FrancophonIA/ELRC3.0 huggingface dataset:
English: The review included all contraceptives containing low-dose oestrogen and the following progestogens: chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, nomegestrol, norelgestromin and norgestimate.
Croatian: Pregled je uključio sve kontraceptive koji sadrže male doze estrogena i sljedeće progestogene: klormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestoden, nomegestrol, norelgestromin i norgestimat.
English: It is important that women are made aware of the risk of VTE and its signs and symptoms, and that doctors take into consideration a woman's individual risk factors when prescribing a contraceptive.
Croatian: Izuzetno je važno da su žene upoznate s rizikom od VTE-a, kao i njegovim znakovima i simptomima, te da liječnici pri propisivanju kontraceptiva u obzir uzmu individualne faktore rizika svake žene.
English: • When prescribing a CHC, careful consideration should be given to the individual woman's current risk factors, particularly those for VTE, and the difference in risk of VTE between products.
Croatian: • Prilikom propisivanja CHC-a potrebno je obratiti posebnu pozornost na aktualne individualne faktore rizika svake žene, posebice onih od VTE-a, kao i na razliku u riziku od VTE-a između proizvoda.
English: The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of CHCs in preventing unwanted pregnancies continue to outweigh their risks, and that the well-known risk of VTE with all CHCs is small.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Europskoj agenciji za lijekove zaključilo je da koristi od CHC-ova za sprječavanje neželjene trudnoće i dalje nadmašuju s njima povezane rizike, te da je vrlo nizak dobro poznat rizik od VTE-a povezan sa svim CHC-ovima.
English: Risk factors include being very overweight, increasing age, having a member of your family who has had a blood clot at a relatively young age (e.g. below 50), having migraine or being immobilised for a long time (e.g. because of an illness or injury).
Croatian: Faktori rizika uključuju pretilost, poodmaklu dob, obiteljsku anamnezu krvnog ugruška u relativno mladoj dobi (mlađi od 50 godina), migrene ili imobilizacija tijekom duljeg vremena (primjerice zbog bolesti ili ozljede).
English: During the review, the risk of VTE with these medicines was compared with that of CHCs containing levonorgestrel and norethisterone (also known as ‘second generation' contraceptives).
Croatian: Tijekom pregleda, rizik od VTE-a s ovim lijekovima uspoređen je s rizikom od CHCova, koji sadrže levonorgestrel i norethisteron (također poznati pod nazivom kontraceptivi „druge generacije”).
English: • There is no evidence for differences between low-dose CHCs in their risk of arterial thromboembolism (ATE).
Croatian: • Nema dokaza za razlike između CHC-ova male doze s obzirom na rizik od arterijske tromboembolije (ATE).
English: Currently available data indicate that CHCs containing the progestogens levonorgestrel, norethisterone or norgestimate have the lowest risk of VTE (see table below).
Croatian: Trenutno dostupni podaci navode da CHC-ovi koji sadrže progestogene levonorgestrel, noretisteron ili norgestimat imaju najniži rizik od VTE-a (vidjeti tablicu niže u tekstu).
English: Information to patients
Croatian: Informacije za korisnice
English: Your risk of a blood clot is also higher in the first year of using a CHC.
Croatian: Rizik od krvnih ugrušaka je također povišen tijekom prve godine primjene CHC-a.
English: The CHMP opinion was forwarded to the European Commission, which issued a final decision on 16 January 2014.
Croatian: Mišljenje CHMP-a dostavljeno je Europskoj Komisiji, koja je usvojila konačnu odluku dana 16.
English: • Healthcare professionals should always consider the possibility of a CHC-associated thromboembolism when presented with a woman who has symptoms.
Croatian: • Zdravstveni djelatnici moraju uvijek razmotriti mogućnost tromboembolije povezane sa CHC-om, u slučaju kada propisuju lijek ženi koja ima simptome.
English: It confirmed that the benefits of CHCs outweigh the risk of blood clots, which has been known for many years and is very low.
Croatian: Potvrđeno je da koristi CHC-a nadmašuju rizik od krvnih ugrušaka, koji je poznat već dugi niz godina i vrlo je nizak.
English: CHCs contain two types of hormones, an oestrogen and a progestogen.
Croatian: CHC sadrži dva tipa hormona, estrogen ili progestogen.
English: • This Europe-wide review looked at the benefits and risks of combined hormonal contraceptives (CHCs), particularly the risk of blood clots associated with these medicines.
Croatian: • Ovaj pregled proveden u cijeloj Europi istražio je koristi i rizike kombiniranih hormonalnih kontraceptiva (CHC-ova), posebice rizik od krvnih ugrušaka povezan s ovim lijekovima.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted the Agency's final opinion.
Croatian: Preporuke PRAC-a dostavljene su Povjerenstvu za lijekove za primjenu kod ljudi (CHMP), odgovornom za sva pitanja u vezi s lijekovima za primjenu u ljudi, koje je usvojilo konačno mišljenje Agencije.
English: • It is also important to raise awareness of the signs and symptoms of VTE and ATE when prescribing a CHC.
Croatian: • Također je važno podizanje svijesti o znakovima i simptomima VTE-a i ATE-a prilikom propisivanja CHC-a.
English: The CHMP opinion, in agreement with the previous recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), was sent to the European Commission, which adopted on 16 January 2014 a legally binding decision to update the product information of all CHCs throughout the EU.
Croatian: Mišljenje CHMP-a suglasno s prethodnom preporukom Povjerenstva za ocjenu rizika na području farmakovigilancije (PRAC) dostavljeno je Europskoj komisiji koja je 16. siječnja 2014. usvojila pravno obvezujuću odluku o ažuriranju informacija o lijeku svih CHC-ova na razini EU-a.
English: Product information updated to help women make informed decisions about their choice of contraception
Croatian: Ažurirane informacije o lijeku kao pomoć ženama pri donošenju informiranih odluka o njihovom odabiru kontracepcije
English: On 21 November 2013, the European Medicines Agency completed its review of combined hormonal contraceptives (CHCs), particularly of the risk of venous thromboembolism (VTE or blood clots in veins) associated with their use.
Croatian: Dana 21. studenog 2013., Europska agencija za lijekove završila je svoj pregled kombiniranih hormonalnih kontraceptiva (CHC-ova), i to posebice pregled rizika od venske tromboembolije (VTE-a ili krvnih ugrušaka u venama) povezan s primjenom ovih kontraceptiva.
English: A review of the data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Croatian: Pregled podataka prvo je pokrenulo Povjerenstvo za ocjenu rizika na području farmakovigilancije (PRAC), odnosno Povjerenstvo odgovorno za evaluaciju pitanja sigurne primjene za lijekove za primjenu u ljudi, koje je donijelo niz preporuka.
English: The review has reinforced the importance of ensuring that clear and up-to-date information is provided to women who use these medicines and to the healthcare professionals giving advice and clinical care.
Croatian: Pregledom je još jednom utvrđena važnost osiguravanja da se ženama, koje će uzimati lijekove, i zdravstvenim djelatnicima, koji će savjetovati korisnice i pružati kliničku skrb, omoguće jasne i ažurirane informacije.
English: • Differences exist between CHCs in their risk of VTE depending on the type of progestogen they contain.
Croatian: • Postoje razlike između CHC-a s obzirom na rizik od VTE-a ovisno o tipu progestogena kojeg sadrže.
English: • The EU-wide review of combined hormonal contraceptives (CHCs) has confirmed that the known risk of venous thromboembolism (VTE) with all low-dose CHCs (ethinylestradiol < 50 mcg) is small.
Croatian: • Pregled kombiniranih hormonalnih kontraceptiva (CHC-a) proveden na razini EU-a potvrdio je vrlo mali poznati rizik od venske tromboembolije (VTE-a) sa svim CHC-ovima koji se primjenjuju u malim dozama (etinilestradiol < 50 mcg).
English: Doctors should also consider how the risk of VTE with a particular CHC compares with other CHCs (see table below).
Croatian: Liječnici moraju također razmotriti rizik od VTE-a povezan s dotičnim CHC-om u odnosu na druge CHC-ove (vidjeti tabelu niže u tekstu).
English: The product information of CHCs has been updated to help women make informed decisions about their choice of contraception together with their healthcare professional.
Croatian: Informacije o lijeku CHC-a ažurirane su kako bi pomogle ženama pri donošenju informiranih odluka o njihovom odabiru kontracepcije zajedno s njihovim liječnicima.
English: Women using a CHC containing drospirenone, gestodene or desogestrel
Croatian: Žene koje koriste CHC koji sadrži drospirenon, gestoden ili desogestrel
English: Women using a CHC containing etonogestrel or norelgestromin
Croatian: Žene koje koriste CHC koji sadrži etonogestrel ili norelgestromin
English: • You should also be aware of the factors that increase your risk of a clot and be aware of how these may change over time.
Croatian: Vaš rizik od krvnih ugrušaka te biti svjesni kako se ovi faktori mogu promijeniti tijekom vremena.
English: Women using a CHC containing chlormadinone, dienogest or nomegestrol
Croatian: Žene koje koriste CHC koji sadrži klormadinon, dienogest ili nomegestrol
English: Women using a CHC containing levonorgestrel, norethisterone or norgestimate
Croatian: Žene koje koriste CHC koji sadrži levonorgestrel, noretisteron ili norgestimat
English: Then go on as before.
Croatian: Zatim nastavite kao i ranije.
English: After 2 months, you should use a new bottle.
Croatian: Nakon 2 mjeseca morate upotrijebiti novu bočicu.
English: Serious and/or fatal outcomes have been reported.
Croatian: Zabilježeni su ozbiljni i/ili smrtni ishodi.
English: This is very important if you have had a transplant.
Croatian: To je vrlo važno ako ste imali transplantaciju.
English: • The content of the bottle is stable for 2 months after opening.
Croatian: • Sadržaj bočice je stabilan 2 mjeseca nakon otvaranja.
English: Check with your doctor if you are not sure.
Croatian: Provjerite s Vašim liječnikom ako niste sigurni.
English: This is normal and does not mean that there is anything wrong with the capsules.
Croatian: To je normalno i ne znači da nešto nije u redu s kapsulama.
English: This leaflet was last revised in {MM/YYYY} {month YYYY}.
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG} {mjesec GGGG}.
English: • Your doctor will monitor you more closely for a short time.
Croatian: • Liječnik će Vas kratko vrijeme pažljivije motriti.
English: This may affect your baby.
Croatian: To može utjecati na Vaše dijete.
English: • Wearing appropriate protective clothing.
Croatian: • Nositi odgovarajuću zaštitnu odjeću.
English: Sunlight and sun protection
Croatian: Sunčeva svjetlost i zaštita od sunca
English: • Swelling at the back of the eye.
Croatian: • Oticanje pozadine oka.
English: Your dose may need to be changed.
Croatian: Vašu dozu će možda trebati promijeniti.
English: These recommendations apply even if the patient`s values still lie within the laboratory`s normal range.
Croatian: Te preporuke vrijede čak i ako su bolesnikove vrijednosti još uvijek unutar normalnog raspona laboratorija.
English: These findings have not been demonstrated in other species and their relevance for humans is unknown.
Croatian: Ti nalazi nisu bili uočeni u drugih vrsta i njihov značaj za ljude nije poznat.
English: You may need medical attention.
Croatian: Možda ćete trebati liječničku pomoć.
English: Do not take more than the recommended dose.
Croatian: Nemojte uzimati više od preporučene doze.
English: The neurological status of these patients should be carefully monitored.
Croatian: Neurološki status tih bolesnika treba pažljivo motriti.
English: This will not affect the dose in any way.
Croatian: To neće ni na koji način utjecati na dozu.
English: If plasma or serum is used, a standard separation protocol (time and temperature) should be followed.
Croatian: Ako se koristi plazma ili serum, potrebno je slijediti standardni protokol odvajanja (vrijeme i temperatura).
English: Follow your doctor's instructions exactly and never change the dose yourself, even if you feel well.
Croatian: Točno slijedite upute svoga liječnika i nikada sami ne mijenjajte dozu, čak i ako se dobro osjećate.
English: Renal function and blood pressure in these children were normal.
Croatian: Bubrežna funkcija i krvni tlak u te djece bili su normalni.
English: Not known*
Croatian: Nepoznato*
English: You should limit your exposure to sunlight and UV light by:
Croatian: Morate ograničiti svoje izlaganje sunčevoj svjetlosti i UV svjetlu tako što ćete:
English: • Do not store in the refrigerator.
Croatian: • Ne odlagati u hladnjak.
English: • If the medicine is put in the refrigerator by mistake, let it reach room temperature before using it again.
Croatian: • Ako lijek greškom stavite u hladnjak, pustite da se zagrije na sobnu temperaturu prije nego što ga opet upotrijebite.
English: Only remove them when it is time to take your medicine.
Croatian: Izvadite ih tek kad je vrijeme da uzmete lijek.
English: Results should therefore serve only as a guide to dosage in relationship to other clinical and laboratory parameters.
Croatian: Rezultati bi stoga morali poslužiti samo kao vodič za doziranje u odnosu na druge kliničke i laboratorijske parametre.
English: This combination should therefore be given with caution with an interval of at least 3 hours.
Croatian: Tu kombinaciju stoga treba davati oprezno u intervalu od najmanje 3 sata.
English: • Loss of appetite.
Croatian: • Umor. • Gubitak apetita.
English: For severe rash, the treatment usually lasts for 8 weeks.
Croatian: Za ozbiljan osip liječenje obično traje 8 tjedana.
English: Sandimmun with food and drink
Croatian: Sandimmun s hranom i pićem
English: Your doctor will also tell you how often to take your medicine.
Croatian: Liječnik će Vam reći i koliko često trebate uzimati lijek.
English: They may differ from the general information contained in this leaflet.
Croatian: One se mogu razlikovati od općenitih informacija sadržanih u ovoj uputi.
English: However, if it is almost time for your next dose, skip the missed dose.
Croatian: Međutim, ako je skoro vrijeme za sljedeću dozu, preskočite propuštenu dozu.
English: These medicines are used to lower the body's immune reactions.
Croatian: Ti se lijekovi koriste za smanjivanje imunoloških reakcija tijela.
English: This may be associated with blurred vision.
Croatian: To bi moglo biti povezano sa zamagljenim vidom.
English: Do not take Sandimmun with grapefruit or grapefruit juice.
Croatian: Nemojte uzimati Sandimmun s grejpom ili sokom od grejpa.
English: It does not matter if there are a few tiny bubbles in the syringe.
Croatian: Nije važno ako u štrcaljki ima nekoliko sitnih mjehurića.
English: This interaction can occur for a long time after withdrawal of amiodarone, due to its very long half-life (about 50 days).
Croatian: Ta se interakcija može javiti dugo vremena nakon ustezanja amiodarona, zbog njegovog vrlo dugog poluvijeka (oko 50 dana).
English: Tremor, headache
Croatian: Tremor, glavobolja
English: In some patients, continuous maintenance therapy may be necessary.
Croatian: U nekih bolesnika može biti potrebna kontinuirana terapija održavanja.
English: Diluted infusion solutions must be discarded after 24 hours.
Croatian: Razrijeđene otopine za infuziju moraju se baciti nakon 24 sata.
English: • if you are pregnant.
Croatian: • ako ste trudni.
English: When a blister is opened, a characteristic smell is noticeable; this is normal and does not mean that there is anything wrong with the capsule.
Croatian: Kada se blister otvori, zamjetan je karakterističan miris; to je normalno i ne znači da nešto nije u redu s kapsulom.
English: • In adults:
Croatian: • U odraslih:
English: Both generalised and localised infections can occur.
Croatian: Mogu se javiti i generalizirane i lokalizirane infekcije.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Croatian: Ovaj lijek je odobren u državama članicama Europskog gospodarskog prostora (EGP) pod sljedećim nazivima:
English: Keep taking Sandimmun even if you feel well.
Croatian: Nastavite uzimati Sandimmun čak i ako se dobro osjećate.
English: Choose the syringe depending on the prescribed volume.
Croatian: Odaberite štrcaljku ovisno o propisanom volumenu.
English: - For subsequent use, follow steps 5 to 9.
Croatian: - Za naknadne primjene slijedite korake 5 do 9.
English: • Nifedipine.
Croatian: • Nifedipin.
English: • If you forget to take a dose, take it as soon as you remember it.
Croatian: • Ako zaboravite uzeti dozu, uzmite je čim se sjetite.
English: • if you have or have had alcohol related problems.
Croatian: • ako imate ili ste imali tegobe povezane s alkoholom.
English: Elderly population (65 years of age and older)
Croatian: Starija populacija (65 godina starosti i više)
English: These might be signs of an infection of the brain called progressive multifocal leukoencephalopathy.
Croatian: To bi mogli biti znakovi infekcije mozga koja se naziva progresivnom multifokalnom leukoencefalopatijom.
English: However, the pharmacokinetic profile of ciclosporin was not significantly altered.
Croatian: Međutim, farmakokinetički profil ciklosporina nije se značajno promijenio.
English: This is used to treat high blood pressure and heart pain.
Croatian: Koristi se za liječenje visokog krvnog tlaka i bolova u srcu.
English: The initial dose should be given on the day before transplantation.
Croatian: Početna doza treba se primijeniti dan prije transplantacije.
English: • how well your liver and kidneys are working,
Croatian: • koliko dobro Vam funkcioniraju jetra i bubrezi,
English: Some malignancies may be fatal.
Croatian: Neke zloćudne bolesti mogu biti smrtonosne.
English: The physician responsible for maintenance therapy should receive complete information for the follow-up of the patient.
Croatian: Liječnik odgovoran za terapiju održavanja treba dobiti potpune informacije za naknadno praćenje bolesnika.
English: - For initial use, follow steps 1 to 9.
Croatian: - Za prvu primjenu slijedite korake 1 do 9.
English: • the levels of ciclosporin in your blood, especially if you have had a transplant,
Croatian: • razine ciklosporina u krvi, osobito ako ste imali transplantaciju,
English: Time to improvement varies from 3 to 6 months depending on the type of glomerulopathy.
Croatian: Vrijeme do poboljšanja kreće se od 3 do 6 mjeseci ovisno o tipu glomerulopatije.
English: You will be switched to ciclosporin in the form of capsules or oral solution (both of which are taken by mouth) as soon as possible.
Croatian: Prijeći ćete na ciklosporin u obliku kapsula ili otopine (oboje se uzima na usta) čim bude moguće.
English: • Shaking of your body which you cannot control.
Croatian: • Drhtanje tijela koje ne možete kontrolirati.
English: Stir and drink the entire mixture right away.
Croatian: Promiješajte i odmah popijte cijelu mješavinu.
English: • Swelling at the back of the eye which may be associated with an increase in pressure inside the head and eyesight disturbances.
Croatian: • Oticanje u pozadini oka koje može biti povezano s povećanjem tlaka u glavi i poremećajima vida.
English: Push down and pull up the plunger a few times.
Croatian: Pritisnite pa povucite klip nekoliko puta.
English: • Often applying a sunscreen with a high protection factor.
Croatian: • Često nanositi kremu za sunčanje s visokim zaštitnim faktorom.
English: Follow all your doctor's instructions carefully.
Croatian: Pažljivo slijedite sve liječnikove upute.
English: Sandimmun can be used to induce and maintain remissions.
Croatian: Sandimmun se može koristiti za induciranje i održavanje remisija.
English: To achieve full effectiveness, up to 12 weeks of Sandimmun therapy may be required.
Croatian: Da bi se postigla potpuna učinkovitost moglo bi biti potrebno do 12 tjedana terapije Sandimmunom.
English: • Store at room temperature (15°C to 30°C).
Croatian: • Čuvati na sobnoj temperaturi (15°C do 30°C).
English: • In children:
Croatian: • U djece:
English: • When a blister is opened, a characteristic smell is noticeable.
Croatian: • Kada se otvori blister, zamjetan je karakterističan miris.
English: The name of your medicine is Sandimmun.
Croatian: Naziv Vašeg lijeka je Sandimmun.
English: In the blood, 33 to 47% is present in plasma, 4 to 9% in lymphocytes, 5 to 12% in granulocytes, and 41 to 58% in erythrocytes.
Croatian: U krvi je 33 do 47% prisutno u plazmi, 4 do 9% u limfocitima, 5 do 12% u granulocitima, a 41 do 58% u eritrocitima.
English: If it is necessary for you to take this medicine, your doctor will discuss with you the benefits and potential risks of taking it during pregnancy.
Croatian: Ako je nužno da uzimate ovaj lijek, liječnik će razgovarati s Vama o koristima i potencijalnim rizicima njegovog uzimanja tijekom trudnoće.
English: However, there are no adequate and well-controlled studies in pregnant women and therefore Sandimmun should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the foetus.
Croatian: Međutim, nema odgovarajućih i dobro kontroliranih ispitivanja u trudnica pa se stoga Sandimmun ne smije koristiti tijekom trudnoće osim ako potencijalna korist za majku opravdava potencijalni rizik za plod.
English: Once the bottle has been opened, the content must be used within 2 months.
Croatian: Nakon što se boca otvori, sadržaj se mora upotrijebiti u roku od 2 mjeseca.
English: Effective pre-emptive and therapeutic strategies should be employed, particularly in patients on multiple long-term immunosuppressive therapy.
Croatian: Potrebno je primijenjivati učinkovite preventivne i terapijske strategije, osobito u bolesnika na višestrukoj dugoročnoj imunosupresivnoj terapiji.
English: if you have any type of cancer.
Croatian: • ako imate bilo koju vrstu raka.
English: When using Sandimmun in any of the established non-transplantation indications, the following general rules should be adhered to:
Croatian: Kada se Sandimmun koristi u bilo kojoj od utvrđenih netransplantacijskih indikacija, potrebno je pridržavati se sljedećih općih pravila:
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Interakcije s lijekovima
English: Avoid any contact between the syringe and the liquid in the glass.
Croatian: Izbjegavajte svaki kontakt između štrcaljke i tekućine u čaši.
English: If you take more Sandimmun than you should
Croatian: Ako uzmete više Sandimmuna nego što ste trebali
English: If it is not used immediately, the conditions and duration of storage are the responsibility of the user and storage should not be longer than 24 hours at 2 to 8°C, unless dilution has been carried out under controlled and validated aseptic conditions.
Croatian: Ako se ne upotrijebi odmah, uvjeti i trajanje čuvanja odgovornost su korisnika, a čuvanje ne smije trajati duže od 24 sata na 2 do 8°C, osim ako je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: • Do not store your capsules in a hot place (maximum temperature 30°C).
Croatian: • Ne čuvajte kapsule na vrućem mjestu (maksimalna temperatura 30°C).
English: • if you have epilepsy.
Croatian: • ako imate epilepsiju.
English: The presence of a few tiny bubbles is of no importance and will not affect the dose in any way.
Croatian: Prisutnost nekoliko malih mjehurića nije važna i neće ni na koji način utjecati na dozu.
English: Some examples are listed below:
Croatian: Neki su primjeri navedeni u nastavku:
English: • your blood pressure before the start of your treatment and regularly during treatment,
Croatian: • krvni tlak prije početka liječenja te redovito tijekom liječenja,