natgillin/translations-raw huggingface dataset:
Eurartesim is contraindicated in patients already taking other medicinal products that are known to prolong the QTc interval due to the risk of a pharmacodynamic interaction leading to an additive effect on the QTc interval (see sections 4.3 and 4.4).
Zdravilo Eurartesim je kontraindicirano pri bolnikih, ki že jemljejo druga zdravila, za katera je znano, da podaljšujejo interval QTc, zaradi tveganja farmakodinamičnega medsebojnega delovanja, ki bi vodilo v dodatni učinek na interval QTc (glejte poglavji 4.3 in 4.4).
Eurartesim should not be used during the 1st trimester of pregnancy in situations where other suitable and effective antimalarials are available (see section 4.6).
Zdravila Eurartesim se ne sme uporabljati v prvem trimesečju nosečnosti v situacijah, kjer so na voljo drugi ustrezni in učinkoviti antimalariki (glejte poglavje 4.6).
• has a malaria infection caused by a parasite other than Plasmodium falciparum;
• imate vi ali vaš otrok okužbo z malarijo, ki jo povzroča drug parazit, ne Plasmodium falciparum;
Piperaquine was mainly metabolised by CYP3A4 and to a lesser extent by CYP2C9 and CYP2C19.
Piperakin presnavlja pretežno encim CYP3A4, manj pa encima CYP2C9 in CYP2C19.
In vitro drug-drug interaction studies revealed that artenimol is an inhibitor of CYP1A2; therefore, there is the potential for artenimol to increase plasma concentrations of CYP1A2 substrates (see section 4.5).
Študije medsebojnega delovanja zdravila z zdravili in vitro so pokazale, da je artenimol zaviralec encima CYP1A2, zato obstaja možnost, da artenimol zvišuje koncentracije substratov encima CYP1A2 v plazmi (glejte poglavje 4.5).
Artenimol pharmacokinetic parameters were found to be similar in healthy volunteers of Asian and Caucasian origin.
Ugotovili so, da so parametri farmakokinetike artenimola podobni pri zdravih prostovoljcih azijskega porekla in belcih.
White oblong biconvex film-coated tablet (dimension 16x8mm / thickness 5.5mm) with a break-line and marked on one side with two “σ” letters.
Bele podolgovate bikonveksne filmsko obložene tablete (dimenzije 16 x 8 mm/debelina 5,5 mm) z razdelilno zarezo in oznako na eni strani z dvema črkama „σ“.
Therefore Eurartesim should not be used during the 1st trimester of pregnancy in situations where other suitable and effective anti-malarials are available (see section 4.4).
Zato se zdravila Eurartesim ne sme uporabljati v 1. trimesečju nosečnosti v situacijah, kjer so na voljo drugi ustrezni in učinkoviti antimalariki (glejte poglavje 4.4).
• Inhibition of falciparum sarcoplasmic-endoplasmic reticulum calcium ATPase,
• zaviranjem kalcijeve ATPaze sarkoplazemskega-endoplazemskega retikuluma plazmodija falciparum,
No effect on the metabolite profile of piperaquine in human hepatocytes was observed when piperaquine was co-incubated with artenimol.
Učinkov na profil presnovkov piperakina pri človeških hepatocitih pri sočasni inkubaciji piperakina z artenimolom niso opazili.
Piperaquine pharmacokinetic parameters were found to be similar in healthy volunteers of Asian and Caucasian origin.
Ugotovili so, da so parametri farmakokinetike piperakina podobni pri zdravih prostovoljcih azijskega porekla in belcih.
In healthy volunteers, artenimol exposure was increased by 43% when administered with a high fat/high calorie meal.
Pri zdravih prostovoljcih se je izpostavljenost artenimolu pri dajanju z obroki z visoko vsebnostjo maščob/kalorij povečala za 43 %.
Eurtartesim treatment, the piperaquine maximum plasma concentration was higher in female than in male healthy volunteers, the difference being in the order of 30 to 50%.
Eurartesim največja koncentracija piperakina v plazmi višja pri ženskih kot pri moških zdravih prostovoljcih, pri čemer je razlika v razponu od 30 do 50 %.
Caution is therefore, advised when Eurartesim is administered concomitantly with medicinal products metabolised by this enzyme that have a narrow therapeutic index, such as theophylline.
Pozornost je zato potrebna pri dajanju zdravila Eurartesim sočasno z zdravili, ki jih ta encim presnavlja, in imajo ozek terapevtski indeks, na primer teofilin.
95 % two-sided CI on the treatment difference (EurartesimComparator); p-value
95-% dvostranski IZ razlike zdravljenja (zdravilo Eurartesimprimerjano zdravilo); vrednost p
Pharmacokinetics in special patient populations No specific pharmacokinetic studies have been performed in patients with hepatic or renal insufficiency, or in elderly people.
Specifičnih študij farmakokinetike pri bolnikih z jetrnim ali ledvičnim popuščanjem ter pri starejših bolnikih niso izvajali.
You can drive or use machines after taking Eurartesim once you have recovered from your illness.
Vpliv na sposobnost upravljanja vozil in strojev Med jemanjem zdravila Eurartesim lahko vozite in upravljate stroje, potem ko ste že okrevali po bolezni.
Piperaquine was found to be an inhibitor of CYP3A4 (also in a time-dependent way) and to a lesser extent of CYP2C19, while it stimulated the activity of CYP2E1.
Ugotovili so, da je piperakin zaviralec encima CYP3A4 (tudi v odvisnosti od časa) in manj encima CYP2C19, aktivnost encima CYP2E1 pa je stimuliral.
Film coating Hypromellose (E464) Titanium dioxide (E171) Macrogol 400
hipromeloza (E464) titanov dioksid (E171) makrogol 400
95% two-sided CI on the treatment difference (Eurartesim - Comparator); p-value
95-% dvostranski IZ razlike zdravljenja (zdravilo Eurartesim - primerjano zdravilo); vrednost p
A large amount of data (more than 3000 exposed outcomes) from the use of artenimol/piperaquine during the 2nd and 3rd trimester indicate no fetotoxicity.
Večje število podatkov o uporabi artenimola/piperakina v 2. in 3. trimesečju nosečnosti (več kot 3.000 izpostavljenih nosečnosti) ne kaže na njegovo fetotoksičnost.
Artenimol is very rapidly absorbed, Tmax being approximately 1-2 hrs after single and multiple dosing.
Tmax je približno 1-2 uri po enkratnem in večkratnem odmerjanju.
There are only limited (n=3) amount of data from the use of artenimol/piperaquine during the 1st trimester of pregnancy.
Nosečnost Podatki o uporabi artenimola in piperakina v 1. trimesečju nosečnosti so omejeni (n = 3).
• Cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, vinca alkaloids, arsenic trioxide.
• cisaprid, droperidol, domperidon, bepridil, difemanil, probukol, levometadil, metadon, vinka alkaloide, arzenov trioksid.
There are no phototoxicity concerns with artenimol, as it does not absorb in the range of 290-700 nm. Piperaquine has an absorption maximum at 352 nm.
Ni pomislekov glede fototoksičnosti, povezane z artenimolom, saj se v razponu 290-700 nm ne absorbira.
In cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate, including ECG monitoring because of the possibility of QTc interval prolongation (see section 4.4).
V primeru suma na preveliko odmerjanje je treba nuditi ustrezno simptomatsko in podporno zdravljenje, vključno s spremljanjem EKG zaradi možnosti podaljšanja intervala QTc (glejte poglavje 4.4).
Therefore, particular attention should be paid when medicinal products that have a narrow therapeutic index (e.g. antiretroviral medicinal products and cyclosporine) are co-administered with Eurartesim.
Zato je potrebna posebna pozornost, kadar se sočasno z zdravilom Eurartesim dajejo zdravila, ki imajo ozek terapevtski indeks (npr. antiretrovirusna zdravila in ciklosporin).
These may increase the QTc-prolonging effect of Eurartesim (see section 4.3).
To lahko poveča učinke zdravila Eurartesim na podaljšanje intervala QTc (glejte poglavje 4.3).
The concurrent administration of oral Eurartesim with 7.5 mg oral midazolam, a CYP3A4 probe substrate, led to a modest increase (≤2-fold) in midazolam and its metabolites exposures in healthy adult subjects.
Sočasno peroralno dajanje zdravila Eurartesim s 7,5 mg peroralnega midazolama, ki je testni substrat CYP3A4, je povzročilo zmerno (≤ 2-kratno) zvečanje izpostavljenosti midazolamu in njegovim presnovkom pri zdravih odraslih preiskovancih.
Frequency of ADRs in paediatric patients participating in clinical studies with Eurartesim:
Pogostnost neželenih učinkov pri pediatričnih bolnikih, ki so bili vključeni v klinično preskušanje z zdravilom Eurartesim:
Studies in human liver microsomes showed that artenimol was metabolised by the UDP-glucuronosyltransferase (UGT1A9 and UGT2B7) to α-artenimol-G with no cytochrome P450-mediated metabolism.
Študije na mikrosomih človeških jeter so pokazale, da je artenimol presnavljala UDP-glukuronosiltransferaza (UGT1A9 in UGT2B7) v α-artenimol-G brez presnove, v kateri sodeluje citokrom P450.
You should take the Eurartesim tablets with water only.
Zdravilo Eurartesim skupaj s hrano in pijačo Zdravilo Eurartesim tablete vzemite samo z vodo.
- Family history of sudden death or of congenital prolongation of the QTc interval.
- Nenadna smrt ali prirojeno podaljšanje intervala QTc v družinski anamnezi.
Eurartesim are white film-coated tablets, embossed and with a break line along the middle.
Izgled zdravila Eurartesim in vsebina pakiranja Zdravilo Eurartesim so bele filmsko obložene tablete z vtisom in razdelilno zarezo na sredini.
A limited number of drug-drug pharmacokinetic interaction studies with Eurartesim have been performed in healthy adult subjects.
Pri zdravih odraslih preiskovancih so izvedli omejeno število študij farmakokinetičnega medsebojnega delovanja med zdravili in zdravilom Eurartesim.
DM04010 (n=1087) ≤5 years
DM040010 (n = 1.087) ≤ 5 let
• Disruption of parasite mitochondrial function
• prekinitvijo delovanja mitohondrija parazita.
Exposure to piperaquine may also be increased when co-administered with mild or moderate CYP3A4-inhibitors (e.g. oral contraceptives).
Izpostavljenost piperakinu se lahko zveča tudi, kadar ga dajemo sočasno z blagimi ali zmernimi zaviralci CYP3A4 (n.pr.
Frequency of ADRs in adult patients participating in clinical studies with Eurartesim:
Pogostnost neželenih učinkov pri odraslih bolnikih, ki so bili vključeni v klinično preskušanje z zdravilom Eurartesim:
The most frequent ADRs observed at an incidence ≥1.0% were: Headache (3.9%), Electrocardiogram QTc Prolonged (3.4%), P. falciparum infection (3.0%), Anaemia (2.8%), Eosinophilia (1.7%), Haemoglobin decreased (1.7%), Sinus tachycardia (1.7%), Asthenia (1.6%), Haematocrit [decreased] (1.6%), Pyrexia (1.5%), Red Blood Cell Count decreased (1.4%).
Najpogostejši neželeni učinki, ki so jih opazili z incidenco ≥ 1,0 %, so bili: glavobol (3,9 %), podaljšanje QTc na elektrokardiogramu (3,4 %), okužba s P. falciparum (3,0 %), anemija (2,8 %), eozinofilija (1,7 %), znižanje hemoglobina (1,7 %), sinusna tahikardija (1,7 %), astenija (1,6 %), znižanje hematokrita (1,6 %), pireksija (1,5 %), znižanje števila eritrocitov (1,4 %).
In human studies, piperaquine was found to be a mild inhibitor of CYP3A4 enzyme while potent inhibitors of CYP3A4 activity caused mild inhibition of piperaquine metabolism (see section 4.5).
V študijah na ljudeh so ugotovili, da je piperakin blag zaviralec encima CYP3A4, medtem ko so močni zaviralci aktivnosti CYP3A4 blago zavirali presnovo piperakina (glejte poglavje 4.5).
The concurrent administration of a single dose of oral clarithromycin, (a strong CYP3A4 inhibitor probe) with a single dose of oral Eurartesim led to a modest increase (≤2-fold) in piperaquine exposure in healthy adult subjects.
Sočasno dajanje enkratnega peroralnega odmerka klaritromicina (ki je močan testni zaviralec CYP3A4) z enkratnim peroralnim odmerkom zdravila Eurartesim je pri zdravih odraslih preiskovancih povzročilo zmerno (≤ 2-kratno) zvečanje izpostavljenosti piperakinu.
How to take Eurartesim
Kako jemati zdravilo Eurartesim
P. falciparum infection
P. falciparum okužba dihal gripa
From in vitro data, piperaquine undergoes a low level of metabolism by CYP2C19, and is also an inhibitor of this enzyme.
Sodeč po podatkih in vitro se piperakin v majhni meri presnavlja z encimom CYP2C19 in je hkrati zaviralec tega encima.
>12 to ≤18 years >18 to ≤64 years DM04011 (n=1524) ≤1 year
> 18 do ≤ 64 let DM040011 (n = 1.524)
On the other hand, on the last day of
Po drugi strani je bila zadnji dan zdravljenja z zdravilom
A moderate increase of piperaquine plasma concentrations (<2-fold) was observed when co-administered with strong CYP3A4 inhibitors, resulting in a potential exacerbation of the effect on QTc prolongation (see section 4.5).
Ugotovili so zmerno (za < 2-krat) zvišanje koncentracij piperakina v plazmi, kadar so ga dajali sočasno z močnimi zaviralci CYP3A4, kar je povzročilo možno zvečanje učinka na podaljšanje intervala QTc (glejte poglavje 4.5).
Hypromellose (E464) Croscarmellose sodium Magnesium stearate (E572)
predgeliran škrob dekstrin hipromeloza (E464) premrežen natrijev karmelozat magnezijev stearat (E572)
• Inhibition of haem-digestion pathway in the parasite food vacuole.
• zaviranje prebavne poti hema v vakuoli hrane parazita.
Artenimol is eliminated by metabolism (mainly glucuroconjugation).
Artenimol se izloča s presnovo (pretežno glukurokonjugacijo).
Piperaquine was not teratogenic in the rat or rabbit.
Piperakin ni bil teratogen pri podganah ali kuncih.
12 tablets
12 tablet
For the medicine to work effectively, you or your child should take the tablets as instructed and should complete the 3 days course of treatment.
Če ste vi ali vaš otrok prenehali jemati zdravilo Eurartesim Za učinkovitost tega zdravila morate vi ali vaš otrok tablete jemati skladno z navodili in izpeljati 3-dnevni cikel zdravljenja.
• Interference with mitochondrial electron transport
• motnjami prenosa elektronov v mitohondriju,
1.5 tablet
1,5 tablete
(1) This CI is asymptotic because the exact CI could not be computed
> 2 do ≤ 5 let (1) Ta IZ je asimptotičen, ker natančnega IZ ni bilo mogoče izračunati.
Eurartesim contains the active substances piperaquine tetraphosphate and artenimol.
Zdravilo Eurartesim vsebuje zdravilni učinkovini piperakin tetrafosfat in artenimol.
7 to less than 13 One 160 mg/20 mg tablet a day
7 do manj kot 13 Ena 160 mg/20 mg tableta na dan
These include some of the types of medicines used to treat bacterial infections (macrolides [such as erythromycin or clarithromycin] and fluoroquinolones [such as moxifloxacin and sparfloxacin]) or fungal infections (including fluconazole and imidazole) as well as pentamidine (used to treat a specific type of pneumonia) and saquinavir (for treatment of HIV); antihistamines used to treat allergies or inflammation such as terfenadine, astemizole or mizolastine; certain medicines used to treat stomach problems such as cisapride, domperidone or droperidol; other medicines such as vinca alkaloids and arsenic trioxide (used to treat certain cancers), bepridil (used to treat angina), diphemanil (used to treat stomach disturbances), levomethadyl and methadone (used to treat drug addiction), and probucol (used to treat high blood cholesterol levels).
Ta vključujejo nekatere vrste zdravil, s katerimi se zdravijo bakterijske okužbe (makrolidi [kot sta eritromicin ali klaritromicin] in fluorokinoloni [kot sta moksifloksacin in sparfloksacin]) ali glivične okužbe (vključno s flukonazolom in imidazolom) ter pentamidin (uporablja se za zdravljenje nekaterih vrst pljučnice) in sakvinavir (za zdravljenje okužbe z virusom HIV); antihistaminiki, ki se uporabljajo za zdravljenje alergij ali vnetij, kot so terfenadin, astemizol ali mizolastin; nekatera zdravila, ki se uporabljajo za zdravljenje težav z želodcem, kot so cisaprid, domperidon ali droperidol; druga zdravila, kot so vinka alkaloidi in arzenov trioksid (uporabljajo se za zdravljenje nekaterih vrst raka), bepridil (uporablja se za zdravljenje angine), difemanil (uporablja se za zdravljenje trebušnih motenj), levometadil in metadon (uporabljata se za zdravljenje odvisnosti od mamil) in probukol (uporablja se za zdravljenje visokih ravni holesterola v krvi).
In the tables below, ADRs are listed under system organ class (SOC), and ranked by headings of frequency.
V spodnjih tabelah so neželeni učinki našteti po organskih sistemih in razvrščeni po pogostnosti.
Piperaquine is a mild inhibitor of CYP3A4.
Piperakin je blag zaviralec encima CYP3A4.
If you are not sure about any of the above, please ask your doctor or pharmacist.
Če niste prepričani, ali kar koli od zgoraj navedenega velja za vas, se posvetujte z zdravnikom ali farmacevtom.
Eurartesim has not been evaluated in subjects with moderate or severe renal or hepatic insufficiency.
Zdravilo Eurartesim ni bilo ovrednoteno v študijah pri osebah z zmerno ali hudo okvaro delovanja ledvic ali jeter.
• Interference with parasite transport proteins
• motnjami prenosa beljakovin v parazitu,
- medicines used to prevent/treat epileptic seizures: barbiturates (such as phenobarbital),
- zdravila, ki se uporabljajo za preprečevanje/zdravljenje epileptičnih napadov: barbiturati (kot je fenobarbital), karbamazepin ali fenitoin, - zdravila, ki se uporabljajo po presaditvi organov in pri avtoimunih boleznih (kot sta ciklosporin,
Do not give this medicine to infants under 6 months or below 5 kg in weight.
Otroci Dojenčki, stari manj kot 6 mesecev ali težki manj kot 5 kg, ne smejo dobivati tega zdravila.
Therefore, caution should be applied when co administering Eurartesim with any CYP3A4-inhibitor and ECG monitoring should be considered.
Zato je pri sočasnem dajanju zdravila Eurartesim s katerim koli zaviralcem CYP3A4 potrebna previdnost in v poštev pride spremljanje EKG.
Musculoskeletal and connective tissue disorders
Bolezni mišičnoskeletnega sistema in vezivnega tkiva artralgija
Cardiac conduction disorders Sinus arrhythmias Bradycardia
Srčne bolezni podaljšanje QTc tahikardija motnje srčne prevodnosti sinusne aritmije bradikardija
• Antiarrhythmics (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
• antiaritmike (npr. amiodaron, dizopiramid, dofetilid, ibutilid, prokainamid, kinidin, hidrokinidin, sotalol),
− This medicine has been prescribed for you only.
- Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
In patients, mean Cmax (CV %) and AUCINF of artenimol (observed after the first dose of Eurartesim) were 752 (47%) ng/ml and 2,002 (45%) ng/ml*h, respectively.
Pri bolnikih sta bila povprečni Cmax (CV %) in AUCINF za artenimol (opazovano po prvem odmerku zdravila Eurartesim) 752 (47 %) ng/ml oz. 2.002 (45 %) ng/ml*h.
Delayed haemolytic anaemia has been observed up to one month following use of IV artesunate and oral artemisinin-based combination treatment (ACT) including reports involving Eurartesim.
artezunata in kombiniranega peroralnega zdravljenja na osnovi artemizinina (ACT - artemisinin-based combination treatment), vključno s poročili, ki so se nanašala na zdravilo Eurartesim.
The long half-life of piperaquine (about 22 days) should be kept in mind in the event that another antimalarial agent is started due to treatment failure or a new malaria infection (see below and sections 4.3 and 4.5).
V primeru, da se začne zdravljenje z drugim zdravilom proti malariji, če prvotno zdravljenje ni uspešno ali zaradi nove okužbe z malarijo, upoštevajte dolgo razpolovno doba piperakina (približno 22 dni) (glejte spodaj in poglavji 4.3 in 4.5).
Skin and subcutaneous Tissue disorders
Bolezni kože in podkožja pruritus
Effect of co-administered medicinal products on Eurartesim Piperaquine is metabolised by CYP3A4 in vitro.
Učinki sočasno uporabljenih zdravil na zdravilo Eurartesim Encim CYP3A4 in vitro presnavlja piperakin.
Convulsion Headache
Bolezni živčevja konvulzije glavobol
• Neuroleptics (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine), antidepressive medicinal products.
• nevroleptike, (npr. fenotiazin, sertindol, sultoprid, klorpromazin, haloperidol, mesoridazin, pimozid ali tioridazin), antidepresive,
In patients mean (CV%) Cmax and AUC0-24 (observed after the first dose of Eurartesim) were 179 (62%) ng/ml and 1,679 (47%) ng/ml*h, respectively.
Pri bolnikih sta bila povprečni (CV%) Cmax in AUC0-24 (opazovano po prvem odmerku zdravila Eurartesim) 179 (62 %) ng/ml oz. 1.679 (47 %) ng/ml*h.
EU/1/11/716/005 3 film-coated tablets
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/716/005 3 filmsko obložene tablete
Abnormalities in red blood cells, excessive numbers of platelets, enlargement of some organs (such as liver or spleen), swollen lymph glands, convulsions (fits), headache, abnormal heart sounds (heard by your doctor with a stethoscope), nose bleeds, runny nose, nausea, inflammation of the mouth, inflammation or enlargement of the liver, jaundice, abnormal liver function blood tests, skin itching and inflammation, pain in the joints.
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): nenormalnosti rdečih krvnih celic, čezmerno število trombocitov, povečanje nekaterih organov (kot sta jetra ali vranica), otekle bezgavke, konvulzije (napadi), glavobol, nenormalni srčni zvoki (ki jih zdravnik sliši s stetoskopom), krvavitve iz nosu, nahod, navzea, vnetje ust, vnetje ali povečanje jeter, zlatenica, nenormalni krvni testi delovanja jeter, srbenje kože in vnetje, bolečina v sklepih.
• is taking certain other medicines which could cause possible metabolic interactions.
• jemlje vi ali vaš otrok določena zdravila, ki bi lahko povzročila presnovno medsebojno delovanje.
The active substances are piperaquine tetraphosphate and artenimol.
Učinkovini sta piperakin tetrafosfat in artenimol.
If you or your child takes more than the recommended dose, tell your doctor.
Če ste vi ali vaš otrok vzeli večji odmerek zdravila Eurartesim tablete, kot bi smeli Če vi ali vaš otrok vzamete večji odmerek od priporočenega, to povejte zdravniku.
Effect of Eurartesim on co-administered medicinal products Piperaquine is metabolised by, and is an inhibitor of CYP3A4.
Učinki zdravila Eurartesim na sočasno uporabljena zdravila Piperakin se presnavlja z encimom CYP3A4 in je pa hkrati zaviralec tega encima.
Tablet core: pre-gelatinised starch, dextrin, hypromellose (E464), croscarmellose sodium, magnesium stearate (E572).
Druge sestavine zdravila (pomožne snovi) so: jedro tablete: predgeliran škrob, dekstrin, hipromeloza (E464), premrežen natrijev karmelozat, magnezijev stearat (E572); filmska obloga: hipromeloza, titanov dioksid (E171), makrogol 400.
Anaemia, headache, heart rhythm disturbances (ECG changes or noticing unusually fast heart beats or palpitations), fever, general weakness.
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): anemija, glavobol, motnje srčnega ritma (spremembe EKG ali če opazite neobičajno hiter srčni utrip ali palpitacije), zvišana telesna temperatura, splošna oslabelost.
Film-coated tablet 3 tablets
FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta 3 tablete
• The Physician Leaflet including the Contraindicated Conditions of Use and Contraindicated
• vodnik za zdravnika, vključno s seznamom stanj in sočasnih zdravil, kjer je uporaba zdravila kontraindicirana.
No more than two courses of Eurartesim may be given within a 12 month period (see sections 4.4 and
V 12-mesečnem obdobju se bolnika ne sme zdraviti z zdravilom Eurartesim več kot dvakrat (glejte poglavji 4.4 in 5.3).
½ x 160 mg / 20 mg tablet
½ x 160 mg / 20 mg tablete
simvastatin); - medicines used to treat hypertension and heart problems (such as diltiazem, nifedipine,
lovastatin, simvastatin), - zdravila, ki se uporabljajo za zdravljenje hipertenzije in težav s srcem (kot so diltiazem,
No food should be taken within 3 hours after each dose.
Tri ure po uporabi vsakega odmerka se ne sme uživati hrane.
Due to the lack of multiple dose PK data for piperaquine, administration of any strong CYP3A4-inhibitors should be discouraged after initiation (i.e. the first dose) of Eurartesim (see sections 4.5 and 5.2).
Zaradi pomanjkanja FK podatkov o večkratnih odmerkih piperakina ni priporočljiva uporaba katerih koli močnih zaviralcev CYP3A4 po uvedbi (t.j.