FrancophonIA/ELRC3.0 huggingface dataset:
English: In postmenopausal women with osteoporosis the pharmacokinetics and pharmacodynamics of denosumab were not altered by previous alendronate therapy, based on data from a transition study (alendronate to denosumab).
Slovenian: Po izsledkih študije, opravljene pri prehodu z alendronata na denosumab, predhodno zdravljenje z alendronatom pri ženskah po menopavzi z osteoporozo ni spremenilo farmakokinetike in farmakodinamike denosumaba.
English: NAME OF THE MEDICINAL PRODUCT Prolia 60 mg injection denosumab
Slovenian: IME ZDRAVILA Prolia 60 mg injekcija denosumab
English: The data in Table 1 below describe adverse reactions reported from Phase II and III clinical trials in patients with osteoporosis and breast or prostate cancer patients receiving hormone ablation; and/or spontaneous reporting.
Slovenian: in III. faze pri bolnicah oz. bolnikih z osteoporozo ter bolnicah z rakom dojke ali bolnikih z rakom prostate, deležnih ablacije hormonov, in/ali poročane spontano.
English: Fifty nine women participated in the bone biopsy sub-study at month 24 (n = 41) and/or month 84 (n = 22) of the extension study in postmenopausal women with osteoporosis.
Slovenian: V podštudiji biopsije kosti, opravljene po 24 in/ali 84 mesecih nadaljevalne študije pri ženskah po menopavzi, ki so imele osteoporozo, je sodelovalo 59 žensk (n = 41 po 24 mesecih, n = 22 po 84 mesecih).
English: To give an injection, you will need:
Slovenian: Zdravilo lahko injicirate v:
English: • abdominal discomfort,
Slovenian: • nelagodje v trebuhu,
English: What Prolia contains
Slovenian: Kaj vsebuje zdravilo Prolia
English: DO NOT pick up the pre-filled syringe by the plunger or needle cover.
Slovenian: NE prijemajte napolnjene injekcijske brizge za bat ali pokrovček igle.
English: You may have low levels of calcium in your blood while receiving Prolia.
Slovenian: Med prejemanjem zdravila Prolia imate lahko nizko koncentracijo kalcija v krvi.
English: The risk of ONJ increased with duration of exposure to Prolia.
Slovenian: Tveganje za osteonekrozo čeljustnice se poveča s povečanjem časa izpostavljenosti zdravilu Prolia.
English: Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking Prolia, considering the benefit of breast-feeding to the baby and the benefit of Prolia to the mother.
Slovenian: Na podlagi upoštevanja koristi dojenja za otroka in koristi zdravljenja z zdravilom Prolia za vas vam bo zdravnik pomagal pri odločitvi, ali prenehati z dojenjem ali prenehati z jemanjem zdravila Prolia.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Prolia 60 mg denosumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Prolia 60 mg denosumab s.c.
English: NAME OF THE MEDICINAL PRODUCT Prolia 60 mg solution for injection in pre-filled syringe
Slovenian: IME ZDRAVILA Prolia 60 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Re-initiation of Prolia resulted in gains in BMD similar to those when Prolia was first administered.
Slovenian: Ponovna uvedba zdravila Prolia je povzročila podobna povečanja mineralne kostne gostote kot po prvi uporabi zdravila Prolia.
English: Prolia 60 mg solution for injection in pre-filled syringe denosumab
Slovenian: Prolia 60 mg raztopina za injiciranje v napolnjeni injekcijski brizgi denosumab
English: Some people have developed unusual fractures in their thigh bone while being treated with Prolia.
Slovenian: Pri nekaterih bolnikih so se med zdravljenjem z zdravilom Prolia pojavili neobičajni zlomi stegnenice.
English: Read all instructions thoroughly before using the pre-filled syringe.
Slovenian: Preden začnete Pred uporabo napolnjene injekcijske brizge natančno preberite vsa navodila.
English: Adequate intake of calcium and vitamin D is important in all patients.
Slovenian: Za vse bolnike je pomembno, da uživajo dovolj kalcija in vitamina D.
English: Declines of serum calcium levels (less than 1.88 mmol/l) were not reported in either the two phase III placebo-controlled clinical trials in patients receiving hormone ablation or the phase III placebo-controlled clinical trial in men with osteoporosis.
Slovenian: V nobeni od dveh kliničnih, s placebom kontroliranih preskušanjih III. faze pri bolnikih, ki so se zdravili z ablacijo hormonov, ali kliničnem, s placebom kontroliranem preskušanju III. faze pri moških z osteoporozo, niso ugotovili zmanjšanja koncentracije kalcija v serumu (manj kot 1,88 mmol/l).
English: Drug hypersensitivity1 Anaphylactic reaction1
Slovenian: Bolezni imunskega sistema redki redki preobčutljivost na zdravilo1 anafilaktična reakcija1
English: You do not have to remove the air bubble before injecting.
Slovenian: Tega mehurčka vam pred injiciranjem ni treba odstraniti.
English: Thirteen adjudicated cases of osteonecrosis of the jaw (ONJ) and two adjudicated cases of atypical fractures of the femur occurred during the extension study.
Slovenian: V nadaljevalni študiji se je pojavilo trinajst zdravilu prisojenih primerov osteonekroze čeljustnice in dva zdravilu prisojena primera atipičnega zloma stegnenice.
English: 3 Includes pelvis, distal femur, proximal tibia, ribs, proximal humerus, forearm, and hip.
Slovenian: 3 Vključuje zlome medenice, distalne stegnenice, proksimalne golenice, reber, proksimalne nadlahtnice, podlakta in kolka.
English: Uncommonly, patients receiving Prolia may develop skin infections (predominantly cellulitis).
Slovenian: Občasno se lahko pri bolnikih, ki dobivajo zdravilo Prolia, pojavijo okužbe kože (predvsem celulitis).
English: Clinical vertebral fracture
Slovenian: Atipični zlomi stegnenice
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL WITH OR WITHOUT NEEDLE GUARD (BLISTERED)
Slovenian: NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO S ŠČITNIKOM IGLE ALI BREZ NJEGA (V PRETISNIH OMOTIH)
English: Efficacy and safety of Prolia administered once every 6 months for 3 years were investigated in postmenopausal women (7,808 women aged 60-91 years, of which 23.6% had prevalent vertebral fractures) with baseline bone mineral density (BMD) T-scores at the lumbar spine or total hip between -2.5 and -4.0 and a mean absolute 10-year fracture probability of 18.60% (deciles: 7.9-32.4%) for major osteoporotic fracture and 7.22% (deciles: 1.4-14.9%) for hip fracture.
Slovenian: Ženske so imele izhodiščno T-vrednost mineralne kostne gostote v ledvenem delu hrbtenice ali celotnem kolku med -2,5 in -4,0 ter povprečno absolutno 10-letno verjetnost zlomov 18,60 % (decili: 7,9 - 32,4 %) za hujši osteoporotični zlom in 7,22 % (decili: 1,4 - 14,9 %) za zlom kolka.
English: Musculoskeletal pain, including severe cases, has been reported in patients receiving Prolia in the post-marketing setting.
Slovenian: V obdobju trženja zdravila so pri bolnikih, ki so dobivali zdravilo Prolia, poročali o mišično-skeletni bolečini, vključno s hudimi primeri.
English: Osteonecrosis of the Jaw (ONJ) ONJ has been reported rarely in patients receiving Prolia for osteoporosis (see section 4.8).
Slovenian: Pri bolnikih, ki so dobivali zdravilo Prolia za osteoporozo, so redko poročali o osteonekrozi čeljustnice (glejte poglavje 4.8).
English: Adverse reactions
Slovenian: Previdnostni ukrepi
English: Rarely unusual fractures of the thigh bone may occur in patients receiving Prolia.
Slovenian: Redko se lahko pri bolnikih, ki prejemajo zdravilo Prolia, pojavijo neobičajni zlomi stegnenice.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA NAPOLNJENO INJEKCIJSKO BRIZGO
English: Equipment:
Slovenian: Zaradi varnosti:
English: Talk to your doctor or pharmacist before using Prolia
Slovenian: Pred začetkom uporabe zdravila Prolia se posvetujte z zdravnikom ali farmacevtom.
English: Pinch (without squeezing) the skin between your thumb and forefinger.
Slovenian: Primite kožo med palec in kazalec, ne da bi jo stiskali.
English: Prolia increased BMD by 9.2% at the lumbar spine, 6.0% at the total hip, 4.8% at the femoral neck, 7.9% at the hip trochanter, 3.5% at the distal 1/3 radius and 4.1% at the total body over 3 years (all p < 0.0001).
Slovenian: Zdravilo Prolia je v 3-letnem obdobju povečalo mineralno kostno gostoto v ledvenem delu hrbtenice za 9,2 %, v celotnem kolku za 6,0 %, v stegneničnem vratu za 4,8 %, v kolčnem trohantru za 7,9 %, v distalni 1/3 koželjnice za 3,5 % in v celotnem telesu za 4,1 % (vsi p < 0,0001).
English: Prolia significantly increased BMD at all clinical sites measured, relative to treatment with placebo at 3 years: 7.9% at the lumbar spine, 5.7% at the total hip, 4.9% at the femoral neck, 6.9% at the hip trochanter, 6.9% at the distal 1/3 radius and 4.7% at the total body (all p < 0.0001).
Slovenian: Zdravljenje z zdravilom Prolia je v 3 letih v primerjavi s placebom na vseh merjenih kliničnih mestih znatno povečalo mineralno kostno gostoto: v ledvenem delu hrbtenice za 7,9 %, v celotnem kolku za 5,7 %, v stegneničnem vratu za 4,9 %, v kolčnem trohantru za 6,9 %, v distalni 1/3 koželjnice za 6,9 % in v celotnem telesu za 4,7 % (vsi p < 0,0001).
English: Prolia significantly increased BMD at all clinical sites measured, relative to placebo at 12 months: 4.8% at lumbar spine, 2.0% at total hip, 2.2% at femoral neck, 2.3% at hip trochanter, and 0.9% at distal 1/3 radius (all p < 0.05).
Slovenian: Zdravilo Prolia je po 12 mesecih v primerjavi s placebom na vseh merjenih kliničnih mestih značilno povečalo mineralno kostno gostoto: v ledvenem delu hrbtenice za 4,8 %, celotnem kolku za 2,0 %, v stegneničnem vratu za 2,2 %, v kolčnem trohantru za 2,3 %, v distalni 1/3 koželjnice za 0,9 % (vsi p < 0,05).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Prolia 60 mg injection denosumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Prolia 60 mg injekcija denosumab s.c.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 mL pre-filled syringe containing 60 mg of denosumab (60 mg/mL).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN 1 ml napolnjena injekcijska brizga vsebuje 60 mg denosumaba (60 mg/ml).
English: In the post-marketing setting, rare events of drug-related hypersensitivity, including rash, urticaria, facial swelling, erythema, and anaphylactic reactions have been reported in patients receiving Prolia.
Slovenian: V obdobju trženja zdravila so pri bolnikih, ki so dobivali zdravilo Prolia, poročali o redkih primerih z zdravilom povezane preobčutljvosti, vključno z izpuščajem, urtikarijo, otekanjem obraza, eritemom in anafilaktičnimi reakcijami.
English: In clinical studies, patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis were at greater risk of developing hypocalcaemia in the absence of calcium supplementation.
Slovenian: V kliničnih študijah so ugotovili, da je tveganje za pojav hipokalciemije brez dodajanja kalcija večje pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) in bolnikih na dializi.
English: Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.
Slovenian: Če se vam med zdravljenjem z zdravilom Prolia pojavi nova ali neobičajna bolečina v kolku, dimljah ali stegnu, se posvetujte z zdravnikom.
English: Urinary tract infection Upper respiratory tract infection Diverticulitis1
Slovenian: Infekcijske in parazitske bolezni pogosti pogosti občasni občasni občasni okužba sečil okužba zgornjih dihal divertikulitis1 celulitis1 okužba ušesa
English: Calcium levels were transiently decreased and parathyroid hormone levels transiently increased in ovariectomised monkeys treated with denosumab.
Slovenian: Pri ovariektomiranih opicah, ki so dobivale denosumab, se je koncentracija kalcija prehodno zmanjšala, koncentracija paratiroidnega hormona pa prehodno zvečala.
English: Patients received calcium (at least 1,000 mg) and vitamin D (at least 800 IU) supplementation daily.
Slovenian: Bolniki so dnevno dobivali dodatke kalcija (vsaj 1.000 mg) in vitamina D (vsaj 800 IE).
English: Cellulitis1
Slovenian: osteonekroza čeljustnice1
English: • Keep used syringes out of the reach and sight of children.
Slovenian: • Uporabljene brizge shranjujte nedosegljive otrokom.
English: Non-vertebral fracture2
Slovenian: Nevretenčni zlom2
English: Prolia is not recommended for use if you are pregnant.
Slovenian: Če ste noseči, uporaba zdravila Prolia ni priporočljiva.
English: Major non-vertebral fracture3
Slovenian: Hujši nevretenčni zlom3
English: Prolia significantly increased BMD at all clinical sites measured, relative to treatment with placebo at 2 years: 7.6% at lumbar spine, 4.7% at total hip, 3.6% at femoral neck, 5.9% at hip trochanter, 6.1% at distal 1/3 radius and 4.2% at total body (all p < 0.0001).
Slovenian: Zdravljenje z zdravilom Prolia je po 2 letih v primerjavi s placebom na vseh merjenih kliničnih mestih znatno povečalo mineralno kostno gostoto: v ledvenem delu hrbtenice za 7,6 %, v celotnem kolku za 4,7 %, v stegneničnem vratu za 3,6 %, v kolčnem trohantru za 5,9 %, v distalni 1/3 koželjnice za 6,1 % in v celotnem telesu za 4,2 % (vsi p < 0,0001).
English: How to store Prolia
Slovenian: Shranjevanje zdravila Prolia
English: For safety reasons: Do not grasp the plunger.
Slovenian: Ne primite brizge za bat.
English: Unusual thigh bone fractures
Slovenian: Neobičajni zlomi stegnenice
English: All men received calcium (at least 1,000 mg) and vitamin D (at least 800 IU) supplementation daily.
Slovenian: Vsi moški so vsak dan dobivali dodatke kalcija (vsaj 1.000 mg) in vitamina D (vsaj 800 i.e.).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERED PRE-FILLED SYRINGE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Used plunger
Slovenian: Okvara jeter
English: Remove the pre-filled syringe from the refrigerator.
Slovenian: Kaj morate storiti, preden zdravilo Prolia injicirate pod kožo Vzemite napolnjeno injekcijsko brizgo iz hladilnika.
English: • Keep the pre-filled syringe out of the sight and reach of children.
Slovenian: • Napolnjeno injekcijsko brizgo shranjujte nedosegljivo otrokom!
English: This section contains information on how to use the Prolia pre-filled syringe.
Slovenian: Navodila za injiciranje zdravila Prolia v napolnjeni injekcijski brizgi To poglavje obsega informacije o uporabi napolnjene injekcijske brizge zdravila Prolia.
English: All women received calcium (at least 1,000 mg) and vitamin D (at least 400 IU) supplementation daily.
Slovenian: Vse ženske so vsak dan dobivale dodatke kalcija (vsaj 1.000 mg) in vitamina D (vsaj 400 i.e.).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL (UNBLISTERED)
Slovenian: NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO (NE V PRETISNIH OMOTIH)
English: An absence of lactation due to inhibition of mammary gland maturation (lobulo-alveolar gland development during pregnancy) was also observed in knockout mice lacking RANK or RANKL.
Slovenian: Prav tako so pri knockout miših brez RANK ali RANKL opazili odsotnost laktacije zaradi zavrtja dozorevanja mlečnih žlez (razvoj lobulo-alveolarnih žlez med brejostjo).
English: Women received calcium (at least 1,000 mg) and vitamin D (at least 400 IU) supplementation daily.
Slovenian: Ženske so vsak dan dobivale dodatke kalcija (vsaj 1.000 mg) in vitamina D (vsaj 400 i.e.).
English: All men received calcium (at least 1,000 mg) and vitamin D (at least 400 IU) supplementation daily.
Slovenian: Vsi moški so vsak dan dobivali dodatke kalcija (vsaj 1.000 mg) in vitamina D (vsaj 400 i.e.).
English: 1 See section Description of selected adverse reactions 2 See section 4.4
Slovenian: 2 Glejte poglavje 4.4.
English: The mean lumbar spine BMD T-score at the end of the study was1.3 in patients treated for 10 years.
Slovenian: Pri bolnicah, zdravljenih 10 let, je bila ob zaključku študije povprečna T-vrednost mineralne gostote kosti v ledvenem delu hrbtenice -1,3.
English: Do not shake the pre-filled syringe.
Slovenian: Napolnjene injekcijske brizge NE stresajte.
English: DO NOT shake the pre-filled syringe.
Slovenian: Napolnjene injekcijske brizge ne stresajte.
English: Instructions for injecting with the Prolia pre-filled syringe
Slovenian: NAPOLNJENA INJEKCIJSKA BRIZGA V PRETISNEM OMOTU
English: Hepatic impairment
Slovenian: Klinični zlom vretenc
English: If no improvement is noted within 48 hours, the diagnosis should be confirmed.
Slovenian: Če v 48 urah ne opazite izboljšanja, je treba potrditi diagnozo.
English: No data to support the term “control” were provided.
Slovenian: Predloženi niso bili nobeni podatki v podporo izrazu „nadzor“.
English: 8 hours 8 hours
Slovenian: 8 ur 8 ur
English: Member State EU/EEA
Slovenian: Država članica EU/EGS
English: In particular its activity has been demonstrated against the following micro-organism:
Slovenian: Njegovo delovanje so pokazali predvsem proti naslednjim mikroorganizmom:
English: 1 hour 1 hour
Slovenian: 1 ura 1 ura
English: Each vial is packed into a carton.
Slovenian: Vsaka viala je pakirana v škatli.
English: The treatment appears to be intended to be preventive, which is not in line with the principles of prudent use of antibiotics.
Slovenian: Zdi se, da je zdravljenje preventivno, kar ni v skladu z načeli preudarne uporabe antibiotikov.
English: Use only according to the benefit/risk assessment by the responsible veterinarian.
Slovenian: Uporabite le skladno z oceno razmerja korist/tveganje odgovornega veterinarja.
English: • Avoid contact with skin and eyes.
Slovenian: • Preprečite stik s kožo in očmi.
English: • Ensure that animals are properly restrained, including those in the vicinity.
Slovenian: • Zagotovite, da so živali ustrezno obvladane, vključno z živalmi v okolici.
English: Occasionally, a soft diffuse swelling may occur at the injection site but this disappears within five to eight days.
Slovenian: Včasih se lahko na mestu injiciranja pojavi mehka difuzna oteklina, ki pa izgine v petih do osmih dneh.
English: Scientific evidence suggests that macrolides act synergistically with the host immune system.
Slovenian: Znanstveni dokazi kažejo, da makrolidi delujejo sinergistično z imunskim sistemom gostitelja.
English: Rinse any splashes from skin or eyes immediately with water.
Slovenian: Vse brizge na kožo ali v oči takoj sperite z vodo.
English: However the bulk of the tilmicosin is excreted unchanged.
Slovenian: Vendar se večina tilmikozina izloči nespremenjenega.
English: It is believed to affect protein synthesis.
Slovenian: Menijo, da učinkuje na sintezo beljakovin.
English: Overall it can be concluded that data to substantiate the proposed indications in rabbits is minimally reported or lacking.
Slovenian: Na splošno je mogoče zaključiti, da so podatki za utemeljitev predlaganih indikacij pri kuncih minimalni ali jih ni.
English: In rare cases recumbency, incoordination and convulsions have been observed.
Slovenian: V redkih primerih so opazili neaktivnost, nekoordiniranost in konvulzije.
English: As tilmicosin persists in tissues for several days, the cardiovascular system should be closely monitored and supportive treatment provided.
Slovenian: Ker tilmikozin v tkivih ostane več dni, je treba skrbno spremljati kardiovaskularni sistem in nuditi podporno zdravljenje.
English: The main areas of disharmony in the existing SPCs relate to:
Slovenian: Glavna področja razhajanja v obstoječih povzetkih glavnih značilnosti zdravila se nanašajo na:
English: Minimum inhibition concentration measured in recently (2009-2012) isolated European field strains, derived from respiratory bovine disease.
Slovenian: Minimalna inhibicijska koncentracija, izmerjena pri nedavno (2009-2012) izoliranih evropskih sevih s terena, ki izhajajo iz respiratorne bolezni govedi.
English: Do not administer to horses, donkeys, pigs, goats or primates.
Slovenian: Ne uporabljajte pri konjih, oslih, prašičih, kozah ali primatih.
English: With regard to P. multocida it can be concluded that based on the information available for cattle this pathogen should remain in the indication.
Slovenian: V zvezi z bakterijo P. multocida je mogoče zaključiti, da mora na osnovi razpoložljivih podatkov za govedo ta patogen ostati v indikaciji.
English: The half-life following subcutaneous injection in cattle is 2-3 days.
Slovenian: Razpolovna doba po subkutanem injiciranju pri govedu je od 2 do 3 dni.
English: Tilmicosin in vitro microbiological data of European isolates from respiratory disease in bovines were presented for several periods (2002-2004; 2004-2006 and 2009-2013).
Slovenian: In vitro mikrobiološki podatki za tilmikozin evropskih izolatov iz bolezni dihal pri govedu so bili predloženi za več obdobij (2002−2004; 2004−2006 in 2009−2013).
English: Wherever possible, the use of the product should be based on susceptibility testing.
Slovenian: Kadar je mogoče, mora uporaba zdravila temeljiti na preiskavah za susceptibilnost.
English: Physicians treating patients exposed to this compound are advised to discuss clinical management with the National Poison Information Service on: ... relevant national number stated (to be completed nationally)
Slovenian: Zdravniki, ki zdravijo bolnike, izpostavljene tej učinkovini, naj se posvetujejo s kliničnim vodstvom Nacionalnega organa za informacije o strupih na telefonski številki: ... navedba ustrezne nacionalne številke (izpolni država članica)
English: Furthermore, the safety of margin of the product is not in line with a safe use of the product in the rabbit species given the very small volume to administer.
Slovenian: Nadalje meja varnosti zdravila ni v skladu z varno uporabo zdravila pri kunčjih vrstah zaradi zelo majhnega volumna za dajanje.
English: 40 kg animals 28-50 kg animals
Slovenian: 40-kilogramske živali Od 28- do 50-kilogramske živali
English: At day 10 tilmicosin still appeared to have lower udderscores although no longer significant.
Slovenian: Na 10. dan je imel tilmikozin še vedno nižje ocene vimena, čeprav niso bile več pomembne.
English: It has bacteriostatic action but at high concentrations it may be bactericidal.
Slovenian: Deluje bakteriostatično, vendar je lahko pri velikih koncentracijah baktericiden.
English: Do not administer to pigs.
Slovenian: Ne uporabljajte pri prašičih.
English: Cross resistance between tilmicosin and other macrolides and lincomycin has been observed.
Slovenian: Opazili so navzkrižno rezistenco med tilmikozinom in drugimi makrolidi ter linkomicinom.
English: The primary cardiac effects are increased heart rate (tachycardia) and decreased contractility (negative inotrophy).
Slovenian: Primarni srčni učinki so povečan srčni utrip (tahikardija) in zmanjšana kontraktilnost (negativna inotropija).
English: PROHIBITION OF SALE, SUPPLY AND/OR USE To be completed nationally.
Slovenian: PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE
English: These results suggest that intravenous epinephrine may be contraindicated.
Slovenian: Ti rezultati kažejo, da je lahko intravenski adrenalin kontraindiciran.
English: Other symptoms observed were: difficulty in moving, reduced appetite and tachycardia.
Slovenian: Drugi opaženi simptomi so bili: težave pri premikanju, zmanjšan tek in tahikardija.
English: This restriction in sheep seems difficult to “coexist” with an authorisation in rabbits whose weight is less than 5 kg (rabbits are generally slaughtered around 2.5 kg).
Slovenian: Ta omejitev pri ovcah težko „soobstaja“ z dovoljenjem za kunce, ki so lažji od 5 kg (kunce se običajno zakolje pri približno 2,5 kg).
English: Once broached use within 28 days.
Slovenian: Odprto zdravilo uporabite v 28 dneh.
English: Sometimes (1 in 12) a pain reaction was seen after subcutaneous injection of tilmicosin.
Slovenian: Občasno (pri 1 od 12) so po subkutanem injiciranju tilmikozina zabeležili bolečinsko reakcijo.
English: Milk: 18 days
Slovenian: Mleko: 18 dni
English: On 24 April 2012, the Netherlands sent a referral notification under Article 34(1) of Directive 2001/82/EC, as amended, to the CVMP/European Medicines Agency for Micotil 300 mg/ml Injectie and its associated names.
Slovenian: Dne 24. aprila 2012 je Nizozemska poslala obvestilo o napotitvi v skladu s členom 34(1) Direktive 2001/82/ES, kakor je bila nazadnje spremenjena, odboru CVMP/Evropski agenciji za zdravila za zdravilo Micotil 300 mg/ml Injectie in z njim povezana imena.