natgillin/translations-raw huggingface dataset:
Advice on action if a pregnancy occurs or is suspected during or shortly after being treated with mycophenolate mofetil.
• Savjet o koracima koje treba poduzeti ako dođe do trudnoće ili ako se na nju posumnja tijekom liječenja mofetilmikofenolatom ili ubrzo nakon njega.
The need to avoid foetal exposure: Contraceptive requirements for patients of reproductive potential prior to, during and after treatment with mycophenolate mofetil.
• Potreba za izbjegavanjem izlaganja fetusa lijeku: Zahtjevi za primjenom kontracepcije kod bolesnika i bolesnica reproduktivne dobi prije, tijekom i nakon liječenja mofetilmikofenolatom.
An estimated total of 1557 patients received CellCept during five clinical trials in the prevention of acute organ rejection.
Procjenjuje se da je u pet kliničkih ispitivanja ukupno 1557 bolesnika primilo CellCept za sprječavanje akutnog odbacivanja presatka.
Safety and efficacy of CellCept for infusion in paediatric patients have not been established.
Sigurnost i djelotvornost infuzije lijeka CellCept kod djece nije ustanovljena.
LIST OF EXCIPIENTS Also contains aspartame (E951) and methyl parahydroxybenzoate (E218).
POPIS POMOĆNIH TVARI Pomoćne tvari: aspartam (E951) i metilparahidroksibenzoat (E218)
• septum pellucidum agenesis;
• ageneze septuma pellucidum
Patients receiving CellCept should be monitored for neutropenia, which may be related to CellCept itself, concomitant medications, viral infections, or some combination of these causes.
Bolesnike koji primaju CellCept potrebno je pažljivo nadzirati kako bi se opazili znakovi neutropenije, koju može izazvati sam CellCept, lijekovi koji se istodobno primjenjuju, virusne infekcije ili kombinacija tih uzroka.
If this happens, rinse with plenty of plain water.
• Ako se to dogodi, isperite s puno obične vode.
Gastrointestinal effects were observed in the dog at systemic exposure levels equivalent to or less than the clinical exposure at the recommended dose.
Gastrointestinalni učinci primijećeni su kod pasa pri razinama sistemske izloženosti ekvivalentnim ili manjim od kliničke izloženosti pri preporučenim dozama.
The change in predose level may not accurately represent changes in overall MPA exposure.
Promjene koncentracije lijeka neposredno prije sljedeće doze možda nisu točan pokazatelj promjene ukupne izloženosti MPA.
An estimated total of 1268 patients received CellCept during four clinical trials in the prevention of acute organ rejection.
Procjenjuje se da je u četiri klinička ispitivanja ukupno 1268 bolesnika primilo CellCept za sprječavanje akutnog odbacivanja presatka.
Male patients of reproductive potential should be made aware of and discuss with a qualified health-care professional the potential risks of fathering a child.
Muške bolesnike reproduktivne dobi kvalificirani zdravstveni radnik treba upoznati i s njima razgovarati o mogućim rizicima povezanima sa začećem djeteta.
CellCept has a moderate influence on the ability to drive and use machines.
CellCept umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Therefore, care should be taken if CellCept 1 g/5 ml powder for oral suspension is administered to patients with phenylketonuria (see section 6.1)
Stoga treba paziti ako se prašak za pripremu oralne suspenzije CellCept 1 g/5 ml daje bolesnicima s fenilketonurijom (pogledajte odjeljak 6.1).
Diarrhoea, leucopenia, sepsis and vomiting were among the most common and/or serious adverse drug reactions associated with the administration of CellCept in combination with ciclosporin and corticosteroids.
Proljev, leukopenija, sepsa i povraćanje bile su neke od najčešćih i/ili najozbiljnijih nuspojava primjene lijeka CellCept u kombinaciji s ciklosporinom i kortikosteroidima.
Venous thrombosis
Venska tromboza
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON FOR BLISTER
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA ZA BLISTER
In addition, a pregnancy follow-up questionnaire including details of exposure during pregnancy, including timing and dose; duration of therapy, before and during pregnancy; concomitant drugs; known teratogenic risks and full details of congenital malformations should be agreed to with the national competent authorities.
Osim toga, s nacionalnim nadležnim tijelom treba dogovoriti i upitnik za praćenje trudnoće koji će obuhvatiti pojedinosti o izlaganju lijeku tijekom trudnoće, uključujući vrijeme primjene i dozu; trajanje liječenja prije i tijekom trudnoće; istodobno primijenjene lijekove; poznate teratogene rizike i sve pojedinosti o prirođenim malformacijama.
Reconstituted solution and infusion solution: Store at 15 - 30°C.
Rekonstituirani koncentrat i infuzijska otopina: čuvati na temperaturi od 15-30°C.
If you are not sure, talk to your doctor or pharmacist before taking CellCept.
Ako niste sigurni, razgovarajte sa svojim liječnikom ili ljekarnikom prije uzimanja lijeka CellCept.
Shake the closed bottle well for about 5 seconds before each use.
Prije svake uporabe dobro protresite zatvorenu bocu tijekom 5 sekundi.
Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilise salvage pathways, MPA has more potent cytostatic effects on lymphocytes than on other cells.
Budući da su T- i B-limfociti izuzetno ovisni o de novo sintezi purina u svojoj proliferaciji, dok druge vrste stanica mogu iskoristiti pomoćne puteve, citostatski učinci MPA izraženiji su na limfocite nego na druge stanice.
OTHER SPECIAL WARNING(S), IF NECESSARY CellCept film-coated tablets should be handled with care Do not crush the tablets
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO CellCept filmom obloženim tabletama rukujte oprezno Tablete ne lomite
Cardiac transplant n = 289
Srčani presadak n = 289
Do this by: wearing protective clothing which also covers your head, neck, arms and legs using a sunscreen with a high protection factor.
• nosite zaštitnu odjeću koja također pokriva Vašu glavu, vrat, ruke i noge
Take 3 tablets in the morning and then 3 tablets in the evening.
• Uzmite 3 tablete ujutro te 3 tablete navečer.
Add the remainder of water and shake the closed bottle well for about 1 minute.
Dodajte preostalu vodu i snažno protresite zatvorenu bočicu oko 1 minutu.
• If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients in this medicine (listed in Section 6)
• ako ste alergični (preosjetljivi) na mofetilmikofenolat, mikofenolatnu kiselinu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
Your doctor will decide the most appropriate dose based on your child's height and weight (body surface area - measured as square metres or “m²”).
• Liječnik će odrediti odgovarajuću dozu na temelju visine i težine Vašeg djeteta (tjelesna površina djeteta mjerena u metrima kvadratnim ili „m²“).
A reduction in the AUC of MPA of approximately 40% is associated with the co-administration of cholestyramine (4 g TID), indicating that there is a significant amount of enterohepatic recirculation.
Smanjenje AUC-a MPA od otprilike 40% vezano je uz istodobnu primjenu kolestiramina (4 g triput dnevno), što ukazuje na značajnu količinu enterohepatične recirkulacije.
There is no basis for CellCept dose adjustment following cardiac transplant rejection.
Ne postoji osnova za promjenu terapijske doze lijeka CellCept nakon odbacivanja presađenog srca.
CellCept 500 mg powder for concentrate for solution for infusion must be prepared in two steps: the first step is a reconstitution step with glucose intravenous infusion 5% and the second step is a dilution step with glucose intravenous infusion 5%.
CellCept 500 mg prašak za koncentrat za otopinu za infuziju priprema se u dva koraka: prvi je korak rekonstitucija otopinom 5%-tne glukoze za intravensku infuziju, a drugi korak razrjeđivanje otopinom 5%-tne glukoze za intravensku infuziju.
If this happens, wash the area thoroughly with soap and water.
• Ako do toga dođe, temeljito isperite područje sapunom i vodom.
Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (2327 %) in the unborn baby.
Mikofenolat vrlo često uzrokuje spontani pobačaj (50%) i teške prirođene mane (23 - 27%) kod nerođena djeteta.
OTHER SPECIAL WARNING(S), IF NECESSARY Avoid skin contact with infusion solution
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Izbjegavajte doticaj kože s otopinom za infuziju
The most common gastrointestinal disorders, however, were diarrhea, nausea and vomiting.
Međutim, najčešći poremećaji probavnog sustava bili su proljev, mučnina i povraćanje.
In volunteers with alcoholic cirrhosis, hepatic MPA glucuronidation processes were relatively unaffected by hepatic parenchymal disease.
Kod dobrovoljnih ispitanika s alkoholnom cirozom, procesi glukuronidacije MPA u jetri bili su relativno nepromijenjeni bolešću jetrenog parenhima.
Neoplasms benign, malignant and unspecified (including cysts and polyps) Benign neoplasm of skin
Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Dobroćudna kožna novotvorina
Decreased MPA exposure has been observed when antacids, such as magnesium and aluminium hydroxides, and PPIs, including lansoprazole and pantoprazole, were administered with CellCept.
Primijećeno je smanjenje izloženosti MPA-u u slučajevima kada su antacidi, poput magnezijevog i aluminijevog hidroksida te IPP, uključujući lanzoprazol i pantoprazol bili primjenjivani zajedno s lijekom CellCept.
CellCept contains mycophenolate mofetil.
CellCept sadrži mofetilmikofenolat.
Take care not to let the made-up medicine get into your eyes.
Pazite da pripremljen lijek ne dospije u Vaše oči.
Reconstituted solution and infusion solution: If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 3 hours from reconstitution and dilution of the medicinal product.
Rekonstituirani koncentrat i infuzijska otopina: ako infuzijska otopina nije priređena neposredno prije primjene, primjenu infuzijske otopine treba započeti najkasnije 3 sata od rekonstitucije i razrjeđivanja lijeka.
Caution should be exercised when switching combination therapy from regimens containing immunosuppressants, which interfere with MPA enterohepatic recirculation, e.g. ciclosporin, to others devoid of this effect, e.g. tacrolimus, sirolimus, belatacept, or vice versa, as this might result in changes of MPA exposure.
Potreban je oprez kada se kombinirana terapija prebacuje s protokola koji sadrže imunosupresive koji interferiraju s enterohepatičnom recirkulacijom MPA (npr. ciklosporin), na druge lijekove koji nemaju takav učinak (npr. takrolimus, sirolimus, belatacept) ili obratno, jer to može dovesti do promjena u izloženosti MPA u.
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, CellCept tablets should not be crushed.
Budući da je mofetilmikofenolat pokazao teratogene učinke kod štakora i kunića, CellCept tablete ne smiju se drobiti.
Decrease in MPA Cmax and AUC0-12h by 30% and 25%, respectively, were observed when CellCept was concomitantly administered with sevelamer without any clinical consequences (i.e. graft rejection).
Smanjenje Cmax i AUC0 - 12 h MPA za 30% odnosno 25% primijećeno je pri istodobnoj primjeni lijeka CellCept i sevelamera bez ikakvih kliničkih posljedica (tj. odbacivanja presatka).
Write the expiry date of the made-up medicine on the bottle label.
Zapišite datum isteka roka valjanosti pripremljenog lijeka na naljepnicu boce.
CellCept 500 mg powder for concentrate for solution for infusion is contraindicated in patients who are allergic to polysorbate 80.
CellCept 500 mg prašak za koncentrat za otopinu za infuziju kontraindiciran je kod bolesnika koji su alergični na polisorbat 80.
Holding onto the body of the dispenser, carefully pull the dispenser out of the bottle adapter.
• Držeći tijelo dozatora, pažljivo izvucite dozator iz plastičnog nastavka za bocu.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Za uputu o rekonstituciji i razrjeđivanju lijeka prije primjene, vidjeti dio 6.6.
In the early post-transplant period (< 40 days post-transplant), renal, cardiac and hepatic transplant patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower compared to the late post-transplant period (3 - 6 months post-transplant).
U ranom razdoblju nakon presađivanja (< 40 dana nakon presađivanja), srednja vrijednost AUC-a MPA kod bolesnika s presađenim bubregom, srcem ili jetrom bila je otprilike 30% niža, dok je Cmax bio otprilike 40% niži u odnosu na kasnije razdoblje nakon presađivanja (3 - 6 mjeseci nakon presađivanja).
• CellCept should not be given to women of childbearing potential who are not using highly effective contraception (see section 4.6).
• CellCept se ne smije davati ženama reproduktivne dobi koje ne koriste visoko učinkovite metode kontracepcije (vidjeti dio 4.6).
If this happens, rinse your eyes with plain water.
• Ako do toga dođe, isperite oči s običnom vodom.
Patients treated with immunosuppressants, including CellCept, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Bolesnici liječeni imunosupresivima, uključujući i CellCept, imaju povećani rizik za oportunističke infekcije (bakterijske, gljivične, virusne i protozoalne), infekcije koje mogu imati smrtni ishod i sepse (vidjeti dio 4.8).
A kidney or liver.
• Bubreg ili jetru.
The health professional educational material should contain: · The Summary of Product Characteristics · Guide for healthcare professionals
Edukacijski materijali za zdravstvene radnike moraju sadržavati: · Sažetak opisa svojstava lijeka
Patients should be advised that during treatment with CellCept, vaccinations may be less effective and the use of live attenuated vaccines should be avoided (see section 4.5).
Bolesnike je potrebno upozoriti da će tijekom liječenja lijekom CellCept cijepljenje možda biti manje učinkovito te da moraju izbjegavati primjenu živog atenuiranog cjepiva (vidjeti dio 4.5).
Agranulocytosis and neutropenia have been reported; therefore, regular monitoring of patients taking CellCept is advised (see section 4.4).
Budući da su prijavljene agranulocitoza i neutropenija, preporučuje se redovito praćenje bolesnika koji uzimaju CellCept (vidjeti dio 4.4).
Cytopenias, including leucopenia, anemia, thrombocytopenia and pancytopenia, are known risks associated with mycophenolate mofetil and may lead or contribute to the occurrence of infections and hemorrhages (see section 4.4).
Citopenije, uključujući leukopeniju, anemiju, trombocitopeniju i pancitopeniju, poznat su rizik povezan s mofetilmikofenolatom i mogu dovesti do infekcija i krvarenja ili pridonijeti njihovu razvoju (vidjeti dio 4.4).
Antibiotics eliminating β-glucuronidase-producing bacteria in the intestine (e.g. aminoglycoside, cephalosporin, fluoroquinolone, and penicillin classes of antibiotics) may interfere with MPAG/MPA enterohepatic recirculation thus leading to reduced systemic MPA exposure.
Antibiotici koji uništavaju bakterije koje proizvode ß-glukuronidaze u crijevima (npr. aminoglikozidi, cefalosporini, fluorokinoloni i penicilinske skupine antibiotika) mogu interferirati s enterohepatičnom recirkulacijom MPAG-a/MPA i tako dovesti do smanjene sistemske izloženost MPA.
Hepatic enzyme increased
Povišene vrijednosti jetrenih enzima
The type and frequency of adverse reactions in a clinical study, which recruited 92 paediatric patients aged 2 to 18 years who were given 600 mg/m2 mycophenolate mofetil orally twice daily, were generally similar to those observed in adult patients given 1 g CellCept twice daily.
Vrsta i učestalost nuspojava zabilježenih u kliničkom ispitivanju s 92 pedijatrijska bolesnika u dobi od 2 do 18 godina, koji su peroralno primali 600 mg/m2 mofetilmikofenolata dvaput dnevno, bila je uglavnom slična onima uočenima kod odraslih bolesnika koji su uzimali 1 g lijeka CellCept dvaput dnevno.
CellCept has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation.
Primjena lijeka CellCept povezuje se s povećanom incidencijom štetnih događaja vezanih uz probavni sustav, uključujući manje česte pojave ulkusa gastrointestinalnog trakta, krvarenja i perforacije.
What you need to know before you take CellCept
Što morate znati prije nego počnete uzimati CellCept
Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation and infections caused by polyomaviruses (BK virus associated nephropathy, JC virus associated progressive multifocal leukoencephalopathy PML).
Takve infekcije uključuju reaktivaciju latentnih virusa, poput reaktivacije hepatitisa B ili hepatitisa C i infekcije uzrokovane polioma virusima (nefropatija povezana s BK virusom, progresivna multifokalna leukoencefalopatija (PML) povezana s JC virusom).
Renal transplant n = 991
Bubrežni presadak n = 991
CsA interferes with MPA enterohepatic recycling, resulting in reduced MPA exposures by 30-50% in renal transplant patients treated with CellCept and CsA compared with patients receiving sirolimus or belatacept and similar doses of CellCept (see also section 4.4).
A smanjuje izloženost MPA-u za 30-50% u usporedbi s bolesnicima koji primaju sirolimus ili belatacept i slične doze lijeka CellCept (vidjeti i dio 4.4).
The initial dose of CellCept 500 mg powder for concentrate for solution for infusion should be given within 24 hours following transplantation.
Inicijalna doza CellCept 500 mg praška za koncentrat za otopinu za infuziju mora se primijeniti u roku od 24 sata nakon presađivanja.
There are no data on CellCept with phosphate binders other than sevelamer.
Ne postoje podaci o primjeni lijeka CellCept s lijekovima koji vežu fosfate, osim sevelamera.
In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2) were 28 - 75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
U ispitivanju primjene jedne doze (6 ispitanika/skupina), srednje vrijednosti AUC-a MPA u plazmi ispitanika s teškim kroničnim oštećenjem bubrežne funkcije (brzina glomerularne filtracije < 25 ml/min/1,73 m2) bile su 28 - 75% više u odnosu na srednje vrijednosti koje su primijećene kod normalnih, zdravih ispitanika ili ispitanika s blažim stupnjevima oštećenja bubrežne funkcije.
CellCept 1 g/5 ml powder for oral suspension sorbitol silica, colloidal anhydrous sodium citrate soybean lecithin mixed fruit flavour xanthan gum aspartame* (E951) methyl parahydroxybenzoate (E218) citric acid anhydrous
CellCept 1 g/5 ml prašak za oralnu suspenziju sorbitol silikon, koloidni bezvodni natrijev citrat sojin lecitin okus miješanog voća ksantanska guma aspartam* (E951) metilparahidroksibenzoat (E218) citratna kiselina bezvodna
• They are available as packs of 50 (in blister packs of 10) or Multipacks containing 150 (3 packs of 50) tablets.
• Nalaze se u pakiranju od 50 tableta (u blister pakiranjima od po 10 tableta) ili višestrukom pakiranju od 150 tableta (3 pakiranja od po 50 tableta)
When comparing rates of transplant rejection, rates of graft loss or adverse event profiles between CellCept patients with and without concomitant telmisartan medication, no clinical consequences of the pharmacokinetic drug-drug interaction were seen.
Kada su se uspoređivale stope odbacivanja transplantata, stope gubitka presatka ili profili nuspojava između bolesnika liječenih lijekom CellCept koji su istodobno primali telmisartan i onih koji nisu primali telmisartan, nisu primijećene kliničke posljedice farmakokinetičke interakcije između tih dvaju lijekova.
If you forget to take CellCept
Ako ste zaboravili uzeti CellCept
Sodium less than 1 mmol (23 mg) per dose
Natrij: manje od 1 mmol (23 mg) po dozi.
Medicinal products that affect glucuronidation (e.g. isavuconazole, telmisartan) Concomitant administration of drugs affecting glucuronidation of MPA may change MPA exposure.
Lijekovi koji utječu na glukuronidaciju (npr. izavukonazol, telmisartan) Istodobna primjena lijekova koji utječu na glukuronidaciju MPA može promijeniti izloženost MPA-u.
Take the dispenser and push the plunger completely down toward the tip of the dispenser.
Uzmite dozator i potisnite cijeli klip prema vrhu dozatora.
• phosphate binders - used by people with chronic kidney failure to reduce how much phosphate gets absorbed into their blood
• lijekove koji vežu fosfate - primjenjuju se kod bolesnika s kroničnim zatajenjem bubrega kako bi se smanjila apsorpcija fosfata u krv
Thus, other substances known to undergo renal tubular secretion may compete with MPAG, and thereby raise plasma concentrations of MPAG or the other substance undergoing tubular secretion.
Na taj se način druge tvari koje se izlučuju putem bubrežnih tubula mogu natjecati s MPAG-om i tako povećavati plazmatske koncentracije MPAG-a ili drugih tvari koje se izlučuju tubularnom sekrecijom.
If you stop taking CellCept
Ako prestanete uzimati CellCept
Gently shake the vial to dissolve the medicinal product yielding a slightly yellow solution.
Lagano protresite bočicu da se lijek otopi i stvori žućkasta otopina.
CellCept capsules: oblong, blue/brown, branded with black "CellCept 250" on the capsule cap and "Roche" name on the capsule body.
CellCept kapsule: duguljasta, plavosmeđa kapsula s crnim natpisom "CellCept 250" na kapici kapsule i imenom „Roche“ na tijelu kapsule.
Cardiac disorders Tachycardia
Srčani poremećaji Tahikardija
They have “CellCept 250” printed in black on the capsule cap and “Roche” printed in black on the capsule body.
"CellCept 250" na kapici kapsule i crni natpis „Roche“ na tijelu kapsule.
Oral administration of radiolabelled mycophenolate mofetil results in complete recovery of the administered dose, with 93% of the administered dose recovered in the urine and 6% recovered in faeces.
Peroralna primjena radioizotopom označenog mofetilmikofenolata rezultira potpunom ponovnom detekcijom primijenjene doze, od čega se 93% primijenjene doze ponovno detektira u urinu, a 6% u fecesu.
CellCept tablets: lavender coloured caplet-shaped tablet, engraved with "CellCept 500" on one side and "ROCHE" name on the other.
CellCept tablete: ovalna tableta boje lavande s utisnutim "CellCept 500" s jedne strane i imenom
When comparing rates of transplant rejection or rates of graft loss between CellCept patients taking PPIs vs. CellCept patients not taking PPIs, no significant differences were seen.
Uspoređujući stope odbacivanja transplantata ili stope gubitka presatka između bolesnika koji su uzimali CellCept i IPP naspram bolesnika koji s lijekom CellCept nisu uzimali IPP, nisu primijećene značajne razlike.
• Based on literature reports, malformations occurred in 23 to 27% of live births in women exposed to mycophenolate mofetil during pregnancy (compared to 2 to 3 % of live births in the overall population and approximately 4 to 5% of live births in solid organ transplant recipients treated with immunosuppressants other than mycophenolate mofetil).
• Prema izvješćima iz literature, malformacije su se pojavile u 23 - 27% živorođene djece čije su majke bile izložene mofetilmikofenolatu tijekom trudnoće (u usporedbi sa stopom od 2 - 3% kod živorođene djece u cjelokupnoj populaciji te približno 4 - 5% kod živorođene djece bolesnica s presatkom solidnog organa liječenih drugim imunosupresivima osim mofetilmikofenolata).
There have been published reports of bronchiectasis in adults and children who received CellCept in combination with other immunosuppressants.
Objavljeni su izvještaji o bronhiektazijama u odraslih i djece koji su primili CellCept u kombinaciji s drugim imunosupresivima.
Hernia
Hernija
Urinary problems such as: blood in the urine.
Poteškoće s mokrenjem kao što su: krv u mokraći
Then, tightly close the bottle with child safety bottle cap.
Čvrsto zatvorite bocu sigurnosnim zatvaračem za djecu.
Contents of the pack and other information Making-up the medicine
Sadržaj pakiranja i druge informacije Priprema lijeka