FrancophonIA/ELRC3.0 huggingface dataset:
English: Cattle 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily for 3-5 days.
Croatian: Doza za goveda je 5 mg enrofloksacina/kg t.m., što odgovara 1 mL/20 kg t.m., jednom dnevno tijekom 3-5 dana.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name> 100 mg/ml solution for injection Enrofloxacin
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA <Izmišljeno ime>, 100 mg/mL otopina za injekciju Enrofloksacin
English: NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name> 25 mg/ml solution for injection
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA <Izmišljeno ime>, 25 mg/mL otopina za injekciju
English: PACKAGE LEAFLET FOR: <Invented name> 100 mg/ml solution for injection
Croatian: UPUTA O VMP ZA: <Izmišljeno ime>, 100 mg/mL otopina za injekciju
English: METHOD AND ROUTE(S) OF ADMINISTRATION SC, IM
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name> 100 mg/ml solution for injection
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA <Izmišljeno ime> 100 mg/mL otopina za injekciju
English: NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name> 25 mg/ml solution for injection Enrofloxacin
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA <Izmišljeno ime>, 25 mg/mL otopina za injekciju Enrofloksacin
English: 10 mg/kg bw, corresponding to 2 ml/5 kg bw, once daily by subcutaneous injection for 5 to 10 consecutive days.
Croatian: Doza za kuniće je 10 mg/kg t.m.,što odgovara 2 mL/5 kg t.m., jednom dnevno potkožnom injekcijom tijekom 5-10 uzastopnih dana.
English: Residue depletion data were made available and supported a cattle meat and offal withdrawal period of 10 days following a subcutaneous injection at the recommended dose of 5 mg/kg bw.
Croatian: Dostavljeni su podaci o pražnjenju rezidua koji govore u prilog karencije za goveđe meso i iznutrice u trajanju od 10 dana nakon supkutane injekcije u preporučenoj dozi od 5 mg/kg tjelesne težine.
English: 10 mg/kg bw, corresponding to 0.4 ml/kg bw, once daily by subcutaneous injection for 5 to 10 consecutive days.
Croatian: Doza za glodavce je 10 mg/kg t.m.,što odgovara 0,4 mL/kg t.m., jednom dnevno potkožnom injekcijom tijekom 5 do 10 uzastopnih dana.
English: Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Croatian: VMP primijeniti samo nakon procjene veterinara o odnosu koristi/rizika.
English: Cats: Treatment of infections of the alimentary, respiratory and urogenital tracts (as adjunctive antibiotic therapy for pyometra), skin and wound infections, caused by susceptible strains of: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp., Proteus spp.
Croatian: Mačke: Liječenje infekcija probavnog, respiratornog i urogenitalnog trakta (uključujući prostatu, dodatnu antibiotsku terapiju za piometru), kožne infekcije i infekcije rana, otitis uzrokovanih podložnim sojevima patogena: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp., Proteus spp.
English: Dogs, cats, cattle, poultry, pigs
Croatian: Psi, mačke, goveda, perad, svinje
English: Calves 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily for 3-5 days.
Croatian: Doza za telad je 5 mg enrofloksacina/kg t.m., što odgovara 1 mL/10 kg t.m., jednom dnevno tijekom 3-5 dana.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name> 50 mg/ml solution for injection Enrofloxacin
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA <Izmišljeno ime>, 50 mg/mL otopina za injekciju Enrofloksacin
English: TARGET SPECIES Cattle (calves), sheep, goats, pigs, dogs and cats.
Croatian: CILJNE VRSTE ŽIVOTINJA Govedo (telad), ovca, koza, svinja, pas i mačka.
English: PACKAGE LEAFLET FOR: <Invented name> 50 mg/ml solution for injection
Croatian: UPUTA O VMP ZA: <Izmišljeno ime>, 50 mg/mL otopina za injekciju
English: Cattle (calves), sheep, goats, pigs, dogs and cats.
Croatian: Govedo (telad), ovca, koza, svinja, pas i mačka.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name> 50 mg/ml solution for injection
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA <Izmišljeno ime>, 50 mg/mL otopina za injekciju
English: Calves
Croatian: Sisavci
English: Enrofloxacin 100 mg
Croatian: Enrofloksacin 100 mg
English: Residue depletion data were made available and supported a cattle milk withdrawal period of 3 days following an intravenous injection at the recommended dose of 5 mg/kg bw.
Croatian: Dostavljeni su podaci o pražnjenju rezidua koji govore u prilog karencije za goveđe mlijeko u trajanju od 3 dana nakon intravenozne injekcije u preporučenoj dozi od 5 mg/kg tjelesne težine.
English: Sheep milk (50 mg/ml and 100 mg/ml strengths)
Croatian: Ovčje mlijeko (jačine 50 mg/ml i 100 mg/ml)
English: EXPIRY DATE
Croatian: EXP { mjesec/godina }
English: Residue depletion data were made available and supported a cattle milk withdrawal period of 4 days following a subcutaneous injection at the recommended dose of 5 mg/kg bw.
Croatian: Dostavljeni su podaci o pražnjenju rezidua koji govore u prilog karencije za goveđe mlijeko u trajanju od 4 dana nakon supkutane injekcije u preporučenoj dozi od 5 mg/kg tjelesne težine.
English: Enrofloxacin 50 mg
Croatian: Enrofloksacin 50 mg
English: TARGET SPECIES Cattle (calves), sheep, goats, pigs, dogs and cats
Croatian: CILJNE VRSTE ŽIVOTINJA Govedo (telad),ovca, koza, svinja, pas i mačka.
English: Residue depletion data were made available and supported a sheep milk withdrawal period of 3 days following a subcutaneous injection at the recommended dose of 5 mg/kg bw.
Croatian: Dostavljeni su podaci o pražnjenju rezidua koji govore u prilog karencije za ovčje mlijeko u trajanju od 3 dana nakon supkutane injekcije u preporučenoj dozi od 5 mg/kg tjelesne težine.
English: Alimentary tract infection, or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily by intramuscular injection for 3 days.
Croatian: U slučaju infekcije probavnog sustava ili septikemije uzrokovane s Escherichia coli doza je 5 mg enrofloksacina/kg t.m., što odgovara 1 mL/20 kg t.m., jednom dnevno injekcijom u mišić tijekom 3 dana.
English: Calves, cattle, pigs, dogs
Croatian: Telad, goveda, svinje, psi
English: Rabbits
Croatian: Glodavci
English: 50 ml 100 ml
Croatian: 100 mL
English: Cattle Calves
Croatian: Svinje Goveda Goveda
English: Sheep: Meat and offal: 4 days.
Croatian: Meso i jestive iznutrice: 4 dana Mlijeko: 3 dana.
English: 2.5 mg of enrofloxacin/kg bw, corresponding to 0.5 ml/10 kg bw, once daily by intramuscular injection for 3 days.
Croatian: Doza za svinje je 2,5 mg enrofloksacin/kg t.m., što odgovara 0,5 mL/10 kg t.m., jednom dnevno injekcijom u mišić tijekom 3 dana.
English: Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily by intramuscular injection for 3 days.
Croatian: U slučaju infekcije probavnog sustava ili septikemije uzrokovane s Escherichia coli doza je 5 mg enrofloksacina/kg t.m., što odgovara 1 mL/10 kg t.m., jednom dnevno injekcijom u mišić tijekom 3 dana.
English: Dose rate (mg/kg bw) Route of administration im im iv sc
Croatian: Doza (mg/kg t.m.) Put primjene u mišić u mišić u venu potkožno
English: Calves, pigs, poultry, dogs, cats
Croatian: Telad, svinje, perad, psi, mačke
English: Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of: Pasteurella multocida, Mycoplasma spp., Actinobacillus pleuropneumoniae.
Croatian: Liječenje infekcija respiratornog trakta uzrokovanih sojevima bakterija Pasteurella multocida, Mycoplasma spp. i Actinobacillus pleuropneumoniae osjetljivih na enrofloksacin.
English: Goat milk (50 mg/ml and 100 mg/ml strengths)
Croatian: Kozje mlijeko (jačine 50 mg/ml i 100 mg/ml)
English: Treatment of infections of the alimentary, respiratory and urogenital tracts (including prostatitis, adjunctive antibiotic therapy for pyometra), skin and wound infections, otitis (externa/media) caused by enrofloxacin susceptible strains of Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Croatian: Liječenje infekcija probavnog , dišnog i mokraćno-spolnog sustava (uključujući prostatitis, pomoćna terapija piometre), infekcija kože i rana, upala uha (otitis externa/media) uzrokovanih sojevima bakterija Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp. i Proteus spp.osjetljivih na enrofloksacin.
English: Reptiles
Croatian: NUSPOJAVE
English: 2.5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily by intramuscular injection for 3 days.
Croatian: Doza za svinje je 2,5 mg enrofloksacina/kg t.m., što odgovara 1 mL/10 kg t.m., jednom dnevno . injekcijom u mišić tijekom 3 dana.
English: Disposal: read package leaflet.
Croatian: Odlaganje otpadnih materijala u skladu s propisima o zbrinjavanju otpada.
English: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily by subcutaneous injection for 3 days.
Croatian: Doza za koze i ovce je 5 mg enrofloksacina/kg t.m., što odgovara 1 mL/20 kg t.m., jednom dnevno potkožnom injekcijom tijekom 3 dana.
English: Treatment of infections of the alimentary, respiratory and urogenital tracts (including prostatitis, adjunctive antibiotic therapy for pyometra), skin and wound infections, otitis (externa/media) caused by enrofloxacin susceptible strains of: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Croatian: Liječenje infekcija probavnog, dišnog i mokraćno spolnog sustava (uključujući prostatitis, pomoćna terapija piometre), infekcije kože i rana,upale uha (otitis externa/media) uzrokovanih sojevima bakterija: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp. i Proteus spp. osjetljivih na enrofloksacin.
English: Summaries of product characteristics, labelling and package leaflets
Croatian: Dodatak III Sažetak opisa svojstava lijeka, etikete i uputa za uporabu
English: Treatment of infections of the alimentary, respiratory and urogenital tracts (as adjunctive antibiotic therapy for pyometra), skin and wound infections, caused by enrofloxacin susceptible strains of: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Croatian: Liječenje infekcija probavnog, dišnog i mokraćno spolnog sustava (kao dodatna antimikrobna terapija piometre), infekcija kože i rana uzrokovanih sojevima bakterija: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp. i Proteus spp. osjetljivih na enrofloksacin.
English: and Proteus spp.
Croatian: UPUTA O VMP
English: Pig, rabbits, dogs, cats
Croatian: Svinje, kunići, psi, mačke
English: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily by subcutaneous injection for up to 5 days.
Croatian: Doza za pse i mačke je 5 mg enrofloksacina/kg t.m., što odgovara 1 mL/10 kg t.m., jednom dnevno potkožnom injekcijom tijekom 5 dana.
English: Contaminated clothing should be removed immediately.
Croatian: Kontaminiranu odjeću treba odmah skinuti.
English: This overview was last updated in April 2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u travnju 2018.
English: Further information on Dany's BienenWohl can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Više informacija o VMP-u Dany's BienenWohl nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Hands and exposed skin should be washed with soap and plenty of water immediately.
Croatian: Ruke i izložena područja kože treba odmah oprati sapunom i obilnom količinom vode.
English: The mite can also help spread viruses and bacteria.
Croatian: Preko grinja se također mogu prenijeti virusi i bakterije.
English: This authorisation was based on the authorisation granted to Oxybee in 2018 (‘informed consent').
Croatian: Odobrenje se temeljilo na odobrenju koje je izdano za VMP Oxybee 2018. godine („informirani pristanak”).
English: Three weeks of treatment Dany's BienenWohl led to the death of 97 and 95 % of the mites.
Croatian: Tri tjedna liječenja VMP-om Dany's BienenWohl rezultirala su smrću 97 % odnosno 95 % grinja.
English: This medicine is the same as Oxybee, which is already authorised in the European Union (EU).
Croatian: Ovaj VMP isti je kao i VMP Oxybee, koji je već odobren u Europskoj uniji (EU).
English: Up to 6 ml of Dany's BienenWohl are trickled onto bees in the hive and should only be used when the temperature outside the hives is at least 3˚C.
Croatian: Do 6 ml VMP-a Dany's BienenWohl nakapava se na pčele u košnici, a treba ga primjenjivati samo kada je temperatura izvan košnice najmanje 3 ˚C.
English: The most common side effect with Dany's BienenWohl (which may affect more than 1 in 10 bee colonies) is an increased number of bee deaths.
Croatian: Najčešća nuspojava VMP-a Dany's BienenWohl (može se javiti u više od 1 na 10 kolonija pčela) jest povećana smrtnost pčela.
English: Dany's BienenWohl is highly acidic and could be irritating or corrosive to the skin, eyes and mucous membranes (inner lining of body cavities like the mouth or nose).
Croatian: VMP Dany's BienenWohl visoke je kiselosti i može biti nadražujuć ili nagrizajuć za kožu, oči i sluznicu (sluznica tjelesnih šupljina kao što su usta ili nos).
English: If the product is accidentally swallowed by a person, their mouth should be cleaned with water and water or milk should be drunk, but vomiting should not be induced.
Croatian: U slučaju da se VMP nehotice proguta, potrebno je isprati usta vodom i piti vodu ili mlijeko, ali ne smije se izazivati povraćanje.
English: Dany's BienenWohl can only be used on colonies without brood and should be used as part of a wider management programme.
Croatian: VMP Dany's BienenWohl može se primjenjivati samo u kolonija bez legla, a treba ga primjenjivati kao dio šireg programa upravljanja.
English: The varroa mite feeds on the haemolymph (blood) of adult bees and on brood (developing stages of the honey bee) resulting in harm and/or death of bees.
Croatian: Grinje varoe hrane se hemolimfom (krv) odraslih pčela i leglom (razvojna faza medonosne pčele), što rezultira oštećenjem i/ili smrću pčela.
English: Dany's BienenWohl (oxalic acid)
Croatian: Dany's BienenWohl (oksalna kiselina)
English: The effectiveness of Dany's BienenWohl against varroa mites was investigated in two field studies in European countries with different climates.
Croatian: Djelotvornost VMP-a Dany's BienenWohl u suzbijanju grinja varoa istraživana je u dvama terenskim ispitivanjima u europskim zemljama različitih klima.
English: In the first study treatment with Dany's BienenWohl was compared to another oxalic acid medicine and to a group with no treatment whilst in the second study treatment with Dany's BienenWohl was compared to a group with no treatment.
Croatian: U prvom ispitivanju liječenje VMP-om Dany's BienenWohl uspoređeno je s drugim VMP-om koji sadrži oksalnu kiselinu i sa skupinom koja nije tretirana, dok je u drugom ispitivanju liječenje VMP-om Dany's BienenWohl uspoređeno sa skupinom koja nije tretirana.
English: The withdrawal period for honey from honey bees treated with Dany's BienenWohl is ‘zero' days, which means that there is no mandatory waiting time.
Croatian: Razdoblje karencije za med medonosnih pčela liječenih VMP-om Dany's BienenWohl iznosi „nula” dana, odnosno nema obveznog razdoblja čekanja.
English: The company that makes Oxybee has agreed that its scientific data can be used for Dany's BienenWohl (‘informed consent').
Croatian: Proizvođač VMP-a Oxybee pristao je na to da se njegovi znanstveni podatci koriste za VMP Dany's BienenWohl (tzv. „informirani pristanak”).
English: The European Medicines Agency concluded that Dany's BienenWohl's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove odlučila je da koristi od VMP-a Dany's BienenWohl nadmašuju s njim povezane rizike te se može izdati odobrenje za njegovu primjenu u EU-u.
English: Dany's BienenWohl received a marketing authorisation valid throughout the EU on 14 June 2018.
Croatian: Za VMP Dany's BienenWohl izdano je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 14/06/2018.
English: Dany's BienenWohl is a medicine used to treat varroosis in honey bee colonies.
Croatian: Dany's BienenWohl je VMP koji se koristi za liječenje varooze u kolonijama medonosnih pčela.
English: An overview of Dany's BienenWohl and why it is authorised in the EU
Croatian: Pregled VMP-a Dany's BienenWohl i zašto je odobren u EU-u
English: How oxalic acid works on mites is not well understood but it is thought that the activity of oxalic acid on mites is due to the acidity of the medicine, which kills the mites on contact.
Croatian: Način djelovanja oksalne kiseline na grinje nije u potpunosti poznat, ali smatra se da oksalna kiselina djeluje na grinje zbog kiselosti i ubija grinje u dodiru s VMP-om.
English: What is Dany's BienenWohl and what is it used for?
Croatian: Što je Dany's BienenWohl i za što se koristi?
English: Other information about Dany's BienenWohl
Croatian: Ostale informacije o VMP-u Dany's BienenWohl
English: For more information about using Dany's BienenWohl, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni VMP-a Dany's BienenWohl pogledajte uputu o VMP-u, odnosno obratite se svom veterinaru ili ljekarniku.
English: Dany's BienenWohl is available as a powder and solution to prepare a bee-hive dispersion (a liquid for use inside the bee hive) and can be obtained without a prescription.
Croatian: VMP Dany's BienenWohl dostupan je kao prah i otopina za pripremu disperzije za košnice (tekućina za korištenje unutar košnice) i može se dobiti bez veterinarskog recepta.
English: If possible, the use of Dany's BienenWohl should be alternated with another medicine that kills mites in a different way to reduce the chance of the mites developing resistance.
Croatian: Ako je moguće, trebalo bi naizmjenično primjenjivati VMP Dany's BienenWohl i drugi VMP protiv grinja s drugačijim načinom djelovanja kako bi se smanjila vjerojatnost da će grinje razviti otpornost.
English: Dany's BienenWohl contains the active substance oxalic acid.
Croatian: VMP Dany's BienenWohl sadrži djelatnu tvar oksalnu kiselinu.
English: What are the risks associated with Dany's BienenWohl?
Croatian: Koji su rizici povezani s VMP-om Dany's BienenWohl?
English: Why is Dany's BienenWohl authorised in the EU?
Croatian: Zašto je VMP Dany's BienenWohl odobren u EU-u?
English: How is Dany's BienenWohl used?
Croatian: Kako se Dany's BienenWohl koristi?
English: How does Dany's BienenWohl work?
Croatian: Kako djeluje Dany's BienenWohl?
English: What benefits of Dany's BienenWohl have been shown in studies?
Croatian: Koje su koristi VMP-a Dany's BienenWohl utvrđene u ispitivanjima?
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/14/955/001 Lymphoseek
Croatian: Farmaceutski oblik Put primjene
English: EU/1/14/955/002 Lymphoseek
Croatian: EMA broj postupka
English: Silgard is given according to official recommendations.
Croatian: Silgard se primjenjuje u skladu sa službenim preporukama.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Silgard on 20 September 2006.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Silgard vrijedi na prostoru Europske unije od 20. rujna 2006.
English: The full EPAR for Silgard can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Silgard nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The proteins are assembled in ‘virus-like particles' (structures that look like HPV, so that the body can recognise them easily).
Croatian: . Proteini se skupljaju u „čestice slične virusu” (strukture koje izgledaju poput HPV-a, tako da ih tijelo može lakše prepoznati).
English: Patients who show signs of an allergy after a dose of Silgard should not receive further doses of the vaccine.
Croatian: Bolesnici koji pokazuju znakove alergije nakon doze lijeka Silgard ne smiju primiti daljnje doze cjepiva.
English: Silgard is used in males and females from the age of nine years to protect against the following conditions caused by specific types of human papillomavirus (HPV):
Croatian: Silgard se koristi u muškaraca i žena od devete godine starosti za prevenciju sljedećih stanja uzrokovanih specifičnim tipovima humanoga papilomavirusa (HPV):
English: The vaccine also contains an ‘adjuvant' (a compound containing aluminium) to stimulate a better
Croatian: Cjepivo također sadrži „adjuvans” (spoj koji sadrži aluminij) za poticanje boljeg odgovora.
English: In contrast, 85 of the more than 8,000 women who received the placebo vaccine developed lesions that were due to these two HPV types.
Croatian: Nasuprot tome, 85 od više od 8 000 žena koje su primile placebo cjepivo razvile su lezije koje su uzrokovala ova dva tipa virusa HPV-a.
English: This document is a summary of the European public assessment report (EPAR) for Silgard.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Silgard.
English: A risk management plan has been developed to ensure that Silgard is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Silgard.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Silgard.
English: It is recommended that individuals who receive the first dose of Silgard should complete the dosing regimen with Silgard.
Croatian: Preporuča se da pojedinci koji prime prvu dozu lijeka Silgard završe cjelokupan režim doziranja lijekom Silgard.
English: Silgard contains the purified L1 proteins for HPV types 6, 11, 16 and 18, which are produced by a method known as ‘recombinant DNA technology': they are made by yeast cells into which a gene (DNA) has been introduced that makes them able to produce the L1 proteins.
Croatian: Silgard sadrži pročišćene L1 proteine za tipove HPV-a 6, 11, 16 i 18, koji se proizvode metodom poznatom pod nazivom „tehnologija rekombinantne DNK”: proizvode se od stanica kvasca u koje se ugradio gen (DNK), što im omogućuje proizvodnju L1 proteina.
English: What measures are being taken to ensure the safe and effective use of
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Silgard?
English: For more information about treatment with Silgard, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Silgard pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: In studies, the most common side effects with Silgard (seen in more than 1 patient in 10) were headache and reactions at the site of the injection (redness, pain and swelling).
Croatian: Najčešće nuspojave lijeka Silgard u ispitivanjima (kod više od 1 na 10 osoba) su glavobolja i reakcija u mjestu injekcije (crvenilo, bol i oticanje).