FrancophonIA/ELRC3.0 huggingface dataset:
English: Lymphadenopathy localised to the region of the injection site
Croatian: Poremećaji krvi i limfnog sustava: limfadenopatija ograničena na regiju mjesta primjene injekcije
English: Rare side effects (these may occur with up to 1 in 1,000 doses of the vaccine) are:
Croatian: Rijetke nuspojave (mogu se pojaviti u najviše 1 na 1000 primijenjenih doza cjepiva) su:
English: Prevenar will not protect against other Streptococcus pneumoniae serotypes than those included in the vaccine or other micro-organisms that cause invasive disease or otitis media.
Croatian: Prevenar neće osigurati zaštitu protiv drugih serotipova bakterije Streptococcus pneumoniae osim onih uključenih u cjepivo ili protiv drugih mikroorganizama koji uzrokuju invazivnu bolest ili upalu srednjeg
English: Prevenar will not protect against other Streptococcus pneumoniae serotypes than those included in the vaccine nor other micro-organisms that cause invasive disease or otitis media.
Croatian: Prevenar neće pružiti zaštitu od drugih serotipova bakterije Streptococcus pneumoniae osim onih uključenih u cjepivo, kao niti od drugih mikroorganizama koji uzrokuju invazivnu bolest ili upalu srednjeg
English: Vaccination in high-risk groups should be considered on an
Croatian: Cijepljenje djece u visokorizičnim skupinama treba razmotriti zasebno u svakom
English: - if your child has any present or past medical problems after any dose of Prevenar.
Croatian: Budite posebno oprezni s Prevenarom: - Ako Vaše dijete trenutno ima ili je imalo zdravstvene tegobe nakon neke prethodne doze Prevenara.
English: urticaria or urticaria-like rash (hives)
Croatian: • osip/koprivnjača (urtikarija)
English: Pneumococcal polysaccharide serotype 9V*
Croatian: Pneumokokni polisaharid serotipa 9V*
English: 1 or 10 vials without syringe/needles.
Croatian: 1 ili 10 bočica bez štrcaljki/igala.
English: Hypersensitivity reactions such as anaphylactic/anaphylactoid reactions including shock, angioneurotic oedema, bronchospasm, dyspnoea, face oedema.
Croatian: Poremećaji imunološkog sustava: reakcije preosjetljivosti kao što su anafilaktičke/anafilaktoidne reakcije uključujući šok, angioneurotski edem, bronhospazam, dispneja, edem lica napadaji, uključujući febrilne konvulzije povraćanje, proljev, slabiji apetit
English: Pneumococcal polysaccharide serotype 18C*
Croatian: Pneumokokni polisaharid serotipa 18C*
English: • Pain, tenderness, redness, swelling, or hardness at the injection site; fever of 38 °C or higher,
Croatian: • bol, osjetljivost na dodir, crvenilo, oteklina ili otvrdnuće na mjestu primjene injekcije; vrućica od
English: However, the overall benefit was a 34 % (95 % CI: 21, 45) reduction in the incidence of all pneumococcal AOM.
Croatian: Međutim, ukupna korist bila je smanjenje incidencije svih pneumokoknih akutnih upala srednjeg uha za 34% (95% CI: 21, 45).
English: The effect of the vaccine in the per-protocol analysis was a 9 % reduction (95 % CI: 3, 15) in recurrent AOM (defined as 3 episodes in six months or 4 episodes in one year) or a 23 % (95 % CI: 7, 36) reduction for recurrent AOM (5 episodes in six months or 6 episodes in one year).
Croatian: Prema analizi populacije prema protokolu, cjepivo je smanjilo redicivirajuće akutne upale srednjeg uha (definirane kao 3 epizode u šest mjeseci ili 4 epizode u jednoj godini) za 9% (95 % CI: 3, 15) odnosno recidivirajuću akutnu upalu srednjeg uha (5 epizoda u šest mjeseci ili 6 epizoda u jednoj godini) za 23% (95% CI: 7, 36).
English: Pack sizes of 1 and 10 vials without syringe/needles.
Croatian: Veličine pakovanja od 1 i 10 bočica bez štrcaljke/igala.
English: A repeated dose intramuscular toxicity study (13 weeks, 5 injections, one every three weeks) of pneumococcal conjugate vaccine in rabbits revealed no evidence of any significant local or systemic toxic effects.
Croatian: Ispitivanjem intramuskularne toksičnosti ponovljene doze (13 tjedana, 5 injekcija, jedna svaka tri tjedna) pneumokoknog konjugiranog cjepiva u kunića nisu dokazani nikakvi značajni lokalni ili sistemski toksični učinci.
English: irritability, crying, drowsiness, restless sleep
Croatian: 38 °C ili više, razdražljivost, plakanje, omamljenost, nemiran san
English: Manufacturing Authorisation Holder responsible for batch release:
Croatian: Proizvođač odgovoran za puštanje serije lijeka u promet:
English: DATE OF REVISION OF THE TEXT
Croatian: ZNANSTVENI ZAKLJUČCI
English: Redness or induration >2cm in diameter was reported in 22.6 % and 13.9% of children respectively.
Croatian: Crvenilo promjera > 2 cm je zabilježeno u 22,6%, a otvrdnuće promjera > 2 cm u 13,9% djece.
English: Pneumococcal polysaccharide serotype 23F*
Croatian: Pneumokokni polisaharid serotipa 23F*
English: The primary infant series consists of three doses, each of 0.5 ml, the first dose usually given at 2 months of age and with an interval of at least 1 month between doses.
Croatian: Prva serija cijepljenja za dojenčad sastoji se od tri doze, svaka po 0,5 ml, s time da se prva doza obično daje u dobi od 2 mjeseca a sljedeće doze u razmaku od najmanje 1 mjeseca između doza.
English: A repeated dose intramuscular toxicity study (13 weeks, 5 injections, one every three weeks) of pneumococcal conjugate vaccine in rabbits revealed no evidence of any significant local or systemic toxic
Croatian: Ispitivanjem intramuskularne toksičnosti ponovljene doze (13 tjedana, 5 injekcija, jedna svaka tri tjedna) pneumokoknog konjugiranog cjepiva u kunića nisu dokazani nikakvi značajni lokalni ili sistemski toksični
English: Pneumococcal polysaccharide serotype 6B*
Croatian: Pneumokokni polisaharid serotipa 6B*
English: Do not inject intravenously.
Croatian: Nemojte ubrizgavati u venu.
English: Sodium chloride Water for injections
Croatian: 6.1 Popis pomoćnih tvari natrijev klorid voda za injekcije
English: Pfizer AB Tel: +46 (0)8 550 520 00
Croatian: Tel: +46 (0)8 550 520 00
English: Acute otitis media (AOM) is a common childhood disease with different aetiologies.
Croatian: Akutna upala srednjeg uha različite etiologije česta je bolest u djece.
English: When Prevenar is co-administered with hexavalent vaccines (DTaP/Hib(PRP-T)/IPV/HepB), the physician should be aware that data from clinical studies indicate that the rate of febrile reactions was higher compared to that occurring following the administration of hexavalent vaccines alone.
Croatian: Liječnik mora biti upoznat s podacima iz kliničkih ispitivanja koji pokazuju da je stopa febrilnih reakcija veća kad se Prevenar primjenjuje istovremeno s heksavalentnim cjepivima (DTaP/Hib(PRP-T)/IPV/HepB) nego nakon primjene samo heksavalentnih cjepiva.
English: Pneumococcal polysaccharide serotype 19F*
Croatian: Pneumokokni polisaharid serotipa 19F*
English: Infants aged 2 - 6 months: the primary infant series consists of three doses, each of 0.5 ml, the first dose usually given at 2 months of age and with an interval of at least 1 month between doses.
Croatian: Dojenčad u dobi od 2 do 6 mjeseci: primarna serija za dojenčad sastoji se od tri doze, svake od 0,5 ml; prva doza obično se daje u dobi od 2 mjeseca uz vremenski razmak od najmanje 1 mjeseca između doza.
English: Injection site reactions (e.g. erythema, induration/swelling, pain/tenderness); fever  38 °C, irritability, crying, drowsiness, restless sleep.
Croatian: Opći poremećaji i reakcije na mjestu primjene: reakcije na mjestu primjene injekcije (npr. eritem, otvrdnuće/otok, bol/osjetljivost na dodir); vrućica  38°C, razdražljivost, plakanje, omamljenost, nemiran san otok/otvrdnuće i eritem > 2,4 cm na mjestu primjene injekcije, osjetljivost koja ometa hipotono-hiporesponzivne epizode, reakcije preosjetljivosti na mjestu primjene injekcije (npr., dermatitis, pruritus, urtikarija), crvenilo praćeno osjećajem užarenosti.
English: Prophylactic antipyretic medication is recommended: - for all children receiving Prevenar simultaneously with vaccines containing whole cell pertussis because of higher rate of febrile reactions (see section 4.8).
Croatian: Profilaksa antipireticima preporučuje se: - u sve djece koja primaju Prevenar istovremeno s celularnim cjepivima protiv pertusisa, zbog visoke stope febrilnih reakcija (vidjeti dio 4.8). - u djece s konvulzivnim poremećajima ili febrilnim konvulzijama u povijesti bolesti.
English: Suomi/Finland Pfizer Oy
Croatian: Suomi/Finland
English: Pneumococcal polysaccharide serotype 14*
Croatian: Pneumokokni polisaharid serotipa 14*
English: • Hypersensitivity reaction, including swelling of the face and/or lips, difficulty in breathing, rash,
Croatian: • reakcija preosjetljivosti, uključujući otok lica i/ili usana, otežano disanje, osip, urtikarija ili osip sličan urtikariji (koprivnjači)
English: OUTER CARTON TEXT - 10 pre-filled syringes pack without needle
Croatian: TEKST NA KUTIJI - pakovanje s 10 napunjenih štrcaljki bez igle
English: OUTER CARTON TEXT - 10 pre-filled syringes pack with separate needle
Croatian: TEKST NA KUTIJI - pakovanje s 10 napunjenih štrcaljki sa zasebnom iglom
English: Children aged 12 - 23 months: two doses, each of 0.5 ml, with an interval of at least 2 months between doses.
Croatian: Djeca u dobi od 12 do 23 mjeseca: dvije doze, svaka od 0,5 ml, s razmakom od najmanje 2 mjeseca između doza.
English: 10 single-dose (0.5 ml) pre-filled syringes without needle.
Croatian: 10 jednodoznih napunjenih štrcaljki (0,5 ml), bez igle.
English: Infants aged 7 - 11 months: two doses, each of 0.5 ml, with an interval of at least 1 month between doses.
Croatian: Dojenčad u dobi od 7 do 11 mjeseci: dvije doze, svaka od 0,5 ml, s razmakom od najmanje 1 mjeseca između doza.
English: OUTER CARTON TEXT - 1 pre-filled syringe pack without needle
Croatian: TEKST NA KUTIJI - pakovanje s 1 napunjenom štrcaljkom bez igle
English: In all studies, Prevenar was administered concurrently with the recommended childhood vaccines.
Croatian: Prevenar primijenio istovremeno s preporučenim cjepivima za djecu.
English: OUTER CARTON TEXT - 1 vial pack with syringe/needles
Croatian: TEKST NA KUTIJI - pakovanje s 1 bočicom sa štrcaljkom/iglama
English: CONDITIONS OF THE MARKETING AUTHORISATION
Croatian: I RAZLOZI ZA IZMJENU UVJETA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: 1 single-dose (0.5 ml) pre-filled syringe without needle.
Croatian: 1 jednodozna napunjena štrcaljka (0,5 ml), bez igle.
English: OUTER CARTON TEXT - 1 pre-filled syringe pack with separate needle
Croatian: TEKST NA KUTIJI - pakovanje s 1 napunjenom štrcaljkom sa zasebnom iglom
English: 10 single-dose (0.5 ml) pre-filled syringes with separate needle.
Croatian: 10 jednodoznih napunjenih štrcaljki (0,5 ml), sa zasebnom iglom.
English: OUTER CARTON TEXT - 1 vial pack
Croatian: TEKST NA KUTIJI - pakovanje s 1 bočicom
English: 1 single-dose (0.5 ml) pre-filled syringe with separate needle.
Croatian: 1 jednodozna napunjena štrcaljka (0,5 ml), sa zasebnom iglom.
English: Children aged 12 - 23 months: two doses, each of 0.5 ml, with an interval of at least 2 months between
Croatian: Djeca u dobi od 12 do 23 mjeseca: dvije doze, svaka od 0,5 ml, uz vremenski razmak između doza od
English: Prevenar suspension for injection Pneumococcal saccharide conjugated vaccine, adsorbed
Croatian: Prevenar suspenzija za injekciju cjepivo protiv pneumokoka, saharidno, konjugirano, adsorbirano
English: Marketing Authorisation Holder:
Croatian: Rok valjanosti:
English: Injection site swelling/induration and erythema >2.4 cm, tenderness interfering
Croatian: • crvenilo, oteklina ili otvrdnuće na mjestu primjene injekcije veće od 2,4 cm; osjetljivost na mjestu primjene injekcije koje ometa kretnje
English: Prevenar suspension for injection in pre-filled syringe Pneumococcal saccharide conjugated vaccine, adsorbed
Croatian: Prevenar suspenzija za injekciju u napunjenoj štrcaljki cjepivo protiv pneumokoka, saharidno, konjugirano, adsorbirano
English: Slovenija
Croatian: Magyarország
English: OUTER CARTON TEXT- 10 vials pack
Croatian: TEKST NA KUTIJI - pakovanje s 10 bočica
English: EXPIRY DATE
Croatian: ROK VALJANOSTI
English: Pfizer Biofarmacêutica, Sociedade Unipessoal Lda Tel: +351 21 423 5500
Croatian: Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0
English: Pfizer BV
Croatian: Nositelj odobrenja: Pfizer Limited
English: Pfizer Corporation Austria Ges.m.b.H.
Croatian: Pfizer Ελλάς A.E.(Cyprus Branch)
English: Slovenská Republika
Croatian: Velika Britanija
English: Pfizer Luxembourg SARL, organizačná zložka Tel: + 421 2 3355 5500
Croatian: Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 00
English: 200 tablets
Croatian: 200 tableta
English: Film-coated tablet Oral use bottle (HDPE)
Croatian: Peroralna primjena Bočica (HDPE)
English: (<1/10,000), not known (cannot be estimated from the available data).
Croatian: (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: 21 months.
Croatian: 21 mjeseci.
English: Other side effects were similar.
Croatian: Ostale nuspojave bile su podjednake.
English: Children and adolescents Herceptin is not recommended for anyone under the age of 18 years.
Croatian: Djeca i adolescenti Herceptin se ne preporučuje osobama mlađima od 18 godina.
English: No grade 4 or grade 5 adverse events were reported.
Croatian: Nije prijavljen nijedan štetan događaj 4. ili 5. stupnja.
English: 1000 New Horizons Way Vacaville, CA 95688 USA
Croatian: 1000 New Horizons Way Vacaville, CA 95688
English: Hyaluronidase is found in most tissues of the human body.
Croatian: Hijaluronidaza se nalazi u većini tkiva u ljudskom tijelu.
English: Herceptin is not genotoxic.
Croatian: Herceptin nije genotoksičan.
English: Some of the severe events occurred on the day of the injection.
Croatian: Neki teški događaji pojavili su na dan primjene injekcije.
English: This medicinal product must not be mixed or diluted with other medicinal products except those mentioned under section 6.6.
Croatian: Ovaj lijek se ne smije miješati ni razrjeđivati s drugim lijekovima, osim onih navedenih u dijelu 6.6.
English: For the comparative safety profile see section 4.8.
Croatian: Za usporedni sigurnosni profil vidjeti dio 4.8.
English: Table 12: Summary of pathological Complete Response (pCR)
Croatian: Tablica 12: Sažetak potpunog patološkog odgovora (pCR)
English: The rabbit study was performed to specifically examine local tolerance aspects.
Croatian: Ispitivanje na kunićima provedeno je kako bi se specifično ispitali aspekti lokalne podnošljivosti.
English: D-82377 Penzberg Germany
Croatian: D-82377 Penzberg
English: If not used immediately, preparation should take place in controlled and validated aseptic conditions.
Croatian: Ako se ne primjenjuje odmah, priprema se mora obaviti u kontroliranim i validiranim aseptičkim uvjetima.
English: Two different types (formulations) of Herceptin exist:
Croatian: Postoje dva različita oblika (formulacije) lijeka Herceptin:
English: Date of first authorisation: 28 August 2000 Date of latest renewal: 28 August 2010
Croatian: Datum posljednje obnove odobrenja: 28. kolovoza 2010.
English: There were also more local reactions at the site of injection and more increases in blood pressure.
Croatian: Također je bilo više lokalnih reakcija na mjestu primjene i češće je dolazilo do povišenja krvnog tlaka.
English: Malta (See United Kingdom)
Croatian: Malta (See Ireland)
English: Portsmouth, NH 03801 USA
Croatian: Portsmouth, NH 03801
English: • increased muscle tone or tension (hypertonia)
Croatian: • povećani tonus ili napetost mišića (hipertonija)
English: Fertility There is no fertility data available.
Croatian: Plodnost Nema dostupnih podataka o plodnosti.
English: The median Tmax following subcutaneous administration was approximately 3 days, with high interindividual variability (range 1-14 days).
Croatian: Medijan vrijednosti Tmax nakon supkutane primjene bio je približno 3 dana, uz visoku interindividualnu varijabilnost (raspon od 1-14 dana).
English: What Herceptin is and what it is used for
Croatian: Što je Herceptin i za što se koristi
English: It is not known whether Herceptin can affect reproductive capacity.
Croatian: Nije poznato može li primjena lijeka Herceptin utjecati na sposobnost reprodukcije.
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije kontuzije
English: Herceptin may also be given once a week for metastatic breast cancer.
Croatian: Herceptin se također može davati jednom tjedno za metastatski rak dojke.
English: All doses should be taken at the right time every three weeks.
Croatian: Svaku dozu treba primijeniti u odgovarajuće vrijeme svaka tri tjedna.
English: 637394 Singapore
Croatian: 637394 Singapur
English: What Herceptin looks like and contents of the pack
Croatian: Kako Herceptin izgleda i sadržaj pakiranja
English: Non-clinical data for recombinant human hyaluronidase reveal no special hazard for humans based on conventional studies of repeated dose toxicity including safety pharmacology endpoints.
Croatian: Neklinički podaci za rekombinantnu humanu hijaluronidazu ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza, uključujući mjere ishoda sigurnosne farmakologije.
English: Other medicines and Herceptin
Croatian: Drugi lijekovi i Herceptin
English: A volume overage of 4 % ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Croatian: Višak volumena od 4 % jamči da se naznačena doza od 150 mg može izvući iz svake bočice.
English: Water for injections
Croatian: voda za injekcije
English: The most frequent severe reaction was drug hypersensitivity.
Croatian: Najčešći težak događaj bila je preosjetljivost na lijek.
English: Subcutaneous formulation
Croatian: Supkutana formulacija
English: No injection should be given into areas where the skin is red, bruised, tender or hard.
Croatian: Injekcije se ne smiju davati na područja gdje je koža crvena, s modricama, bolna na dodir ili tvrda.
English: Once removed from the refrigerator Herceptin subcutaneous formulation must be administered within 6 hours and should not be kept above 30°C.
Croatian: Kada se izvadi iz hladnjaka, Herceptin u supkutanoj formulaciji mora se primijeniti unutar 6 sati i ne smije se čuvati na temperaturi iznad 30°C.
English: t1/2 range from Cmax,ss to
Croatian: Raspon t1/2 od Cmax,ss do
English: Women who become pregnant should be advised of the possibility of harm to the fetus.
Croatian: Žene koje zatrudne potrebno je upozoriti na mogućnost štetnog utjecaja na fetus.
English: These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with Herceptin.
Croatian: Ti lijekovi (ili neki drugi antraciklini) mogu oštetiti srčani mišić i povećati rizik od srčanih problema pri primjeni lijeka Herceptin.
English: If you stop using Herceptin
Croatian: Ako prestanete primati Herceptin
English: New injections should be given at least 2.5 cm away from an old site.
Croatian: Nove injekcije treba primijeniti najmanje 2,5 cm dalje od mjesta prethodne injekcije.
English: Herceptin loading dose should be administered as a 90-minute intravenous infusion.
Croatian: Udarnu dozu lijeka Herceptin potrebno je primijeniti u 90-minutnoj intravenskoj infuziji.
English: What Herceptin contains
Croatian: Što Herceptin sadrži
English: Instructions for aseptic reconstitution:
Croatian: Upute za aseptičku rekonstituciju:
English: 637377 Singapore Singapore
Croatian: 637377 Singapur
English: Observation N= 1697***
Croatian: Opservacija N= 1697***
English: No loading dose is required.
Croatian: Nije potrebna udarna doza.
English: Herceptin may affect your ability to drive a car or operate machines.
Croatian: Herceptin može utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
English: If you receive Herceptin in combination with chemotherapy, some of them may also be due to the chemotherapy.
Croatian: Ako primate Herceptin u kombinaciji s kemoterapijom, neke od njih mogu biti i posljedica primljene kemoterapije.
English: Herceptin can cause breathing difficulties, especially when it is first given.
Croatian: Herceptin može izazvati poteškoće u disanju, osobito prilikom prve primjene.
English: The dose of Herceptin depends on your body weight.
Croatian: Potrebna doza lijeka Herceptin ovisi o Vašoj tjelesnoj težini.
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Croatian: • Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, morate se obratiti svom liječniku, ljekarniku ili medicinskoj sestri za savjet prije nego primite ovaj lijek.
English: Therefore, these patients should not be treated with Herceptin (see section 4.3).
Croatian: Te se bolesnike zato ne smije liječiti lijekom Herceptin (vidjeti dio 4.3).
English: FP + H: Fluoropyrimidine/cisplatin + Herceptin FP: Fluoropyrimidine/cisplatin a Odds ratio
Croatian: FP + H: fluoropirimidin/cisplatin + Herceptin FP: fluoropirimidin/cisplatin a omjer šansi
English: Some of these symptoms can be serious and some patients have died (see the section “Warnings and precautions”).
Croatian: Neki od ovih simptoma mogu biti ozbiljni, a neki su bolesnici preminuli (pogledajte dio "Upozorenja i mjere opreza").
English: For monotherapy, the rate was 6 % - 9 %.
Croatian: Kod primjene u monoterapiji, stopa je iznosila 6% do 9%.
English: Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in Section 4.4.
Croatian: Pojedinosti o mjerama minimizacije rizika u skladu s Europskim planom upravljanja rizikom navedene su u dijelu 4.4.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, and would not normally be longer than 24 hours at 2°C - 8°C.
Croatian: Ako se lijek ne primijeni odmah, vrijeme i uvjeti čuvanja prije uporabe postaju odgovornost korisnika i obično ne bi trebali biti dulji od 24 sata na temperaturi od 2°C do 8°C.
English: Reproductive toxicology studies with rHuPH20 revealed embryofetal toxicity in mice at high systemic exposure, but did not show teratogenic potential.
Croatian: Ispitivanja reproduktivne toksičnosti s rHuPH20 ukazala su na embriofetotoksičnost u miševa pri visokim razinama sistemske izloženosti, ali nisu pokazala teratogeni potencijal.
English: The efficacy results from study BO18225 are summarized in Table 13: Table 13 Efficacy Results from BO18225
Croatian: Rezultati djelotvornosti dobiveni ispitivanjem BO18225 sažeti su u Tablici 13: Tablica 13 Rezultati djelotvornosti iz ispitivanja BO18225
English: Herceptin was administered weekly with chemotherapy and 3 weekly thereafter for a total of 52 weeks.
Croatian: Herceptin je primjenjivan tjedno uz kemoterapiju i svaka 3 tjedna nakon toga, ukupno 52 tjedna.
English: It may take up to 7 months for Herceptin to be removed from your body.
Croatian: Može biti potrebno i do 7 mjeseci da se Herceptin ukloni iz Vašeg tijela.
English: • feeling weak and unwell
Croatian: • osjećaj slabosti i loše osjećanje
English: The injection site should be alternated between the left and right thigh.
Croatian: Injekciju treba naizmjence davati u lijevo i desno bedro.
English: Some adverse events / reactions were reported with a higher frequency for the subcutaneous formulation:
Croatian: Neki štetni događaji/nuspojave prijavljeni su s većom učestalošću kod primjene supkutane formulacije:
English: Herceptin may have a minor influence on the ability to drive or use machines (see section 4.8).
Croatian: Herceptin može imati manji utjecaj na sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio 4.8).
English: • one is given as an infusion into a vein over 30 to 90 minutes
Croatian: • jedan se primjenjuje u venu tijekom 30 do 90 minuta,
English: • you suffer from breathlessness., especially if you are currently using a taxane.
Croatian: • Ako imate nedostatak zraka, osobito ako trenutno primate taksan.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 600 mg/5 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 600 mg/5 ml
English: As Herceptin does not contain any antimicrobial-preservative, from a microbiological point of view, the medicine should be used immediately.
Croatian: S obzirom da Herceptin ne sadrži antimikrobni konzervans, s mikrobiološkog stajališta lijek se mora odmah primijeniti.