natgillin/translations-raw huggingface dataset:
KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for concentrate for solution for infusion
KANJINTI 150 mg prašek za koncentrat za raztopino za infundiranje KANJINTI 420 mg prašek za koncentrat za raztopino za infundiranje
4 adverse reaction in the 2-year treatment arm (20.4%) compared with the 1-year treatment arm
Več bolnikov je doživelo najmanj en neželeni učinek stopnje 3 ali 4 v skupini z dvoletnim zdravljenjem (20,4 %) v primerjavi s skupino z enoletnim zdravljenjem (16,3 %).
Patients with EBC should be treated with KANJINTI for 1 year or until disease recurrence, whichever occurs first; extending treatment in EBC beyond one year is not recommended (see section 5.1).
Podaljšanje zdravljenja zgodnjega raka dojk na več kot eno leto ni priporočljivo (glejte poglavje 5.1).
The reconstituted KANJINTI solution contains 21 mg/mL of trastuzumab.
Pripravljena raztopina zdravila KANJINTI vsebuje 21 mg/ml trastuzumaba.
In the joint analysis of the NSABP B-31 and NCCTG N9831 studies, EBC was limited to women with operable breast cancer at high risk, defined as HER2-positive and axillary lymph node positive or
V skupni analizi preskušanj NSABP B-31 in NCCTG N9831 je bil zgodnji rak dojk omejen na ženske z operabilnim rakom dojk z visokim tveganjem, opredeljenim kot pozitivna oblika HER2 s pozitivnimi aksilarnimi bezgavkami ali pozitivna oblika HER2 z negativnimi bezgavkami z dejavniki visokega tveganja (velikost tumorja > 1 cm in negativni estrogenski receptorji ali velikost tumorja > 2 cm neodvisno od hormonskega statusa).
Pulmonary hypoplasia
• mišična šibkost
KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for concentrate for solution for infusion trastuzumab
KANJINTI 150 mg prašek za koncentrat za raztopino za infundiranje KANJINTI 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
• capecitabine - 1,000 mg/m2 orally twice daily for 14 days every 3 weeks for 6 cycles (evening of day 1 to morning of day 15 of each cycle)
Kemoterapijo so dajali, kot je navedeno spodaj: - kapecitabin - 1.000 mg/m2 peroralno dvakrat na dan 14 dni vsake 3 tedne, skupaj 6 ciklov
Metastatic gastric cancer
Metastatski rak dojk
MBC EBC Table 15 Population predicted steady-state PK exposure values (median with 5th - 95th percentiles) for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo, v stanju dinamičnega ravnovesja (mediana s 5.-95. percentilom) za režima odmerjanja trastuzumaba v intravenski obliki pri bolnikih z MBC, EBC in AGC
- Study BO16348 was designed to compare one and two years of three-weekly trastuzumab treatment versus observation in patients with HER2 positive EBC following surgery, established chemotherapy and radiotherapy (if applicable).
Pri adjuvantnem zdravljenju so trastuzumab proučevali v 4 obsežnih, multicentričnih, randomiziranih preskušanjih: - Študija BO16348 je bila zasnovana za primerjavo enoletnega in dvoletnega zdravljenja s trastuzumabom (odmerjanjem na 3 tedne) z opazovanjem bolnikov z zgodnjo obliko HER2pozitivnega raka dojk po operaciji, standardni kemoterapiji in radioterapiji (kar so uporabili).
KANJINTI 150 mg powder for concentrate for solution for infusion
KANJINTI 150 mg prašek za koncentrat za raztopino za infundiranje
+Pleural effusion
+dihalna stiska neznano
This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab.
Rekonstitucija da 7,4 ml raztopine za enkratno uporabo in vsebuje približno 21 mg/ml trastuzumaba.
Do not use KANJINTI if you notice any particulate matter or discolouration prior to administration.
Če pred dajanjem opazite kakršne koli delce ali obarvanje, ne uporabljajte zdravila KANJINTI.
When trastuzumab was administered after completion of adjuvant chemotherapy NYHA class III-IV heart failure was observed in 0.6% of patients in the one-year arm after a median follow-up of 12 months.
Srčno popuščanje razreda III−IV po NYHA se je po mediani časa spremljanja 12 mesecev pojavilo pri 0,6 % bolnikov v skupini, ki se je s trastuzumabom po zaključku adjuvantne kemoterapije zdravila eno leto.
This yields a 21 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab.
Rekonstitucija da 21 ml raztopine za enkratno uporabo in vsebuje približno 21 mg/ml trastuzumaba.
Distant recurrence No. patients with event p < 0.0001
Pojav oddaljenih metastaz: število bolnikov z dogodkom p < 0,0001
How to store KANJINTI
Kako uporabljati zdravilo KANJINTI
Biopsy specimen - staining pattern HER2 overexpression assessment
Vzorci biopsije - videz preparata po barvanju
Hazard Ratio (95% CI)
Razmerje ogroženosti (95-% IZ)
• The other ingredient(s) are histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20.
• Pomožne snovi so histidin, histidinijev klorid monohidrat, trehaloza dihidrat in polisorbat 20.
Febrile neutropenia
• vročinski oblivi
+Acute pulmonary oedema
+akutni pljučni edem neznano
Disease-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation Recurrence-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation Distant disease-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation Overall survival (death) - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation
Preživetje brez pojava oddaljenih metastaz - št. bolnikov z dogodkom - št. bolnikov brez dogodka P-vrednost v primerjavi z opazovanjem
Overall survival No. patients with event
Celokupno preživetje Število bolnikov z dogodkom 22
Hazard Ratio vs AC→P (95% CI) p-value
Razmerje ogroženosti v primerjavi z AC → P (95-% IZ) p-vrednost
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 trastuzumab intravenous formulation and have revealed no evidence of impaired fertility or harm to the foetus.
Študije o vplivu na sposobnost za razmnoževanje so opravili pri opicah Cynomolgus z odmerki, ki so bili do 25-krat večji od tedenskega vzdrževalnega odmerka intravenske oblike trastuzumaba pri ljudeh (2 mg/kg).
• deafness
• omotica
KANJINTI vial
Viala zdravila KANJINTI
3+ Strong complete membrane staining is detected in > 10% of the tumour cells.
Močno obarvane celotne membrane pri > 10 % tumorskih celic.
Immune thrombocytopenia
• vnetje dojk tesnoba
No reactivity or membranous reactivity in any tumour cell
Obarvanje ni prisotno pri nobeni tumorski celici.
The recommended maintenance dose of KANJINTI at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Priporočen vzdrževalni odmerek zdravila KANJINTI je 6 mg/kg telesne mase po 3 tednih od prejema polnitvenega odmerka, in nato v tritedenskih razmakih.
t1/2 range from
Obseg t1/2 od Cmax, ss do
The incidence of symptomatic cardiac dysfunction was 1.7% in the trastuzumab arm.
Pogostnost simptomatske motnje v delovanju srca je bila v skupini, ki je prejemala trastuzumab,
or - intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle) which was followed by: - carboplatin - at target AUC = 6 mg/mL/min administered by intravenous infusion over
- paklitaksel intravensko - 80 mg/m2 v obliki kontinuirane intravenske infuzije, vsak teden, skupaj 12 tednov ali - paklitaksel intravensko - 175 mg/m2 v obliki kontinuirane intravenske infuzije, vsake 3 tedne,
Table 5 Efficacy results from the non-comparative monotherapy and combination therapy studies
Rezultati učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine
Disease-free survival No. patients with event p < 0.0001
Preživetje brez bolezni: število bolnikov z dogodkom p < 0,0001
Trastuzumab washout period was assessed following q1w or q3w intravenous administration using the population PK model.
Obdobje izpiranja trastuzumaba je bilo ocenjeno po intravenski aplikaciji zdravila enkrat na teden ali enkrat na tri tedne s pomočjo populacijskega farmakokinetičnega modela.
Papilloedema
trastuzumab
Hazard Ratio versus AC→P (95% CI)
Razmerje ogroženosti v primerjavi z AC → P (95-% IZ)
KANJINTI and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
Pri zdravljenju metastatskega raka dojk kombinacije zdravila KANJINTI in antraciklinov ne smemo dajati sočasno.
It is important for you to keep all your appointments to receive KANJINTI.
Če je bil odmerek zdravila KANJINTI izpuščen Pomembno je, da pridete na vse dogovorjene termine za prejem zdravila KANJINTI.
Paclitaxel, in combination with trastuzumab, was administered as follows: - intravenous paclitaxel - 80 mg/m2 as a continuous intravenous infusion, given every week for
Odmerjanje docetaksela je bilo naslednje: - docetaksel intravensko - 100 mg/m2 v obliki intravenske infuzije v 1 uri, vsake 3 tedne, skupaj
2+ A weak to moderate complete membrane staining is detected in > 10% of the tumour cells.
Šibko do srednje močno obarvane celotne membrane pri > 10 % tumorskih celic.
Median TTP (months) (95%CI) Median Survival (months) (95%CI)
Mediana TTP (meseci) (95-% IZ)
Retinal haemorrhage
Izpiranje trastuzumaba
• cisplatin - 80 mg/m2 every 3 weeks for 6 cycles on day 1 of each cycle.
Kapecitabin ali 5-fluorouracil so dajali skupaj s: - cisplatinom - 80 mg/m2 vsake 3 tedne 6 ciklov, 1. dan vsakega cikla.
In addition, terms reported in the post marketing setting are included in Table 1.
Dodatno so v preglednici 1 vključeni neželeni učinki, o katerih so poročali v obdobju po prihodu zdravila na trg.
infection of lungs pain in the arms and/or legs lung disorders itchy rash back pain sleepiness (somnolence)
• bolečina v rokah in/ali nogah okužba pljuč
+Respiratory distress
Pljučni zapleti
The median overall survival for the high HER2 expressing group was 11.8 months versus 16 months, HR 0.65 (95% CI 0.51-0.83) and the median progression free survival was 5.5 months versus 7.6 months, HR 0.64 (95% CI 0.51-0.79) for FP versus FP + H, respectively.
Mediana celokupnega preživetja v skupini, ki je imela visoko izražen HER2, je bila 11,8 meseca za skupino, ki ni prejemala trastuzumaba, v primerjavi s 16 meseci za skupino, ki je prejemala tudi trastuzumab - razmerje ogroženosti 0,65 (95-% interval zaupanja; 0,51-0,83).
- intravenous docetaxel - 100 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 4 cycles (day 2 of first docetaxel cycle, then day 1 of each subsequent cycle)
6 ciklov (na 2. dan prvega cikla z docetakselom, nato na 1. dan vsakega nadaljnjega cikla).
AC→DH (n = 1074) Hazard Ratio vs AC→D (95% CI) p-value
Razmerje ogroženosti v primerjavi z AC → D (95-% IZ) p-vrednost
+1Wheezing
+1piskanje zelo pogosto
or - intravenous paclitaxel - 175 mg/m2 as a continuous intravenous infusion, given every 3 weeks for 4 cycles (day 1 of each cycle).
ali - docetaksel intravensko - 75 mg/m2 v obliki intravenske infuzije v 1 uri, vsake 3 tedne, skupaj
The recommended scoring system to evaluate the IHC staining patterns is as stated in table 2: Table 2 Recommended scoring system to evaluate the IHC staining patterns in breast cancer Score Staining pattern
Priporočeno točkovanje za vrednotenje obarvanja preparatov po metodi IHC pri raku dojk
HER2 over expression should be detected using an immunohistochemistry (IHC)-based assessment of fixed tumour blocks; HER2 gene amplification should be detected using in situ hybridisation using either SISH or FISH on fixed tumour blocks.
Amplifikacijo gena HER2 se določa z metodo hibridizacije in situ, torej s SISH ali FISH fiksiranih tumorskih blokov.
• dizziness
• gluhost
• respiratory distress
• bolečina v trebuhu
Pneumonitis
Bolezni živčevja
Hazard Ratio vs AC→D (95% CI)
Razmerje ogroženosti v primerjavi z AC → D (95-% IZ)
NAME OF THE MEDICINAL PRODUCT KANJINTI 420 mg powder for concentrate for solution for infusion trastuzumab
KANJINTI 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
Liver tenderness
• vnetje jeter depresija
• chest pain
• dihalna stiska
The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Priporočen vzdrževalni odmerek je 6 mg/kg telesne mase po 3 tednih od prejema polnitvenega odmerka, in nato v tritedenskih razmakih.
The recommended scoring system to evaluate the IHC staining patterns is as stated in table 3: Table 3 Recommended scoring system to evaluate the IHC staining patterns in gastric cancer Score Surgical specimen - staining pattern
Priporočen način vrednotenja rezultatov obarvanja preparatov po metodi IHC je naveden v preglednici
Thinking abnormal
• bolezni ledvic nenormalno razmišljanje
Dry skin
• kožni izpuščaj
6.1 List of excipients
4.1 Terapevtske indikacije
• fatigue
• driska
The risk of neutropenia may be slightly increased when trastuzumab is administered with docetaxel following anthracycline therapy.
Če trastuzumab dajemo z docetakselom po antraciklinski terapiji, je lahko tveganje za nevtropenijo rahlo povečano.
DFS analysis was also performed at the final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831.
Ob končni analizi celokupnega preživetja iz skupne analize študij NSABP B-31 in NCCTG N9831 so opravili tudi analizo preživetja brez bolezni.
Immune system disorders
Bolezni imunskega sistema preobčutljivost pogosto
Refer to the SmPC for paclitaxel, docetaxel or aromatase inhibitor for information on dose reduction or delays.
Za zmanjšanje odmerka ali odlog dajanja paklitaksela, docetaksela ali zaviralca aromataze glejte njihove Povzetke glavnih značilnosti zdravila.
Docetaxel was administered as follows:
Odmerjanje doksorubicina in ciklofosfamida, ki so ju dajali sočasno, je bilo naslednje:
Cmax
MBC
Ear and labyrinth disorders
Ušesne bolezni, vključno z motnjami labirinta gluhost občasno
NAME OF THE MEDICINAL PRODUCT KANJINTI 150 mg powder for concentrate for solution for infusion trastuzumab
KANJINTI 150 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
Most patients who developed CHF or asymptomatic cardiac dysfunction in pivotal trials improved with standard CHF treatment consisting of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and a beta-blocker.
To vključuje zaviralec angiotenzinske konvertaze ali zaviralec angiotenzinskih receptorjev in antagonist receptorjev beta.
Common side effects (may affect up to 1 in 10 people): allergic reactions dry mouth and skin throat infections dry eyes bladder and skin infections sweating shingles feeling weak and unwell inflammation of the breast anxiety inflammation of the liver depression kidney disorders abnormal thinking increased muscle tone or tension asthma
Očesne bolezni konjunktivitis zelo pogosto povečano solzenje zelo pogosto suhe oči pogosto edem papile vidnega živca neznano retinalna krvavitev neznano
Pericardial effusion
• odpoved ledvic
1Heart beat irregular
1nereden srčni utrip zelo pogosto
After a median follow-up of 12 months, the hazard ratio (HR) for disease-free survival (DFS) was 0.54 (95% CI 0.44, 0.67) which translates into an absolute benefit, in terms of a 2-year disease-free survival rate, of 7.6 percentage points (85.8% versus 78.2%) in favour of the trastuzumab arm.
Po mediano 12-mesečnem spremljanju je bilo razmerje ogroženosti za preživetje brez bolezni 0,54 (95-% IZ: 0,44; 0,67).
Faint/barely perceptible membranous reactivity in ≥ 10% of tumour cells; cells are reactive only in part of their membrane
Bledo, komaj zaznavno obarvanje membrane je prisotno pri ≥ 10 % tumorskih celic.
Orthopnoea
Imunogenost
Skin and subcutaneous tissue disorders
• okužbe mehurja in kože znojenje
Neutropenia
Odmerjanje
The relationship between fluconazole use and these events is unclear.
Povezava med flukonazolom in temi dogodki ni jasna.
Adopted at the 6-9 February 2017 PRAC
Sprejeto na seji odbora PRAC med 6. in 9. februarjem 2017
Nivolumab - Pemphigoid (EPITT no 18759)
Nivolumab - pemfigoid (EPITT št. 18759)
Undesirable effects e Rash is a composite term which includes maculopapular rash, rash erythematous, rash pruritic, rash follicular, rash macular, rash morbilliform, rash papular, rash pustular, rash papulosquamous, rash vesicular, rash generalised, dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis atopic, dermatitis bullous, dermatitis exfoliative, dermatitis psoriasiform, and drug eruption and pemphigoid.
Neželeni učinki e Izpuščaj je sestavljen izraz, ki vključuje makulopapulozni izpuščaj, eritemski izpuščaj, srbeči izpuščaj, folikularni izpuščaj, makulozni izpuščaj, morbiliformni izpuščaj, papulozni izpuščaj, pustulozni izpuščaj, papuloskvamozni izpuščaj, vezikulozni izpuščaj, generalizirani izpuščaj, dermatitis, akneiformni dermatitis, alergijski dermatitis, atopični dermatitis, bulozni dermatitis, eksfoliativni dermatitis, psoriaziformni dermatitis, in medikamentni izpuščaj in pemfigoid.
An observational study has suggested an increased risk of spontaneous abortion in women treated with fluconazole during the first trimester.
Opazovalna študija kaže na povečano tveganje spontanega splava pri ženskah, zdravljenih s flukonazolom v prvem trimesečju.
There have been reports of multiple congenital abnormalities (including brachycephalia, ears dysplasia, giant anterior fontanelle, femoral bowing and radio-humeral synostosis) in infants whose mothers were treated for at least three or more months with high doses (400-800 mg daily) of fluconazole for coccidioidomycosis.
Poročali so o multiplih kongenitalnih anomalijah (vključno z brahicefalijo, displazijo ušes, veliko sprednjo fontanelo, upognjenostjo stegnenice in radio-humeralno sinostozo) pri dojenčkih, katerih matere so najmanj tri mesece ali več dobivale velike odmerke (od 400 do 800 mg/dan) flukonazola za zdravljenje kokcidioidomikoze.
Data from several hundred pregnant women treated with standard doses (<200 mg/day) of fluconazole, administered as a single or repeated dose in the first trimester, show no increased risk of undesirable effects in the foetus.
Podatki, dobljeni pri več sto nosečnicah, zdravljenih z običajnimi odmerki flukonazola (< 200 mg/dan) v enkratnem ali večkratnih odmerkih v prvem trimesečju nosečnosti, niso pokazali nobenih neželenih učinkov pri plodu.
Fluconazole in high dose and/or in prolonged regimens should not be used during pregnancy except for potentially life-threatening infections.
Flukonazol se v velikih odmerkih in/ali pri dolgotrajnem zdravljenju ne sme uporabljati med nosečnostjo, razen v primeru potencialno življenjsko ogrožajočih okužb.
Fluconazole in standard doses and short-term treatments should not be used in pregnancy unless clearly necessary.
Flukonazol se v običajnih odmerkih in pri kratkotrajnem zdravljenju ne sme uporabljati med nosečnostjo, razen če to ni nujno potrebno.
4 - Possible side effects Skin rash sometimes with blisters, itching
Navodilo za uporabo 4 - Možni neželeni učinki Kožni izpuščaj, včasih z mehurčki, srbenje
Fluconazole - Spontaneous abortion and stillbirth (EPITT no 18666)
Flukonazol - spontani splav in mrtvorojenost (EPITT št.
Water may be given.
Lahko se jim ponudi voda.
The stopper may be safely punctured up to 100 times.
Zamašek lahko varno prebodete do 100-krat.
The following doses are recommended:
Priporočeni so naslednji odmerki:
SPECIAL WARNINGS, IF NECESSARY
POSEBNA OPOZORILA, ČE SO POTREBNA
At maximal effect, the animal is relaxed, recumbent and does not respond to external stimulus.
Pri največjem učinku je žival sproščena, neaktivna in se ne odziva na zunanje dražljaje.
Spontaneous recovery occurs within 3 hours.
Do spontanega prenehanja delovanja pride v treh urah.
Frequent and regular monitoring of respiratory and cardiac function should be performed.
Pogosto in redno spremljajte dihanje in delovanje srca.
In a clinical study, the requirement for propofol was reduced by 50%.
V klinični študiji je bila potreba po propofolu zmanjšana za 50 %.
Do not use in animals with severe systemic disease or in animals that are moribund.
Ne uporabite pri živalih s hudimi sistemskimi boleznimi ali pri umirajočih živalih.
Blood pressure will increase initially and then return to normal or below normal.
Krvni pritisk se najprej poviša in se nato vrne na normalno raven ali pod njo.
The eyes should be protected by a suitable eye lubricant.
Oči morate zaščititi z ustreznim mazilom za oči.
If symptoms occur, seek the advice of a physician.
Če se pojavijo simptomi, poiščite zdravniško pomoč.
*only intramuscularly
*samo intramuskularno
However this duration is dependent on a number of variables and further analgesia should be administered in accordance with clinical judgement.
Vendar je njeno trajanje odvisno od številnih dejavnikov, zato je treba nadaljnjo analgezijo dajati glede na klinično presojo.
It is also advisable to have oxygen readily available, should hypoxaemia be detected or suspected.
Priporočljivo je imeti na voljo kisik, če bi se pojavila hipoksemija ali če bi posumili nanjo.
Sympathetic neurotransmission is prevented and the level of consciousness decreases.
Tako se prepreči simpatetična nevrotransmisija in zniža raven zavesti.
Within 15 minutes dogs and cats are normally awake and standing.
Psi in mačke so navadno budni in stojijo po 15 minutah.
All known metabolites lack pharmacological activity.
Vsi znani presnovki so brez farmakološke aktivnosti.
In case of skin or mucosal contact, wash the exposed skin immediately after exposure with large amounts of water and remove contaminated clothes that are in direct contact with skin.
V primeru stika s kožo ali sluznico izpostavljen del nemudoma sperite z veliko količino vode in odstranite umazana oblačila, ki so v neposrednem stiku s kožo.
The maximum plasma concentration is reached about 0.24 h after intramuscular administration.
Najvišja koncentracija v plazmi je dosežena približno 0,24 ure po intramuskularnem dajanju.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z nacionalnimi zahtevami.
According to studies in rats, the maximum concentration in the central nervous system is several times that of the corresponding concentration in plasma.
Raziskave na podganah kažejo, da je najvišja koncentracija v osrednjem živčevju nekajkrat višja kot ustrezna koncentracija v plazmi.
Respiration rate can occasionally decrease.
Občasno lahko pride do zmanjšanja hitrosti dihanja.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Za vse nadaljnje informacije o tem zdravilu se obrnite na krajevno predstavništvo imetnika dovoljenja za promet z zdravilom.>
The elimination half-life (t1⁄2) is 40-50 minutes.
Razpolovni čas izločanja (t1⁄2) je 40-50 minut.
Respiratory and haemodynamic symptoms should be treated symptomatically.
Dihalne in hemodinamične simptome je treba zdraviti simptomatsko.
Pulse oximetry may be useful but is not essential for adequate monitoring.
Pulzna oksimetrija je lahko ustrezen, vendar ne nujen način spremljanja teh funkcij.
In a clinical study, dexmedetomidine contributed to postoperative analgesia for 0.5 - 4 hours.
V klinični študiji je deksmedetomidin prispeval k pooperativni analgeziji, ki je trajala 0,5-4 ure.
The veterinary medicinal product is not intended for repeat injections.
Zdravilo za uporabo v veterinarski medicini ni namenjeno za ponavljajoče injiciranje.
Ventricular arrhythmias have also been reported.
Poročali so tudi o ventrikularni aritmiji.
After treatment, the animal should not be given water or food before it is able to swallow.
Po zdravljenju se živalim, dokler ne morejo požirati, ne daje voda ali hrana.
The bioavailability of dexmedetomidine is 60% and the apparent volume of distribution (Vd) is 0.9 l/kg.
Biološka razpoložljivost deksmedetomidina je 60-odstotna in navidezni volumen porazdelitve (Vd) je 0,9 l/kg.