FrancophonIA/ELRC3.0 huggingface dataset:
English: Animal Health Division Bayer House Strawberry Hill Newbury
Slovenian: Strawberry Hill Newbury
English: The use of fluoroquinolones during the growth phase combined with a marked and prolonged increase in the intake of drinking water, and hence active ingredient, possibly due to high temperatures, may potentially be associated with damage of the articular cartilage.
Slovenian: Uporaba fluorokinolonov v fazi rasti v kombinaciji z znatnim in dolgotrajnim povečanjem uživanja pitne vode (in s tem aktivne učinkovine), zaradi visokih temperatur, so lahko potencialno povezana s poškodbami sklepnega hrustanca.
English: In vitro, an antagonism was shown, when combining fluoroquinolones with bacteriostatic antimicrobial agents such as macrolides or tetracyclines and phenicols.
Slovenian: In vitro, je kombinacija fluorokinolonov z bakteriostatičnimi protimikrobnimi pripravki kot so makrolidi ali tetraciklini povzročila antagonistične učinke.
English: Chickens must not be slaughtered for human consumption until 3 days after the last treatment.
Slovenian: Piščanci se ne smejo zaklati za prehrano ljudi 3 dni po zadnjem dajanju zdravila.
English: This veterinary medicinal product does not require any special storage conditions.
Slovenian: Za shranjevanje zdravila ni posebnih navodil.
English: Use of the product deviating from the instructions given may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other fluoroquinolones due to the potential for cross-resistance.
Slovenian: Uporaba zdravila, ki ni v skladu z navodili iz tega Povzetka glavnih značilnosti zdravila, lahko poveča razširjenost bakterij, ki so odporne na fluorokinolone in zmanjša učinek zdravljenja z drugimi kinoloni zaradi možnosti navzkrižne odpornosti.
English: • Those with known hypersensitivity to (fluoro)quinolones should avoid contact with this product.
Slovenian: • Osebe z znano preobčutljivostjo na kinolone naj se izogibajo stiku z zdravilom.
English: Do not administer to layer replacement birds within 14 days of coming into lay.
Slovenian: Ne uporabite pri bodočih kokoših nesnicah 14 dni pred pričakovano nesnostjo.
English: In addition, data from the challenge studies provide evidence that a dose of 10 mg/kg bodyweight for 5 days will be tolerated in rabbits.
Slovenian: Poleg tega podatki iz provokacijskih študij kažejo, da kunci prenašajo odmerek 10 mg/kg telesne mase, ki ga dobivajo 5 dni.
English: To be completed nationally {Name and address} <{Tel}> <{Fax}> <{E-mail}>
Slovenian: Se dopolni -nacionalno Ime in naslov} <{Tel}> <{Fax}> <{E-mail}>
English: • Wash hands and exposed skin after use.
Slovenian: • Po uporabi si umijte roke.
English: Therefore, a 3-day meat withdrawal period can be adopted for the harmonised product information for both chickens and turkeys.
Slovenian: Zato se lahko za usklajene informacije o zdravilu sprejme 3dnevna karenca za piščančje in puranje meso.
English: Enrofloxacin should be used where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the active substance of choice.
Slovenian: Enrofloksacin peroralno raztopino dajemo v primerih, ko klinične izkušnje, ki so po možnosti podprte z antibiogrami, kažejo, da je enrofloksacin zdravilo izbire.
English: Do not use when resistance / cross-resistance to (fluoro)quinolones is known to occur.
Slovenian: Ne uporabite v primerih, kjer je možen nastanek odpornosti / navzkrižne odpornosti na (fluoro)kinolone.
English: Turkeys must not be slaughtered for human consumption until 3 days after the last treatment
Slovenian: Purani se ne smejo zaklati za prehrano ljudi 3 dni po zadnjem dajanju zdravljenja.
English: Calculate the daily quantity (ml) of “Product name” (to be completed nationally) required for treatment period as follows:
Slovenian: Izračunajte dnevno količino (v ml) “Ime zdravila” (se dopolni nacionalno) , ki je potrebna za čas zdravljenja kot sledi:
English: • Rinse any splashes from skin or eyes immediately with water.
Slovenian: • V primeru stika s kožo ali očmi, zdravilo nemudoma sperite z vodo.
English: Those with known hypersensitivity to (fluoro)quinolones should avoid contact with this product.
Slovenian: Osebe z znano preobčutljivostjo na kinolone naj se izogibajo stiku z zdravilom.
English: Treatment of the respiratory tract and of the digestive tract infections caused by the following bacteria susceptible to enrofloxacin:
Slovenian: Zdravljenje okužb respiratornega trakta in prebavnega trakta, ki jih povzročajo bakterije, občutljive na enrofloksacin:
English: 10 mg enrofloxacin/kg bodyweight per day for 3-5 consecutive days.
Slovenian: 10 mg enrofloksacina/kg telesne mase na dan, 3-5 zaporednih dni.
English: Rinse any splashes from skin or eyes immediately with water.
Slovenian: V primeru stika s kožo ali očmi, zdravilo nemudoma sperite z vodo.
English: In vitro susceptibility has been shown in strains of (i) Gram-negative species such as Escherichia coli, Pasteurella multocida and Avibacterium (Haemophilus) paragallinarum and (ii) Mycoplasma gallisepticum and Mycoplasma synoviae.
Slovenian: In vitro občutljivost je bila dokazana pri sevih (i) Gram-negativnih vrst kot so Escherichia coli, Pasteurella multocida in Avibacterium (Haemophilus) paragallinarum ter (ii) Mycoplasma gallisepticum in Mycoplasma synoviae.
English: Doses up to 100 mg/kg bodyweight during 5 days or 30 mg/kg bodyweight for 3 weeks were clinically well tolerated in broilers.
Slovenian: Odmerke do 100 mg/kg telesne mase pri 5-dnevnem zdravljenju ali 30 mg/kg telesne mase pri 3tedenskem zdravljenju so pitovni piščanci dobro prenašali.
English: Target inhibition is caused by non-covalent binding of fluoroquinolone molecules to an intermediate state in this sequence of reactions, in which DNA is cleaved, but both strands are retained covalently attached to the enzymes.
Slovenian: Nato se skozi nastalo vrzel vstavi oddaljen DNK segment, preden se vijačnica ponovno združi.Ciljna inhibicija nastane zaradi nekonvalentne vezave molekul fluorokinolonov na vmesno fazo v sekvenci reakcij, kjer se DNK razcepi, oba dela vijačnice pa ostaneta kovalentno združena z encimi.
English: “Product name” (to be completed nationally)
Slovenian: “Ime zdravila” (se dopolni nacionalno)
English: Chicken, turkey and rabbit.
Slovenian: Piščanci, purani in kunci.
English: CVMP Reflection paper on the use of fluoroquinolones in food- producing animals - Precautions for use in the SPC regarding prudent use guidance (EMEA/CVMP/416168/2006)http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500005173.pdf
Slovenian: Dokument CVMP za razmislek o uporabi fluorokinolonov pri živalih za proizvodnjo hrane - opozorila za uporabo v povzetku glavnih značilnosti zdravila glede smernic za preudarno uporabo (EMEA/CVMP/416168/2006)http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500005173.pdf je odbor CHMP priporočil spremembo dovoljenj za promet z zdravilom, za katera so v Prilogi III za zdravilo Baytril 10 % peroralna raztopina in povezana imena določeni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo (glejte Prilogo I).
English: To be completed nationally {MM/YYYY}
Slovenian: Se dopolni - nacionalno{MM/YYYY}
English: • Target species;
Slovenian: • ciljno živalsko vrsto,
English: • Withdrawal period;
Slovenian: • rok uporabnosti.
English: A recent paper by de Jong et al quotes data from the European Antimicrobial Susceptibility Surveillance in Animals (EASSA) collected from EU countries.
Slovenian: Evropskega spremljanja protimikrobne občutljivosti pri živalih (European Antimicrobial Susceptibility Surveillance in Animals, EASSA), zbrane v državah EU.
English: 10 mg/kg bodyweight per day for 5 consecutive days.
Slovenian: 10 mg/kg telesne mase na dan 5 zaporedni dni.
English: Chickens: 3 days Turkeys: 4 days
Slovenian: Piščanci: 3 dni Purani: 4 dni
English: There is no evidence of chondrotoxicity in chickens, turkeys or rabbits from Periodic Safety Update Reports over the last 10 years.
Slovenian: Redno posodobljena poročila o varnosti zdravila za zadnjih 10 let ne kažejo znakov hondrotoksičnosti pri piščancih, puranih ali kuncih.
English: Chicken: 7 days Turkey: 10 days Do not administer to laying birds producing eggs for human consumption
Slovenian: Piščanci: 7 dni Purani: 10 dni Ni za ptice, katerih jajca so namenjena prehrani ljudi.
English: Rabbits: Meat and offal: 15 days.
Slovenian: Kunci: meso in organi: 15 dni.
English: Chickens: 3 days Turkeys: 3 days
Slovenian: Piščanci: 3 dni Purani: 3 dni
English: They modulate the topological state of DNA through cleaving and resealing reactions.
Slovenian: Spreminjajo topološko stanje DNK s cepitvijo in kasnejšo povezavo cepljenih verig.
English: Do not use in laying hens producing eggs for human consumption.
Slovenian: Ne uporabite pri kokoših nesnicah, katerih jajca so namenjena prehrani ljudi.
English: No adverse clinical symptoms were observed in chickens and turkeys treated respectively with doses up to 10 and 6 times higher than the therapy dose.
Slovenian: Piščanci in purani, ki so bili zdravljeni z odmerki z do 10 in 6 - krat višjimi od priporočenih, niso kazali nobenih neželenih kliničnih znakov.
English: Enrofloxacin 100 mg/ml oral solution Poultry
Slovenian: Enrofloxacin 100 mg/ml peroralna raztopina
English: The product has been shown to be efficacious in the treatment of E. coli, Avibacterium paragallinarum, Pasteurella multocida, Mycoplasma gallisepticum and Mycoplasma synoviae in chickens; E. coli, Mycoplasma gallisepticum, Mycoplasma synoviae and Pasteurella multocida in turkeys.
Slovenian: Zdravilo je učinkovito pri zdravljenju okužb z E. coli, Avibacterium paragallinarum, Pasteurella multocida, Mycoplasma gallisepticum in Mycoplasma synoviae pri piščancih ter okužb z E. coli, Mycoplasma gallisepticum, Mycoplasma synoviae in Pasteurella multocida pri puranih.
English: Condition of the marketing authorisations
Slovenian: Pogoj za dovoljenja za promet z zdravilom
English: Benefit-risk assessment
Slovenian: Ocena razmerja med koristmi in tveganji
English: Chickens: Meat and offal: 3 days.
Slovenian: Piščanci: meso in organi: 3 dni.
English: Chickens, turkeys: 3 days Do not use in poultry producing eggs for human consumption
Slovenian: Piščanci, purani: 3 dni Ni za perutnino, katerih jajca so namenjena prehrani ljudi.
English: Chickens: 8 days Not for use in birds producing eggs for human consumption
Slovenian: Piščanci: 8 dni Ni za ptice, katerih jajca so namenjena prehrani ljudi.
English: BAYTRIL 10 % Enrofloxacin 100 mg/ml oral solution Chickens and turkeys
Slovenian: Baytril 10% Enrofloxacin 100 mg/ml peroralna raztopina
English: Turkeys: Meat and offal: 3 days.
Slovenian: Purani: meso in organi: 3 dni.
English: Satisfactory data have been submitted to support the use of enrofloxacin at the proposed harmonised dose rate to treat Avibacterium paragallinarum, Pasteurella multocida, Mycoplasma gallisepticum and Mycoplasma synoviae in chickens; Mycoplasma gallisepticum, Mycoplasma synoviae and Pasteurella multocida in turkeys.
Slovenian: V podporo uporabi enrofloksacina v predlaganem usklajenem odmerku za zdravljenje okužb z Avibacterium paragallinarum, Pasteurella multocida, Mycoplasma gallisepticum in Mycoplasma synoviae pri piščancih ter za zdravljenje okužb z Mycoplasma gallisepticum, Mycoplasma synoviae in Pasteurella multocida pri puranih so bili predloženi zadovoljivi podatki.
English: Not for use in laying birds whose eggs are intended for human consumption
Slovenian: Ni za ptice, katerih jajca so namenjena prehrani ljudi.
English: Baytril 10% Enrofloxacin 100 mg/ml oral solution Chickens and turkeys
Slovenian: BAYTRIL 10 % Enrofloksacin 100 mg/ml peroralna raztopina
English: Two enzymes essential in DNA replication and transcription, DNA gyrase and topoisomerase IV, have been identified as the molecular targets of fluoroquinolones.
Slovenian: Ciljno delovanje flourokinolonov sta dva pomembna encima: DNK giraza in topoizomeraza IV, ki sodelujeta pri podvojevanju in prepisu DNK v bakterijski celici.
English: Birds must not be slaughtered for human consumption during treatment.
Slovenian: Med zdravljenjem ni dovoljeno klanje ptic.
English: MARKETING AUTHORISATION HOLDER
Slovenian: IMETNIK DOVOLJENJ ZA PROMET
English: PACKAGE LEAFLET FOR: “Product name” To be completed nationally.
Slovenian: NAVODILO ZA UPORABO “Ime zdravila” (se dopolni nacionalno)
English: Enrofloxacin 100 mg/ml oral solution Poultry (specifically broiler chickens, broiler breeders and pullets being reared as layers) and turkeys
Slovenian: Perutnina (zlasti brojlerski piščanci in kokoši, ki niso nesnice in purani
English: Pharmacotherapeutic group: quinolone and quinoxaline antibacterials, fluoroquinolones.
Slovenian: Farmakoterapevtska skupina, oznaka ATC vet: kinoloni, sistemsko protimikrobno zdravilo, flourokinoloni ATCvet oznaka:QJ 01 MA90.
English: • Posology;
Slovenian: • odmerjanje,
English: Mommaertslaan 14
Slovenian: 4.11 Karenca
English: These changes may be permanent.
Slovenian: Te spremembe so lahko trajne.
English: This is enough for 4 weeks' usage.
Slovenian: To zadošča za 4-tedensko uporabo.
English: Date of first authorisation 19 May 2006 Date of latest renewal 23 June 2011
Slovenian: Datum prve odobritve: 19. maj 2006 Datum zadnjega podaljšanja: 23. junij 2011
English: Characteristics in older people
Slovenian: Značilnosti pri starejših ljudeh
English: • Low blood sugar
Slovenian: • nizek krvni sladkor,
English: Tilt your head back and look at the ceiling.
Slovenian: Glavo nagnite nazaj in poglejte v strop.
English: <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
Slovenian: <{MM/LLLL}> <{DD/MM/LLLL}> <{DD. mesec LLLL}>
English: This reduces the pressure inside the eye.
Slovenian: Tako zmanjša tlak v očesu.
English: It may harm them,
Slovenian: Njim bi lahko škodovalo,
English: Frequency cannot be estimated from available data
Slovenian: Pogostnosti ni mogoče oceniti iz razpoložljivih podatkov.
English: The half-life of timolol in plasma is about 4 to 6 hours.
Slovenian: Razpolovna doba timolola v plazmi je približno 4 do 6 ur.
English: Put your next dose in at the usual time.
Slovenian: Naslednji odmerek vkapajte ob običajnem času.
English: The ocular and systemic safety profile of the individual components is well established.
Slovenian: Profil lokalne in sistemske varnosti posamezne sestavine je dobro poznan.
English: You can usually carry on taking the drops, unless the effects are serious.
Slovenian: Običajno lahko nadaljujete z uporabo kapljic, razen če so neželeni učinki resni.
English: The response of these patients should be closely observed.
Slovenian: Odziv takšnih bolnikov je treba pozorno opazovati.
English: This may result in a decrease in systemic side effects and an increase in local activity.
Slovenian: To lahko pripelje do zmanjšanja sistemskih neželenih učinkov in povečanja lokalnega delovanja.
English: Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.
Slovenian: Dokazano je bilo, da je kemična in biološka stabilnost po odprtju 28 dni pri 25 °C.
English: If one dose is missed, treatment should continue with the next dose as planned.
Slovenian: Če je bil odmerek izpuščen, se zdravljenje nadaljuje z naslednjim odmerkom, kot je načrtovano.
English: Liquid is constantly being drained out of the eye and new liquid is made to replace this.
Slovenian: Ta tekočina ves čas izteka iz očesa in nastaja nova tekočina, da jo nadomesti.
English: If overdose occurs treatment should be symptomatic and supportive.
Slovenian: V primeru prevelikega odmerjanja naj bo zdravljenje simptomatsko in podporno.
English: The plasma protein binding of bimatoprost is approximately 88%.
Slovenian: Plazemski proteini vežejo približno 88 % bimatoprosta.
English: The long term effects of increased iridial pigmentation are not known.
Slovenian: Dolgoročni učinki povečane pigmentacije šarenice niso znani.
English: No adequate clinical data in exposed pregnancies are available.
Slovenian: Na voljo ni ustreznih kliničnih podatkov o izpostavljenosti nosečnic.
English: Side effects where the frequency is not known
Slovenian: Neželeni učinki, kjer pogostnost ni znana
English: The single-dose container is for single use only; one container is sufficient to treat both eyes.
Slovenian: Enoodmerni vsebnik je namenjen samo za enkratno uporabo; en vsebnik zadostuje za zdravljenje obeh očes.
English: Let go of the lower lid, and close your eye.
Slovenian: Spustite spodnjo veko in zaprite oko.
English: In fact, the upper limit of the 95% CI did not exceed 0.14 mm Hg at week 12.
Slovenian: V 12. tednu zgornja meja 95 % CI dejansko ni presegla 0,14 mm Hg.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}
Slovenian: Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> <{mesec LLLL}
English: • Severe allergic reactions with swelling and difficulty breathing which could be life-threatening
Slovenian: • hude alergijske reakcije z otekanjem in težavami pri dihanju, ki lahko ogrožajo življenje,
English: • Reduced sexual urge; sexual dysfunction
Slovenian: • zmanjšanja spolna sla, spolna disfunkcija,
English: When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced.
Slovenian: Pri uporabi nazalokrimalne okluzije ali pri zapiranju vek za 2 minuti se sistemska absorpcija zmanjša.
English: The frequency of possible adverse reactions listed below is defined using the following convention:
Slovenian: Pogostnost možnih neželenih učinkov, navedena spodaj, je opredeljena na naslednji način:
English: In the publication: Nanda T, Rasool N, Callahan AB, Stamper RL, Odel JG. Ophthalmic Timolol Hallucinations: A Case Series and Review of the Literature.
Slovenian: V objavi: Nanda T, Rasool N, Callahan AB, Stamper RL, Odel JG. Ophthalmic Timolol Hallucinations: A Case Series and Review of the Literature.
English: Timolol may get into your breast milk.
Slovenian: Timolol lahko prehaja v materino mleko.
English: Bimatoprost selectively mimics the effects of newly discovered biosynthesised substances called prostamides.
Slovenian: Bimatoprost selektivno posnema učinke pred kratkim odkritih biosintetiziranih substanc, imenovanih prostamidi.
English: Clinical effects
Slovenian: Klinični učinki
English: Patients with cardiovascular diseases should be watched for signs of deterioration of these diseases and of adverse reactions.
Slovenian: Pri bolnikih s srčnožilnimi boleznimi je treba biti pozoren na znake poslabšanja teh bolezni in na znake neželenih učinkov.
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli zdravilo.
English: The dose should not exceed one drop in the affected eye(s) daily.
Slovenian: Odmerek ne sme presegati ene kapljice v prizadeto oko (oči) dnevno.
English: Increased iris pigmentation is likely to be permanent, and may lead to differences in appearance between the eyes if only one eye is treated.
Slovenian: Povečana pigmentacija šarenice bo najverjetneje trajna in lahko vodi do razlik v izgledu oči, če je zdravljeno le eno oko.
English: It is not known if bimatoprost is excreted in human breast milk but it is excreted in the milk of the lactating rat.
Slovenian: Ni znano, ali se tudi bimatoprost izloča v materino mleko pri človeku, izloča pa se v mleko pri podganah.
English: Before you use this medicine, tell your doctor if you have now or have had in the past
Slovenian: Preden uporabite to zdravilo, povejte svojemu zdravniku, če imate ali ste imeli:
English: Therefore caution should be used in treating such patients.
Slovenian: Zato je pri zdravljenju tovrstnih bolnikov potrebna previdnost.
English: Use at the same time each day.
Slovenian: Kapljice uporabljajte vsak dan ob istem času.
English: Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3).
Slovenian: Študije na živalih so pokazale reproduktivno toksičnost ob visokih maternotoksičnih odmerkih (glejte poglavje 5.3).
English: This dose expressed as mg/m2 is at least 70-times higher than the accidental dose of one bottle of GANFORT in a 10 kg child.
Slovenian: Ta odmerek, izražen kot mg/m2, je najmanj 70-krat višji kot naključni odmerek ene plastenke zdravila GANFORT pri otroku, ki tehta 10 kg.
English: In human blood, bimatoprost resides mainly in the plasma.
Slovenian: Pri človeku se bimatoprost zadržuje predvsem v krvni plazmi.
English: Superior sulcus deepening:
Slovenian: Poglabljanje superiornega sulkusa:
English: Use any eye ointment or eye gel last.
Slovenian: Mazilo ali gel za oči uporabite nazadnje.
English: The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes.
Slovenian: Sprememba pigmentacije je posledica povečane vsebnosti melanina v melanocitih in ne povečanja števila melanocitov.
English: Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP at all follow up timepoints throughout the study (p < 0.001).
Slovenian: V obeh zdravljenih skupinah se je pokazalo statistično in klinično pomembno povprečno znižanje od osnovne vrednosti IOT v slabšem očesu pri vseh časovnih točkah spremljanja skozi celotno študijo (p < 0,001).
English: The use of two topical beta-adrenergic blocking agents is not recommended (see section 4.5).
Slovenian: Uporaba dveh lokalnih antagonistov adrenergičnih receptorjev beta ni priporočljiva (glejte poglavje 4.5).
English: If the liquid cannot drain out quickly enough, the pressure inside the eye builds up and could eventually damage your sight (an illness called glaucoma).
Slovenian: Če tekočina ne more dovolj hitro odtekati, se tlak v očesu povečuje in lahko poškoduje vid (bolezen, imenovana glavkom).
English: It is a synthetic prostamide, structurally related to prostaglandin F2α (PGF2α) that does not act through any known prostaglandin receptors.
Slovenian: strukturalno podoben prostaglandinu F2α (PGF2α), ki ne deluje preko kateregakoli znanega prostaglandinskega receptorja.
English: Based on this outcome, update of section 4.8 of the Summary of Product Characteristic to add ‘hallucination' with the frequency ‘not known' is recommended.
Slovenian: Na podlagi tega izida priporočamo posodobitev poglavja 4.8 Povzetka glavnih značilnosti zdravila tako, da se doda neželeni učinek »halucinacije« s pogostnostjo »neznana pogostnost«.
English: Affecting other parts of the body shortness of breath.
Slovenian: Učinki na druge dele telesa oteženo dihanje.
English: Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Slovenian: Obstajajo poročila, da benzalkonijev klorid povzroča točkasto keratopatijo in/ali toksično ulcerozno keratopatijo.
English: The increased iris pigmentation appears to be caused by increased stimulation of melanin production in melanocytes and not by an increase in melanocyte number.
Slovenian: Povečanje pigmentacije irisa je, kot kaže, povzročeno s povečano stimulacijo tvorbe melanina v melanocitih, in ne zaradi povečanega števila melanocitov.
English: There are no adequate data from the use of the bimatoprost / timolol fixed combination in pregnant women.
Slovenian: Ni ustreznih podatkov o uporabi fiksne kombinacije bimatoprosta/timolola pri nosečnicah.
English: • An increase in blood test results that show how your liver is working
Slovenian: • povišane vrednosti rezultatov krvnih preiskav, ki kažejo delovanje jeter.
English: On the basis of the scientific conclusions for bimatoprost / timolol the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing bimatoprost / timolol is unchanged subject to the proposed changes to the product information
Slovenian: Na podlagi znanstvenih zaključkov za bimatoprost/timolol odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) bimatoprost/timolol, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu