natgillin/translations-raw huggingface dataset:
EU/1/15/1044/007 (25 modified-release hard capsules) EU/1/15/1044/008 (100 modified-release hard capsules) EU/1/15/1044/009 (240 modified-release hard capsules) 
EU/1/15/1044/007 (25 trdih kapsul s prirejenim sproščanjem) EU/1/15/1044/008 (100 trdih kapsul s prirejenim sproščanjem) EU/1/15/1044/009 (240 trdih kapsul s prirejenim sproščanjem)
Povidone 
Glavkom
Levodopa/Carbidopa 
Levodope (ng/ml)
EU/1/15/1044/004 (25 modified-release hard capsules) EU/1/15/1044/005 (100 modified-release hard capsules) EU/1/15/1044/006 (240 modified-release hard capsules) 
EU/1/15/1044/004 (25 trdih kapsul s prirejenim sproščanjem) EU/1/15/1044/005 (100 trdih kapsul s prirejenim sproščanjem) EU/1/15/1044/006 (240 trdih kapsul s prirejenim sproščanjem)
Sporadic cases of a symptom complex resembling neuroleptic malignant syndrome (NMS) have been associated with dose reductions and withdrawal of levodopa/carbidopa containing medicinal products. 
Z zmanjšanjem odmerka in odtegnitvijo zdravil, ki vsebujejo levodopo/karbidopo, so povezani sporadični primeri kompleksa simptomov, podobnega nevroleptičnemu malignemu sindromu (NMS).
EU/1/15/1044/001 (25 modified-release hard capsules) EU/1/15/1044/002 (100 modified-release hard capsules) EU/1/15/1044/003 (240 modified-release hard capsules) 
EU/1/15/1044/001 (25 trdih kapsul s prirejenim sproščanjem) EU/1/15/1044/002 (100 trdih kapsul s prirejenim sproščanjem) EU/1/15/1044/003 (240 trdih kapsul s prirejenim sproščanjem)
N entered N in conversion N randomised N completed 
N bolnikov, ki so vstopili v študijo N bolnikov, pri katerih so zamenjali zdravljenje
Dyskinesias 
Odmerjanje
Baseline, mean Change at endpoint Difference (95% CI) p-value 
Opazovani dogodek, povprečje Razlika (95-odstotni IZ)
Each 245 mg/61.25 mg modified-release hard capsule contains 245 mg levodopa and 61.25 mg carbidopa (as monohydrate) 
Ena kapsula vsebuje 245 mg levodope in 61,25 mg karbidope (v obliki monohidrata).
Dystonia, on and off phenomenon, dyskinesia, somnolence, gait disturbance, dizziness, worsening of Parkinson's disease, paraesthesia, headache, tremor 
Bolezni živčevja distonija, fenomen »vklop/izklop«, diskinezija, somnolenca, motnje pri hoji, omotica, poslabšanje Parkinsonove bolezni, parestezija, glavobol, tremor konvulzije, nenaden nastop spanca (glejte poglavje 4.4), trizmus, sindrom nemirnih nog nevroleptični maligni sindrom (glejte poglavji 4.3 in 4.4), ataksija
Contents of the pack and other information What Numient contains 
Shranjevanje zdravila Numient Vsebina pakiranja in dodatne informacije
Outcomes Study arms 
Skupine v študiji
Psychotic episode, impulse control disorder (see section 4.4), agitation 
alergijski edem, pruritus (glejte poglavje 4.3)
Each 145 mg/36.25 mg modified-release hard capsule contains 145 mg levodopa and 36.25 mg carbidopa (as monohydrate) 
Ena kapsula vsebuje 145 mg levodope in 36,25 mg karbidope (v obliki monohidrata).
It is taken as one tablet twice a day with meals. 
Zdravilo se jemlje kot ena tableta zdravila dvakrat na dan s hrano.
It must not be used in women who are breastfeeding. 
Ne smejo ga uporabljati ženske, ki dojijo.
The European Commission granted a marketing authorisation valid throughout the European Union for Komboglyze on 24 November 2011. 
Evropska komisija je dovoljenje za promet z zdravilom Komboglyze, veljavno po vsej Evropski uniji, izdala 24. novembra 2011.
What measures are being taken to ensure the safe and effective use of Komboglyze? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Komboglyze?
The full EPAR for Komboglyze 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 Komboglyze je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Saxagliptin is a dipeptidyl peptidase 4 (DPP4) inhibitor. 
Saksagliptin je zaviralec dipeptidil-peptidaze 4 (DPP4).
This is a summary of the European public assessment report (EPAR) for Komboglyze. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Komboglyze.
Komboglyze is available as tablets (2.5 mg/850 mg and 2.5 mg/1,000 mg) and can only be obtained with a prescription. 
Zdravilo Komboglyze je na voljo v obliki tablet (2,5 mg/850 mg in 2,5 mg/1.000 mg), predpisovanje in izdaja je le na recept.
Saxagliptin has been authorised in the EU as Onglyza since 2009. 
Saksagliptin je v EU odobren od leta 2009 kot zdravilo Onglyza.
Other information about Komboglyze 
Druge informacije o zdravilu Komboglyze
The European Medicines Agency therefore concluded that the benefits of Komboglyze outweigh its risks and recommended that it be given marketing authorisation. 
Evropska agencija za zdravila je zato zaključila, da koristi zdravila Komboglyze odtehtajo z njim povezana tveganja, in priporočila, da se zanj izda dovoljenje za promet.
EPAR summary for the public saxagliptin / metformin 
Povzetek EPAR za javnost saksagliptin/metformin
It is not intended to provide practical advice on how to use Komboglyze. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What benefits of Komboglyze have been shown in studies? 
Kakšne koristi je zdravilo Komboglyze izkazalo v študijah?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Komboglyze have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Komboglyze upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
In all the studies the main measure of effectiveness was the reduction in blood levels of a substance called glycosylated haemoglobin (HbA1c) after 24 weeks of treatment. 
V vseh študijah je bilo glavno merilo učinkovitosti znižanje koncentracije snovi, imenovane glikozilirani hemoglobin (HbA1c), v krvi po 24 tednih zdravljenja.
It must not be used in patients with diabetic ketoacidosis or diabetic pre-coma (a dangerous condition that can occur in diabetes), patients with moderately to severely reduced kidney function or with acute (sudden) conditions which can affect kidney function, patients with diseases which can deprive tissue of oxygen such as heart failure or difficulty breathing, patients with reduced liver function, alcohol poisoning or alcoholism. 
Ne smejo ga uporabljati bolniki z diabetično ketoacidozo ali diabetično predkomo (nevarnim stanjem, ki se lahko pojavi pri sladkorni bolezni), bolniki z zmerno do hudo zmanjšanim delovanjem ledvic ali z akutnimi (nenadnimi) boleznimi, ki prizadenejo delovanje ledvic, bolniki z boleznimi, ki lahko povzročijo zmanjšano oskrbo tkiv s kisikom, kot je srčno popuščanje ali težave z dihanjem, bolniki z zmanjšanim delovanjem jeter ali alkoholno zastrupitvijo ter alkoholiki.
What is Komboglyze and what is it used for? 
Kaj je zdravilo Komboglyze in za kaj se uporablja?
For more information about treatment with Komboglyze, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Komboglyze preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
• in patients already being treated with saxagliptin and metformin as separate tablets; 
• pri bolnikih, ki se že zdravijo s saksagliptinom in metforminom v obliki ločenih tablet;
Komboglyze has been shown to help reduce blood glucose levels and it does not cause any unexpected side effects. 
Za zdravilo Komboglyze je dokazano, da pripomore k zniževanju ravni glukoze v krvi in ne povzroča nepričakovanih neželenih učinkov.
The strength of tablet to use depends on the dose of the other diabetes medicines that the patient was taking and the patient's kidney function. 
Jakost tablete, ki jo je treba uporabiti, je odvisna od odmerka drugih zdravil za zdravljenje sladkorne bolezni, ki jih je bolnik jemal prej, in od njegove ledvične funkcije.
Patients not adequately controlled on metformin alone who start taking Komboglyze should continue to receive the same dose of metformin as they were taking. 
Bolniki, pri katerih se raven glukoze ne uravnava zadostno samo z metforminom in ki začnejo jemati zdravilo Komboglyze, naj še naprej jemljejo enak odmerek metformina kot pred tem.
Komboglyze must not be used in patients who are hypersensitive (allergic) to saxagliptin and metformin or any of the other ingredients, or who have ever had a serious allergic reaction to any DPP4 inhibitor. 
Zdravila Komboglyze ne smejo uporabljati bolniki, ki so preobčutljivi za (alergični na) saksagliptin in metformin ali katero koli drugo sestavino zdravila ali pri katerih se je v preteklosti pojavila huda alergijska reakcija na zaviralec DPP-4.
What is the risk associated with Komboglyze? 
Kakšna tveganja so povezana z zdravilom Komboglyze?
Why has Komboglyze been approved? 
Zakaj je bilo zdravilo Komboglyze odobreno?
The most common side effects seen with saxagliptin used together with metformin (seen in between 1 and 10 patients in 100) are upper respiratory infection (nose and throat infection), urinary tract infection (infection of the structures that carry urine such as the bladder), gastroenteritis (diarrhoea and vomiting), sinusitis (inflammation of the sinuses), nasopharyngitis (inflammation of the nose and throat), headache and vomiting. 
Najpogostejši neželeni učinki saksagliptina, ki se uporablja skupaj z metforminom (opaženi pri 1 do 10 bolnikih od 100), so okužbe zgornjih dihal (okužbe nosu in žrela), okužbe sečil (okužbe struktur za odvajanje seča, kot je mehur), gastroenteritis (driska in bruhanje), sinuzitis (vnetje sinusov), nazofaringitis (vnetje nosu in žrela), glavobol in bruhanje.
For practical information about using Komboglyze, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Komboglyze naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
• One study examined the effects of saxagliptin added to metformin in 160 patients. 
• V eni študiji so preučili učinke dodatka saksagliptina metforminu pri 160 bolnikih.
For the full list of all side effects reported with saxagliptin and metformin, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi saksagliptina in metformina, glejte navodilo za uporabo.
Saxagliptin does not work when the blood glucose is low. 
Saksagliptin ne učinkuje, kadar je raven glukoze v krvi nizka.
• in patients whose blood glucose levels are not adequately controlled by metformin alone; 
• pri bolnikih, pri katerih se raven glukoze v krvi ne uravnava zadostno samo z metforminom;
Results showed that adding saxagliptin to metformin was effective in lowering HbA1c levels. 
Rezultati so pokazali, da je dodatek saksagliptina učinkovito znižal ravni HbA1c.
The active substance metformin works mainly by blocking glucose production and reducing its absorption in the gut. 
Zdravilna učinkovina metformin deluje predvsem tako, da zavira tvorjenje glukoze in zmanjšuje njeno absorpcijo v črevesju.
Several studies in patients with type 2 diabetes have shown that the combination of the active substances in Komboglyze, saxagliptin and metformin, is effective in lowering patients' blood glucose. 
Več študij pri bolnikih s sladkorno boleznijo tipa 2 je pokazalo, da je kombinacija zdravilnih učinkovin v zdravilu Komboglyze, saksagliptina in metformina, učinkovita pri zniževanju ravni glukoze v krvi bolnikov.
• Another five studies looked at the effects of saxagliptin alone or in combination with metformin, compared either with placebo or another diabetes medicine (a sulphonylurea or sitagliptin) in over 4,000 patients. 
• V drugih petih študijah so proučili učinke saksagliptina samega ali v kombinaciji z metforminom v primerjavi s placebom ali drugim zdravilom za sladkorno bolezen (sulfonilsečnino ali sitagliptinom) pri več kot 4000 bolnikih.
By increasing levels of incretin hormones in the blood, saxagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. 
Saksagliptin s povečanjem ravni inkretinskih hormonov v krvi spodbudi trebušno slinavko k tvorjenju večjih količin insulina, kadar so ravni glukoze v krvi visoke.
Komboglyze is a diabetes medicine used with diet and exercise to treat adults with type 2 diabetes to improve control of blood glucose (sugar) levels. 
Komboglyze je zdravilo za zdravljenje sladkorne bolezni, ki se kot dodatek k dieti in telesni vadbi uporablja za zdravljenje odraslih s sladkorno boleznijo tipa 2 za izboljšanje uravnavanja ravni glukoze (sladkorja) v krvi.
If Komboglyze is taken with a sulphonylurea (medicines that make the body produce insulin) or insulin, the dose of these medicines may need to be lowered, to avoid hypoglycaemia (low blood sugar levels). 
(zdravilom, ki spodbudi telo k tvorbi insulina) ali insulinom, bo morda treba znižati odmerek teh zdravil, da bi preprečili hipoglikemijo (nizko raven sladkorja v krvi).
Komboglyze contains the active substances saxagliptin and metformin. 
Zdravilo Komboglyze vsebuje zdravilni učinkovini saksagliptin in metformin.
This gives an indication of how well the blood glucose is controlled. 
To je pokazatelj, kako dobro je raven glukoze v krvi uravnana.
• A study in 257 patients compared saxagliptin with placebo when added to metformin and a sulphonylurea. 
• V študiji z 257 bolniki so primerjali saksagliptin in placebo ob dodatku metformina in sulfonilsečnine.
How is Komboglyze used? 
Kako se zdravilo Komboglyze uporablja?
The active substances in Komboglyze, saxagliptin and metformin, work in a different way to help reduce blood glucose levels and control type 2 diabetes. 
Zdravilni učinkovini v zdravilu Komboglyze, saksagliptin in metformin, imata različen način delovanja, s katerim vplivata na zniževanje ravni glukoze v krvi in urejanje sladkorne bolezni tipa 2.
• A study in 455 patients compared saxagliptin with placebo when added to insulin, with or without metformin. 
• V študiji pri 455 bolnikih so primerjali saksagliptin in placebo ob dodatku insulina v kombinaciji z metforminom ali brez njega.
HbA1c levels fell by around 0.7 percentage points in patients adding saxagliptin, compared with a fall of around 0.3 percentage points in patients who added placebo. 
Ravni HbA1c so se znižale za okoli 0,7 odstotne točke pri bolnikih, ki so jemali saksagliptin, v primerjavi z znižanjem za okoli 0,3 odstotne točke pri bolnikih, ki so jemali placebo.
Results showed that in patients taking saxagliptin with metformin HbA1c levels fell by around 0.6 percentage points, compared with a fall of 0.2 percentage points in patients taking placebo (a dummy treatment) with metformin. 
Rezultati so pokazali, da so pri bolnikih, ki so jemali saksagliptin in metformin, koncentracije HbA1c upadle za približno 0,6 odstotnih točk v primerjavi z 0,2 odstotnima točkama pri bolnikih, ki so jemali placebo (zdravilo brez zdravilne učinkovine) in metformin.
How does Komboglyze work? 
Kako zdravilo Komboglyze deluje?
• A study in 534 patients whose blood glucose levels were not satisfactorily controlled with metformin alone showed that when saxagliptin and dapagliflozin were taken together with metformin, they decreased HbA1c levels by 1.5 percentage points, compared with a reduction of 0.9 percentage points with saxagliptin and metformin and 1.2 percentage points with dapagliflozin and metformin. 
• Rezultati študije pri 534 bolnikih, pri katerih ravni glukoze v krvi niso bile zadovoljivo uravnane samo z metforminom, so pokazali, da se je raven HbA1c ob hkratnem jemanju saksagliptina in dapagliflozina z metforminom znižala za 1,5 odstotne točke, v primerjavi z znižanjem za 0,9 odstotne točke pri jemanju saksagliptina in metformina ter za 1,2 odstotne točke pri jemanju dapagliflozina in metformina.
• A study in 315 patients whose blood glucose levels were not satisfactorily controlled with metformin and dapagliflozin showed that adding saxagliptin to dapagliflozin and metformin reduced HbA1c levels by 0.5 percentage points, compared with a reduction of 0.2 percentage points when placebo was added to treatment with dapagliflozin and metformin. 
• Rezultati študije pri 315 bolnikih, pri katerih ravni glukoze v krvi niso bile zadovoljivo uravnane z metforminom in dapagliflozinom, so pokazali, da se je raven HbA1c ob dodajanju saksagliptina zdravljenju z dapagliflozinom in metforminom znižala za 0,5 odstotne točke v primerjavi z znižanjem za 0,2 odstotne točke, ko so zdravljenju s dapagliflozinom in metforminom dodajali placebo.
A reduction of 0.7 percentage points was seen in patients who received saxagliptin, metformin and a sulphonylurea compared with a reduction of 0.1 percentage points in patients who received placebo in place of saxagliptin. 
Ravni HbA1c so se znižale za okoli 0,7 odstotne točke pri bolnikih, ki so jemali saksagliptin, metformin in sulfonilsečnino, v primerjavi z znižanjem za okoli 0,1 odstotne točke pri bolnikih, ki so namesto saksagliptina jemali placebo.
• A study in 320 patients not controlled with metformin and saxagliptin, showed that adding dapagliflozin to treatment with saxagliptin and metformin reduced HbA1c levels by 0.8 percentage points, compared with a reduction of 0.1 percentage points when placebo was added to saxagliptin and metformin. 
• V študiji pri 320 bolnikih, pri katerih bolezen z metforminom in saksagliptinom ni bila uravnana, so ugotovili, da se je po dodajanju dapagliflozina zdravljenju s saksagliptinom in metforminom raven HbA1c znižala za 0,8 odstotne točke v primerjavi z znižanjem za 0,1 odstotne točke, ko so zdravljenju s saksagliptinom in metforminom dodajali placebo.
• in combination with other diabetes medicines, including insulin, in patients whose blood glucose is not adequately controlled by these medicines and metformin. 
• v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni, vključno z insulinom, pri bolnikih,
4.6 Adverse reactions (frequency and seriousness) 
4.6 Stranski učinki (pogostnost in resnost)
ATC vet code: QI09AB02. 
Oznaka ATCvet: QI09AB02.
- Shake well before use. 
− Pred uporabo dobro pretresite.
Pharmacotherapeutic group: inactivated bacterial vaccine. 
Farmakoterapevtska skupina: inaktivirano bakterijsko cepivo.
Do not mix with any other vaccine or immunological product. 
Ne mešajte z nobenim drugim cepivom ali imunoloških izdelkom.
It is therefore recommended that no other vaccine should be administered within 14 days before or after vaccination with this product. 
Zato odsvetujemo uporabo katerega koli cepiva v obdobju 14 dni pred ali po cepljenju s tem izdelkom.
Swelling and redness at the injection site may occasionally last for at least 14 days. 
Oteklina in rdečina na mestu injekcije lahko včasih trajata najmanj 14 dni.
QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of two ml: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA V odmerku po dva ml:
SPECIAL WARNING(S), IF NECESSARY Accidental injection is dangerous. 
POSEBNA OPOZORILA, ČE SO POTREBNA Nenamerno injiciranje je nevarno.
For a full list of excipients, see section 6.1. 
150 mg Celoten seznam pomožnih snovi, glej razdelek 6.1.
10 DATE OF REVISION OF THE TEXT {MM/YYYY} or <month YYYY> 
DATUM REVIZIJE BESEDILA {MM/LLLL} ali <mesec LLLL>
Animal Species 
Živalska vrsta
PHARMACEUTICAL FORM Suspension for injection. 
FARMACEVTSKA OBLIKA Suspenzija za injiciranje
D. STATEMENT OF THE MRLs Annex II of Council Regulation (EEC) No 2377/90 
D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Dodatek II Uredbe Sveta (EGS) No 2377/90
Store in a refrigerator (+2°C to +8°C). 
Shranjujte v hladilniku (+2 °C do +8 °C).
Basic vaccination: Sows/gilts which have not yet been vaccinated with the product shall be given an injection preferably 6 to 8 weeks before the expected date of farrowing followed by a second injection 4 weeks later. 
Osnovno cepljenje: svinjam in mladicam, ki z izdelkom še niso bile cepljene, je najbolje dati prvi odmerek 6 do 8 tednov pred pričakovano prasitvijo in drugi odmerek 4 tedne pozneje.
In the absence of incompatibility studies this vaccine must not be mixed with other veterinary medical products. 
Ker ni študij inkompatibilnosti, cepiva ne smete mešati z drugimi zdravili za uporabo v veterinarski medicini.
The diameter of the swelling is in general below 5 cm, but in some cases a larger swelling may occur. 
Premer otekline je večinoma manjši kot 5 cm, v nekaterih primerih pa je oteklina lahko večja.
- Before using the vaccine allow it to reach room temperature. 
− Pred uporabo počakajte, da se cepivo ogreje na sobno temperaturo.
- LT toxoid 
toksoid LT
No information is available on the safety and efficacy from concurrent use of this vaccine with any other. 
Ni podatkov o varnosti ter učinkovitosti ob sočasni uporabi tega cepiva s katerim koli drugim cepivom.
Name and address of the manufacturer of the biological active substances 
Ime in naslov izdelovalca bioloških zdravilnih učinkovin:
These immunogens are incorporated in an adjuvant in order to enhance a prolonged stimulation of immunity. 
Imunogeni so vgrajeni v adjuvans, kar podaljša stimulativni učinek na razvoj imunosti.
5830 AA Boxmeer, The Netherlands. 
5830 AA Boxmeer Nizozemska
4.5 Special precautions for use 
4.5 Posebni previdnostni ukrepi za uporabo
- Use sterile syringes and needles. 
− Uporabite sterilne brizge in igle.
Shelf-life after first opening: 3 hours. 
Rok uporabnosti po prvem odpiranju: 3 ure
Reduced feed intake and listlessness may occur in approximately 10% of the animals on the day of vaccination, but returns to normal within 1-3 days. 
Na dan cepljenja se lahko pojavita zmanjšan tek in ravnodušnost pri 10 do 20 % živali, kar se normalizira v 1-3 dneh.
Intramuscular injection in sows/gilts of 2 ml of the vaccine per animal in the neck in the area behind the ear. 
Intramuskularno svinjam in mladicam po 2 ml cepiva za eno žival v vrat v predel za ušesom.
Revaccination: A single revaccination shall be carried out during the second half of each subsequent pregnancy, preferably 2 to 4 weeks before the expected date of farrowing. 
Revakcinacija: en odmerek v drugi polovici vsake naslednje brejosti, najbolje 2 do 4 tedne pred pričakovano prasitvijo.
OJ No L290 of 5.12.95 g OJ No L290 of 5.12.95 
f OJ št. L290 z dne 5.12.95 g OJ št. L290 z dne 5.12.95
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S) 
NAVEDBA ZDRAVILNE UČINKOVIN(E) IN DRUGE(IH) SESTAVIN(E)
Before using the vaccine allow it to reach room temperature (15-25 °C) and shake well before use. 
Posebni previdnostni ukrepi za uporabo pri živalih Pred uporabo počakajte, da se cepivo ogreje na sobno temperaturo (15-25 ºC) in ga dobro pretresite.
DATE OF RENEWAL OF THE AUTHORISATION 
DATUM PODALJŠANJA DOVOLJENJA ZA PROMET
Each dose of two ml contains the F4ab (K88ab) fimbrial adhesin, the F4ac (K88ac) fimbrial adhesin, the F5 (K99) fimbrial adhesin, the F6 (987P) fimbrial adhesin and of LT toxoid, which induce a mean antibody titre of respectively ≥ 9.0 log2 Ab titre, ≥ 5.4 log2 Ab titre, ≥ 6.8 log2 Ab titre, ≥ 7.1 log2 Ab titre, and 6.8 log2 Ab titre after vaccination of mice with a 1/20 sow dose. 
En odmerek po dva ml vsebuje fimbrijski adhezin F4ab (K88ab), fimbrijski adhezin F4ac (K88ac), fimbrijski adhezin F5 (K99), fimbrijski adhezin F6 (987P) in toksoid LT, ki spodbudijo srednji titer protiteles ≥ 9,0 log2 titra protiteles, ≥ 5,4 log2 titra protiteles, ≥ 6,8 log2 titra protiteles, ≥ 7,1 log2 titra protiteles in 6,8 log2 titra protiteles po cepljenju miši z 1/20 odmerka za svinje.
- Vaccinate only healthy animals. 
− Cepite samo zdrave živali.
A transient swelling and redness at the injection site may be observed in approximately 5% of the animals. 
Pri približno 5 % živali se lahko na mestu injiciranja pojavita prehodna oteklina in rdečina.
In the case of accidental self-injection, seek medical advice immediately and show the package insert or label to the physician. 
V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.