FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 colonies treated displaying adverse reaction(s)) - common (more than 1 but less than 10 colonies in 100 colonies treated) - uncommon (more than 1 but less than 10 colonies in 1,000 colonies treated) - rare (more than 1 but less than 10 colonies in 10,000 colonies treated) - very rare (less than 1 colony in 10,000 colonies treated, including isolated reports.
Croatian: - rijetke (više od 1, ali manje od 10 kolonija na 10 000 tretiranih kolonija) - vrlo rijetke (manje od 1 kolonije na 10 000 tretiranih kolonija, uključujući izolirane slučajeve).
English: Oxybee should not be used when honey supers are present.
Croatian: Oxybee ne smije se koristiti ako su prisutne posude za prikupljanje meda.
English: Bees
Croatian: Pčele
English: 1 ml of mixed bee-hive dispersion contains:
Croatian: 1 ml miješane disperzije za košnice sadrži:
English: Citric acid monohydrate Glycerol (85%) Water, purified
Croatian: Otopina: monohidrat limunske kiseline glicerol (85 %)
English: A maximum dose of 5-6 ml of the final bee-hive dispersion should be administered once per seam occupied by bees.
Croatian: Treba primijeniti maksimalnu dozu od 5 do 6 ml gotove disperzije za košnice jednom po ulici koju nastanjuju pčele.
English: After overdosing, increased bee mortality was very commonly observed.
Croatian: Nakon predoziranja primijećeno je vrlo učestalo povećanje smrtnosti pčela.
English: In clinical trials, increased bee mortality was very commonly observed.
Croatian: U kliničkim ispitivanjima primijećeno je vrlo učestalo povećanje smrtnosti pčela.
English: Open the sachet(s) of the sucrose powder with a pair of scissors.
Croatian: Otvorite vrećicu(e) s prahom saharoze pomoću škara.
English: Solution for bee-hive dispersion (bottle containing the active substance): Clear and colourless solution.
Croatian: Otopina za disperziju za košnice (boca sadrži djelatnu tvar): Bistra i bezbojna otopina.
English: Dose:
Croatian: Doza:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (for powder and solution for bee-hive dispersion)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kartonska kutija (za prah i otopinu za disperziju za košnice)
English: Excipients: For the full list of excipients, see section 6.1
Croatian: Pomoćne tvari: Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: The veterinary medicinal product should be used as a treatment within an Integrated Varroa Management program with mite drop monitored regularly.
Croatian: Ovaj veterinarsko-medicinski proizvod treba primjenjivati samo u okviru cjelovitog programa za kontrolu varroe, pri čemu redovito treba pratiti smanjenje broja grinja.
English: Seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: Odmah potražite savjet liječnika i pokažite mu uputu o VMP ili etiketu.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI „SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA
English: Place the bottle containing the oxalic acid dihydrate solution into warm (30 - 35 °C) water.
Croatian: Bocu koja sadrži otopinu dihidrata oksalne kiseline stavite u toplu vodu (30 - 35 °C).
English: Oxybee has corrosive properties on corrosion-sensitive parts of beekeeping equipment.
Croatian: Oxybee ima nagrizajuća svojstva i djeluje na pčelarsku opremu osjetljivu na nagrizanje.
English: The final bee-hive dispersion is to be trickled onto the bees in the seams.
Croatian: Gotovu disperziju za košnice treba nakapati na pčele u ulicama.
English: Special warnings for each target species:
Croatian: Posebna upozorenja za svaku od ciljnih vrsta životinja
English: When possible, rotate the use of this veterinary medicinal product with another approved varroacide with a different mode of action to decrease the potential for Varroa mites to develop resistance.
Croatian: Ako je moguće, izmjenjujte upotrebu ovog veterinarsko-medicinskog proizvoda s drugim odobrenim varocidima koji imaju drugačiji način djelovanja kako bi se smanjila mogućnost da varroa grinje razviju otpornost.
English: TARGET SPECIES Honey bees (Apis mellifera)
Croatian: CILJNE VRSTE ŽIVOTINJA Medonosne pčele (Apis mellifera)
English: Do not eat, drink or smoke whilst handling and applying the veterinary medicinal product.
Croatian: Prilikom uporabe veterinarsko-medicinskog proizvoda ne jesti, piti niti pušiti.
English: Mix with Oxybee solution before use.
Croatian: Prije uporabe pomiješati s Oxybee otopinom.
English: The solution should be warm (30 - 35 °C) during application.
Croatian: Otopina treba biti topla (30 - 35 °C) tijekom primjene.
English: Oxybee must only be applied only once in brood-free colonies.
Croatian: Oxybee treba primijeniti samo jednokratno u kolonijama bez legla.
English: After mixing the bee-hive dispersion: Store in a refrigerator (2 °C - 8 °C).
Croatian: Nakon miješanja disperzije za košnice: držati u hladnjaku (2 °C - 8 °C).
English: When possible, rotate the use of this product with another approved varroacide with a different mode of action to decrease the potential for Varroa mites to develop resistance.
Croatian: Ako je moguće, izmjenjujte upotrebu ovog veterinarsko-medicinskog proizvoda s drugim odobrenim varocidima koji imaju drugačiji način djelovanja kako bi se smanjila mogućnost da grinje varroa razviju otpornost.
English: Before use the content of the sachet(s) containing the flavoured sucrose powder should be added to the bottle containing the solution for bee-hive dispersion as follows:
Croatian: Prije uporabe sadržaj vrećice koja sadrži prah aromatizirane saharoze treba dodati u bocu s otopinom za disperziju za košnicu na sljedeći način:
English: The full content of the sachet(s) should be poured into the bottle with the solution.
Croatian: Čitav sadržaj vrećice(a) treba uliti u bocu s otopinom.
English: Final bee-hive dispersion (after mixing): Store in a refrigerator (2 °C - 8 °C).
Croatian: Gotovu disperziju za košnice (nakon miješanja): čuvati u hladnjaku (2 °C - 8 °C).
English: The final bee-hive dispersion should be a colourless, clear to slightly turbid dispersion.
Croatian: Gotova disperzija za košnicu treba biti bezbojna, jasna do blago mutna.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Boca
English: Four-layered foil (low-density polyethylene (LDPE)/ aluminium/ LDPE/ clay-coated paper) sealed sachets containing 125 g of flavoured sucrose.
Croatian: (LDPE)/aluminij/LDPE/papir obložen glinom) koje sadrže 125 g aromatizirane saharoze.
English: Oxybee must only be applied once in brood-free colonies.
Croatian: Oxybee treba primijeniti jednokratno u kolonijama bez legla.
English: Keep the bottle and the sachet in the outer carton in order to protect from light.
Croatian: Bocu i vrećicu držite u vanjskom kartonu radi zaštite od svjetla.
English: 6.5 Nature and composition of immediate packaging
Croatian: 6.5 Osobine i sastav unutarnjeg pakiranja Boca:
English: Powder and solution for bee-hive dispersion.
Croatian: Prah i otopina za disperziju za košnice.
English: Do not exceed the recommended dose and do not administer this veterinary medicinal product more than once.
Croatian: Ne prekoračujte preporučenu dozu i ne primjenjujte ovaj veterinarsko-medicinski proizvod (VMP)
English: 10 DATE OF REVISION OF THE TEXT
Croatian: DATUM REVIZIJE TEKSTA <{MM/GGGG}>
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/216/001-002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/17/216/001-002
English: One sachet of 125 g powder contains: Excipients:
Croatian: Jedna vrećica praha od 125 g sadrži: Pomoćne tvari:
English: Mix with Oxybee powder as instructed, before use.
Croatian: Prije uporabe pomiješati s Oxybee prahom prema uputama.
English: EU/2/17/216/002 (750 g solution)
Croatian: EU/2/17/216/002 (750 g otopina)
English: Powder for bee-hive dispersion (sachet):
Croatian: Prah za disperziju za košnice (vrećica):
English: 17.5 g oxalic acid dihydrate (equivalent to 12.5 g of oxalic acid) (375 g solution) 35 g oxalic acid dihydrate (equivalent to 25.0 g of oxalic acid) (750 g solution)
Croatian: 17,5 g dihidrata oksalne kiseline (istovjetno 12,5 g oksalne kiseline) (otopina od 375 g) 35 g dihidrata oksalne kiseline (istovjetno 25,0 g oksalne kiseline) (otopina od 750 g)
English: WITHDRAWAL PERIOD(S) Honey: Zero days.
Croatian: Razdoblje karencije (med): nula dana
English: One bottle of 375 g solution contains:
Croatian: Jedna boca otopine od 375 g sadrži:
English: Oxalic acid dihydrate 39.4 mg (equivalent to 28.1 mg of oxalic acid)
Croatian: Dihidrat oksalne kiseline 39,4 mg (istovjetno 28,1 mg oksalne kiseline).
English: One bottle of 750 g of solution contains:
Croatian: Jedna boca otopine od 750 g sadrži:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Oxybee solution for bee-hive dispersion oxalic acid dihydrate
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Oxybee otopina za disperziju za košnice dihidrat oksalne kiseline
English: No entry Antiinfectious agent
Croatian: Antiinfektivna tvar
English: 750 g oxalic acid dihydrate solution to achieve 888 ml bee-hive dispersion.
Croatian: Otopina dihidrata oksalne kiseline od 750 g, za dobivanje 888 ml disperzije za košnice.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije u promet
English: EU/2/17/216/002 (750 g g solution)
Croatian: EU/2/17/216/002 (otopina od 750 g)
English: METHOD AND ROUTE(S) OF ADMINISTRATION In-hive use
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: Preparation of the 444 ml final bee-hive dispersion: Pour the content of one sachet into the bottle containing 375 g of the oxalic acid dihydrate acid solution.
Croatian: Priprema gotove disperzije za košnicu od 444 ml: sadržaj jedne vrećice ulijte u bocu koja sadrži 375 g otopine dihidrata oksalne kiseline.
English: In-hive use.
Croatian: Primjena u košnici.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Oxybee powder for bee-hive dispersion sucrose
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Oxybee prah za disperziju za košnice saharoza
English: 375 g oxalic acid dihydrate solution to achieve 444 ml bee-hive dispersion.
Croatian: Otopina dihidrata oksalne kiseline od 375 g, za dobivanje 444 ml disperzije za košnice.
English: Sucrose 125 g
Croatian: 125 g saharoze
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Oxybee powder and solution for 39.4 mg/ml bee-hive dispersion oxalic acid dihydrate
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Oxybee prah i otopina 39,4 mg/ml za disperziju za košnice dihidrat oksalne kiseline
English: SPECIAL STORAGE CONDITIONS Keep the bottle and the sachet in the outer carton in order to protect from light.
Croatian: 11. POSEBNI UVJETI ČUVANJA Bocu i vrećicu držite u vanjskom kartonu radi zaštite od svjetla.
English: Oxybee powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Croatian: Oxybee prah i otopina 39,4 mg/ml za disperziju za košnice za medonosne pčele
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/216/001 (375 g solution)
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/17/216/001 (otopina od 375 g)
English: Oxalic acid
Croatian: Oksalna kiselina Nije primjenjivo
English: Oxalic acid dihydrate 17.5 g (equivalent to 12.5 g of oxalic acid)
Croatian: Dihidrat oksalne kiseline 17,5 g (istovjetno 12,5 g oksalne kiseline).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/216/001 (375 g g solution)
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/17/216/001 (375 g otopina)
English: Preparation of the 888 ml final dispersion: Pour the content of the two sachets into the bottle containing 750 g of the oxalic acid oxalic dihydrate acid solution.
Croatian: Priprema gotove disperzije od 888 ml: sadržaj dviju vrećica ulijte u bocu koja sadrži 750 g otopine dihidrata oksalne kiseline.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One bottle of 375 g of solution contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna boca otopine od 375 g sadrži:
English: One cardboard box containing one 500 ml bottle (containing 375 g oxalic acid dihydrate solution) and one sachet (containing 125 g sucrose powder), providing 444 ml of the final bee-hive dispersion after mixing.
Croatian: Jedna kartonska kutija sadrži jednu bocu od 500 ml (s otopinom dihidrata oksalne kiseline 375 g) i jednu vrećicu (koja sadrži 125 g praha saharoze) što odgovara količini od 444 ml gotove disperzije za košnice nakon miješanja.
English: None known.
Croatian: Nema unosa
English: Oxalic acid dihydrate 35.0 g (equivalent to 25.0 g of oxalic acid)
Croatian: Dihidrat oksalne kiseline 35,0 g (istovjetno 25,0 g oksalne kiseline).
English: Preparation of the 888 ml final bee-hive dispersion: Pour the content of the two sachets into the bottle containing 750 g of the oxalic acid oxalic dihydrate acid solution.
Croatian: Priprema gotove disperzije za košnicu od 888 ml: sadržaj dviju vrećica ulijte u bocu koja sadrži 750 g otopine dihidrata oksalne kiseline.
English: One cardboard box containing one HDPE bottle (750 g) and two sachets (each containing 125 g) providing 888 ml final bee-hive dispersion after mixing.
Croatian: Jedna kartonska kutija koja sadrži jednu bocu od HDPE-a (750 g) i dvije vrećice (svaka po 125 g), nakon miješanja daje 888 ml gotove disperzije za košnice.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Sachet
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: 1 bottle with 750 g oxalic acid dihydrate solution and two sachets (each containing 125 g) of sucrose powder to achieve 888 ml bee-hive dispersion after mixing with sucrose.
Croatian: 1 boca s otopinom dihidrata oksalne kiseline od 750 g i dvije vrećice (svaka od 125 g) praha saharoze od kojeg se dobiva disperzija za košnice od 888 ml nakon miješanja sa saharozom.
English: SPECIAL STORAGE CONDITIONS Keep the bottle in the outer carton in order to protect from light.
Croatian: Bocu držite u vanjskom kartonu radi zaštite od svjetla.
English: STATEMENT OF ACTIVE SUBSTANCES One bottle contains:
Croatian: Jedna boca sadrži:
English: Read the package leaflet before use.
Croatian: Prije uporabe pročitajte uputu o VMP.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Croatian: DODATAK I. SAŽETAK OPISA SVOJSTAVA
English: One cardboard box containing one HDPE bottle (375 g) and one sachet (125 g), providing 444 ml final bee-hive dispersion after mixing.
Croatian: Jedna kartonska kutija koja sadrži jednu bocu od HDPE-a (375 g) i jednu vrećicu (125 g), nakon miješanja daje 444 ml gotove disperzije za košnice.
English: High-density polyethylene (HDPE) bottle with an HDPE/ polypropylene (PP) child-proof screw cap containing 375 g or 750 g solution.
Croatian: a/polipropilena (PP) koja sadrži otopinu od 375 g ili 750 g.
English: 1 bottle with 375 g oxalic acid dihydrate solution and one sachet (125 g) of sucrose powder, to achieve 444 ml bee-hive dispersion after mixing with sucrose.
Croatian: VELIČINA PAKIRANJA 1 boca s otopinom dihidrata oksalne kiseline od 375 g i jedna vrećica (125 g) praha saharoze od kojeg se dobiva disperzija za košnice od 444 ml nakon miješanja sa saharozom.
English: insecticides
Croatian: NUSPOJAVE
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product not subject to prescription.
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE
English: Read the package leaflet before use
Croatian: Prije uporabe pročitajte uputu o VMP
English: WITHDRAWAL PERIOD Withdrawal period (honey): Zero days Do not use during honey flow.
Croatian: RAZDOBLJE KARENCIJE Razdoblje karencije (med): nula dana
English: ADVERSE REACTIONS
Croatian: PRIMJENE
English: MA (EU) number (Invented) name
Croatian: EMA broj postupka Broj (EU) odobrenja
English: If you stop taking this medicine your symptoms may worsen.
Croatian: Ako prestanete uzimati ovaj lijek, Vaši simptomi se mogu pogoršati.
English: Date of first authorisation: 10/04/2017
Croatian: Datum prvog odobrenja: 10/04/2017
English: Data exists only in the adult population.
Croatian: Podaci postoje samo za odraslu populaciju.
English: This medicine is for long-term use.
Croatian: Ovaj lijek je za dugoročnu uporabu.
English: The suspension should be stored in a glass bottle.
Croatian: Suspenziju treba čuvati u staklenoj boci.
English: Reabsorption is not complete.
Croatian: Reapsorpcija nije potpuna.
English: *number of divided doses dependant on advice from doctor.
Croatian: *broj podijeljenih doza ovisi o savjetu liječnika.
English: Efficacy and safety was studied in two retrospective trials in two centres in Europe.
Croatian: Djelotvornost i sigurnost su ispitane u dva retrospektivna ispitivanja u dva centra u Europi.
English: Liver function should also be monitored.
Croatian: Funkciju jetre treba također pratiti.
English: Daily dose:
Croatian: Dnevna doza:
English: This can cause damage to the affected areas.
Croatian: To može uzrokovati štetu na tim mjestima.
English: Limited safety data are available (see section 4.8).
Croatian: Dostupni su ograničeni podaci o sigurnosti (vidjeti dio 4.8).
English: The capsules can be taken with or without food.
Croatian: Kapsule možete uzeti s hranom ili bez nje.
English: The suspension is stable for up to 7 days.
Croatian: Suspenzija je stabilna najviše 7 dana.
English: Your doctor will tell you how many capsules you need to take, and when you should take the capsules.
Croatian: Liječnik će Vam reći koliko kapsula trebate uzeti i kada ih trebate uzeti.
English: The suspension is then stable for up to 7 days.
Croatian: Suspenzija je tada stabilna najviše 7 dana.
English: Germany e-mail: info@leadiantbiosciences.com
Croatian: Njemačka e-mail: info@leadiantbiosciences.com
English: Signs and symptoms of the disease remained stable in most of the patients.
Croatian: Znakovi i simptomi bolesti ostali su stabilni kod većine bolesnika.
English: Patients who are unable to swallow capsules
Croatian: Bolesnici koji ne mogu progutati kapsule
English: Stir the mixture until all the powder is in suspension.
Croatian: Miješajte dok sav prah ne bude suspendiran.
English: Side effects of unknown frequency (cannot be estimated from the available data)
Croatian: Nuspojave s nepoznatom učestalošću (ne može se odrediti iz dostupnih podataka)
English: However, these patients should be carefully monitored and the dose titrated individually.
Croatian: Međutim, te bolesnike treba pažljivo nadzirati, a dozu titrirati prema individualnim potrebama.
English: The doctor will decide how many times and when your child should receive the dose(s) to make up the total dose for the day.
Croatian: Liječnik će odlučiti koliko puta i u koje vrijeme Vaše dijete treba primiti dozu (doze) da bi dobilo ukupnu dozu za taj dan.
English: Adverse reactions are ranked according to system organ class, using the following convention: 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), not known (cannot be estimated from the available data).
Croatian: Nuspojave su klasificirane prema organskim sustavima, prema sljedećim skupinama učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 do <1/10), manje često (≥ 1/1000 do <1/100), rijetko (≥ 1/10 000 do < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: This mixture will be provided to you by your pharmacy.
Croatian: Tu mješavinu će Vam dati u ljekarni.
English: Take care to scrape any powder from the side of the bowl into the mixture and stir (for about 5 minutes) to make sure that there are no lumps.
Croatian: Pažljivo sastružite prah sa stijenki zdjelice natrag u mješavinu i promiješajte (otprilike 5 minuta) kako biste bili sigurni da nema grudica.
English: Paediatric population (1 month -18 years)
Croatian: Pedijatrijska populacija (1 mjesec -18 godina)
English: Neonates less than one month of age
Croatian: Novorođenčad mlađa od mjesec dana
English: In babies and children the dose will be calculated from the child's weight.
Croatian: Kod beba i djece doza će se izračunati prema djetetovoj težini.
English: Your doctor or pharmacist will give you instructions on how much and how often your child needs to take the mixture.
Croatian: Vaš liječnik ili ljekarnik će Vam dati upute koliko i kako često Vaše dijete treba primiti mješavinu.
English: The mixture is ready when there are no visible lumps or powder.
Croatian: Mješavina je spremna kada nema vidljivih grudica ili praha.
English: A pharmacy label should be placed on the bottle and include the patient's name, dosing instructions, use by date, name of medicinal product and any other required information to be in compliance with local pharmacy regulations.
Croatian: Na boci bi trebala biti naljepnica od ljekarne koja sadrži ime bolesnika, upute za doziranje, datum do kad je potrebno upotrijebiti lijek, naziv lijeka i sve druge informacije potrebne da bi bila u skladu s nacionalnim ljekarničkim propisima.
English: The safety and efficacy in neonates less than one month of age has not been established.
Croatian: Sigurnost i djelotvornost u novorođenčadi mlađe od jednog mjeseca nisu još ustanovljene.
English: Please speak to your doctor if you are taking any of these medicines.
Croatian: Razgovarajte sa svojim liječnikom ako uzimate neke od tih lijekova.
English: • Constipation • Abnormal liver test values
Croatian: • Konstipacija • Abnormalne vrijednosti testova jetre
English: Phenobarbital
Croatian: Fenobarbital
English: The hard capsules should be taken whole with sufficient water at approximately the same time each day.
Croatian: Tvrde kapsule treba uzeti cijele s dovoljno vode i otprilike u isto vrijeme svaki dan.
English: However, parkinsonian symptoms, a rare disease manifestation/association that occurred in only 2 patients during the course of the study, did not respond.
Croatian: Međutim, simptomi parkinsonizma, rijetka manifestacija/povezanost s bolešću, koji su se pojavili kod samo 2 bolesnika za vrijeme trajanja ispitivanja, nisu odgovorili na liječenje.
English: A similar effect on CYP27A1, albeit at higher doses, is also seen with sirolimus.
Croatian: Sličan učinak na CYP27A1, iako u višim dozama, je uočen i sa sirolimusom.
English: Packs size: 100 capsules
Croatian: Veličina pakiranja: 100 kapsula
English: Epilepsy resolved in 100% (3/3 patients) and polyneuropathy stabilised or improved in 100% (11/11).
Croatian: Epilepsija se povukla u 100 % (3/3) bolesnika, a polineuropatija se stabilizirala ili poboljšala u 100 % (11/11).
English: • ciclosporin and sirolimus (medicines used to suppress the immune system)
Croatian: • ciklosporin i sirolimus (lijekovi koji se koriste za potiskivanje imunološkog sustava)
English: Use in children (aged one month to 18 years)
Croatian: Primjena u djece (u dobi od mjesec dana do 18 godina)
English: During your treatment, your doctor will carry out blood and urine tests to monitor your response to this medicine, and adjust your dose if necessary.
Croatian: Za vrijeme liječenja, Vaš liječnik će obaviti testove krvi i urina kako bi pratio Vaš odgovor na ovaj lijek te prilagodio dozu ako je potrebno.
English: Concurrent elevation of liver enzymes above normal levels may indicate overdose.
Croatian: Istovremeni porast jetrenih enzima iznad normalnih razina može ukazivati na predoziranje.
English: The capsules should be swallowed whole with water at approximately the same time each day.
Croatian: Kapsule treba progutati cijele s vodom i otprilike u isto vrijeme svaki dan.
English: Capsule shell: gelatin, titanium dioxide (E 171), quinoline yellow (E 104), erythrosine (E 127)
Croatian: Ovojnica kapsule: želatina, titanijev dioksid (E 171), kinolin žuti (E 104), eritrozin (E 127)
English: See section 4.5 for further details.
Croatian: Pogledajte dio 4.5 za dodatne informacije.
English: • phenobarbital (a medicine used for epilepsy)
Croatian: • fenobarbital (lijek koji se koristi za epilepsiju)