, upper respiratory tract infection (colds), increased blood platelet counts, gastroenteritis (diarrhoea and vomiting) and increased levels of alanine aminotransferase (a liver enzyme).
Najpogostejši neželeni učinki zdravila Cholib so zvišane ravni kreatinina v krvi, okužba zgornjih dihal (prehladi), zvišano število trombocitov, gastroenteritis (driska in bruhanje) ter zvišane ravni alaninaminotransferaze (jetrnega encima).
Cholib fenofibrate / simvastatin
Povzetek EPAR za javnost fenofibrat/simvastatin
Cholib is a medicine for improving blood fat levels.
Cholib je zdravilo, ki se uporablja za zniževanje ravni maščob v krvi.
Cholib has been shown to be more effective than statins alone in reducing levels of triglycerides and increasing levels of good cholesterol.
Zdravilo Cholib je bilo učinkovitejše od samih statinov pri znižanju ravni trigliceridov in zvišanju ravni dobrega holesterola.
For the full list of all side effects reported with Cholib, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Cholib, glejte navodilo za uporabo.
It reduces total blood cholesterol by blocking the action of HMG-CoA reductase, an enzyme in the liver involved in the production of cholesterol.
Znižuje raven skupnega holesterola v krvi, tako da zavira delovanje reduktaze HMG-CoA, tj. encima v jetrih, ki sodeluje pri tvorbi holesterola.
Grapefruit juice should be avoided during Cholib treatment as this is known to alter the amount of simvastatin in the blood.
Med zdravljenjem z zdravilom Cholib se je treba izogibati soku grenivke, ki dokazano vpliva na količino simvastatina v krvi.
How is Cholib used?
Kako se zdravilo Cholib uporablja?
How does Cholib work?
Kako zdravilo Cholib deluje?
In all studies the reductions in triglycerides and the increases in good cholesterol were higher with Cholib than with a statin alone.
Zdravilo Cholib je v vseh študijah v večji meri znižalo ravni trigliceridov in zvišalo ravni dobrega holesterola kot sami statini.
Intravenous use ampoule (glass) 10 ml
Ampula (steklo) 10 ml
10 ampoules
10 ampul
* Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
* Enota relativne potence s ELISA antigen kvantifikacijo (in vitro test potence) v primerjavi z referenčnim cepivom.
--1 Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein
--1 Inaktivirani rekombinantni himerni prašičji cirkovirus tipa 1, ki vsebuje prašičjega cirkovirusa tipa 2, beljakovino ORF2 2,3-12,4 RP * Inaktivirana Mycoplasma hyopneumoniae sev P-5722-3 (inaktivirano) 1,5-3,8 RP *
Route of administration
10 vial
Withdrawal period
1 viala
Strength Pharmaceutical form
1 injekcijski vložek
For full details, see the Summary of Product Characteristics, also part of the EPAR.
Za vse podrobnosti glejte povzetek glavnih značilnosti zdravila, ki je prav tako del EPAR.
This means that it is similar to a ‘reference medicine' containing the same active substance.
To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje isto zdravilno učinkovino.
EPAR summary for the public topotecan
Povzetek EPAR za javnost topotekan