FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP recommended that the marketing authorisations for powders containing a combination of lincomycin and spectinomycin for use in the drinking water should be varied in order to amend the product information accordingly.
Croatian: CVMP je preporučio izmjenu odobrenja za stavljanje u promet praškova za uporabu u vodi za piće koji sadrže kombinaciju linkomicina i spektinomicina kako bi se u skladu s tim izmijenile informacije o proizvodu.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for premixes for medicated feeding stuff and powders to be administered with the feed containing a combination of lincomycin and spectinomycin is negative, as the use of these products at the recommended dosing regimens entails a high risk of resistance selection and development due to exposure to low antimicrobial levels for prolonged periods.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji zaključio je da je ukupan omjer koristi i rizika za premikse za hranu za životinje s dodatkom lijekova ili praškova za primjenu s hranom za životinje koji sadrže kombinaciju linkomicina i spektinomicina negativan te da primjena tih proizvoda uz preporučeni režim doziranja predstavlja veliki rizik od odabira i razvoja otpornosti zbog izloženosti malim razinama antimikrobnih lijekova tijekom produljenih razdoblja.
English: Based on the evaluation of the currently available data, the CVMP concluded that the overall benefitrisk balance for premixes for medicated feeding stuff and powders containing a combination of lincomycin and spectinomycin, to be administered with the feed, is negative, as the use of these products at the recommended dosing regimens entails a high risk of resistance selection and development due to exposure to low antimicrobial levels for prolonged periods.
Croatian: Na osnovi procjene trenutačno dostupnih podataka CVMP je zaključio da je ukupan omjer koristi i rizika za premikse za hranu za životinje s dodatkom lijekova ili praškove koji sadrže kombinaciju linkomicina i spektinomicina za primjenu u hrani za životinje negativan te da primjena tih proizvoda uz preporučeni režim doziranja predstavlja veliki rizik od odabira i razvoja otpornosti zbog izloženosti malim razinama antimikrobnih lijekova tijekom produljenih razdoblja.
English: The CVMP also concluded that the overall benefit-risk balance for powders for use in the drinking water containing a combination of lincomycin and spectinomycin is positive and recommended harmonised indications, dosing regimens and warning sentences on prudent use.
Croatian: CVMP je također zaključio da je ukupan omjer koristi i rizika za praškove za uporabu u vodi za piće koji sadrže kombinaciju linkomicina i spektinomicina pozitivan te je preporučio usklađene indikacije, režime doziranja i upozorenja o opreznoj uporabi.
English: The CVMP recommended the withdrawal of the marketing authorisations for premixes for medicated feeding stuff and powders containing a combination of lincomycin and spectinomycin to be administered with feed.
Croatian: CVMP je preporučio povlačenje odobrenja za stavljanje u promet premiksa za hranu za životinje s dodatkom lijekova i praškove za primjenu s hranom koji sadrže kombinaciju linkomicina i spektinomicina.
English: The CVMP further concluded that the overall benefit-risk balance for powders for use in the drinking water containing a combination of lincomycin and spectinomycin is positive and agreed harmonised indications, dosing regimens and warning sentences on prudent use.
Croatian: CVMP je također zaključio da je ukupan omjer koristi i rizika za praškove za uporabu u vodi za piće koji sadrže kombinaciju linkomicina i spektinomicina pozitivan te se usuglasio u vezi s usklađenim indikacijama, režimima doziranja i upozorenjima o opreznoj uporabi.
English: Spectinomycin is an aminocyclitol antibiotic derived from Streptomyces spectabilis; it has bacteriostatic activity and is active against some aerobic gram-negative bacteria, gram-positive cocci and Mycoplasma spp.
Croatian: Djeluje bakteriostatski i djelotvoran je protiv nekih aerobnih gram-negativnih bakterija, gram-pozitivnih koka te bakterije Mycoplasma spp.
English: ATCvet code QI04AA02.
Croatian: ATCvet kod QI04AA02.
English: The level of efficacy for other species may differ from that observed in sheep.
Croatian: Razina djelotvornosti kod drugih vrsta može se razlikovati od one kod ovaca.
English: Annual.
Croatian: Godišnje.
English: a) the administration of the product to animals will interfere with the implementation of national programmes for the diagnosis, control and 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.
Croatian: a) će primjena proizvoda na životinjama interferirati s provedbom nacionalnog programa otkrivanja, kontrole i eradikacije bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živim životinjama ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
English: **Haemolytic units.
Croatian: **Hemolitičke jedinice.
English: The periodic safety update report (PSUR) cycle should be re-started for submission of 6 monthly reports (covering all authorised presentations of this product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at three-yearly intervals.
Croatian: Periodička izvješća o neškodljivosti (PSUR) treba ponovo podnositi putem 6 mjesečnih izvješća (koja uključuju sva odobrena pakovanja proizvoda) za naredne dvije godine, nakon kojih slijede godišnja izvješća za sljedeće dvije godine, a nakon toga u trogodišnjim intervalima.
English: The duration of immunity is 1 year after primary vaccination course.
Croatian: Trajnost imuniteta je 1 godina nakon prvog cijepljenja.
English: If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Croatian: Ako se primjenjuje na druge domaće i divlje preživače za koje se smatra da postoji opasnost od zaraze, za te vrste treba upotrijebiti s oprezom, a preporučuje se i testiranje cjepiva na malom broju životinja prije masovnog cijepljenja.
English: The marketing authorization holder should provide a suitable system for quantifying active ingredient at blending stage as soon as feasible.
Croatian: Nositelj odobrenja za stavljanje VMP u promet mora pružiti odgovarajući sustav za kvantificiranje djelatne tvari u fazi miješanja što je prije moguće.
English: **Haemolytic units For the full list of excipients, see section 6.1.
Croatian: **Hemolitičke jedinice Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: One injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune sheep).
Croatian: Jedna injekcija: od 1 mjeseca starosti (ili od 2,5 mjeseca starosti u mladih životinja rođenih od imunih ovaca).
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of bluetongue.
Croatian: Primjena ovog veterinarsko-medicinskog proizvoda dopuštena je samo pod posebnim uvjetima ustanovljenima zakonodavstvom Europske Unije o kontroli bolesti plavog jezika.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member States 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 their territory if it is established that:
Croatian: Sukladno članku 71. Direktive 2001/82/EV i Europskog Parlamenta i Vijeća koja je dopunjena, države članice mogu sukladno nacionalnoj legislativi, zabraniti proizvodnju, uvoz, posjedovanje, prodaju, opskrbu i/ili primjenu imunološkog veterinarsko-medicinskog proizvoda na cijelom teritoriju ili jednom njegovom dijelu ako je utvrđeno da:
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Croatian: Djelatne tvari koje se sastoje od tvari biološkog podrijetla, namijenjene za izazivanje aktivne imunosti na koje se ne primjenjuju odredbe Uredbe (EK) 470/2009.
English: In this category of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or National Competent Authorities on the current vaccination policies against bluetongue virus (BTV).
Croatian: U toj kategoriji životinja cjepivo treba primijeniti samo po procjeni odnosa koristi/rizika od strane odgovornog veterinara i/ili nadležnih tijela sukladno važećim odredbama o cijepljenju protiv virusa bolesti plavog jezika (BTV).
English: MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ UNITED KINGDOM
Croatian: Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ Ujedinjeno Kraljevstvo
English: Incompatibilities: Do not mix with any other veterinary medicinal product.
Croatian: Inkompatibilnosti: Ne miješati s bilo kojim drugim veterinarsko medicinskim proizvodom.
English: 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: Once broached, use immediately.
Croatian: Jednom načeto, upotrijebiti odmah.
English: A transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.
Croatian: Prolazno povišenje tjelesne temperature, obično ne više od 1,1 °C, može se javiti unutar 24 sata nakon
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 °C - 8 °C).
Croatian: 11. POSEBNI UVIJETI ČUVANJA Čuvati i prevoziti rashlađeno (2 °C - 8 °C).
English: It induces an active and specific immunity against bluetongue virus serotypes 2 and 4 in the vaccinated animals.
Croatian: Inducira aktivnu i specifičnu imunost protiv virusa bolesti plavog jezika serotip 2 i 4 u cijepljenim životinjama.
English: The vaccine contains inactivated bluetongue virus serotypes 2 and 4 with aluminium hydroxide and saponin adjuvants.
Croatian: Cjepivo sadrži inaktivirani virus bolesti plavog jezika serotipi 2 i 4 s aluminijevim hidroksidom i saponinom kao adjuvansima.
English: Onset of immunity has been demonstrated 3 and 5 weeks after the primary vaccination course for serotype 4 and serotype 2, respectively.
Croatian: Početak imuniteta javio se 3 i 5 tjedna nakon prvog cijepljenja za serotip 4 odnosno serotip 2.
English: Revaccination Annual.
Croatian: Docjepljivanje Godišnje.
English: Pharmacotherapeutic group: inactivated bluetongue virus vaccine for sheep.
Croatian: Farmakoterapijska grupa: inaktivirano cjepivo protiv virusa bolesti plavog jezika za ovce.
English: *Cell culture infectious dose 50% equivalent to titre prior to inactivation (log10).
Croatian: 30 HU** *Infektivna doza stanične kulture 50% jednako titru prije inaktivacije (log10).
English: Any person intending to manufacture, import, possess, sell, supply and use BTVPUR AlSap 2-4 must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Croatian: Tko namjerava proizvoditi, uvesti, posjedovati, prodavati, opskrbljivati i primjenjivati BTVPUR AlSap 2-4 mora konzultirati nadležno tijelo odnosne države članice u pogledu važećih odredbi o cijepljenju prije proizvodnje, uvoza, posjedovanja, prodaje, opskrbe i/ili primjene.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 doses (10 ml)
Croatian: SADRŽAJ, TEŽINA, VOLUMEN IL BROJ DOZA 10 doza (10 ml)
English: 50 doses (50 ml)
Croatian: 50 doza (50 ml)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1ml of vaccine contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka doza od 1 ml cjepiva sadrži:
English: ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: DODATAK II A. PROIZVOĐAČ(I) BIOLOŠKI DJELATNIH TVARI I NOSITELJ(I) ODOBRENJA ZA PROIZVODNJU ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET B. UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE C.
English: PHARMACEUTICAL FORM Suspension for injection.
Croatian: OBLIK Suspenzija za injekcije.
English: B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Croatian: UVIJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU OPSKRBE I PRIMJENE
English: NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 2-4 suspension for injection for sheep
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA BTVPUR AlSap 2-4 suspenzija za injekciju za ovce
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 1 bottle of 50 ml, or of 10 bottles of 50 ml, or of 1 bottle of 100 ml, or of 10 bottles of 100 ml
Croatian: PODACI NA VANJSKOM PAKOVANJU Kutija s 1 bočicom od 50 ml ili s 1 bočicom od 100 ml ili s 10 bočica od 100 ml
English: Type I glass bottle of 10 ml with butyl elastomer closure.
Croatian: Staklena bočica (staklo tip I) od 10 ml s čepom od butilnog elastomera.
English: PACKAGE LEAFLET FOR: BTVPUR AlSap 2-4 suspension for injection for sheep
Croatian: UPUTA O VMP: BTVPUR AlSap 2-4 suspenzija za injekciju za ovce
English: Box of 1 bottle of 10 doses (1 x 10 ml) Box of 1 bottle of 50 doses (1 x 50 ml) Box of 10 bottles of 50 doses (10 x 50 ml) Box of 1 bottle of 100 doses (1 x 100 ml) Box of 10 bottles of 100 doses (10 x 100 ml)
Croatian: Kutija s 1 bočicom od 10 doza (1 x 10 ml) Kutija s 1 bočicom od 50 doza (1 x 50 ml) Kutija s 10 bočica od 50 doza (10 x 50 ml) Kutija s 1 bočicom od 100 doza (1 x 100 ml) Kutija s 10 bočica od 100 doza (10 x 100 ml)
English: Vaccination may be followed by a small local swelling at the injection site (at most 24 cm2) for a short period (at most 14 days).
Croatian: Nakon cijepljenja može se na mjestu uboda javiti prolazni mali otok (najviše 24 cm²) koji se povlači za 14 dana.
English: Manufacturer responsible for batch release: MERIAL
Croatian: Nositelj odobrenja za proizvodnju za puštanje proizvodne serije: MERIAL
English: The manufacture, import, possession, sale, supply and/or use of BTVPUR AlSap 2-4 may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Croatian: Proizvodnja, uvoz, posjedovanje, prodaja, opskrba i/ili primjena BTVPUR AlSap 2-4 može biti zabranjena u određenim državama članicama na cijelom teritoriju ili na jednom njegovom dijelu sukladno nacionalnim odredbama o zaštiti zdravlja životinja.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/108/005
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/10/108/005
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/108/001 (1 bottle of 100 ml) EU/2/10/108/002 (10 bottles of 100 ml)
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/10/108/001 (1 bočica od 100 ml) EU/2/10/108/002 (10 bočica od 100 ml)
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the label after EXP.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: upotrijebiti odmahNe koristiti ovaj veterinarski medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i naljepnici nakon EXP.
English: SC. Read the package leaflet before use.
Croatian: s.c. Pročitati uputu o VMP prije primjene.
English: Each dose of 1ml of vaccine contains:
Croatian: Svaka doza od 1ml cjepiva sadrži:
English: No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double-dose of the vaccine.
Croatian: Nakon primjene dvostruke doze cjepiva nisu primijećeni nikakvi neželjeni učinci osim onih već spomenutih u odjeljku 4.6.
English: EU/2/10/108/003 (1 bottle of 50 ml) EU/2/10/108/004 (10 bottles of 50 ml) EU/2/10/108/001 (1 bottle of 100 ml) EU/2/10/108/002 (10 bottles of 100 ml)
Croatian: EU/2/10/108/003 (1 bočica od 50 ml) EU/2/10/108/004 (10 bočica od 50 ml) EU/2/10/108/001 (1 bočica od 100 ml) EU/2/10/108/002 (10 bočica od 100 ml)
English: Shelf life of the veterinary medicinal product as package for sale: 18 months.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 18 mjeseci Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: upotrijebiti odmah.
English: PACKAGE SIZE 10 doses (10 ml)
Croatian: VELIČINA PAKOVANJA 10 doza (10 ml).
English: BTV2 antigen ................................................................................................................ 6.8-9.5 CCID50*, BTV4 antigen ................................................................................................................ 7.1-8.5 CCID50*, Aluminium hydroxide, Saponin, qs 1 dose *.
Croatian: BTV2 antigen .............................................................................................................. 6,8 - 9,5 CCID50*, BTV4 antigen .............................................................................................................. 7,1 - 8,5 CCID50*, Aluminij hidroksid, saponin, q.s. 1 doza*.
English: *below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission.
Croatian: Aktivna imunizacija ovaca za sprječavanje viremije* i za smanjenje kliničkih znakova uzrokovanih virusom bolesti plavog jezika serotip 2 i 4. *vrijednosti ispod razine otkrivanja validiranom RT-PCR metodom na 3,68 log10 RNA copies/ml, ukazuje na odsutnost virusa zaraze.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Administer one dose of 1 ml subcutaneously according to the following vaccination scheme: Primary vaccination
Croatian: Injicirajte jednu dozu 1 ml cjepiva subkutano u skladu sa slijedećim rasporedom cijepljenja: Prvo cijepljenje
English: *(below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission)
Croatian: Aktivna imunizacija ovaca za sprječavanje viremije* i za smanjenje kliničkih znakova uzrokovanih virusom bolesti plavog jezika serotip 2 i 4. *(vrijednosti ispod razine otkrivanja validiranom RT-PCR metodom na 3,68 log10 RNA copies/ml, ukazuje na odsutnost virusa zaraze)
English: Silicon antifoam Phosphate buffer Glycine buffer Aluminium hydroxide Saponin.
Croatian: Silikonsko sredstvo protiv pjenjenja Fosfatni pufer
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKI DJELATNIH TVARI I NOSITELJ(I) ODOBRENJA ZA PROIZVODNJU ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
English: *see package leaflet.
Croatian: *vidjeti uputu o VMP
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 10 or 50 ml
Croatian: PODACI NA VANJSKOM PAKOVANJU Kutija s 1 bočicom od 10 ml
English: Bluetongue virus serotype 2 antigen .............................................................................. 6.8-9.5 CCID50*, Bluetongue virus serotype 4 antigen .............................................................................. 7.1-8.5 CCID50*, Aluminium hydroxide
Croatian: Virusni antigen protiv bolesti plavog jezika serotip 2 ................................................. 6,8 - 9,5 CCID50* Virusni antigen protiv bolesti plavog jezika serotip 4 .................................................. 7,1 - 8,5 CCID50* aluminijev hidroksid
English: Primary vaccination
Croatian: Prvo cijepljenje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Croatian: OSNOVNI DJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA
English: Special precautions for use in animals: Vaccinate healthy animals only.
Croatian: Posebne mjere opreza za primjenu na životinjama:
English: Revaccination
Croatian: FARMACEUTSKI
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Croatian: PODACI NA UNUTARNJEM PAKOVANJU
English: Always use Pelmeg exactly as your doctor has told you.
Croatian: Uvijek primijenite Pelmeg točno onako kako Vam je rekao liječnik.
English: • nausea and headaches.
Croatian:  mučnina i glavobolje.
English: Stop using Pelmeg and seek medical attention immediately if you notice any of the symptoms described in section 4.
Croatian: Prestanite s primjenom lijeka Pelmeg i odmah potražite medicinsku pomoć ako primijetite bilo koji od simptoma opisanih u dijelu 4.
English: Other medicines and Pelmeg
Croatian: Drugi lijekovi i Pelmeg
English: B Carefully pull the needle cap straight out and away from your body.
Croatian: B Pažljivo i ravno povucite kapicu s igle dalje od Vašeg tijela.
English: • Pelmeg is given as an injection into the tissue just under the skin (subcutaneous injection).
Croatian: • Pelmeg se daje kao injekcija u tkivo odmah ispod kože (supkutana injekcija).
English: Pelmeg is for use in adults aged 18 and over.
Croatian: Pelmeg se primjenjuje u odraslih osoba u dobi od 18 i više godina.
English: What Pelmeg contains
Croatian: Što Pelmeg sadrži
English: If you use more Pelmeg than you should
Croatian: Ako primijenite više lijeka Pelmeg nego što ste trebali
English: It is important to tell your doctor if you:
Croatian: Obavezno recite svom liječniku:
English: Pelmeg has not been tested in pregnant women.
Croatian: Pelmeg nije ispitivan u trudnica.
English: What you need to know before you use Pelmeg
Croatian: Što morate znati prije nego počnete primjenjivati Pelmeg
English: Important Before you use a Pelmeg pre-filled syringe with automatic needle guard, read this important information:
Croatian: Prije korištenja Pelmeg napunjene štrcaljke s automatskim štitnikom za iglu, pročitajte ove važne informacije:
English: Pelmeg left at room temperature for more than 96 hours should be discarded.
Croatian: Pelmeg ostavljen na sobnoj temperaturi dulje od 96 sati mora se baciti.
English: Pelmeg may be used if it is accidentally frozen for two periods of less than 72 hours each.
Croatian: Pelmeg se može upotrijebiti ako je bio slučajno zamrznut tijekom dva odvojena razdoblja ne dulja od 72 sata.
English: Talk to your doctor, pharmacist or nurse before using Pelmeg:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Pelmeg:
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Pelmeg therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Pelmeg uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Your doctor may decide that it would be more convenient for you to inject Pelmeg yourself.
Croatian: Vaš liječnik može odlučiti da će Vam biti pogodnije ako si sami injicirate Pelmeg.
English: However, the long-term effects of Pelmeg have not been established in AML; therefore, it should be used with caution in this patient population.
Croatian: Međutim, dugoročni učinci Pelmega na AML nisu ustanovljeni, stoga se lijek mora primjenjivati s oprezom u toj populaciji bolesnika.
English: OTHER Mundipharma
Croatian: DRUGO Mundipharma
English: If you become pregnant during Pelmeg treatment, please inform your doctor.
Croatian: Ako zatrudnite tijekom primjene lijeka Pelmeg, obavijestite liječnika.
English: Stop using Pelmeg if you develop these symptoms and contact your doctor or seek medical attention immediately.
Croatian: Prestanite koristiti lijek Pelmeg ako razvijete ove simptome i obratite se liječniku ili odmah potražite medicinsku pomoć.
English: *Sodium acetate is prepared by mixing sodium acetate trihydrate and acetic acid.
Croatian: * Natrijev acetat pripremljen je miješanjem natrijevog acetata trihidrata i octene kiseline.