FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Bonviva 3 mg solution for injection Ibandronic acid
Croatian: NAZIV LIJEKA Bonviva 3 mg otopina za injekciju ibandronatna kiselina
English: Very rare (may affect up to 1 in 10,000 people):
Croatian: Vrlo rijetko (mogu se javiti u manje od 1 na 10 000 osoba)
English: Bonviva 3 mg intravenous injection, administered every 3 months, was shown to be at least as effective as oral ibandronic acid 2.5 mg daily in a 2-year, randomised, double-blind, multicentre, noninferiority study (BM16550) of postmenopausal women (1386 women aged 55 - 80) with osteoporosis (lumbar spine BMD T-score below -2.5 SD at baseline).
Croatian: Mineralna gustoća kosti (BMD - Bone mineral density) Dvogodišnje, randomizirano, dvostruko slijepo, multicentrično, ispitivanje neinferiornosti (BM 16550) u žena s osteoporozom (početna T-vrijednost mineralne gustoće kosti lumbalne kralježnice manja od -2,5 SD) i u postmenopauzi (1386 žena od 55 do 80 godina) pokazalo je da intravenska injekcija lijeka Bonviva od 3 mg koja se primjenjuje svaka tri mjeseca barem jednako djelotvorna kao peroralno primijenjena ibandronatna kiselina od 2,5 mg koja se uzima jedanput dnevno.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/265/005
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/265/005
English: Marketing Authorisation Holder Atnahs Pharma Netherlands B.V. Strawinskylaan 3127
Croatian: Nositelj odobrenja Atnahs Pharma Netherlands B.V.
English: At two years 93.4 % (p<0.001) of patients receiving Bonviva 150 mg once monthly and 78.4 %, of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline.
Croatian: Nakon dvije godine je u 93,4% (p<0,001) bolesnika koji su primali lijek Bonviva 150 mg jedanput mjesečno odnosno 78,4% bolesnika koji su primali ibandronatnu kiselinu 2,5 mg jedanput dnevno došlo do povećanja BMD cijelog kuka više ili jednako početnoj razini.
English: Tablet core
Croatian: Tablica nuspojava
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bonviva 3 mg solution for injection
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Bonviva 3 mg otopina za injekciju ibandronatna kiselina
English: METHOD OF ADMINISTRATION Read the package leaflet before use
Croatian: NAČIN PRIMJENE LIJEKA Prije uporabe vidjeti uputu o lijeku
English: At two years, 80.1 % and 68.8 % of patients met this criterion in the 3 mg every 3 months injection arm and the 2.5 mg daily arm (p=0.001).
Croatian: Nakon dvije godine taj je kriterij zadovoljilo 80,1% bolesnika koji su primali injekciju lijeka Bonviva od 3 mg svaka tri mjeseca odnosno 68,8% bolesnika koji su peroralno primali lijek Bonviva od 2,5 mg jedanput dnevno (p=0,001).
English: Angioedema, Facial swelling/oedema, Urticaria
Croatian: Poremećaji kože i potkožnog tkiva osip angioedem, edem lica, urtikarija
English: ibandronic acid 2.5 mg daily (N=318)
Croatian: Ibandronatna kiselina 2,5 mg jedanput dnevno (n=318)
English: ibandronic acid 2.5 mg daily (N=294)
Croatian: Ibandronatna kiselina 2,5 mg jedanput dnevno (n=294)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/265/005 1 pre-filled syringe EU/1/03/265/006 4 pre-filled syringes
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/265/005 1 napunjena štrcaljka
English: - Patients should not lie down for 1 hour after taking Bonviva.
Croatian: - Nakon uzimanja lijeka Bonviva bolesnik ne smije leći sljedećih sat vremena.
English: At two years, 93.5 % (p=0.004) and 86.4 % of patients receiving Bonviva 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders.
Croatian: Nakon dvije godine odgovorilo je 93,5% (p=0,004) bolesnika koji su primali lijek Bonviva 150 mg jedanput mjesečno, odnosno 86,4% onih koji su primali ibandronatnu kiselinu 2,5 mg jedanput dnevno.
English: How to take Bonviva
Croatian: Kako uzimati lijek Bonviva
English: At two years 78.7 % (p=0.002) and 65.6 % of patients were identified as responders in the 150 mg monthly and 2.5 mg daily arms respectively.
Croatian: Nakon dvije godine odgovorilo je 78,7% (p=0,002) bolesnika koji su primali lijek Bonviva 150 mg jedanput mjesečno odnosno 65,6% bolesnika koji su primali lijek Bonviva 2,5 mg jedanput dnevno.
English: How to store Bonviva
Croatian: Kako čuvati lijek Bonviva
English: Oesophagitis including oesophageal ulcerations or strictures and dysphagia, Vomiting, Flatulence
Croatian: ezofagitis, gastritis, gastroezofagealni refluks, dispepsija, proljev, bol u abdomenu, mučnina ezofagitis uključujući ulceracije ili strikture jednjaka i disfagiju, povraćanje, flatulencija duodenitis
English: At two years the median relative change was -68 % and -62 %, in the 150 mg monthly and 2.5 mg daily arms respectively.
Croatian: Nakon dvije godine medijan relativne vrijednosti promjene iznosio je -68% za lijek Bonviva 150 mg jedanput mjesečno odnosno -62% za lijek Bonviva 2,5 mg jedanput dnevno.
English: Continuing to receive Bonviva
Croatian: Nastavljanje primjene lijeka Bonviva
English: How to receive Bonviva
Croatian: Kako ćete primati lijek Bonviva
English: Due to the limited clinical experience, Bonviva is not recommended in patients with severe renal impairment (see section 4.2 and section 4.4).
Croatian: Bonviva se ne preporučuje bolesnicima s teškim oštećenjem funkcije bubrega zbog ograničenih kliničkih iskustava (vidjeti dijelove 4.2 i dio 4.4).
English: ibandronic acid 2.5 mg daily (N=977)
Croatian: Ibandronatna kiselina 2,5 mg jedanput dnevno (n=977)
English: Rare (may affect up to 1 in 1000 people):
Croatian: Rijetko (mogu se javiti u manje od 1 na 1000 osoba)
English: If you are unable to do so, you should inform your doctor
Croatian: Obavijestite liječnika ako to ne možete učiniti.
English: Immune system disorders
Croatian: Poremećaji probavnog sustava*
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Manje često (mogu se javiti u manje od 1 na 100 osoba )
English: • You should take calcium and vitamin-D supplements while receiving Bonviva.
Croatian: • za vrijeme liječenja lijekom Bonviva neophodno je uzimati preparate s kalcijem i vitaminom D.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 150 mg ibandronic acid (as sodium monohydrate).
Croatian: TVARI Jedna filmom obložena tableta sadrži 150 mg ibandronatne kiseline (u obliku natrijevog hidrata).
English: An expected decrease in bone turnover, normal quality of bone and absence of defects in mineralization were also seen after two years of treatment with Bonviva 3 mg injection.
Croatian: Nakon dvije godine liječenja injekcijom lijeka Bonviva od 3 mg primijećeno je očekivano smanjenje koštanog metabolizma, normalna kvaliteta kosti bez znakova poremećaja mineralizacije.
English: Bonviva 150 mg once monthly was shown to be at least as effective as ibandronic acid 2.5 mg daily at increasing BMD in a two year, double-blind, multicentre study (BM 16549) of postmenopausal women with osteoporosis (lumbar spine BMD T score below -2.5 SD at baseline).
Croatian: Mineralna gustoća kosti (BMD - Bone mineral density) Dvogodišnje, dvostruko slijepo, multicentrično ispitivanje (BM 16549) u žena s postmenopauzalnom osteoporozom (početna T-vrijednost BMD lumbalne kralježnice manja od -2,5 SD) pokazala je da je Bonviva 150 mg jedanput mjesečno barem jednako djelotvorna u povećanju BMD kao ibandronatna kiselina 2,5 mg jedanput dnevno.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe of 3 ml solution contains 3 mg of ibandronic acid (as sodium monohydrate).
Croatian: TVARI Jedna napunjena štrcaljka s 3 ml otopine sadrži 3 mg ibandronatne kiseline (u obliku natrijeva hidrata).
English: Bonviva is essentially sodium free.
Croatian: Bonviva sadrži zanemarive količine natrija.
English: (dead bone tissue) in the jaw bone)
Croatian: (nekroze, tj. odumiranja koštanog tkiva)
English: Skin and subcutaneous tissues disorders
Croatian: Atipični prijelomi bedrene kosti
English: Arthralgia, Myalgia, Musculoskeletal pain, Muscle cramp, Musculoskeletal stiffness
Croatian: Jezgra tablete laktoza hidrat povidon celuloza, mikrokristalična krospovidon stearatna kiselina silicijev dioksid, koloidni, bezvodni
English: Please see the Summary of Product Characteristics for more information.
Croatian: Dodatne informacije potražite u Sažetku opisa svojstava lijeka.
English: Femoral neck BMD
Croatian: BMD lumbalne kralježnice
English: Injection site reactions, Asthenia
Croatian: Opći poremećaji i reakcije na mjestu primjene bolest slična gripi * umor
English: Ocular inflammation
Croatian: Oštećenje funkcije bubrega
English: Lumbar spine L2-L4 BMD 3.8 [3.4, 4.2] 4.8 [4.5, 5.2] 4.8 [4.3, 5.4] 6.3 [5.7, 6.8]
Croatian: Incidencija kliničkih prijeloma kralježaka 5,33% (3,73; 6,92)
English: Administration failures
Croatian: Greške prilikom primjene
English: Sodium chloride solution (0.9%)
Croatian: Otopina natrijevog klorida (0,9 %)
English: Keep the bottle in the outer carton in order to protect from light.
Croatian: Čuvati bočicu u vanjskom pakovanju radi zaštite od svjetla.
English: After administration of a double dose (4 ml), no adverse reactions other than those described in section 4.6 were observed.
Croatian: Nakon primjene dvostruke doze (4 ml), nisu primijećeni nikakvi neželjeni učinci osim onih već spomenutih u odjeljku 4.6. 4.11.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka doza od 2 ml sadrži:
English: PROHIBITION OF SALE; SUPPLY AND/OR USE Not applicable.
Croatian: ZABRANA PRODAJE; OPSKRBE I/ILI PRIMJENE
English: PHARMACEUTICAL FORM Suspension for injection
Croatian: OBLIK Suspenzija za injekcije.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Croatian: Čuvati u hladnjaku
English: On very rare occasions, a slight transient rectal temperature increase might occur after vaccination (“very rare” corresponds to a frequency of adverse reactions less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: U vrlo rijetkim slučajevima nakon cijepljenja može doći do malog povišenja rektalne temperature (¨vrlo rijetko¨ odgovara učestalosti nuspojava manjoj od 1 životinje na 10.000, uključujući izolirane slučajeve).
English: 50 ml (25 doses)
Croatian: 50 ml (25 doza).
English: EXPIRY DATE EXP {month/year} Once opened, use within 10 hours.
Croatian: ROK VALJANOSTI EXP {mjesec/godina} Jednom otvoreno, primijeniti u roku 10 sati.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 20 ml (10 doses)
Croatian: SADRŽAJ: TEŽINA, VOLUMEN IL BROJ DOZA 20 ml (10 doza),
English: 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.
Croatian: Komisije (EU) br. 37/2010 naznačeno da se za njih ne zahtijeva određivanje DNK (MRL) ili nisu obuhvaćene odredbama Uredbe (EZ)br. 470/2009, kada se koriste u ovom veterinarskom medicinskom proizvodu.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Respiporc FLU3 suspension for injection for pigs
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA RESPIPORC FLU3 injekcijska suspenzija za svinje.
English: DATE OF FIRST AUTHORISATION Date of first authorisation: 14/01/2010 Date of last renewal: 04/12/2014
Croatian: Datum prvog odobrenja: 14.01.2010
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako zamijetite ozbiljne nuspojave ili druge nuspojave koje nisu opisane u uputi o VMP, molimo da se javite veterinaru.
English: 1GMNU = Geometric mean of neutralizing units induced in Guinea pigs after twice immunisation with 0.5 ml of this vaccine
Croatian: 1GMNU = Geometrijska sredina neutralizirajućih jedinica inducirana kod zamorčadi nakon dvokratne imunizacije s 0,5 ml ovog cjepiva Adjuvans:
English: 0.21 mg For the full list of excipients, see section 6.1.
Croatian: Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: PHARMACEUTICAL FORM Clear, yellowish orange to pink coloured suspension for injection.
Croatian: OBLIK Bistra, žuto narančasta do ružičasta suspenzija za injekcije.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/
English: Special precautions for use
Croatian: Posebne mjere opreza za čuvanje
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box for 20ml, 50 ml, 100 ml, 8 x 500 ml
Croatian: PODACI NA VANJSKOM PAKOVANJU Kartonska kutija za 20 ml, 50 ml, 100 ml
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
Croatian: PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I NOSITELJ(I)
English: or - Between the age of 56 and 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 4 months.
Croatian: - Između 56 i 96 dana starosti, u razmaku od 3 tjedna između injekcija za postizanje imuniteta u trajanju dužem od 4 mjeseca.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Croatian: 13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVETI ILI OGRANIČENJA U
English: A transient slight swelling may occur on very rare occasions after vaccination at the site of injection, regressing within 2 days.
Croatian: NUSPOJAVE Nakon cijepljenja se u vrlo rijetkim slučajevima može na mjestu uboda javiti prolazni mali otok koji se povlači za 2 dana.
English: PACKAGE LEAFLET: Respiporc FLU3 Suspension for injection for pigs
Croatian: UPUTA O VMP RESPIPORC FLU3 Injekcijska suspenzija za svinje
English: Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Croatian: Posebne mjere opreza za odlaganje neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: EXP {month/year} Once opened, use within 10 hours.
Croatian: Jednom otvoreno, primijeniti u roku 10 sati.
English: STATEMENT OF ACTIVE SUBSTANCES Each dose of 2 ml contains:
Croatian: Svaka doza od 2 ml sadrži:
English: Duration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above.
Croatian: Trajanje imuniteta: 4 mjeseca kod svinja cijepljenih u dobi između 56 i 96 dana i
English: Major incompatibilities
Croatian: Inkompatibilnosti
English: 20 ml vials, glass type I 50 ml vials, glass type II 100 ml vials, glass type II
Croatian: Staklene bočice: 20 ml bočice, staklo tip I, 50 ml bočice, staklo tip II, 100 ml bočice, staklo tip II.
English: Bakum/IDT1769/2003 (H3N2)
Croatian: A /svinja/ Bakum/IDT1769/2003 (H3N2)
English: Interactions:
Croatian: Inkompatibilnosti:
English: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above.
Croatian: 6 mjeseci kod svinja cijepljenih prvi puta u dobi od 96 dana i starijih.
English: 0.21 mg Clear, yellowish orange to pink coloured suspension for injection.
Croatian: Bistra, žuto narančasta do ružičasta suspenzija za injekcije.
English: MARKETING AUTHORISATION NUMBER EU/2/09/103/001-007
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/09/103/001-006
English: MATERIALS, IF ANY
Croatian: PROIZVODNE SERIJE, AKO JE RAZLIČITO
English: The vaccine stimulates an active immunity against Swine Influenza A virus subtypes H1N1, H3N2 and H1N2.
Croatian: 15. OSTALE INFORMACIJE Cjepivo stimulira aktivni imunitet na virus influence svinja A, podtipove H1N1, H3N2 i H1N2.
English: 20 ml (10 doses) 50 ml (25 doses) 100 ml (50 doses) 8 x 500 ml (250 doses)
Croatian: 20 ml (10 doza), 50 ml (25 doza), 100 ml (50 doza).
English: Nature and composition of immediate packaging Glass vial:
Croatian: Osobine i sastav unutarnjeg pakovanja
English: Name and address of the manufacturers responsible for batch release
Croatian: Njemačka Naziv i adresa proizvođača odgovornog za puštanje serije u promet
English: Can be used during pregnancy and lactation.
Croatian: Primjena tijekom graviditeta laktacije ili nesenja Može se primijeniti tijekom graviditeta i laktacije.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/103/003
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/09/103/003
English: Keep the vial in the outer carton in order to protect from light.
Croatian: Zaštiti od svjetla.
English: Special precautions for use in animals Not applicable.
Croatian: Posebne mjere opreza za primjenu na životinjama
English: Strains of inactivated Influenza A virus/swine/
Croatian: Inaktivirani sojevi virusa influence
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Croatian: POGLEDU OPSKRBE I PRIMJENE Veterinarsko-medicinski proizvod koji se izdaje na recept.
English: WITHDRAWAL PERIOD Zero days
Croatian: Karencija Nula dana.
English: Piglets:
Croatian: Prasad:
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I PROIZVOĐAČ
English: Withdrawal period
Croatian: DATUM PRVOG ODOBRENJA
English: Contraindications
Croatian: PRIMJENE
English: Caps:
Croatian: Ili:
English: PACKAGE SIZE 100 ml (50 doses) 500 ml (250 doses)
Croatian: 100 ml (50 doza).
English: 20 ml Polyethylene terephthalate (PET) vials, clear 50 ml PET vials, clear
Croatian: 20 ml polietilen tereftalat (PET) bočice, prozirne, 50 ml PET bočice, prozirne, 100 ml PET bočice, prozirne.
English: Primary vaccination: 2 injections of one dose (2 ml) - From the age of 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 6 months.
Croatian: Od 96 dana starosti, u razmaku od 3 tjedna između injekcija za postizanje imuniteta u trajanju dužem od 6 mjeseci.
English: Flanged caps
Croatian: Am Pharmapark
English: Name and address of the manufacturers of the biological active substances
Croatian: ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET Naziv i adresa proizvođača biološki djelatne tvari IDT Biologika GmbH
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial of 20 ml and 50 ml
Croatian: OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA
English: Zero days
Croatian: ROK VALJANOSTI
English: Oral use sachet (PET/alu/LLDPE)
Croatian: Vrećica (PET/alu/LLDPE)
English: The significance of these changes is unknown.
Croatian: Značajnost ovih promjena nije poznat.
English: Not known: cannot be estimated from the available data.
Croatian: Nije poznato: ne može se procijeniti iz dostupnih podataka.
English: • If you have a combination of any of the following symptoms:
Croatian: • ako imate bilo koju kombinaciju sljedećih simptoma:
English: Accofil is useful in several different conditions which are:
Croatian: Accofil je koristan u nekoliko različitih situacija, a to su:
English: You will need to have your injections at about the same time every day.
Croatian: Injekcije ćete trebati primjenjivati svaki dan u približno isto vrijeme.
English: AT / BE / BG / CY / CZ / DE / DK / EE / EL / FI / HR / HU / IS / LT / LV / LX/ MT / NL / NO / PT / PL / RO / SE / SI / SK / UK/ ES Accord Healthcare S.L.U.
Croatian: AT / BE / BG / CY / CZ / DE / DK / EE / EL / FI / HR / HU / IS / LT / LV / LX/ MT / NL / NO / PT / PL / RO / SE / SI / SK / UK/ ES
English: Use each syringe only for one injection.
Croatian: Koristite svaku štrcaljku samo za jedno injektiranje.
English: Do not warm Accofil in any other way (for example, do not warm it in a microwave or in hot water).
Croatian: Ne zagrijavajte Accofil na bilo koji drugi način (na primjer, ne zagrijavajte ga u mikrovalnoj pećnici ili vrućoj vodi).
English: These changes all reversed after discontinuation of treatment.
Croatian: Sve su se ove promjene povukle nakon prekida liječenja.
English: The syringe may contain more liquid than you need.
Croatian: Štrcaljka može sadržavati više tekućine nego što Vam je potrebno.
English: It is advisable to wait and see how you feel after taking Accofil and before driving or operating machinery.
Croatian: Preporučljivo je da pričekate i vidite kako se osjećate nakon uzimanja Accofila i prije upravljanja vozilima ili strojevima.
English: If you use more Accofil than you should
Croatian: Ako primjenite više Accofila nego što ste trebali
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Croatian: Kao što je slučaj sa svim terapijskim proteinima, moguća je pojava imunogenosti.
English: This leaflet was last revised in
Croatian: Ova uputa je zadnji puta revidirana u:
English: International Retrospective Study (2006)
Croatian: Međunarodno retrospektivno ispitivanje (2006)
English: This medicine may cause dizziness.
Croatian: Ovaj lijek može izazvati omaglicu.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i lijekove koji se izdaju bez recepta.
English: Your healthcare professional should always record the exact product you are using.
Croatian: Vaš zdravstveni radnik uvijek treba evidentirati točan lijek koji koristite.
English: Particular attention should be paid to haematological values and infectious diseases.
Croatian: Osobitu pozornost potrebno je posvetiti hematološkim vrijednostima i zaraznim bolestima.
English: Your doctor or nurse will give you instructions on how to do this (see information below on instructions for injecting Accofil).
Croatian: Vaš liječnik ili medicinska sestra će Vam dati upute kako to učiniti (pogledajte u nastavku upute za ubrizgavanje Accofila).
English: Other medicines and Accofil
Croatian: Drugi lijekovi i Accofil
English: It is important to tell your doctor if you:
Croatian: Važno je da obavijestite svog liječnika ako:
English: If you are receiving this medicine by subcutaneous injection, your doctor may suggest that you learn how to give yourself the injections.
Croatian: Ako dobivate ovaj lijek potkožnom injekcijom, Vaš liječnik može predložiti da naučite kako da si sami dajete injekcije.
English: You do not have to remove the air bubble before injecting.
Croatian: Nemorate istisnuti mjehurić zraka prije ubrizgavanja.
English: European Retrospective Study (2004)
Croatian: Europsko retrospektivno ispitivanje (2004)
English: FR Accord Healthcare France SAS
Croatian: Accord Healthcare France SAS
English: Discontinue filgrastim
Croatian: Prekinuti filgrastim
English: The efficacy of the treatment was clear for this age group, which included most patients with congenital neutropenia.
Croatian: Djelotvornost liječenja bila je jasna za ovu dobnu skupinu, koja je uključivala većinu bolesnika s kongenitalnom neutropenijom.
English: This section contains information on how to give yourself an injection of Accofil.
Croatian: Ovaj dio sadrži informacije o tome kako možete sami sebi dati injekciju lijeka Accofil.