natgillin/translations-raw huggingface dataset:
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Aripiprazole Mylan.
Zato je CHMP v času umika menil, da družba ni predložila zadostnih podatkov v podporo vlogi za zdravilo Aripiprazole Mylan.
Aripiprazole Mylan was developed as a ‘generic medicine'.
Zdravilo Aripiprazole Mylan je bilo razvito kot „generično zdravilo“.
This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but it has a weaker effect than the natural neurotransmitters.
To pomeni, da aripiprazol z aktiviranjem teh receptorjev deluje kot dopamin in 5-hidroksitriptamin, vendar šibkeje kot naravni živčni prenašalci.
agonist' on the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
domnevno deluje kot „delni agonist“ na receptorje za živčna prenašalca dopamin in 5-hidroksitriptamin (imenovanega tudi serotonin).
Because Aripiprazole Mylan is a generic medicine, the company had presented results of studies in volunteers to show that Aripiprazole Mylan 10-mg tablet and the 10-mg orodispersible tablet were bioequivalent to the corresponding tablets of the reference medicine, Abilify.
Ker je Aripiprazole Mylan generično zdravilo, je družba predložila rezultate študij, izvedenih na prostovoljcih, da bi dokazala, da so 10-miligramske tablete in 10-miligramske orodisperzibilne tablete zdravila Aripiprazole Mylan biološko enakovredne ustreznim tabletam referenčnega zdravila Abilify.
The CHMP considered that the dissolution tests required for the biowaiver had not been carried out according to existing recommendations and thus, bioequivalence for all the different strengths of tablets and orodispersible tablets had not been demonstrated.
Prav tako je menil, da preiskave raztapljanja, potrebne za opustitev izvedbe študij biološke enakovrednosti, niso bile izvedene v skladu z obstoječimi priporočili in tako ni bila dokazana biološka enakovrednost za različne jakosti tablet in orodisperzibilnih tablet.
Aripiprazole's action alters dopamine and 5-hydroxytryptamine activity, which is abnormal in schizophrenia and bipolar disorder.
Zaradi delovanja aripiprazola se spremeni tudi aktivnost dopamina in 5-hidroksitriptamina, kar je pri shizofreniji in bipolarni motnji nenormalno.
What is Aripiprazole Mylan?
Kaj je zdravilo Aripiprazole Mylan?
Aripiprazole Mylan is a medicine that contains the active substance aripiprazole.
Aripiprazole Mylan je zdravilo, ki vsebuje zdravilno učinkovino aripiprazol.
Based on the review of the data, at the time of the withdrawal, the CHMP was of the provisional opinion that Aripiprazole Mylan could not have been approved for the treatment of schizophrenia and for the treatment and prevention of manic episodes in patients with bipolar I disorder.
Na podlagi pregleda podatkov je Odbor v času umika začasno menil, da zdravila Aripiprazole Mylan ni mogoče odobriti za zdravljenje shizofrenije ter zdravljenje in preprečevanje maničnih epizod pri bolnikih z bipolarno motnjo I.
On 8 January 2016, Mylan S.A.S.
Družba Mylan S.A.S.
To support an application for a ‘biowaiver', the company also presented laboratory tests to show that other strengths of Aripiprazole Mylan tablets dissolve in an identical way to the reference medicine.
V podporo vlogi za „opustitev izvedbe študij biološke enakovrednosti“ je družba predložila tudi laboratorijske preiskave, da bi dokazala, da se tablete zdravila Aripiprazole Mylan drugačnih jakosti raztopijo na enak način kot referenčno zdravilo.
The active substance in Aripiprazole Mylan, aripiprazole, is an antipsychotic medicine.
Zdravilna učinkovina v zdravilu Aripiprazole Mylan, aripiprazol, je antipsihotik.
officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Aripiprazole Mylan, for the treatment of schizophrenia and the treatment and prevention of manic episodes in patients with bipolar I disorder.
je dne 8. januarja 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Aripiprazole Mylan, namenjenim zdravljenju shizofrenije ter zdravljenju in preprečevanju maničnih epizod pri bolnikih z bipolarno motnjo I.
The biowaiver removes the need to repeat bioequivalence studies for all the other strengths of Aripiprazole Mylan tablets.
Zaradi opustitve izvedbe študij biološke enakovrednosti teh ni več treba ponoviti za vse ostale jakosti tablet zdravila Aripiprazole Mylan.
The CHMP considered that the tests to support a biowaiver were not acceptable.
Menil je, da preiskave, predložene v podporo opustitve izvedbe študij biološke enakovrednosti, niso sprejemljive.
How is Aripiprazole Mylan expected to work?
Kako naj bi zdravilo Aripiprazole Mylan delovalo?
What was Aripiprazole Mylan expected to be used for?
Za kaj naj bi se zdravilo Aripiprazole Mylan uporabljalo?
These clinical signs disappear within 7 days without any particular treatment.
Ti klinični znaki izginejo brez kakršne koli posebne terapije v sedmih dneh.
were commonly observed in safety studies.
so se prav tako pogosto pojavili v študijah varnosti.
These parameters return to normal in the week following the last injection.
Ti parametri se vrnejo na običajne v roku tedna dni po zadnji injekciji.
The use of supplementary supportive treatments improves prognosis.
Uporaba dodatnih podpornih zdravljenj izboljša prognozo.
Date of first autorisation: 06.11.2001 / Date of last renewal: 21.11.2006
Datum pridobitve dovoljenja za promet: 06.11.2001 / Datum zadnjega podaljšanja dovoljenja za promet: 21.11.2006.
Detailed information on this product is available on the website of the European Medicines Agency http://emea.europa.eu/.
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.emea.europa.eu/).
After injection it is quickly bound to specific receptors of a large variety of cells.
Po injiciranju se hitro veže na specifične receptorje raznolikih celic.
EXP: {month/year}
EXP {mesec/leto}
*MU : Million Units
*ME: milijonov enot
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
Dispose of waste material in accordance with local requirements.
Odpadne snovi odstranite v skladu z lokalnimi zahtevami.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ali uporabo zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
Do not use after the expiry date stated on the label.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki.
Three separate 5-day treatments must be performed at day 0, day 14 and day 60.
Izvesti se morajo tri ločena 5-dnevna zdravljenja z začetkom na 0., 14. in 60. dan.
• in anaemic cats, mortality rate of about 60% at 4, 6, 9 and 12 months was reduced by approximately 30% following treatment with interferon.
• pri anemičnih mačkah z okrog 60 % stopnjo smrtnosti pri 4, 6, 9 in 12 mesecih je zdravljenju z interferonom sledilo zmanjšanje smrtnosti za približno 30 %.
Lyophilisate: white pellet.
Liofilizat: bele pelete.
Interaction with other medicinal products and other forms of interaction
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
• slight increase of body temperature.
• rahlo povečanje telesne temperature
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
b) bolezen, za katero se z zdravilom za uporabo v veterinarski medicini pridobi imunost, na območju skoraj ni prisotna.
Overdose (symptoms, emergency procedures, antidotes)
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi)
The product should be used with the accompanying solvent only.
Izdelek je treba uporabljati samo s priloženim vehiklom.
Do not freeze.
Zaščitite pred zamrznitvijo.
No information is available on the safety and efficacy from the concurrent use of this product with any vaccine.
Ni podatkov o varnosti ter učinkovitosti ob sočasni uporabi tega zdravila s katerim koli cepivom.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN(E)
Sodium chloride Water for injections
Vehikel: natrijev klorid voda za injekcije
Such side effects have been described after multiple and long-term administration of type I interferon in man.
Takšni stranski učinki so bili opisani pri ljudeh po večkratnem in dolgotrajnem dajanju interferona tipa I .
SPECIAL WARNING(S) Special warnings for each target species
POSEBNO(A) OPOZORIL(O)A Posebna opozorila za vsako ciljno živalsko vrsto
Solvent: colourless liquid.
Vehikel: brezbarvna tekočina.
However, as specific information on possible interactions of interferon with other products are missing, supplementary supportive treatments should be used cautiously and after a thorough risk/benefit analysis.
Vendar manjkajo specifične informacije o možni interakciji interferona z drugimi izdelki, zato je pri uporabi dodatnih podpornih zdravjenj potrebna previdnost, ter natančna analiza koristi in tveganja.
In cats infected by FIV, mortality was low (5%) and was not influenced by the treatment.
Pri mačkah okuženih s FIV je bila smrtnost nizka (5 %) in zdravljenje z interferonom nanjo ni vplivalo.
Interferon does not act directly and specifically on the pathogenic virus, but exerts its effect by inhibition of the internal synthesis mechanisms of the infected cells.
Interferon ne deluje neposredno in specifično na virus, ki bolezen povzroča, ampak je njegovo delovanje usmerjeno na inhibiranje znotrajceličnih mehanizmov sinteze v okuženih celicah.
Dogs and cats: it was shown that strict compliance with the recommended posology is compulsory to achieve clinical benefit.
Psi in mačke: dokazano je bilo, da je za klinično učinkovitost obvezno strogo upoštevanje priporočene posologije.
Store in the original carton.
Shranjujte v originalni ovojnini.
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the product.
Ne mešajte z nobenim drugim veterinarskim zdravilom za uporabo v veterinarski medicini, razen z vehiklom, ki je priložen.
VIRBAGEN OMEGA Solvent for suspension for injection
VIRBAGEN OMEGA Vehikel za suspenzijo za injiciranje
Sodium hydroxide 0.2 M Sodium chloride D-Sorbitol
Liofilizat: natrijev hidroksid 0,2 M natrijev klorid D-sorbitol prečiščena želatina prašičjega porekla
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 treated, including isolated reports)
- pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali)
Type I glass vial closed with stopper made with butyl rubber polymer coated with a fluorocarbon polymer resin.
Viala iz stekla tipa I z zamaškom iz gumijastega butilnega polimera, prevlečenim s polimerno fluoroogljikovo smolo.
For dogs, it is recommended that no vaccines should be administered until the animal appears to have recovered.
Za pse se odsvetuje dajanje kakršnega koli cepiva, dokler žival ne okreva.
• in non-anaemic cats, mortality rate of 50 % in cats infected by FeLV was reduced by 20% following treatment with interferon.
• pri mačkah, ki niso bile anemične, je 50 % stopnji smrtnosti pri mačkah okuženih s FeLV po zdravljenju z interferonom sledilo zmanjšanje smrtnosti za 20 %.
The exact mechanism of action of interferon omega is not perfectly known, but may involve enhancement of the non-specific defence of the body, in particular in the dog against canine parvovirosis and in the cat against feline retrovirosis (FeLV, FIV).
Natančen mehanizem delovanja interferona omega ni popolnoma znan, verjetno pa vključuje izboljšanje nespecifične obrambe organizma pri psih zlasti proti pasji parvovirozi in pri mačkah proti mačji levkozi (FeLV) in mačjem imunosupresivnem virusu (FIV).
A slight decrease in white blood cells, platelets and red blood cells, and rise in the concentration of alanine aminotransferase were observed very commonly in safety studies.
V študijah varnosti je bilo zelo pogosto opaziti rahlo znižanje števila belih krvničk, trombocitov in rdečih krvničk, ter povečanje koncentracije alanin aminotransferaze.
Each dose of 1 ml contains:
Vsak 1 ml odmerek vsebuje:
In a field study conducted, it was observed that there was: - a reduction of clinical signs during the symptomatic phase (4 months) - a reduction of mortality :
V terenski raziskavi so ugotovili: - zmanjšanje kliničnih znakov med simptomatsko fazo (4 mesece) - zmanjšanje smrtnosti:
Slight and transient clinical signs such as hyperthermia (3-6 hours after injection) lethargy and digestive signs (vomiting and soft faeces to mild diarrhoea, in cats only. )
Rahli in prehodni klinični znaki, kot so hipertermija (3-6 ur po injiciranju), letargičnost in težave s prebavo (bruhanje in mehko blato do blaga diareja, samo pri mačkah.)
The possibility of occurrence of autoimmune disorders in treated animals cannot therefore be ruled out and has to be balanced with the risk associated with FeLV/FIV infections.
Zaradi tega možnosti pojava avtoimunskih bolezni pri zdravljenih živalih ni mogoče izključiti in jo moramo oceniti tveganje, ki ga predstavljata okužbi s FeLV/FIV.
Dogs: Vaccination during and after VIRBAGEN OMEGA treatment is contra-indicated, until the dog appears to have recovered.
Psi: cepljenje med in po terapiji z zdravilom VIRBAGEN OMEGA je kontraindicirano, dokler se ne zdi, da je pes okreval.
Omega interferon of feline origin, produced by genetic engineering, is a type Ι interferon closely related to alpha interferon.
5.1 Farmakodinamične lastnosti Omega interferon mačjega izvora, proizveden z genskim inžineringom, je interferon tipa I soroden interferonu alfa.
No interaction has been observed during the treatment with VIRBAGEN OMEGA together with antibiotics, solution for rehydration, vitamins and non steroidal anti-inflammatory agents.
Interakcija med zdravljenjem z zdravilom VIRBAGEN OMEGA ni bila opažena, kar velja tudi za antibiotike, raztopino za rehidracijo, vitamine in ne-steroidna sredstva proti vnetju.
The import, possession, sale, supply and/or use of this veterinary medicinal product may be prohibited in a Member State on the whole or part of its territory, see package leaflet for further information.
Uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba tega zdravila je lahko v državi članici prepovedana na njenem celotnem ozemlju ali delu ozemlja; za nadaljnje informacije glej navodilo za uporabo.
Reduction of mortality and clinical signs of parvovirosis (enteric form) in dogs from one month of age.
Zmanjšanje smrtnosti in kliničnih znakov parvoviroze (črevesne oblike) pri psih, starejših od enega meseca.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali nalepko na zunanji ovojnini.
No information on the induction of long-term side effects is available in dog and cat, especially for autoimmune disorders.
O pojavljanju dolgotrajnih stranskih učinkov, zlasti avtoimunskih bolezni pri psih in mačkah, ni podatkov.
In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician.
V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
After a tenfold overdose in both dog and cat the following clinical signs have been observed:
Po desetkratnem predoziranju so se pri psih in pri mačkah pojavili naslednji klinični znaki:
10 MU*
10 ME*
06516 Carros, France
06516 Carros, Francija
Cats: Treatment of cats infected with FeLV and/or FIV, in non-terminal clinical stages, from the age of 9 weeks.
Mačke: Zdravljenje mačk okuženih s FeLV in/ali FIV v kliničnem stadiju, ki ni terminalen, starejših od 9
Pharmacotherapeutic group: Interferons ATCvet code : QL03AB
Oznaka ATC vet: QL03AB.
STATEMENT OF ACTIVE SUBSTANCES Each dose of 1 ml contains:
NAVEDBA UČINKOVIN(E) Vsak 1 ml odmerek vsebuje:
4.4 Special warnings for each target species
Posebna opozorila za vsako ciljno živalsko vrsto
Efficacy of the product on cats with a tumorous form of the infection by FeLV, or cats infected by FeLV or coinfected by FIV in terminal stages was not tested.
Učinkovitosti izdelka pri mačkah s tumorozno obliko okužbe s FeLV, mačkah okuženih s FeLV ali v primeru sočasne okužbe s FIV v terminalnem stadiju niso testirali.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PROIZVAJALEC ZDRAVILA, ODGOVORNEGA ZA SPROŠČANJE SERIJ, ČE STA
5 MU*
5 ME*
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Pregnancy and lactation
Brejost in laktacija
It is mainly in cells infected by virus that the mechanism of replication is stopped both by destruction of mRNA and by inactivation of translation proteins (2'5' oligo-adenylate synthetase activation).
Ustavi se mehanizem replikacije, pretežno v celicah okuženih z virusom, z uničenjem mRNA in z inaktivacijo translacijskih proteinov
Solvent: Type I glass vial of 1 ml of solvent closed with butyl elastomer rubber stopper.
Vehikel: Viala iz stekla tipa I z 1 ml vehikla z gumijastim zamaškom iz butilnega elastomera.
Cat vaccination during and after VIRBAGEN OMEGA treatment is contra-indicated as both FeLV and FIV infections are known to be immunosuppressive.
Pri mačkah je cepljenje med in po zdravljenju z VIRBAGEN OMEGA kontraindicirano, saj tako FeLV, kot FIV infekcije lahko zavirajo imunski sistem.
EXP: {month/year} Once reconstituted use immediately.
EXP {mesec/leto} Rekonstituirano zdravilo uporabite takoj.
Cats: as vaccination is contra-indicated in the symptomatic phase of FeLV/FIV infections, the effect of VIRBAGEN OMEGA on cat vaccination has not been evaluated.
Mačke: ker je cepljenje v simptomatski fazi okužbe s FeLV/FIV kontraindicirano, vpliv zdravila VIRBAGEN OMEGA na cepljenje mačk ni bil ocenjen.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
VIRBAGEN OMEGA 10 MU for dogs and cats
VIRBAGEN OMEGA 10 ME za pse in mačke
Any person intending to import, sell, supply and/or use VIRBAGEN OMEGA must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Vsakdo, ki namerava proizvajati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in uporabljati to zdravilo, se mora najprej posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja, saj so lahko te dejavnosti prepovedane v državi članici na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
In the case of intravenous administration in cats, increased adverse reactions may be seen, e.g. hyperthermia, soft faeces, anorexia, decreased drinking or collapse.
hipertermija, mehko blato, anoreksija, zmanjšano pitje in kolaps.
VIRBAGEN OMEGA 5 MU for dogs and cats VIRBAGEN OMEGA 10 MU for dogs and cats
VIRBAGEN OMEGA 5 ME za pse in mačke VIRBAGEN OMEGA 10 ME za pse in mačke
06516 CARROS France
06516 CARROS Francija
Recombinant Omega interferon of feline origin
rekombinant omega interferon mačjega izvora
VIRBAGEN OMEGA 5 MU for dogs and cats
VIRBAGEN OMEGA 5 ME za pse in mačke
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
B. POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA ZUNANJI OVOJNINI
Once reconstituted use immediately.
Rekonstituirano zdravilo uporabite takoj.
For the 10MU presentation:
Jakost zdravila 10 ME:
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
Dogs: The dose is 2.5 MU/kg bodyweight.
Psi: odmerek je 2,5 ME/kg telesne mase.
Cats: In case of repeated treatments of chronic diseases associated with hepatic, cardiac and renal failure, the corresponding disease has to be monitored prior to administration of VIRBAGEN OMEGA.
Mačke: V primeru ponavljajočih se zdravljenj kroničnih bolezni, povezanih z odpovedjo jeter, srca ali ledvic, je pred dajanjem zdravila VIRBAGEN OMEGA obvezno nadzorovanje dotične bolezni.
• slight increase of respiratory rate
• nekoliko pospešeno dihanje
Name and address of the manufacturer responsible for batch release
Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega za sproščanje serije VIRBAC
• slight sinus tachycardia.
• blaga sinusna tahikardija
Marketing authorisation holder and manufacturer responsible for batch release
Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij
Dogs: The reconstituted product should be injected intravenously once daily for 3 consecutive days.
Psi: Rekonstituirano zdravilo je treba injicirati intravensko enkrat na dan 3 dni zapored.
The dose is 2.5 MU/kg bodyweight.
Odmerek je 2,5 ME/kg telesne mase.
The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain a suspension containing 5 MU of recombinant interferon.
Liofilizirano frakcijo je treba rekonstituirati z 1 ml specifičnega vehikla, da dobimo suspenzijo s 5 ME
The reconstituted product should be injected intravenously once daily for 3 consecutive days.
Rekonstituirano zdravilo je treba injicirati intravensko enkrat na dan 3 dni zapored.
The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain a solution containing 10 MU of recombinant interferon.
Liofilizirano frakcijo je treba rekonstituirati z 1 ml specifičnega vehikla, da dobimo suspenzijo z 10
Cats: The dose is 1 MU/kg bodyweight.
Mačke: odmerek je 1 ME/kg telesne mase.
Cats: The reconstituted product should be injected subcutaneously once daily for 5 consecutive days.
Mačke: Rekonstituirano zdravilo je treba injicirati subkutano enkrat na dan 5 dni zapored.
Dogs: Intravenous route Cats: Subcutaneous route
Psi: intravenska uporaba.
Recombinant Omega interferon of feline origin 5 MU*/ ml * MU: Million Units
KOLIČINA UČINKOVIN(E) Rekombinantni omega interferon mačjega izvora 5 ME* / ml
Box containing 5 vials of lyophilisate and 5 vials with 1 ml of solvent.
Škatla s 5 vialami liofilizata in 5 vialami po 1 ml vehikla.