natgillin/translations-raw huggingface dataset:
In the first study, the average time to ejaculation in patients treated with Senstend was 2.6 minutes, compared with 0.8 minutes in those using placebo; in the second study,
U prvom je ispitivanju prosječno vrijeme koje je proteklo do ejakulacije u bolesnika koji su primijenili Senstend iznosilo 2,6 minuta, u usporedbi s 0,8 minuta u bolesnika koji su primili placebo.
How is Senstend used?
Kako se Senstend primjenjuje?
The effectiveness of Senstend has been shown in two main studies involving 256 and 300 heterosexual adult men with premature ejaculation, respectively; both studies compared the medicine with a placebo (dummy) spray over 12 weeks.
Učinkovitost lijeka Senstend utvrđena je u dva glavna ispitivanja koja su uključivala 256, odnosno 300 heteroseksualnih odraslih muškaraca s preuranjenom ejakulacijom.
For the full list of side effects reported with Senstend, see the package leaflet.
Potpuni popis zabilježenih nuspojava povezanih s lijekom Senstend potražite u uputi o lijeku.
The response was sustained for at least 48 weeks;
Reakcija je održavana barem 48 tjedana;
This was switched to a full marketing authorisation on 14 July 2009.
To je odobrenje pretvoreno u potpuno odobrenje za stavljanje u promet 14. srpnja 2009.
Further information on Isentress can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Više informacija o lijeku Isentress možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Therefore, the effectiveness observed in adults is also expected in children.
Stoga se učinak utvrđen kod odraslih također očekuje i kod djece.
Isentress was as effective as efavirenz.
Isentress je bio jednako djelotvoran kao efavirenz.
When the enzyme is blocked, the virus cannot reproduce normally, slowing down the spread of infection.
Kada je taj enzim blokiran, virus se ne može normalno razmnožavati što usporava širenje infekcije.
Equivalent doses of these different forms do not all produce the same levels of raltegravir in the body, so they must not be used interchangeably.
Jednake doze različitih oblika lijeka ne proizvode iste razine raltegravira u tijelu te ih se ne smije naizmjence koristiti.
Side effects in children were comparable to those in adults.
Nuspojave u djece bile su usporedive s onima u odraslih.
This study looked at viral loads after 24 and 48 weeks.
U ispitivanju je istraživano virusno opterećenje nakon 24 i 48 tjedana.
What measures are being taken to ensure the safe and effective use of Isentress?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Isentress?
Isentress has been studied in six main studies.
Isentress je ispitan u šest glavnih ispitivanja:
Isentress received a conditional marketing authorisation valid throughout the European Union for Isentress on 20 December 2007.
Isentress je dobio uvjetno odobrenje za stavljanje u promet koje je za lijek Isentress na snazi u Europskoj uniji od 20. prosinca 2007.
• Two studies involved a total of 699 ‘treatment-experienced' patients who were already receiving treatment for HIV infection that was not working.
• dva su ispitivanja uključivala ukupno 699 bolesnika „s iskustvom terapije” koji su već primali terapiju za infekciju HIV-om koja nije djelovala.
Side effects reported with Isentress are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Isentress pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
What is Isentress and what is it used for?
Što je Isentress i za što se koristi?
• A fourth study in 802 patients who had not taken HIV treatment before showed that giving Isentress as a single dose of 1,200 mg once daily was as effective as giving 400 mg twice daily.
• četvrto ispitivanje na 802 bolesnika koji prethodno nisu bili liječeni protiv HIV-a pokazalo je da je primjena lijeka Isentress kao jednokratne dnevne doze od 1.200 mg jednako djelotvorna kao doza od 400 mg dva puta dnevno.
The medicine is available as tablets to be swallowed (400 and 600 mg), chewable tablets (25 and 100 mg) and sachets containing granules for an oral suspension (each sachet containing 100 mg).
Lijek je dostupan u obliku tableta koje se uzimaju na usta (400 mg i 600 mg), tableta topivih u ustima (25 mg i 100 mg) i vrećica koje sadrže granule za oralnu suspenziju (svaka vrećica sadrži 100 mg).
Isentress does not cure HIV infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Isentress ne liječi infekciju HIV-om niti AIDS, ali može odgoditi oštećenje imunosnog sustava te razvoj infekcija i bolesti povezanih sa AIDS-om.
The most common serious side effects are immune reconstitution syndrome (symptoms of infection caused by a recovering immune system) and rash.
Najčešće ozbiljne nuspojave su imunološki rekonstitucijski sindrom (simptomi infekcije uzrokovani imunosnim sustavom u oporavku) i osip.
The main measure of effectiveness was the number of patients who had ‘undetectable' viral loads (below 50 copies per millilitre of blood) after 48 weeks.
Glavno mjerilo djelotvornosti bio je broj bolesnika koji su imali „neutvrdivo” virusno opterećenje (manje od 50 kopija na mililitar krvi) nakon 48 tjedana.
The European Medicines Agency therefore decided that Isentress'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 lijeka Isentress nadmašuju s njim povezane rizike te da se može izdati odobrenje za njegovu primjenu u EU-u.
The granules are to make a mixture for babies and children to drink, the chewable tablets are for bigger children, and the 400- and 600-mg tablets are for different dose regimens in older children and adults, as recommended by the doctor.
Granule se koriste za mješavinu za bebe i djecu koja se pije, tablete topive u ustima su za veću djecu, a tablete od 400 mg i 600 mg su za različita doziranja za stariju djecu i odrasle, prema preporuci liječnika.
As for all medicines, data on the use of Isentress are continuously monitored.
Kao za sve lijekove, podatci o primjeni lijeka Isentress kontinuirano se prate.
Patients also received the medicine Truvada (emtricitabine with tenofovir disoproxil).
Bolesnici su također dobivali lijek Truvada (emtricitabin s tenofovir disoproksilom).
• A sixth study included 26 children aged 4 weeks to 2 years who were given Isentress oral granules made into a suspension.
• šesto ispitivanje uključivalo je 26-ero djece u dobi od četiri tjedna do dvije godine koja su primala Isentress kao granule od kojih se priprema oralna suspenzija.
• Additional supportive studies established doses that provide similar effective levels of Isentress in newborn infants as in young children.
• Dodatnim potpornim ispitivanjima utvrđene su doze koje uzrokuju slične razine učinka kao i lijek Isentress u novorođenčadi i male djece.
• A third study involved 566 patients who had not taken HIV treatment before and compared Isentress with efavirenz (another HIV medicine).
• treće je ispitivanje uključivalo 566 bolesnika koji prethodno nisu bili liječeni protiv HIV-a i usporedilo Isentress s efavirenzom (drugim lijekom protiv HIV-a).
Why is Isentress authorised in the EU?
Zašto je lijek Isentress odobren u EU-u?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Isentress have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Isentress nalaze se u sažetku opisa svojstava i u uputi o lijeku.
• Isentress has also been studied in a fifth study involving 126 HIV-1 infected children between 2 and 18 years whose existing treatment for HIV infection was not working.
• Isentress je također ispitivan u petom ispitivanju koje je uključivalo 126-ero djece u dobi od 2 do 18 godina zaražene virusom HIV-1 koja nisu reagirala na postojeću terapiju protiv infekcije HIVom.
The active substance in Isentress, raltegravir, is an integrase inhibitor.
Djelatna tvar lijeka Isentress, raltegravir, inhibitor je integraze.
All of the patients also took tenofovir and emtricitabine (other HIV medicines).
Svi su bolesnici također uzimali tenofovir i emtricitabin (drugi lijekovi protiv HIV-a).
The studies compared Isentress with placebo (a dummy treatment), which were added to ‘optimised background therapy' (a combination of other HIV medicines chosen for each patient as it had the best chances of reducing the levels of HIV in the blood).
U ispitivanjima je Isentress uspoređen s placebom (prividnim liječenjem) koji je dodan „optimiziranoj potpornoj terapiji” (kombinaciji drugih lijekova protiv HIV-a odabranih za svakog bolesnika koji imaju najveće šanse za smanjenje razina HIV-a u krvi).
Isentress treatment led to a reduction in viral load and after 48 weeks 53% of the children had viral loads below 50 copies/ml.
Terapija lijekom Isentress dovela je do smanjenja virusnog opterećenja i nakon 48 tjedana 53 % djece imalo je virusno opterećenje manje od 50 kopija/ml.
After 48 weeks, 89% (472 of 531) of those on the once daily dose and 88% (235 of 266) of those taking Isentress twice daily had viral loads less than 40 copies/ml;
Nakon 48 tjedana, kod 89 % (472 od 531) bolesnika koji su bili na jednokratnoj dnevnoj dozi i 88 % (235 od 266) onih koji su primali Isentress dva puta dnevno virusno opterećenje bilo je manje od 40 kopija/ml;
For more information about using Isentress see the package leaflet or contact your doctor or pharmacist.
Više informacija o primjeni lijeka Isentress pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
The most common side effects with Isentress (seen in between 1 and 10 patients in 100) are headache, abdominal pain (stomach ache) and nausea (feeling sick).
Najčešće nuspojave lijeka Isentress (utvrđene kod 1 do 10 na 100 bolesnika) su glavobolja, bol u abdomenu (bol u trbuhu) te mučnina (slabost).
What are the risks associated with Isentress?
Koji su rizici povezani s lijekom Isentress?
Isentress is an HIV medicine that is used in combination with other HIV medicines to treat patients who are infected with human immunodeficiency virus (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Isentress je lijek protiv HIV-a koji se koristi u kombinaciji s drugim lijekovima protiv HIV-a za liječenje bolesnika zaraženih virusom humane imunodeficijencije (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
The study showed that Isentress, given as tablets to be swallowed or chewable tablets, was safe in children and levels of the medicine obtained in the blood in children were similar to those obtained in adults.
Ispitivanje je pokazalo da je primjena lijeka Isentress u obliku tableta za gutanje ili tableta za žvakanje sigurna u djece te su razine lijeka u krvi djece bile slične razinama u krvi odraslih.
Isentress can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Isentress se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u liječenju infekcije HIV-om.
It blocks an enzyme called integrase, which is involved in a step in the reproduction of HIV.
Blokira enzim naziva integraza, uključenog u dio reprodukcije HIV-a.
After 48 weeks, 86% of the patients taking Isentress had viral loads below 50 copies/ml (241 out of 281), compared with 82% of those taking efavirenz (230 out of 282);
Nakon 48 tjedana, kod 86 % bolesnika koji su uzimali Isentress virusno je opterećenje bilo manje od 50 kopija/ml (241 od 281), u usporedbi s 82 % bolesnika koji su uzimali efavirenz (230 od 282);
Other information about Isentress:
Ostale informacije o lijeku Isentress
There have also been uncommon reports of rhabdomyolysis (breakdown of muscle fibres).
Također je rjeđe prijavljena rabdomioliza (razgradnja mišićnih vlakana).
How is Isentress used?
Kako se Isentress koristi?
Isentress has been shown to be effective in helping control HIV when used with other HIV medicines.
Lijek Isentress pokazao se djelotvornim kao pomoć u kontroliranju HIV-a u kombinaciji s drugim lijekovima protiv HIV-a.
An overview of Isentress and why it is authorised in the EU
Pregled informacija o lijeku Isentress i razlozima njegova odobrenja u EU-u
How does Isentress work?
Kako djeluje Isentress?
Isentress, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Kad se uzima u kombinaciji s najmanje još jednim lijekom protiv HIV-a, Isentress smanjuje koncentraciju HIV-a u krvi i održava je na niskoj razini.
What benefits of Isentress have been shown in studies?
Koje su koristi lijeka Isentress utvrđene u ispitivanjima?
For the full list of side effects and restrictions with Isentress, see the package leaflet.
Potpuni popis svih nuspojava i ograničenja zabilježenih pri primjeni lijeka Isentress potražite u uputi o lijeku.
The main measure of effectiveness was the reduction in the levels of HIV in the blood (viral load) after 16 weeks; 77% of the patients who took Isentress had viral loads below 400 copies/ml after 16 weeks, compared with 42% of those who took placebo.
Od bolesnika koji su uzimali Isentress, kod 77 % je virusno opterećenje bilo ispod 400 kopija/ml nakon 16 tjedana, u usporedbi s 42 % onih koji su uzimali placebo.
LOT {number}
Lot {broj}
Once broached, use by ….
Jednom otvorenu, upotrijebiti do…
Do not broach more than 50 times.
Nemojte bušiti poklopac više od 50 puta.
Date of last renewal: 09/08/2016
Datum posljednjeg produljenja odobrenja: 09/08/2016
• Other conditions
• Ostali uvjeti
The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No. 37/2010 indicates that no MRLs are required.
Pomoćne tvari navedene u dijelu 6.1 SPC su dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno.
Marketing authorisation holder and manufacturer responsible for batch release: Bimeda Animal Health Limited,
Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet: Bimeda Animal Health Limited,
The MAH must ensure that the system of pharmacovigilance, as described in Part 1 of the marketing authorisation application, is in place and functioning before and whilst the product is on the market.
Nositelj odobrenja treba osigurati da je sustav farmakovigilancije, kako je opisano u Dijelu I zahtjeva za izdavanje odobrenja, uspostavljen i funkcionalan prije i za vrijeme stavljanja veterinarsko medicinskog proizvoda u promet.
Excipient: Ethanol 99.9% 150 mg
Pomoćna tvar: Etanol 99,9 % 150 mg
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams) ATCvet code: QM01AC06
Farmakoterapijska skupina: protuupalni i protureumatski proizvodi, nesteroidi (oksikami) ATKvet kod: QM01AC06
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
U nedostatku ispitivanja kompatibilnosti ovaj veterinarsko medicinski proizvod se ne smije miješati s drugim veterinarsko-medicinskim proizvodima.
The active substance in Recocam 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:
Djelatna tvar u Recocam 20 mg/ml otopina za injekcije za goveda, svinje i konje, meloksikam je dopuštena tvar kako je navedeno u tablici 1 Dodatka Uredbe Komisije (EU) br. 37/2010:
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and vial after “EXP”.
Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i bočici poslije EXP.
Antiinflammatory agents/Nonsteroidal antiinflammatory agents
Protuupalna sredstva/nesteroidna protuupalna sredstva
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13/09/2011
Datum prvog odobrenja: 13/09/2011
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
I DOSEGA DJECE" Čuvati izvan pogleda i dosega djece.
A slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Lagano prolazno oticanje na mjestu uboda nakon subkutane primjene opaženo je u manje od 10% goveda liječenih u sklopu kliničkih ispitivanja.
Cattle: SC, IV
Goveda: s.c., i.v.
People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Osobe preosjetljive na nesteroidne protuupalne lijekove (NSAID) moraju izbjegavati doticaj s ovim veterinarsko-medicinskim proizvodom.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.
Za pomoćnu terapiju u liječenju puerperalne septikemije i toksemije (sindrom mastitis-metritisagalakcija) uz odgovarajuću antibiotsku terapiju.
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Ne primjenjivati istodobno s glukokortikosteroidima, drugim nesteroidnim protuupalnim lijekovima ili s antikoagulacijskim sredstvima.
STATEMENT OF THE MRLS
C. IZVJEŠĆE O MRL
Vials contain 10 ml, 50 ml or 100 ml.
Bočice su veličine 10 ml, 50 ml ili 100 ml.
Cattle and pigs:
Goveda i svinje:
For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculoskeletal disorders, oral suspensions of meloxicam may be used for continuation of treatment at a dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.
Za ublažavanje upale i olakšavanje bola u akutnim kroničnim mišićno-koštanim poremećajima, meloksikama oralna suspenzija može se upotrijebiti za nastavak liječenja u dozi od 0,6 mg meloksikama/kg tjelesne težine, 24 sata nakon primjene injekcije.
MANUFACTURER'S BATCH NUMBER LOT {number}
BROJ PROIZVODNE SERIJE Lot {broj}
Excipient: Ethanol
Etanol
4.7 Use during pregnancy, lactation or lay
4.7 Primjena tijekom graviditeta, laktacije ili nesenja Graviditet i laktacija:
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
6.6 Posebne mjere predostrožnosti za odlaganje neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima.
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.
Nakon dvije intramuskularne doze od 0,4 mg meloksikama/kg, vrijednost Cmax od 1,9 µg/ml dosegnuta je u svinja nakon 1 sata.
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values 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.
Nakon jedne subkutane doze od 0,5 mg meloksikama/kg, vrijednosti Cmaxod 2,1 µg/ml i 2,7 µg/ml postignute su nakon 7,7 te nakon 4 sata u mladih goveda i krava u razdoblju laktacije.
MARKETING AUTHORISATION NUMBERS EU/2/11/133/001-003
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/11/133/001-003
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Podrobnije informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
13. POSEBNE MJERE PREDOSTROŽNOSTI ZA ODLAGANJE NEUPOTREBLJENOG PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard Box: 10 ml, 50 ml or 100 ml vials
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija: bočice od 10 ml, 50 ml ili 100 ml
Pigs: IM
Svinje: i.m.
Pack size of 1 Type I clear glass vial with Teflon coated bromobutyl rubber stoppers and sealed with an aluminium flip-off tear-off seal.
I s teflonskim premazom bromobutil gumenim čepovima i zapečaćena s aluminijskim (tear off / flip off) zatvaračem.
Bimeda Animal Health Limited, 2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland.
Bimeda Animal Health Limited, 2, 3 & 4 Airton Close, Tallaght, Dublin 24, Irska.
METHOD AND ROUTE(S) OF ADMINISTRATION Cattle: SC, IV
PUT(EVI) PRIMJENE Goveda: s.c., i.v.
Meglumine
NUSPOJAVE
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING UNITS Glass vial label for 50 ml and 100 ml
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Etiketa za staklenu bočicu od 50 ml i 100 ml
QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 20 mg/ml
KOLIČINA DJELATNE(IH) TVARI) Meloksikam 20 mg/ml
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
U slučaju da se nehotice samo injiciranja, odmah potražiti pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life after first opening the immediate packaging: 28 days 6.4.
Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 3 godine.
• Conditions or restrictions with regard to the safe and effective use of the medicinal product
• Uvjeti i ograničenja s obzirom na neškodljivu i djelotvornu primjenu
MRLs Target tissues
MRL Ciljna tkiva Ostale odredbe
Active substance: Meloxicam20 mg
Djelatna tvar: Meloksikam 20 mg
Horses: IV
Konji: i.v.
• Conditions or restrictions regarding supply and use imposed on the marketing authorisation holder
• Uvjeti ili ograničenja odobrenja za stavljanje u promet u pogledu opskrbe i primjene Veterinarsko-medicinski proizvod se izdaje na veterinarski recept.
Single subcutaneous or intravenous injection at a dosage 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.
Goveda Jedna subkutana ili intravenska injekcija u dozi od 0,5 mg meloksikama/kg tjelesne težine (tj. 2,5 ml/100 kg tjelesne težine) u kombinaciji s antibiotskom terapijom ili oralnom rehidracijskom terapijom, kako je odgovarajuće.
Single intramuscular injection at a dose of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate.
Jedna intramuskularna injekcija u dozi od 0,4 mg meloksikama/kg tjelesne težine (tj. 2,0 ml/100 kg tjelesne težine) u kombinaciji s antibiotskom terapijom, kako je odgovarajuće.
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
- etanol 99,9 % - Anhidrirana limunska kiselina - poloksamer 188 - makrogol 300 - glicin - natrijev hidroksid (za regulaciju pH) - hidroklorna kiselina (za regulaciju pH) - meglumin - voda za injekcije
Cattle: meat and offal: 15 days; milk: 5 days Pigs: meat and offal: 5 days
Goveda: Meso i jestive iznutrice: 15 dana; mlijeko: 5 dana Svinje: Meso i jestive iznutrice: 5 dana Konji:
Special precautions to be taken by the person administering the veterinary medicinal product to animals Accidental self-injection may give rise to pain.
Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama
Horses: meat and offal: 5 days.
Konji: meso i jestive iznutrice 5 dana.
Pregnancy and lactation:
Graviditet i laktacija: Goveda i svinje:
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vial label for 10 ml
OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA