FrancophonIA/ELRC3.0 huggingface dataset:
English: ZOLVIX oral solution is a broad spectrum anthelmintic for the treatment and control of gastrointestinal nematode infections and associated diseases in sheep including lambs, hoggets, breeding rams and ewes.
Croatian: Peroralna otopina ZOLVIX je antihelmintik širokog spektra za liječenje i kontrolu probavnih infestacija nematodama i pridruženih bolesti ovaca uključujući janjce, omaše, rasplodne ovnove i ovce.
English: The veterinary medicinal product can be used in breeding sheep including pregnant and lactating ewes.
Croatian: Veterinarsko-medicinski proizvod može se koristiti u rasplodnih ovaca uključujući gravidne i dojne ovce.
English: RRR-α-tocopherol Beta-carotene
Croatian: RRR-α-tokoferol Beta-karoten
English: The veterinary medicinal product is administered as a single treatment.
Croatian: Veterinarsko-medicinski proizvod primjenjuje se kao pojedinačno liječenje.
English: To assure complete swallowing of this low volume solution, administer orally on the back of the tongue.
Croatian: Kako biste osigurali da životinja proguta svu otopinu malog volumena, primijenite je peroralno na stražnji kraj jezika.
English: Shelf life after first opening the container: 1 year.
Croatian: Rok valjanosti poslije prvog otvaranja spremnika: 1 godina.
English: Elanco France S.A.S 26 Rue de la Chapelle F-68330 Huningue France
Croatian: Elanco France S.A.S 26 Rue de la Chapelle F-68330 Huningue Francuska
English: To be supplied only on veterinary prescription.
Croatian: Izdaje se samo na veterinarski recept.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE Pročitati uputu o VMP prije primjene.
English: Monepantel is an anthelmintic belonging to the amino-acetonitrile derivative (AAD) class of molecules.
Croatian: Monepantel je antihelmintik koji pripada klasi derivata amino-acetonitrila (AAD).
English: Marketing authorisation holder: Elanco GmbH
Croatian: Nositelj odobrenja za stavljanje u promet: Elanco GmbH
English: Orange clear solution.
Croatian: Narančasta bistra otopina.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Croatian: Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama:
English: Monepantel acts on the nematode specific nicotinic acetylcholine receptor sub-unit HcoMPTL-1.
Croatian: Monepantel djeluje na podjedinicu specifičnog nikotinsko acetilkolinskog receptora nematoda, Hco-MPTL-1.
English: SPECIAL STORAGE CONDITIONS
Croatian: POSEBNI UVJETI ČUVANJA
English: 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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Croatian: Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko-medicinskim proizvodima.
English: In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju da se nehotice proguta, odmah potražiti pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
English: EXPIRY DATE EXP {month/year} Once opened use within 1 year.
Croatian: Jednom otvoren upotrijebiti unutar godine dana.
English: ZOLVIX was shown to be effective against strains of gastro-intestinal parasites, listed in section 4, resistant to (pro)benzimidazoles, levamisole, morantel, macrocyclic lactones and H. contortus strains resistant to salicylanilides.
Croatian: Pokazalo se da je ZOLVIX učinkovit protiv želučano-crijevnih parazita, navedenih u dijelu 4, rezistentnih na (pro) benzimidazole, levamizol, morantel, makrocikličke laktone i sojeve H. contortus rezistentne na salicilanilide.
English: Argenta Dundee Limited Kinnoull Road Dunsinane Industrial Estate Dundee, DD2 3XR United Kingdom
Croatian: Argenta Dundee Limited Kinnoull Road Dunsinane Industrial Estate Dundee
English: Manufacturer responsible for batch release: Argenta Dundee Limited Kinnoull Road
Croatian: Proizvođač odgovoran za puštanje serije u promet: Argenta Dundee Limited
English: Antiparasitic agents/ Agents acting against endoparasites
Croatian: Antiparazitici/ tvari za suzbijanje endoparazita.
English: ATCvet code: QP52AX09.
Croatian: FARMAKOLOŠKA SVOJSTVA Farmakoterapijska grupa: antihelmintici ATCvet kod: QP52AX09
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
English: MARKETING AUTHORISATION HOLDER Elanco GmbH
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET Elanco GmbH
English: Fluorinated high density polyethylene (HDPE) bottles with a polypropylene cap.
Croatian: Bočice od fluoriranog polietilena visoke gustoće (HDPE) s polipropilenskim čepom.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Croatian: 6.6 Posebne mjere opreza prilikom odlaganja 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.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Croatian: POSEBNE MJERE OPREZA PRI ODLAGANJU NEUPOTREBLJENIH PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: Propylene glycol monocaprylate Propylene glycol dicaprylocaprate
Croatian: Propilen glikol monokaprilat Propilen glikol dikaprilokaprat
English: Special warnings for each target species:
Croatian: POSEBNO(A) UPOZORENJE(A) Posebna upozorenja za svaku od ciljnih vrsta životinja:
English: Target tissues
Croatian: MRL Ciljna tkiva
English: Each ml of ZOLVIX orange clear oral solution contains 25 mg of monepantel
Croatian: Jedan ml ZOLVIX narančaste bistre peroralne otopine sadrži 25 mg monepantela.
English: Shelf life after first opening the immediate packaging: 1 year
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: 1 godina.
English: The dose is 2.5 mg/kg bodyweight of monepantel.
Croatian: Doza monepantela iznosi 2,5 mg/kg tjelesne težine.
English: 170 µg/kg
Croatian: 170 µg/kg mišić,
English: Disposal: read the package leaflet.
Croatian: Odlaganje: pročitati uputu o VMP.
English: 4.11 Withdrawal period(s)
Croatian: 4.11 Karencija(e)
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Croatian: NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE
English: SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.
Croatian: Držati izvan pogleda i dosega djece.
English: PHARMACEUTICAL FORM Oral solution.
Croatian: OBLIK Peroralna otopina.
English: Dunsinane Industrial Estate Dundee, DD2 3XR
Croatian: Dunsinane Industrial Estate Dundee
English: Pregnancy and lactation: Can be used in breeding sheep including pregnant and lactating ewes.
Croatian: Može se koristiti u rasplodnih ovaca uključujući gravidne i dojne ovce.
English: STATEMENT OF ACTIVE SUBSTANCES Each ml contains 25 mg of monepantel
Croatian: SASTAV DJELATNIH TVARI Jedan ml sadrži 25 mg monepantela.
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Croatian: POSEBNO(A) UPOZORENJE(A), UKOLIKO JE POTREBNO
English: Overdose (symptoms, emergency procedures, antidotes): No adverse effects were observed after a 10-fold overdose.
Croatian: Predoziranje (simptomi, hitni postupci, antidoti):
English: Name and address of the manufacturers responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornih za puštanje serije u promet
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZOLVIX 25 mg/ml oral solution for sheep Monepantel
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA ZOLVIX 25 mg/ml peroralna otopina za ovce Monepantel
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZOLVIX 25 mg/ml oral solution for sheep
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA ZOLVIX 25 mg/ml peroralna otopina za ovce
English: PHARMACEUTICAL FORM Oral solution
Croatian: Farmakološki djelatna tvar
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE U PROMET
English: PACKAGE LEAFLET: ZOLVIX 25 mg/ml oral solution for sheep
Croatian: UPUTA O VMP: ZOLVIX 25 mg/ml peroralna otopina za ovce
English: In addition, the product was shown to be effective against 4th stage larvae of a strain of H. contortus in a laboratory study where a combination of abamectin with derquantel was not effective.
Croatian: contortus u laboratorijskom ispitivanju u kojem kombinacija abamektina s derkvantelom nije bila učinkovita.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND IMMEDIATE PACKAGE Cardboard box and HDPE bottle
Croatian: Kartonska kutija i HDPE boca
English: Special precautions for use in animals
Croatian: Posebne mjere opreza prilikom primjene na životinjama:
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No adverse effects were observed after a 10-fold overdose.
Croatian: 1 ml za svakih dodatnih 10 kg 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno
English: Each ml contains 25 mg of monepantel Excipient:
Croatian: Jedan ml sadrži 25 mg monepantela.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Dose table Bodyweight, kg
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI)
English: Monepantel
Croatian: INDIKACIJE
English: Dose table:
Croatian: Pomoćna tvar:
English: OTHER INFORMATION
Croatian: DODATAK
English: Liver Kidney Milk
Croatian: masno tkivo, jetra, bubreg, mlijeko
English: Animal species
Croatian: Životi njska vrsta
English: In comparison to the daily intake levels calculated based on ICH M7(R1) using non-clinical toxicology, it is possible to generate additional safety factors ranging from 2.73 - 27.3 for NDMA and 10.0 - 100 for NDEA, by defining 0.03 ppm as the common technical target limit for NDEA and NDMA in tetrazole sartan APIs.
Croatian: U usporedbi s razinama dnevnog unosa koje su s pomoću nekliničke toksikologije izračunate na temelju Smjernica ICH M7(R1) mogu se dobiti dodatni sigurnosni čimbenici u rasponu od 2,73 - 27,3 za NDMA i 10,0 - 100 za NDEA, na osnovi utvrđivanja 0,03 ppm kao zajedničkog tehničkog ciljnog ograničenja za NDEA i NDMA u aktivnim farmaceutskim sastojcima sartana s tetrazolnim prstenom.
English: For these reasons, N-nitrosamine impurities in pharmaceuticals such as sartans intended for long-term use should be reduced as much as possible.
Croatian: Zbog tih je razloga N-nitrozaminske nečistoće u farmaceutskim proizvodima, kao što su sartani namijenjeni za dugotrajnu primjenu, potrebno smanjiti na najmanju moguću mjeru.
English: In addition to NDMA and NDEA, other N-nitrosamines have been detected in a few sartan-containing medicinal products.
Croatian: Osim tvari NDMA i NDEA, u nekoliko lijekova koji sadržavaju sartan otkriveni su i drugi N-nitrozamini.
English: The key issue of this referral concerns the detection of N-nitrosamine (esp. NDMA and/or NDEA) contaminations in sartans, the resulting potential long-term risk to patients and measures to minimise as much as possible these contaminations.
Croatian: Ključno pitanje ovog postupka upućivanja odnosi se na otkrivanje kontaminacija Nnitrozaminom (osobito tvarima NDMA i/ili NDEA) u sartanima, potencijalni dugoročni rizik za bolesnike koji proizlazi iz tih kontaminacija te mjere za njihovo smanjivanje na najmanju moguću mjeru.
English: • Based on the analysis of potential root causes the CHMP considered that all the MAHs should perform risk assessment of the manufacturing processes used for the APIs in their finished products to evaluate the risk of N-nitrosamine formation and contamination.
Croatian: • Na temelju analize potencijalnih osnovnih uzroka CHMP smatra da svi nositelji odobrenja za stavljanje lijeka u promet trebaju provesti procjenu rizika proizvodnih procesa aktivnih farmaceutskih sastojaka u svojim krajnjim proizvodima kako bi se ocijenio rizik od nastanka Nnitrozamina i kontaminacije njime.
English: Limit in ppm in API
Croatian: Granična vrijednost u aktivnim farmaceutskim sastojcima (ppm)
English: N-nitrosamines belong to a “cohort of concern” compounds in this guideline.
Croatian: U Smjernicama su N-nitrozamini uvršteni u kohortu spojeva koji izazivaju zabrinutost.
English: Drug substance
Croatian: Djelatna tvar lijeka
English: Olmesartan 40
Croatian: Prilog IV.
English: Irbesartan 300
Croatian: valsartan losartan olmesartan 40 irbesartan 300 kandesartan 32
English: 1 June 2018
Croatian: 1. lipnja 2018.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Croatian: Ako sudjelujete u kliničkom ispitivanju te vam je potrebno više informacija o liječenju, obratite se liječniku koji vas liječi.
English: What is Restaysis?
Croatian: Što je Restaysis?
English: What consequences does this withdrawal have for patients in clinical trials?
Croatian: Koje posljedice ima ovo povlačenje zahtjeva za bolesnike u kliničkim ispitivanjima?
English: The active substance in Restaysis, ciclosporin, reduces the activity of cells of the immune system (the body's natural defences) that are involved in the processes that cause inflammation.
Croatian: Djelatna tvar u lijeku Restaysis , ciklosporin, smanjuje djelovanje stanica imunosnog sustava (prirodni obrambeni sustav tijela) koje su uključene u procese koji izazivaju upalu.
English: Withdrawal of the marketing authorisation application for Restaysis (ciclosporin)
Croatian: Povlačenje zahtjeva za izdavanje odobrenja za stavljanje u promet lijeka Restaysis (ciklosporin)
English: Restaysis is a medicine that contains the active substance ciclosporin.
Croatian: Restaysis je lijek koji sadrži djelatnu tvar ciklosporin.
English: It was to be available as eye drops.
Croatian: Trebao je biti dostupan u obliku kapi za oči.
English: On 25 April 2018, Allergan Pharmaceuticals International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Restaysis, for the treatment of moderate dry eye disease.
Croatian: Dana 25. travnja 2018. tvrtka Allergan Pharmaceuticals International Limited službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Restaysis za liječenje umjerenog simptoma suhog oka.
English: Applying it directly to the eye was expected to reduce inflammation and the symptoms of the disease.
Croatian: Očekivalo se da će primjena izravno u oko smanjiti upalu i simptome bolesti.
English: The CHMP concluded that the results presented by the company were not robust enough to demonstrate that Restaysis is effective.
Croatian: CHMP je zaključio da rezultati koje je predstavila tvrtka nisu bili dovoljno snažni kako bi se dokazala učinkovitost lijeka Restaysis.
English: The company informed the CHMP that the withdrawal will have no consequences on ongoing clinical trials.
Croatian: Tvrtka je obavijestila CHMP da povlačenje neće imati posljedice za klinička ispitivanja koja su u tijeku.
English: The main measures of effectiveness were the number of patients with damaged eye surface and with blurred vision, after 6 months of treatment.
Croatian: Glavno mjerilo učinkovitosti bio je broj bolesnika s oštećenom površinom oka i zamućenim vidom nakon šest mjeseci liječenja.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Croatian: Nakon što je CHMP procijenio odgovore tvrtke na posljednji niz pitanja, još su uvijek postojale neke nedoumice.
English: Inflammation seems to have an important role in the development of dry eye disease, regardless of the cause of the disease.
Croatian: Čini se da upala ima važnu ulogu u razvoju simptoma suhog oka, neovisno o uzroku bolesti.
English: How does Restaysis work?
Croatian: Kako djeluje Restaysis?
English: The company presented an analysis of the results from three studies with ciclosporin conducted in the 1990s in patients with moderate to severe dry eye disease, where Restaysis was compared with placebo (a dummy treatment).
Croatian: Tvrtka je predstavila analizu rezultata triju ispitivanja s ciklosporinom provedenih tijekom devedesetih godina 20. stoljeća, u kojima su sudjelovali bolesnici s umjerenim do teškim simptomom suhog oka, kod kojih je lijek Restaysis uspoređen s placebom (prividno liječenje).
English: What was Restaysis expected to be used for?
Croatian: Za što se Restaysis trebao koristiti?
English: Restaysis was expected to be used in adults with moderate dry eye disease that was inadequately controlled despite treatment with tear substitutes or eye lubricants.
Croatian: Očekivalo se da će se lijek Restaysis primjenjivati u odraslih osoba s umjerenim oblikom simptoma suhog oka koji se, unatoč liječenjem zamjenskim suzama ili očnim lubrikantima, nije primjereno kontrolirao.
English: In particular, the way the results were analysed in patients with moderate dry eye disease could have introduced a bias in favour of Restaysis.
Croatian: Konkretno, način na koji su rezultati analizirani u bolesnika s umjerenim simptomom suhog oka mogao je dovesti do pristranosti u korist lijeka Restaysis.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it withdrew its application because of the CHMP's view that the data provided did not allow concluding on a positive benefit-risk balance in the intended patient population.
Croatian: U svojem dopisu kojim je obavijestila Agenciju o povlačenju zahtjeva tvrtka je navela da povlači zahtjev zbog mišljenja CHMP-a da dostavljeni podatci ne omogućuju donošenje zaključka o pozitivnom omjeru koristi i rizika u predviđenoj populaciji bolesnika.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that, because of lack of proven effectiveness, the benefits of Restaysis did not outweigh its risks.
Croatian: Sukladno navedenome, CHMP je u vrijeme povlačenja smatrao da, zbog izostanka potvrde o učinkovitosti, koristi lijeka Restaysis ne nadmašuju s njim povezane rizike.
English: The analysis focused on a subgroup of patients with moderate dry eye disease.
Croatian: Analiza je bila usmjerena na podskupinu bolesnika s umjerenim simptomom suhog oka.
English: Withdrawal of the marketing authorisation application for Restaysis (ciclosporin) EMA/275525/2018
Croatian: (ciklosporin) EMA/275525/2018
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Restaysis could not have been approved for the treatment of moderate dry eye disease.
Croatian: Na temelju pregleda podataka te odgovora tvrtke na popise pitanja CHMP-a, u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Restaysis za liječenje umjerenog oblika simptoma suhog oka.
English: However, this difference was not statistically significant.
Croatian: Međutim, ova razlika nije bila statistički značajna.
English: Allow the area to dry for 10 seconds.
Croatian: Pustite da se područje suši 10 sekundi.
English: Read the following instructions carefully.
Croatian: Pažljivo pročitajte sljedeće upute.
English: Never inject Ceplene any faster or all at once.
Croatian: Nikad ne ubrizgavajte Ceplene brže ili sav odjednom.
English: For the injection you will need the following:
Croatian: Za ubrizgavanje ćete trebati sljedeće:
English: >50 to ≤60 >60 to ≤70 >70 to ≤80 >80 to ≤90 >90 to ≤100
Croatian: >50 do ≤60 >60 do ≤70 >70 do ≤80 >80 do ≤90 >90 do ≤100
English: Twice daily.
Croatian: Dvaput dnevno.
English: The dose reductions can be temporary or permanent.
Croatian: Smanjenje doze može biti privremeno ili trajno.
English: • If you have severe heart problems.
Croatian: • Ako imate teške probleme sa srcem.
English: 08757 Corbera de Llobregat (Barcelona) Spain
Croatian: 08757 Corbera de Llobregat (Barcelona) Španjolska
English: Each dose is calculated from your body weight.
Croatian: Svaka doza se izračunava prema Vašoj tjelesnoj težini.
English: Make sure that the area of the skin you select is exposed.
Croatian: Provjerite je li područje kože koje ste odabrali izloženo.
English: Biotransformation/Elimination
Croatian: Biotransformacija/eliminacija
English: The recommended dosing regimen is presented in Tables 1 and 2.
Croatian: Preporučeni režim doziranja nalazi se u tablicama 1 i 2.
English: Noventia Pharma srl Via Carlo PISACANE 31 I-47121 Forli (FC) Italy
Croatian: Noventia Pharma srl Via Carlo PISACANE 31 I-47121 Forli (FC) Italija
English: Results of this pilot study were used to design and implement a multi-national phase 3 trial.
Croatian: Rezultati ovog pilot ispitivanja upotrijebljeni su za dizajniranje i implementiranje multinacionalnog ispitivanja faze 3.
English: Do not take any additional dose to make up for the forgotten doses.
Croatian: Nemojte uzeti dodatnu dozu kako biste nadoknadili zaboravljenu dozu.
English: Wash your hands thoroughly with soap and water.
Croatian: 3. Ruke temeljito operite sapunom i vodom.
English: Wait 1 to 3 minutes.
Croatian: 3. Pričekajte 1 do 3 minute.
English: You must be monitored to check how you respond to treatment.
Croatian: Mora Vas se nadzirati kako bi se provjerilo kako reagirate na liječenje.
English: Your doctor may change your dose.
Croatian: Liječnik će Vam možda promijeniti dozu.
English: Find a comfortable, well-lit place to sit and where you can lie back.
Croatian: Nađite udobno, dobro osvijetljeno mjesto gdje možete leći.
English: Other medicines and Ceplene
Croatian: Drugi lijekovi i Ceplene
English: If you have an infection, your doctor will closely monitor you.
Croatian: Ako imate infekciju liječnik će Vas pažljivo nadzirati.
English: • If you are pregnant.
Croatian: • Ako ste trudni.
English: Do not lay the syringe down or let the needle touch anything.
Croatian: Ne odlažite štrcaljku niti ne dopustite da igla išta dotakne.
English: Do not use if the date has passed the last day of the month shown.
Croatian: 2. Ne upotrebljavajte ako je datum premašio zadnji dan navedenog mjeseca.
English: Do not try to inject yourself unless a qualified professional has trained you.
Croatian: Ne pokušavajte samoinjiciranje osim ako Vas je kvalificirani zdravstveni djelatnik obučio.
English: Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove dobivene bez recepta.
English: It is used to maintain the remission (the period during which the disease is less severe or not detectable).
Croatian: Koristi se za održavanje remisije (razdoblja tijekom kojeg je bolest manje teška ili se ne može otkriti).
English: Frequencies are defined as very common ( 1/10), common ( 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), or not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane kao vrlo često ( 1/10), često ( 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) ili nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • Anti-malarial or medicines used to treat infections responsible for sleeping sickness.
Croatian: • lijekovi protiv malarije ili lijekovi korišteni za liječenje infekcija odgovornih za bolest spavanja.