natgillin/translations-raw huggingface dataset:
Reproduction is authorised provided the source is acknowledged. to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Reproduction is authorised provided the source is acknowledged. za liječenje perzistentne neutropenije u bolesnika s uznapredovalom infekcijom virusom humane imunodeficijencije (HIV-a) u svrhu smanjenja rizika od bakterijskih infekcija kad drugi načini liječenja nisu prikladni.
Reproduction is authorised provided the source is acknowledged. treatment for as long as the doctor believes the patient is benefiting from it.
Reproduction is authorised provided the source is acknowledged. od četiri tjedna nakon razdoblja bez liječenja od četiri tjedna, sve dok ima koristi od liječenja prema mišljenju liječnika.
Reproduction is authorised provided the source is acknowledged. treatment with Marixino should be reassessed on a regular basis.
Reproduction is authorised provided the source is acknowledged. lijekom Marixino trebaju se redovito ponovno procjenjivati.
Reproduction is authorised provided the source is acknowledged. weekly injections followed by monthly maintenance injections.
Reproduction is authorised provided the source is acknowledged. zatim se nastavlja davanjem injekcije jedanput mjesečno.
Reproduction is authorised provided the source is acknowledged. weight is given by infusion into a vein every twelve hours, up to a maximum dose of 50 mg every 12 hours.
Reproduction is authorised provided the source is acknowledged. sati.
Reproduction is authorised provided the source is acknowledged. where tap water contains a lot of dissolved calcium, bottled water with a low mineral content may be used).
Reproduction is authorised provided the source is acknowledged. niskom koncentracijom minerala).
Reproduction is authorised provided the source is acknowledged. which results in uncontrolled activity of the central nervous system and death of these parasites.
Reproduction is authorised provided the source is acknowledged. sustava krpelja i buha, blokirajući prijenos iona u stanice i iz njih, što rezultira nekontroliranom aktivnošću središnjeg živčanog sustava i smrću ovih parazita.
Reproduction is authorised provided the source is acknowledged. with a type of diabetes medicine called a sulphonylurea or with insulin, the dose of the sulphonylurea or insulin may need to be lowered to avoid hypoglycaemia (low blood sugar levels).
Ako se koristi u kombinaciji s tipom lijeka protiv dijabetesa naziva sulfonilurea ili s inzulinom, može biti potrebno snižavanje doze sulfonilureje ili inzulina da bi se izbjegla hipoglikemija (niske razine glukoze u krvi).
Reproduction is authorised provided the source is acknowledged. work in similar ways to reduce blood pressure by allowing the blood vessels to relax.
Reproduction is authorised provided the source is acknowledged. krvni tlak tako što omogućuju opuštanje krvnih žila.
Reproduction is authorised provided the source is acknowledged. work in similar ways to reduce blood pressure by allowing the blood vessels to relax.
Reproduction is authorised provided the source is acknowledged. snizio krvni tlak tako što omogućuju opuštanje krvnih žila.
Reproduction is authorised provided the source is acknowledged. work in similar ways to reduce blood pressure by allowing the blood vessels to relax.
Reproduction is authorised provided the source is acknowledged. tako što omogućuju opuštanje krvnih žila.
Reproduction studies have been conducted in Cynomolgus monkeys at doses up to 25 times that of the weekly human maintenance dose of 2 mg/kg Herceptin intravenous formulation and have revealed no evidence of impaired fertility or harm to the fetus.
Ispitivanjima utjecaja na reprodukciju provedenima na makaki majmunima, s dozama intravenske formulacije lijeka Herceptin do 25 puta većim od tjedne doze održavanja u ljudi od 2 mg/kg, nije dokazano smanjenje plodnosti niti opasnost za fetus.
Reproduction studies have been conducted in Cynomolgus monkeys at doses up to 25 times that of the weekly human maintenance dose of 2 mg/kg Herceptin intravenous formulation and have revealed no evidence of impaired fertility or harm to the foetus.
Ispitivanjima utjecaja na reprodukciju provedenim na makaki majmunima s dozama intravenske formulacije lijeka Herceptin do 25 puta većim od tjedne doze održavanja u ljudi od 2 mg/kg, nije dokazano smanjenje plodnosti niti opasnost za fetus.
Reproduction studies in the rat and the rabbit showed no effect of agomelatine on fertility (see section 5.3).
Studije reprodukcije štakora i kunića pokazuju da agomelatin nema utjecaja na plodnost (vidjeti dio 5.3 ).
Reproduction studies showed embryo-foetotoxic effects (resorptions and post-implantation losses) in rats at the 100 mg/kg/day dose level and in rabbits receiving cysteamine 50 mg/kg/day.
Ispitivanja reprodukcije pokazala su embriofetotoksični učinak (resorpcije i odbacivanje nakon implantacije) kod štakora pri razini doze od 100 mg/kg/dan, te kod zečeva koji su primali 50 mg/kg/dan cisteamina.
Reproduction toxicity studies with timolol showed delayed foetal ossification in rats with no adverse effects on postnatal development (at 50 mg/kg/day or 3500 times the daily clinical dose of 14 g/kg/day) and increased foetal resorptions in rabbits (at 90 mg/kg/day or 6400 times the daily clinical dose).
Istraživanja reprodukcijske toksičnosti timolola pokazala su odgođeno okoštavanje u fetusa štakora, bez štetnih učinaka na postnatalni razvoj (pri 50 mg/kg/dan ili dozi 3500 puta većoj od dnevne kliničke doze koja iznosi 14 g/kg/dan), kao i pojačanu fetalnu resorpciju u kunića (pri 90 mg/kg/dan, tj. dozi 6400 puta većoj od kliničke doze).
Reproduction toxicity studies with travoprost have been undertaken in rat, mice and rabbit by systemic route.
Studije reprodukcijske toksičnosti travoprosta provedene su u štakora, miševa i kunića sustavnim putem.
Reproduction toxicology studies in rats and rabbits indicated that corifollitropin alfa does not adversely affect fertility.
Istraživanja reproduktivne toksičnosti na štakorima i kunićima pokazala su da korifolitropin alfa ne utječe štetno na plodnost.
Reproduction: sexual dysfunction, decreased libido, male sexual difficulty.
Reprodukcija: poremećaj spolne funkcije, oslabljen libido, seksualne poteškoće u muškaraca.
Reproduction:sexual dysfunction, decreased libido.
Reprodukcija: spolna disfunkcija, oslabljen libido.
Reproductive and breast disorders
Poremećaji reproduktivnog sustava i dojki
Reproductive and developmental toxicology
Reproduktivna i razvojna toksičnost
Reproductive studies have been performed in pregnant cynomolgus monkeys receiving belimumab 150 mg/kg by intravenous infusion (approximately 9 times the anticipated maximum human clinical exposure) every 2 weeks for up to 21 weeks, and Benlysta treatment was not associated with direct or indirect harmful effects with respect to maternal toxicity, developmental toxicity, or teratogenicity.
Provedene su reproduktivne studije u trudnih makaki majmuna koji su primali belimumab 150 mg/kg putem intravenske infuzije (otprilike 9 puta više od predviđenog maksimuma kliničke ekspozicije za ljude), svaka 2 tjedna tijekom najviše 21 tjedna, te liječenje lijekom Benlysta nije bilo povezano s posrednim ili neposrednim štetnim učincima vezanim uz reproduktivnu toksičnost, razvojnu toksičnost ili teratogenost.
Reproductive system
Reproduktivni sustav
Reproductive system and breast
Poremećaji reproduktivnog sustava i dojki
Reproductive system and breast disorder
Poremećaj reproduktivnog sustava dojki
Reproductive system and breast disorder
Poremećaj reproduktivnog sustava i dojki
Reproductive system and breast disorder
Poremećaji reproduktivno g sustava i dojki
Reproductive system and breast disorders
Bubrežni i poremećaji mokraćnog sustava
Reproductive system and breast disorders
Infekcije i infestacije
Reproductive system and breast disorders
Poremećaj reproduktivnog sustava i dojki
Reproductive system and breast disorders
Poremećaji imunološkog sustava
Reproductive system and breast disorders
Poremećaji mišićno- koštanog sustava i vezivnog tkiva
Reproductive system and breast disorders
Poremećaji mišićno-koštanog sustava i vezivnog tkiva
Reproductive system and breast disorders
Poremećaji probavnog sustava
Reproductive system and breast disorders
Poremećaji reproduktiv- nog sustava i dojki
Reproductive system and breast disorders
Poremećaji reproduktivn og sustava i dojki
Reproductive system and breast disorders
Poremećaji reproduktivnog
Reproductive system and breast disorders
Poremećaji reproduktivnog sustava i dojk
Reproductive system and breast disorders
Poremećaji reproduktivnog sustava i dojki Često:
Reproductive system and breast disorders Common: Mild or moderate OHSS Uncommon: Severe OHSS, breast pain
Poremećaji reproduktivnog sustava i dojki Često: blagi ili umjereni OHSS Manje često: teški OHSS, bol u dojkama
Reproductive system and breast disorders uncommon: dysmenorrhoea and uterine bleeding
Poremećaji reproduktivnog sustava i dojki manje često: dismenoreja i uterino krvarenje
Reproductive system and breast disorders:
Poremećaji kože i potkožnog tkiva:
Reproductive system and breast disorders:
Poremećaji reproduktivnog sustava i dojki
Reproductive system and breast disorders: uncommon: gynaecomastia
Poremećaji reproduktivnog sustava i dojki: manje često: ginekomastija
Reproductive system and breast Uncommon: sexual dysfunction, libido changes  disorders:
Poremećaji reproduktivnog Manje često: seksualna disfunkcija, promjene libida  sustava i dojki:
Reproductive system and Uncommon: sexual dysfunction, libido changes  breast disorders
Poremećaji reproduktivnog Manje često: seksualna disfunkcija, promjene libida  sustava i dojki
Reproductive system bleedingsk
Krvarenje u reproduktivnom sustavuk
Reproductive system bleedingsk
Poremećaji reproduktivnog sustava i dojki
Reproductive system disorders: Impotence (inability to maintain an erection)
Poremećaji reprodukcijskog sustava: impotencija (nemogućnost zadržavanja erekcije)
Reproductive system, and breast disorders
Poremećaji reproduktivnog sustava i dojki
Reproductive systems and
Poremećaji reproduktivnog sustava i dojki
Reproductive systems and breast disorders
Klasifikacija organskih sustava
Reproductive systems and breast disorders
Poremećaji mišićno-koštanog sustava i vezivnog tkiva
Reproductive systems and breast disorders
Poremećaji živčanog sustava
Reproductive systems and breast disorders
reproduktivnog sustava i dojki
Reproductive toxicity
Dojenje
Reproductive toxicity
Karcinogenost
Reproductive toxicity
NAČIN I PUT PRIMJENE LIJEKA
Reproductive toxicity
Reproduktivna toksičnost:
Reproductive toxicity and impairment of fertility studies with CE/bazedoxifene have not been conducted.
Ispitivanja reproduktivne toksičnosti i oštećenja plodnosti s KE/bazedoksifenom nisu provedena.
Reproductive toxicity studies have not been conducted with blinatumomab.
Ispitivanja reproduktivne toksičnosti blinatumomaba nisu provedena.
Reproductive toxicity studies in rats and rabbits showed no effects on mating, fertility, pregnancy or fetal parameters.
Ispitivanja reproduktivne toksičnosti u štakora i kunića nisu pokazala učinke na parenje, plodnost, graviditet ili fetalne parametre.
Reproductive toxicity studies in rats and rabbits showed no effects on mating, fertility, pregnancy or fetal parameters.
Ispitivanja reproduktivne toksičnosti u štakora i kunića nisu pokazala učinke na parenje, plodnost, trudnoću ili fetalne parametre.
Reproductive toxicity studies in rats and rabbits with cobicistat showed no effects on mating, fertility, pregnancy or fetal parameters.
Ispitivanja reproduktivne toksičnosti na štakorima i kunićima s kobicistatom nisu pokazala učinke na parenje, plodnost, trudnoću i fetalne parametre.
Reproductive toxicity studies with fesoterodine in animals show minor embryotoxicity (see section 5.3).
Ispitivanja reproduktivne toksičnosti fesoterodina na životinjama pokazala su manju embriotoksičnost (vidjeti dio 5.3).
Reproductive toxicity testing showed no evidence of effects on fertility, embryofetal, or postnatal development.
Ispitivanje reproduktivne toksičnosti nije pokazalo učinke na plodnost, embriofetalni ni postnatalni razvoj.
Reproductive toxicity was shown in a study of cynomolgus monkeys, dosed throughout pregnancy with denosumab at AUC exposures 119-fold higher than the human dose (see section 5.3).
Reproduktivna toksičnost je dokazana ispitivanjem na makaki majmunima koji su tijekom trudnoće primali doze denosumaba uz AUC 119 puta veći u odnosu na doze u ljudi (vidjeti dio 5.3.)
Reproductive toxicity was shown in a study of cynomolgus monkeys, dosed throughout pregnancy with denosumab at AUC exposures 12-fold higher than the human dose (see section 5.3).
Ispitivanjem na cynomolgus majmunima koji su tijekom trudnoće primali doze denosumaba uz AUC 12 puta veću u odnosu na izloženost kod doziranja u ljudi, utvrđena je reproduktivna toksičnost (vidjeti dio 5.3).
Reproductive toxicology studies (i.e. embryo-foetal development studies) in pregnant rats and rabbits indicated no foetotoxicity or teratogenicity after dosing with ceritinib during organogenesis; however, maternal plasma exposure was less than that observed at the recommended dose of 750 mg in clinical trials.
Ispitivanja reproduktivne toksikologije (tj. ispitivanja embrio-fetalnog razvoja) u skotnih štakora i kunića nisu ukazala ni na kakvu fetotoksičnost ili teratogenost nakon doziranja s ceritinibom tijekom organogeneze; međutim, izloženost majčinske plazme bila je manja od izloženosti uočene pri preporučenoj dozi od 750 mg u kliničkim ispitivanjima.
reproductive tract infections
infekcije reproduktivnih organa
reproductive tract infections;
infekcije reproduktivnih organa,
Repso 10 mg film-coated tablets are white, round film-coated tablets, engraved with “10” on one side and “L” on the other.
Repso 10 mg filmom obložene tablete su bijele, okrugle, filmom obložene tablete, s utisnutom oznakom „10“ na jednoj strani i „L“ na drugoj.
Repso 10 mg film-coated tablets Repso 20 mg film-coated tablets
Repso 10 mg filmom obložene tablete Repso 20 mg filmom obložene tablete
Repso 10 mg tablets leflunomide
Repso 10 mg tablete leflunomid
Repso 20 mg film-coated tablets are dark beige, triangle shaped, film-coated tablets, engraved with ”20” on one side and “L” on the other.
Repso 20 mg filmom obložene tablete su tamno bež, filmom obložene tablete, trokutastog oblika, s utisnutom oznakom „20“ na jednoj strani i „L“ na drugoj.
Repso 20 mg tablets leflunomide
Repso 20 mg tablete leflunomid
Repso is not recommended for use in children and adolescents below 18 years of age.
Repso se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina.
Repso is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Repso se primjenjuje za liječenje odraslih bolesnika s aktivnim oblikom reumatoidnog artritisa ili aktivnim oblikom psorijatičnog artritisa.
Request to inform the physician of all medical conditions before treatment
Zahtjev da se liječnika prije liječenja obavijesti o svim zdravstvenim tegobama
Request to inform the physician of all medical conditions before treatment.
Zahtjev bolesniku da prije liječenja obavijesti liječnika o svim medicinskim problemima.
require additional titration
biti potrebna dodatna titracija
require dose reduction when
mogu tražiti smanjenje doze
required
PRIMJENJI
Required amount of concentrate-solvent mixture
19 Potrebna količina mješavine koncentrata i otapala
Required amount of pre-donated blood Required amount of pre-donated blood [units] [units]
Potrebne količine predonirane krvi Potrebne količine predonirane krvi [jedinice] [jedinice]
required for carisoprodol;
prilagođavati dozu za
required for diazepam;
Nije potrebno prilagođavati dozu za
required for Victrelis or
dozu lijeka Victrelis niti
Required IU = body weight (kg) × desired factor VIII rise (% of normal) × 0.5
Potreban broj IU = tjelesna težina (kg) × željeni porast faktora VIII (% od normalne vrijednosti) × 0,5
Required number of Ebilfumin capsules
Potreban broj Ebilfumin kapsula (mg oseltamivira)
required to obtain the desired clinical effect.
Potrebno je razmotriti zamjenu za te
required to obtain the desired clinical effect.
ranitidina da bi se postigao željeni klinički
Required training
Potrebna poduka
Required units = body weight (kg) x desired factor VIII rise (% or IU/dL) x reciprocal of observed recovery (i.e.
Potreban broj jedinica = tjelesna težina (kg) x željeni porast faktora VIII (% ili IU/dl) x recipročna vrijednost vidljivog oporavka (npr.
Required units = body weight [kg] x desired FVIII rise [% or IU/dl] x 0.5.
potrebne jedinice = tjelesna težina [kg] x željeni porast FVIII [% ili IU/dl] x 0,5.
Required volume of vehicle
Potreban volumen
Required volumes of 10 mg/ml Voriconazole Hospira Concentrate
Potreban volumen koncentrata lijeka Vorikonazol Hospira od 10 mg/ml
Required Volumes of 10 mg/ml Voriconazole Hospira Concentrate
Potreban volumen koncentrata lijeka Vorikonazola Hospira od 10 mg/ml
required when co-administered with telaprevir.
Nije potrebna prilagodba doze buprenorfina kad se primjenjuje istodobno s telaprevirom.
required when OLYSIO is
povisite ju po potrebi, uz
required, starting with the
treba razmotriti započinjanje
required.
doze.
required.
prilagodba doze.
required: increase at
razmacima od dva
Requirement to closely monitor blood pressure, pulse rate, oxygen saturation, and end tidal CO2 when spraying the product, for the occurrence of gas embolism
Zahtjevu za pomnim praćenjem krvnog tlaka, pulsa, zasićenosti kisikom i CO2 na kraju izdaha prilikom raspršivanja lijeka, zbog mogućnosti pojave zračne embolije
Requirement to dry the wound using standard techniques (e.g., intermittent application of compresses, swabs, use of suction devices) prior to using the product
Zahtjevu za sušenjem rane primjenom standardnih tehnika (primjerice naizmjeničnom primjenom kompresa, tupfera, korištenjem uređaja za aspiraciju) prije primjene lijeka
requirement to dry the wound using standard techniques (e.g., intermittent application of compresses, swabs, use of suction devices) prior to using the product requirement to closely monitor blood pressure, pulse rate, oxygen saturation, and end tidal CO2 when spraying the product, for the occurrence of gas embolism. which regulator(s) should be used, in line with manufacturer recommendations and the SmPC instructions for use
potrebi za sušenjem rane primjenom standardnih tehnika (npr. povremenim prislanjanjem kompresa, tupfera ili napravom za sukciju) prije uporabe lijeka zahtjevu za pomnim praćenjem krvnog tlaka, pulsa, saturacije kisikom i CO2 na kraju izdaha kada se lijek nanosi raspršivanjem zbog opasnosti od pojave plinske embolije tome koje regulatore je potrebno koristiti, sukladno s preporukama proizvođača i uputama za uporabu u Sažetku opisa svojstava lijeka
Requirements for home infusion (home condition, patient assessment, emergency treatment);
uvjeti za primjenu infuzije kod kuće (uvjeti kod kuće, procjena bolesnika, liječenje u hitnim situacijama);
requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
Requirements in the event of pregnancy
Zahtjeve u slučaju trudnoće
Requirements in the event of pregnancy
Zahtjevi u slučaju trudnoće
Requires a pregnancy status check before treatment
zahtijeva provjeru statusa trudnoće prije liječenja
Requires concomitant use of effective contraception in women of child-bearing potential
zahtijeva istodobnu primjenu djelotvorne kontracepcije u žena reproduktivne dobi
Requires parenteral or enteral support
Zahtijeva parenteralnu ili enteralnu potporu
Requiring inotropes
potrebna primjena inotropnih lijekova
Requiring inotropes
životno ugrožavajućed
Requiring surgical intervention
potrebna kirurška intervencija
Requiring surgical intervention
potrebna primjena inotropnih lijekova
Requiring transfusion (≥ 4 units)
potrebna transfuzija (≥ 4 jedinice)
Requiring transfusion (≥4 units)
potrebna transfuzija (≥ 4 jedinice)
Rescue medicinal products
Lijekovi za hitno ublažavanje simptoma
Research has shown a link between the occurrence of a factor IX inhibitor and allergic reactions.
Istraživanja su pokazala povezanost između pojave inhibitora faktora IX i alergijskih reakcija.
Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines.
Istraživanja su pokazala povećan rizik od prirođenih mana u djece majki koje uzimaju lijekove protiv epilepsije.
Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines.
Istraživanja su pokazala povećani rizik prirođenih grešaka u djece žena koje su uzimale lijekove protiv epilepsije.
Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines.
Istraživanje je pokazalo povećan rizik od prirođenih mana u djece majki koje uzimaju lijekove protiv epilepsije.
Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines.
Istraživanje je pokazalo povećani rizik urođenih mana kod djece žena koje su uzimale antiepileptičke lijekove.
Reservoir
premnik
reservoir holder
držač spremnika
RESET Study
Ispitivanje RESET
Residual activity in the midsagittal sinus can be sometimes observed (see section 5.2).
Povremeno se može opaziti rezidualna aktivnost u sagitalnom sinusu (vidjeti dio 5.2).
Residual concentrations are around 10- 15 mg/l 24 hours after the last dose of 5 mg/kg.
Ostatne koncentracije su oko 10-15 mg/l 24 sata nakon zadnje doze od 5 mg/kg.
Residual scale
Skala preostalog inzulina
RESIST participants receiving tipranavir with ritonavir tended to have an increased risk of bleeding; at 24 weeks the relative risk was 1.98 (95% CI=1.03, 3.80).
Bolesnici u RESIST kliničkim ispitivanjima koji su dobivali tipranavir s ritonavirom imali su povećan rizik krvarenja; nakon 24 tjedna relativni rizik iznosio je 1,98 (95% CI=1,03; 3,80).
Resistance
Nuspojave
resistance (i.e. lack of
posljedica
Resistance and specific precaution for lamivudine-refractory patients: mutations in the HBV polymerase that encode lamivudine-resistance substitutions may lead to the subsequent emergence of secondary substitutions, including those associated with entecavir associated resistance (ETVr).
Rezistencija i posebne mjere opreza kod bolesnika refrakternih na lamivudin: mutacije HBV polimeraze koje kodiraju supstitucije zaslužne za rezistenciju na lamivudin mogu dovesti do posljedičnog nastanka sekundarnih supstitucija, uključujući onih povezanih s rezistencijom na entekavir (ETVr).
Resistance can however be observed when ESBLs or other potent beta-lactamases (e.g.
Rezistencija se, međutim, može uočiti kada je uz beta-laktamaze proširenog spektra ili druge snažne beta-laktamaze (npr.
Resistance in cell culture: relative to wild-type HBV, LVDr viruses containing rtM204V and rtL180M substitutions within the reverse transcriptase exhibit 8-fold decreased susceptibility to entecavir.
Rezistencija u staničnim kulturama: u odnosu na divlji tip HBV-a, LVDr virusi čija reverzna transkriptaza sadrži supstitucije rtM204V i rtL180M imaju 8 puta smanjenu osjetljivost na entekavir.
Resistance in vitro and in vivo: (abacavir and lamivudine)
Rezistencija in vitro i in vivo: (abakavir and lamivudin)
Resistance may be chromosomal or plasmid-encoded and may be transferable if associated with transposons or plasmids.
Otpornost može biti kromosomska ili kodirana plazmidima i može biti prijenosna ako je povezana s transposonima ili plazmidima.