natgillin/translations-raw huggingface dataset:
The phase II trial, study YU203, randomised 402 subjects with active rheumatoid arthritis to placebo (n=102), leflunomide 5 mg (n=95), 10 mg (n=101) or 25 mg/day (n=104).
U ispitivanju faze II, YU203, 402 randomizirana bolesnika s aktivnim reumatoidnim artritisom dobivala su placebo (n=102), leflunomid 5 mg/dan (n=95), 10 mg/dan
Tell your doctor immediately and stop taking Leflunomide Teva: - If you feel weak, light-headed or dizzy or have difficulty breathing, as these may be signs of a
Ako osjetite slabost, ošamućenost ili omaglicu ili imate poteškoće s disanjem jer to mogu biti
- Severe liver damage (i.e. liver failure, liver necrosis), which may be fatal.
- teško oštećena funkcija jetre (zatajenje jetre ili nekroza) koja može biti opasna po život.
Immune system disorders severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous hypokalaemia, hyperlipidemia, hypophosphataemia paraesthesia, headache, dizziness, peripheral neuropathy
Manje često: hipokalijemija, hiperlipidemija, hipofosfatemija parestezija, glavobolja, omaglica, periferna neuropatija
Both colestyramine and activated powdered charcoal may influence the absorption of oestrogens and progestogens such that reliable contraception with oral contraceptives may not be guaranteed during the washout procedure with colestyramine or activated powdered charcoal.
Stoga se kontracepcija oralnim kontraceptivima ne može smatrati pouzdanom tijekom postupka eliminacije u kojima se primjenjuje kolestiramin ili aktivni ugljen u prahu.
Absorption
Eliminacija
Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97 00 7
Österreich ratiopharm Arzneimittel Vertriebs-GmbH
Human pharmacology
Pedijatrijska populacija
- If you get any side effects , talk to your doctor, pharmacist or nurse.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex
Some vaccinations should not be given while taking Leflunomide Teva, and for a certain amount of time after stopping treatment.
Za vrijeme uzimanja Leflunomida Teva kao i određeno vrijeme nakon prekida liječenja ne smije se provoditi cijepljenje određenim cjepivima.
SPECIAL STORAGE CONDITIONS Do not store above 25°C
Ne čuvati na temperaturi iznad 25°C
All elevations resolved, 2 with continuation of both drugs and 3 after discontinuation of leflunomide.
Sve su se povišene vrijednosti smanjile u 2 bolesnika koji su nastavili istodobno uzimati oba lijeka i u 3
Leflunomide at a daily dose of at least 10 mg (10 to 25 mg in study YU203, 20 mg in studies MN301 and US301) was statistically significantly superior to placebo in reducing the signs and symptoms of rheumatoid arthritis in all 3 placebo-controlled trials.
MN301 i US301) bio je statistički značajno bolji u odnosu na placebo u smanjivanju znakova i simptoma reumatoidnog artritisa u sva 3 placebom-kontrolirana ispitivanja.
Dark beige, triangle shaped, film-coated tablets, engraved with ”20” on one side and “L” on the other.
Tamnobež, filmom obložene tablete, u obliku trokuta, s oznakom „20“ utisnutom na jednoj strani i „L“
In such cases re-exposure to leflunomide is contra-indicated (see
U tim je slučajevima neophodna potpuna eliminacija lijeka, a ponovno uzimanje leflunomida je kontraindicirano (vidjeti dio 4.3.).
- unusual tingling, weakness or pain in your hands or feet as these may indicate problems with your nerves (peripheral neuropathy).
- Neuobičajenih trnaca, slabosti li bolova u šakama ili stopalima jer mogu upućivati na probleme sa
Leflunomide Teva 20 mg film-coated tablets
Leflunomid Teva 20 mg filmom obložene tablete
4.4 Special warnings and precautions for use Concomitant administration of hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) is not advisable.
Ne preporučuje se istodobna primjena hepatotoksičnih ili hematotoksičnih DMARD-a (npr.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of leflunomide.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 10 mg leflunomida.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of leflunomide.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 20 mg leflunomida.
- Vomiting.
- mučnina; - povraćanje;
- Hedache.
- proljev;
NAME OF THE MEDICINAL PRODUCT Leflunomide Teva 20 mg film-coated tablets
NAZIV GOTOVOG LIJEKA Leflunomid Teva 20 mg filmom obložene tablete
SPECIAL STORAGE CONDITIONS Do not store above 30°C
Ne čuvati na temperaturi iznad 30°C
toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Vrlo rijetko: toksična epidermalna nekroliza, Stevens-Johnsonov sindrom, multiformni eritem kožni eritemski lupus, pustularna psorijaza ili pogoršanje psorijaze
Uncommon side effects (may affect up to 1 in 100 people) - Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness - Mild reduction in blood platelets, which increases the risk of bleeding or bruising.
Manje česte nuspojave (mogu se javiti u 1 od 100 ljudi): - smanjeni broj crvenih krvnih stanica što može uzrokovati bljedoću kože te slabost i otežano
NAME OF THE MEDICINAL PRODUCT Leflunomide Teva 10 mg film-coated tablets
NAZIV GOTOVOG LIJEKA Leflunomid Teva 10 mg filmom obložene tablete
Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that A771726, the primary metabolite of leflunomide, is not dialysable.
Studije s hemodijalizom i kroničnom ambulantnom peritonealnom dijalizom upućuju da se A771726,
Your doctor may recommend a treatment to remove Leflunomide Teva rapidly and sufficiently from your body.
Ako liječnik potvrdi trudnoću, može preporučiti liječenje određenim lijekovima za brzo i djelotvorno izlučivanje Leflunomida Teva iz organizma, što može
Especially if you are taking any of the following: - Any other medicine used to treat rheumatoid arthritis, e.g. methotrexate and azathioprine (immunosuppressants), chloroquine and hydroxychloroquine (antimalarials), gold (by mouth or injection), and D-penicillamine.
(imunosupresivni lijekovi), klorokin i hidroksiklorokin (antimalarici), zlato (kroz usta ili injekcijom) i D-penicilamin.
Leflunomide Teva contains lactose.
Sadrži djelatnu tvar leflunomid.
Discuss with your doctor to find out if any medicine you are taking is broken down by CYP2C9.
Upitajte svog liječnika razgrađuje li se neki od lijekova koji uzimate putem enzima
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Nositelj odobrenja za stavljanje gotovog lijeka u promet:
Rare side effects (may affect up to 1 in 1,000 people) - Severe reduction in blood cells which can cause weakness, bruising or make infections more - Severe reduction in the number of white blood cells, which makes infections more likely
Rijetke nuspojave (mogu se javiti u 1 od 1000 ljudi): - značajno smanjenje broja svih krvnih stanica, što može uzrokovati slabost, nastajanje modrica ili
Study US301 randomised 482 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=182), methotrexate 7.5 mg/week increasing to 15 mg/week (n=182), or placebo (n=118).
U studiji US301, 482 randomizirana bolesnika s aktivnim reumatoidnim artritisom primala su leflunomid 20 mg/dan (n=182), metotreksat 7,5 mg/tjedan, s povećanjem doze na 15 mg/tjedan (n=
- Abdominal pain.
- pojačan gubitak kose;
Leflunomide Teva 10 mg film-coated tablets
Leflunomid Teva 10 mg filmom obložene tablete
In this trial, the loading dose and maintenance dose of leflunomide was based on three weight categories: < 20 kg, 20-40 kg, and > 40 kg. After 16 weeks treatment, the difference in response rates was statistically significant in favour of methotrexate for the JRA Definition of Improvement (DOI) ≥ 30 % (p = 0.02).
U ovom su se ispitivanju udarna doza i doza održavanja leflunomida zasnivale na 3 kategorije tjelesne težine: <20 kg, 20-40 kg i >40 kg.
The concentration may be expected to decrease below 0.02 mg/l about 2 years after stopping the treatment
Smanjenje koncentracije A771726 u plazmi na razinu nižu od 0,02 mg/l očekuje se za oko dvije godine nakon prekida liječenja leflunomidom.
The active metabolite A771726 is extensively protein bound and cleared via hepatic metabolism and biliary secretion.
A771726 ekstenzivno se veže za proteine plazme i uklanja jetrenim metabolizmom te izlučuje putem žuči.
NAME OF THE MARKETING AUTHORISATION HOLDER
IME NOSITELJA
Pharmacovigilance system
Postmarketinške studije
hepatitis, jaundice/cholestasis
anemija, leukopenija, svrbež i osip.
Deutschland Teva GmbH Tel: (49) 731 402 08
Teva Italia S.r.l. Tel: +(39) 028917981
Pack sizes of 30 and 100 film-coated tablets.
Veličine pakovanja od 30 i 100
Common side effects (may affect up to 1 in 10 people) - Mild increase in blood pressure.
Česte nuspojave (mogu se javiti u 1 od 10 ljudi):
Very rare side effects (may affect up to 1 in 10,000 people) - An infection characterised by high fever, sore throat, skin lesions and an extreme reduction of white blood cells (agranulocytosis).
Česte nuspojave (mogu se javiti u 1 od 10 ljudi): - smanjeni broj bijelih krvnih stanica, što povećava sklonost razvoju infekcija (leukopenija); - kožne reakcije, npr. osjećaj pečenja i bockanja, svrbež ili trnci (parestezija);
Leflunomide Teva tablets
filmom obloženih tableta.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product
Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
Medicinal product subject to medical prescription.
NAZIV GOTOVOG LIJEKA
- If you are male and wish to father a child. As it cannot be excluded that Leflunomide Teva passes into semen, reliable contraception should be used during treatment with Leflunomide Teva.
Teva u sjeme, tijekom terapije Leflunomidom Teva treba primjenjivati učinkovitu kontracepciju.
EU/1/11/675/007 100 film-coated tablets
BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/11/675/006 30 filmom obloženih tableta EU/1/11/675/007 100 filmom obloženih tableta
Male patients should be aware of the possible male-mediated foetal toxicity.
Planiranje obitelji (preporuke za muškarce) Muški bolesnici moraju biti svjesni da mogu biti posrednici u pojavi fetalne toksičnosti.
The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after
Kad se razmišlja o primjeni živih atenuiranih cjepiva nakon prekida liječenja Leflunomidom Teva, treba uzeti u obzir
Similarly, recent treatment with hepatotoxic or haematotoxic medicinal products (e.g. methotrexate) may result in increased side effects; therefore, the initiation of leflunomide treatment has to carefully be considered regarding these benefit/risk aspects and closer monitoring is recommended in the initial
Isto tako, nedavno provedeno liječenje hepatotoksičnim ili hematotoksičnim lijekovima (npr. metotreksatom) može dovesti do pojave većeg broja nuspojava.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some
Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe)
EU/1/11/675/002 100 film-coated tablets
BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/11/675/001 30 filmom obloženih tableta EU/1/11/675/002 100 filmom obloženih tableta
- Diarrhoea.
Aktivni metabolit
In a study with radiolabelled
Zbog ekstenzivnog vezanja za bjelančevine
Skin and subcutaneous tissue disorders Common:
Poremećaji mišićno-koštanog sustava i vezivnog tkiva
- An increase of certain enzymes in the blood (creatine phosphokinase).
- bol, oticanje i osjetljivost, najčešće u šakama ili ručnim zglobovima; - porast koncentracije određenih enzima u krvi (kreatin fosfokinaze);
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku,
cutaneous lupus erythematosus, pustular psoriasis or worsening psoriasis Musculoskeletal and connective tissue disorders
psorijaza (novonastala psorijaza ili pogoršanje psorijaze).
mild allergic reactions severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous hypokalaemia, hyperlipidemia, hypophosphataemia paraesthesia, headache, dizziness, peripheral neuropathy
Vrlo rijetko: teške anafilaktične/anafilaktoidne reakcije, vaskulitis, uključujući kožni nekrotizirajući
Respiratory, thoracic and mediastinal disorders interstitial lung disease (including interstitial pneumonitis), which may be fatal diarrhoea, nausea, vomiting, oral mucosal disorders (e.g., aphthous stomatitis,
leukopenija, parestezija, glavobolja, omaglica, proljev, mučnina, povraćanje, poremećaji sluznice usne šupljine (npr. aftozni stomatitis, ulceracije u ustima), bol u trbuhu, pojačani gubitak kose, ekcem, osip (uključujući makulopapulozni osip), svrbež, suha koža, tenosinovitis, povećanje CPK, anoreksija,
leucopenia (leucocytes > 2 G/l)
0,02 mg/l (vidjeti dio 4.6.).
Danmark
Mađarska
Entresto tablets are taken twice a day.
Tablete lijeka Entresto uzimaju se dva puta na dan.
The doctor may choose lower doses for certain patients.
Liječnik može propisati niže doze određenim bolesnicima.
In general, patients were monitored for about 27 months, during which they took the medicine for about 24 months on average.
Bolesnike se u pravilu nadziralo otprilike 27 mjeseci tijekom kojih su u prosjeku uzimali lijek otprilike 24 mjeseca.
The full EPAR and risk management plan summary for Entresto can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Entresto nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended starting dose is one tablet of Entresto 49 mg / 51 mg twice a day and the dose is then doubled after 2 to 4 weeks to 97 mg / 103 mg twice a day.
Preporučena početna doza je jedna tableta lijeka Entresto od 49 mg / 51 mg dva puta na dan, a doza se zatim nakon dva do četiri tjedna udvostručuje na 97 mg / 103 mg dva puta na dan.
Other information about Entresto
Ostale informacije o lijeku Entresto
Entresto sacubitril / valsartan
Entresto sakubitril/valsartan
Why is Entresto approved?
Zašto je Entresto odobren?
What measures are being taken to ensure the safe and effective use of Entresto?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Entresto?
It is not intended to provide practical advice on how to use Entresto.
Svrha sažetka nije davati praktične savjete o korištenju lijeka Entresto.
Entresto is available as tablets (24 mg sacubitril / 26 mg valsartan, 49 mg sacubitril / 51 mg valsartan, and 97 mg sacubitril / 103 mg valsartan).
Entresto je dostupan u obliku tablete (24 mg sakubitrila / 26 mg valsartana, 49 mg sakubitrila / 51 mg valsartana i 97 mg sakubitrila / 103 mg valsartana).
What is Entresto and what is it used for?
Što je Entresto i za što se koristi?
The study was stopped early because there was compelling evidence that Entresto was more effective than enalapril.
Ispitivanje je prekinuto u ranoj fazi zbog uvjerljivih dokaza da je Entresto djelotvorniji od enalaprila.
This is a summary of the European public assessment report (EPAR) for Entresto.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Entresto.
Entresto can only be obtained with a prescription.
Entresto se izdaje samo na liječnički recept.
A risk management plan has been developed to ensure that Entresto is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Entresto.
It must not be taken by patients who have suffered angioedema, those who have severe liver disease or by women who are pregnant.
Ne smiju ga uzimati bolesnici koji su imali angioedem, oni koji boluju od teške bolesti jetre i trudnice.
Valsartan is an ‘angiotensin-II-receptor antagonist', which means that it blocks the action of a hormone called angiotensin II.
Valsartan je „antagonist receptora angiotenzina II”, što znači da sprečava djelovanje hormona angiotenzin II.
Entresto must not be taken with medicines known as ACE inhibitors (which are used to treat heart failure and high blood pressure).
Entresto se ne smije uzimati s lijekovima poznatima kao ACE inhibitori (koji se koriste za liječenje zatajenja srca i visokog krvnog tlaka).
What are the risks associated with Entresto?
Koji su rizici povezani s lijekom Entresto?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Entresto's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Entresto nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
A potentially severe side effect, angioedema (rapid swelling of deeper skin tissues as well as the tissues around the throat, causing breathing difficulty), can occur uncommonly (affecting fewer than 1 in 100 people).
Moguća ozbiljna nuspojava, odnosno angioedem (brzo oticanje dubljih kožnih tkiva i tkiva oko grla, što dovodi do otežanog disanja), rijetko se pojavljuje (javlja se u manje od 1 na 100 osoba).
Sacubitril blocks the breakdown of natriuretic peptides produced in the body.
Sakubitril sprečava raspadanje natriuretskih peptida koji se proizvode u tijelu.
The effects of angiotensin II can be harmful in patients with heart failure.
Učinci hormona angiotenzin II mogu biti štetni za bolesnike sa zatajenjem srca.
It is used in adults with long-term heart failure who have symptoms of the disease.
Upotrebljava se u odraslih osoba s kroničnim zatajenjem srca koji imaju simptome te bolesti.
The two active substances in Entresto, sacubitril and valsartan, work in different ways.
Dvije djelatne tvari u lijeku Entresto, sakubitril i valsartan, djeluju na različite načine.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Entresto, including the appropriate precautions to be followed by healthcare professionals and patients.
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Entresto nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
Entresto is a heart medicine that contains the active substances sacubitril and valsartan.
Entresto je lijek za srce koji sadrži djelatne tvari sakubitril i valsartan.
In the group treated with Entresto, 21.8% (914 of 4,187) patients either died as a result of heart and circulation problems or were admitted to hospital with heart failure compared to 26.5% (1,117 of 4,212) patients treated with enalapril.
Za razliku od 26,5 % bolesnika (1 117 od 4 212) liječenih enalaprilom, u skupini bolesnika liječenih lijekom Entresto 21,8 % bolesnika (914 od 4 187) umrlo je od srčanih i problema i problema s cirkulacijom ili je primljeno u bolnicu zbog zatajenja srca.
The most common side effects with Entresto (which may affect more than 1 in 10 people) are high blood potassium levels, low blood pressure and the kidneys working less well.
Najčešće nuspojave lijeka Entresto (mogu se javiti u više od 1 na 10 osoba) su visoka razina kalija u krvi, niski krvni tlak i lošiji rad bubrega.
Natriuretic peptides also reduce blood pressure and protect the heart from developing fibrosis (scar tissues) that occurs in heart failure.
Natriuretski peptidi također smanjuju krvni tlak i štite srce od nastanka fibroze (ožiljkasto tkivo) koja se javlja pri zatajenju srca.
Valsartan, one of the active substances in the medicine, is well established for the treatment of high blood pressure and heart failure; its side effects are well known.
Poznato je da se valsartan, jedna od djelatnih tvari lijeka, koristi za liječenje visokog krvnog tlaka i zatajenja srca; dobro su poznate i njegove nuspojave.
Heart failure is the inability of the heart to pump enough blood around the body.
Zatajenje srca stanje je pri kojemu srce ne može istisnuti dovoljnu količinu krvi kroz tijelo.
By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone's harmful effects on the heart and it also reduces blood pressure by allowing blood vessels to widen.
Valsartan blokiranjem receptora na koje se angiotenzin II inače vezuje zaustavlja štetne učinke koje taj hormon ima na srce te također smanjuje krvni tlak omogućivanjem širenja krvnih žila.
Natriuretic peptides cause sodium and water to pass into the urine thereby reducing the strain on the heart.
Natriuretski peptidi uzrokuju ispuštanje natrija i vode u urin, čime se smanjuje pritisak na srce.
Patients in the study had long-term heart failure with symptoms of the disease and reduced ejection fraction (the proportion of blood leaving the heart).
U ispitivanju su sudjelovali bolesnici s kroničnim zatajenjem srca sa simptomima te bolesti i smanjenom ejekcijskom frakcijom (količina krvi koju istiskuje srce).
Entresto's serious side effects in the main study were similar to those of enalapril, which is already authorised for use in heart failure.
Ozbiljne nuspojave lijeka Entresto otkrivene u glavnom ispitivanju slične su onima enalaprila, koji je već odobren za primjenu pri zatajenju srca.
For further information, see the summary of product characteristic (also part of the EPAR).
Za dodatne informacije vidjeti sažetak opisa svojstava lijeka (također dio EPAR-a).
For more information about treatment with Entresto, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Entresto pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
The main study found that Entresto reduced deaths from heart and circulation problems or hospital admissions for heart failure.
Glavno je ispitivanje pokazalo da Entresto smanjuje broj smrtnih slučajeva uzrokovanih srčanim problemima i problemima s cirkulacijom te broj prijama u bolnicu zbog zatajenja srca.
How is Entresto used?
Kako se Entresto koristi?
What benefits of Entresto have been shown in studies?
Koje su koristi lijeka Entresto utvrđene u ispitivanjima?
For practical information about using Entresto, patients should read the package leaflet or contact their doctor or pharmacist.
Praktične informacije o korištenju lijeka Entresto pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
In the main study, Entresto was compared to enalapril, another medicine used for heart failure.
U glavnom je ispitivanju Entresto uspoređen s enalaprilom, drugim lijekom za zatajenje srca.
How does Entresto work?
Kako djeluje Entresto?
For the full list of all side effects reported with Entresto, see the package leaflet.
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Entresto potražite u uputi o lijeku.
All these reactions disappear within 6 days.
Sve ove reakcije nestaju unutar 6 dana.
Date of first authorisation: 07/11/2014.
Datum prvog odobrenja: 07/11/2014.
Protect from direct sunlight.
Zaštiti od direktnog sunčevog svjetla.
ATCvet code: QI09AL08.
ATCvet kod: QI09AL08
If such reactions occur, appropriate treatment is recommended.
Ukoliko se pojave takve reakcije preporuča se odgovarajuće liječenje.
In laboratory studies and field trials:
U laboratorijskim i terenskim ispitivanjima:
This veterinary medicinal product contains mineral oil.
Ovaj veterinarsko-medicinski proizvod sadrži mineralno ulje.
Avoid introduction of contamination.
Izbjegavati mogućnost kontaminacije.
Needle length and diameter should be adapted to the age of the animal.
Duljinu i promjer igle treba prilagoditi starosti životinje.
Light mineral oil
Svijetlo mineralno ulje
A-3500, Krems
A-3500, Krems Austria
Aluminium (as hydroxide)
Aluminij (hidroksid)
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Nema dostupnih podataka.