natgillin/translations-raw huggingface dataset:
For major depression, Xeristar has been compared with placebo (a dummy treatment) in eight main studies involving a total of 2,544 patients.
Za zdravljenje večjih depresivnih motenj so zdravilo Xeristar v osmih glavnih študijah, v katere je bilo vključenih 2 544 bolnikov, primerjali s placebom (zdravilom brez zdravilne učinkovine).
What is Xeristar used for?
Za kaj se zdravilo Xeristar uporablja?
How has Xeristar been studied?
Kako je bilo zdravilo Xeristar raziskano?
The other two studies looked at how long it took for symptoms to return in patients who had initially responded to Xeristar, including 288 patients with a history of repeated episodes of depression for up to five years.
V drugih dveh študijah, v katerih je sodelovalo 288 bolnikov z anamnezo ponavljajočih se epizod depresije v največ zadnjih petih letih, so proučevali, kako hitro se simptomi povrnejo pri bolnikih, ki so se sprva odzvali na zdravljenje z zdravilom Xeristar.
It also took longer for symptoms to return in patients taking Xeristar than in those taking placebo.
Pri bolnikih, ki so jemali zdravilo Xeristar, je trajalo dalj časa, da so se simptomi ponovno pojavili, kot pri bolnikih, ki so jemali placebo.
What is Xeristar?
Kaj je zdravilo Xeristar?
How is Xeristar used?
Kako se zdravilo Xeristar uporablja?
How does Xeristar work?
Kako zdravilo Xeristar deluje?
Patients who also have major depression should start with 60 mg once a day.
Večina bolnikov bo morala jemati 60 mg na dan. Bolniki, ki imajo tudi hujše depresivne motnje, morajo začeti s 60 mg enkrat na dan. Za bolnike, ki se odzivajo na zdravilo Xeristar, je zdravljenje priporočljivo nadaljevati še nekaj mesecev, da se prepreči ponovni pojav bolezni.
London, 17 January 2008 EMEA/31266/2008
London, 17. januar 2008 EMEA/31266/2008
If you are in a clinical trial and have any questions, contact your doctor.
Če sodelujete v kliničnih preizkušanjih in imate kakršnakoli vprašanja, se posvetujte z vašim zdravnikom.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for ZOMETA
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA SPREMEMBO DOVOLJENJA ZA PROMET za zdravilo ZOMETA
International non-proprietary name (INN): zoledronic acid
Mednarodno nelastniško ime (INN): zoledronska kislina
The CHMP normally takes up to 90 days to adopt an opinion after it has received an application for a change to a marketing authorisation.
CHMP običajno potrebuje do 90 dni za sprejetje mnenja od prejema vloge za spremembo dovoljenja za promet z zdravilom.
After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Po tem ko je CHMP ocenil odgovore podjetja na seznam vprašanj, so nekatera tehtna vprašanja še vedno ostala nerešena.
The reduction of bone loss helps to make bones less likely to break, which may be useful in preventing fractures.
Zahvaljujoč zmanjšanju izgube kostne mase je manj verjetno, da se bodo kosti zlomile, kar je lahko koristno pri preprečevanju zlomov.
The main measure of effectiveness was the change in ‘bone mineral density' (the amount of bone) in the spine, between the start of the study and one year later.
Glavno merilo učinkovitosti je bila sprememba „mineralne gostote v kosteh“ (količine kosti) v hrbtenici v obdobju enega leta od pričetka študije.
Following the CHMP's opinion, it usually takes around six weeks for the European Commission to update the licence.
Ko CHMP izda mnenje, Evropska komisija v približno šestih tednih posodobi dovoljenje.
Bone mineral density was measured using a special type of X-ray called ‘dual energy X-ray absorptiometry' (DEXA).
Mineralno gostoto v kosteh so merili s posebno vrsto rentgenskega slikanja, imenovano „dvoenergijska rentgenska absorpciometrija (dual-energy Xray absorptiometry - DEXA)“.
This leads to less bone loss.
To vodi k zmanjšanju izgube kostne mase.
The CHMP had concerns over the way the two main studies were designed, since they did not look directly at bone fractures.
CHMP je izrazil zadržke glede zasnove dveh glavnih študij, saj ti nista neposredno preučevali zlomov kosti.
The CHMP was also concerned that there was insufficient information to show that the dose of Zometa used in the studies was the most appropriate for these patients.
CHMP je imel tudi zadržke, da ni dovolj informacij, ki bi dokazale, da je odmerek zdravila Zometa, uporabljen v študijah, najprimernejši za te bolnice.
This includes fractures (broken bones), spinal compression (pressure on the spinal cord), bone disorders needing radiotherapy or surgery, and hypercalcaemia (high levels of calcium in the blood).
Ti zapleti vključujejo frakture (zlome kosti), spinalno kompresijo (pritisk na hrbtenjačo), kostne zaplete, ki zahtevajo obsevanje ali operacijo, ter hiperkalciemijo (visoko raven kalcija v krvi).
There are no consequences on the use of Zometa in its approved indications, for which the balance of benefits and risks remains positive.
Za uporabo zdravila Zometa za odobrene indikacije, za katere ostaja razmerje med koristmi in tveganji pozitivno, ni nikakršnih posledic.
It is available as a powder and solvent to be made up into a solution for infusion (drip into a vein), and as a concentrate for infusion.
Na voljo je kot prašek in vehikel za pripravo raztopine za infundiranje (kapalna infuzija v veno ter kot koncentrat za pripravo raztopine za infundiranje.
The company also compared the results of these studies with results from studies of Aclasta, another medicine that also contains zoledronic acid, but which is used to prevent fractures in postmenopausal women with osteoporosis.
Podjetje je rezultate teh študij primerjalo tudi z rezultati študij z zdravilom Aclasta, drugim zdravilom, ki prav tako vsebuje zoledronsko kislino, vendar pa se uporablja za preprečevanje zlomov pri ženskah po menopavzi z osteoporozo.
The company informed the CHMP that this withdrawal does not have any effect on patients currently included in clinical trials with Zometa.
Podjetje je CHMP obvestilo, da ta umik nima posledic za bolnice, ki trenutno sodelujejo v kliničnih preizkušanjih zdravila Zometa.
Zometa can also be used to treat the hypercalcaemia caused by tumours.
Zdravilo Zometa se lahko uporablja tudi za zdravljenje hiperkalciemije, ki jo povzročijo tumorji.
This was not overcome by providing information on fractures from studies looking at Aclasta in the treatment of osteoporosis.
Ta pomanjkljivost ni bila odpravljena z zagotovitvijo informacij o zlomih iz študij, v katerih so preučevali zdravilo Aclasta pri zdravljenju osteoporoze.
Zometa is a medicine containing the active substance zoledronic acid.
Zometa je zdravilo, ki vsebuje zdravilno učinkovino zoledronska kislina.
What are the consequences of the withdrawal for patients in clinical trials using Zometa?
Kakšne so posledice umika za bolnice, ki sodelujejo v kliničnih preizkušanjih zdravila Zometa?
The application was at day 90 when the company withdrew.
Podjetje je vlogo umaknilo na 90. dan postopka.
The effectiveness of Zometa in preventing bone loss was studied in two main studies involving a total of 1,667 postmenopausal women treated for early-stage breast cancer with letrozole (an aromatase inhibitor).
Učinkovitost zdravila Zometa pri preprečevanju izgube kostne mase so preučevali v dveh glavnih študijah s skupno 1.667 ženskami po menopavzi, ki so se zdravile zaradi raka dojke v zgodnji fazi z letrozolom (zaviralcem aromataze).
What is Zometa?
Kaj je zdravilo Zometa?
On 15 November 2007, Novartis Europharm Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Zometa, in the prevention of fracture and bone loss in postmenopausal women with early-stage breast cancer treated with aromatase inhibitors.
Podjetje Novartis Europharm Limited je dne 15. novembra 2007 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da se je odločilo umakniti vlogo za novo indikacijo za zdravilo Zometa, in sicer za preprečevanje zlomov in izgube kostne mase pri ženskah po menopavzi z rakom dojke v zgodnji fazi, zdravljenimi z zaviralci aromataze.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zometa could not have been approved for the prevention of fractures and bone loss in women being treated with aromatase inhibitors.
Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj, ki jih je zastavil CHMP, je imel Odbor v času umika vloge določene zadržke in je začasno menil, da za zdravilo Zometa ni mogoče odobriti dovoljenja za preprečevanje zlomov in izgube kostne mase pri ženskah, zdravljenih z zaviralci aromataze.
This comparison was intended to provide information on the effect of zoledronic acid on bone fractures in women being treated with aromatase inhibitors.
Ta primerjava naj bi podala informacije o učinku zoledronske kisline na zlome kosti pri ženskah, zdravljenih z zaviralci aromataze.
Although Zometa seemed to reduce bone loss when it was started at the same time as letrozole, the CHMP was not convinced of the relevance of this finding in the absence of adequate information on fractures.
Čeprav se je zdelo, da zdravilo Zometa zmanjša izgubo kostne mase, če se prične uporabljati sočasno z letrozolom, CHMP zaradi pomanjkanja ustreznih informacij o zlomih ni bil prepričan o pomembnosti te ugotovitve.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Zometa had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
CHMP je zato v času umika menil, da korist zdravila Zometa ni bila zadostno dokazana in da ni večje od znanih tveganj.
Zometa is already approved for use in the prevention of bone complications in patients with advanced cancer that affects the bone.
Zdravilo Zometa je že odobreno za uporabo za preprečevanje zapletov, povezanih z okostjem, pri bolnikih z napredovalim rakom, ki zajame kosti.
Both studies looked at the effects of starting Zometa at the same time as starting letrozole treatment, compared with the effects of waiting until there was significant bone loss or evidence of a fracture before starting Zometa.
V obeh študijah so preučevali učinke začetka zdravljenja z zdravilom Zometa sočasno s pričetkom zdravljenja z letrozolom, ki so jih primerjali z učinki v primeru čakanja s pričetkom zdravljenja z zdravilom Zometa do večje izgube kostne mase ali dokazanega zloma.
What was Zometa expected to be used for?
Za kaj naj bi se zdravilo Zometa uporabljalo?
The active substance in Zometa, zoledronic acid, is a bisphosphonate.
Zdravilna učinkovina zdravila Zometa, zoledronska kislina, je difosfonat.
What is happening for Zometa for the prevention of bone complications and hypercalcaemia?
Kakšne so posledice za zdravilo Zometa pri uporabi za preprečevanje zapletov na kosteh in hiperkalciemije?
Aromatase inhibitors include anastrozole, letrozole and exemastane, and can cause bone loss and fractures as a side effect.
Med zaviralce aromataze sodijo anastrozol, letrozol in eksemestan, ta vrsta zdravil pa lahko kot neželeni učinek povzroči izgubo kostne mase in zlome.
In the new indication, Zometa was expected to be used to prevent fractures and bone loss in postmenopausal women with early-stage breast cancer who were being treated with anticancer medicines called aromatase inhibitors.
Nova indikacija je predvidevala uporabo zdravila Zometa za preprečevanje zlomov in izgube kostne mase pri ženskah po menopavzi z rakom dojke v zgodnji fazi, ki se zdravijo z zdravili proti raku, imenovanimi zaviralci aromataze.
How is Zometa expected to work?
Kako naj bi zdravilo Zometa delovalo?
Uxbridge UB9 6LS United Kingdom
Uxbridge UB9 6LS Velika Britanija
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 13 March 2001
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET 13. marec 2001
In rare cases, particularly in older or in sensitive dogs, these undesirable effects may be serious or fatal.
Izjemoma, še posebno pri starejših in občutljivih psih so neželjeni učinki lahko resni ali smrtni.
Monitor the hematocrit frequently.
Pogosto nadzorujte vrednosti hematokrita.
Alopecia and erythema may also occur occasionally.
Občasno se lahko pojavita tudi alopecija in rdečina (eritem).
NAME OF THE MARKETING AUTHORISATION HOLDER Intervet International B. V.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Intervet International B. V.
The duration of treatment is dependent on clinical response.
Trajanje zdravljenja je odvisno od kliničnega odziva.
The weight of the animal should be accurately determined before start of treatment.
Teža živali mora biti natančno določena pred pričetkom zdravljenja.
If you notice any other side effects, please inform your veterinary surgeon.
Če opazite kakršnekoli druge stranske učinke, obvestite svojega veterinarja.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMA) http://www.ema.europa.eu.
Keep the mouth of the dog closed for a few seconds to ensure complete tablet wetting.
Držite gobec psa zaprt še nekaj sekund, zato da se tableta v celoti navlaži.
Long term treatment should be under regular veterinary supervision.
Dolgotrajno zdravljenje naj bo pod rednim veterinarskim nadzorom.
Pharmacotherapeutic group: Anti-inflammatory Products, Non Steroids ATCvet code: QM01AE92
Farmakoterapevtska skupina: nesteroidno protivnetno zdravilo Oznaka ATCvet: QM01AE92
200 mg / oral lyophilisate For a full list of excipients, see section 6.1.
200 mg / peroralni liofilizat Celoten seznam pomožnih snovi, glej razdelek 6.1.
The recommended dose should not be exceeded.
Ne prekoračite priporočenega odmerka.
Maintain the animal on intravenous fluids and, if necessary, administer whole blood.
Žival vzdržujte s intravenoznim vnosom tekočin in, če je potrebno, uporabite transfuzijo krvi.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z nacionalnimi zahtevami.
Use in animals less than 6 months of age, with a weight below 5 kg, or in aged animals, may involve additional risk.
Uporaba zdravila pri živalih, ki so mlajše od 6 mesecev, s telesno maso manj kot 5 kg ali starih živalih je lahko dodatno tvegana.
The oral lyophilisates are available in the following pack sizes:
Peroralni liofilizati se nahajajo v naslednjih velikostih pakiranj:
If the oral lyophilisate disintegrates prematurely, wash hands thoroughly.
Če se peroralni liofilizat prehitro razgradi, dobro umijte roke.
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Navedba ni smiselna.
Place the tablet in the dog's mouth.
Daj tableto živali v gobec.
Push the bottom of the blister and the tablet will pop out.
Pritisni dno pretisnega omota in tableta se prikaže.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tepoxalin
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Tepoksalin
Tepoxalin and its metabolites are highly protein-bound, more than 98%.
Tepoksalin in njegovi presnovki se dobro vežejo na proteine, v več kot v 98 odstotkih.
If vomiting continues, administer anti-emetics.
Če se bruhanje še vedno pojavlja, uporabite antiemetike.
After a treatment period of 7-10 days, the condition of the dog should be re-evaluated in order to establish the need for continuation of treatment.
Po 7-10 dnevnem zdravljenju se psa ponovno pregleda, da se ugotovi ali je potrebno nadaljevati z zdravljenjem.
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance
KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilna učinkovina
If such use cannot be avoided, close veterinary supervision to monitor for gastrointestinal blood loss is necessary.
Če se uporabi ne moremo izogniti, je potrebna pozorna klinična oskrba za nadzor morebitne izgube krvi v prebavilih.
Do not use after the expiry date, which is stated on the blister.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na pretisnem omotu.
If there are such undesirable effects, treatment should be discontinued immediately.
Če se neželeni učinki pojavijo, je potrebno zdravljenje takoj prenehati.
1 box containing 1 or 3 blisters.
1 škatla vsebuje 1 ali 3 pretisne omote.
Special precautions to be taken by the person administering the medicinal product to animals
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
• has cardiac or hepatic disease
• z boleznimi srca ali jeter
The tablet will disintegrate upon contact with moisture.
Tableta se bo v stiku z vlago razgradila.
The acid metabolite is a potent, active cyclooxygenase inhibitor and prolongs the activity of the parent compound.
Kisli presnovek je močan, aktiven zaviralec ciklooksigenaze in podaljša delovanje izvorne sestavine.
1 box containing 1, 3 or 6 blisters.
1 škatla vsebuje 1, 3 ali 6 pretisnih omotov.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMA) http://www.ema.europa.eu.
Each blister contains 10 oral lyophilisates.
Vsak pretisni omot vsebuje 10 peroralnih liofilizatov.
Other NSAIDs, diuretics, anticoagulants and substances with high plasma protein binding may compete for binding leading to potentially toxic effects.
Druga NSPVZ, diuretiki, antikoagulanti in druge sestavine z veliko sposobnostjo vezave na proteine krvne plazme lahko tekmujejo pri vezavi, kar vodi v možnost pojava škodljivih učinkov.
Tepoxalin
Tepoksalin
• is dehydrated, hypovolaemic or hypotensive, as there is an increased risk of renal toxicity.
• ki so dehidrirane, hipovolemične ali hipotenzivne, ker obstaja povečana nevarnost toksičnega učinka na ledvice.
10 mg/kg once daily.
10 mg/kg enkrat dnevno.
During clinical trial testing of the product, the incidence of gastrointestinal reactions (diarrhoea/vomiting) was 10%.
V času kliničnega preiskušanja proizvoda je bila pojavnost želodčno črevesnih reakcij (driska/bruhanje) 10 %.
Tepoxalin is rapidly (Tmax of approximately 2 hours) absorbed after oral administration in dogs.
Tepoksalin se po peroralnem vnosu pri psih hitro absorbira (Tmax je približno 2 uri).
Ensure the food or treat containing the medication is completely consumed.
Prepričajte se, da je zaužita celotna količina hrane, ki vsebuje zdravilo.
During clinical trial testing of the product, the incidence of gastrointestinal reactions (diarrhoea/vomiting) occurred in 1 out of 10 animals.
V času kliničnega preiskušanja proizvodaso se želodčno črevesne reakcije (driska/bruhanje) pojavile pri 1 od 10 živali.
OTHER INFORMATION Not all pack sizes may be marketed.
DRUGE INFORMACIJE Ni nujno, da so v prometu vsa navedena pakiranja.
In case of ingestion of a number of oral lyophilisates by a person, the advice of a doctor should be sought immediately.
V primeru, da neka oseba zaužije številne peroralne liofilizate, se takoj posvetujte z zdravnikom.
Tepoxalin is a dual cyclooxygenase / 5-lipoxygenase inhibitor with anti-inflammatory activity.
Tepoksalin je dvojni zaviralec ciklooksigenaze / 5-lipoksigenaze s protivnetnim delovanjem.
• is hypersensitive to the product
• ki so preobčutljive na zdravilo
Tepoxalin is not watersoluble and becomes very sticky upon wetting.
Tepoksalin ni topen v vodi in postane po vlaženju zelo lepljiv.
Plasma concentrations of the acid metabolite are higher than those of the parent compound in the dog.
Koncentracije kislega presnovka v krvni plazmi so višje kot koncentracije matične sestavine.
• is pregnant or lactating or in bitches intended for breeding
• v času brejosti in laktacije, ter pri psicah, ki so namenjene za razplod
Oral administration of 10 mg tepoxalin / kg bodyweight results in inhibition of prostaglandin and leukotriene synthesis.
Po peroralnem vnosu 10 mg tepoksalina/kg telesne mase pride do zaviranja sinteze prostaglandinov in leukotrienov.
Do not use in pregnant or lactating dogs or in bitches intended for breeding.
Ne uporabljajte pri psicah v času brejosti ali laktacije in pri psicah namenjenih za razplod.
Do not use in dehydrated, hypovolaemic or hypotensive dogs, as there is an increased risk of renal toxicity.
Zdravila ne dajemo dehidriranim, hipovolemičnim ali hipotenzivnim psom, ker obstaja povečana nevarnost toksičnega učinka na ledvice.
Tepoxalin must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Tepoksalina ne smemo dajati skupaj z drugimi NSPVZ ali glukokortikoidi.
MANUFACTURER'S BATCH NUMBER Batch {number}
IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA Serija {številka}
Zubrin oral lyophilisates for dogs
Zubrin peroralni liofilizat za pse
10 mg tepoxalin per kg bodyweight once daily.
10 mg tepoksalina na kg telesne mase enkrat dnevno.
5.2 Pharmacokinetic properties
5.2 Farmakokinetične posebnosti
Tepoxalin is extensively converted to its acid metabolite.
Tepoksalin se v veliki meri pretvori v svoj kisli presnovek.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
ODMEREK ZA POSAMEZNE ŽIVALSKE VRSTE TER NAČIN UPORABE IN DAJANJA ZDRAVILA
D. STATEMENT OF THE MRLs Not applicable
D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Navedba ni smiselna
If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought.
Če se pojavijo stranski učinki, prenehajte z zdravljenjem in se posvetujte z veterinarjem.
Ensure hands are dry to prevent the tablet from sticking to fingers.
Roke morajo biti suhe, zato da preprečimo morebitno lepljenje na prste.
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA
Tepoxalin must not be administered in conjunction with other NSAIDs or glucocorticosteroids, diuretics or anticoagulants.
Tepoksalina ne smemo dajati skupaj z drugimi NSPVZ ali analgetiki, glukokortikoidi, diuretiki, inantikoagulanti.
When this is not possible, or when dogs resist having the product placed directly into the mouth, put the tablet immediately before administration into a small amount of moistened food, or in a moist treat.
Zdravilo dajte psom 1-2 uri po hranjenju.V kolikor to ni mogoče ali ko zdravila ne morete dati psom neposredno v gobec, vstavite tableto neposredno pred dajanjem v manjšo količino navlažene hrane ali v navlažen obrok.
10 mg/kg of body weight once daily.
10 mg/kg telesne mase enkrat dnevno.
Manufacturer for the Batch Release:
Izdelovalec, odgovoren za sprostitev serije:
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
C. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABO
MARKETING AUTHORISATION NUMBER(S) EU/2/00/028/002-008
ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/00/028/002-008
At a therapeutic dose of 10 mg/kg, the Cmax of tepoxalin was 1.08 ± 0.37 μg/ml in dogs fed a low fat meal and 1.19 ± 0.29 μg/ml in dogs fed a high fat meal.
Pri psih, ki so bili hranjeni z obroki z visoko vsebnostjo maščob je bila Cmax 1.19 ± 0.29 μg/ml.
Do not use if your dog
Ne uporabljajte pri živalih:
Marketing Authorisation Holder
IMETNIKA DOVOLJENJA ZA PROMET
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če
Typical undesirable side-effects associated with NSAIDs are vomiting, soft faeces/diarrhoea, blood in faeces, reduced appetite, lethargy and renal disorders.
Značilni stranski učinki uporabe nesteroidnih protivnetnih zdravil (NSPVZ)so bruhanje, mehko blato/driska, kri v blatu, zmanjšan apetit , letargija in ledvične motnje.