natgillin/translations-raw huggingface dataset:
Initially, it stimulates pituitary function and secretion of the gonadotrophins LH (luteinising hormone) and FSH (follicle stimulating hormone). 
Na začetku spodbuja hipofizno funkcijo in izločanje gonadotropinov LH (luteinizirajočega hormona) in FSH (folikle stimulirajočega hormona).
High standards of biosecurity must be observed at the time of injection in order to prevent introduction and spread of infectious diseases between broodstock fish. 
Pri injiciranju je treba ravnati v skladu z visokimi standardi biološke varnosti, da bi preprečili vnos in širjenje kužnih bolezni med plemenskimi ribami.
Gonazon concentrate for solution for injection of female salmonid fish 
Gonazon, koncentrat za raztopino za injiciranje za plemenke salmonidnih vrst rib
After adequate (local) anaesthesia is present, apply gentle digital pressure to the far end of the implant. 
Ob ustrezni (lokalni) anesteziji s prsti narahlo pritisnemo na oddaljeni konec implantata.
Azagly-nafarelin is a synthetic analogue of gonadotrophin-releasing hormone (GnRH). 
Azagli-nafarelin je sintetični analog gonadotropin sproščajočega hormona (GnRH).
After first opening the container, the solvent may be stored for 28 days. 
Rok uporabnosti vehikla po prvem odpiranju vsebnika je 28 dni.
Prevention of gonadal function in bitches via long term blockade of gonadotrophin synthesis. 
Preprečevanje gonadne funkcije pri psicah z dolgotrajno blokado sinteze gonadotropina.
Store at 2 - 8C (in a refrigerator). 
Shranjujte pri temperaturi 2 ºC-8 ºC (v hladilniku).
Treatment in proestrus will not suppress that particular heat (proestrus and oestrus). 
Uporaba v proestrusu ne zavre gonitve, ki mu sledi (proestrus in estrus).
The diluted solution for injection should be used immediately. 
Razredčeno raztopino za injiciranje je treba uporabiti takoj po pripravi.
Metabolism and excretion: The clearance of azagly-nafarelin following intravenous administration of the same dose is 0.46 l/h and the elimination half-life is 1.8 hours. 
Presnova in izločanje: Očistek azagli-nafarelina je po intravenskem dajanju enakega odmerka 0,46 l/h, razpolovni čas izločanja pa 1,8 ure.
If necessary, dissect away any fibrous tissue to free the implant. 
Če je potrebno, implantat sprostimo, tako da odstranimo fibrozno tkivo.
Based on field trial data, it is evident that the implant may not be retained in a proportion (1.2%) of treated bitches. 
Podatki s terena kažejo, da implantat pri določenem deležu (1,2 %) psic ne ostane na mestu.
The long term effects of azagly-nafarelin on treated broodstock fish have not been studied. 
Dolgoročni učinki azagly-nafarelina na plemenske ribe niso raziskani.
Push the implant gently towards the stab incision. 
Implantat narahlo potisnemo proti vbodnemu rezu.
Distribution: The apparent volume of distribution of azagly-nafarelin following intravenous bolus administration, at a dose equivalent to the content of one implant, is 0.12 l/kg. 
Porazdelitev: Navidezni volumen porazdelitve azagli-nafarelina je po intravenskem dajanju bolusa v odmerku, ki je enakovreden vsebnosti enega implantata, 0,12 l/kg.
In case of accidental contact with either the skin or the eyes, rinse thoroughly with water. 
Če izdelek nanesete na kožo ali v oči, jih temeljito sperite z vodo.
With your free hand, use the thumb grip to hold the injection device in position, and depress the plunger as far as it can go. 
S prosto roko primite nastavek na injektorju in ga držite v tem položaju ter pritisnite bat do konca navzdol.
Benzyl alcohol 
benzilni alkohol
Prepare a small area (e.g. 4 cm²) of the ventral anterior abdominal/umbilical region for an aseptic procedure (Fig. 1). 
Pripravimo majhno mesto (na primer 4 cm²) na ventralni, anteriorni abdominalni steni v predelu popka za aseptični postopek (slika 1).
The incidence of induced heat following administration of a repeat treatment to bitches that have not shown signs of oestrus following a previous administration of the product is low (estimated to be 8%). 
Pogostnost spodbujene gonitve je pri psicah, ki po prejšnji uporabi izdelka niso imele znakov estrusa, po ponovljeni uporabi majhna (ocenjujejo, da je 8 %).
Using aseptic technique, raise a small piece of skin in the region of the dog's umbilicus. 
Z aseptično tehniko dvignemo majhen del kože v predelu popka.
Record the date of treatment in the clinical records of the animals. 
Datum posega vpišite v zdravniški karton živali.
Longterm administration results in pituitary desensitisation to the effects of GnRH resulting in a suppression of LH and FSH secretion by the pituitary. 
Med dolgotrajno uporabo pride do desenzibilizacije hipofize za učinke GnRH, kar povzroči supresijo izločanja LH in FSH iz hipofize.
The elimination half-life (T1/2) and Mean Residence Time of azagly-nafarelin in trout after IP treatment of 32 µg/kg BW are 4.9 h and 6.8 h, respectively. 
Razpolovni čas izločanja (T1/2) in srednji čas zadrževanja azagli-nafarelina sta pri postrvih po intraperitonealnem dajanju odmerka po 32 µg/kg telesne mase 4,9 ure in 6,8 ure.
Azagly-nafarelin, like other GnRH analogues, mimics the action of GnRH, through modulation of the secretion of LH and FSH in mammals and fish. 
Azagli-nafarelin tako kot drugi analogi GnRH posnema delovanje GnRH, tako da pri sesalcih in ribah spreminja izločanje LH in FSH.
Induction and synchronisation of ovulation for the production of eyed-eggs and fry. 
Indukcija in sinhronizacija ovulacije za proizvodnjo iker v fazi oči in ribjega zaroda
The table below provides the required volume of concentrate and the required volume of solvent to obtain thepreferred injection volumes of 0.1 ml/kg fish, 0.2 ml/kg fish, 0.5 ml/kg fish or 1 ml/kg fish. 
V tabeli sta navedena potrebna volumna koncentrata in topila za pripravo volumnov raztopine za injiciranje 0,1 ml/kg rib, 0,2 ml/kg rib, 0,5 ml/kg rib in 1 ml/kg rib.
The distribution and metabolism of azagly-nafarelin have not been studied in the target species. 
Porazdelitve in presnove azagli-nafarelina pri ciljni živalski vrsti niso raziskovali.
The product, when administered at the recommended treatment dose, is ineffective in bitches aged seven years or older. 
Izdelek je v priporočenem odmerku neučinkovit pri psicah, starih sedem let in starejših.
In addition, the frequency of induced heat is lower in younger bitches than in older bitches. 
Poleg tega je pri mlajših psicah manj pogosta kot pri starejših.
Carton containing one vial with 2 ml of concentrate solution and 1 bottle with 100 ml of solvent. 
Kartonska zloženka z eno vialo po 2 ml koncentrata za raztopino in 1 steklenička po 100 ml vehikla.
Prepare a small area (e.g. 4 cm²) of the ventral anterior abdominal/ umbilical region for an aseptic procedure. 
Pripravimo majhno mesto (na primer 4 cm²) na ventralni, anteriorni abdominalni steni v predelu popka za aseptični postopek.
The product when administered at the recommended treatment dose is ineffective in bitches aged 7 years or older. 
Zdravilo je v priporočenem odmerku neučinkovito pri psicah, starih 7 let in starejših.
No information on interactions with other veterinary medicinal products is available. 
Ni podatkov o interakcijah z drugimi zdravili.
In adult bitches, the first treatment should be administered preferably in metoestrus. 
Pri odraslih psicah je izdelek prvič najbolje uporabiti v metestrusu.
Gonazon should be injected subcutaneously, in the ventral anterior abdominal wall, in the region of the umbilicus, using aseptic technique. 
Gonazon moramo injicirati aseptično s podkožno injekcijo v ventralno, anteriorno abdominalno steno, v predel popka.
Shelf life after dilution according to directions: the product should be used immediately. 
Rok uporabnosti po razredčenju ali rekonstituciji v skladu z navodili: izdelek je treba takoj uporabiti.
This retracts the needle and withdraws it, leaving the implant beneath the skin (Fig. 3). 
Ob tem se igla samodejno vrne, implantat pa ostane pod kožo (slika 3).
Therefore, the first treatment should preferably be administered in metoestrus. 
Prvič ga je zato bolje uporabiti v metestrusu.
Excipient: Benzyl alcohol 
Pomožna snov: benzilni alkohol
However, the timing of return to heat cannot be predicted. 
Toda v tem primeru ne moremo časovno določiti ponovne gonitve.
A proportion of bitches that show induced heat may subsequently develop pseudopregnancy. 
Pri določenem številu psic, pri katerih se pojavi spodbujena gonitev, lahko pride do namišljene brejosti.
Azagly-nafarelin (18.5 mg) 
Azagli-nafarelin (18,5 mg)
Do not use after the expiry date stated on the label. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po 'EXP'.
Batch < number > 
Serija <številka>
The unit is sterile and comes in a sealed, light-proof, aluminium foil laminate pouch, packed in an individual carton box. 
En napolnjen injektor za enkratno uporabo v igli za podkožno dajanje z zaščitnim pokrovčkom Enota je sterilna in pakirana v zavarjeni, proti svetlobi odporni vrečki iz laminata iz aluminijeve folije posamezno v zloženki.
Do not use in bitches (prepubertal and adult) intended for breeding. 
Ne uporabite pri psicah (pred puberteto in odraslih), namenjenih za vzrejo.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ, ČE STA RAZLIČNA
This retracts the needle and withdraws it, leaving the implant beneath the skin. 
Ob tem se igla samodejno vrne, implantat pa ostane pod kožo.
Sodium chloride Annex II for all food 
natrijev klorid Dodatek II za vse živali za proizvodnjo živil
These maximal azagly-nafarelin concentrations are followed by a slow decline in circulating azagly-nafarelin concentrations lasting up to 12 months. 
Po doseganju največje koncentracije raven azagli-nafarelina v obtoku do 12 mesecev počasi upada.
In the event of accidental self-administration of the implant, seek medical advice immediately and show the package leaflet or the label to the physician. 
Če si implantat nenamerno samoinjicirate, se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali nalepko na zunanji ovojnini.
No data are available on repeat treatments in prepubertal bitches. 
O ponovljeni uporabi pri psicah pred puberteto ni podatkov.
Open the foil pouch using the pre-cut incision to remove the sterile injection device. 
Odpremo vrečko iz folije na mestu z zarezo in vzamemo sterilni injektor.
"Month/Year" After dilution, the product should be used immediately. 
''Mesec/Leto'' Razredčen izdelek je treba takoj uporabiti.
Total kg of fish to be injected 50 kg 
Skupna teža rib v kg
For animal treatment only 
Samo za živali
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
PODATKI, KI MORAJO BITI NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
An individual carton box contains a single disposable injection device, preloaded inside a hypodermic needle covered with a protective cap. 
V eni zloženki je en napolnjen injektor za enkratno uporabo v igli za podkožno dajanje z zaščitnim pokrovčkom
The supplied solvent is used to dilute the concentrate to the correct dilution to allow for optimisation of the preferred injection volumes for fish of widely varying body weights. 
S priloženim vehiklom razredčimo koncentrat do ustrezne razredčitve, s katero lahko pripravimo optimalni volumen raztopine za injiciranje za ribe z najrazličnejšimi telesnimi masami.
Azagly-nafarelin 1600 g/ml as azagly-nafarelin acetate. 
Azagli-nafarelin, 1600 g/ml, v obliki azagli-nafarelin acetata
EXP {month/year} After dilution, the product should be used immediately. 
EXP {mesec/leto} Razredčen izdelek morate takoj uporabiti.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH 
A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
Solvent vial: 100 ml clear glass vial containing 100 ml of solution; rubber stopper and crimp cap. 
Viala z vehiklom: viala po 100 ml iz prozornega stekla, ki vsebuje 100 ml raztopine; gumijasti zamašek in zaporka brez navoja.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR 
IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE
ADMINISTRATION: 
DAJANJE:
Position the dog as described for administration of the implant. 
Psico namestimo v enak položaj kot pri vnašanju implantata.
Concentrate vial: 3 ml brown glass vial containing 2 ml of solution; rubber stopper and crimp cap. 
Viala s koncentratom: viala po 3 ml iz rjavega stekla, ki vsebuje 2 ml raztopine; gumijasti zamašek in zaporka brez navoja.
For animal treatment only- to be supplied only on veterinary prescription. 
Izdaja zdravila je le na veterinarski recept.
<Batch> <Lot> <BN> {number} 
<Serija> <lot><številka serije>{številka}
Personal protective equipment, consisting of gloves, should be worn when handling the veterinary medicinal product. 
Osebe, ki dajejo zdravilo živalim, morajo pri mešanju koncentrata z vehiklom uporabljati zaščitne rokavice.
Marketing authorisation holder and manufacturer 
Imetnik dovoljenja za promet z zdravilom in izdelovalec:
Azagly-nafarelin, a GnRH agonist, has biphasic effects on the pituitary gland when administered continuously. 
Azagli-nafarelin, agonist GnRH, deluje pri trajnem dajanju dvofazno na hipofizo.
Operators should wear gloves when mixing the concentrate solution with the solvent. 
Osebe, ki dajejo zdravilo živalim, morajo pri mešanju koncentrata s topilom uporabljati zaščitne rokavice.
Owing to their pharmacological activity (inhibition of the production of sex steroids), administration of GnRH agonists to bitches might be associated with vaginitis. 
Pri dajanju agonistov GnRH psicam se lahko zaradi njihovega farmakološkega delovanja (zaviranja nastajanja spolnih steroidov) pojavi vaginitis.
VIAL CONTAINING SOLVENT: 
VIALA Z VEHIKLOM:
Fig.4 
Slika 4
Azagly-nafarelin is rapidly absorbed after intraperitoneal treatment in rainbow trout. 
Azagli-nafarelin se pri kalifornijskih postrvih (šarenkah) po intraperitonealnem dajanju hitro absorbira.
With the bevel of the needle facing upwards, insert the needle at a 30 degree angle to the tented skin in a single motion (Fig. 2). 
Iglo držimo tako, da je njena konica obrnjena navzgor in jo z eno potezo vbodemo pod kotom 30 stopinj podkožno v kožno gubo (slika 2).
After dilution, the product should be used immediately. 
Razredčeni izdelek morate takoj uporabiti.
Sodium chloride / Hydrochloric acid 4N (for pH adjustment) 
6.1 Seznam pomožnih snovi benzilni alkohol natrijev acetat (trihidrat) ocetna kislina, koncentrirana; ledocet natrijev klorid / klorovodikova kislina 4N (za uravnavo pH)
Vial containing solvent 
Viala z vehiklom
A reduction in the egg quality is seen after administration of doses above the recommended therapeutic dose. 
Po dajanju odmerkov nad priporočenim terapevtskim odmerkom so zasledili manjšo kakovost iker.
Acetic acid, glacial 
ocetna kislina (ledocet)
Active substance: Azagly-nafarelin 18.5 mg per implant 
Azagli-nafarelin 18,5 mg v implantatu
An empty sterile mixing vial is supplied separately. 
Posebej je priložena prazna, sterilna mešalna viala.
Remove the needle cap. 
Snamemo igelni pokrovček.
Reductions in fecundity, egg quality and survival to the eyed-egg stage have been observed in fish treated with azagly-nafarelin too early in the spawning season. 
Pri ribah, ki so jim dajali azagli-nafarelin prezgodaj v sezoni mrestenja, so zasledili manjšo plodnost, slabšo kakovost iker in slabše preživetje do stopnje z očmi.
With the bevel of the needle facing upwards, insert the needle at a 30 degree angle to the tented skin in a single motion, subcutaneously. 
Iglo držimo tako, da je njena konica obrnjena navzgor in jo z eno potezo vbodemo pod kotom 30 stopinj podkožno v kožno gubo.
Active substance(s) 
Zdravilna(e) učinkovina(e):
Medical advice should be sought immediately in cases in which the concentrated solution or several ml of the diluted solution are spilled onto the skin or into the eyes or in the case of accidental self-injection. 
Če na kožo ali v oči nanesete koncentrirano raztopino ali več mililitrov razredčene raztopine ali si raztopino nenamerno samo-injicirate, se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali nalepko na zunanji ovojnini.
Azagly-nafarelin is rapidly eliminated from plasma after IP treatment in rainbow trout. 
Pri kalifornijskih postrvih (šarenkah) se azagli-nafarelin po intraperitonealnem dajanju hitro izloči iz plazme.
The dose should be administered in the preferred volume for the particular body weight of fish. 
Odmerek dajemo v volumnu, ki ustreza telesni masi ribe.
Solvent for solution for injection. 
Vehikel za raztopino za injiciranje
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” 
BESEDILO ''ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM''
PARTICULARS TO APPEAR ON THE OUTER PACKAGE 
PODATKI, KI MORAJO BITI NAVEDENI NA STIČNI OVOJNINI
Sachet 
KARENCA
ATC vet code: QH01CA 
Farmakoterapevtska skupina: gonadotropin sproščajoči hormon Oznaka ATCvet: QH01CA
WITHDRAWAL PERIOD 
Povprečno trajanje blokade
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION 
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
Avoid self injection. 
Pazite, da si izdelka ne bi injicirali.
Sodium acetate (tri-hydrate) 
Ni za uporabo pri ribah, katerih ikre so namenjene za prehrano natrijev acetat (trihidrat)
Strength Pharmaceutical Form Route of Administration 
Jakost Farmacevtska oblika Pot uporabe Stična ovojnina
23 October 2000 
23. oktober 2000
See the Module “All authorised presentations” 
Glejte modul ”All authorised presentations”
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) 
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR)
type 2 (MEF 1) 
tipa 2 (MEF 1)
type 3 (Saukett) 
tipa 3 (Saukett)
These studies showed the protective efficacy of Hexavac against the above diseases in infants. 
Te študije so pokazale zaščitno učinkovitost zdravila Hexavac proti zgoraj omenjenim otroškim boleznim.
For detailed conditions for the use of this product, scientific information or procedural aspects please refer to the relevant modules. 
Podrobnosti o pogojih uporabe tega zdravila, znanstvene informacije in postopkovne vidike najdete v ustreznih modulih.
type 1 (Mahoney) 
tipa 1 (Mahoney)
AVENTIS PASTEUR MSD, SNC 8, rue Jonas Salk 
Imetnik dovoljenja za promet z zdravilom: AVENTIS PASTEUR MSD, SNC 8 rue Jonas Salk
The CHMP, on the basis of quality, efficacy and safety data submitted, consideres that the overall benefit /risk ratio for Hexavac remains favourable in the approved indication. 
Na podlagi predloženih podatkov o kakovosti, učinkovitosti in varnosti CHMP meni, da vsesplošno razmerje med koristmi in tveganji za zdravilo Hexavac ostaja ugodno za odobreno indikacijo.
Bacterial and viral vaccines, combined (J07CA) 
Kombinacije bakterijskih in virusnih cepiv (JO7CA)
Pharmaco-therapeutic group (ATC Code): 
Farmakoterapevtska skupina (ATC oznaka):
The most common adverse events were transient local reactions (pain, redness, swelling at the injection site) and systemic reactions (loss of appetite, fever, drowsiness, irritability). 
Najpogostejši neželeni učinki so bile prehodne lokalne reakcije (bolečina, rdečina, oteklina na mestu injiciranja) in sistemske reakcije (izguba apetita, telesna temperatura, zaspanost, razdražljivost).
The approval was based on results from clinical trials, which investigated the immunogenicity and reactogenicity of Hexavac when administered according to specific primary and booster vaccination schedules. 
Odobritev je temeljila na kliničnih preizkušanjih, v katerih so raziskovali imunogenost in reaktogenost zdravila Hexavac, kadar se ga daje v skladu z določeno shemo osnovnega in obnovitnega cepljenja.
The following adverse effects were reported very rarely: allergic reaction, chills, fatigue, hypotonichyporesponsive episode, malaise, oedema, pallor, swelling or oedema of the entire limb(s), transient local lymph node swelling, convulsions (febrile and non febrile), encephalitis, encephalopathy with acute brain oedema, eyes rolling, Guillain Barré Syndrome, hypotonia, neuritis, abdominal pain, meteorism, nausea, petechiae, purpura, purpura thrombocytopenic, thrombocytopenia, agitation, sleep disorder, dyspnoea or Stridor inspiratory, angioedema, erythema, pruritus, rash, urticaria and flushing. 
Zelo redko pa poročajo o naslednjih neželenih učnikih: alergične reakcije, mrzlica, utrujenost, hipotonična-hipoodzivna epizoda, splošna slabost, edem bledica, otekanje ali edem celotnega uda(ov), prehodno otekanje lokalnih limfnih vozljev, krči (vročinski in nevročinski), encefalitis, encefalopatija za akutnim edemom v možganih, vrtenje oči, sindrom Guillain Barré hipotonija, nevritis, bolečine v trebuhu meteorizem, slabost, petehije, purpura, trombocitopenična purpura, trombocitopenija, razburjenje, motnje spanja, oteženo dihanje ali škripavo vdihovanje, angioedem, rdeč kožni madeži, srbečica, izpuščaj, urtikarija in rdenje.
Hexavac is a hexavalent vaccine which contains combined antigens derived from Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, polio virus and Haemophilus influenzae type b. It is developed for primary and booster vaccination of children against the viruses and bacteria mentioned above. 
Hexavac je heksavalentno cepivo, ki vsebuje kombinirane antigene, ki izhajajo iz Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, virusa hepatitisa B, virusa polia ter Haemophilusu influenzae typa b. Razvito je za osnovno in obnovitveno cepljenje otrok proti zgoraj omenjenim virusom in bakterijam.
This combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis B caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by Haemophilus influenzae type b. 
Kombinirano cepivo je indicirano za osnovno in obnovitveno cepljenje otrok proti davici, tetanusu, pertusisu, hepatitisu B, ki ga povzročajo vsi znani podtipi virusov, otroški ohromelosti in invazivnim okužbam, ki jih povzroča Haemophilus influenzae
Purified adsorbed diptheria toxoid (PDT) Purified tetanus toxoid (PTT) Purified pertussis toxoid (PTxT) Purified pertussis filamentous haemagglutinin (FHA) Hepatitis B S surface antigen recombinant (HBsAG) Inactivated poliovirus (IPV): 
Prečiščen adsorbiran davični toksoid (PDT) Prečiščen tetanusni toksoid (PTT) Prečiščen toksoid pertusisa (PTxT) Prečiščen filamentozni hemaglutinin pertusisa (FHA) Rekombinantni površinski antigen virusa hepatitisa B S (HBsAG)
Haemophilus influenzae type b polysaccharide, conjugated to tetanus protein (PRP-T) 
Polisaharid bakterije Hemofilius influenzae tipa b, konjugiran na tetanusni protein (PRP-T)
International Nonproprietary Name (INN): Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted 
Mednarodno nelastniško ime (INN): Adsorbirano cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno), otroški ohromelosti (inaktivirano), hepatitisu B (rekombinantno) in proti Hemofilius influenzae tipa b (konjugirano cepivo), z adjuvansom
Oral use sachet (LDPE/Alu/LDPE/paper) 
60 mg zrnca za peroralno raztopino peroralna uporaba vrečka (LDPE/Alu/LDPE/papir)
1 sachet 
1 vrečka
Granules for oral suspension 
Pot uporabe Stična ovojnina
Pack size 
Vsebina
Frequencies are defined as: very common (≥1/10), common (1/100 to 1/10), uncommon (1/1000 to 1/100), rare (1/10,000 to <1/1000) and not known (frequency cannot be estimated from the available data). 
Pogostnosti so opredeljene kot: zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10), občasni ( 1/1.000 do < 1/100), redki ( 1/10.000 do < 1/1.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).