natgillin/translations-raw huggingface dataset:
- If your child has any reaction like swelling or shortness of breath after being given Alkindi, get medical help straight away and tell your endocrinologist as soon as possible as these can be signs of an allergic reaction (see section 2). 
Alkindi, odmah potražite liječničku pomoć i što prije obavijestite svojeg endokrinologa, jer to mogu biti znakovi alergijske reakcije (vidjeti dio 2.).
Keep this medicine out of the sight and reach of children. 
Kako čuvati Alkindi Lijek čuvajte izvan pogleda i dohvata djece.
Alkindi granules can sometimes appear in a child's nappy or poo after taking Alkindi. 
Nakon uzimanja lijeka Alkindi ponekad se granule lijeka mogu pojaviti u pelenama ili stolici djeteta.
The capsule is printed with "INF-0.5" in red ink. 
Na kapsuli je oznaka „INF-0.5” otisnuta crvenom tintom.
- Anticonvulsants: phenytoin, carbamazepine and oxcarbazepine - Antibiotics: rifampicin and rifabutin - Barbiturates including phenobarbital and primidone - Antiretroviral medicinal products: efavirenz and nevirapine 
- Antikonvulzive: fenitoin, karbamazepin i okskarbazepin - Antibiotike: rifampicin i rifabutin
Undesirable effects of corticosteroid replacement therapy Most undesirable effects of corticosteroids are dose and duration of exposure related. 
Većina nuspojava uzrokovanih kortikosteroidima povezana je s doziranjem i trajanjem izloženosti.
- being fed through a nasogastric tube. 
- se Vaše dijete hrani putem nazogastrične sonde.
- Medicine used to treat human immunodeficiency virus (HIV) infection and AIDS: ritonavir. 
- Lijek koji se primjenjuje za liječenje infekcije virusom humane imunodeficijencije (HIV) i
The capsule is printed with "INF-1.0" in blue ink. 
Na kapsuli je oznaka „INF-1.0” otisnuta plavom tintom.
Let your endocrinologist know when your child is due for vaccinations. 
Obavijestite svojeg endokrinologa kada se Vaše dijete treba cijepiti. - se Vaše dijete mora podvrgnuti operaciji.
- Liquorice. 
- Sladić.
Medicinal products/substances inhibiting CYP3A4, requiring a potential decrease in Alkindi dosing, include but are not limited to: 
- Antiretrovirusne lijekove: efavirenz i nevirapin Lijekovi/tvari koji inhibiraju CYP3A4 i kod kojih može trebati smanjenje doze lijeka Alkindi uključuju, ali nisu ograničeni na:
The capsule is printed with "INF-5.0" in grey ink. 
Na kapsuli je oznaka „INF-5.0” otisnuta sivom tintom.
The capsule is printed with "INF-2.0" in green ink. 
Na kapsuli je oznaka „INF-2.0” otisnuta zelenom tintom.
If your child gets any side effects, talk to your doctor or pharmacist. 
- Ako u djeteta primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
Bone mineral density may be impacted in children when higher doses of replacement steroids are used. 
Primjena viših doza nadomjesnih steroida može utjecati na gustoću minerala u kostima u djece.
Pre-operatively, during serious trauma or illness in patients with known adrenal insufficiency or doubtful adrenal reserve 
Prije kirurškog zahvata, za vrijeme ozbiljne traume ili bolesti u bolesnika s potvrđenom adrenalnom insuficijencijom ili s upitnom adrenalnom rezervom Prije kirurškog zahvata treba obavijestiti anesteziologa uzima li bolesnik kortikosteroide ili ih je prethodno uzimao.
overexcitement and overactivity (mania). 
(halucinacije) i mentalnu zbunjenost (delirij).
- Alkindi 0.5 mg granules in capsules for opening: the capsule is printed with "INF-0.5" in red ink. 
- Alkindi 0,5 mg granule u kapsulama za otvaranje: na kapsuli je oznaka „INF-0.5” otisnuta crvenom tintom.
Each capsule contains 0.5 mg hydrocortisone. 
Jedna kapsula sadrži 0,5 mg hidrokortizona
Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroids, especially when a patient has a history of allergies to medicinal products. 
osobito kada bolesnik u povijesti bolesti ima alergijske reakcije na lijekove.
- Alkindi 1 mg granules in capsules for opening: the capsule is printed with "INF-1.0" in blue ink. 
- Alkindi 1 mg granule u kapsulama za otvaranje: na kapsuli je oznaka „INF-1.0” otisnuta plavom tintom.
- Alkindi 5 mg granules in capsules for opening: the capsule is printed with "INF-5.0" in grey ink. 
- Alkindi 5 mg granule u kapsulama za otvaranje: na kapsuli je oznaka „INF-5.0” otisnuta sivom tintom.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 0.5 MG CAPSULES 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S KAPSULAMA OD 0,5 MG
Each capsule contains 2 mg hydrocortisone. 
Jedna kapsula sadrži 2 mg hidrokortizona.
Each capsule contains 5 mg hydrocortisone. 
Jedna kapsula sadrži 5 mg hidrokortizona.
- Alkindi 2 mg granules in capsules for opening: the capsule is printed with "INF-2.0" in green ink. 
- Alkindi 2 mg granule u kapsulama za otvaranje: na kapsuli je oznaka „INF-2.0” otisnuta zelenom tintom.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE 0.5 MG CAPSULES 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BOCA S KAPSULAMA OD 0,5 MG
Each capsule contains 1 mg hydrocortisone. 
Jedna kapsula sadrži 1 mg hidrokortizona.
Alkindi 0.5 mg granules in capsules for opening Each capsule contains 0.5 mg hydrocortisone 
Alkindi 0,5 mg granule u kapsulama za otvaranje Jedna kapsula sadrži 0,5 mg hidrokortizona
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE 1 MG CAPSULES 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BOCA S KAPSULAMA OD 1 MG
Alkindi 2 mg granules in capsules for opening Each capsule contains 2 mg hydrocortisone 
Alkindi 2 mg granule u kapsulama za otvaranje Jedna kapsula sadrži 2 mg hidrokortizona
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 1 MG CAPSULES 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S KAPSULAMA OD 1 MG
Alkindi has no influence on a child's ability to perform skilled tasks (e.g. riding a bicycle) or using machines. 
Lijek Alkindi ne utječe na sposobnost djeteta da obavlja poslove koji zahtijevaju određene vještine
Alkindi 1 mg granules in capsules for opening Each capsule contains 1 mg hydrocortisone 
Alkindi 1 mg granule u kapsulama za otvaranje Jedna kapsula sadrži 1 mg hidrokortizona
Alkindi 5 mg granules in capsules for opening Each capsule contains 5 mg hydrocortisone 
Alkindi 5 mg granule u kapsulama za otvaranje Jedna kapsula sadrži 5 mg hidrokortizona
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE 2 MG CAPSULES 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BOCA S KAPSULAMA OD 2 MG
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 2 MG CAPSULES 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S KAPSULAMA OD 2 MG
Alkindi 5 mg granules in capsules for opening 
Alkindi 5 mg granule u kapsulama za otvaranje
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE 5 MG CAPSULES 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BOCA S KAPSULAMA OD 5 MG
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 5 MG CAPSULES 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S KAPSULAMA OD 5 MG
No side effects have been observed with Alkindi, but the following side effects have been reported for other hydrocortisone medicines used to replace cortisol: Frequency not known (cannot be estimated from the available data): - Changes in behaviour including: loss of contact with reality (psychosis) with sensations that are not real (hallucinations) and mental confusion (delirium). 
Učestalost nepoznata (ne može se procijeniti iz dostupnih podataka): - Promjene u ponašanju, uključujući:
Alkindi 0.5 mg granules in capsules for opening 
Alkindi 0,5 mg granule u kapsulama za otvaranje
Alkindi 1 mg granules in capsules for opening 
Alkindi 1 mg granule u kapsulama za otvaranje
Alkindi 2 mg granules in capsules for opening 
Alkindi 2 mg granule u kapsulama za otvaranje
Alkindi 1 mg granules in capsules for opening hydrocortisone 
Alkindi 1 mg granule u kapsulama za otvaranje hidrokortizon
Alkindi 2 mg granules in capsules for opening hydrocortisone 
Alkindi 2 mg granule u kapsulama za otvaranje hidrokortizon
Alkindi 0.5 mg granules in capsules for opening hydrocortisone 
Alkindi 0,5 mg granule u kapsulama za otvaranje hidrokortizon
Alkindi 5 mg granules in capsules for opening hydrocortisone 
Alkindi 5 mg granule u kapsulama za otvaranje hidrokortizon
Pre-operatively, anaesthetists must be informed if the patient is taking corticosteroids or has previously taken corticosteroids. 
Zabilježeni su rijetki slučajevi anafilaktičkih reakcija u bolesnika koji su primali kortikosteroide,
- Liquorice 
- Sladić
Gastrointestinal disorders 
Nuspojave nadomjesne terapije kortikosteroidima
EU/1/17/1260/004 50 capsules 
EU/1/17/1260/004 50 kapsula
- The active substance is hydrocortisone - Alkindi 0.5 mg granules in capsules for opening: each capsule contains 0.5 mg of hydrocortisone - Alkindi 1 mg granules in capsules for opening: each capsule contains 1 mg of hydrocortisone - Alkindi 2 mg granules in capsules for opening: each capsule contains 2 mg of hydrocortisone - Alkindi 5 mg granules in capsules for opening: each capsule contains 5 mg of hydrocortisone - The other ingredients are microcrystalline cellulose, hypromellose, magnesium stearate and ethyl cellulose. 
Alkindi 0,5 mg granule u kapsulama za otvaranje Alkindi 1 mg granule u kapsulama za otvaranje Alkindi 2 mg granule u kapsulama za otvaranje Alkindi 5 mg granule u kapsulama za otvaranje hidrokortizon
Hydrocortisone 
Gastritis
EU/1/17/1260/001 50 capsules 
EU/1/17/1260/001 50 kapsula
EU/1/17/1260/003 50 capsules 
EU/1/17/1260/003 50 kapsula
EU/1/17/1260/002 50 capsules 
EU/1/17/1260/002 50 kapsula
- Too much Alkindi can affect your child's growth, so your endocrinologist will adjust the dose depending on your child's size and monitor your child's growth carefully. 
Budući da lijek Alkindi zamjenjuje prirodni hormon kojeg Vaše dijete nema dovoljno, nuspojave su manje česte, međutim: - Prevelike količine lijeka Alkindi mogu utjecati na rast Vašeg djeteta, stoga će endokrinolog prilagoditi dozu ovisno o veličini djeteta te će pomno pratiti rast Vašeg djeteta.
Gastritis Nausea 
Prijavljivanje nuspojava
Renal and urinary disorders 
Poremećaji bubrega i mokraćnog sustava
How to store Alkindi 
Moguće nuspojave 5. Kako čuvati Alkindi
White homogeneous suspension. 
Bijela homogena suspenzija.
Date of first authorisation: 16/09/2010 
Datum prvog odobrenja: 16/09/2010.
Very rare adverse reactions: 
Vrlo rijetke nuspojave:
Date of last renewal: 30/06/2015 
Datum posljednjeg produljenja odobrenja: 30/06/2015
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder. 
Za bilo koju informaciju o ovom veterinarsko-medicinskom proizvodu, molimo kontaktirajte lokalnog predstavnika nositelja odobrenja za stavljanje u promet.
Pregnancy: Can be used during pregnancy. 
Graviditet: Može se primijeniti tijekom graviditeta.
- A transient increase in body temperature of about 0.7°C can occur during the first 6 hours after injection. 
- Prolazni porast tjelesne temperature od približno 0,7 C može se pojaviti tijekom prvih 6 sati nakon injiciranja.
In case of accidental self-injection only a minor injection site reaction is expected. 
U slučaju da se nehotice samoinjicira, očekuje se samo manja reakcija na mjestu injiciranja.
ATCvet code: QI09AB04 
ATCvet kod: QI09AB04.
This rectal temperature increase is spontaneously resolved within 24 hours without treatment. 
Porast rektalne temperature spontano prolazi unutar 24 sata bez liječenja.
A transient slight swelling of less than 2 to 3 cm in diameter can occur at the injection site which may last up to five days and occasionally up to two weeks. 
Prolazna lagana oteklina promjera manjeg od 2 do 3 cm može se pojaviti na mjestu injiciranja i može trajati do pet dana, a ponekad i do dva tjedna.
The active substances being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009. 
Djelatne tvari se sastoje od tvari biološkog podrijetla, namijenjene za stvaranje aktivne imunosti, na njih se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
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 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 su ili 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 (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko-medicinskim proizvodima.
The first injection should be administered 6-8 weeks before the expected date of farrowing. 
Prvu injekciju primijeniti 6-8 tjedna prije predviđenog datuma prasenja.
Pharmacotherapeutic group: Inactivated bacterial vaccines (Bordetella and Pasteurella) for pigs. 
Farmakoterapijska grupa: inaktivirana bakterijska cjepiva (Bordetella i Pasteurella) za svinje.
- Anaphylactic type reactions have been reported in spontaneous reports and appropriate symptomatic treatment is recommended. 
- Reakcije anafilaktičkog tipa zabilježene su u spontanim izvješćima i preporučuje se odgovarajuća simptomatska terapija.
An increase of rectal temperature up to 1.5ºC may occur. 
Može se pojaviti porast rektalne temperature do 1,5 ºC.
No adverse reactions other than already mentioned under point 4.6 can be expected, except for an increase of rectal temperature up to 2ºC. 
Ne očekuju se druge nuspojave pored onih navedenih u točki 4.6, osim porasta rektalne temperature do 2ºC.
Basic vaccination: sows and gilts which have not been previously vaccinated with the product should be given two injections with an interval of 3-4 weeks. 
Osnovno cijepljenje: krmače i nazimice koje prethodno nisu bile cijepljenje tim cjepivom trebaju dobiti dvije injekcije u razmaku od 3 do 4 tjedna.
1 x 10 doses (20 ml) 10 x 10 doses (20 ml) 1 x 25 doses (50 ml) 1 x 50 doses (100 ml) 1 x 125 doses (250 ml) 1 x 10 doses (20ml) 10 x 10 doses (20 ml) 1 x 25 doses (50 ml) 1 x 50 doses (100 ml) 
1 x 10 doza (20 ml) 10 x 10 doza (20 ml) 1 x 25 doza (50 ml) 1 x 50 doza (100 ml) 1x 125 doza (250 ml) 1 x10 doza (20ml) 10 x 10 doza (20 ml) 1 x 25 doza (50 ml) 1 x 50 doza (100 ml)
Revaccination: a single injection should be given 3-4 weeks prior to each subsequent farrowing. 
Docjepljivanje: jednu injekciju primijeniti 3-4 tjedna prije svakog sljedećeg prasenja.
1 dose (2 ml): 
1 doza (2 ml):
RHINISENG suspension for injection for pigs. 
RHINISENG suspenzija za injekciju za svinje.
This discoloration is attributable to aluminium hydroxide and may be observed up to seven weeks after the injection of a double dose of vaccine. 
Promjena boje je posljedica aluminijevog hidroksida i vidljiva je do sedam tjedana nakon injiciranja dvostruke doze cjepiva.
Challenge studies have demonstrated that passive immunity lasts until piglets are 6 weeks of age while in clinical field trials, the beneficial effects of vaccination (reduction in nasal lesion score and weight loss) are observed until slaughter. 
Ispitivanja izazivanja imunološkog odgovora pokazala su da pasivna imunost traje dok prasad ne dostigne 6 tjedna starosti, a u kliničkim terenskim ispitivanjima korisni učinci cijepljenja (smanjenje lezija nosa i gubitak tjelesne mase) zapaženi su do klanja.
No adverse reactions other than already mentioned under point “Adverse reactions” can be expected, except for an increase of rectal temperature up to 2ºC. 
Ne očekuju se druge nuspojave pored onih navedenih u točki “Nuspojave“, osim porasta rektalne temperature do 2ºC.
Store and transport refrigerated (2 °C - 8 °C). 
Čuvati i prevoziti na hladnom (2°C - 8°C)
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 
Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobivenih primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima.
Each dose of 2 ml contains: 
Jedna doza od 2 ml sadrži:
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX 
PODACI NA VANJSKOM PAKOVANJU KARTONSKA KUTIJA
50 doses (100 ml) 50 doses (100 ml) 125 doses (250 ml) 
50 doza (100 ml) 50 doza (100 ml) 125 doza (250 ml)
Type II colourless glass vials of 50 ml and 100 ml . 
Bezbojne bočice od stakla tipa II od 50 ml i 100 ml.
Laboratorios Hipra, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) Spain 
Laboratorios Hipra, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL 
OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
Inactivated Bordetella bronchiseptica, strain 833CER: ........................................9.8 BbCC(*) Recombinant Type D Pasteurella multocida toxin (PMTr): ............................ ≥ 1 MED63(**) (*) Bordetella bronchiseptica Cell Count in log10. 
Inaktivirani soj bakterije Bordetella bronchiseptica, 833CER: .............................9,8 BbCC(*) Rekombinantni toksin bakterije Pasteurella multocida tipa D (PMTr): .......... ≥ 1 MED63(**) (*) Bordetella bronchiseptica broj stanica u log10.
Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Sodium chloride 
FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari aluminijev hidroksid DEAE-dekstran ginseng formaldehid simetikon dinatrijev fosfat dodekahidrat kalijev dihidrogenfosfat natrijev klorid kalijev klorid voda za injekcije
20 ml, 50 ml, 100 ml and 250 ml Polyethylene (PET) bottles closed with a rubber stopper and aluminium cap. 
Polietilenske (PET) boce od 20 ml, 50 ml, 100 ml i 250 ml zatvorene gumenim čepom i aluminijskim zatvaračem.
Aluminium hydroxide gel .......................................................................... 6.4 mg (aluminium) DEAE-Dextran 
aluminijev hidroksid, gel ................................................................................ 6,4 mg (aluminij) DEAE-dekstran ginseng
Shelf life after first opening the immediate packaging: 10 hours stored at room temperature. 
Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: 10 sati, čuvano na sobnoj temperaturi.
PACKAGE LEAFLET: RHINISENG suspension for injection for pigs 
UPUTA O VMP: RHINISENG suspenzija za injekciju za svinje
Allow the vaccine to reach room temperature (15-25˚C) before administration. 
Prije primjene pričekajte da cjepivo dostigne sobnu temperaturu (15-25oC).
Discoloration of muscular fibres of the inoculation site (0.5 cm wide x 2 cm long) may be observed at necropsy in 10% of animals. 
Prilikom sekcije može se zapaziti promjena boje mišićnih vlakana na mjestu cijepljenja (0,5 cm širine x 2 cm dužine) u 10% životinja.
For the passive protection of piglets via colostrum after active immunisation of sows and gilts to reduce the clinical signs and lesions of progressive and non-progressive atrophic rhinitis, as well as to reduce weight loss associated with Bordetella bronchiseptica and Pasteurella multocida infections during the fattening period. 
Za pasivnu zaštitu prasadi preko kolostruma nakon aktivne imunizacije krmača i nazimica da bi se umanjili klinički znakovi i lezije progresivnog i neprogresivnog atrofičnog rinitisa te da bi se umanjio gubitak tjelesne mase povezan sa zarazama s Bordetella bronchiseptica i Pasteurella multocida u razdoblju tova.
To stimulate active immunity in order to provide passive immunity to the progeny against atrophic rhinitis associated with Bordetella bronchiseptica and Pasteurella multocida infections. 
Poticanje aktivne imunosti radi postizanja pasivne imunosti u potomstvu protiv atrofičnog rinitisa povezanog sa zarazama s Bordetella bronchiseptica i Pasteurella multocida.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE BOTTLE AND VIAL LABEL 
PODACI NA UNUTARNJEM PAKOVANJU BOCA I ETIKETA BOČICE
Inactivated Bordetella bronchiseptica, strain 833CER: ............................................ 9.8 BbCC Recombinant Type D Pasteurella multocida toxin (PMTr): ................................... ≥ 1 MED63 
Inaktivirani soj bakterije Bordetella bronchiseptica, 833CER: ................................. 9,8 BbCC Rekombinantni toksin bakterije Pasteurella multocida tipa D (PMTr): .................
(**) Murine Effective Dose 63: vaccination of mice with 0.2 ml of a 5-fold diluted vaccine by subcutaneous route induces seroconversion in at least 63 % of the animals. 
(**) Djelotvorna doza u miševa 63: subkutano cijepljenje miševa s 0,2 ml 5-erostruko razrijeđenim cjepivom inducira serokonverziju u najmanje 63% životinja.
(**) Murine Effective Dose 63: vaccination of mice with 0.2 ml of a 5-fold diluted vaccine by subcutaneous route induces seroconversion in at least 63% of the animals. 
(**) Djelotvorna doza u miševa 63: subkutano cijepljenje miševa s 0,2 ml 5-erostruko razrijeđenim cjepivom inducira serokonverziju u najmanje 63 % životinja.
HIPRA FRANCE Tél. 
HIPRA FRANCE
Store and transport refrigerated. 
11. POSEBNI UVIJETI ČUVANJA Čuvati i prevoziti na hladnom.
LABORATORIOS HIPRA, S.A. Avda. 
LABORATORIOS HIPRA, S.A.
EXP {month/ year} Once opened, use within a 10-hour period, stored at 15 ºC to 25 ºC. 
Jednom otvoreno pakovanje, primijeniti u roku od 10 sati, čuvano između 15°C i 25ºC.
6.5 Nature and composition of immediate packaging 
6.5 Osobine i sastav unutarnjeg pakovanja Bezbojne bočice od stakla tipa
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČI BIOLOŠKI DJELATNIH TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
Shelf life after first opening the immediate packaging: 10 hours stored at 15 ºC to 25 ºC. 
Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: 10 sati čuvano između 15ºC i 25°C.
- Transient local reactions may occur after the administration of one dose of vaccine. 
Česte nuspojave: - Nakon primjene jedne doze cjepiva mogu se pojaviti prolazne lokalne reakcije.
A. LABELLING 
ETIKETA
Pack sizes: - Cardboard box with 1 or 10 glass vials of 10 doses. 
15. OSTALE INFORMACIJE Veličine pakovanja: - Kartonska kutija s 1 ili 10 staklenih bočica po 10 doza.
- Cardboard box with 1 or 10 PET bottles of 10 doses. 
- Kartonska kutija s 1 ili 10 plastičnih (PET) boca po 10 doza.
Name and address of the manufacturer
 responsible for batch release 
Naziv i adresa proizvođača odgovornog za puštanje serije u promet
IM. 
C.
- Cardboard box with 1 PET bottle of 125 doses. 
- Kartonska kutija s 1 plastičnom (PET) bocom po 125 doza.
- Cardboard box with 1 PET bottle of 25 doses. 
- Kartonska kutija s 1 staklenom bočicom po 25 doza.
Excipient: 
Inkompatibilnosti:
- Cardboard box with 1 PET bottle of 50 doses. 
- Kartonska kutija s 1 staklenom bočicom po 50 doza.
Formaldehyde .................................................................................................................. 0.8 mg For the full list of excipients, see section 6.1. 
formaldehid ..................................................................................................................... 0,8 mg Bijela homogena suspenzija.
It was to be available as capsules. 
Trebao je biti dostupan u kapsulama.
The company that applied for authorisation is Portola Pharma UK Limited. 
Zahtjev za izdavanje odobrenja podnijela je tvrtka Portola Pharma UK Limited.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is treating you in the clinical trial. 
Ako sudjelujete u kliničkom ispitivanju te vam je potrebno više informacija o liječenju, obratite se liječniku koji vas liječi u kliničkom ispitivanju.
The company presented the results of one main study involving over 7,500 adults who had been admitted to hospital for a recent medical illness. 
Tvrtka je predstavila rezultate jednog glavnog ispitivanja u kojem je sudjelovalo više od 7 500 odraslih osoba koje su u bolnicu primljene radi nedavne bolesti.
What is Dexxience? 
Što je Dexxience?