natgillin/translations-raw huggingface dataset:
The dose should be escalated gradually to minimise the incidence and severity of gastrointestinal adverse reactions and aminotransferase elevations.
Odmerek je treba večati postopoma, da se čim bolj zmanjša incidenca in resnost neželenih učinkov na prebavila ter povišanja ravni aminotransferaze.
If a patient has biopsy-proven steatohepatitis or fibrosis, the benefit-risk should be reassessed and treatment stopped if necessary.
Če se pri bolniku steatohepatitis ali fibroza potrdi z biopsijo, je treba ponovno oceniti razmerje med tveganji ter koristmi in zdravljenje po potrebi prekiniti.
• triglycerides (fat carried in the blood)
• trigliceridov (maščobe v krvnem obtoku).
Patients will be instructed to carry this card and show it to all doctors who treat them.
Bolnikom je treba naročiti, naj imajo to kartico ves čas pri sebi in naj jo pokažejo vsakemu zdravniku, ki jih zdravi.
The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke o tem zdravilu.
Your treatment may affect your ability to drive or use machines.
Zdravljenje lahko vpliva na sposobnost uporabe vozil in strojev.
More frequent monitoring of liver-related tests may be warranted.
Morda bo potrebno pogostejše spremljanje rezultatov jetrnih preiskav.
Do not take this medicine if you are pregnant, trying to get pregnant, or think you may be pregnant, as there is a possibility that it could harm an unborn baby.
Če ste noseči, načrtujete zanositev ali menite, da bi lahko bili noseči, ne jemljite tega zdravila, saj lahko poškoduje nerojenega otroka.
Upon multiple dosing Cmax and AUC increased in approximate proportion to lomitapide dose.
Pri večkratnih odmerkih sta se vrednosti Cmax in AUC povečali približno sorazmerno z odmerkom lomitapida.
• Information about clinical findings (i.e., hepatic enzyme increases and steatosis) in subjects treated with Lojuxta during the developmental phase;
• Podatki o kliničnih ugotovitvah (tj. povišanih ravneh jetrnih encimov in steatozi) pri preskušancih, zdravljenih z zdravilom Lojuxta med razvojno fazo;
Use of Lojuxta is contraindicated in patients treated with high doses of simvastatin (>40 mg) (see sections 4.3 and 4.4).
Uporaba zdravila Lojuxta je kontraindicirana pri bolnikih, ki se zdravijo z velikimi odmerki simvastatina (> 40 mg) (glejte poglavji 4.3 in 4.4).
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
Consider limiting the maximum dose of Lojuxta according to desired LDL-C response.
Razmislite o omejitvi največjega odmerka zdravila Lojuxta glede na želeni odziv holesterola LDL.
Since the recommended dose regimen involves starting at the low end of the dosing range and escalating cautiously according to individual patient tolerability, no adjustment to the dosing regimen is recommended for the elderly.
Ker priporočeni režim odmerjanja vključuje začetek z nizkim odmerkom in previdno postopno povečevanje v skladu z toleranco posameznega bolnika, posebna priporočila za prilagajanje odmerka pri starejših bolnikih niso potrebna.
• decrease in levels of potassium, carotene, vitamin E, vitamin K in your blood
• znižanje ravni kalija, karotena, vitamina E, vitamina K v krvi,
P-gp substrates: Lomitapide inhibits P-gp in vitro, and may increase the absorption of P-gp substrates.
Substrati P-gp: Lomitapid zavira P-gp in vitro, kar lahko poveča absorpcijo substratov P-gp.
You also need to take daily vitamin E and essential fatty acid (omega-3 and omega-6) supplements while taking this medicine.
Med jemanjem tega zdravila morate vsak dan jemati tudi nadomestke vitamina E in bistvenih maščobnih kislin (omega-3 in omega-6).
Lojuxta with food, drink and alcohol
Zdravilo Lojuxta skupaj s hrano, pijačo in alkoholom
list is not intended to be comprehensive and prescribers should check the prescribing information of medicinal products to be co-administered with Lojuxta for potential CYP3A4 mediated interactions.
Ta seznam ni izčrpen, zato morajo zdravniki preveriti informacije o predpisovanju zdravil, ki se bodo uporabljala skupaj z zdravilom Lojuxta, zaradi morebitnih interakcij, ki jih povzroča CYP3A4.
Of the 23 patients who completed through Week 26, 19 (83%) had LDL-C reductions ≥25% with 8 (35%) having LDL-C <100 mg/dL and 1 having LDL-C <70 mg/dL at that time point.
Od 23 bolnikov, ki so končali 26. teden, jih je imelo na tej časovni točki 19 (83 %) znižanje ravni holesterola LDL ≥ 25 %, 8 (35 %) vrednost holesterola LDL < 100 mg/dl, 1 bolnik pa vrednost holesterola LDL < 70 mg/dl.
A single arm, open-label study (UP1002/AEGR-733-005) evaluated the efficacy and safety of lomitapide when co-administered with a low-fat diet and other lipid-lowering therapies in adult patients with HoFH.
Odprta študija z eno skupino (UP1002/AEGR-733-005) je ocenila učinkovitost in varnost lomitapida v kombinaciji z dieto z majhnim vnosom maščob ter drugimi oblikami zdravljenja za zniževanje ravni lipidov pri odraslih bolnikih s HoFH.
Table 3 lists all adverse reactions reported across the 35 patients treated in the Phase 2 Study UP1001 and in the Phase 3 Study UP1002/AEGR-733-005 or its extension study AEGR-733-012.
Preglednica 3 navaja vse neželene učinke, o katerih so poročali pri 35 bolnikih, ki so se zdravili v študiji 2. faze UP1001 in študiji 3. faze UP1002/AEGR-733-005 ali njeni podaljšani študiji AEGR-733-012.
Lojuxta has not been investigated in patients aged 65 years or older.
Zdravilo Lojuxta se ni preučevalo pri bolnikih, starih 65 let ali več.
Diarrhoea occurred in 79% of patients, nausea in 65%, dyspepsia in 38%, and vomiting in 34%.
Diareja se je pojavila pri 79 % bolnikov, navzea pri 65 %, dispepsija pri 38 %, bruhanje pa pri 34 %.
Lojuxta is contraindicated during pregnancy.
Nosečnost Zdravilo Lojuxta je med nosečnostjo kontraindicirano.
• if you have liver problems or unexplained abnormal liver tests.
• če imate težave z jetri ali nepojasnjene nenormalne rezultate jetrnih preiskav;
* IU - international units, mg - milligrams
200 mg * i.e. - mednarodne enote, mg - miligrami
Data from individuals who had repeat measurements after stopping lomitapide show that hepatic fat accumulation is reversible, but whether histological sequelae remain is unknown.
Podatki posameznikov, pri katerih so meritve ponovili po prekinitvi lomitapida, kažejo, da je kopičenje maščob v jetrih reverzibilno, vendar ni znano, ali ostanejo histološke posledice.
If the baseline liver-related tests are abnormal, consider initiating the medicinal product after appropriate investigation by a hepatologist and the baseline abnormalities are explained or resolved.
Če so izhodiščni rezultati jetrnih preiskav nenormalni, je treba o uvedbi zdravila razmisliti šele, ko stanje ustrezno razišče hepatolog in se izhodiščne nenormalnosti pojasnijo ali odpravijo.
Lojuxta has not been investigated in children less than 18 years of age.
Zdravilo Lojuxta se ni preučevalo pri otrocih, mlajših od 18 let.
Apheresis was discontinued in 3 out of 13 patients who were on it at Week 26, and frequency was reduced in 3 patients while maintaining low LDL-C levels through Week 78.
Afereza se je ukinila pri 3 od 13 bolnikov, ki so jo prejemali v 26. tednu, njena pogostnost pa se je zmanjšala pri 3 bolnikih, pri čemer so se nizke ravni holesterola LDL
If aminotransferase levels do not fall below 3x ULN within approximately 4 weeks refer the patient to a hepatologist for further investigation.
Če ravni aminotransferaze v približno 4 tednih ne padejo pod 3-kratno vrednost ULN, bolnika napotite k hepatologu, ki bo opravil nadaljnje preiskave.
Patients treated with lomitapide should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.
Bolnike, ki se zdravijo z lomitapidom, je treba seznaniti z možnim tveganjem za dehidracijo v povezavi z gastrointestinalnimi neželenimi učinki in s previdnostnimi ukrepi za preprečitev izgube tekočine.
At steady state the accumulation of lomitapide was 2.7 at 25 mg and 3.9 at 50 mg.
V stanju dinamičnega ravnovesja je bilo kopičenje lomitapida 2,7 pri 25 mg in 3,9 pri 50 mg.
Careful titration may then be considered according to LDL-C response and safety/tolerability.
Potem lahko razmislite o previdnem titriranju odmerka glede na odziv holesterola LDL in varnost/toleranco.
Increases in the dose of Lojuxta may lead to supratherapeutic anticoagulation, and decreases in the dose may lead to subtherapeutic anticoagulation.
Povečanje odmerka zdravila Lojuxta lahko povzroči supraterapevtsko antikoagulacijo, zmanjšanje pa subterapevtsko antikoagulacijo.
The “bad” cholesterol can lead to heart attacks, strokes or other events at an early age.
„Slab“ holesterol lahko pri nizki starosti povzroči srčno kap, možgansko kap ali druge dogodke.
The MAH shall provide an educational pack prior to launch targeting all physicians who are expected to prescribe/use lomitapide.
Imetnik dovoljenja za promet z zdravilom mora pred dajanjem zdravila v promet pripraviti izobraževalni komplet za vse zdravnike, za katere se pričakuje, da bodo predpisovali/uporabljali lomitapid.
A single-dose, open-label study was conducted to evaluate the pharmacokinetics of 60 mg lomitapide in healthy volunteers with normal hepatic function compared with patients with mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment.
Opravili so odprto študijo z enkratnim odmerkom, s katero so ocenili farmakokinetiko 60 mg lomitapida pri zdravih prostovoljcih z normalnim jetrnim delovanjem v primerjavi z bolniki z blago (stadij A po Child-Pughu) in zmerno (stadij B po Child-Pughu) jetrno okvaro.
Lomitapide is a selective inhibitor of microsomal transfer protein (MTP), an intracellular lipid-transfer protein that is found in the lumen of the endoplasmic reticulum and is responsible for binding and shuttling individual lipid molecules between membranes.
Lomitapid je selektivni zaviralec mikrosomalnega transportnega proteina (MTP), znotrajceličnega proteina za prenos lipidov, ki je v svetlini endoplazemskega retikuluma in je odgovoren za vezavo ter premikanje posameznih lipidnih molekul med membranami.
Fenofibrate, niacin and ezetimibe: When lomitapide was administered to steady state prior to micronised fenofibrate 145 mg, extended release niacin 1000 mg, or ezetimibe 10 mg, no clinically significant effects on the exposure of any of these medicinal products were observed.
Fenofibrat, niacin in ezetimib: Ko se je lomitapid dajal do stanja dinamičnega ravnovesja pred uvajanjem mikroniziranega fenofibrata 145 mg, niacinom s podaljšanim sproščanjem 1000 mg ali ezetimibom 10 mg, niso opazili nobenih klinično pomembnih učinkov na izpostavljenost kateremu koli od teh zdravil.
Lomitapide is not a P-gp substrate but does inhibit P-gp.
Lomitapid ni substrat P-gp, vendar zavira P-gp.
CYP isoforms 2E1, 1A2, 2B6, 2C8, and 2C19 are involved to a lesser extent and isoforms 2D6 and 2C9 are not involved in the metabolism of lomitapide.
Izooblike CYP 2E1, 1A2, 2B6, 2C8 ter 2C19 so vključene v manjši meri, izoobliki 2D6 ter 2C9 pa nista vključeni v presnovo lomitapida.
Lojuxta has not been studied in patients with severe hepatic impairment (Child-Pugh score 10-15).
Zdravilo Lojuxta se ni preučevalo pri bolnikih s hudo jetrno okvaro (rezultat 10-15 po Child-Pughu).
The risk of myopathy with simvastatin is dose related.
Tveganje miopatije pri sočasni uporabi s simvastatinom je odvisno od odmerka.
Patients taking Lojuxta should avoid consumption of grapefruit juice.
Bolniki, ki prejemajo zdravilo Lojuxta, se morajo izogibati uživanju soka grenivke.
• changes to blood clotting tests
• spremembe izvidov preiskav strjevanja krvi,
• The need to avoid grapefruit juice;
• Potrebo po izogibanju alkoholu; • Potrebo po izogibanju soku grenivke;
Coumarin anticoagulants: When lomitapide 60 mg was administered to steady state and 6 days following warfarin 10 mg, INR increased 1.26-fold.
Kumarinski antikoagulanti: Ko se je lomitapid 60 mg dajal do stanja dinamičnega ravnovesja in 6 dni po dajanju varfarina 10 mg, se je vrednost INR povečala za 1,26-krat.
It is recommended to increase the frequency of LDL-C assessment during such concomitant use and consider increasing the dose of Lojuxta to ensure maintenance of the desired level of efficacy if the CYP3A4 inducer is intended for chronic use.
Priporočeno je, da med tako sočasno uporabo povečate pogostnost ocenjevanja ravni holesterola LDL in razmislite o povečanju odmerka zdravila Lojuxta, da se zagotovi vzdrževanje želene stopnje učinkovitosti, če je induktor CYP3A4 namenjen kronični uporabi.
Patients were instructed to maintain a low-fat diet (<20% calories from fat) and their lipid-lowering therapies at study entry, including apheresis if applicable, from 6 weeks prior to baseline through at least Week 26.
Bolnikom so ob vključitvi v študijo naročili, naj vzdržujejo dieto z majhnim vnosom maščob (< 20 % kalorij iz maščob) in zdravljenje za zniževanje ravni lipidov, vključno z aferezo, če je primerno, od 6 tednov pred izhodiščem do zadnjega, 26. tedna.
• hair loss (alopecia)
• izpadanje las (alopecija),
The recommended starting dose is a 5 mg capsule each day.
Priporočeni začetni odmerek je 5 miligramska kapsula enkrat na dan.
Ask your doctor, or dietitian how to obtain these supplements.
Obrnite se na zdravnika ali nutricionista, ki vam bo svetoval, kje dobiti ta prehranska dopolnila.
On withdrawal of a CYP3A4 inducer, the possibility of increased exposure should be considered and a reduction in the dose of Lojuxta may be necessary.
Pri prekinitvi uporabe induktorja CYP3A4 je treba upoštevati možnost povečane izpostavljenosti in morda bo potrebno zmanjšanje odmerka zdravila Lojuxta.
Interactions between moderate CYP3A4 inhibitors and lomitapide have not been studied.
Interakcij med zmernimi zaviralci CYP3A4 in lomitapidom niso preučevali.
Upon discontinuation of atorvastatin the dose of Lojuxta should be up-titrated according to LDL-C response and safety/tolerability.
Ko prekinete uporabo atorvastatina, je treba odmerek zdravila Lojuxta večati glede na odziv holesterola LDL in varnost/toleranco.
Lojuxta may affect the way other medicines work.
Zdravilo Lojuxta lahko vpliva na delovanje drugih zdravil.
p-value is based on the mean percent change b p-value on the mean percent change from baseline based on paired t-test
b Vrednost p za srednjo odstotno spremembo od izhodiščne vrednosti na podlagi parnega t-testa.
• The Summary of Product Characteristics
• povzetek glavnih značilnosti zdravila
In patients taking coumarins (such as warfarin) and Lojuxta concomitantly, INR should be determined before starting Lojuxta and monitored regularly with dosage of coumarins adjusted as clinically indicated (see section 4.4).
Pri bolnikih, ki sočasno jemljejo kumarine (kot je varfarin) in zdravilo Lojuxta, je treba vrednost INR izmeriti pred uvajanjem zdravila Lojuxta, jo redno spremljati in prilagoditi odmerek kumarina, kot je klinično indicirano (glejte poglavje 4.4).
Liver related tests should be monitored.
Treba je spremljati jetrne teste.
• tetracycline antibiotics to treat infections such as urinary tract infections
• tetraciklinski antibiotiki za zdravljenje okužb, kot so okužbe sečil,
EU/1/13/851/001 - Lojuxta 5 mg hard capsules EU/1/13/851/002 - Lojuxta 10 mg hard capsules EU/1/13/851/003 - Lojuxta 20 mg hard capsules EU/1/13/851/004 - Lojuxta 30 mg hard capsules EU/1/13/851/005 - Lojuxta 40 mg hard capsules EU/1/13/851/006 - Lojuxta 60 mg hard capsules
EU/1/13/851/001 - Lojuxta 5 mg trde kapsule EU/1/13/851/002 - Lojuxta 10 mg trde kapsule EU/1/13/851/003 - Lojuxta 20 mg trde kapsule EU/1/13/851/004 - Lojuxta 30 mg trde kapsule EU/1/13/851/005 - Lojuxta 40 mg trde kapsule EU/1/13/851/006 - Lojuxta 60 mg trde kapsule
• Advice on monitoring liver function (measuring hepatic enzymes and total bilirubin) before and during treatment with Lojuxta and routine screening to detect presence of steatohepatitis and hepatic fibrosis including specific details of the screening tests at baseline and annually as follows: - Imaging for tissue elasticity, e.g. Fibroscan, acoustic radiation force impulse (ARFI), or magnetic resonance (MR) elastography; - Measurement of biomarkers and/or scoring methods.
• Nasvet o spremljanju jetrnega delovanja (merjenju jetrnih encimov in celokupnega bilirubina) pred ter med zdravljenjem z zdravilom Lojuxta in rednem presejanju, s katerim se ugotavlja prisotnost steatohepatitisa ter jetrne fibroze, vključno s posebnimi podrobnostmi preiskav za presejanje ob izhodišču in potem enkrat na leto: - slikanje za preverjanje elastičnosti tkiva, npr. Fibroscan, prehodna elastografija (ARFI), ali magnetnoresonančna (MR) elastografija; - merjenje bioloških označevalcev in/ali metode za ocenjevanje.
The long term consequences of hepatic steatosis associated with lomitapide treatment are unknown.
Dolgotrajne posledice jetrne steatoze, povezane z zdravljenjem z lomitapidom, niso znane.
• The Prescriber Guide
• navodila za predpisovanje
Regular screening for steatohepatitis/fibrosis should be performed at baseline and on an annual basis using the following imaging and biomarker evaluations:
Spremljanje dokazov za napredujočo jetrno bolezen Redno presejanje za steatohepatitis/fibrozo je treba opravljati na izhodišču in potem enkrat na leto z uporabo naslednjih oblik slikanja in ocen bioloških označevalcev:
Pharmacotherapeutic group: Lipid modifying agents, other lipid modifying agents, ATC code: C10AX12
Farmakoterapevtska skupina: zdravila za spreminjanje ravni serumskih lipidov, druga zdravila za spreminjanje ravni serumskih lipidov, oznaka ATC: C10AX12
Because bile acid sequestrants can interfere with the absorption of oral medicines, bile acid sequestrants should be taken at least 4 hours before or at least 4 hours after Lojuxta.
Ker lahko snovi, ki vežejo žolčno kislino, ovirajo absorpcijo peroralnih zdravil, jih je treba jemati vsaj 4 ure pred odmerkom zdravila Lojuxta ali vsaj 4 ure po njem.
Patients should follow a diet supplying less than 20% of energy from fat prior to initiating treatment, and should continue this diet during treatment.
Bolnikova prehrana mora vsebovati manj kot 20 % energije, pridobljene iz maščob, preden se uvede zdravljenje.
Name and address of the manufacturers responsible for batch release
Ime in naslov izdelovalcev, odgovorneih za sproščanje serij
Table 1 summarizes recommendations for dose adjustment and monitoring for patients who develop elevated aminotransferase during therapy with Lojuxta.
Preglednica 1 povzema priporočila za prilagajanje odmerka in spremljanje bolnikov, pri katerih med zdravljenjem z zdravilom Lojuxta pride do povišanih ravni aminotransferaze
The effect of concomitant administration of lomitapide with other hepatotoxic medicine is unknown.
Učinek sočasne uporabe lomitapida z drugimi hepatotoksičnimi zdravili ni znan.
Patients taking oestrogen-based oral contraceptives should be advised about possible loss of effectiveness due to diarrhoea and/or vomiting (see section 4.5).
Bolnicam, ki jemljejo estrogenska peroralna kontracepcijska sredstva, je treba svetovati glede morebitne izgube učinkovitosti zaradi diareje in/ali bruhanja (glejte poglavje 4.5).
Accumulation of lomitapide in plasma was consistent with that predicted after a single dose following once daily oral dosing above 25 mg for up to 4 weeks.
Kopičenje lomitapida v plazmi je bilo skladno s predvidenim kopičenjem po enkratnem odmerku, pri čemer so upoštevali peroralno odmerjanje nad 25 mg enkrat na dan do 4 tedne.
Data in the pivotal clinical study were analysed with respect to the impact of potential covariates on lomitapide exposure.
Posebne skupine bolnikov Podatke v ključni klinični študiji so analizirali glede na vpliv morebitnih sospremenljivk na izpostavljenost lomitapidu.
Reintroduction of treatment may be considered if the benefits are considered to outweigh the risks associated with potential liver disease.
O ponovni uvedbi zdravljenja je treba razmisliti le v primeru, če so morebitne koristi večje od tveganj,
Other liver-related changes in repeat-dose toxicity studies in rats and dogs included increased serum aminotransferases, subacute inflammation (rats only), and single-cell necrosis.
Druge jetrne spremembe v študijah toksičnosti z večkratnimi odmerki na podganah in psih so vključevale povečano vrednost aminotransferaz v serumu, subakutno vnetje (samo pri podganah) ter enocelično nekrozo.
HMG-CoA Reductase Inhibitors (“Statins”): Lomitapide increases plasma concentrations of statins.
Zaviralci reduktaze HMG-CoA (statini): Lomitapid poveča koncentracijo statinov v plazmi.
Lojuxta is used to treat adult patients with very high cholesterol because of a condition that runs in their families (homozygous familial hypercholesterolaemia or HoFH).
Zdravilo Lojuxta se uporablja za zdravljenje odraslih bolnikov z zelo visoko ravnjo holesterola, ki je posledica dednega stanja (homozigotne družinske hiperholesterolemije ali HoFH).
Oral contraceptives: When lomitapide 50 mg was administered to steady state along with an oestrogen-based oral contraceptive, no clinically meaningful or statistically significant impact on the pharmacokinetics of the components of the oral contraceptive (ethinyl estradiol and 17-deacetyl norgestimate, the metabolite of norgestimate) was observed.
Peroralna kontracepcijska sredstva: Ko se je lomitapid 50 mg dajal do stanja dinamičnega ravnovesja skupaj z estrogenskimi peroralnimi kontracepcijskimi sredstvi, niso opazili nobenih klinično ali statistično pomembnih učinkov na farmakokinetiko sestavin peroralnega kontracepcijskega sredstva (etinilestradiol in 17-deacetilnorgestimat, presnovek norgestimata).
Other reactions reported by at least 20% of patients include abdominal pain, abdominal discomfort, abdominal distension, constipation, and flatulence.
Drugi neželeni učinki, o katerih je poročalo vsaj 20 % bolnikov, vključujejo bolečino v trebuhu, neugodje v trebuhu, distenzijo trebuha, obstipacijo in flatulenco.
CARTON AND BOTTLE (5 mg, 10 mg, 20 mg, 30 mg, 40 mg and 60 mg)
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA IN PLASTENKA (5 mg, 10 mg, 20 mg, 30 mg, 40 mg in 60 mg)
Do not take any of the following medicines with Lojuxta:
Skupaj z zdravilom Lojuxta ne jemljite naslednjih zdravil:
Gastrointestinal adverse reactions occurred more frequently during the dose escalation phase of the study and decreased once patients established the maximum tolerated dose of lomitapide.
Neželeni učinki na prebavila so se v študiji pogosteje pojavili med fazo povečevanja odmerka in so se zmanjšali, ko se je pri bolnikih dosegel največji tolerirani odmerek lomitapida.
• Patient Brochures
• brošure za bolnike
If you use contraceptive pills and suffer from an episode of diarrhoea or vomiting that lasts more than 2 days, you must use an alternative method of contraception (e.g. condoms, diaphragm) for 7 days following resolution of symptoms.
Če uporabljate kontracepcijske tablete in imate epizodo driske ali bruhanja, ki traja vsaj 2 dneva, morate 7 dni po izginotju simptomov uporabljati dodatno metodo kontracepcije (npr. kondome, diafragmo).
• low red blood cell count (anaemia)
• majhno število rdečih krvničk (anemija),
Lojuxta can lower blood levels of:
Zdravilo Lojuxta lahko zniža ravni naslednjih parametrov v krvi:
Gastrointestinal adverse reactions of severe intensity were reported by 6 (21%) of 29 patients in the Phase 3 clinical study, with the most common being diarrhoea (4 patients, 14%); vomiting (3 patients, 10%); and abdominal pain, distension, and/or discomfort (2 patients, 7%).
O hudih neželenih učinkih na prebavila je poročalo 6 (21 %) od 29 bolnikov v klinični študiji 3. faze, pri čemer so bili najpogostejši diareja (4 bolniki, 14 %), bruhanje (3 bolniki, 10 %) ter bolečina,
In cases of protracted or severe diarrhoea and/or vomiting lasting more than 2 days, additional contraceptive measures should be used for 7 days after resolution of symptoms.
Če se pojavi dolgotrajna ali huda diareja in/ali bruhanje, ki traja več kot 2 dneva, je treba 7 dni po izginotju simptomov uporabljati dodatne kontracepcijske metode.