natgillin/translations-raw huggingface dataset:
This vaccine is the same as the Celvapan H5N1 mock-up vaccine, which was previously authorised in the European Union (EU).
Cepivo je enako modelnemu cepivu Celvapan H5N1, ki je že bilo odobreno v Evropski uniji (EU).
The full EPAR for Pandemic Influenza Vaccine H5N1 Baxter AG can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Pandemic Influenza Vaccine H5N1 Baxter AG je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
At 21 days after the second injection, 72% of the adults below 60 years of age (192 out of 265) and 74% of those above 60 years of age (200 out of 270) had levels of antibodies that would protect them against H5N1.
Na 21. dan po drugi injekciji so pri 72 % (192 od 265) odraslih, mlajših od 60 let, in 74 % (200 od 270) oseb, starejših od 60 let, nastale ravni protiteles, ki bi jih ščitile pred virusom H5N1.
When the company that makes Pandemic Influenza Vaccine H5N1 Baxter AG includes the flu strain responsible for a pandemic in the vaccine, it will collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Ko bo družba, ki izdeluje cepivo Pandemic Influenza Vaccine H5N1 Baxter AG, vanj vključila sev gripe, odgovoren za pandemijo, bo zbrala informacije o varnosti in učinkovitosti končnega pandemičnega cepiva in jih predložila CHMP v oceno.
This vaccine contains a virus called H5N1 that has been inactivated (killed) so that it does not cause any disease.
Cepivo vsebuje inaktivirani (uničeni) virus H5N1, ki ne povzroča nobene bolezni.
The second main study involved 305 children aged 9 to 17 years, 306 aged 3 to 8 years and 73 aged 6 to 35 months, and also examined the effect of two 7.5 microgram doses of the vaccine 21 days apart.
V drugi glavni študiji, v katero je bilo vključenih 305 otrok, starih 9 do 17 let, 306 otrok, starih 3 do 8 let, in 73 otrok, starih 6 do 35 mesecev, so tudi proučevali učinek dveh 7,5-mikrogramskih odmerkov cepiva, injiciranih v razmiku 21 dni.
For more information about treatment with Pandemic Influenza Vaccine H5N1 Baxter AG, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Pandemic Influenza Vaccine H5N1 Baxter AG preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Pandemic Influenza Vaccine H5N1 Baxter AG in adults (seen in more than 1 person in 10) are headache, fatigue (tiredness) and pain at the site of the injection.
Najpogostejši neželeni učinki zdravila Pandemic Influenza Vaccine H5N1 Baxter AG pri odraslih (opaženi pri več kot 1 osebi od 10) so glavobol, utrujenost in bolečina na mestu injiciranja.
This is a summary of the European public assessment report (EPAR) for Pandemic Influenza Vaccine H5N1 Baxter AG.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pandemic Influenza Vaccine H5N1 Baxter AG.
The European Commission granted a marketing authorisation valid throughout the European Union for Pandemic Influenza Vaccine H5N1 Baxter AG on 16 October 2009.
Evropska komisija je dovoljenje za promet z zdravilom Pandemic Influenza Vaccine H5N1 Baxter AG, veljavno po vsej Evropski uniji, odobrila dne 16. oktobra 2009.
The CHMP decided that Pandemic Influenza Vaccine H5N1 Baxter AG's benefits are greater than its risks in all age groups investigated and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Pandemic Influenza Vaccine H5N1 Baxter AG pri vseh proučevanih starostnih skupinah večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The company that made the Celvapan H5N1 mock-up vaccine has agreed that its scientific data can be used for Pandemic Influenza Vaccine H5N1 Baxter AG (‘informed consent').
Družba, ki proizvaja modelno cepivo Celvapan H5N1, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za cepivo Pandemic Influenza Vaccine H5N1 Baxter AG („uporaba dokumentacije s soglasjem“).
Similarly in children, after the second 7.5-microgram dose, 85% of children aged 9 to 17 years, 73% of those 3 to 8 years, and 69% of those aged 6 to 35 months had protective levels of antibodies 21 days after the second injection.
Podobno je bilo pri otrocih, kjer so 21 dni po drugem 7,5-mikrogramskem odmerku zaščitne ravni protiteles nastale pri 85 % otrok, starih 9 do 17 let, 73 % otrok, starih 3 do 8 let, in 69 % otrok, starih 6 do 35 mesecev.
A flu pandemic happens when a new type (strain) of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Do pandemije gripe pride, ko se pojavi novi sev virusa gripe, ki se med ljudmi hitro širi, ker proti njemu niso imuni (zaščiteni).
Pandemic Influenza Vaccine H5N1 Baxter AG is given by injection into the shoulder muscle or thigh in two doses, at least three weeks apart.
Cepivo Pandemic Influenza Vaccine H5N1 Baxter AG se injicira v hrbtno mišico ali stegno v dveh odmerkih v razmiku najmanj treh tednov.
The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
Ob ponovni izpostavitvi virusu jih bo imunski sitem tako tvoril hitreje.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pandemic Influenza Vaccine H5N1 Baxter AG, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Pandemic Influenza Vaccine H5N1 Baxter AG in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The viruses used in Pandemic Influenza Vaccine H5N1 Baxter AG are grown in mammal cells (‘vero cells'), unlike those in some other flu vaccines, which are grown in hen's eggs.
Viruse, ki so uporabljeni v zdravilu Pandemic Influenza Vaccine H5N1 Baxter AG, gojijo v celicah sesalcev („celicah Vero“), medtem ko viruse, uporabljene v nekaterih drugih cepivih proti gripi, gojijo v kokošjih jajcih.
The study looked at the ability of two 7.5 microgram doses of the vaccine, given 21 days apart, to trigger the production of antibodies (‘immunogenicity').The main measures of effectiveness were the levels of antibodies against the flu virus in the blood before vaccination, on the day of the second injection (day 21), and 21 days after the second vaccination (day 42).
Glavna merila učinkovitosti so bile koncentracije protiteles proti virusu gripe v krvi bolnikov pred cepljenjem, na dan drugega injiciranja (21. dan) in 21 dni po drugem cepljenju (42. dan).
The study showed that Pandemic Influenza Vaccine H5N1 Baxter AG produced an antibody response that met these criteria.
Študija je pokazala, da je cepivo Pandemic Influenza Vaccine H5N1 Baxter AG izzvalo odziv protiteles, ki izpolnjuje ta merila.
What measures are being taken to ensure the safe and effective use of Pandemic Influenza Vaccine H5N1 Baxter AG?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pandemic Influenza Vaccine H5N1 Baxter AG?
For the full list of all side effects reported with Pandemic Influenza Vaccine H5N1 Baxter AG, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Pandemic Influenza Vaccine H5N1 Baxter AG, glejte navodilo za uporabo.
Pandemic Influenza Vaccine H5N1 Baxter AG has been authorised under ‘Exceptional Circumstances'.
Cepivo Pandemic Influenza Vaccine H5N1 Baxter AG je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pandemic Influenza Vaccine H5N1 Baxter AG.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Pandemic Influenza Vaccine H5N1 Baxter AG, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What benefit has Pandemic Influenza Vaccine H5N1 Baxter AG shown during the studies?
Kakšne koristi je zdravilo Pandemic Influenza Vaccine H5N1 Baxter AG izkazalo med študijami?
Pandemic Influenza Vaccine H5N1 Baxter AG is a vaccine that is given by injection.
Pandemic Influenza Vaccine H5N1 Baxter AG je cepivo, ki se daje z injekcijo.
A risk management plan has been developed to ensure that Pandemic Influenza Vaccine H5N1 Baxter AG is used as safely as possible.
Za zagotovitev čim varnejše uporabe cepiva Pandemic Influenza Vaccine H5N1 Baxter AG je bil pripravljen načrt obvladovanja tveganj.
Pandemic Influenza Vaccine H5N1 Baxter AG is a vaccine to prevent ‘pandemic' flu.
Pandemic Influenza Vaccine H5N1 Baxter AG je cepivo, ki se uporablja za preprečevanje pandemične gripe.
Baxter AG will have to be replaced by the strain causing the pandemic before the vaccine can be used.
Med pandemijo bo treba sev virusa v cepivu Pandemic Influenza Vaccine H5N1 Baxter AG nadomestiti s sevom, ki povzroča pandemijo, preden bo cepivo mogoče uporabiti.
Other information about Pandemic Influenza Vaccine H5N1 Baxter AG
Druge informacije o zdravilu Pandemic Influenza Vaccine H5N1 Baxter AG
Why has Pandemic Influenza Vaccine H5N1 Baxter AG been approved?
Zakaj je bilo zdravilo Pandemic Influenza Vaccine H5N1 Baxter AG odobreno?
What is the risk associated with Pandemic Influenza Vaccine H5N1 Baxter AG?
Kakšna tveganja so povezana z zdravilom Pandemic Influenza Vaccine H5N1 Baxter AG?
Pandemic Influenza Vaccine H5N1 Baxter AG is a ‘mock-up' vaccine.
Pandemic Influenza Vaccine H5N1 Baxter AG je modelno cepivo.
What is Pandemic Influenza Vaccine H5N1 Baxter AG?
Kaj je zdravilo Pandemic Influenza Vaccine H5N1 Baxter AG?
What is Pandemic Influenza Vaccine H5N1 Baxter AG used for?
Za kaj se zdravilo Pandemic Influenza Vaccine H5N1 Baxter AG uporablja?
How does Pandemic Influenza Vaccine H5N1 Baxter AG work?
Kako zdravilo Pandemic Influenza Vaccine H5N1 Baxter AG deluje?
How is Pandemic Influenza Vaccine H5N1 Baxter AG used?
Kako se zdravilo Pandemic Influenza Vaccine H5N1 Baxter AG uporablja?
How has Pandemic Influenza Vaccine H5N1 Baxter AG been studied?
Kako je bilo zdravilo Pandemic Influenza Vaccine H5N1 Baxter AG raziskano?
Do not breach the vial more than 50 times.
Viale ne prebodite več kot 50-krat.
150 mg For the full list of excipients, see section 6.1.
150 mg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Date of first authorisation: 18.08.2011 Date of last renewal: 21.06.2016
Datum pridobitve dovoljenja za promet: 18. 8. 2011 Datum zadnjega podaljšanja dovoljenja za promet: 21.06.2016
Treatment of calves with Emdocam 20 minutes before dehorning reduces post-operative pain.
Zdravljenje telet z zdravilom Emdocam 20 minut pred odstranitvijo rogov zmanjša pooperativno bolečino.
15 days;
15 dni;
Cattle: S.C., I.V.
Govedo: s.c., i.v.
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Za pomožne snovi, navedene v poglavju 6.1 SPC , tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.
Približno 50 % vnesenega odmerka se izloči z urinom, preostanek pa z blatom.
Emdocam alone will not provide adequate pain relief during the dehorning procedure.
Samo zdravilo Emdocam ne zagotavlja ustreznega lajšanja bolečine med postopkom odstranjevanja rogov.
Name and address of the manufacturer responsible for batch release Produlab Pharma bv
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije Produlab Pharma bv
In horses, a transient swelling at the injection site can occur but resolves without intervention.
Pri konjih se lahko na mestu injiciranja pojavi prehodna oteklina, ki mine brez intervencije.
MANUFACTURER´S BATCH NUMBER
IZDELOVALČEVA ŠTEVILKA SERIJE
DD.MM.YYYY
DD.MM.LLLL
THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN
Overdose (symptoms, emergency procedures, antidotes): In case of overdose, symptomatic treatment should be initiated.
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Pri prevelikem odmerjanju uvedite simptomatsko zdravljenje.
People with known hypersensitivity to Non-Steroidal AntiInflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila (NSAID) naj se izogibajo stiku z zdravilom.
Meloxicam is predominantly found in plasma.
Presnavljanje Meloksikam se pretežno nahaja v plazmi.
Meloxicam in Emdocam 20 mg/ml solution for injection for cattle, pigs and horses is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Meloksikam v zdravilu Emdocam 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje, kot je navedeno v tabeli 1( dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010, je dovoljena učinkovina:
Clear yellow solution.
Prozorna rumena raztopina.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - 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 (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - 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) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).>
To a minor extent it also inhibits collagen-induced thrombocyte aggregation.
V manjši meri zavira agregacijo trombocitov, ki jo povzroča kolagen.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.
Za zmanjšanje kliničnih znakov driske, v kombinaciji s peroralnim rehidracijskim zdravljenjem, pri teletih, starejših od enega tedna, in mladem govedu, ki ni v obdobju laktacije.
Not authorised for use in horses producing milk for human consumption.
5 dni Ni dovoljena uporaba pri konjih, katerih mleko je namenjeno prehrani ljudi.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
B. POGOJI DOVOLJENJA TER OMEJITVE GLEDE OSKRBE IN UPORABE
Meloxicam 20 mg/ml
meloksikam 20 mg/ml
Marketing authorisation holder Emdoka bvba
Imetnik dovoljenja za promet z zdravilom Emdoka bvba
Any unused medicines should not be disposed of via wastewater or household waste.
Ne odvrzite zdravila v odpadno vodo ali <med gospodinjske odpadke.
Shelf-life after first opening of the container: 28 days.
Rok uporabnosti po prvem odpiranju vsebnika: 28 dni.
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
Za zmanjšanje simptomov šepavosti in vnetja pri neinfekcijskih lokomotornih motnjah.
Cattle, pigs and horses
govedo, prašiči in konji
After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 µg/ml was reached after 1 hour in pigs.
Po dveh intramuskularnih odmerkih meloksikama po 0,4 mg/kg je znašala Cmax pri prašičih po 1 uri 1,9 µg/ml.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE OUTER CARTON - 50, 100 or 250 ml vials
ZUNANJA KARTONSKA ŠKATLA - viale s 50, 100 ali 250 ml
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues of 2.1 µg/ml and 2.7 µg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
Po enkratnem subkutanem odmerku meloksikama po 0,5 mg/kg je znašala Cmax pri mladem govedu in kravah v obdobju laktacije 2,1 µg/ml in 2,7 µg/ml po 7,7 ure in 4 urah.
Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively.
Razpolovna doba izločanja meloksikama je po subkutani injekciji pri mladem govedu in kravah v obdobju laktacije 26 in 17,5 ure.
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant medicinal products.
Zdravila ne smete dajati hkrati z glukokortikosteroidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulantnimi zdravili.
NL-4941 SJ Raamsdonksveer The Netherlands
Produlab Pharma bv NL-4941 SJ Raamsdonksveer Nizozemska
For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo-skeletal disorders, a suitable oral therapy containing meloxicam, administered in accordance with label recommendations, may be used for continuation of treatment.
Pri umirjanju vnetja in lajšanju bolečine pri akutnih in kroničnih mišično-skeletnih obolenjih lahko za nadaljevanje zdravljenja uporabimo ustrezno peroralno zdravljenje, ki vsebuje meloksikam in se daje v skladu z navodili za uporabo.
Ethanol (96%) Poloxamer 188
etanol (96 %)
4.7 Use during pregnancy, lactation or lay Cattle and pigs:
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
Za zmanjšanje kliničnih znakov pri akutnih okužbah dihal pri govedu ob ustreznem antibiotičnem zdravljenju.
Shelf-life after first opening the container: 28 days.
EXP {mesec/leto} Rok uporabnosti po prvem odpiranju vsebnika: 28 dni.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.
Za pomožno zdravljenje pri zdravljenju puerperalne septikemije in toksemije (sindroma mastitisa,
A slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
NEŽELENI UČINKI V kliničnih raziskavah so zasledili blago in prehodno oteklino na mestu injiciranja po subkutanem dajanju, in sicer pri manj kot 10 % goveda.
Emdocam 20 mg/ml solution for injection for cattle, pigs and horses
Emdocam 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje
THE WORDS "KEEP OUT OF SIGHT AND REACH OF CHILDREN"
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM”
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN(E)
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and vial after EXP.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini in viali za EXP. Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.
Ethanol (96%) 150 mg Clear yellow solution for injection.
150 mg Prozorna rumena raztopina za injiciranje.
Meloxicam Meloxicam Bovine, caprine, porcine, rabbit,
Terapevtske indikacije meloksikam meloksikam govedo, koze,
Do not use in pregnant and lactating mares.
Ne uporabite pri kobilah v obdobju brejosti in laktacije.
Emdocam 20 mg/ml solution for injection for cattle, pigs and horses meloxicam
Emdocam 20 mg/ml, raztopina za injiciranje za govedo, prašiče in konje meloksikam
Single subcutaneous or intravenous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Govedo Enkratna subkutana ali intravenska injekcija odmerka po 0,5 mg meloksikama na kilogram telesne mase (to je 2,5 ml/100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem ali s peroralno rehidracijsko terapijo.
Once broached, use by…
Načeto zdravilo uporabite do …
QUANITITY OF THE ACTIVE SUBSTANCE(S)
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E)
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years Shelf-life after first opening the immediate packaging: 28 days
Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet code: QM01AC06
Oznaka ATCvet: QM01AC06
Single intramuscular injection at a dose of 0.4 mg meloxicam/kg body weight (i.e. 2 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate.
Enkratna intramuskularna injekcija odmerka po 0,4 mg meloksikama na kilogram telesne mase (to je 2 ml/100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem.
Bovine, caprine
kunci, kopitarji
Cattle: Meat and offal:
Govedo: Meso in organi:
Cattle: meat and offal: 15 days; milk: 5 days
Karenca: Govedo: meso in organi: 15 dni; mleko: 5 dni
meat and offal: 5 days
meso in organi: 5 dni
Withdrawal periods: Cattle: meat and offal: 15 days; milk: 5 days.
Karenca: Govedo: meso in organi: 15 dni; mleko: 5 dni.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label for 100 ml and 250 ml
Etiketa viale s 100 ml in 250 ml
Single intravenous injection at a dose of 0.6 mg meloxicam/kg body weight (i.e. 3 ml/100 kg body weight).
Enkratna intravenska injekcija odmerka po 0,6 mg meloksikama na kilogram telesne mase (to je 3 ml/100 kg telesne mase).
Pack size of 1 colourless Type I glass vial containing 50 ml, 100 ml or 250 ml.
Velikost pakiranja 1 viala iz brezbarvnega stekla tipa I po 50 ml, 100 ml ali 250 ml. Viale so zaprte z brombutilnimi gumijastimi zamaški in zapečatene z aluminijastimi zaporkami.
SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS , IF ANY
ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
Once broached, use by _____
UPORABE, če je smiselno
Do not use in pregnant or lactating mares.
Ne uporabite pri brejih kobilah ali kobilah v obdobju laktacije.
Excipient:
Karenca:
Pharmacologically active substance
Farmakološko aktivna snov(i)
Can be used during pregnancy and lactation.
Govedo in prašiči: Lahko se uporablja v obdobju brejosti in laktacije.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label for 50 ml
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Sodium hydroxide Hydrochloric acid Meglumine Water for injections
- etanol (96 %) - poloksamer 188 - makrogol 300 - glicin - natrijev hidroksid - klorovodikova kislina - meglumin - voda za injekcije
The European Commission granted a marketing authorisation valid throughout the European Union for DepoCyte on 11 July 2001.
Evropska komisija je dovoljenje za promet z zdravilom DepoCyte, veljavno po vsej Evropski uniji, odobrila dne 11. julija 2001.
Other information about DepoCyte:
Druge informacije o zdravilu DepoCyte:
DepoCyte cytarabine
Depocyte citarabin
A patient was classified as a ‘responder' if they had no cancer cells in the spinal fluid after treatment and if their symptoms had not got worse after four weeks.
Bolnik je bil označen kot „odziven“, če po zdravljenju v spinalni tekočini ni imel rakavih celic in če se njihovi simptomi po štirih tednih niso poslabšali.
The marketing authorisation holder is Pacira Limited.
Imetnik dovoljenja za promet je družba Pacira Limited.
This document is a summary of the European Public Assessment Report (EPAR) for DepoCyte.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo DepoCyte.