natgillin/translations-raw huggingface dataset:
Patients presenting with pruritus and/or persistent diarrhoea should be investigated for a potential overdose by a serum and/or urine bile acid assay (see section 4.9).
Pri bolnikih s pruritusom in/ali dolgotrajno drisko je treba z določanjem žolčnih kislin v serumu in/ali urinu ugotoviti, ali morda ne prejemajo prevelikega odmerka (glejte poglavje 4.9).
Administration with food may increase cholic acid bioavailability and improve tolerability.
Jemanje s hrano lahko poveča biološko razpoložljivost holne kisline in izboljša prenašanje zdravila.
The available non-clinical data in the literature reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.
Razpoložljivi predklinični podatki v literaturi na osnovi študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
Cholic acid therapy has been used for infants from one month of age, and for children and adolescents.
Zdravljenje s holno kislino so uporabili za zdravljenje dojenčkov od starosti enega meseca naprej, otroke in mladostnike.
The MAH, in agreement with the competent authorities in the Member States, shall implement, prior to the launch, an educational programme for physicians aiming to provide educational material on correct diagnosis and therapeutic managements of the treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency and to inform on expected and potential risks associated with the treatment.
Preden imetnik dovoljenja za promet z zdravilom da zdravilo v promet, mora v dogovoru s pristojnimi organi držav članic izvesti izobraževalni program za zdravnike, katerega cilj je zagotoviti izobraževalno gradivo o pravilnem diagnosticiranju in izvajanju terapije pri zdravljenju prirojenih napak v sintezi primarne žolčne kisline zaradi pomanjkanja 3β-hidroksi-Δ5-C27-steroid-oksidoreduktaze ali pomanjkanja Δ4-3-oksosteroid-5β-reduktaze ter obvestiti zdravnike o pričakovanih in možnih tveganjih, povezanih z zdravljenjem.
The intravenous LD50 of cholic acid in mice is 350 mg/kg body weight.
Pri miših je intravenska vrednost LD50 holne kisline 350 mg/kg telesne mase.
How to take Orphacol
Kako jemati zdravilo Orphacol
The daily dose ranges from 5 to 15 mg/kg in infants, children, adolescents and adults.
Dnevni odmerek je od 5 do 15 mg/kg za dojenčke, otroke, mladostnike in odrasle.
No data are available for patients with renal impairment.
Podatki o bolnikih z okvarjenim delovanjem ledvic niso na voljo.
- If you get any side effects, talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte zdravnikom ali farmacevtom.
What Orphacol looks like and contents of the pack
Izgled zdravila Orphacol in vsebina pakiranja
For babies and children who cannot swallow capsules, the capsule can be opened and its contents added to baby formula or apple/orange or apple/apricot juice adapted for small children.
Za dojenčke in otroke, ki ne morejo pogoltniti kapsul, lahko kapsule odprete in vsebino dodate otroški formuli ali jabolčnemu/pomarančnemu ali jabolčnemu/mareličnemu soku, ki je prilagojen majhnim otrokom.
3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency The daily dose ranges from 5 to 15 mg/kg in infants, children, adolescents and adults.
Pomanjkanje 3β-hidroksi-Δ5-C27-steroid-oksidoreduktaze Dnevni odmerek je od 5 do 15 mg/kg za dojenčke, otroke, mladostnike in odrasle.
Oblong, opaque, blue and white capsule.
trda kapsula (kapsula) Podolgovate, neprozorne, modro-bele kapsule.
The oral LD50 in mice is 1520 mg/kg.
Pri miših je peroralna vrednost LD50 1520 mg/kg.
Patients are expected to present with some degree of hepatic impairment at diagnosis, which improves under cholic acid therapy.
Ob postavitvi diagnoze je pričakovana prisotnost določene stopnje jetrne okvare, ki se izboljša z zdravljenjem s holno kislino.
Lactose monohydrate, Colloidal anhydrous silica, Magnesium stearate.
Vsebina kapsule: laktoza monohidrat, koloidni brezvodni silicijev dioksid, magnezijev stearat.
Do not use Orphacol after the expiry date which is stated on the carton and blister after EXP.
Zdravila Orphacol ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
The rational basis for treatment consists of restoration of the bile aciddependent component of bile flow enabling restoration of biliary secretion and biliary elimination of toxic metabolites; inhibition of the production of the toxic bile acid metabolites by negative feedback on cholesterol 7α-hydroxylase, which is the rate-limiting enzyme in bile acid synthesis; and improvement of the patient's nutritional status by correcting intestinal malabsorption of fats and fat-soluble vitamins.
Osnova zdravljenja je obnova sestavnega dela toka žolča, ki je odvisen od žolčne kisline in omogoča obnovitev biliarne sekrecije žolča in biliarnega izločanja toksičnih presnovkov; zaviranje nastajanja toksičnih presnovkov žolčnih kislin z negativno povratno zanko do holesterol-7α-hidroksilaze, ki omejuje sintezo žolčne kisline; in izboljšanje prehranskega statusa bolnika z odpravo intestinalne malabsorpcije maščob in vitaminov, topnih v maščobah.
For infants and children who cannot swallow capsules, the capsules may be opened and the content added to infant formula or infant-adapted apple/orange or apple/apricot juice.
Za dojenčke in otroke, ki ne morejo pogoltniti kapsul, se lahko kapsule odprejo in vsebina doda otroški formuli ali jabolčnemu/pomarančnemu ali jabolčnemu/mareličnemu soku, ki je prilagojen dojenčkom.
Development of gallstones associated with long-term treatment have been reported in very limited number of patients.
Pri zelo majhnem številu bolnikov so v povezavi z dolgotrajnim zdravljenjem poročali o nastanku žolčnih kamnov.
Orphacol is available as hard capsules (capsules) of oblong shape.
Zdravilo Orphacol je na voljo v obliki trdih kapsul podolgovate oblike.
In the absence of treatment, unphysiologic cholestatic and hepatotoxic bile acid metabolites are predominant in the liver, serum and urine.
Brez zdravljenja v jetrih, serumu in urinu prevladujejo nefiziološki holestatski in hepatotoksični presnovki žolčnih kislin.
In patients with inborn deficiency of 3β-Hydroxy-Δ5-C27-steroid oxidoreductase and Δ4-3-Oxosteroid-5β-reductase, the biosynthesis of primary bile acids is reduced or absent.
Pri bolnikih s prirojenim pomanjkanjem 3β-hidroksi-Δ5-C27-steroid-oksidoreduktaze ali Δ4-3-oksosteroid-5β-reduktaze je biosinteza primarnih žolčnih kislin zmanjšana ali odsotna.
Patients with newly diagnosed or a family history of familial hypertriglyceridaemia may have poor absorption of cholic acid from the intestine.
Bolniki z novo diagnozo ali družinsko hipertrigliceridemijo v družinski anamnezi imajo lahko slabo absorpcijo holne kisline iz črevesja.
Ciclosporin alters the pharmacokinetics of cholic acid by inhibition of the hepatic uptake and hepatobiliary secretion of bile acids, as well as its pharmacodynamics by inhibition of cholesterol 7α-hydroxylase.
Ciklosporin spremeni farmakokinetiko holne kisline z zaviranjem jetrnega privzema in hepatobiliarnega izločanja žolčne kisline ter tudi farmakodinamiko z zaviranjem holesterol-7α-hidroksilaze.
The remaining part is transformed by reduction of the 7α-hydroxy group to deoxycholic acid (3α, 12α-dihydroxy) by intestinal bacteria.
Preostali del črevesne bakterije pretvorijo z redukcijo 7α-hidroksi skupine v deoksiholno kislino (3α, 12α-dihidroksi).
Gallstones have been reported after long-term therapy with Orphacol.
Po dolgoročnem zdravljenju z zdravilom Orphacol so opazili žolčne kamne.
Use of phenobarbital in patients with 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency treated with cholic acid is contraindicated (see section 4.3).
Uporaba fenobarbitala pri bolnikih s pomanjkanjem 3β-hidroksi-Δ5-C27-steroid-oksidoreduktaze ali pomanjkanjem Δ4-3-oksosteroid-5β-reduktaze, ki se zdravijo s holno kislino, je kontraindicirana (glejte poglavje 4.3).
Orphacol contains lactose
Zdravilo Orphacol vsebuje laktoza
The objectives of this surveillance programme is to monitor accumulating data on efficacy and safety in the treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency with Orphacol in infants, children, adolescents and adults.
Cilj tega programa spremljanja je spremljanje zbranih podatkov o učinkovitosti in varnosti zdravljenja prirojenih napak sinteze primarnih žolčnih kislin zaradi pomanjkanja 3β-hidroksi-Δ5-C27-steroid-oksidoreduktaze ali pomanjkanja Δ4-3-oksosteroid-5β-reduktaze z zdravilom Orphacol pri dojenčkih, otrocih, mladostnikih in odraslih bolnikih.
The exposed pregnancies showed no adverse reactions to cholic acid and resulted in normal, healthy children.
Izid nosečnosti so bili normalni, zdravi otroci.
- if you are allergic to cholic acid or any of the other ingredients of this medicine (listed in section - if you are taking phenobarbital, a medicine to treat epilepsy.
- če ste alergični na holno kislino ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
Patients with newly diagnosed or a family history of familial hypertriglyceridemia are expected to poorly absorb cholic acid in the intestine.
Pri bolnikih z novo diagnozo ali družinsko hipertrigliceridemijo v družinski anamnezi je pričakovana slaba absorpcija holne kisline v črevesju.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
Oblong, opaque, green and white capsule.
trda kapsula (kapsula) Podolgovate, neprozorne, zeleno-bele kapsule.
The usual starting dose is 5 to 15 mg per kilogram body weight every day in infants, children, adolescents and adults.
Običajen začetni odmerek je od 5 do 15 mg na kilogram telesne mase vsak dan za dojenčke, otroke,
PVC/PVDC-aluminium blister of 10 capsules.
Pretisni omot iz PVC/PVDC in aluminija z 10 kapsulami Velikosti pakiranja: 30, 60, 120.
- The active substance is cholic acid.
- Učinkovina je holna kislina.
Overall, cholic acid treatment results for about 60 patients with 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency are reported in the literature.
Na splošno so v literaturi objavljeni rezultati zdravljenja s holno kislino za približno 60 bolnikov s pomanjkanjem 3β-hidroksi-Δ5-C27-steroid-oksidoreduktaze.
Orphacol 250 mg: Each hard capsule contains 250 mg of cholic acid.
Orphacol 250 mg: Ena trda kapsula vsebuje 250 mg holne kisline.
Some medicines used to lower cholesterol levels, so-called bile acid sequestrants (cholestyramine, colestipol, colesevelam), and medicines to treat heartburn that contain aluminium may lessen the effect of Orphacol.
(holestiramin, kolestipol, holesevelam) in zdravila za zdravljenje zgage, ki vsebujejo aluminij, lahko zmanjšajo učinek zdravila Orphacol.
- PSUR - Annual Reassessment
- letni ponovni pregled
Cholic acid treatment results for seven patients with Δ4-3-Oxosteroid-5β-reductase deficiency for up to 14 years are reported in the literature.
V literaturi so objavljeni rezultati zdravljenja s holno kislino za sedem bolnikov s pomanjkanjem Δ4-3-oksosteroid-5β-reduktaze za obdobje do 14 let.
Cholic acid showed non-significant mutagenic activity in a battery of genotoxicity tests performed in vitro.
V seriji in vitro testov genotoksičnosti holna kislina ni izkazala pomembne mutagene aktivnosti.
Orphacol 50 mg: Each hard capsule contains 50 mg of cholic acid.
Orphacol 50 mg: Ena trda kapsula vsebuje 50 mg holne kisline.
Orphacol 50 mg: gelatin, titanium dioxide (E171), carmine blue (E132);
Orphacol 50 mg: želatina, titanov dioksid (E171), indigotin (E132);
Your doctor will prescribe laboratory tests on your blood, urine and liver for you when you start treatment and regularly thereafter.
Ob začetku zdravljenja, nato pa redno, vam bo zdravnik predpisal laboratorijske preiskave krvi, urina in jeter.
Orphacol is indicated for the treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency in infants, children and adolescents aged 1 month to 18 years and adults.
Zdravilo Orphacol je indicirano za zdravljenje prirojenih napak sinteze primarnih žolčnih kislin zaradi pomanjkanja 3β-hidroksi-Δ5-C27-steroid-oksidoreduktaze ali pomanjkanja Δ4-3-oksosteroid-5β-reduktaze pri dojenčkih, otrocih in mladostnikih, starih od 1 meseca do 18 let, ter pri odraslih.
Pharmacotherapeutic group: Bile and liver therapy, bile acid and derivatives, ATC code: A05AA03
5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Zdravila za bolezni žolča in jeter, žolčne kisline in derivati, oznaka ATC:
Both inborn diseases are extremely rare, with a prevalence in Europe of about 3 to 5 patients with 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency per 10 million inhabitants, and an estimated ten-fold lower prevalence for Δ4-3-Oxosteroid-5β-reductase deficiency.
pogostnost v Evropi je približno od 3 do 5 bolnikov s pomanjkanjem 3β-hidroksi-Δ5-C27-steroid-oksidoreduktaze na 10 milijonov prebivalcev, za pogostnost pomanjkanja Δ4-3-oksosteroid-5β-reduktaze pa se ocenjuje, da je desetkrat manjša.
The development of pruritus and/or diarrhoea has been observed during treatment with Orphacol.
Pri zdravljenju z zdravilom Orphacol so opazili pojav pruritusa in/ali driske.
Gallstones have been reported after long-term therapy.
Po dolgoročnem zdravljenju so opazili žolčne kamne.
Orphacol 250 mg: gelatin, titanium dioxide (E171), carmine blue (E132), yellow iron oxide (E172).
Orphacol 250 mg: želatina, titanov dioksid (E171), indigotin (E132); rumeni železov oksid (E172).
How to store Orphacol
Shranjevanje zdravila Orphacol
3β, 7α, 12α-trihydroxy-5-cholenoic acids) or in Δ4-3-Oxosteroid-5β-reductase deficiency (3-oxo-7α-hydroxy- and 3-oxo-7α, 12α-dihydroxy-4-cholenoic acids) should be determined.
(3β, 7α-dihidroksi- in 3β, 7α, 12α-trihidroksi-5-holenojske kisline) oz. pomanjkanja Δ4-3-oksosteroid-5β-reduktaze (3-okso-7α-hidroksi- in 3-okso-7α, 12α-dihidroksi-4-holenojske kisline).
There is a risk of permanently damaging your liver if you stop taking Orphacol.
Če prenehate jemati zdravilo Orphacol, se pojavi nevarnost trajnih poškodb jeter.
Contents of the pack and other information
Shranjevanje zdravila Orphacol Vsebina pakiranja in dodatne informacije
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
B. ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
Increased liver weight and gallstones have been reported in repeated dose studies in which cholic acid was co-administered with cholesterol.
V študijah s ponavljajočimi se odmerki, kjer so holno kislino dajali skupaj s holesterolom, so ugotovili povečano maso jeter in žolčne kamne.
Gelatin (bovine origin), Titanium dioxide (E171), Carmine blue (E132), Yellow Iron Oxide (E172).
Ovoj kapsule: želatina (govejega izvora), titanov dioksid (E171), indigotin (E132), rumeni železov oksid (E172).
Each hard capsule contains 250 mg of cholic acid.
Ena trda kapsula vsebuje 250 mg holne kisline.
EU/1/13/870/001 [30 hard capsules] EU/1/13/870/002 [60 hard capsules] EU/1/13/870/003 [120 hard capsules]
EU/1/13/870/001 [30 trdih kapsul] EU/1/13/870/002 [60 trdih kapsul] EU/1/13/870/003 [120 trdih kapsul]
Concurrent elevation of serum gamma glutamyltransferase (GGT), alanine aminotransferase (ALT) and/or serum bile acids above normal levels may indicate overdose.
Sočasno zvišanje serumskih vrednosti gama-glutamiltransferaze (GGT), alanin-aminotransferaze
EU/1/13/870/004 [30 hard capsules] EU/1/13/870/005 [60 hard capsules] EU/1/13/870/006 [120 hard capsules]
EU/1/13/870/004 [30 trdih kapsul] EU/1/13/870/005 [60 trdih kapsul] EU/1/13/870/006 [120 trdih kapsul]
Each hard capsule contains 50 mg of cholic acid.
Ena trda kapsula vsebuje 50 mg holne kisline.
Limited data are available for patients with minor to severe hepatic impairment related to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency.
Podatkov o bolnikih z blago do hudo okvaro delovanja jeter v povezavi s pomanjkanjem 3β-hidroksi-Δ5-C27-steroid-oksidoreduktaze ali pomanjkanjem Δ4-3-oksosteroid-5β-reduktaze je malo.
If itching and/or diarrhoea last for more than three days, tell your doctor.
Obvestite svojega zdravnika, če srbenje ali driska ali oboje traja več kot tri dni.
Gelatin (bovine origin), Titanium dioxide (E171), Carmine blue (E132).
Ovoj kapsule: želatina (govejega izvora), titanov dioksid (E171), indigotin (E132).
No experience exists in patients with hepatic impairment from causes other than 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency and no dose recommendation can be given.
Izkušenj pri bolnikih z okvarjenim delovanjem jeter, ki ni posledica pomanjkanja 3β-hidroksi-Δ5-C27-steroid-oksidoreduktaze ali pomanjkanja Δ4-3-oksosteroid-5β-reduktaze ni, zato ni mogoče navesti priporočil za odmerjanje.
Orphacol 50 mg capsules Cholic acid
Orphacol 50 mg kapsule holna kislina
Orphacol 50 mg hard capsules
Orphacol 50 mg trde kapsule
The concentrations of the abnormal bile acid metabolites synthesised in 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency (3β, 7α-dihydroxy- and
Določiti je treba koncentracije nenormalnih presnovkov žolčnih kislin, ki se sintetizirajo pri pomanjkanju 3β-hidroksi-Δ5-C27-steroid-oksidoreduktaze
Orphacol 250 mg capsules Cholic acid
Orphacol 250 mg kapsule holna kislina
Diarrhoea
ZDRAVILOM
Orphacol 250 mg hard capsules
Orphacol 250 mg trde kapsule
The clinical experience reported in the literature is from a patient population with inborn deficiency of 3β-Hydroxy-Δ5-C27-steroid oxidoreductase or Δ4-3-Oxosteroid-5β-reductase that includes principally infants from the age of one month, children and adolescents.
3β-hidroksi-Δ5-C27-steroid-oksidoreduktaze ali Δ4-3-oksosteroid-5β-reduktaze, ki v glavnem zajema dojenčke po enem mesecu starosti, otroke in mladostnike.
Orphacol 50 mg hard capsules Cholic acid
Orphacol 50 mg trde kapsule holna kislina
Regular and fixed times of administration support the patient's or caregiver's compliance.
Skladnost z navodili za jemanje je pri bolnikih oz. negovalcih večja, če je jemanje redno in ob isti uri.
Orphacol 250 mg hard capsules Cholic acid
Orphacol 250 mg trde kapsule holna kislina
E.
DODATEK I
It is very important to continue taking Orphacol during pregnancy.
Če menite, da ste noseči, čim prej opravite nosečnostni test. Zelo pomembno je, da med nosečnostjo nadaljujete z jemanjem zdravila Orphacol.
This summary was last updated in January-2013.
Povzetek je bil nazadnje posodobljen januarja 2013.
The vaccine is given in the neck in the area behind the ear.
Cepivo se daje v vrat v področje za ušesom.
The main measure of effectiveness was the percentage cumulative mortality (overall death rate) of the piglets.
Glavno merilo učinkovitosti je bil odstotek kumulativne smrtnosti (celokupne smrtnosti) pujskov.
The vaccine (or parts of the vaccine) has been studied in several trials in pregnant pigs of various breeds.
Cepivo (ali dele cepiv) so proučevali v več preskušanjih pri brejih svinjah različnih pasem.
Female pigs that have not been vaccinated should be given two injections with an interval of six weeks between them.
Svinje, ki niso bile cepljene, morajo dobiti dve injekciji v šesttedenskem časovnem razmiku.
Enterotoxicosis is a reaction in the intestines to toxins produced by some bacteria.
Enterotoksikoza je črevesna reakcija na toksine, ki jih tvorijo nekatere bakterije.
It is a suspension for injection and contains the active substances F4ab, F4ac, F5, F6, and LT toxoid.
Gre za suspenzijo za injiciranje, ki vsebuje zdravilne učinkovine F4ab, F4ac, F5, F6 in toksoid LT.
It is preferable to vaccinate female pigs during the second half of their pregnancy, but not within two weeks before the expected date of farrowing.
Zaželeno je, da se svinje cepijo v drugi polovici brejosti, toda ne pozneje kot dva tedna pred pričakovano prasitvijo.
Porcilis Porcoli Diluvac Forte is used to immunise against E. coli which have the adhesins (surface components) F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P).
Zdravilo Porcilis Porcoli Diluvac Forte se uporablja za imunizacijo proti sevom bakterije E. coli, ki vsebujejo adhezine (površinske sestavine) F4ab (K88ab), F4ac (K88ac), F5 (K99) ali F6 (987P).
These pigs were given two injections of the vaccine and then the litters of these pigs, as well as litters where the mother had not been vaccinated (controls), were exposed to E. coli containing the adhesins or LT toxin present in the vaccine.
Dali so jim dve injekciji cepiva; legla teh prašičev, prav tako pa tudi legla prašičev, katerih mati ni bila cepljena (kontrolna skupina), so bila izpostavljena bakteriji E. coli, ki je vsebovala adhezine ali toksin LT, prisotne v cepivu.
When the sow is injected, this small exposure helps the pig's immune system to recognise and attack the E. coli bacteria.
Ko svinja prejme injekcijo, ta majhna izpostavitev pripomore, da njen imunski sistem prepozna in napade bakterijo E. coli.
There may be redness and/or a swelling at the injection site, for up to 2 weeks after vaccination.
Na mestu injiciranja se lahko pojavi rdečina in/ali oteklina, ki traja do dva tedna po cepljenju.
When exposed to any of these bacteria later in life, the pig will either not become infected or have a much less serious infection.
Če bo pozneje izpostavljena tem sevom, se ne bo okužila oziroma bo okužba bistveno blažja.
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Porcilis Porcoli Diluvac Forte, to reduce death and clinical signs of enterotoxicosis caused by E. coli bacteria, are greater than any risks.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Porcilis Porcoli Diluvac Forte pri zmanjševanju smrtnosti in kliničnih znakov enterotoksikoze, ki jo povzroča bakterija E. coli, večje od katerih koli tveganj.
To maintain the immunity, a single injection should be given before each subsequent farrowing (giving birth to the piglets).
Za vzdrževanje imunosti je potrebna ena injekcija pred vsako naslednjo prasitvijo (kotitvijo pujskov).
The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis Porcoli Diluvac Forte to Intervet International B.V. on 2 May 2002.
Evropska komisija je dovoljenje za promet z zdravilom Porcilis Porcoli Diluvac Forte, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B.V.
The Package Leaflet should be taken to the doctor.
Zdravniku je treba pokazati navodilo za uporabo.
The benefit-risk balance may be found in module 6 of this EPAR.
Priporočil je, da se zanj odobri dovoljenje za promet Razmerje med koristmi in tveganji je na voljo v modulu 6 tega evropskega javnega poročila o oceni zdravila (EPAR).
Porcilis Porcoli Diluvac Forte contains adhesins that are found on the surface of E. coli bacteria.
Zdravilo Porcilis Porcoli Diluvac Forte vsebuje adhezine, ki se nahajajo na površini bakterije E. coli.
Other information about Porcilis Porcoli Diluvac Forte:
Druge informacije o zdravilu Porcilis Porcoli Diluvac Forte:
Porcilis Porcoli Diluvac Forte is a vaccine for use in pigs.
Zdravilo Porcilis Porcoli Diluvac Forte je cepivo, ki se uporablja pri prašičih.
Porcilis Porcoli Diluvac Forte is given as a dose of 2 ml by intramuscular (into a muscle) injection to female pigs.
Zdravilo Porcilis Porcoli Diluvac Forte se daje svinjam v odmerku 2 ml z intramuskularno injekcijo (v mišico).