natgillin/translations-raw huggingface dataset:
Co-administration of drugs that are substrates of CYP3A4, P-gp and OATP with ciclosporin may increase plasma levels of co-medications that are substrates of this enzyme and/or transporter.
Istodobna primjena lijekova koji su supstrati CYP3A4, P-gP i OATP-a s ciklosporinom može povećati razine u plazmi istodobno primjenjenih lijekova koji su supstrati ovog enzima i/ili prijenosnika.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion containing 50 mg ciclosporin per mL.
OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju sadrži 50 mg ciklosporina po ml.
Discontinuation of Sandimmun therapy is recommended if hypertension developing during treatment cannot be controlled with appropriate therapy.
Preporučuje se prekid terapije Sandimmunom ako se hipertenzija koja se razvije tijekom liječenja ne može kontrolirati odgovarajućom terapijom.
Sandimmun 50 mg/ml concentrate for solution for infusion ciclosporin
Uputa o lijeku: Informacija za bolesnika Sandimmun 50 mg/ml koncentrat za otopinu za infuziju ciklosporin
One ml oral solution contains 100 mg ciclosporin.
Jedan ml oralne otopine sadrži 100 mg ciklosporina.
In nephrotic syndrome patients with impaired renal function, the initial dose should not exceed 2.5 mg/kg/day.
U bolesnika s nefrotskim sindromom i oštećenom bubrežnom funkcijom početna doza ne bi smjela premašivati 2,5 mg/kg/dan.
Driving and using machines Sandimmun contains alcohol.
Sandimmun sadrži alkohol.
These include: anti-bacterial medicines (gentamycin, tobramycin, ciprofloxacin), anti-fungal medicines which contain amphotericin B, medicines used for urinary tract infections which contain trimethoprim, medicines for cancer which contain melphalan, medicines used to lower the amount of acid in your stomach (acid secretion inhibitors of the H2-receptor antagonist type), tacrolimus, pain killers (non-steroid antiinflammatory medicines such as diclofenac), fibric acid medicines (used to lower the amount of fat in the blood).
tobramicin, ciprofloksacin), antifungike koji sadrže amfotericin B, lijekove koji se koriste za infekcije mokraćnog sustava i sadrže trimetoprim, lijekove za rak koji sadrže melfalan, lijekove koji se koriste za snižavanje količine kiseline u želucu (inhibitori izlučivanja kiseline tipa antagonista H2-receptora), takrolimus, analgetike (nesteroidne protuupalne lijekove poput diklofenaka), lijekove s fibratnom kiselinom (koriste se za snižavanje količine masnoća u krvi).
Blood lipids increased
Povišeni lipidi u krvi
• Weight gain.
• Porast tjelesne težine.
The concentrate for solution for infusion contains 50 mg/ml.
KVALITATIVNI I KVANTITATIVNI SASTAV Koncentrat za otopinu za infuziju sadrži 50 mg/ml.
In patients with impaired renal function, the initial dose should not exceed 2.5 mg/kg/day.
U bolesnika s oštećenom funkcijom bubrega početna doza ne bi smjela prelaziti 2,5 mg/kg/dan.
Thrombotic microangiopathy, thrombotic thrombocytopenic purpura Metabolism and nutrition disorders
Trombotska mikroangiopatija, trombotska trombocitopenička purpura
Experience with Sandimmun in pregnant women is limited.
Iskustva sa Sandimmunom u trudnica su ograničena.
Ethanol: 50 mg/capsule.
Etanol: 50 mg/kapsula.
Infectious causes of uveitis should be ruled out before immunosuppressants can be used.
Prije nego što se mogu primijeniti imunosupresivi potrebno je isključiti infektivne uzroke uveitisa.
Myalgia, muscle cramps
Mialgija, grčevi u mišićima
Sandimmun and associated names (see Annex I) 50 mg/ml concentrate for solution for infusion [See Annex I - To be completed nationally]
Sandimmun i pridružena imena (vidjeti Dodatak I) 50 mg/ml koncentrat za otopinu za infuziju [Vidjeti Dodatak I - ispunjava država članica]
50 mg ciclosporin.
5 mg ciklosporina).
Table 1: Adverse drug reactions from clinical trials Blood and lymphatic system disorders Common
Tablica 1: Nuspojave iz kliničkih ispitivanja
The total dose each day for adults is usually 5 mg per kilogram body weight.
Ukupna doza svakoga dana za odrasle je obično 5 mg po kilogramu tjelesne težine.
Ethanol: 100 mg/capsule.
Etanol: 100 mg/kapsula.
Ciclosporin is an inhibitor of CYP3A4, the multidrug efflux transporter P-glycoprotein (P-gp) and organic anion transporter proteins (OATP).
Ciklosporin je inhibitor CYP3A4, P-glikoproteina, efluksnog transportera za protok više lijekova i organskih anionskih prijenosnih proteina (OATP).
• The other ingredients are ethanol anhydrous, maize oil interesterified, maize oil refined.
• Drugi sastojci su bezvodni etanol, interesterificirano kukuruzno ulje, rafinirano kukuruzno ulje.
{Name and address} {tel} {fax} {e-mail}
{Naziv i adresa} {tel} {fax} {e-mail}
Sandimmun 100 mg/ml oral solution ciclosporin
Uputa o lijeku: Informacija za bolesnika Sandimmun 100 mg/ml oralna otopina ciklosporin
For monitoring ciclosporin levels in whole blood, a specific monoclonal antibody (measurement of parent compound) is preferred; a high-performance liquid chromatography (HPLC) method, which also measures the parent compound, can be used as well.
Za praćenje razina ciklosporina u punoj krvi poželjno je specifično monoklonsko protutijelo (mjerenje matičnog spoja).
Sandimmun 50 mg soft capsules are corn yellow and oblong.
Sandimmun 50 mg meke kapsule su kukuruzno žute i duguljaste.
Ciclosporin enhances the clearance of magnesium.
Ciklosporin povećava klirens magenzija.
Special excipients: Sorbitol
Sandimmun sadrži sorbitol
Encephalopathy including Posterior Reversible Encephalopathy Syndrome (PRES), signs and symptoms such as convulsions, confusion, disorientation, decreased responsiveness, agitation, insomnia, visual disturbances, cortical blindness, coma, paresis and cerebellar ataxia
(PRES), znakovi i simptomi kao što su konvulzije, konfuzija, dezorijentiranost, smanjena reaktivnost, agitacija, nesanica, poremećaji vida,
Musculoskeletal and connective tissue disorders Common
Alergijski osipi Poremećaji mišićno-koštanog sustava i vezivnog tkiva
• Destruction of red blood cells, involving kidney problems with symptoms such as swelling of the face, stomach, hands and/or feet, decreased urination, breathing difficulty, chest pain, fits,
• Propadanje eritrocita, uključujući tegobe s bubrezima uz simptome poput oticanja lica, trbuha,
• Nausea (feeling sick), vomiting, abdominal pain, constipation, diarrhoea.
• Mučnina, povraćanje, bol u trbuhu, zatvor, proljev.
Very common side effects: These side effects may affect more than 1 in 10 people.
Vrlo česte nuspojave: Ove se nuspojave mogu javiti u više od 1 na 10 osoba.
• The other ingredients are: o Capsule content: ethanol anhydrous, maize oil interesterified, maize oil refined.
• Drugi sastojci su: o Sadržaj kapsule: bezvodni etanol, interesterificirano kukuruzno ulje, rafinirano kukuruzno ulje.
This contains 5 mg of ciclosporin.
Taj volumen sadrži 5 mg ciklosporina.
Nephrotic syndrome For inducing remission, the recommended daily dose is given in 2 divided oral doses.
Za postizanje remisije preporučena dnevna doza daje se podijeljena u dvije oralne doze.
Tabulated summary of adverse drug reactions from clinical trials Adverse drug reactions from clinical trials (Table 1) are listed by MedDRA system organ class.
Nuspojave iz kliničkih ispitivanja (Tablica 1) navedene su prema klasifikaciji organskih sustava po MedDRA-i.
Bone marrow transplantation
Transplantacija koštane srži
STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 100 mg ciclosporin
NAVOĐENJE DJELATNE(IH) TVARI Svaki ml sadrži 100 mg ciklosporina.
PHARMACEUTICAL FORM AND CONTENTS Capsule, soft [To be completed nationally]
OBLIK I SADRŽAJ Kapsula, meka
Capsule content Ethanol anhydrous Maize oil interesterified Maize oil refined
Sadržaj kapsule etanol, bezvodni kukuruzno ulje, interesterificirano kukuruzno ulje, rafinirano
In non-transplant patients, occasional monitoring of ciclosporin blood levels is recommended, e.g. when Sandimmun is co-administered with substances that may interfere with the pharmacokinetics of ciclosporin, or in the event of unusual clinical response (e.g. lack of efficacy or increased drug intolerance such as renal dysfunction).
kada se Sandimmun primjenjuje istodobno s tvarima koje bi mogle ometati farmakokinetiku ciklosporina, ili u slučaju neuobičajenog kliničkog odgovora (npr. nedostatak učinkovitosti ili povećana intolerancija na lijek kao što je bubrežna disfunkcija).
Sandimmun contains castor oil Sandimmun contains castor oil, which may cause stomach discomfort and diarrhoea.
Sandimmun sadrži ricinusovo ulje, koje može uzrokovati nelagodu u želucu i proljev.
Each mark on the syringe is 0.05
Svaka oznaka na štrcaljki je
Sandimmun will only be prescribed for you by a doctor with experience in transplants.
Što morate znati prije nego počnete uzimati Sandimmun Sandimmun Vam može propisati samo liječnik koji ima iskustva s presađivanjem.
PHARMACEUTICAL FORM AND CONTENTS Oral solution containing 100 mg ciclosporin per mL
OBLIK I SADRŽAJ Oralna otopina sadrži 100 mg ciklosporina po ml.
Your doctor should monitor how well your kidneys work.
Liječnik bi trebao pratiti koliko
Bone marrow transplantation Prevention of graft rejection following allogeneic bone marrow and stem cell transplantation.
Prevencija odbacivanja presatka nakon alogenog presađivanja koštane srži i matičnih stanica.
The total dose each day is usually between 5 mg and 7 mg per kilogram body weight.
Ukupna doza svakoga dana obično je između 5 mg i 7 mg po kilogramu tjelesne težine.
Muscle weakness, myopathy Renal and urinary disorders Very common
Mišićna slabost, miopatija Poremećaji bubrega i mokraćnog sustava Vrlo često
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT [To be completed nationally]
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
Measuring your dose
smanjenje doze.
If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Sandimmun.
Ako se bilo što od navedenoga odnosi na Vas (ili ako niste sigurni), obratite se svom liječniku ili ljekarniku prije nego što uzmete Sandimmun.
Vascular disorders Very common
Poremećaji živčanog sustava Vrlo često
Oedema, weight increase * Adverse events reported from post marketing experience where the ADR frequency is not known due to the lack of a real denominator.
* Štetni događaji zabilježeni nakon stavljanja lijeka u promet pri čemu je učestalost nuspojava nepoznata zbog neutvrđene veličine populacije.
{Name and Address} <{tel}> <{fax}> <{e-mail}>
{Ime I adresa} {tel} {fax} {e-mail}
This contains 10 mg of ciclosporin.
Taj volumen sadrži 10 mg ciklosporina.
The total dose each day is usually between 2.5 mg per kilogram of your body weight and 5 mg per kilogram body weight.
Ukupna doza svakoga dana obično je između 2,5 mg po kilogramu tjelesne težine i 5 mg tjelesne težine.
An approximate 2- to 3-fold increase in ciclosporin exposure may be observed in patients with hepatic impairment.
U bolesnika s oštećenjem jetre može se uočiti povećanje u izloženosti ciklosporinu od otprilike 2 do 3 puta.
The total dose each day is usually between 3 mg per kilogram of your body weight and 5 mg per kilogram body weight.
Ukupna doza svakoga dana obično je između 3 mg po kilogramu tjelesne težine i 5 mg po kilogramu tjelesne težine.
The excretion is primarily biliary, with only 6% of an oral dose excreted in the urine, and with less than 1% in the unchanged form (see sections 4.2 and 4.4).
1% u nepromijenjenom obliku (vidjeti dijelove 4.2 i 4.4).
- Medicines which may decrease the level of ciclosporin in your blood include: barbiturates (used to help you to sleep), some anti-convulsant medicines (such as carbamazepine or phenytoine), octreotide (used to treat acromegaly or neuroendocrine tumours in the gut), antibacterial medicines used to treat tuberculosis, orlistat (used to help weight loss), herbal medicines containing St. John's wort, ticlopidine (used after a stroke), certain medicines which lower blood pressure (bosentan), and terbinafine (an anti-fungal medicine used to treat infections of the toes and nails).
- Lijekovi koji mogu smanjiti razinu ciklosporina u Vašoj krvi uključuju: barbiturate (koriste se za pomoć u spavanju), antikonvulzivne lijekove (kao što su karbamazepin ili fenitoin), oktreotid (koristi se za liječenje akromegalije ili neuroendokrinih tumora u crijevima), antibakterijske lijekove koji se koriste za liječenje tuberkuloze, orlistat (koristi se kao pomoć u mršavljenju), biljne lijekove koji sadrže gospinu travu, tiklopidin (koristi se nakon moždanog udara), određene lijekove koji snižavaju krvni tlak (bosentan) i terbinafin (antifungalni lijek koji se koristi za liječenje infekcija nožnih pristiju i noktiju).
Each capsule contains 25 mg ciclosporin.
Svaka kapsula sadrži 25 mg ciklosporina.
If any of the above apply to you (or you are not sure), tell your doctor before taking Sandimmun.
Ako se bilo što od navedenog odnosi na vas (ili ako niste sigurni), obavijestite svog liječnika prije nego što uzmete Sandimmun.
In some cases, mainly in transplant patients, fatal outcomes have been reported (see section 4.8).
zabilježeni su smrtni ishodi (vidjeti dio 4.8).
Renal toxicity
Bubrežna toksičnost
- Medicines which may increase the level of ciclosporin in your blood include: antibiotics (such as erythromycin or azythromycin), anti-fungals (voriconazole, itraconazole), medicines used for heart problems or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to stop sickness), oral contraceptives, danazol (used to treat menstrual problems), medicines used to treat gout (allopurinol), cholic acid and derivatives (used to treat gallstones), protease inhibitors used to treat HIV, imatinib (used to treat leukaemia or tumours), colchicine, telaprevir (used to treat hepatitis C).
- Lijekovi koji bi mogli povećati razinu ciklosporina u krvi uključuju: antibiotike (kao što su eritromicin ili azitromicin), antifungike (vorikonazol, itrakonazol), lijekove koji se koriste za srčane probleme ili visoki krvni tlak (diltiazem, nikardipin, verapamil, amiodaron), metoklopramid (koristi se za obustavljanje mučnine), oralni kontraceptivi, danazol (koristi se za liječenje menstrualnih tegoba), lijekove koji se koriste za liječenje gihta (alopurinol), kolnu kiselinu i derivate (koristi se za liječenje žučnih kamenaca), inhibitore proteaze koji se koriste za liječenje HIV-a, imatinib (koristi se za liječenje leukemije ili tumora), kolhicin, telaprevir (koristi se za liječenje hepatitisa C).
How Sandimmun will be used
Kako će se Sandimmun primjenjivati
Very rare side effects: These side effects may affect between 1 and 10 in every 100,000 people.
Vrlo rijetke nuspojave: Ove se nuspojave mogu javiti između 1 i 10 na svakih 100 000 osoba.
Ciclosporin is also an inhibitor of CYP3A4, the multidrug efflux transporter P-glycoprotein and organic anion transporter proteins (OATP) and may increase plasma levels of co-medications that are substrates of this enzyme and/or transporters.
Ciklosporin je također inhibitor CYP3A4, P-glikoproteina, efluksnog transportera za protok više lijekova i organskih anionskih prijenosnih proteina (OATP) te može povećati razine u plazmi istodobno primijenjenih lijekova koji su supstrati ovih enzima i/ili prijenosnika.
Caution is also required when ciclosporin is co-administered with potassium-sparing drugs (e.g. potassiumsparing diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists) or potassium-containing medicinal products as well as in patients on a potassium rich diet. Control of potassium levels in these situations is advisable.
Oprez je također potreban kada se ciklosporin primjenjuje istodobno s lijekovima koji štede kalij (npr. diuretici koji štede kalij, inhibitori angiotenzin konvertirajućeg enzima (ACE), antagonisti angiotenzin II
Headache.
MedDRA-i.
How long Sandimmun will be used
Koliko dugo će se Sandimmun primjenjivati
Ciclosporin is an inhibitor of CYP3A4, the multidrug efflux transporter P-glycoprotein and organic anion transporter proteins (OATP) and may increase plasma levels of co-medications that are substrates of this enzyme and/or transporter.
Ciklosporin je inhibitor CYP3A4, P-glikoproteina, efluksnog transportera za protok više lijekova i organskih anionskih prijenosnih proteina (OATP) te može povećati razine u plazmi istodobno primijenjenih lijekova koji su supstrati ovog enzima i/ili transportera.
Hypomagnesaemia
Hiperuricemija
Sandimmun can also be combined with low-dose weekly methotrexate in patients who have insufficient response to methotrexate alone, by using 2.5 mg/kg Sandimmun in 2 divided doses per day initially, with the option to increase the dose as tolerability permits.
primjenom 2,5 mg/kg Sandimmuna u 2 podijeljene doze dnevno za početak, uz mogućnost povećavanja doze ako se podnosi.
Patients with abnormal baseline renal function should initially be treated with 2.5 mg/kg/day and must be monitored very carefully.
2,5 mg/kg/dan i vrlo pažljivo motriti.
4.1 Therapeutic indications
4.1 Terapijske indikacije Transplantacijske indikacije Transplantacija solidnih organa
Each capsule contains 50 mg ciclosporin.
Svaka kapsula sadrži 50 mg ciklosporina.
NAME OF THE MEDICINAL PRODUCT Sandimmun and associated names (see Annex I) 100 mg/ml oral solution [See Annex I - To be completed nationally] Ciclosporin
NAZIV LIJEKA Sandimmun i pridružena imena (vidjeti Dodatak I) 100 mg/ml oralna otopina
Each capsule contains 100 mg ciclosporin.
Svaka kapsula sadrži 100 mg ciklosporina.
Concomitant administration of dabigatran extexilate is not recommended due to the P-gp inhibitory activity of ciclosporin (see section 4.3).
Istodobna primjena dabigatran eteksilata se ne preporučuje zbog inhibicijskog učinka ciklosporina na
If you have any questions about how Sandimmun works or why this medicine has been prescribed for you, ask your doctor.
Ako imate bilo kakvih pitanja o tome kako Sandimmun djeluje ili zašto
How much Sandimmun you will be given
Koliko ćete Sandimmuna dobiti
If the renal function (except for proteinuria) is normal, the recommended daily dose is the following: - adults: 5 mg/kg - children: 6 mg/kg
Ako je bubrežna funkcija (osim proteinurije) normalna, preporučena dnevna doza je sljedeća:
Starting a new bottle of Sandimmun oral solution Lift the flap in the centre of the metal sealing ring.
Prva primjena Sandimmun oralne otopine iz nove bočice
{Name of the Member State} {Name of the medicinal product} {Name of the Member State}{Name of the medicinal product}
{Naziv države članice} {Naziv lijeka} {Naziv države članice} {Naziv lijeka}
Excretion is primarily biliary, with only 6% of an oral dose excreted in the urine, and with less than 1% in the unchanged form (see sections 4.2 and 4.4).
Izlučivanje se prvenstveno odvija putem žuči, pri čemu se samo 6% oralne doze izlučuje u mokraći, a manje od
o Capsule shell: Iron oxide yellow (E172), titanium dioxide (E171), glycerol 85%, sorbitol syrup special, gelatin.
o Ovojnica kapsule: žuti željezov oksid (E172), titanijev dioksid (E171), glicerol 85%, posebni sorbitol sirup, želatina.
o Capsule shell: Iron oxide red (E172), titanium dioxide (E 171), glycerol 85%, sorbitol syrup special, gelatin.
o Ovojnica kapsule: crveni željezov oksid (E172), titanijev dioksid (E 171), glicerol 85%, posebni sorbitol sirup, želatina.
METHOD OF ADMINISTRATION [To be completed nationally]
14. NAČIN IZDAVANJA LIJEKA [Ispunjava država članica]
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Sandimmun and associated names (see Annex I) 50 mg/ml concentrate for solution for infusion [See Annex I - To be completed nationally]
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Sandimmun i pridružena imena (vidjeti Dodatak I) 50 mg/ml koncentrat za otopinu za infuziju
Administration of ciclosporin 3 hours after lercanidipine yielded no change of the lercanidipine AUC, but the ciclosporin AUC was increased by 27%.
AUC-a lerkanidipina, ali AUC ciklosporina povećao se za 27%.
• High level of lipids in your blood.
• lipide (masnoće) u krvi.
Uncoloured glass (type I) ampoule.
6.5 Vrsta i sadržaj spremnika Ampula od bezbojnog stakla (tip I).
Rare side effects: These side effects may affect between 1 and 10 in every 10,000 people.
Rijetke nuspojave: Ove se nuspojave mogu javiti između 1 i 10 na svakih 10 000 osoba.
if you have kidney problems.
• ako imate tegobe s bubrezima.
DATE OF REVISION OF THE TEXT [To be completed nationally]
DATUM REVIZIJE TEKSTA
Common side effects: These side effects may affect between 1 and 10 in every 100 people.
Česte nuspojave: Ove se nuspojave mogu javiti u između 1 i 10 na svakih 100 osoba.
NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name}
Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač [Ispunjava država članica]
Patients on Sandimmun should not receive concomitant ultraviolet B irradiation or PUVA photochemotherapy.
Bolesnici koji primaju Sandimmun ne smiju se istodobno liječiti ultraljubičastim
if you have liver problems.
• ako imate tegobe s jetrom.
Uncommon side effects: These side effects may affect between 1 and 10 in every 1,000 people.
Manje česte nuspojave: Ove se nuspojave mogu javiti između 1 i 10 na svakih 1000 osoba.
Renal dysfunction (see section 4.4) Reproductive system and breast disorders Rare
Disfunkcija bubrega (vidjeti dio 4.4)
Capsule shell Iron oxide yellow (E172) Titanium dioxide (E171) Glycerol 85% Sorbitol syrup special Gelatin
Ovojnica kapsule željezov oksid, žuti (E172) titanijev dioksid (E171) glicerol 85% sorbitol sirup, posebni želatina
if you have gout.
• ako se trebate cijepiti.
In most cases, Sandimmun concentrate for solution for infusion is preferred for this purpose.
Sandimmun koncentrat za otopinu za infuziju.
Care should be taken when using ciclosporin together with other active substances that exhibit nephrotoxic synergy such as: aminoglycosides (including gentamycin, tobramycin), amphotericin B, ciprofloxacin, vancomycin, trimethoprim (+ sulfamethoxazole); fibric acid derivatives (e.g. bezafibrate, fenofibrate); NSAIDs (including diclofenac, naproxen, sulindac); melphalan histamine H2-receptor antagonists (e.g. cimetidine, ranitidine); methotrexate (see section 4.4).
bezafibrat, fenofibrat); NSAIL-ovi (uključujući diklofenak, naproksen, sulindak); antagonisti melfalan histamin H2-receptora (npr. cimetidin, ranitidin); metotreksat (vidjeti dio 4.4).
Capsule shell Iron oxide red (E172) Titanium dioxide (E 171) Glycerol 85% Sorbitol syrup special Gelatin
Ovojnica kapsule željezov oksid, crveni (E172) titanijev dioksid (E 171) glicerol 85% sorbitol sirup, posebni želatina
Capsule shell Iron oxide red (E172) Titanium dioxide (E171) Glycerol 85% Sorbitol syrup special Gelatin
Ovojnica kapsule željezov oksid, crveni (E172) titanijev dioksid (E171) glicerol 85% sorbitol sirup, posebni želatina
Talk to your doctor before taking Sandimmun: if you have or have had alcohol-related problems.
Prije i tijekom liječenja Sandimmunom, odmah obavijestite svog liječnika: • ako imate bilo kakve znakove infekcije, kao što su vrućica i grlobolja.
Intravenous use
Peroralna primjena
How to store Sandimmun
Moguće nuspojave Kako čuvati Sandimmun
• Stomach ulcer.
• Tegobe s jetrom.
No impairment in fertility was demonstrated in studies in male and female rats.
U ispitivanjima na mužjacima i ženkama štakora nije bilo uočeno smanjivanje plodnosti.
Very common
Često
Macrogolglycerol ricinoleate/polyethoxylated castor oil
6.1 Popis pomoćnih tvari etanol, bezvodni makrogolglicerolricinoleat/polietoksilirano ricinusovo ulje
Method of administration Oral use
OBLIK Oralna otopina
What Sandimmun looks like and contents of the pack Sandimmun 25 mg soft capsules are pink and oval.
Sandimmun 25 mg meke kapsule su ružičaste i ovalne.
The usual dose is 60 mg once a day.
Uobičajena doza je 60 mg jedanput na dan.
Thrombin is essential for blood clotting.
Trombin je neophodan za zgrušavanje krvi.
The full EPAR for Roteas can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Roteas nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This medicine is the same as Lixiana, which is already authorised in the European Union (EU).
Taj je lijek isti kao i lijek Lixiana, koji je već odobren u Europskoj uniji (EU).