natgillin/translations-raw huggingface dataset:
Highest concentrations of doramectin in liver, kidney, muscle and fat were found at 14 days (mean values were: liver, 38.8 + 14.5 μg/kg; kidney, 12.3 + 7.4 μg/kg; skeletal muscle, 9.8 + 4.6 μg/kg and fat, 62.2 + 25.6 μg/kg).
Najvišje koncentracije doramektina v jetrih, ledvicah, mišicah in maščevju so bile določene v vzorcih, ki so bili odvzeti 14 dni po terapiji (povprečne vrednosti so bile: jetra, 38,8 + 14,5 μg/kg; ledvica, 12,3 + 7,4 μg/kg; skeletna mišica, 9,8 + 4,6 μg/kg in maščevje, 62,2 + 25,6 μg/kg).
Four sheep (group 3) were given a single intramuscular injection of doramectin at a dose of 300 μg/kg bw on study day 0.
Štiri ovce (skupina 3) so prvi dan študije (dan 0) prejele eno intramuskularno injekcijo doramektina v odmerku 300 μg/kg telesne teže.
Pfizer Animal Health B.V.
Nizozemska Pfizer Animal Health B.V.
Not for use in dairy cows.
Ni namenjeno uporabi pri kravah molznicah.
Meat: Cattle, sheep: 60 days
Meso: govedo, ovce: 60 dni
Product trade name
Imetnik dovoljenja za promet z zdravilom
Sheep: 35 days.
Ovce: 35 dni.
The concentration of doramectin in the various tissues was determined in duplicate tissue samples (injection site quadruplicate) using a validated HPLC procedure (limit of detection 0.5 μg/kg, limit of quantification 2.5 μg/kg (5 μg/kg in fat).
Koncentracije doramektina v različnih tkivih so bile določene z validiranim postopkom s HPLC v dveh ponovitvah (duplikatih) za vse tkivne vzorce, razen za vzorec tkiva z mestom vbrizga, ki je bil analiziran v štirih ponovitvah (meja detekcije 0,5 μg/kg, meja kvantifikacije 2,5 μg/kg (5 μg/kg v maščevju).
Cattle and reindeer: 42 days Swine: 49 days
Govedo in severna jelenjad: 42 dni svinje: 49 dni
At sacrifice the liver, kidneys, the injection site, samples of fat and skeletal muscle were taken from each animal.
Po zakolu so iz vsake žrtvovane živali vzeli jetra, ledvici, tkivo z mestom vbrizga, vzorce maščevja in skeletno mišico.
Sheep: Not to be used in dairy ewes, for at least 70 days before giving birth, if the milk is going to be used for human consumption
Ovce: Uporaba pri brejih ovcah molznicah v času najmanj 70 dni pred jagnjitvijo, ni dovoljena v primeru, da gre za mleko, namenjeno prehrani ljudi.
Cattle esp. bullocks, Not for use in lactating cows producing milk for human consumption, even in the resting period
Govedo, zlasti voli.Ni namenjeno uporabi pri kravah molznicah, ki proizvajajo mleko za prehrano ljudi, in sicer niti v mirujočem obdobju.
76139 Karlsruhe Germany
Pfizer GmbH Pfizerstrasse 1 76139 Karlsruhe Nemčija
Sheep: 70 days
Ovce: 70 dni
Sheep: 56 days
Ovce: 56 dni
Concentrations of doramectin in injection site tissue were very variable and the mean value remained above the MRL at all sacrifice times (629 + 829 μg/kg at 14 days, 108 + 101 μg/kg at 35 days, 25.5 + 42.4 μg/kg at 42 days, 103 + 101 μg/kg at 49 days and 112 + 106 μg/kg at 56 days).
Koncentracije doramektina v tkivih z mestom vbrizga so bile zelo različne; povprečna vrednost je bila nad vrednostjo MRL v vseh časovnih točkah (629 + 829 μg/kg po 14 dneh, 108 + 101 μg/kg po 35 dneh, 25,5 + 42,4 μg/kg po 42 dneh , 103 + 101 μg/kg po 49 dneh in 112 + 106 μg/kg po 56 dneh).
On the basis of the data that were available, no withdrawal period could be set for the subcutaneous injection of doramectin and references to administration by this route should be removed from the product literature.
Na podlagi podatkov, ki so bili na voljo, ni bilo mogoče določiti karence po subkutanem injiciranju doramektina.
Dectomax 10 mg/ml Solution for injection
Dectomax 10 mg/ml Raztopina za injiciranje ovce govedo
Sheep: Not for use in dairy ewes producing milk for human consumption.
ovce: Ni namenjeno uporabi v ovcah molznicah, ki proizvajajo mleko za prehrano ljudi.
The product has been authorised in the EU Member States and EEA/EFTA States listed in Annex I as an injectable solution for intramuscular and/or subcutaneous administration.
Zdravilo v obliki raztopine za injiciranje za intramuskularno in/ali subkutano uporabo ima dovoljenje za promet v državah članicah Evropske unije (EU) in v državah članicah EGP/EFTA, ki so navedene v Dodatku I. Karence, določene za užitna tkiva ovčjih živalskih vrst, se med posameznimi državami članicami pomembno razlikujejo; gibljejo se med 35 in 70 dnevi.
Cattle, sheep and pigs Use not permitted in animals producing milk for human use
govedo, ovce in prašiči Uporaba pri živalih, ki proizvajajo mleko za prehrano ljudi, ni dovoljena.
DK 2750 Ballerup
Pfizer Aps Lautrupvang 8 2750 Ballerup Danska
Cattle: 42 days Sheep: 60 days
Govedo: 42 dni Ovce: 60 dni
Withdrawal period for milk 60 days for heifers, reindeer and animals during the dry period
V suhi dobi je karenca za mleko telic, severne jelenjadi in drugih živali 60 dni.
Sheep: 35 days
Ovce: 35 dni
Muscle: 20 µg/kg
mišice: 20 µg/kg maščevje: 100 µg/kg jetra: 50 µg/kg ledvica: 30 µg/kg
Sheep: 35 days (im), 56 days (sc)
), 56 dni (s.c.)
Cattle: 42 days Sheep: 40 days
Meso: govedo: 42 dni ovce: 40 dni
Meat: Cattle: 49 days
Govedo: 49 dni
Cattle: Not for use in the last 60 days before calving.
Govedo: Ni namenjeno uporabi v času 60 dni pred otelitvijo.
300 g/kg bw (im)
300 g/kg telesne teže (i.m.)
Sheep: Not for use in the last 70 days before lambing.
Ovce: Ni namenjeno uporabi v času 70 dni pred jagnjitvijo.
200 g/kg bw (sc) Pigs:
200 g/kg telesne teže (s.c.) prašiči
Cattle and reindeer: 200 g/kg bw Sheep:
govedo in severna jelenjad: 200 g/kg telesne teže ovce:
Sheep: 45 days (im); 60 days (sc) Reindeer: 42 days Milk:
); 60 dni (s.c.) Severnega jelena: 42 dni Mleko:
Sheep: Do not use in dairy sheep, including pregnant ewes within 50 days of lambing
Ovce: uporaba pri ovcah molznicah, vključujoč breje ovce samice v času 50 dni pred jagnjitvijo, ni dovoljena.
Not for use in sheep producing milk for human consumption
Ni namenjeno uporabi pri ovcah, ki proizvajajo mleko za prehrano ljudi.
Fat: 100 µg/kg
300 μg/kg.
Cattle and sheep No treatment of animals producing milk for human consumption
Raztopina za injiciranje za govedo in ovce govedo in ovce Ni namenjeno zdravljenju živali, ki proizvajajo mleko za prehrano ljudi
Cattle and sheep: 200 g / kg bw Pigs:
govedo in severna jelenjad: 200 g / kg telesne teže svinje:
200 μg/kg bw (sc only) Sheep:
200 μg/kg telesne teže (samo s.c.) ovce:
200 g/kg bw (sc) Sheep:
200 g/kg telesne teže (s.c.) ovce:
300 μg/kg bw
300 μg/kg telesne teže
200 μg/kg bw (sc) Sheep:
200 μg/kg telesne teže (s.c.) ovce:
Cattle: Forbidden in lactating cows, not to be administered 60 days before calving.
Govedo: Prepovedana uporaba pri kravah molznicah in v času 60 dni pred otelitvijo.
Sheep: Forbidden in lactating sheep, not to be administered 70 days before lambing
Ovce: Prepovedana uporaba v ovcah molznicah in v času 70 dni pred jagnjitvijo.
Despite the extensive re-homogenisation and increased number of sub-samples the results remained highly variable with mean values exceeding the MRL at all time-points (1866.8 + 1725.9 μg/kg at 14 days, 267 + 283.1 μg/kg at 35 days, 81.8 + 60.1 μg/kg at 42 days, 261.4 + 302.6 μg/kg at 49 days and 82.8 + 66.4 μg/kg at 56 days).
14 dneh, 267 + 283,1 μg/kg po 35 dneh, 81,8 + 60,1 μg/kg po 42 dneh, 261,4 + 302,6 μg/kg po 49 dneh in 82,8 + 66,4 μg/kg po 56 dneh).
Sheep and cattle Not permitted for use in lactating ewes or cows used to produce milk for human consumption
Raztopina za injiciranje ovce in govedo Uporaba pri ovcah ali kravah molznicah, ki proizvajajo mleko za prehrano ljudi, ni dovoljena ovce:
200 μg/kg bw (sc or im)
200 μg/kg telesne teže (s.c. ali i.m.)
300 g/kg bw (sc or im)
300 g/kg telesne teže (s.c. ali i.m.)
Pigs: Meat: 49 days Milk:
Meso: ovce: 35 dni govedo: 42 dni prašiči: 49 dni mleko:
Cattle: 200 g/kg bw Sheep: 300 g/kg bw
Raztopina za injiciranje govedo in ovce govedo: 200 g/kg telesne teže ovce: 300 g/kg telesne teže meso: govedo: 63 dni ovce: 63 dni
Cattle: 42 days Sheep: 35 days Milk:
Meso: govedo: 42 dni ovce: 35 dni (i.m.
Cattle, sheep, (reindeer)
Dectomax vet govedo, ovce, (severna jelenjad)
Cattle: Do not use in dry dairy cows including pregnant heifers within 60 days before calving.
Govedo: uporaba pri kravah molznicah v suhi dobi, vključno z brejimi telicami, v času 60 dni pred otelitvijo ni dovoljena.
200 g/kg bw (sc or im)
200 g/kg telesne teže (s.c. ali i.m.)
Cattle: forbidden in lactating cows, not to be administered less than 60 days before calving Sheep: forbidden in lactating sheep, not to be administered less than 70 days before lambing
Ovce: Prepovedana uporaba pri ovcah molznicah ter brejih ovcah molznicah v času 70 dni pred jagnjitvijo.
Cattle, sheep and pigs Single dose
Dectomax Raztopina za injiciranje govedo, ovce in prašiči enkratni odmerek govedo in ovce:
Not to be used in cattle producing milk for human consumption.
Ni namenjeno zdravljenju živali, ki proizvajajo mleko za prehrano ljudi.
Not for use in pregnant ewes Pigs
Ni namenjeno uporabi v brejih ovcah.
Cattle and reindeer: 42 days Sheep: 45 days (im), 60 days (sc)Nematodirus battus 55 days (im), 70 days (sc)
), 60 dni (s.c.)Nematodirus battus 55 dni (i.m.
Cattle: Not to be used for pregnant cows 60 days before giving birth.
Govedo: Uporaba pri brejih kravah v času 60 dni pred otelitvijo ni dovoljena.
Cattle, Reindeer, Pigs Not permitted for use in animals producing milk for human consumption during lactation
Dectomax Vet govedo, severna jelenjad, prašiči Zdravljenje živali, ki priozvajajo mleko za prehrano ljudi, ni dovoljena.
200 g/kg bw (sc, im), (Nematodirus 300 g/kg bw (sc, im)) Pigs:
), (Nematodirus 300 g/kg telesne teže (s.c., i.m.))
Strength Pharmaceutical Form
Farmacevtska oblika Pot uporabe Stična ovojnina
EU (MA) Number
Številka (EU) dovoljenja za promet
Packaging Content Package size
Pakiranje Vsebina Velikost pakiranja
EU (MA) Number
EU (MA) številka Izmišljeno ime
Route of administration
Način uporabe
Prior to the launch in each Member State, the Marketing Authorisation Holder shall agree with the National Competent Authority the format and content of the Physician Educational Materials and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare information pack containing:
Pred začetkom trženja v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom dogovoriti z nacionalnim pristojnim organom glede formata in vsebine izobraževalnega gradiva za zdravnike ter dogovorjeni program vpeljati nacionalno tako, da pred predpisovanjem zagotovi, da vsi zdravniki prejmejo paket informacij za zdravnike, ki vsebuje:
- Summary of Product Characteristics (in full)
- Povzetek glavnih značilnosti zdravila (v celoti),
The member States must ensure that all conditions with regard to the safe and effective use of the medicinal product described below are implemented.
Države članice morajo zagotoviti uveljavitev vseh spodaj opisanih pogojev glede varne in učinkovite uporabe zdravila.
Key elements to be included in the educational material:
Izobraževalno gradivo za zdravnike mora vsebovati naslednje ključne podatke:
• Detailed information about the risk of haematological disorders (notably anaemia) associated with Victrelis, consisting of factual description of the haematological disorders in terms of frequency and time to onset and related clinical symptoms.
• Natančne informacije o tveganju za hematološke motnje (še posebej anemijo) povezane z zdravilom Victrelis.
The final study report shall be submitted by 31 December 2021.
Končno poročilo o študiji bo predloženo do 31. decembra 2021.
• what dose to take and for how long.
• kakšen odmerek morate jemati in kako dolgo;
Your doctor will tell you:
Zdravnik vam bo povedal:
The potential risk for humans is unknown.
Morebitno tveganje za človeka ni znano.
Do not change the dose yourself.
Odmerka ne spreminjajte sami.
The usual dose that you will need to take is listed below.
Običajni odmerek, ki ga morate vzeti, je naveden spodaj.
3 years.
3 leti
The objectives of the study are:
Cilji študije so:
Treatment and monitoring recommendations*
Priporočila za zdravljenje in spremljanje*
• when to increase or decrease your dose.
• kdaj povečati ali zmanjšati odmerek.
• Advice to patients about:
• Nasvet bolnikom glede:
Not known (frequency cannot be estimated from the available data)
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
There are no reliable data on its use in pregnant women.
Zanesljivih podatkov o uporabi pri nosečnicah ni.
o statins such as simvastatin.
o statini, kot je simvastatin.
Parameter/Abnormality
Parameter/abnormalnost
• Confirm elevation with a repeat measurement within one week.
• Potrdite povišanje s ponovno meritvijo v roku enega tedna.
*Recommendations based on an ULN of approximately 30-40 international units/L.
* Priporočila temeljijo na vrednosti ULN, ki je približno 30-40 mednarodnih enot/l.
This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measure:
Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet v določenem časovnem okviru izvesti naslednje ukrepe:
Annual reports will be submitted at time of annual reassessment
Letna poročila se bodo priložila v času ponovne letne ocene.
Statins occasionally cause myopathy.
Statini občasno povzročajo miopatijo.
• Advice to patients about the risk of concomitant alcohol intake;
• Nasvet za bolnike o tveganju sočasnega uživanja alkohola;
Age and gender
Starost in spol
• Pregnancy (see section 4.6).
• nosečnost (glejte poglavje 4.6).
• blood or protein in the urine
• kri ali beljakovine v urinu,
If you feel dizzy during treatment then do not drive or use machines until you feel better.
Če ste med zdravljenjem omotični, ne uporabljajte vozil ali strojev, dokler se ne počutite bolje.
Twenty-nine patients were enrolled, of whom 23 completed through Week 78.
Vključenih je bilo devetindvajset bolnikov, od katerih jih je 23 zaključilo 78. teden.
Date of latest renewal: 23 April 2018
Datum prve odobritve: 31. julij 2013 Datum zadnjega podaljšanja: 23. april 2018
The study provided for a total of 78 weeks of treatment.
Študija je skupno vključevala 78 tednov zdravljenja.
Because of the possibility of interactions with other medicines, your doctor may change the time of day you take your medicines.
Zaradi možnih interakcij z drugimi zdravili lahko zdravnik spremeni čas v dnevu, ko boste zdravilo jemali.
Consequently, this would reduce the effect of lomitapide.
Posledično bo to zmanjšalo učinek lomitapida.
• All capsules have edible black ink for printing.
• Vse kapsule vsebujejo užitno črnilo za tiskanje.
These blood tests help your doctor adjust your dose.
Krvne preiskave zdravniku pomagajo prilagajati vaš odmerek.
Any impact on efficacy is likely to be variable.
Verjetno je, da bo vpliv na učinkovitost variabilen.
Study Week
Teden v študiji
The risk of liver damage is increased when this medicine is used at the same time as statins.
Tveganje jetrne poškodbe se poveča, če se to zdravilo uporablja sočasno s statini.
>5% to ≤10% >10% to ≤15% >15% to ≤20% >20% to ≤25%
> 5 % do ≤ 10 % > 10 % do ≤ 15 % > 15 % do ≤ 20 % > 20 % do ≤ 25 %
• tiredness, lack of energy or general weakness
• utrujenost, pomanjkanje energije ali splošna šibkost,
These capsules may cause side effects which can also be symptoms of liver problems.
Te kapsule lahko povzročijo neželene učinke, ki lahko vključujejo tudi simptome težav z jetri.
The MAH must agree the content and format of the educational materials together with a communication plan with the national competent authority in each Member State prior to distribution in their territory.
Imetnik dovoljenja za promet z zdravilom se mora o vsebini in obliki izobraževalnih gradiv skupaj s komunikacijskim načrtom dogovoriti skupaj z nacionalnim pristojnim organom v posamezni državi članici pred distribucijo na njenem ozemlju.
The performance of these tests and their interpretation should involve collaboration between the treating physician and the hepatologist.
Izvedba teh preiskav in njihova interpretacija morata vključevati sodelovanje lečečega zdravnika ter hepatologa.
The elimination half-life of lomitapide was approximately 29 hours.
Razpolovni čas izločanja lomitapida je bil približno 29 ur.
This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
Inform your doctor of any change in the medicines you are taking.
Zdravnika obvestite o vseh spremembah zdravil, ki jih jemljete.
Appropriate patient selection
Ustrezna izbira bolnikov
Alcohol may increase levels of hepatic fat and induce or exacerbate liver injury.
Alkohol lahko poviša ravni maščob v jetrih in povzroči ali poslabša jetrno poškodbo.
There was no clinically relevant effect of age (18-64 years) or gender on the pharmacokinetics of lomitapide.
Klinično pomembnega učinka starosti (18-64 let) ali spola na farmakokinetiko lomitapida ni bilo.
Educational materials for patients
Izobraževalno gradivo za bolnike
The dose of warfarin should be adjusted as clinically indicated.
Odmerek varfarina je treba prilagoditi, kot je klinično indicirano.
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.
Zaužiti ga je treba na prazen želodec vsaj 2 uri po večernem obroku, saj lahko vsebnost maščob v zadnjem obroku neželeno učinkuje na gastrointestinalno toleranco.
The Prescriber Guide shall include the following key elements:
Navodila za predpisovanje morajo vsebovati naslednje ključne elemente:
Approximately 33% of the radioactivity was excreted in urine as metabolites.
Približno 33 % radioaktivnosti se je izločilo z urinom v obliki presnovkov.
• The need to inform their doctor if they have had any liver problems in the past;
• Potrebo po obveščanju svojega zdravnika o kakršnih koli težavah z jetri v preteklosti;
Women who become pregnant should be counselled and referred to an expert in teratology;
Ženskam, ki zanosijo, je treba ponuditi svetovanje in jih napotiti k strokovnjaku za teratologijo;
It is important to avoid dehydration by drinking enough fluids (see section 4).
Pomembno je preprečiti dehidracijo z zadostnim pitjem tekočin (glejte poglavje 4).
Store below 30°C.
Shranjujte pri temperaturi pod 30 °C.
Fifteen of 23 (65%) patients had their lipid-lowering treatment reduced by Week 78, including planned and unplanned reductions/interruptions.
Pri 15 od 23 (65 %) bolnikov so se odmerki zdravil za zniževanje ravni lipidov do 78. tedna zmanjšali, vključno z načrtovanimi in nenačrtovanimi zmanjšanji/prekinitvami.
• Women should tell their doctor immediately if they suspect that they might be pregnant.
• Ženske se morajo takoj posvetovati s svojim zdravnikom, če menijo, da bi bile lahko noseče.
Patients on 5 mg should remain on 5 mg.
Bolniki na odmerku 5 mg morajo na odmerku 5 mg ostati.
• The need to inform their doctor of all other medicines they are taking as special care should be taken if other medicines which can cause liver problems are taken at the same time;
• Potrebo po obveščanju zdravnika o vseh drugih zdravilih, ki jih jemljejo, saj je treba biti še posebej previden, če se sočasno jemljejo zdravila, ki lahko povzročijo težave z jetri;
Absorption is not limited by penetration of the active substance across the intestinal barrier but is predominantly influenced by an extensive first pass effect.
Absorpcija ni omejena na prehajanje učinkovine prek črevesne pregrade, ampak nanjo večinoma vpliva učinek obsežnega prvega prehoda.
Sixteen males (55%) and 13 females (45%) were included with a mean age of 30.7 years, ranging from 18 to 55 years.
16 moških (55 %) in 13 žensk (45 %) s povprečno starostjo 30,7 leta, tj. od 18 do 55 let.
If you stop taking this medicine your cholesterol may rise again.
Če prenehate jemati to zdravilo, se lahko ravni holesterola spet povišajo.
Week 78 (N=23)
78. teden (N = 23)
It is typically passed down by both father and mother, who also have high cholesterol passed down from their parents.
Navadno se prenese z očeta in matere, ki sta visoke ravni holesterola podedovala od svojih staršev.
• Do not drink any type of grapefruit juice.
• Ne uživajte soka grenivke v nobeni obliki.
Information that the educational materials for patients included in the prescribers pack can be used for patient counselling.
Informacije, da se lahko izobraževalno gradivo za bolnike, priloženo kompletu za zdravnike, uporabi za svetovanje bolnikom.
Genetic confirmation of HoFH should be obtained whenever possible.
Kadar je mogoče, je treba HoFH potrditi z genetskimi preiskavami.
• The safety and effectiveness of Lojuxta in children below the age of 18 have not been established;
• Varnost in učinkovitost zdravila Lojuxta pri otrocih, mlajših od 18 let, nista bili dokazani;
In the Phase 3 study, 3 of 4 patients with ALT elevations >5x ULN reported alcohol consumption beyond the limits recommended in the protocol.
V študiji 3. faze so 3 od 4 bolnikov s povišanjem ravni ALT > 5-kratna vrednost ULN poročali o uživanju alkohola zunaj omejitev, priporočenih v protokolu.
• total cholesterol
• celokupnega holesterola;
In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required.
V primeru prevelikega odmerjanja je treba bolnika zdraviti simptomatsko in po potrebi uvesti podporne ukrepe.
Lancaster Way, Wingates Industrial Estate, Westhoughton, Bolton, Lancashire, BL5 3XX United Kingdom
Lancaster Way, Wingates Industrial Estate, Westhoughton, Bolton, Lancashire, BL5 3XX Velika Britanija
These changes are secondary to the mechanism of action of lomitapide.
Te spremembe so posledica mehanizma delovanja lomitapida.
• To evaluate the long-term effectiveness of lomitapide in maintaining control of serum lipid levels in clinical practice.
• Oceniti dolgotrajno učinkovitost lomitapida pri vzdrževanju ravni lipidov v serumu v klinični praksi.
In animal studies lomitapide was highly concentrated (200-fold) in the liver.
V študijah na živalih je bil lomitapid izjemno koncentriran (200-kratno) v jetrih.
• if you are pregnant, trying to get pregnant, or think you may be pregnant (see section 2 under ‘Pregnancy and breast-feeding').
• če ste noseči, načrtujete zanositev ali menite, da bi lahko bili noseči (glejte poglavje 2 „Nosečnost in dojenje“).
• To lower the chance of stomach problems, you must stay on a low-fat diet whilst taking this medicine.
• Da zmanjšate možnost želodčnih težav, morate med jemanjem tega zdravila vzdrževati dieto z majhnim vnosom maščob.
Doses higher than 60 mg suggest a trend toward nonlinearity and are not recommended.
Odmerki, večji od 60 mg, kažejo nelinearnost in niso priporočljivi.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serij
The liver enzyme changes can occur at any time during therapy, but occur most often during dose escalation.
Spremembe jetrnih encimov se lahko pojavijo kadarkoli med zdravljenjem, vendar najpogosteje med povečevanjem odmerka.
• Do not take this medicine with food, as taking these capsules with food can cause stomach problems.
• Tega zdravila ne jemljite skupaj s hrano, saj lahko povzroči želodčne težave.
Median presented for TG and Lp(a).
a Mediana, predstavljena za TG in Lp(a).
In the renal impairment population, lomitapide was only studied in patients with end-stage renal disease (ESRD).
Glede populacije z ledvično okvaro se je lomitapid preučeval samo pri bolnikih z ledvično boleznijo v končnem stadiju (ESRD).
Effects on lomitapide levels
Učinki na ravni lomitapida
The physician educational pack should contain:
Izobraževalni komplet za zdravnike mora vsebovati: