natgillin/translations-raw huggingface dataset:
The Boots Company Plc, 1 Thane Road West, NG2 3AA, Nottingham, United Kingdom aspirin + codeine phosphate
The Boots Company Plc, 1 Thane Road West, NG2 3AA, Nottingham, Velika Britanija aspirin + kodeinfosfat Boots Aspirin and Codeine Tablets
FRANCE 500 mg/30 mg, comprimé effervescent sécable
FRANCE 500 mg/30 mg, comprimé effervescent sécable šumeća tableta kroz usta
Paracetamol, Buclizine chlorhidrate, codeine phosphate and docusate sodium
Barcelona Španjolska paracetamol, buklizin klorhidrat, kodeinfosfat i natrijev dokuzat
200 mg/ 12.8 mg film-coated tablet oral use
200 mg/ 12.8 mg filmom obložena tableta
500 mg and 30 mg film-coated tablet oral use
500 mg and 30 mg filmom obložena tableta
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom paracetamol + codeine Paracodol Tablets tablet for oral solution
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, Velika Britanija paracetamol + kodein Paracodol Tablets tableta za oralnu otopinu
200 mg and 10 mg /1 ml oral solution oral use
200 mg and 10 mg /1 ml oralna otopina kroz usta
500 mg, 8 mg, 30 mg effervescent tablet
500mg, 8mg, 30mg šumeća tableta kroz usta
A.C.
Ltd.
30mg + 500 mg capsule, hard oral use
30mg + 500 mg kapsula, tvrda kroz usta
Codeine phosphate + paracetamol + doxylamine succinate + caffeine
kodeinfosfat hemihidrat + paracetamol doksilaminsukcinat + kofein
Ibuprofen Codeine phosphate hemihydrate
ibuprofen kodeinfosfat hemihidrat
U kabelovny 130 102 37 Praha 10Dolní Měcholupy Czech Republic
U kabelovny 130 102 37 Praha 10 Republika Češka kodeinfosfat hemihidrat+ paracetamol
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED 103-105 Bath Road, Slough, Berkshire SL1 3UH, United Kingdom ibuprofen, fosfat de codeină hemihidrat
Berkshire SL1 3UH, velika Britanija ibuprofen, kodeinfosfat hemihidrat
Paracetamol/Codeine COMPRALGYL 400 mg/20 mg, comprimé sécable
69151 Décines Cedex Francuska paracetamol/kodein COMPRALGYL 400 mg/20 mg, comprimé sécable
Teva Sante 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France
Francuska Teva Sante 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex Francuska paracetamol/kodein PARACETAMOL CODEINE TEVA 500 mg/30 mg, comprimé effervescent sécable šumeća tableta kroz usta
Paracetamol/ Codeine phosphate
paracetamol/ kodeinfosfat
500 mg/8 mg/30 mg hard capsule
500 mg/8 mg/30 mg tvrda kapsula kroz usta
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom paracetamol + codeine Co-Codamol Disp tablet for oral solution
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, Velika Britanija paracetamol + kodein Co-Codamol Disp tableta za oralnu otopinu
Sweden BioPhausia AB Blasieholmsgatan 2
BioPhausia AB Blasieholmsgatan 2 111 48 Stockholm Švedska kodein/paracetamol
8mg +500mg + 30mg effervescent tablet
8mg + 500mg + 30mg tableta za oralnu otopinu
8 mg/ml oral solution oral use
8 mg/ml oralna otopina kroz usta
Paracetamol Codeine Phosphate Hemihydrate
Paracetamol i kodeinfosfat hemihidrat
Germany codeinphosphathemihydrat paracetamol talvosilen forte suppository rectal use
Njemačka kodeinfosfat hemihidrat paracetamol talvosilen forte čepić rektalno
Paracetamol and codeine phospate
Španjolska paracetamol i kodeinfosfat
200mg +12.8mg coated tablet
200mg +12.8mg filmom obložena tableta
Paracetamol and codeine phosphate hemihydrate
Španjolska paracetamol and kodeinfosfat hemihidrat
Quintanavides, 15 28050 Madrid Spain
Quintanavides, 15
Film-coated tablet
filmom obložena tableta
Codipar effervescent tablets 15mg/500mg
Codipar effervescent tablets 15mg/500mg šumeća tableta kroz usta
10237 Dolni Mecholupy Czech Republic
10237 Dolni Mecholupy Republika Češka paracetamol + kodeinfosfat hemihidrat
Paracetamol Codeine phosphate hemihydrate Doxylamine succinate Caffeine
paracetamol kodeinfosfat hemihidrat doksilaminsukcinat kofein
Kodein Recip
Rumunjska kodein
Paracetamol Codeine
Nizozemska paracetamol kodein
500mg + 30mg + 8mg effervescent tablet
500mg +8mg + 30mg tableta za oralnu otopinu
ALKALOID - INT d.o.o Šlandrova ulica 4, 1231 LjubljanaČrnuče, Slovenia paracetamol, propifenazonă , cafeină , fosfat de codeină sesquihidrat
Črnuče, Slovenija paracetamol, propifenazon, kofein, kodeinfosfat seskvihidrat
30mg + 500 mg tablet
30mg + 500 mg tableta
Paracetamol and codeine phosphate
Spain paracetamol and kodeinfosfat hemihidrat
Paracetamol/Codeine PARACETAMOL CODEINE ARROW 500 mg/30 mg, comprimé effervescent sécable
Francuska paracetamol/kodein PARACETAMOL CODEINE ARROW 500 mg/30 mg, comprimé effervescent sécable šumeća tableta kroz usta
Acidum acetylsalicylicum + Codeini phosphas
Poljska acetilsalicilatna kiselina + kodeinfosfat
500mg + 12.8mg + 30mg effervescent tablet
500mg + 12.8mg + 30mg šumeća tableta kroz usta
30 mg +500 mg tablet
30 mg +500 mg tableta
Sweden codeine phosphate hemihydrate/ paracetamol
Bugarska acetilsalicilatna kiselina/ kofein/ kodeinfosfat/ paracetamol
S.C. SINTOFARM S.A.Str.
Rumunjska S.C. TERAPIA S.A Str.
500 mg+8 mg+30 mg effervescent tablet
500 mg+8 mg+30 mg šumeća tableta kroz usta
Hameenlinna Finland
Nizozemska kodein
500mg 8mg 30mg effervescent tablet
500mg 8mg 30mg šumeća tableta kroz usta
Codeini phosphas hemihydricus
Španjolska kodeinfosfat hemihidrat CODEISAN JARABE
Ibuprofen and codeine phosphate hemihydrate
Španjolska ibuprofen i kodeinfosfat hemihidrat
Co-codamol 8/500 mg tablets effervescent tablet
Co-codamol 8/500 mg tablets šumeća tableta kroz usta
Codeini phosphas hemihydricus + paracetamolum + pitofenoni hydrochloridum + fenpiverinii bromidum
U kabelovny 130 102 37 Praha 10Dolní Měcholupy Republika Češka kodeinfosfat hemihidrat+ paracetamol + pitofenonklorid + fenpiverinijev bromid
Acetylsalicylic acid + Codeine phosphate hemihydrate + Caffeine
Carnaxide Portugal acetilsalicilatna kiselina + kodeinfosfat hemihidrat+ kofein
Paracetamol/ Codeine phosphate hemihydrate
Finska paracetamol/ kodeinfosfat hemihidrat
Mercury Pharms Cocodamol Tablets 15mg/500mg
Mercury Pharms Cocodamol Tablets 15mg/500mg obložena tableta kroz usta
Paracetamol/Codeine PARACETAMOL CODEINE BIOGARAN 500 mg/30 mg, comprimé effervescent sécable
92700 Colombes Francuska paracetamol/kodein PARACETAMOL CODEINE BIOGARAN 500 mg/30 mg, comprimé effervescent sécable šumeća tableta kroz usta
Paracetamol Codeine Phosphate Hemihydrate Caffeine
Irska paracetamol kodeinfosfat hemihidrat kofein
Paracetamolum/Codeini phosphas hemihydricus/Coffeinu m
Cipar paracetamol/ kodeinfosfat hemihidrat/ kofein
500 mg and 30 mg effervescent granules
500 mg and 30 mg šumeće granule kroz usta
Ireland codeine phosphate+paracetamo l
Irska kodeinfosfat +paracetamol
200mg +12,8 mg film-coated tablet oral use
200mg +12,8 mg filmom obložena tableta
SOLPADEINE SOLUBLE 500 mg/8 mg/30 mg effervescent tablet
SOLPADEINE SOLUBLE 500 mg/8 mg/30 mg šumeća tableta kroz usta
8mg + 520mg + 6.25mg
8mg + 520mg + 6.25mg obložena tableta kroz usta
Paracetamol Codeine Phosphate hemihydrate
Irska paracetamol kodeinfosfat hemihidrat
3 mg/ml oral solution oral use
3 mg/ml oralna otopina kroz usta
Germany codeinphosphathemihydrat coffein paracetamol
Njemačka kodeinfosfat hemihidrat kofein paracetamol
Paracetamol+ Caffeine+ Codeine phosphate hemihydrate
Hameenlinna Finska paracetamol + kodeinfosfat hemihidrat
Strength Pharmaceutical Form
Farmaceutsk i oblik
1 cartridge and 1 pen
1 uložak i 1 brizgalica
3 cartridges
3 uloška
Immediate Packaging
Unutarnje pakovanje
Route of Administration
Put primjene
1 cartridge
1 uložak
Pack size
Doza
EU (MA) Number
Broj (EU) odobrenja
Strength Pharmaceutical Form
Farmaceutski oblik Put primjene Unutarnje pakovanje
Invented name
Izmišljeno ime
EU (MA) Number
EU broj odobrenja
• what dose to take and for how long.
• koju dozu uzimati i koliko dugo.
Your doctor will tell you:
Liječnik će Vam reći:
Do not change the dose yourself.
Ne mijenjajte dozu sami.
The usual dose that you will need to take is listed below.
Uobičajena doza koju ćete morati uzeti navedena je ispod.
The final study report shall be submitted by 31 December 2021.
Konačno izvješće o ispitivanju bit će podneseno do 31. prosinca 2021.
• At least one marker from each of the following categories:
• barem jedan marker iz svake od sljedećih kategorija:
Any impact on efficacy is likely to be variable.
Svaki utjecaj na djelotvornost vjerojatno će se razlikovati.
Therefore, particular caution should be exercised in these patients.
Stoga je u tih bolesnika potreban poseban oprez.
Just take your normal dose at the usual time the next day.
Dovoljno je da uzmete svoju redovnu dozu u uobičajeno vrijeme sljedećeg dana.
Keep the bottle tightly closed in order to protect from moisture.
Bočicu čuvati čvrsto zatvorenu radi zaštite od vlage.
• Confirm elevation with a repeat measurement within one week.
• Potvrditi povećanje ponovljenim mjerenjem unutar tjedan dana.
Daily Amount Vitamin E
Dnevna količina Vitamin E
*Recommendations based on an ULN of approximately 30-40 international units/L.
*Preporuke se temelje na GGN od približno 30-40 međunarodnih jedinica/l.
o Ginkgo (to improve memory)
o ginkgo (za poboljšanje pamćenja)
There is no specific treatment in the event of overdose.
Nema specifične terapije u slučaju predoziranja.
• when to increase or decrease your dose.
• kada povećati ili smanjiti dozu.
• Do not drink any type of grapefruit juice.
• Nemojte piti nikakvu vrstu soka od grejpa.
48155 Münster Germany
48155 Münster Njemačka
• regurgitation (bringing food back up)
• regurgitacija (vraćanje hrane)
Use of alcohol
Uporaba alkohola
Treatment and monitoring recommendations*
Preporuke za liječenje i nadzor*
o statins such as simvastatin.
o statini kao što je simvastatin.
Date of latest renewal: 23 April 2018
Datum posljednje obnove odobrenja: 23. travnja 2018.
There are no reliable data on its use in pregnant women.
Nema pouzdanih podataka o njegovoj primjeni u trudnica.
If you stop taking this medicine your cholesterol may rise again.
Ako prestanete uzimati ovaj lijek, kolesterol Vam se opet može povisiti.
• Advice to patients about:
• upozorenja bolesnicima o:
• Do not take this medicine with food, as taking these capsules with food can cause stomach problems.
• Ovaj lijek nemojte uzimati s hranom jer uzimanje ovih kapsula s hranom može prouzročiti želučane tegobe.
This medicine has been authorised under ‘exceptional circumstances'.
Ovaj lijek je odobren u „iznimnim okolnostima”.
Not known (frequency cannot be estimated from the available data)
Nepoznato (iz dostupnih podataka nije moguće utvrditi učestalost)
The objectives of the study are:
Ciljevi ovog ispitivanja jesu:
Doses higher than 60 mg suggest a trend toward nonlinearity and are not recommended.
Doze iznad 60 mg upućuju na tendenciju prema nelinearnosti i ne preporučuju se.
Your treatment may affect your ability to drive or use machines.
Ovaj lijek može utjecati na Vašu sposobnost vožnje ili uporabe strojeva.
• tiredness, lack of energy or general weakness
• umor, nedostatak energije ili opća slabost
Statins occasionally cause myopathy.
Statini katkad prouzroče miopatiju.
* IU - international units, mg - milligrams
* IU - međunarodne jedinice, mg - miligrami
>5% to ≤10% >10% to ≤15% >15% to ≤20% >20% to ≤25%
> 5% do ≤ 10% > 10% do ≤ 15% > 15% do ≤ 20% > 20% do ≤ 25%
Genetic confirmation of HoFH should be obtained whenever possible.
Potrebno je genetički utvrditi postojanje HoFH-a kad god je to moguće.
Store below 30°C.
Čuvati na temperaturi ispod 30 °C.
If you feel dizzy during treatment then do not drive or use machines until you feel better.
Ako za vrijeme liječenja osjetite omaglicu, nemojte voziti ili upotrebljavati strojeve dok to ne prestane.
• The need to avoid alcohol;
• Potreba izbjegavanja alkohola.
Because of the possibility of interactions with other medicines, your doctor may change the time of day you take your medicines.
Zbog mogućih interakcija s drugim lijekovima, liječnik Vam može promijeniti vrijeme u koje ćete tijekom dana uzimati svoj lijek.
Educational materials for patients
Edukacijski materijali za bolesnike
Approximately 33% of the radioactivity was excreted in urine as metabolites.
Približno 33% radioaktivnosti izlučeno je u mokraći kao metaboliti.
• Advice to patients about the risk of concomitant alcohol intake;
• upozorenje bolesnicima o riziku povezanom s istodobnim uzimanjem alkohola;
• Pregnancy (see section 4.6).
• Trudnoća (vidjeti dio 4.6).
If you get pregnant while taking this medicine, call your doctor immediately and stop taking the capsules.
Ako zatrudnite dok uzimate ovaj lijek, odmah se javite liječniku i prestanite uzimati kapsule.
The study provided for a total of 78 weeks of treatment.
Ispitivanje je omogućilo ukupno 78 tjedana liječenja.
• Gamma-GT and serum albumin to detect possible liver injury
• gama-GT i serumski albumin za otkrivanje mogućeg oštećenja jetre
The elimination half-life of lomitapide was approximately 29 hours.
Poluvijek eliminacije lomitapida bio je otprilike 29 sati.
No studies have been conducted in children and adolescents under the age of 18.
Nisu provedena ispitivanja u djece i adolescenata mlađih od 18 godina.
Week 78 (N=23)
78. tjedan (N = 23)
The safety and efficacy of lomitapide in children <18 years have not been established and the use of this medicinal product in children is therefore not recommended.
Sigurnost i djelotvornost lomitapida u djece < 18 godina nije ustanovljena pa se stoga u djece ne preporučuje upotreba ovog lijeka.
These side-effects are listed in section 4 and you must tell your doctor immediately if you have any of these signs and symptoms, as they may be caused by liver damage.
Te su nuspojave navedene u dijelu 4 i morate odmah obavijestiti liječnika ako imate bilo koji od navedenih znakova i simptoma, jer mogu biti uzrokovani oštećenjem jetre.
The risk of liver damage is increased when this medicine is used at the same time as statins.
Rizik od oštećenja jetre povećava se ako se ovaj lijek uzima u isto vrijeme kada i statini.
It is typically passed down by both father and mother, who also have high cholesterol passed down from their parents.
Bolest se obično nasljeđuje od majke i od oca koji također imaju visoki kolesterol, a naslijedili su ga od svojih roditelja.
• At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• Na zahtjev Europske agencije za lijekove; • Prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
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.
Nemojte uzimati ovaj lijek ako ste trudni, pokušavate zatrudnjeti ili mislite da biste mogli biti trudni jer postoji mogućnost da ovaj lijek našteti nerođenom djetetu.
Approximately
približno
The patient brochure shall include the following key elements:
Brošura za bolesnike uključivat će sljedeće ključne elemente:
• The safety and effectiveness of Lojuxta in children below the age of 18 have not been established;
• sigurnost i djelotvornost Lojuxte u djece mlađe od 18 godina nije ustanovljena;
• total cholesterol
• ukupnog kolesterola
These capsules may cause side effects which can also be symptoms of liver problems.
Ove kapsule mogu uzrokovati nuspojave koje mogu biti i simptomi bolesti jetre.
• Women should tell their doctor immediately if they suspect that they might be pregnant.
• Žene moraju odmah obavijestiti liječnika ako sumnjaju da bi mogle biti trudne.
Alcohol may increase levels of hepatic fat and induce or exacerbate liver injury.
Alkohol može povećati razine masti u jetri i potaknuti ili pogoršati oštećenje jetre.
You must also tell your doctor or pharmacist if you are taking any of the following medicines, as they may need to change your dose of Lojuxta:
Također morate obavijestiti liječnika ili ljekarnika ako uzimate neki od sljedećih lijekova jer će možda biti potrebno promijeniti Vašu dozu Lojuxte:
Your doctor may increase your dose slowly over time, up to a maximum of 60 mg each day.
Liječnik Vam s vremenom može polako povećavati dozu do najviše 60 mg svakoga dana.
SPECIAL STORAGE CONDITIONS Store below 30°C.
POSEBNE MJERE ČUVANJA Čuvati na temperaturi ispod 30 °C.
There was no clinically relevant effect of age (18-64 years) or gender on the pharmacokinetics of lomitapide.
Nije bilo klinički značajnog utjecaja dobi (od 18 do 64 godine) ili spola na farmakokinetiku lomitapida.
• blood or protein in the urine
• krv ili proteini u mokraći
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
The most common adverse reactions were gastrointestinal effects.
Najčešće nuspojave bile su gastrointestinalni učinci.
Lancaster Way, Wingates Industrial Estate, Westhoughton, Bolton, Lancashire, BL5 3XX United Kingdom
Lancaster Way, Wingates Industrial Estate, Westhoughton, Bolton, Lancashire, BL5 3XX Ujedinjeno Kraljevstvo
The MAH shall complete, within the stated timeframe, the below measure: Description
Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere: Opis
Sixteen males (55%) and 13 females (45%) were included with a mean age of 30.7 years, ranging from 18 to 55 years.
Uključeno je 16 muškaraca (55%) i 13 žena (45%) prosječne dobi od 30,7 godina u rasponu od 18 do 55 godina.
The performance of these tests and their interpretation should involve collaboration between the treating physician and the hepatologist.
U izvedbi tih testova i njihovoj interpretaciji trebaju surađivati nadležni liječnik i hepatolog.
• Symptoms of liver disease for which the patient should consult a doctor;
• Simptomi bolesti jetre zbog koje bolesnik treba konzultirati liječnika.
The dose of warfarin should be adjusted as clinically indicated.
Dozu varfarina treba prilagoditi kako je klinički indicirano.
Annual reports will be submitted at time of annual reassessment
Godišnja izvješća podnosit će se u vrijeme godišnje procjene.
Frequency of the adverse reactions is defined as: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Učestalost nuspojava definirana je kao: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nije poznato (ne može se procijeniti iz dostupnih podataka).
Animal studies have shown developmental toxicity (teratogenicity, embryotoxicity, see section 5.3).
Ispitivanja na životinjama pokazala su razvojnu toksičnost (teratogenost, embriotoksičnost, vidjeti dio 5.3).
• If, after you have started treatment with Lojuxta, you decide that you would like to become pregnant, please inform your doctor, as your treatment will need to be changed.
• Ako nakon što ste počeli terapiju lijekom Lojuxta odlučite da biste htjeli zatrudnjeti, molimo obavijestite o tome liječnika jer Vam treba promijeniti terapiju.
Therefore the use of this medicine in children and adolescents is not recommended.
Stoga se upotreba ovog lijeka u djece i adolescenata ne preporuča.
Inter-individual variability in lomitapide AUC was approximately 50%.
Interindividualna varijabilnost AUC-a lomitapida bila je približno 50%.
It should be taken on an empty stomach, at least 2 hours after the evening meal because the fat content of a recent meal may adversely impact gastrointestinal tolerability.
Lomitapid treba uzeti na prazan želudac, barem 2 sata nakon večernjeg obroka jer masnoće iz nedavnog obroka mogu negativno utjecati na gastrointestinalnu podnošljivost.
Tell your doctor immediately if you have any of these symptoms as your doctor may decide to stop the treatment.
Odmah obavijestite liječnika ako imate bilo koji od ovih simptoma jer će liječnik možda odlučiti prekinuti terapiju.
• apolipoprotein-B, a protein that carries “bad cholesterol” in the blood
• apolipoproteina B, proteina koji prenosi „loš kolesterol“ u krvi
Warnings and precautions Talk to your doctor or pharmacist before taking Lojuxta if you:
Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Lojuxta:
≥3x and <5x Upper Limit of Normal (ULN)
≥ 3 x i < 5 x iznad gornje granice normale (GGN)
• if you take more than 40 mg of simvastatin daily (another medicine used to lower cholesterol).
• ako uzimate više od 40 mg simvastatina na dan (drugi lijek za snižavanje kolesterola)
Patients on 5 mg should remain on 5 mg.
Bolesnici koji uzimaju 5 mg trebaju ostati na dozi od 5 mg.
What Lojuxta is and what it is used for
Što je Lojuxta i za što se koristi
− The timing of medicine intake (Lojuxta should be taken on an empty stomach, at least 2 hours after the evening meal);
− vremenu uzimanja lijeka (Lojuxtu treba uzimati na prazni želudac, barem 2 sata nakon večernjeg obroka);
After the first year, do these tests at least every 3 months and before any increase in dose.
Nakon prve godine navedene pretrage provodite barem svaka 3 mjeseca te prije svakog povećanja doze.
• Lojuxta is only indicated for use in adult patients with HoFH;
• Lojuxta je indicirana samo za primjenu u odraslih bolesnika s HoFH;
Following intravenous administration, the volume of distribution of lomitapide was high (mean=1200 litres) despite a high degree (>99.8%) of binding to plasma protein.
Nakon intravenske primjene, volumen distribucije lomitapida bio je visok (srednja vrijednost = 1200 litara) unatoč visokom stupnju (> 99,8%) vezanja na proteine plazme.
The remainder was excreted in faeces, primarily as oxidised metabolites.
Ostatak se izlučio u stolici, prvenstveno kao oksidirani metaboliti.
Because of the potential for adverse effects based on findings in animal studies with lomitapide (see section 5.3), a decision should be made whether to discontinue breast-feeding or discontinue the medicinal product, taking into account the importance of the medicinal product to the mother.
Zbog mogućih štetnih učinaka na temelju rezultata ispitivanja lomitapida na životinjama (vidjeti dio 5.3) potrebno je odlučiti treba li prekinuti dojenje ili terapiju lijekom, uzimajući u obzir važnost lijeka za majku.
• abnormal blood tests for liver function have been reported commonly (may affect up to 1 in 10 people).
• Često su prijavljivani poremećeni rezultati krvnih pretraga za procjenu funkcije jetre (mogu se pojaviti u do 1 na 10 osoba).
These blood tests help your doctor adjust your dose.
Krvne pretrage pomažu liječniku prilagoditi dozu koja Vam je potrebna.
Your doctor may advise you to stop taking Lojuxta or to stop breast-feeding.
Liječnik Vam može savjetovati da prekinete s uzimanjem Lojuxte ili da prestanete dojiti.
• An explanation of the types of tests required (imaging and blood) to check liver function and the importance of them being performed regularly;
• Objašnjenje o vrstama potrebnih pretraga (snimanje i krvne pretrage) kako bi se provjerila funkcija jetre te važnost da se te pretrage provode redovito.
Fifteen of 23 (65%) patients had their lipid-lowering treatment reduced by Week 78, including planned and unplanned reductions/interruptions.
U 15 (65%) od ukupno 23 bolesnika je smanjena terapija za snižavanje lipida do 78. tjedna, uključujući planirana i neplanirana smanjenja/prekide.
The effect of Lojuxta on cardiovascular morbidity and mortality has not been determined.
Učinak Lojuxte na kardiovaskularni morbiditet i mortalitet nije ustanovljen.
− The absence of pregnancy should be confirmed;
− potrebno je isključiti trudnoću;