natgillin/translations-raw huggingface dataset:
For more information about treatment with Ovaleap, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Više informacija o liječenju lijekom Ovaleap pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
For practical information about using Ovaleap, patients should read the package leaflet or contact their doctor or pharmacist. 
Praktične informacije o korištenju Ovaleap bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
What benefits of Ovaleap have been shown in studies? 
Koje koristi Ovaleap su dokazane u ispitivanjima?
The dose of Ovaleap and how often it is given depend on why it is being used and on the patient's response to treatment. 
Doza lijeka Ovaleap i učestalost primjene ovise o razlogu korištenja i odgovoru bolesnika na liječenje.
Ovaleap is given together with a medicine containing LH to stimulate the eggs to mature in the ovaries; 
Ovaleap se preporučuje zajedno s lijekom koji sadrži LH za poticanje sazrijevanja jajašca u jajnicima;
• women who do not produce eggs and do not respond to treatment with clomiphene citrate 
• u žena koje ne proizvode jajašca i ne odgovaraju na liječenje klomifen citratom (drugi lijek koji potiče jajnike na stvaranje jajašca);
Ovaleap is a medicine that contains the active substance follitropin alfa. 
Ovaleap je lijek koji sadrži djelatnu tvar folitropin alfa.
Ovaleap has been shown to be comparable to the reference medicine, GONAL-f. 
Dokazano je da je Ovaleap usporediv s referentnim lijekom, GONAL-f.
How is Ovaleap used? 
Kako se Ovaleap koristi?
How does Ovaleap work? 
Kako Ovaleap djeluje?
The reference medicine for Ovaleap is GONAL-f. For more information on biosimilar medicines, see the question-and-answer document here. 
Za više informacija o sličnim biološkim lijekovima pogledajte dokument s pitanjima i odgovorima ovdje.
For the full list of all side effects reported with Ovaleap, see the package leaflet. 
Potpuni popis nuspojava koje su zabilježene s lijekom Ovaleap potražite u uputi o lijeku.
Date of first authorisation: 22.12.2014 Date of last renewal: 
Datum prvog odobrenja: 22.12.2014 Datum posljednjeg produljenja odobrenja:
8 hours. 
8 sati.
Revaccination is recommended after 1 year. 
Ponovno cijepljenje preporučuje se nakon 1 godine.
This should be considered in case of herd vaccination. 
To treba uzeti u obzir u slučaju cijepljenja stada.
Can be used during lactation. 
Može se primjenjivati tijekom laktacije.
Solvent for Bovela 
Otapalo za Bovela
A definitive diagnosis of persistent infection can only be established upon re-testing in blood after an interval of at least 3 weeks. 
Definitivna dijagnoza trajne zaraze može se utvrditi samo ponovnim ispitivanjem krvi nakon intervala od najmanje 3 tjedna.
Duration of immunity: 1 year after immunisation. 
Trajanje imunosti: 1 godina nakon imunizacije.
Avoid multiple broaching. 
Izbjegavajte višestruko probijanje gumenog čepa.
Interaction with other medical products and other forms of interaction: 
Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija
50 doses (100 ml) 
50 doza (100 ml)
If you notice any side effects, even those not already listed in this package leaflet or think that the medicine has not worked, please inform your veterinary surgeon. 
Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj uputi o VMP ili mislite da veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog veterinara.
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
Pomoćne tvari (uključujući adjuvanse) navedene u dijelu 6.1 SPC ili su dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno, ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EZ) br. 470/2009 kada se primjenjuju u tom veterinarsko-medicinskom proizvodu.
The reconstituted vaccine is transparent and colourless. 
Rekonstituirano cjepivo prozirno je i bezbojno.
* Bovine viral diarrhoea virus ** Tissue culture infectious dose 50% 
* virus virusnog proljeva goveda ** infektivna doza za kulturu tkiva 50%
The vaccine has not been tested in breeding bulls and should therefore not be used in breeding bulls. 
Cjepivo nije testirano na rasplodnim bikovima i stoga se ne smije koristiti na rasplodnim bikovima.
12 months after primary vaccination most studied animals still had antibody titres at plateau while some animals had lower titres. 
Dvanaest mjeseci nakon primarnog cijepljenja većina životinja iz ispitivanja još uvijek je imala titar protutijela na nivou dok su neke životinje imale niži titar.
Ensure that the lyophilisate is completely reconstituted before use. 
Pazite da liofilizat bude potpuno rekonstituiran prije primjene.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after the abbreviation EXP. 
Ne koristite veterinarsko-medicinski proizvod nakon isteka roka valjanosti naznačenog na kutiji i bočici poslije EXP.
Studies have shown that vaccine virus may be excreted in milk up to 23 days after vaccination at low amounts (~ 10 TCID50/ml), although when such milk was fed to calves, no seroconversion occurred in those calves. 
Ispitivanja su pokazala da se cjepni virus može izlučivati u mlijeko do 23 dana nakon cijepljenja pri niskim količinama (~ 10 TCID50/ml), iako prilikom davanja takvog mlijeka teladi kod istih nije došlo do serokonverzije.
Additional laboratory tests to differentiate vaccine strain virus from field strain are available upon request from the marketing authorisation holder. 
Dodatna laboratorijska ispitivanja za razlikovanje cjepnog soja virusa od terenskog soja dostupna su na zahtjev nositelja odobrenja za stavljanje u promet.
To ensure the protection of animals introduced to the herd where BVDV is circulating, vaccination has to be completed 3 weeks before introduction. 
Kako bi se osigurala zaštita životinja koje se uvode u stado u kojem kruži BVDV, životinju je potrebno cijepiti 3 tjedna prije uvođenja u stado.
Animals which are vaccinated later than 3 weeks before gestation or during the early gestation may not be protected against foetal infection. 
Životinje koje se cijepe kasnije od 3 tjedna prije gestacije ili tijekom rane gestacije možda neće biti zaštićene od fetalne infekcije.
Specific pharmacovigilance requirements: Periodic safety update reports are required at yearly intervals. 
Specifični zahtjevi farmakovigilancije: Treba podnositi periodička izvješća o neškodljivosti (PSUR) u godišnjim intervalima.
Shedding of the vaccine virus by body fluids cannot be excluded. 
Izlučivanje cjepnog virusa putem tjelesnih tekućina ne može se isključiti.
Hypersensitivity reactions, including anaphylactic-type reactions, have been reported very rarely (post-marketing safety experience). 
Reakcije preosjetljivosti, uključujući reakcije anafilaktičkog tipa, zabilježene su u vrlo rijetkim slučajevima (izvješće o neškodljivosti nakon stavljanja u promet).
Recommended re-vaccination programme: 
Preporučeni program ponovnog cijepljenja:
Preparation of vaccine for use (reconstitution): 
Način pripreme vakcine (rekonstitucija):
The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009. 
Djelatna tvar koja se sastoji od tvari biološkog podrijetla, namijenjena je za stvaranje aktivne imunosti na koju se ne primjenjuju odredbe Uredbe (EZ) br. 470/2009.
Therefore, use during pregnancy should only be on a case-by-case basis decided by the responsible veterinarian, taking into consideration e.g. the BVD immunological status of the animal, the time-span between vaccination and mating/insemination, the stage of pregnancy and the risk of infection. 
Stoga, primjena tijekom graviditeta treba biti samo od slučaja do slučaja, a odluku mora donijeti odgovorni veterinar uzimajući u obzir primjerice BVD imunološki status životinje, vremensko razdoblje između cijepljenja i parenja/inseminacije, status graviditeta i rizik od infekcije.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: 
Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama
Lyophilisate: Off-white colour without foreign matter. 
Liofilizat: prljavo bijele boje bez stranih čestica.
Name and address of the manufacturer of the biological active substance Boehringer Ingelheim Animal Health USA Inc. 2621 North Belt Highway, St. Joseph, Missouri, 64506-2002 USA 
Boehringer Ingelheim Animal Health USA Inc. 2621 North Belt Highway, St. Joseph, Missouri, 64506-2002 SAD
In some limited cases with newborn calves, positive ear notches for BVDV vaccine strain were reported by molecular diagnostic tests. 
U malom broju slučajeva u tek oteljene teladi pozitivne oznake na ušima za cjepni soj BVDV zabilježene su u molekularnim dijagnostičkim ispitivanjima.
Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product. 
Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim s otapalom priloženim za primjenu s veterinarsko-medicinskim proizvodom.
After reconstitution, administer one dose (2 ml) of the vaccine by intramuscular (IM) injection. 
Poslije rekonstitucije primijenite jednu dozu (2 ml) cjepiva intramuskularnom (i.m.) injekcijom.
The vaccine is designed to stimulate the development of an active immune response against BVDV-1 and BVDV-2 in cattle. 
Namjena je cjepiva potaknuti razvoj aktivnog imunosnog odgovora protiv virusa BVDV-1 i BVDV-2 u goveda.
Shelf life after reconstitution according to directions: 
Rok valjanosti nakon rekonstitucije u skladu s uputama:
The field studies to investigate the efficacy of the vaccine were done in herds where persistently infected animals had been removed. 
Terenska ispitivanja za dokazivanje učinkovitosti cjepiva provedena su na stadima iz kojih su uklonjene trajno zaražene životinje.
CONTRAINDICATION 
KONTRAINDIKACIJA
Do not use in cases of hypersensitivity to the active substances or to any of the excipients. 
Ne primjenjivati u slučajevima preosjetljivosti na djelatnu tvar ili na bilo koju od pomoćnih tvari.
For active immunisation of cattle from 3 months of age to reduce hyperthermia and to minimise the reduction of leukocyte count caused by bovine viral diarrhoea virus (BVDV-1 and BVDV-2), and to reduce virus shedding and viraemia caused by BVDV-2. 
Za aktivnu imunizaciju goveda u dobi od 3 mjeseca nadalje kako bi se smanjila hipertermija i umanjila redukcija broja leukocita uzrokovana virusom virusnog proljeva goveda (BVDV-1 i BVDV-2) i smanjilo izlučivanje virusa te viremija uzrokovana virusom BVDV-2.
Each dose (2 ml) contains: Lyophilisate: 
Svaka doza (2 ml) sadrži: Liofilizat:
It is recommended to vaccinate before pregnancy to ensure protection against persistent infection of the foetus. 
Preporučuje se provesti cijepljenje prije graviditeta kako bi se osigurala zaštita od trajne infekcije ploda.
Reconstitute the lyophilisate by adding the full content of the solvent at room temperature. 
Rekonstituirajte liofilizat dodavanjem cijele količine otapala na sobnoj temperaturi.
It is recommended to vaccinate cattle at least 3 weeks before insemination/mating to provide foetal protection from the first day of conception. 
Preporučuje se cijepiti goveda barem 3 tjedna prije inseminacije/parenja kako bi se osigurala zaštita fetusa od prvog dana začeća.
For active immunisation of cattle against BVDV-1 and BVDV-2, to prevent the birth of persistently infected calves caused by transplacental infection. 
Za aktivnu imunizaciju goveda protiv BVDV-1 i BVDV-2 kako bi se spriječilo teljenje trajno zaražene teladi uzrokovano transplacentarnom infekcijom.
EXP {month/year} Once reconstituted use within: 8 hours. 
EXP {mjesec/godina} Nakon rekonstitucije upotrijebiti unutar: 8 sati.
3 weeks after immunisation. 
Početak imunosti: 3 tjedna nakon imunizacije.
5 doses (10 ml) 10 doses (20 ml) 25 doses (50 ml) 
5 doza (10 ml) 10 doza (20 ml) 25 doza (50 ml)
EXP {month/year} Once reconstituted use within 8 hours. 
EXP {mjesec/godina} Nakon rekonstitucije upotrijebiti unutar 8 sati.
Keep the bottle in the outer carton. 
Držati bočicu u vanjskom kartonu.
The cornerstone of bovine viral diarrhoea (BVD)-eradication is identification and culling of persistently infected animals. 
Kod eradikacije virusa virusnog proljeva goveda (BVD) najvažnije je identificirati i smanjiti populaciju trajno zaraženih životinja.
This may result in transplacental transmission on the vaccine virus, but no adverse effects on foetus or pregnancy was observed in studies. 
To može uzrokovati transplacentarnu transmisiju cjepnog virusa, ali u ispitivanjima nisu uočene nuspojave na plod ili na graviditet.
Longlasting viremia has been observed after vaccination, in particular in pregnant seronegative heifers (10 days in a study). 
Dugotrajna viremija uočena je nakon cijepljenja, posebice kod steonih seronegativnih junica (10 dana u ispitivanju).
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that: 
Sukladno članku 71. Direktive 2001/82/EZ i Europskog parlamenta i Vijeća s izmjenama i dopunama, države članice, u skladu s nacionalnim zakonodavstvom mogu zabraniti proizvodnju, uvoz,
Solvent: Clear, colourless solution. 
Otapalo: bistra, bezbojna otopina.
Mild swellings or nodules up to 3 cm diameter were observed at the injection site and disappeared within 4 days post vaccination (clinical studies). 
Blaga oticanja ili čvorići promjera do 3 cm uočeni su na mjestu primjene injekcije, a nestali su unutar 4 dana nakon cijepljenja (klinička ispitivanja).
Shelf life after reconstitution: 8 hours. 
Rok valjanosti nakon rekonstitucije: 8 sati.
Bovine viral diarrhoea virus type 1: 104.0-106.0 TCID50, Bovine viral diarrhoea virus type 2: 104.0-106.0 TCID50. 
virus virusnog proljeva goveda tip 1: 104,0-106,0 TCID50, virus virusnog proljeva goveda tip 2: 104,0-106,0 TCID50.
While persistent infection of the foetus caused by the vaccine was not observed, transmission of vaccine virus to the foetus may occur.. 
Iako perzistentna infekcija ploda uzrokovana cjepivom nije uočena, prijenos cjepnog virusa na fetus je moguć.
Sodium chloride Potassium chloride Potassium dihydrogen phosphate Disodium hydrogen phosphate Water for injections 
Otapalo: natrijev klorid kalijev klorid kalijev dihidrogenfosfat dinatrijev hidrogenfosfat voda za injekcije
High density polyethylene (HDPE) bottles sof solvent, closed with a siliconised chlorobutyl rubber stopper with lacquered aluminium seal. 
Bočice od polietilena visoke gustoće (HDPE), zatvorene silikoniziranim čepom od klorobutilne gume i lakiranim aluminjskim nepropusnim zatvaračem.
Modified live BVDV*-1, non-cytopathic parent strain KE-9: 104.0-106.0 TCID50**, Modified live BVDV*-2, non-cytopathic parent strain NY-93: 104.0-106.0 TCID50**. 
Modificirani živi BVDV*-1, necitopatogeni roditeljski soj KE-9: 104,0-106,0 TCID50**, Modificirani živi BVDV*-2, necitopatogeni roditeljski soj NY-3: 104,0-106,0 TCID50**.
EU/2/14/176/013 50 doses EU/2/14/176/014 4 x 50 doses EU/2/14/176/015 6 x 50 doses EU/2/14/176/016 10 x 50 doses 
EU/2/14/176/013 50 doza EU/2/14/176/014 4 x 50 doza EU/2/14/176/015 6 x 50 doza EU/2/14/176/016 10 x 50 doza
Each dose (2 ml) contains: BVDV-1: 104.0-106.0 TCID50, BVDV-2: 104.0-106.0 TCID50. 
Svaka doza (2 ml) sadrži: BVDV-1: 104,0-106,0 TCID50, BVDV-2: 104.0-106,0 TCID50.
5 doses (10 ml) 10 doses (20 ml) 25 doses (50 ml) 50 doses (100 ml) 4 x 5 doses (10 ml) 4 x 10 doses (20 ml) 4 x 25 doses (50 ml) 4 x 50 doses (100 ml) 6 x 5 doses (10 ml) 6 x 10 doses (20 ml) 6 x 25 doses (50 ml) 6 x 50 doses (100 ml) 10 x 5 doses (10 ml) 10 x 10 doses (20 ml) 10 x 25 doses (50 ml) 10 x 50 doses (100 ml) 
5 doza (10 ml) 10 doza (20 ml) 25 doza (50 ml) 50 doza (100 ml) 4 x 5 doza (10 ml) 4 x 10 doza (20 ml) 4 x 25 doza (50 ml) 4 x 50 doza (100 ml) 6 x 5 doza (10 ml) 6 x 10 doza (20 ml) 6 x 25 doza (50 ml) 6 x 50 doza (100 ml) 10 x 5 doza (10 ml) 10 x 10 doza (20 ml) 10 x 25 doza (50 ml) 10 x 50 doza (100 ml)
Potassium hydroxide L-Glutamine acid Potassium dihydrogen phosphate Dipotassium phosphate Sodium chloride Water for injections 
Liofilizat: saharoza želatina kalijev hidroksid L-glutaminska kiselina kalijev dihidrogenfosfat dikalijev fosfat natrijev klorid voda za injekcije
The vaccine strains are able to infect sheep and swine when administered intranasally, but no adverse reactions or spreading to in-contact animals has been demonstrated. 
Cjepni sojevi mogu zaraziti ovcu i svinju kada se primjenjuju intranazalno, ali nisu dokazane nuspojave ili širenje virusa na životinje u kontaktu sa zaraženom životinjom.
Furthermore, an increase of the rectal body temperature was common within 4 hours following administration and spontaneously resolves within 24 hours (see section 4.6). 
Nadalje, porast rektalno mjerene tjelesne temperature često se javlja unutar 4 sata nakon primjene i spontano nestaje unutar 24 sata (vidi odjeljak 4.6).
PACKAGE SIZE 
VELIČINE PAKOVANJA
Type I amber glass vials closed with siliconised bromobutyl rubber stopper with lacquered aluminium seal. 
Bočice od stakla tipa I, boje jantara, zatvorene čepom od silikonizirane bromobutilne gume i lakiranim aluminijskim nepropusnim zatvaračem.
An increase in body temperature within the physiological range is common within 4 hours of vaccination and spontaneously resolves within 24 hours (clinical studies). 
Porast tjelesne temperature unutar fiziološkog raspona često se javlja unutar 4 sata od cijepljenja i spontano nestaje u roku od 24 sata (klinička ispitivanja).
a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals. 
posjedovanje, prodaju, opskrbu i/ili primjenu imunoloških veterinarsko-medicinskih proizvoda na cijelom ili na dijelu svog teritorija ako je utvrđeno da: a) će primjena proizvoda na životinjama interferirati s provedbom nacionalnih programa za otkrivanje, kontrolu ili iskorjenjivanje bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živih životinja ili hrani ili drugim proizvodima dobivenim od tretiranih životinja b) je bolest, za koju je proizvod namijenjen da pruži imunost, u velikoj mjeri odsutna s odnosnog područja.
EU/2/14/176/005 10 doses and 20 ml EU/2/14/176/006 10 doses and 20 ml (4 x) EU/2/14/176/007 10 doses and 20 ml (6 x) EU/2/14/176/008 10 doses and 20 ml (10 x) EU/2/14/176/009 25 doses and 50 ml EU/2/14/176/010 25 doses and 50 ml (4 x) EU/2/14/176/011 25 doses and 50 ml (6 x) EU/2/14/176/012 25 doses and 50 ml (10 x) EU/2/14/176/013 50 doses and 100 ml EU/2/14/176/014 50 doses and 100 ml (4 x) EU/2/14/176/015 50 doses and 100 ml (6 x) EU/2/14/176/016 50 doses and 100 ml (10 x) 
EU/2/14/176/005 10 doza i 20 ml EU/2/14/176/006 10 doza i 20 ml (4 x) EU/2/14/176/007 10 doza i 20 ml (6 x) EU/2/14/176/008 10 doza i 20 ml (10 x) EU/2/14/176/009 25 doza i 50 ml EU/2/14/176/010 25 doza i 50 ml (4 x) EU/2/14/176/011 25 doza i 50 ml (6 x) EU/2/14/176/012 25 doza i 50 ml (10 x) EU/2/14/176/013 50 doza i 100 ml EU/2/14/176/014 50 doza i 100 ml (4 x) EU/2/14/176/015 50 doza i 100 ml (6 x) EU/2/14/176/016 50 doza i 100 ml (10 x)
EU/2/14/176/001 5 doses and 10 ml EU/2/14/176/002 5 doses and 10 ml (4 x) EU/2/14/176/003 5 doses and 10 ml (6 x) EU/2/14/176/004 5 doses and 10 ml (10 x) 
EU/2/14/176/001 5 doza i 10 ml EU/2/14/176/002 5 doza i 10 ml (4 x) EU/2/14/176/003 5 doza i 10 ml (6 x) EU/2/14/176/004 5 doza i 10 ml (10 x)
Furthermore, a increase of the rectal body temperature was common within 4 hours following administration and spontaneously resolves within 24 hours (see section “Adverse reactions”). 
Nadalje, porast rektalno mjerene tjelesne temperature često se javljao unutar 4 sata nakon primjene i spontano nestaje unutar 24 sata (vidjeti odjeljak “Nuspojave”).
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box: 5 doses, 10 doses, 25 doses, 50 doses lyophilisate and 10 ml, 20 ml, 50 ml, 100 ml solvent 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija: 5 doza, 10 doza, 25 doza, 50 doza liofilizata i otapalo od 10 ml, 20 ml, 50 ml i 100 ml
Keep the lyophilisate and the solvent vials in the outer carton. 
Držati bočice liofilizata i otapala u vanjskom kartonu.
Sucrose 
Otapalo:
Bovela lyophilisate for suspension for injection for cattle 
Bovela liofilizat za suspenziju za injekciju za goveda
Mild swellings or nodules up to 3 cm diameter were observed at the injection site after administration of a 10-fold overdose and disappeared within 4 days post vaccination. 
Nakon primjene 10 puta veće doze opažena su blaga oticanja ili čvorići promjera do 3 cm na mjestu primjene injekcije, a nestali su unutar 4 dana poslije cijepljenja.
Intramuscular use. 
U mišić.
PACKAGE LEAFLET: Bovela lyophilisate and solvent for suspension for injection for cattle 
UPUTA O VMP: Bovela liofilizat i otapalo za suspenziju za injekciju za goveda
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Lyophilisate vials: 50 doses 
Bočice s liofilizatom: 50 doza
Pharmacotherapeutic group: immunologicals for bovidae, live viral vaccines. 
Farmakoterapijska grupa: imunološki proizvodi za goveda, živa virusna cjepiva ATCvet kod: QI02AD02
Keep the vials in the outer carton. 
Držati bočice u vanjskom kartonu.
Bovela lyophilisate and solvent for suspension for injection for cattle. 
Bovela liofilizat i otapalo za suspenziju za injekciju za goveda
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vials: 5 doses, 10 doses and 25 doses 
Bočice s liofilizatom: 5 doza, 10 doza i 25 doza
MARKETING AUTHORISATION NUMBER(S) 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE PROMET
Gelatine 
OBLIK
1 lyophilisate vial of 10 ml (5 doses), 20 ml (10 doses), 50 ml (25 doses) or 100 ml (50 doses) and 1 solvent bottle of 10 ml, 20 ml, 50 ml or 100 ml packed in one cardboard box. 
1 bočica liofilizata od 10 ml (5 doza), 20 ml (10 doza), 50 ml (25 doza) ili 100 ml (50 doza) i 1 bočica otapala od 10 ml, 20 ml, 50 ml ili 100 ml pakirane u jednoj kartonskoj kutiji.
6 lyophilisate vials of 10 ml (5 doses), 20 ml (10 doses), 50 ml (25 doses) or 100 ml (50 doses) and 6 solvent bottles of 10 ml, 20 ml, 50 ml or 100 ml packed in one cardboard box. 
6 bočica liofilizata od 10 ml (5 doza), 20 ml (10 doza), 50 ml (25 doza) ili 100 ml (50 doza) i 6 bočica otapala od 10 ml, 20 ml, 50 ml ili 100 ml pakiranih u jednoj kartonskoj kutiji.
4 lyophilisate vials of 10 ml (5 doses), 20 ml (10 doses), 50 ml (25 doses) or 100 ml (50 doses) and 4 solvent bottles of 10 ml, 20 ml, 50 ml or 100 ml packed in one cardboard box. 
4 bočice liofilizata od 10 ml (5 doza), 20 ml (10 doza), 50 ml (25 doza) ili 100 ml (50 doza) i 4 bočice otapala od 10 ml, 20 ml, 50 ml ili 100 ml pakirane u jednoj kartonskoj kutiji.
10 lyophilisate vials of 10 ml (5 doses), 20 ml (10 doses), 50 ml (25 doses) or 100 ml (50 doses) and 10 solvent bottles of 10 ml, 20 ml, 50 ml or 100 ml packed in one cardboard box. 
10 bočica liofilizata od 10 ml (5 doza), 20 ml (10 doza), 50 ml (25 doza) ili 100 ml (50 doza) i 10 bočica otapala od 10 ml, 20 ml, 50 ml ili 100 ml pakiranih u jednoj kartonskoj kutiji.
MA (EU) number (Invented) name 
(Novoizumljeno) ime
• dementia (loss of intellectual function). 
• demencije (gubitka intelektualne funkcije).