natgillin/translations-raw huggingface dataset:
Products such as Prevomax should be used in conjunction with other supportive measures such as dietary control and fluid replacement therapy, as recommended by your veterinary surgeon.
Zdravila, kot je Prevomax, naj bi uporabljali v povezavi z ostalimi podpornimi terapijami, kot je kontrolirana dieta in terapija z nadomeščanjem tekočin, po priporočilu vašega veterinarja.
Shelf life after first opening the vial: 56 days.
Rok uporabnosti po prvem odprtju viale: 56 dni.
Substance P is found in significant concentrations in the nuclei comprising the emetic centre and is considered the key neurotransmitter involved in vomiting.
Substanca P se v večjih koncentracijah nahaja v jedrih, ki sestavljajo center za bruhanje, in se šteje za ključni nevrotransmiter, udeležen pri bruhanju.
Marketing authorisation holder: Le Vet Beheer B.V.
Imetnik dovoljenja za promet: Le Vet Beheer B.V.
Therefore, it is recommended to administer the veterinary medicinal product prior to administration of the chemotherapeutic agent.
Zato je priporočljivo dajati zdravilo za uporabo v veterinarski medicini pred dajanjem kemoterapevtika.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
QUANTITY OF THE ACTIVE SUBSTANCE(S) 10 mg/ml
KOLIČINA UČINKOVIN(E) 10 mg/ml
PHARMACEUTICAL FORM Solution for injection A clear, colourless to light yellow solution
FARMACEVTSKA OBLIKA raztopina za injiciranje bistra, brezbarvna do svetlo rumena raztopina
As the pharmacokinetic variation is large and maropitant accumulates in the body after once daily repeated administration, lower doses than recommended might be sufficient in some individuals and when repeating the dose.
Zaradi velikega farmakokinetičnega razpona in kopičenja maropitanta v telesu po enkratni dnevni aplikaciji lahko pri nekaterih živalih in ob ponovitvi odmerka zadostujejo tudi nižji odmerki od priporočenih.
Do not use this veterinary medicinal product after the expiry date which is stated on the label of the vial after EXP.
Tega zdravila za uporabo v veterinarski medicini ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki viale poleg oznake „Uporabno do“.
The elimination t1/2 following intravenous dosing was approximately 4.9 h. There appears to be an age-related effect on the pharmacokinetics of maropitant in cats with kittens having higher clearance than adults.
Razpolovni čas izločanja t1/2 po intravenskem odmerjanju je bil približno 4,9 h. Kaže, da je farmakokinetika maropitanta odvisna od starosti živali, pri čemer je očistek pri mladih mačkah večji kot pri odraslih.
Good veterinary practice indicates that antiemetics should be used in conjunction with other veterinary and supportive measures such as dietary control and fluid replacement therapy while addressing the underlying causes of the vomiting.
V skladu z dobro veterinarsko prakso bi bilo treba antiemetike uporabljati v povezavi z ostalimi veterinarskimi in podpornimi terapijami, kot sta dieta in tekočinska terapija, ter hkrati zdraviti osnovne vzroke bruhanja.
Pain at injection site may occur when injected subcutaneously.
Bolečina na mestu injiciranja se lahko pojavi, če je zdravilo injicirano subkutano.
Maropitant undergoes cytochrome P450 (CYP) metabolism in the liver.
Maropitant je podvržen presnovi s citokromom P450 (CYP) v jetrih.
Maropitant is highly bound to plasma proteins and may compete with other highly bound medicines.
Maropitant se močno veže na plazemske proteine in lahko konkurira z ostalimi zdravili, ki se tudi močno vežejo.
In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
Vomiting can be associated with serious, severely debilitating conditions including gastrointestinal obstructions; therefore, appropriate diagnostic evaluations should be employed.
Bruhanje je lahko povezano z resnimi stanji, ki žival močno izčrpajo, vključno z gastrointestinalnimi obstrukcijami, zato je treba postaviti pravilno diagnozo.
The anti-emetic efficacy of maropitant against central and peripheral emetics was demonstrated in experimental studies including apomorphine, cisplatin and syrup of ipecac (dogs) and xylazine (cats).
V eksperimentalnih študijah je bila dokazana antiemetična učinkovitost maropitanta proti centralnim in perifernim emetikom, vključno z apomorfinom, cisplatinom in sirupom ipekakuanje (psi) in ksilazinom (mačke).
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products in the same syringe.
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za uporabo v veterinarski medicini v isti brizgi.
Amber glass type I vial closed with a coated bromobutyl rubber stopper and aluminium cap in a cardboard box.
Steklena viala tipa I, jantarjeve barve, zaprta s klorobutilnim gumijastim zamaškom in aluminijastim pokrovčkom z zaporko v kartonski škatli.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
A. PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) D. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
The safety of maropitant has not been established in dogs less than 8 weeks of age, or in cats less than 16 weeks of age, and in pregnant or lactating dogs and cats.
Varnost maropitanta ni bila dokazana pri psih, mlajših od 8 tednov, mačkah, mlajših od 16 tednov, ter pri psicah in mačkah v obdobju brejosti in laktacije.
C. STATEMENT OF THE MRLs Not applicable.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Navedba ni smiselna.
• For the treatment and prevention of nausea induced by chemotherapy.
• Za zdravljenje in preprečevanje navzeje, povzročene zaradi kemoterapije
People with known hypersensitivity to maropitant should administer the veterinary medicinal product with caution.
Osebe z znano preobčutljivostjo na maropitant naj zdravilo dajejo previdno.
In laboratory studies, maropitant has been shown to be a potential eye irritant.
V laboratorijskih raziskavah se je izkazalo, da lahko maropitant draži oči.
CYP2D15 and CYP3A12 were identified as the canine isoforms involved in the hepatic biotransformation of maropitant.
CYP2D15 in CYP3A12 sta pasji izoformi, vključeni v biotransformacijo maropitanta v jetrih.
The veterinary medicinal product should be used with caution in animals suffering from or with predisposition for cardiac diseases as maropitant has affinity to Ca- and K-ion channels.
Posebna previdnost je potrebna pri uporabi zdravila pri živalih, ki so predisponirane za kardiološke bolezni, saj ima maropitant afiniteto do Ca- in K- ionskih kanalov.
Plasma protein binding of maropitant in dogs is more than 99%.
Vezava maropitanta na plazemske proteine pri psih je več kot 99 %.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals, including isolated reports treated).
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pojavijo se pri več kot 1 živali od 10 zdravljenih živali in kažejo negativno(e) reakcijo(e)) - pogosti (pojavijo se pri več kot 1 a manj kot 10 živalih od 100 zdravljenih živali) - občasni (pojavijo se pri več kot 1 a manj kot 10 živalih od 1 000 zdravljenih živali) - redki (pojavijo se pri več kot 1 a manj kot 10 živalih od 10 000 zdravljenih živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10 000 zdravljenih živali, vključujoč posamezne primere).
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Na veterinarski recept.
To prevent vomiting, Prevomax solution for injection should be administered more than 1 hour in advance.
Za preprečevanje bruhanja dajemo Prevomax raztopino za injiciranje več kot eno uro vnaprej.
The bioavailability of maropitant after subcutaneous administration in dogs was 90.7%.
Biorazpoložljivost maropitanta po subkutanem dajanju pri psih je 90,7 %.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Produlab Pharma B.V.
A. PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca, odgovornega za sproščanje serij Produlab Pharma B.V.
ATCvet code: QA04AD90
Farmakoterapevtska skupina: antiemetiki Oznaka ATC vet: QA04AD90
The duration of effect is approximately 24 h and therefore treatment can be given the night before administration of an agent that may cause emesis, e.g. chemotherapy.
Učinek traja približno 24 ur, zato se lahko zdravilo da večer pred dajanjem zdravila, ki bi lahko povzročilo slabost, na primer pri kemoterapiji.
Renal clearance is a minor route of elimination, with less than 1% of a 1 mg/kg subcutaneous dose appearing in the urine as either maropitant or its major metabolite.
Ledvični očistek predstavlja manjši delež izločanja, saj se manj kot 1 % subkutanega odmerka 1 mg/kg izloči z urinom kot maropitant ali njegov glavni presnovek.
The efficacy of maropitant in reduction of nausea in cats was demonstrated in studies using a model (xylazine-induced nausea).
Učinkovitost maropitanta pri zmanjševanju navzeje pri mačkah so dokazali v študijah z uporabo modela (s ksilazinom povzročena navzea).
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET Z ZDRAVILOM
Vomiting can be associated with serious, severely debilitating conditions and the cause should be investigated.
Bruhanje je lahko povezano z resnimi stanji, ki žival močno izčrpajo, in treba je najti vzrok.
The efficacy of maropitant in reduction of nausea was demonstrated in studies using a model (xylazine-induced nausea).
Učinkovitost maropitanta pri zmanjševanju navzeje so dokazali v študijah z uporabo modela (s ksilazinom povzročena navzeja).
STATEMENT OF ACTIVE SUBSTANCES 10 mg/ml maropitant
NAVEDBA UČINKOVIN 10 mg/ml maropitant
Prevomax should be used with caution in animals suffering from or with predisposition for heart diseases.
Posebna previdnost je potrebna pri uporabi zdravila Prevomax pri živalih s potrjenimi boleznimi srca ali predispozicijo za bolezni srca.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated)
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pojavijo se pri več kot 1 živali od 10 zdravljenih živali in kažejo negativno(e) reakcijo(e)) - pogosti (pojavijo se pri več kot 1 a manj kot 10 živalih od 100 zdravljenih živali) - občasni (pojavijo se pri več kot 1 a manj kot 10 živalih od 1 000 zdravljenih živali) - redki (pojavijo se pri več kot 1 a manj kot 10 živalih od 10 000 zdravljenih živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
TARGET SPECIES Dogs, cats
CILJNE ŽIVALSKE VRSTE Psi, mačke
CYP1A and CYP3A-related enzymes were identified as the feline isoforms involved in the hepatic biotransformation of maropitant.
CYP1A in encimi, povezani s CYP3A, so potrjeni kot mačje izoforme, vključene v biotransformacijo maropitanta v jetrih.
EXP Once broached use within 56 days.
EXP Načeto zdravilo uporabite v 56 dneh.
Specific pharmacovigilance requirements: The PSURs for Prevomax shall be submitted at the same frequency as for Cerenia (reference product).
Za zdravilo Prevomax se poročila PSUR predložijo v enakih intervalih kot za zdravilo Cerenia (referenčno zdravilo).
The use of Prevomax solution for injection against vomiting due to motion sickness is not recommended.
Uporaba raztopine za injiciranje Prevomax za preprečevanje bruhanja zaradi vožnje ni priporočljiva.
Maropitant is metabolised in the liver and therefore should be used with caution in patients with hepatic disease.
Maropitant se metabolizira v jetrih, zato je potrebna previdna uporaba pri živalih z jetrnimi obolenji.
The use of the veterinary medicinal product against vomiting due to motion sickness is not recommended.
Uporaba zdravila za uporabo v veterinarski medicini proti bruhanju zaradi slabosti zaradi vožnje ni priporočljiva.
The bioavailability of maropitant after subcutaneous administration in cats was 91.3%.
Biorazpoložljivost maropitanta po subkutanem dajanju pri mačkah je 91,3 %.
To prevent vomiting, the veterinary medicinal product solution for injection should be administered more than 1 hour in advance.
Za preprečevanje se bruhanja daje zdravilo za uporabo v veterinarski medicini v obliki raztopine za injiciranje vsaj 1 uro vnaprej.
MARKETING AUTHORISATION NUMBER(S) EU/2/17/211/001-004 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/06/2017
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET Z ZDRAVILOM EU/2/17/211/001-004
The volume of distribution at steady-state (Vss) was 2.3 l/kg and systemic clearance was 0.51 l/h/kg.
Volumen porazdelitve v stanju dinamičnega ravnovesja (Vss) je bil 2,3 l/kg, sistemski očistek pa 0,51 l/h/kg.
TARGET SPECIES Dogs and cats.
CILJNE ŽIVALSKE VRSTE Psi in mačke
Following a single intravenous dose at 1 mg/kg the initial plasma concentration was 363 ng/ml.
Po enkratnem intravenskem odmerku 1 mg/kg je bila začetna plazemska koncentracija 363 ng/ml.
Following a single intravenous dose at 1 mg/kg the initial plasma concentration was 1040 ng/ml.
Po enkratnem intravenskem odmerku 1 mg/kg je bila začetna plazemska koncentracija 1040 ng/ml.
The pharmacokinetic profile of maropitant when administered as a single subcutaneous dose of 1 mg/kg body weight to dogs was characterised by a maximum concentration (Cmax) in plasma of approximately 92 ng/ml; this was achieved within 0.75 hours post-dosing (Tmax).
Za farmakokinetični profil maropitanta, danega psom v enkratnem subkutanem odmerku 1 mg/kg telesne mase, je značilna najvišja koncentracija (Cmax) v plazmi okoli 92 ng/ml; ta je dosežena v 0,75 ure po dajanju (Tmax).
Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t1/2) of 8.84 hours.
Vrhu koncentracije sledi upadanje sistemske izpostavljenosti z razpolovnim časom izločanja (t1/2) 8,84 ure.
The veterinary medicinal product should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to Ca-channels.
Ne uporabljajte zdravila hkrati z antagonisti Ca kanalov, saj ima maropitant afiniteto do Ca kanalov.
Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t1/2) of 16.8 hours.
Vrhu koncentracije sledi upadanje sistemske izpostavljenosti z razpolovnim časom izločanja (t1/2) 16,8 ure.
The volume of distribution at steady-state (Vss) was 9.3 l/kg and systemic clearance was 1.5 l/h/kg.
Volumen porazdelitve v stanju dinamičnega ravnovesja (Vss) je bil 9,3 l/kg, sistemski očistek pa 1,5 l/h/kg.
Following repeated subcutaneous administration of once-daily doses of 1 mg/kg bodyweight for five consecutive days, accumulation was 146%.
Pri ponavljajočem se subkutanem dajanju 5 zaporednih dni, dnevni odmerek 1 mg/kg telesne mase, je akumulacija 146 %.
The pharmacokinetic profile of maropitant when administered as a single subcutaneous dose of 1 mg/kg body weight to cats was characterised by a maximum concentration (Cmax) in plasma of approximately 165 ng/ml; this was achieved on average 0.32 hours (19 min) post-dosing (Tmax).
Za farmakokinetični profil maropitanta, danega mačkam v enkratnem subkutanem odmerku 1 mg/kg telesne mase, je značilna najvišja koncentracija (Cmax) v plazmi okoli 165 ng/ml; ta je v povprečju dosežena v 0,32 ure (19 min) po dajanju (Tmax).
Prevomax solution for injection should be injected subcutaneously or intravenously, once daily, at a dose of 1 mg of maropitant/kg body weight (1 ml/10 kg body weight).
Prevomax raztopino za injiciranje dajemo enkrat dnevno subkutano ali intravensko, v odmerku 1 mg maropitanta/kg telesne mase (1 ml/10 kg telesne mase).
Plasma protein binding of maropitant in cats was estimated to be 99.1%.
Ocenjujemo, da je vezava maropitanta na plazemske proteine pri mačkah 99,1 %.
D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
D. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Posebne zahteve glede farmakovigilance:
Maropitant is metabolised in the liver and therefore should be used with caution in dogs and cats with liver disease.
Maropitant se metabolizira v jetrih, zato je potrebna previdna uporaba pri psih z jetrnimi obolenji.
For the major metabolite 10.4% of the maropitant dose was recovered in urine and 9.3% in faeces.
V urinu najdemo 10,4 % oziroma v blatu 9,3 % njegovega glavnega presnovka.
A variety of in vitro assays have demonstrated that maropitant binds selectively at the NK1 receptor with dose-dependent functional antagonism of substance P activity.
V več in vitro poskusih je bilo dokazano, da se maropitant selektivno veže na NK1 receptor.
Intravenous administration of the veterinary medicinal product should be given as a single bolus without mixing the product with any other fluids.
Zdravilo za uporabo v veterinarski medicini je treba dajati intravensko kot posamezen bolus brez mešanja zdravila z drugimi tekočinami.
Apart from transient reactions at the injection site following subcutaneous administration, maropitant was well tolerated in dogs and young cats injected daily with up to 5 mg/kg (5 times the recommended dose) for 15 consecutive days (3-times the recommended duration of administration).
Razen prehodnih reakcij na mestu injiciranja so psi in mlade mačke dobro prenašali dnevno injiciranje odmerka maropitanta do 5 mg/kg (5× večji odmerek od priporočenega) 15 zaporednih dni (3× daljše obdobje od priporočenega).
Maropitant displays linear kinetics when administered subcutaneously within the 0.25-3 mg/kg dose range.
Maropitant kaže linearno kinetiko po subkutanem dajanju v odmerku 0,25-3 mg/kg.
Intravenous administration of Prevomax should be given as a single bolus without mixing the product with any other fluids.
Zdravilo Prevomax je treba dajati intravensko kot poseben bolus brez mešanja zdravila z drugimi tekočinami.
• For the prevention of vomiting and the reduction of nausea, except that induced by motion sickness.
• Za preprečevanje bruhanja in zmanjšanje navzeje, razen tiste, ki je posledica slabosti zaradi vožnje
The veterinary medicinal product solution for injection should be injected subcutaneously or intravenously, once daily, at a dose of 1 mg of maropitant / kg bodyweight (1 ml/10 kg bodyweight) for up to 5 consecutive days.
Zdravilo za uporabo v veterinarski medicini v obliki raztopine za injiciranje dajemo enkrat dnevno subkutano ali intravensko, v odmerku 1 mg maropitanta/kg telesne mase (1 ml/10 kg telesne mase) do 5 zaporednih dni.
Following repeated subcutaneous administration of once-daily doses of 1 mg/kg bodyweight for five consecutive days, accumulation was 250%.
Pri ponavljajočem se subkutanem dajanju 5 zaporednih dni, dnevni odmerek 1 mg/kg telesne mase, je akumulacija 250 %.
QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains:
KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml vsebuje: Zdravilna učinkovina: maropitant
Maropitant displays linear kinetics when administered subcutaneously within the 0.5-2 mg/kg dose range.
Maropitant kaže linearno kinetiko po subkutanem dajanju v odmerku 0,5-2 mg/kg.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vial
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton
PODATKI NA ZUNANJI OVOJNINI Zunanja škatla
METHOD AND ROUTE(S) OF ADMINISTRATION SC, IV
NAČIN IN POT(I) UPORABE ZDRAVILA s.c., i.v.
4.1 Target species
Ciljne živalske vrste
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
• For the prevention of vomiting except that induced by motion sickness.
• Za preprečevanje bruhanja, razen bruhanja, ki je posledica slabosti zaradi vožnje
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 1 ml contains:
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN 1 ml vsebuje: Zdravilna učinkovina: maropitant
As maropitant is accumulated in the body during a 14 day treatment period due to metabolic saturation, careful monitoring of liver function and any adverse events should be implemented during long term treatment.
Med dolgotrajnim zdravljenjem je treba skrbno spremljati delovanje jeter in druge neželene učinke, ker se maropitant zaradi saturacije presnove med 14-dnevnim zdravljenjem kopiči v telesu.
NAME OF THE VETERINARY MEDICINAL PRODUCT Prevomax 10 mg/ml solution for injection for dogs and cats
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Prevomax 10 mg/ml raztopina za injiciranje za pse in mačke
4.2 Indications for use, specifying the target species
Indikacije za uporabo pri ciljnih živalskih vrstah Psi
5.2 Pharmacokinetic particulars
Farmakokinetični podatki
PACKAGE LEAFLET: Prevomax 10 mg/ml solution for injection for dogs and cats
NAVODILO ZA UPORABO: Prevomax 10 mg/ml raztopina za injiciranje za pse in mačke
NAME OF THE VETERINARY MEDICINAL PRODUCT Prevomax 10 mg/ml solution for injection for dogs and cats maropitant
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Prevomax 10 mg/ml raztopina za injiciranje za pse in mačke maropitant
The responsible veterinarian should make a benefit-risk assessment before using the veterinary medicinal product in dogs less than 8 weeks of age, or in cats less than 16 weeks of age, or in pregnant or lactating bitches and cats.
Pri psih, mlajših od 8 tednov, mačkah, mlajših od 16 tednov ter pri psicah in mačkah v obdobju brejosti in laktacije uporabite le v skladu z oceno koristi odgovornega veterinarja.
EXPIRY DATE EXP {month/year} Once broached use within 56 days.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
Prevomax must not be mixed with other veterinary medicinal products in the same syringe as its compatibility with other products has not been tested.
Zaradi pomanjkanja študij kompatibilnosti zdravila Prevomax ne smemo v isti brizgi mešati z drugimi zdravili za uporabo v veterinarski medicini.
ROUTE(S) OF ADMINISTRATION SC, IV
POT(I) UPORABE ZDRAVILA s.c., i.v.
(3 weeks)
(3 tedne)
If this happens, do not drive or use any tools or machines until you are feeling well again.
Če pride do tega, ne vozite in ne upravljajte nobenih naprav ali strojev, dokler se ne počutite spet
Follow all your doctor's instructions carefully, even if they differ from the general information contained in
Skrbno se ravnajte po vseh navodilih vašega zdravnika, tudi če se razlikujejo od splošnih informacij v
Results are provided in Table 5.
Rezultati so prikazani v preglednici 5.
* Full follow-up period; NE - Not estimable
* celotno obdobje spremljanja; NO - ni mogoče oceniti
ULN = upper limit of normal for the institution
IULN = zgornja meja normalnih vrednosti, specifična za ustanovo
The median overall survival has not been reached.
Mediano celotno preživetje ni bilo doseženo.
The Kaplan-Meier estimate for survival after 36-month follow-up is 68%.
KaplanMeierjeva ocena za preživetje po 36-mesečnem spremljanju je 68 %.
could cause hepatitis B to become active again, which can be fatal in some cases.
namreč lahko povzroči ponovno aktivacijo hepatitisa B, kar utegne biti v nekaterih primerih smrtno nevarno.
There were no differences in response rates between the two dose groups.
Med obema skupinama z različnima odmerkoma ni bilo razlik v odzivnosti.