natgillin/translations-raw huggingface dataset:
Fifteen of 120 (13%) patients in the atazanavir + ritonavir treatment arm and 17 of 123 (14%) patients in the lopinavir + ritonavir arm had four or more of the PI substitutions L10, M46, I54, V82, I84, and L90.
Petnaest od 120 (13%) bolesnika u terapijskoj skupini koja je primala atazanavir + ritonavir i 17 od 123 (14%) bolesnika u skupini koja je primala lopinavir +
Lopinavir/ritonavirc (400 mg/100 mg twice daily) n=443
(400 mg/100 mg dvaput na dan) n=443
Atazanavir, dosed 1 hr after ddI+d4T (fasted) Atazanavir AUC ↔3% (↓36% Atazanavir cmax ↑12% (↓33% Atazanavir cmin ↔3% (↓39%
Atazanavir AUC ↔3% (↓36% ↑67%) Atazanavir Cmax ↑12% (↓33% ↑18%) Atazanavir Cmin ↔3% (↓39% ↑73%)
CD4 Mean Change from Baseline, cells/mm All patients
CD4 prosječna promjena od početne vrijednosti, stanice/mm3
Cap: titanium dioxide (E171) yellow ferric oxide (E172) red ferric oxide (E172) black ferric oxide (E172) gelatine ink:
Kapica: titanijev dioksid (E171) žuti željezov oksid (E172) crveni željezov oksid (E172) crni željezov oksid (E172) želatina tinta:
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 200 mg atazanavir (as sulphate).
Jedna tvrda kapsula sadrži 200 mg atazanavira (u obliku atazanavirsulfata).
Desacetyl-diltiazem AUC ↑165% Desacetyl-diltiazem cmax ↑172% Desacetyl-diltiazem cmin ↑121%
Dezacetil-diltiazem Cmax ↑172% (↑144% Dezacetil-diltiazem Cmin ↑121% (↑102%
diltiazem, systemic lidocaine, verapamil) - atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol) - salmeterol (used to treat asthma) - cyclosporin, tacrolimus, and sirolimus (medicines to decrease the effects of body's immune system) - certain antibiotics (rifabutin, clarithromycin) - ketoconazole, itraconazole, and voriconazole (antifungals) - warfarin (anticoagulant, used to reduce the blood clots) - carbamazepine, phenytoin, phenobarbital, lamotrigine (antiepileptics) - irinotecan (used to treat cancer) - sedative agents (e.g. midazolam administered by injection) - buprenorphine (used to treat opioid addiction and pain).
- boceprevir i sofosbuvir/velpatasvir/voksilaprevir (koji se koriste u liječenju hepatitisa C) - sildenafil, vardenafil ili tadalafil (uzimaju ga muškarci za liječenje impotencije (erektilna disfunkcija)) - ako uzimate oralnu kontracepciju ("pilule") s lijekom Atazanavir Krka, za sprječavanje trudnoće, pazite da je uzimate točno prema uputama liječnika i da ne propustite niti jednu dozu - bilo koje lijekove za liječenje bolesti povezanih s kiselinom u želucu (npr., antacide, koji se moraju uzeti barem 1 sat prije uzimanja lijeka Atazanavir Krka ili 2 sata nakon uzimanja lijeka Atazanavir Krka, H2-blokatore kao famotidin ili inhibitore protonske pumpe kao omeprazol) - lijekove za snižavanje krvnog tlaka, usporavanje rada srca ili ispravljanje srčanog ritma (amiodaron, diltiazem, sistemski lidokain, verapamil) - atorvastatin, pravastatin i fluvastatin (primjenjuju se za snižavanje kolesterola u krvi)
Atazanavir AUC ↑43% (↑30% Atazanavir cmax ↑12% (↑1% Atazanavir cmin ↑23% (↑13% Grazoprevir AUC: ↑958% (↑678% Grazoprevir cmax: ↑524% (↑342% Grazoprevir cmin: ↑1064% (↑696%
Atazanavir AUC ↑43% (↑30% ↑57%) Atazanavir Cmax ↑12% (↑1% ↑24%)* Atazanavir Cmin ↑23% (↑13% ↑134%)
4.94 log10 copies/ml (range 2.6 to 5.88 log10 copies/ml) b atazanavir /RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
a Prosječni broj CD4 stanica na početku iznosio je 214 stanica/mm3 (raspon od 2 do 810 stanica/mm3) i prosječna početna vrijednost HIV-1 RNK u plazmi bila je 4,94 log10 kopija/ml (raspon od 2,6 do 5,88 log10 kopija/ml) b atazanavir /RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tableti, jedanput na dan).
Rare (may affect up to 1 in 1,000 people): - gait disturbance (abnormal manner of walking) - oedema (swelling) - hepatosplenomegaly (enlargement of the liver and spleen) - myopathy (aching muscles, muscle tenderness of weakness, not caused by exercise) - kidney pain
hepatosplenomegalija (povećanje jetre i slezene) miopatija (bolni mišići, osjetljivost na dodir i slabost mišića, što nije prouzročeno vježbanjem)
Sofosbuvir AUC : ↑40% (↑25% Sofosbuvir cmax :↑29% (↑9% Velpatasvir AUC: ↑93% (↑58% Velpatasvir cmax : ↑29% (↑7% Voxilaprevir AUC : ↑331% Voxilaprevir cmax : ↑342% (↑265%
Sofosbuvir AUC : ↑40% (↑25% ↑57%) Sofosbuvir Cmax :↑29% (↑9% ↑52%)
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products (see section 4.8).
U slučaju istovremene antivirusne terapije zbog hepatitisa B ili C treba provjeriti odgovarajuće
H2-Receptor antagonists Without Tenofovir disoproxil In HIV-infected patients with atazanavir/ritonavir at the recommended dose 300/100 mg once daily
Primjena atazanavira/ritonavira u preporučenoj dozi od 300/100 mg jedanput na dan u bolesnika zaraženih HIV-om
Atazanavir Krka with ritonavir must not be used in patients with moderate to severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Krka s ritonavirom ne smije se primjenjivati u bolesnika s umjerenim do teškim oštećenjem funkcije jetre (vidjeti dijelove 4.3, 4.4 i 5.2).
Fluvastatin is partially metabolised by CYP2C9.
CYP2C9.
with atazanavir is contraindicated (see section 4.3)
Istovremena primjena alfuzosina i atazanvira je kontraindicirana (vidjeti dio 4.3)
QUALITATIVE AND QUANTITATIVE COMPOSITION Atazanavir Krka 150 mg hard capsules Each hard capsule contains 150 mg atazanavir (as sulphate).
KVALITATIVNI I KVANTITATIVNI SASTAV Atazanavir Krka 150 mg tvrde kapsule
Co-administration of atazanavir and elbasvir/grazoprevir is contraindicated because of a significant increase in grazoprevir plasma concentrations and an associated potential increase in the risk of ALT elevations (see section
Istodobna primjena lijeka atazanavira s elbasvirom/grazoprevirom je kontraindicirana zbog očekivanog povišenja koncentracije grazoprevira u plazmi, te povezano povećanog rizika povišenja vrijednosti ALT-a (vdjeti dio 4.3).
HIV RNA <50 copies/ml, %f (responder/evaluable) All patients
HIV RNK <50 kopija/ml, %a Svi bolesnici
Famotidine 20 mg twice daily Atazanavir AUC ↓18% (↓25% Atazanavir cmax ↓20% (↓32% Atazanavir cmin ↔1% (↓16% Famotidine 40 mg twice daily Atazanavir AUC ↓23% (↓32% Atazanavir cmax ↓23% (↓33% Atazanavir cmin ↓20% (↓31% ↓8%) In Healthy volunteers with atazanavir/ritonavir at an increased dose of 400/100 mg once daily Famotidine 40 mg twice daily Atazanavir AUC ↔3% (↓14% Atazanavir cmax ↔2% (↓13% Atazanavir cmin ↓14% (↓32% ↑8%) With Tenofovir disoproxil fumarate 300 mg once daily (equivalent to 245 mg tenofovir disoproxil) In HIV-infected patients with atazanavir/ritonavir at the recommended dose of 300/100 mg once daily
Etinilestradiol AUC ↑48% (↑31% ↑68%) Etinilestradiol Cmax ↑15% (↓1% ↑32%) Etinilestradiol Cmin ↑91% (↑57% ↑133%) Noretindron AUC ↑110% (↑68% ↑162%) Noretindron Cmax↑67% (↑42% ↑196%) Noretindron Cmin ↑262% (↑157% ↑409%) Povećana izloženost progestinu može dovesti do s time povezanih nuspojava (npr. inzulinske rezistencije, dislipidemije, akni i probojnog krvarenja) i tako utjecati na uzimanje kontracepcije.
a Mean baseline CD4 cell count was 214 cells/mm3 (range 2 to 810 cells/mm3) and mean baseline plasma HIV-1 RNA was
(raspon: 2 do 800 stanica/ mm3), a prosječna početna vrijednost HIV-1 RNK u plazmi bila je
Atazanavir AUC ↔6% (↓10%
ritonavir AUC ↓ 36%
* When compared to atazanavir 300 mg once daily with ritonavir 100 mg once daily.
300 mg jedanput na dan u kombinaciji s ritonavirom 100 mg jedanput na dan.
The mean
I DOHVATA
The mechanism of amiodarone or systemic lidocaine/atazanavir interaction is
Mehanizam interakcije amiodarona ili sistemskog lidokaina s atazanavirom je inhibicija enzima CYP3A.
* In a combined analysis from several clinical studies, atazanavir/ritonavir 300/100 mg co-administered with tenofovir disoproxil fumarate 300 mg (n=39) was compared to atazanavir/ritonavir 300/100 mg (n=33).
(n=39) uspoređivani su s atazanavirom/ritonavirom 300/100 mg (n=33).
Atazanavir cmax: ↑120% (↑56%
Voksilaprevir Cmax : ↑342% (↑265%
Abacavir
Abakavir
Tenofovir disoproxil fumarate Cmin
Tenofovirdizoproksilfumarat AUC ↑37%
(atazanavir 300 mg / ritonavir 100 mg once daily)
300 mg/ritonavir 100 mg jedanput na dan,
Mean urinary excretion of unchanged drug was 7% following 2 weeks of dosing at 800 mg once daily.
2 tjedna primjene doze od 800 mg jedanput na dan.
Asymptomatic first- and second-degree AV block was reported in paediatric patients (see section 4.8).
pedijatrijskih je bolesnika bio zabilježen asimptomatski AV blok prvog i drugog stupnja (vidjeti dio Potreban je oprez s lijekovima za koje se zna da izazivaju produljenje PR intervala.
Ethinyloestradiol AUC ↓19% Ethinyloestradiol cmax ↓16% Ethinyloestradiol cmin ↓37%
Etinilestradiol AUC ↓19% (↓25% ↓13%) Etinilestradiol Cmax ↓16% (↓26% ↓5%) Etinilestradiol Cmin ↓37% (↓45% ↓29%)
Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) Lamivudine 150 mg twice daily + zidovudine 300 mg twice daily (atazanavir 400 mg once daily)
Lamivudin 150 mg dvaput na dan + zidovudin 300 mg dvaput na dan (atazanavir 400 mg jedanput na dan)
Glecaprevir 300 mg / pibrentasvir 120 mg once daily
Glekaprevir 300 mg / pibrentasvir 120 mg jedanput na dan (atazanavir 300 mg / ritonavir 100 mg jedanput na dan*)
postpartuma (n=36)
(n=36)
Co-administration with bepridil is contraindicated (see section 4.3)
Istovremena primjena s bepridilom je kontraindicirana (vidjeti dio 4.3).
This overview was last updated in May 2019.
Pregled informacija posljednji je put ažuriran u svibnju 2019.
Further information on Nasym can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/nasym.
Više informacija o VMP-u Nasym nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/veterinary/EPAR/NexGard.
What is Nasym and what is it used for?
Što je Nasym i za što se koristi?
Nasym is a vaccine.
Nasym je cjepivo.
When the animal comes into contact again with this or a similar virus, these antibodies together with other components of the immune system will be able to kill the viruses and help protect against the disease.
U budućnosti, kada životinja dođe u kontakt s tim ili sličnim virusom, ta će protutijela zajedno s drugim dijelovima imunosnog sustava moći uništiti virus i pomoći pri zaštiti od bolesti.
The withdrawal period for meat from cattle treated with Nasym is ‘zero' days, which means that there is no mandatory waiting time.
Razdoblje karencije za meso goveda liječenih VMP-om Nasym iznosi „nula” dana, odnosno nema obveznog razdoblja čekanja.
The most common side effect with Nasym (which may affect up to 1 in 10 animals) is a slight change in the consistency of the faeces.
Najčešća nuspojava VMP-a Nasym (pojavljuje se u 1 od 10 životinja) jest neznatna promjena u konzistenciji fekalija.
The European Medicines Agency decided that Nasym's benefits are greater than its risks and it can be authorised for use in the EU.
Europska agencija za lijekove zaključila je da koristi od VMP-a Nasym nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
Other information about Nasym
Ostale informacije o VMP-u Nasym
Nasym received a marketing authorisation valid throughout the EU on 29 July 2019.
Za VMP Nasym izdano je odobrenje za stavljanje u promet koje je na snazi u EU-u od 29/07/2019.
What are the risks associated with Nasym?
Koji su rizici povezani s VMP-om Nasym?
Why is Nasym authorised in the EU?
Zašto je VMP Nasym odobren u EU-u?
In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
U slučaju nehotičnog samoinjektiranja treba odmah potražiti liječnički savjet te pokazati uputu o VMP-u ili etiketu.
An overview of Nasym and why it is authorised in the EU
Pregled informacija o VMP-u Nasym i zašto je odobren u EU-u
When an animal is given the vaccine, the animal's immune system recognises the virus as ‘foreign' and makes antibodies against it.
Kada životinja primi cjepivo, njezin imunosni sustav prepoznaje virus kao „strano tijelo” i proizvodi protutijela na virus.
These studies involved non-vaccinated animals given a dummy vaccination and all animals were artificially exposed to bovine respiratory syncytial virus.
U ispitivanjima su sudjelovale necijepljene životinje koje su primale lažno cjepivo, a sve su životinje bile izložene goveđem respiratornom sincicijskom virusu.
For cattle from 9 days of age, the vaccine is sprayed into each of the animal's nostrils using an intranasal applicator.
Za goveda u dobi 9 dana i starija cjepivo se raspršuje u svaku nosnicu pomoću intranazalnog aplikatora.
For cattle from 10 weeks of age, the vaccine is given as a single injection into the muscle followed by a second injection into the muscle 4 weeks later.
Za goveda u dobi od 10 tjedana i starija cjepivo se daje kao jedna injekcija u mišić, dok se druga injekcija u mišić daje nakon 4 tjedna.
Nasym contains a strain of bovine respiratory syncytial virus that is weakened and does not cause the disease.
Nasym sadrži soj goveđeg respiratornog sincicijskog virusa koji je oslabljen i ne uzrokuje bolest.
Nasym reduces shedding of virus and respiratory signs such as raised breathing rate, difficulty breathing, watery eyes and runny nose.
Nasym ublažava širenje virusa i znakove respiratornih bolesti kao što su ubrzano disanje, poteškoće s disanjem, suzne oči i curenje nosa.
The effectiveness of Nasym has been shown in 7 laboratory studies in which vaccination of cattle with Nasym, either using the nasal spray route or injection into the muscle, reduced both shedding of virus and signs of respiratory disease, such as increased rate of breathing, difficulty in breathing and watery or mucky eyes.
Djelotvornost VMP-a Nasym utvrđena je u 7 laboratorijskih ispitivanja u kojima je cijepljenje goveda cjepivom Nasym s pomoću nazalnog spreja ili injekcije u mišić smanjilo širenje virusa i ublažilo znakove respiratornih bolesti kao što su ubrzano disanje, otežano disanje i suzne ili sluzave oči.
The medicine can only be obtained with a prescription and is available as a lyophilisate (a freeze dried powder) and solvent to make either a nasal spray or an injection.
VMP se izdaje samo na veterinarski recept te je dostupan kao liofilizat (zamrznuti osušeni prah) i otapalo za pripremu spreja za nos ili injekcije.
Nasym contains bovine respiratory syncytial virus strain Lym-56.
Nasym sadrži goveđi respiratorni sincicijski virus, soj Lym-56.
What benefits of Nasym have been shown in studies?
Koje su koristi od VMP-a Nasym utvrđene u ispitivanjima?
Nasym is a vaccine used to protect cattle against bovine respiratory syncytial virus, a disease that affects their airways.
Nasym je cjepivo koje se koristi za zaštitu goveda od goveđeg respiratornog sincicijskog virusa, bolesti koja napada njihove dišne putove.
Nasym (bovine respiratory syncytial virus vaccine, live)
Nasym (živo cjepivo protiv goveđeg respiratornog sincicijskog virusa)
For the full list of side effects and restrictions of Nasym, see the package leaflet.
Potpuni popis nuspojava i ograničenja pri primjeni VMP-a Nasym potražite u uputi o VMP-u.
The studies confirmed the vaccine starts to be effective 3 weeks after both nasal vaccination and injection into the muscle, with effectiveness lasting 2 months after nasal vaccination and 6 months after injection into the muscle.
U ispitivanjima je potvrđeno da djelotvornost cjepiva počinje 3 tjedna nakon nazalnog cijepljenja ili injekcije u mišić, pri čemu djelotvornost traje 2 mjeseca nakon nazalnog cijepljenja i 6 mjeseci nakon injekcije u mišić.
The vaccine starts to be effective 3 weeks after vaccination into the muscle and protection lasts for 6 months.
Cjepivo postaje djelotvorno 3 tjedna nakon cijepljenja u mišić, a zaštita traje 6 mjeseci.
How does Nasym work?
Kako se Nasym primjenjuje?
Revaccination is given by injection into the muscle 2 months after the initial vaccination and then every 6 months.
Docjepljivanje se primjenjuje injekcijom u mišić 2 mjeseca nakon prvog cijepljenja, a zatim svakih 6 mjeseci.
Revaccination is given as a single injection into the muscle 6 months after the initial vaccination course and then every 6 months.
Docjepljivanje se primjenjuje jednom injekcijom u mišić 6 mjeseci nakon prvog cijepljenja, a zatim svakih 6 mjeseci.
The vaccine starts to be effective 3 weeks after nasal vaccination and protection lasts for 2 months following vaccination.
Cjepivo postaje djelotvorno 3 tjedna nakon nazalnog cijepljenja, a zaštita traje do 2 mjeseca nakon cijepljenja.
Do not freeze.
Ne smije se zamrzavati.
ATCvet code: QM01AC06.
ATKvet kod: QM01AC06.
This was observed in less than 10% of the cattle treated in clinical studies.
Ovo je zabilježeno u manje od 10% goveda tretiranih u kliničkim ispitivanjima.
These measures should help to protect the environment.
Te bi mjere trebale pomoći u zaštiti okoliša.
The expiry date refers to the last day of that month.
Rok valjanosti odnosi se na zadnji dan u tom mjesecu.
Do not use in horses less than 6 weeks of age.
Ne primjenjivati kod konja mlađih od 6 tjedana.
When the product is used according to the recommended dosage regime, the oral bioavailability is approximately 98%.
Kada se proizvod primjenjuje u skladu s preporučenim režimom doziranja, oralna bioraspoloživost iznosi približno 98%.
In case the product is mixed with food, it should be added to a small quantity of food, prior to feeding.
U slučaju miješanja proizvoda s hranom, treba ga dodati hrani u malim količinama prije hranjenja.
5531 AE Bladel THE NETHERLANDS
5531 AE Bladel, NIZOZEMSKA
The metabolism in horses was not investigated.
Metabolizam kod konja nije istraživan.
The active substance in Contacera is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) 37/2010:
Djelatna tvar u Contacera za konje je dopuštena tvar kao je opisano u tablici 1 dodatka Uredbe Komisije (EU) br. 37/2010:
See also section 4.3.
Vidjeti također dio 4.3.
Treatment of calves with Contacera 20 minutes before dehorning reduces post-operative pain.
Liječenje teladi s Contacera 20 minuta prije postupka odrožnjavanja smanjuje postoperativne boli.
Laboratory studies in cattle have not produced any evidence for teratogenic, foetotoxic, or maternotoxic effects.
Laboratorijskim pokusima na govedima nije dokazan nikakav teratogeni, fetotoksični ni maternotoksični učinak.
The syringe fits onto the bottle and has a 2 ml scale.
Štrcaljka pristaje na bočicu i ima označenu skalu od 2 ml.
Contacera alone will not provide adequate pain relief during the dehorning procedure.
Contacera sama neće pružiti odgovarajuću olakšanje bolova tijekom postupka odrožnjavanja.
This is equivalent to 1 ml of Contacera per 25 kg body weight of horse.
To je ekvivalent za 1 ml Contacera po 25 kg tjelesne težine od konja.
Date of last renewal: {DD/MM/YYYY}
Datum posljednjeg produljenja odobrenja: {DD/MM/YYYY}
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15/02/2014
Datum prvog odobrenja: 15/02/2014
Approximately 50% of the administered dose is eliminated via urine and the remainder via faeces.
Otprilike 50% primijenjene doze izlučuje se mokraćom, a ostatak izmetom.
Not authorised for use in horses producing milk for human consumption.
Nije odobrena primjena kod kobila koji proizvode mlijeko za ljudsku uporabu.
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea,
Chanelle Pharmaceuticals Manufacturing Ltd Loughrea, Co.
TARGET SPECIES Horses.
CILJNE VRSTE ŽIVOTINJA Konji.
Cattle and pigs: Can be used during pregnancy and lactation.
Goveda i svinje: može se primijeniti tijekom graviditeta i laktacije.
In pigs, bile and urine contain only traces of the parent compound.
Kod svinja, žuč i mokraća sadrže samo tragove ishodišnog spoja.
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the diagnosis should be made as this could indicate the need for surgical intervention.
U slučaju neodgovarajućeg olakšavanja bolova u liječenju kolika kod konja, potrebno je ponovo pažljivo procijeniti dijagnozu jer bi to moglo upućivati na potrebu kirurškog zahvata.
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
Za primjenu u akutnoj respiratornoj infekciji uz odgovarajuću antibiotsku terapiju kako bi se smanjili klinički znakovi kod goveda.
The suspension should be given using the measuring syringe provided in the package.
Suspenziju treba davati upotrebom mjerne štrcaljke priložene u pakovanju.
For example, a horse weighing 400 kg will receive 16 ml of Contacera, a horse weighing 500 kg will receive 20 ml of Contacera, and a horse weighing 600 kg will receive 24 ml of Contacera.
kg će dobiti 16 ml Contacera, konj težak 500 kg će primiti 20 ml Contacera, a konj težak 600 kilograma će dobiti 24 ml Contacera.
Meloxicam 20 mg Ethanol (96%) 159.8 mg Clear, yellow solution.
Meloksikam 20 mg Etanol (96%) 159,8 mg Jasno, žuta otopina.
In the case of overdose symptomatic treatment should be initiated.
U slučaju predoziranja potrebno je započeti simptomatsko liječenje.
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Uredbe Komisije (EU) br. 37/2010 naznačeno da određivanje MRL nije nužno, ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EZ) br. 470/2009 kada se primjenjuju u tom veterinarskomedicinskom proizvodu.
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 primjenu u slučaju proljeva u kombinaciji s oralnom rehidracijskom terapijom radi smanjenja kliničkih znakova kod teladi starije od tjedan dana i mladih goveda koja nisu u laktaciji.
In pigs, after intramuscular administration the mean plasma elimination half-life is approximately 2.5 hours.
Kod svinja, nakon intramuskularne primjene, prosječni poluživot uklanjanja iz plazme iznosi približno 2,5 sata.
The major metabolites found in all species were the 5-hydroxyand 5-carboxy- metabolites and the oxalyl- metabolite.
Osnovni metaboliti nađeni kod svih vrsta bili su 5-hidroksi- i 5
6.1 List of excipients - Ethanol (96%) - Poloxamer 188 - Macrogol 400 - Glycine - Sodium hydroxide - Hydrochloric acid, concentrated - Meglumine - Water for injections
- etanol (96%) - poloksamer 188 - makrogol 300 - glicin - natrijev hidroksid - hidroklorna kiselina - meglumin - voda za injekcije
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
Za liječenje proljeva kod goveda, ne primjenjivati kod životinja mlađih od tjedan dana.
To be administered either mixed with a small quantity of food, prior to feeding, or directly into the mouth.
Primjenjuje se ili izmiješano s hranom, ili izravno u usta.
After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.
Nakon primjene veterinarsko medicinskogl proizvoda, zatvorite bočicu čepom, isperite mjernu štrcaljku toplom vodom i pustite da se osuši.
Common adverse reactions include slight transient swelling at the injection site following subcutaneous administration in cattle and pigs.
Uobičajene nuspojave uključuju lagano prolazno oticanje na mjestu ubrizgavanja nakon subkutane primjene kod goveda i svinja.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.
Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i bočici nakon EXP.
Sodium benzoate
- natrijev benzoat
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/12/2012
Datum prvog odobrenja: 06/12/2012
TARGET SPECIES Cattle, pigs and horses
CILJNE VRSTE ŽIVOTINJA Goveda, svinje i konji