natgillin/translations-raw huggingface dataset:
A grade 3 decrease in serum calcium levels was experienced in 2.5% of patients treated with XGEVA and 1.2% of patients treated with zoledronic acid. 
Znižanje koncentracije kalcija v serumu 3. stopnje se je pojavilo pri 2,5 % bolnikov, zdravljenih z zdravilom XGEVA, in pri 1,2 % bolnikov, zdravljenih z zoledronsko kislino.
In phase II clinical studies of patients with advanced malignancies involving bone, subcutaneous (SC) dosing of XGEVA administered either every 4 weeks (Q4W) or every 12 weeks resulted in a rapid reduction in markers of bone resorption (uNTx/Cr, serum CTx), with median reductions of approximately 80% for uNTx/Cr occurring within 1 week regardless of prior bisphosphonate therapy or baseline uNTx/Cr level. 
faze pri bolnikih z napredovalimi malignomi, ki so zajeli kosti, je subkutana (s.c.) uporaba zdravila XGEVA, aplicirana bodisi na 4 tedne bodisi na 12 tednov, povzročila hitro znižanje označevalcev resorpcije kosti (uNTx/kreatinin, serumski CTx).
Cases of osteonecrosis of the jaw (see sections 4.4 and section 4.8 - description of selected adverse reactions) have been commonly observed in patients taking XGEVA. 
Pri bolnikih, ki prejemajo zdravilo XGEVA, so pogosto opazili primere osteonekroze čeljustnice (glejte poglavje 4.4 in poglavje 4.8 - Opis izbranih neželenih učinkov).
Your doctor will then help you decide whether to stop breast-feeding or whether to stop taking XGEVA, considering the benefit of breast-feeding to the baby and the benefit of XGEVA to the mother. 
Na podlagi upoštevanja koristi dojenja za otroka in koristi zdravljenja z zdravilom XGEVA za mater vam bo zdravnik pomagal pri odločitvi, ali prenehati z dojenjem ali prenehati z jemanjem zdravila XGEVA.
The decreases in serum calcium were generally appropriately managed by calcium and vitamin D supplementation. 
Znižanje kalcija v serumu so na splošno ustrezno odpravili z dodatki kalcija in vitamina D. Najbolj pogosti neželeni učinki zdravila XGEVA so mišično-skeletne bolečine.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 120 mg of denosumab in 1.7 mL of solution (70 mg/mL). 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 120 mg denosumaba v 1,7 ml raztopine (70 mg/ml).
XGEVA contains sodium 
Zdravilo XGEVA vsebuje natrij
ONJ has been reported commonly in patients receiving XGEVA (see section 4.8). 
Pri bolnikih, zdravljenih z zdravilom XGEVA, so o osteonekrozi čeljustnice poročali pogosto (glejte poglavje 4.8).
In studies 1, 2 and 3, overall survival was balanced between XGEVA and zoledronic acid in patients with advanced malignancies involving bone: patients with breast cancer (hazard ratio and 95% CI was 0.95 [0.81, 1.11]), patients with prostate cancer (hazard ratio and 95% CI was 1.03 [0.91, 1.17]), and patients with other solid tumours or multiple myeloma (hazard ratio and 95% CI was 0.95 [0.83, 1.08]). 
(razmerje ogroženosti in 95 % IZ 0,95 [0,81, 1,11]), bolniki z rakom prostate (razmerje ogroženosti in 95 % IZ 1,03 [0,91, 1,17]) in bolniki z drugimi solidnimi tumorji ali diseminiranim plazmocitomom (razmerje ogroženosti in 95 % IZ 0,95 [0,83, 1,08]).
N = Number of subjects randomised * = Statistically significant for superiority; ** = Statistically significant for non-inferiority 
ZA = Zoledronska kislina 4 mg na 4 tedne N = Število randomiziranih preiskovancev * = Statistično značilno za superiornostf; ** = Statistično značilno za neinferiornost
Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh. 
Če se vam pojavi nova ali neobičajna bolečina v kolku, dimljah ali stegnu, se posvetujte z zdravnikom.
Hypocalcaemia1, 2 
Presnovne in prehranske motnje zelo pogosti hipokalciemija1, 2
• persistent pain in the mouth and/or jaw, and/or swelling or non-healing of sores in the mouth or jaw, discharge, numbness or feeling of heaviness in the jaw, or loosening of a tooth could be signs of bone damage in the jaw (osteonecrosis). 
• trajna bolečina v ustih in/ali čeljustnici, in/ali oteklost ali neceljenje razjed v ustih ali čeljustnici,
Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing the RANKL/RANK interaction from occurring and resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction. 
Tako prepreči pojav interakcije RANKL/RANK ter zmanjša število in delovanje osteoklastov, s čimer zmanjša resorpcijo kosti in z rakom povzročeno razgradnjo kosti.
Patients with prior history of ONJ or osteomyelitis of the jaw, an active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, or any planned invasive dental procedure, were not eligible for inclusion in these studies. 
Za vključitev v te študije niso bili primerni bolniki s predhodno anamnezo osteonekroze čeljustnice ali osteomielitisa čeljustnice, aktivno zobno ali čeljustno boleznijo, ki je zahtevala kirurški poseg v ustih, nezaceljenim stanjem po zobnem/ustnem kirurškem posegu ali katerim koli načrtovanim invazivnim zobozdravstvenim posegom.
First radiation to bone Median time (months) 
Vrednosti p za superiornost Prvo obsevanje kosti Mediana čas (meseci)
The start of treatment/new treatment course should be delayed in patients with unhealed open soft tissue lesions in the mouth. 
Pri bolnikih, ki imajo nezaceljene lezije mehkih tkiv v ustih, je treba začetek zdravljenja/nov ciklus zdravljenja odložiti.
Clinically significant hypercalcaemia requiring hospitalisation and complicated by acute renal injury has been reported in XGEVA-treated patients with giant cell tumour of bone weeks to months following treatment discontinuation. 
Pri bolnikih z gigantocelularnim kostnim tumorjem, ki so bili zdravljeni z zdravilom XGEVA, so še tedne do mesece po prenehanju zdravljenja poročali o klinično pomembni hiperkalciemiji, pri kateri je bilo potrebno bolnišnično zdravljenje in se je zapletla z akutno okvaro ledvic.
Rare side effects (may affect up to 1 in 1,000 people): 
Redki neželeni učinki (lahko se pojavijo pri največ 1 od 1.000 bolnikov)
Hypercalcaemia following treatment discontinuation in patients with giant cell tumour of bone3 
pogosti hipofosfatemija občasni hiperkalciemija po prenehanju zdravljenja pri bolnikih z gigantocelularnim kostnim tumorjem3
A grade 3 decrease in serum calcium levels was experienced in 1.4% of patients treated with XGEVA and 0.6% of patients treated with zoledronic acid. 
Znižanje koncentracije kalcija v serumu 3. stopnje se je pojavilo pri 1,4 % bolnikov, zdravljenih z zdravilom XGEVA, in pri 0,6 % bolnikov, zdravljenih z zoledronsko kislino.
• To avoid discomfort at the site of injection, allow the vial to reach room temperature (up to 
• Za preprečitev nelagodja na mestu dajanja je treba zagotoviti, da viala pred injiciranjem doseže sobno temperaturo (do 25 °C), zdravilo pa je treba injicirati počasi.
A grade 4 decrease in serum calcium levels was experienced in 0.4% of patients treated with XGEVA and 0.1% of patients treated with zoledronic acid. 
Znižanje koncentracije kalcija v serumu 4. stopnje se je pojavilo pri 0,4 % bolnikov, zdravljenih z zdravilom XGEVA, in pri 0,1 % bolnikov, zdravljenih z zoledronsko kislino.
- If you get any side effects, talk to your doctor, pharmacist or nurse. 
- Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/703/001 1 single use vial EU/1/11/703/002 4 single use vials EU/1/11/703/003 3 single use vials 
EU/1/11/703/002 - 4 viale za enkratno uporabo
The patient-year adjusted incidence of ONJ was 0.2% during the first year of treatment and 1.7% in the second year. 
Incidenca osteonekroze čeljustnice, korigirana za bolnik-leta, je bila prvo leto zdravljenja 0,2 % in drugo leto
Efficacy results in patients with advanced malignancies involving bone Study 1 breast cancer 
Rezultati učinkovitosti pri bolnikih z napredovanimi malignomi, ki so zajeli kosti
• shortness of breath, 
• kratka sapa,
A higher incidence of hypocalcaemia among subjects treated with denosumab compared to zoledronic acid has been observed in SRE prevention clinical trials. 
V kliničnih preskušanjih preprečevanja skeletnih dogodkov so opažali večjo pojavnost hipokalciemije med bolniki, zdravljenimi z denosumabom, kot med bolniki, zdravljenimi z zoledronsko kislino.
XGEVA is not recommended for use if you are pregnant. 
Če ste noseči, uporaba zdravila XGEVA ni priporočljiva.
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti mišično-skeletna bolečina1
XGEVA is also used to treat giant cell tumour of bone, which cannot be treated by surgery or where surgery is not the best option, in adults and adolescents whose bones have stopped growing. 
Pri odraslih in pri mladostnikih, pri katerih se je kostna rast končala, se zdravilo XGEVA uporablja tudi za zdravljenje gigantocelularnega kostnega tumorja, ki ga ni mogoče zdraviti z operacijo, ali če operacija ni najboljša možnost.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.7 mL 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
Accompanying increases in parathyroid hormone have also been observed in patients receiving XGEVA with severe renal impairment or receiving dialysis. 
Pri bolnikih, ki so dobivali zdravilo XGEVA in so imeli hudo okvaro ledvic ali so bili na dializi, so opažali tudi spremljajoče zvišanje paratiroidnega hormona.
Your doctor will monitor you for signs and symptoms of high levels of calcium, after you stop receiving XGEVA. 
Ko boste zdravilo XGEVA prenehali jemati, vas bo vaš zdravnik spremljal glede pojava znakov in simptomov visokih ravni kalcija.
Drug hypersensitivity1 
Bolezni imunskega sistema redki preobčutljivost na zdravilo1
- The active substance is denosumab. 
Zdravilo XGEVA vsebuje denosumab.
Water for injections * Acetate buffer is formed by mixing acetic acid with sodium hydroxide 
6.1 Seznam pomožnih snovi ledocet* natrijev hidroksid (za prilagoditev pH)* sorbitol (E420) polisorbat 20 voda za injekcije * acetatni pufer nastane z mešanjem ocetne kisline z natrijevim hidroksidom
In the post-marketing setting, severe symptomatic hypocalcaemia (including fatal cases) has been reported (see section 4.8), with most cases occurring in the first weeks of initiating therapy, but can occur later. 
V obdobju trženja zdravila so poročali o hudi simptomatski hipokalciemiji (vključno s smrtnimi primeri) (glejte poglavje 4.8).
1 See section Description of selected adverse reactions 2 See section Other special populations 3 See section 4.4 
2 Glejte poglavje Druge posebne skupine bolnikov.
GENERAL CLASSIFICATION FOR SUPPLY 
Opozorila glede pomožnih snovi
A higher incidence of ONJ among subjects treated with denosumab compared to zoledronic acid has been observed in SRE prevention clinical trials. 
V kliničnih preskušanjih preprečevanja skeletnih dogodkov so opažali večjo pojavnost osteonekroze čeljustnice med bolniki, zdravljenimi z denosumabom, kot med bolniki, zdravljenimi z zoledronsko kislino.
Osteonecrosis of the jaw1 
pogosti osteonekroza čeljustnice1
42 months 
42 mesecev
Date of last renewal: 10/06/2015 
Datum zadnjega podaljšanja: 10/06/2015
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/07/2005 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja: 08/07/2005
ATC vet code: QI05AB03 
Oznaka ATC-vet: QI05AB03
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports). 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosto (pri več kot 1 živali od 10 živali stranski učinki v času zdravljenja) - pogosto (pri več kot 1 živali toda manj kot pri 10 živalih od 100 živali) - nepogosto (pri več kot 1 živali toda manj kot pri 10 živalih od 1.000 živali) - redko (pri več kot 1 živali toda manj kot pri 10 živalih od 10.000 živali) - zelo redko (pri manj kot 1 živali na 10.000 živali, vključno s posameznimi primeri)
PACKAGE SIZE 10 x 1 dose 
VELIKOST PAKIRANJA 10 x 1 odmerek
62.5 µg For the full list of excipients, see section 6.1 
62,5 µg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon. 
Če opazite kakršne koli resne učinke ali druge učinke, ki niso navedeni v tem navodilu, obvestite svojega veterinarja.
A third vaccination with Equilis Te should be repeated at least four weeks later. 
Tretje cepljenje z Equilisom Te moramo ponoviti najmanj štiri tedne pozneje.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) 470/2009. 
Zdravilna učinkovina je učinkovina biološkega izvora, namenjena za vzbujanje aktivne imunosti, in ni zajeta v Uredbi (ES) 470/2009.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tetanus toxoid 40 Lf/ml 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Toksoid tetanusa 40 Lf/ml
In very rare cases a local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur. 
V zelo redkih primerih lokalna reakcija presega 5 cm in lahko traja dlje kot 2 dni.
ADVICE ON CORRECT ADMINISTRATION Allow the vaccine to reach room temperature before use. 
NASVET O PRAVILNI UPORABI ZDRAVILA Cepivo pred uporabo ogrejte na sobno temperaturo.
Store in a refrigerator (2°C -8°C). 
Shranjujte v hladilniku (2°C -8 °C).
Store in a refrigerator (2 °C - 8 °C). 
Shranjujte v hladilniku (2°C -8 °C)
Vaccination schedule: Primary vaccination course 
Shema cepljenja: Osnovno cepljenje
Administer 1 ml of vaccine intramuscularly. 
Vbrizgajte 1 ml cepiva intramuskularno.
This will lead to a passive protection against tetanus for at least 21 days after concurrent administration. 
To vzbuja pasivno zaščito pred tetanusom,ki traja najmanj 21 dni po sočasnem dajanju.
THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE 
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, ČE JE NAVEDBA SMISELNA
Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness). 
Na mestu dajanja se lahko pojavi bolečina, ki ima lahko za posledico začasno funkcionalno nelagodje (otrdelost).
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/ ). 
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljona spletni strani Evropske agencije za zdravila (European Medicines Agency, http:/ema.europa.eu).
METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use 
NAČIN IN POT(I) UPORABE Intramuskularna uporaba
In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later) 
Kadar je povečana ogroženost zaradi okužbe ali premajhnega vnosa kolostruma, lahko pri starosti 4 mesecev damo dodatni odmerek in nato izvedemo poln program cepljenja (osnovno cepljenje pri starosti 6 mesecev in 4 tedne pozneje).
24 months after the first revaccination 
24 mesecev po prvi revakcinaciji
Special precautions for use in animals: Only healthy animals should be vaccinated. 
Posebni previdnostni ukrepi za uporabo pri živalih Cepimo samo zdrave živali.
In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus-Serum at a separate injection site, using separate syringes and needles. 
V tem primeru lahko damo prvi odmerek (C1) cepiva sočasno z ustreznim profilaktičnim odmerkom Tetanus-Seruma na drugo mesto in z različnimi brizgami in iglami.
Special precautions to be taken by the person administering the veterinary medicinal product to animals 
Posebni varnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
V4 
C4
Special warnings for each target species: 
Posebna opozorila za vsako živalsko vrsto
Purified Saponin 
Prečiščeni saponin
potency test 
preskusu potentnosti Dodatki
Administer one dose (1ml), by intramuscular injection, according to the following schedule: • Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later 
Po en odmerek (1 ml) intramuskularno po naslednji shemi: • Osnovno cepljenje: prvi odmerek po 6 mesecu starosti, drugi odmerek 4 tedne pozneje.
The vaccine can be used together with Tetanus-Serum for treatment of injured horses that have not been immunised against tetanus. 
Cepivo lahko uporabljamo hkrati s Tetanus-Serumom za zdravljenje poškodovanih konj, ki niso bili cepljeni proti tetanusu.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, seek medical advice immediately and show this package insert or the label to the physician. 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Če vam je bil ta izdelek nenamerno injiciran, se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROŠČANJE SERIJ, ČE STA RAZLIČNA
A clear opalescent suspension. 
Bistra opalescentna suspenzija
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Pharmacotherapeutic group: Inactivated bacterial vaccine. 
Za vzbujanje aktivne imunosti proti tetanusu Farmakoterapevtska skupina: inaktivirano bakterijsko cepivo
V3 
C3
Do not use this veterinary medicinal product after the expiry date which is stated on the label. 
Tega zdravila za uporabo v veterinarski mediini ne smete uporabljati po datumu izteka roka uporabnosti,
Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph. Eur. 
flokulacijski ekvivalenti; ustreza ≥ 30 i.e./ml seruma budre v Ph. Eur.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from Intervet. 
Na voljo so podatki o varnosti in učinkovitosti, ki kažejo, da lahko cepivo dajemo isti dan, toda ne pomešano z Intervetovim Tetanus-Serumom.
In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances. 
V zelo redkih primerih se lahko za 1 dan, izjemoma za do 3 dni pojavi vročina, ki jo včasih spremlja letargija in inapetenca.
1 ml suspension in type I glass pre-filled syringe, containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper. 
1 ml suspenzije v napolnjeni brizgi iz stekla tipa I, v kateri je bat z nastavkom iz halogenobutila in je zaprta z zamaškom iz halogenobutilne gume.
1 ml suspension in type I glass vial closed with a halogenobutyl rubber stopper and sealed with an aluminium cap. 
1 ml suspenzije v viali, steklo tipa I, zaprti z zamaškom iz halogenobutilne gume in zatesnjeni z aluminijasto zaporko.
PACKAGE LEAFLET FOR Equilis Te suspension for injection for horses 
Equilis Te, suspenzija za injiciranje za konje
2 weeks after the primary vaccination course 
2 tedna po osnovnem cepljenju
Incompatibilities: Do not mix with any other veterinary medicinal product. 
6.2 Inkompatibilnosti Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: 
Vsak odmerku po 1 ml vsebuje:
17 months after the primary vaccination course 
17 mesecev po osnovnem cepljenju
A diffuse hard or soft swelling (max. diameter 5 cm) may rarely occur at the injection site, regressing within 2 days. 
Neostro omejena trda ali mehka oteklina (s premerom največ 5 cm) se lahko pojavi na mestu dajanja, ki mine v 2 dneh.
Concurrent use of Equilis Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared to horses vaccinated with Equilis Te in the absence of tetanus antitoxin serum. 
Sočasna uporaba Equilisa Te in Intervetovega Tetanus-Seruma lahko zmanjša aktivno imunost proti tetanusu v primerjavi s konji, cepljenimi z Equilisom Te, ki niso prejeli seruma z antitoksinom tetanusa.
Cardboard box with 10 glass vials. 
Škatla z 10 steklenimi vialami.
Suspension for injection. 
FARMACEVTSKA OBLIKA Suspenzija za injiciranje.
Active immunisation of horses from 6 months of age against tetanus to prevent mortality. 
INDIKACIJA(E) Aktivna imunizacija konj po šestem mesecu starosti proti tetanusu za preprečevanje umrljivosti
Onset of immunity: 
Razvoj imunosti:
Following the administration of a double dose of vaccine, no side effects other than those described under section 4.6 have been observed except for some depression at the day of vaccination. 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Dvojni odmerek cepiva ni povzročil neželenih učinkov, ki bi se razlikovali od tistih, opisanih v poglavju 4.6, razen blage depresivnosti na dan cepljenja.
Phosphatidylcholine 
holesterol, fosfatidil holin
EXP {month/year} 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec(leto}
Equilis Te [a clear pictogram of a horse] 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Equilis Te [jasen piktogram konja]
Name and address of the manufacturers of the biological active substance GSK Vaccines GmbH 
Ime in naslov izdelovalcev biološke zdravilne učinkovine
THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN" Keep out of the sight and reach of children. 
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
Cardboard box with 10 pre-filled syringes with needles. 
Škatla z 10 napolnjenimi brizgami z iglami.
Name and address of the manufacturer responsible for batch release 
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije Intervet International BV
EU/2/05/055/001 EU/2/05/055/002 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/05/055/001-002
Emil-von-Behring-Str. 76 35 041 Marburg Germany 
GSK Vaccines GmbH Emil-von-Behring-Str. 76
Phosphate buffer Chloride buffer 
Laktoza, fosfatni pufer, kloridni pufer, sledi formaldehida,
Lot {number} 
(otrdelost).
Cardboard box with 10 pre-filled syringes with needles 
Škatla z 10 vialami Škatla z 10 napolnjenimi brizgami z iglami
MARKETING AUTHORISATION NUMBER(S) 
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA ( MRL)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 1 ml vial and 1 ml pre-filled syringe 
OVOJNINAH Viala z 1 ml in napolnjena brizga
125 µg Phosphatidylcholine 62.5 µg 
62,5 µg
Pack size blister (PVC/alu) 90 x 1 tablets (unit dose) 
90 x 1 filmsko obložena tableta (posamezni odmerek)
This summary was last updated in 03-2010. 
Povzetek je bil nazadnje posodobljen 03-2010.
The European Commission granted a marketing authorisation valid throughout the EU for Avandamet to SmithKline Beecham Ltd. on 20 October 2003. 
Evropska komisija je dovoljenje za promet z zdravilom Avandamet, veljavno po vsej Evropski uniji, odobrila družbi SmithKline Beecham Ltd. dne 20. oktobra 2003.
What benefit has Avandamet shown during the studies? 
Kakšne koristi je zdravilo Avandamet izkazalo med študijami?
After five years, the marketing authorisation was 
Po petih letih je bilo dovoljenje za promet z zdravilom podaljšano za nadaljnjih pet let.
For more information about treatment with Avandamet, read the Package Leaflet (also part of the EPAR). 
Za več informacij o zdravljenju z zdravilom Avandamet preberite navodilo za uporabo (ki je prav tako del EPAR).