natgillin/translations-raw huggingface dataset:
Prolia significantly increased BMD at all clinical sites measured, versus placebo at 1, 2 and 3 years.
Zdravljenje z zdravilom Prolia je v primerjavi s placebom po 1, 2 in 3 letih znatno povečalo mineralno kostno gostoto na vseh merjenih kliničnih mestih.
A decision on whether to abstain from breast-feeding or to abstain from therapy with Prolia should be made, taking into account the benefit of breast-feeding to the newborn/infant and the benefit of Prolia therapy to the woman.
Pri tem je treba upoštevati korist dojenja za novorojenčka/dojenčka in korist zdravljenja z zdravilom Prolia za žensko.
The start of treatment/new treatment course should be delayed in patients with unhealed open soft tissue lesions in the mouth.
Pri bolnikih, ki imajo odprte lezije mehkih tkiv v ustih, je treba začetek zdravljenja/nov ciklus zdravljenja odložiti.
Adverse reactions reported in patients with osteoporosis and breast or prostate cancer patients receiving hormone ablation
Tabela 1: Neželeni učinki, poročani pri bolnicah in bolnikih z osteoporozo ter bolnicah z rakom na dojki ali bolnikih z rakom na prostati, ki so se zdravili z ablacijo hormonov
Osteonecrosis of the external auditory canal has been reported with denosumab.
Pri zdravljenju z denosumabom so poročali o osteonekrozi zunanjega slušnega kanala.
Patients treated with Prolia should be given the package leaflet and the patient reminder card.
Bolniki, zdravljeni z zdravilom Prolia, morajo dobiti navodilo za uporabo in opozorilno kartico za bolnika.
In the glucocorticoid-initiating subpopulation, Prolia demonstrated a greater increase in lumbar spine BMD compared to risedronate at 1 year (Prolia 3.1%, risedronate 0.8%; p < 0.001) and 2 years (Prolia 4.6%, risedronate 1.5%; p < 0.001)
V subpopulaciji, ki je glukokortikoidno zdravljenje začela, je zdravilo Prolia povzročilo večje povečanje MKG v ledvenem delu hrbtenice v primerjavi z risedronatom po 1 letu (zdravilo Prolia 3,1 %, risedronat 0,8 %, p < 0,001) in po 2 letih (zdravilo Prolia 4,6 %, risedronat 1,5 %, p < 0,001).
In a pooled analysis of data from all phase II and phase III placebo-controlled studies, Influenza-like illness was reported with a crude incidence rate of 1.2% for denosumab and 0.7% for placebo.
in III. faze je bila gripi podobna bolezen opisana z okvirno stopnjo incidence 1,2 % za denosumab in 0,7 % za placebo.
In this study, foetal lymph nodes were not examined.
V tej študiji niso pregledali bezgavk pri plodih.
Symptoms include spasms, twitches, or cramps in your muscles, and/or numbness or tingling in your fingers, toes or around your mouth and/or seizures, confusion, or loss of consciousness.
Znaki tega so spazmi, trzljaji ali krči v mišicah in/ali omrtvelost ali mravljinčenje v prstih rok ali nog ali okoli ust in/ali napadi krčev, zmedenost ali izguba zavesti.
The incidence of diverticulitis was comparable between treatment groups in postmenopausal women or men with osteoporosis and in women undergoing aromatase inhibitor therapy for non-metastatic breast cancer.
V terapevtskih skupinah žensk po menopavzi ali moških z osteoporozo in žensk, ki so se zdravile z zaviralcem aromataze zaradi nemetastatskega raka dojke, je bila incidenca divertikulitisa primerljiva.
Osteonecrosis of the jaw
Osteonekroza čeljustnice
In patients treated with Prolia for up to 10 years, BMD increased from the pivotal study baseline by 21.7% at the lumbar spine, 9.2% at the total hip, 9.0% at the femoral neck, 13.0% at the trochanter and 2.8% at the distal 1/3 radius.
Bolnicam, ki so se zdravile z zdravilom Prolia do 10 let, se je mineralna gostota kosti v primerjavi z mineralno gostoto na začetku ključne študije povečala za 21,7 % v ledveni hrbtenici, 9,2 % v celotnem kolku, 9,0 % v vratu stegnenice, 13,0 % v trohantru in 2,8 % v distalni tretjini koželjnice.
Any clinical fracture1
Katerikoli klinični zlom1
Lichenoid drug eruptions (e.g. lichen planus-like reactions), have been reported in patients in the postmarketing setting.
V obdobju trženja zdravila so pri bolnikih poročali o z zdravilom povezanih lihenoidnih erupcijah (npr. reakcijah, podobnih lichen planus).
Next injection Prolia 60 mg injection denosumab SC
Naslednje injiciranje Prolia 60 mg injekcija denosumab s.c.
In the glucocorticoid-continuing subpopulation, Prolia demonstrated a greater increase in lumbar spine BMD compared to risedronate at 1 year (Prolia 3.6%, risedronate 2.0%; p < 0.001) and 2 years (Prolia 4.5%, risedronate 2.2%; p < 0.001).
V subpopulaciji, ki je glukokortikoidno zdravljenje nadaljevala, je zdravilo Prolia povzročilo večje povečanje MKG v ledvenem delu hrbtenice v primerjavi z risedronatom po 1 letu (zdravilo Prolia 3,6 %, risedronat 2,0 %, p < 0,001) in po 2 letih (zdravilo Prolia 4,5 %, risedronat 2,2 %, p < 0,001).
Skin infections reported as serious adverse reactions were similar in the placebo (0.6%, 5 out of 845) and the Prolia (0.6%, 5 out of 860) groups in the breast and prostate cancer studies.
Okužbe kože, opisane kot resni neželeni učinki, so bile v skupinah bolnikov z rakom na dojki ali na prostati med uporabo placeba podobno pogoste (0,6 %, 5 od 845) kot med uporabo zdravila Prolia (0,6 %, 5 od 860).
Surgery or medicines that stop the production of oestrogen or testosterone used to treat patients with breast or prostate cancer can also lead to bone loss.
Izgubljanje kostne mase lahko povzročijo tudi operacija ali zdravila, ki preprečijo nastajanje estrogena ali testosterona in se uporabljajo za zdravljenje raka na dojki ali raka na prostati.
Prolia is used to treat:
Z zdravilom Prolia zdravimo:
One pre-filled syringe.
Ena napolnjena injekcijska brizga.
Disinfect the skin by using an alcohol wipe.
Uporabite alkoholni zloženec in z njim razkužite kožo.
No accumulation or change in denosumab pharmacokinetics with time was observed upon subcutaneous multiple-dosing of 60 mg once every 6 months.
Po večkratnem subkutanem dajanju 60 mg vsakih 6 mesecev niso opazili kopičenja ali sprememb farmakokinetike denosumaba skozi čas.
You should also take calcium and vitamin D supplements while being on treatment with Prolia.
Med zdravljenjem z zdravilom Prolia morate jemati dodatke kalcija in vitamina D. Zdravnik se bo o tem pogovoril z vami.
• Before administration, the solution should be inspected.
• Raztopino je treba pred injiciranjem pregledati.
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).
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.
NAME OF THE MEDICINAL PRODUCT Prolia 60 mg injection denosumab
IME ZDRAVILA Prolia 60 mg injekcija denosumab
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.
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.
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.
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).
To give an injection, you will need:
Zdravilo lahko injicirate v:
• abdominal discomfort,
• nelagodje v trebuhu,
What Prolia contains
Kaj vsebuje zdravilo Prolia
DO NOT pick up the pre-filled syringe by the plunger or needle cover.
NE prijemajte napolnjene injekcijske brizge za bat ali pokrovček igle.
You may have low levels of calcium in your blood while receiving Prolia.
Med prejemanjem zdravila Prolia imate lahko nizko koncentracijo kalcija v krvi.
The risk of ONJ increased with duration of exposure to Prolia.
Tveganje za osteonekrozo čeljustnice se poveča s povečanjem časa izpostavljenosti zdravilu Prolia.
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.
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.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Prolia 60 mg denosumab
IME ZDRAVILA IN POT(I) UPORABE Prolia 60 mg denosumab s.c.
NAME OF THE MEDICINAL PRODUCT Prolia 60 mg solution for injection in pre-filled syringe
IME ZDRAVILA Prolia 60 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Re-initiation of Prolia resulted in gains in BMD similar to those when Prolia was first administered.
Ponovna uvedba zdravila Prolia je povzročila podobna povečanja mineralne kostne gostote kot po prvi uporabi zdravila Prolia.
Prolia 60 mg solution for injection in pre-filled syringe denosumab
Prolia 60 mg raztopina za injiciranje v napolnjeni injekcijski brizgi denosumab
Some people have developed unusual fractures in their thigh bone while being treated with Prolia.
Pri nekaterih bolnikih so se med zdravljenjem z zdravilom Prolia pojavili neobičajni zlomi stegnenice.
Read all instructions thoroughly before using the pre-filled syringe.
Preden začnete Pred uporabo napolnjene injekcijske brizge natančno preberite vsa navodila.
Adequate intake of calcium and vitamin D is important in all patients.
Za vse bolnike je pomembno, da uživajo dovolj kalcija in vitamina D.
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.
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).
Drug hypersensitivity1 Anaphylactic reaction1
Bolezni imunskega sistema redki redki preobčutljivost na zdravilo1 anafilaktična reakcija1
You do not have to remove the air bubble before injecting.
Tega mehurčka vam pred injiciranjem ni treba odstraniti.
Thirteen adjudicated cases of osteonecrosis of the jaw (ONJ) and two adjudicated cases of atypical fractures of the femur occurred during the extension study.
V nadaljevalni študiji se je pojavilo trinajst zdravilu prisojenih primerov osteonekroze čeljustnice in dva zdravilu prisojena primera atipičnega zloma stegnenice.
3 Includes pelvis, distal femur, proximal tibia, ribs, proximal humerus, forearm, and hip.
3 Vključuje zlome medenice, distalne stegnenice, proksimalne golenice, reber, proksimalne nadlahtnice, podlakta in kolka.
Uncommonly, patients receiving Prolia may develop skin infections (predominantly cellulitis).
Občasno se lahko pri bolnikih, ki dobivajo zdravilo Prolia, pojavijo okužbe kože (predvsem celulitis).
Clinical vertebral fracture
Atipični zlomi stegnenice
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL WITH OR WITHOUT NEEDLE GUARD (BLISTERED)
NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO S ŠČITNIKOM IGLE ALI BREZ NJEGA (V PRETISNIH OMOTIH)
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.
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.
Musculoskeletal pain, including severe cases, has been reported in patients receiving Prolia in the post-marketing setting.
V obdobju trženja zdravila so pri bolnikih, ki so dobivali zdravilo Prolia, poročali o mišično-skeletni bolečini, vključno s hudimi primeri.
Osteonecrosis of the Jaw (ONJ) ONJ has been reported rarely in patients receiving Prolia for osteoporosis (see section 4.8).
Pri bolnikih, ki so dobivali zdravilo Prolia za osteoporozo, so redko poročali o osteonekrozi čeljustnice (glejte poglavje 4.8).
Adverse reactions
Previdnostni ukrepi
Rarely unusual fractures of the thigh bone may occur in patients receiving Prolia.
Redko se lahko pri bolnikih, ki prejemajo zdravilo Prolia, pojavijo neobičajni zlomi stegnenice.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA NAPOLNJENO INJEKCIJSKO BRIZGO
Equipment:
Zaradi varnosti:
Talk to your doctor or pharmacist before using Prolia
Pred začetkom uporabe zdravila Prolia se posvetujte z zdravnikom ali farmacevtom.
Pinch (without squeezing) the skin between your thumb and forefinger.
Primite kožo med palec in kazalec, ne da bi jo stiskali.
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).
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).
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).
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).
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).
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).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Prolia 60 mg injection denosumab
IME ZDRAVILA IN POT(I) UPORABE Prolia 60 mg injekcija denosumab s.c.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 mL pre-filled syringe containing 60 mg of denosumab (60 mg/mL).
NAVEDBA ENE ALI VEČ UČINKOVIN 1 ml napolnjena injekcijska brizga vsebuje 60 mg denosumaba (60 mg/ml).
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.
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.
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.
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.
Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.
Če se vam med zdravljenjem z zdravilom Prolia pojavi nova ali neobičajna bolečina v kolku, dimljah ali stegnu, se posvetujte z zdravnikom.
Urinary tract infection Upper respiratory tract infection Diverticulitis1
Infekcijske in parazitske bolezni pogosti pogosti občasni občasni občasni okužba sečil okužba zgornjih dihal divertikulitis1 celulitis1 okužba ušesa
Calcium levels were transiently decreased and parathyroid hormone levels transiently increased in ovariectomised monkeys treated with denosumab.
Pri ovariektomiranih opicah, ki so dobivale denosumab, se je koncentracija kalcija prehodno zmanjšala, koncentracija paratiroidnega hormona pa prehodno zvečala.
Patients received calcium (at least 1,000 mg) and vitamin D (at least 800 IU) supplementation daily.
Bolniki so dnevno dobivali dodatke kalcija (vsaj 1.000 mg) in vitamina D (vsaj 800 IE).
Cellulitis1
osteonekroza čeljustnice1
• Keep used syringes out of the reach and sight of children.
• Uporabljene brizge shranjujte nedosegljive otrokom.
Non-vertebral fracture2
Nevretenčni zlom2
Prolia is not recommended for use if you are pregnant.
Če ste noseči, uporaba zdravila Prolia ni priporočljiva.
Major non-vertebral fracture3
Hujši nevretenčni zlom3
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).
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).
How to store Prolia
Shranjevanje zdravila Prolia
For safety reasons: Do not grasp the plunger.
Ne primite brizge za bat.
Unusual thigh bone fractures
Neobičajni zlomi stegnenice
All men received calcium (at least 1,000 mg) and vitamin D (at least 800 IU) supplementation daily.
Vsi moški so vsak dan dobivali dodatke kalcija (vsaj 1.000 mg) in vitamina D (vsaj 800 i.e.).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERED PRE-FILLED SYRINGE
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Used plunger
Okvara jeter
Remove the pre-filled syringe from the refrigerator.
Kaj morate storiti, preden zdravilo Prolia injicirate pod kožo Vzemite napolnjeno injekcijsko brizgo iz hladilnika.
• Keep the pre-filled syringe out of the sight and reach of children.
• Napolnjeno injekcijsko brizgo shranjujte nedosegljivo otrokom!
This section contains information on how to use the Prolia pre-filled syringe.
Navodila za injiciranje zdravila Prolia v napolnjeni injekcijski brizgi To poglavje obsega informacije o uporabi napolnjene injekcijske brizge zdravila Prolia.
All women received calcium (at least 1,000 mg) and vitamin D (at least 400 IU) supplementation daily.
Vse ženske so vsak dan dobivale dodatke kalcija (vsaj 1.000 mg) in vitamina D (vsaj 400 i.e.).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL (UNBLISTERED)
NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO (NE V PRETISNIH OMOTIH)
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.
Prav tako so pri knockout miših brez RANK ali RANKL opazili odsotnost laktacije zaradi zavrtja dozorevanja mlečnih žlez (razvoj lobulo-alveolarnih žlez med brejostjo).
Women received calcium (at least 1,000 mg) and vitamin D (at least 400 IU) supplementation daily.
Ženske so vsak dan dobivale dodatke kalcija (vsaj 1.000 mg) in vitamina D (vsaj 400 i.e.).
All men received calcium (at least 1,000 mg) and vitamin D (at least 400 IU) supplementation daily.
Vsi moški so vsak dan dobivali dodatke kalcija (vsaj 1.000 mg) in vitamina D (vsaj 400 i.e.).
1 See section Description of selected adverse reactions 2 See section 4.4
2 Glejte poglavje 4.4.
The mean lumbar spine BMD T-score at the end of the study was1.3 in patients treated for 10 years.
Pri bolnicah, zdravljenih 10 let, je bila ob zaključku študije povprečna T-vrednost mineralne gostote kosti v ledvenem delu hrbtenice -1,3.
Do not shake the pre-filled syringe.
Napolnjene injekcijske brizge NE stresajte.
DO NOT shake the pre-filled syringe.
Napolnjene injekcijske brizge ne stresajte.
Instructions for injecting with the Prolia pre-filled syringe
NAPOLNJENA INJEKCIJSKA BRIZGA V PRETISNEM OMOTU
Hepatic impairment
Klinični zlom vretenc
If no improvement is noted within 48 hours, the diagnosis should be confirmed.
Če v 48 urah ne opazite izboljšanja, je treba potrditi diagnozo.
No data to support the term “control” were provided.
Predloženi niso bili nobeni podatki v podporo izrazu „nadzor“.
8 hours 8 hours
8 ur 8 ur
Member State EU/EEA
Država članica EU/EGS
In particular its activity has been demonstrated against the following micro-organism:
Njegovo delovanje so pokazali predvsem proti naslednjim mikroorganizmom:
1 hour 1 hour
1 ura 1 ura
Each vial is packed into a carton.
Vsaka viala je pakirana v škatli.
The treatment appears to be intended to be preventive, which is not in line with the principles of prudent use of antibiotics.
Zdi se, da je zdravljenje preventivno, kar ni v skladu z načeli preudarne uporabe antibiotikov.
Use only according to the benefit/risk assessment by the responsible veterinarian.
Uporabite le skladno z oceno razmerja korist/tveganje odgovornega veterinarja.
• Avoid contact with skin and eyes.
• Preprečite stik s kožo in očmi.
• Ensure that animals are properly restrained, including those in the vicinity.
• Zagotovite, da so živali ustrezno obvladane, vključno z živalmi v okolici.
Occasionally, a soft diffuse swelling may occur at the injection site but this disappears within five to eight days.
Včasih se lahko na mestu injiciranja pojavi mehka difuzna oteklina, ki pa izgine v petih do osmih dneh.
Scientific evidence suggests that macrolides act synergistically with the host immune system.
Znanstveni dokazi kažejo, da makrolidi delujejo sinergistično z imunskim sistemom gostitelja.
Rinse any splashes from skin or eyes immediately with water.
Vse brizge na kožo ali v oči takoj sperite z vodo.
However the bulk of the tilmicosin is excreted unchanged.
Vendar se večina tilmikozina izloči nespremenjenega.
It is believed to affect protein synthesis.
Menijo, da učinkuje na sintezo beljakovin.
Overall it can be concluded that data to substantiate the proposed indications in rabbits is minimally reported or lacking.
Na splošno je mogoče zaključiti, da so podatki za utemeljitev predlaganih indikacij pri kuncih minimalni ali jih ni.
In rare cases recumbency, incoordination and convulsions have been observed.
V redkih primerih so opazili neaktivnost, nekoordiniranost in konvulzije.
As tilmicosin persists in tissues for several days, the cardiovascular system should be closely monitored and supportive treatment provided.
Ker tilmikozin v tkivih ostane več dni, je treba skrbno spremljati kardiovaskularni sistem in nuditi podporno zdravljenje.
The main areas of disharmony in the existing SPCs relate to:
Glavna področja razhajanja v obstoječih povzetkih glavnih značilnosti zdravila se nanašajo na:
Minimum inhibition concentration measured in recently (2009-2012) isolated European field strains, derived from respiratory bovine disease.
Minimalna inhibicijska koncentracija, izmerjena pri nedavno (2009-2012) izoliranih evropskih sevih s terena, ki izhajajo iz respiratorne bolezni govedi.
Do not administer to horses, donkeys, pigs, goats or primates.
Ne uporabljajte pri konjih, oslih, prašičih, kozah ali primatih.