natgillin/translations-raw huggingface dataset:
- if your immune system does not work properly - if you have an increased bleeding risk and or muscle disease
- če vaš imunski sistem ne deluje pravilno; - če imate povečano tveganje za krvavitev ali bolezen mišic;
Do not stop taking these without talking to your doctor.
Teh zdravil ne prenehajte jemati, ne da bi se o tem pogovorili z zdravnikom.
• Tell your doctor if you are suffering from diabetes.
• Povejte zdravniku, če imate sladkorno bolezen.
Effects on male and female fertility have not been evaluated in animal studies.
Učinkov na plodnost pri moških in ženskah niso ocenili v študijah na živalih.
It is important that you take these medicines according to the instructions given.
Pomembno je, da ta zdravila jemljete skladno z danimi navodili.
Talk to your doctor about this.
O tem se posvetujte z zdravnikom.
Your doctor will talk to you about the anaesthetic and how it will be given.
Zdravnik se bo z vami pogovoril o anestetiku in načinu njegovega dajanja.
Strict compliance with dietary fat restriction was difficult.
Strogo upoštevanje omejitve vnosa maščobe s hrano je bilo težavno.
The biodistribution pattern was very similar in the other tested species (cats and rabbits).
Vzorec biološke porazdelitve je bil zelo podoben tudi pri drugih preučevanih živalskih vrstah (mačkah in kuncih).
In addition, an updated RMP should be submitted
Posodobljen RMP je treba predložiti:
Information on the back:
Informacije na zadnji strani:
Additional monitoring tests
Dodatne preiskave za spremljanje
Before launch of the product in each country
Pred dajanjem zdravila v promet v posamezni državi
LPLD involves a state of hyperviscosity/hypercoagulability.
LPLD vključuje stanje hiperviskoznosti/hiperkoagulacije.
You should consider this when driving or using machines.
To morate upoštevati, ko vozite in upravljate stroje.
When reporting possible adverse reactions, please include the individual lot number imprinted on the front of this card.
Pri poročanju morebitnih neželenih učinkov vključite številko posamezne serije, natisnjeno na sprednji strani te kartice.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
An immune response was seen despite the use of immunosuppressants.
Imunogenost Imunski odziv so opazili kljub uporabi imunosupresivnih sredstev.
This is the number of vials that must be dispensed.
Tako dobite število vial, ki jih je treba uporabiti.
Although there is no fully adequate animal model to address the tumourigenic potential, the available toxicological data do not suggest any concern for tumourigenicity
Čeprav za obravnavo tumorigenega potenciala ne obstaja popolnoma primeren živalski model, razpoložljivi toksikološki podatki ne kažejo nobenih težav s tumorigenostjo.
Information on the front:
Informacije na sprednji strani:
- if you are taking oral contraceptives
- če jemljete peroralna kontracepcijska sredstva.
Read it carefully and follow the related
Pozorno jo preberite in upoštevajte navodila na njej.
After thawing, each vial should be gently inverted twice to ensure even mixing.
Ko se viale odtajajo, je treba vsako vialo dvakrat nežno obrniti, da zagotovite enakomerno mešanje.
6.5 Nature and contents of container and special equipment for use, administration or implantation
6.5 Vrsta ovojnine in vsebina ter posebna oprema za uporabo, dajanje ali implantacijo
Local biosafety guidelines applicable for such products should be followed (see section 6.6).
Upoštevati je treba lokalne smernice za biološko varnost, ki veljajo za taka zdravila (glejte poglavje 6.6).
Given the small patient population and size of the cohorts, captured adverse reactions and serious adverse reactions do not provide a complete perspective on the nature and frequency of these events.
Glede na majhno populacijo bolnikov in velikost kohort opaženi neželeni učinki in resni neželeni učinki ne dajejo popolne slike o značaju in pogostnosti teh učinkov.
Patients experiencing dizziness are advised to not drive or use machines.
Bolnikom, pri katerih se pojavi omotica, je treba priporočiti, naj ne vozijo in ne upravljajo strojev.
15 years follow-up is recommended for every patient treated.
Pri vsakem zdravljenem bolniku se priporoča 15-letno sledenje.
Dose of immunosuppressant may need to be adjusted.
Morda bo treba prilagoditi odmerek imunosupresivnih učinkovin.
These effects were dose-dependent but showed regression with time.
Ti učinki so bili odvisni od odmerka, vendar so se sčasoma vrnili na prejšnje stanje.
The Marketing Authorisation Holder should be informed immediately.
O tem je treba takoj obvestiti imetnika dovoljenja za promet z zdravilom.
You will need to stay in hospital for a few hours or overnight to make sure that you have not had any side effects from the medicine or the anaesthetic.
V bolnišnici boste morali ostati nekaj ur ali čez noč, s čimer se bo zdravstveno osebje prepričalo, da nimate kakršnih koli neželenih učinkov zdravila ali anestetika.
The educational pack for healthcare professionals must be agreed with the National Competent Authorities prior to distribution and consist of the following components:
Izobraževalni komplet za zdravstvene delavce morajo pred distribucijo odobriti nacionalni pristojni organi, vsebovati pa mora naslednje komponente:
Using condoms will reduce the amount of Glybera that may be left in the woman's body.
Uporaba kondomov bo zmanjšala količino zdravila Glybera, ki lahko ostane v ženskem telesu.
The most commonly reported adverse reaction is pain in extremity occurring in approximately one third of patients.
Neželeni učinek, o katerem so poročali najpogosteje, je bolečina na okončini, ki se pojavi pri približno tretjini bolnikov.
Please ask your doctor for more information about the exact immunosuppressant medicine you will be taking.
Zdravnika prosite za več informacij o dejanskem imunosupresivnem zdravilu, ki ga boste jemali.
After this time, triglyceride levels reverted back to baseline.
Po tem obdobju so se ravni trigliceridov povrnile na izhodiščno vrednost.
In lipoprotein lipase deficiency, this enzyme is missing due to a genetic defect.
Pri pomanjkanju lipoproteinske lipaze je ta encim odsoten zaradi genetske okvare.
Local pain or sensitivity may be managed by symptomatic treatment such as administration of local or systemic pain relievers.
Lokalna bolečina ali občutljivost se lahko obravnavata s simptomatskim zdravljenjem, kot je uporaba lokalnih ali sistemskih sredstev za lajšanje bolečine.
EXP Shelf life after first opening in the syringes: 8 hours (if space permitted)
Rok uporabnosti po prvem odpiranju v brizgah: 8 ur (če prostor to dovoljuje)
Once thawed, the medicinal product should not be re-frozen.
Ko se zdravilo odmrzne, se ne sme ponovno zamrzniti.
- You have been given a patient card by your doctor.
- Zdravnik vam je dal kartico za bolnika.
PSUR/ annual reassessment
PSUR/letna ponovna ocena
The instructions for use, handling and disposal are given in section 6.6.
Za navodila glede uporabe, ravnanja in odstranjevanja zdravila glejte poglavje 6.6.
• Oral contraceptives (see section 2 ‘Do not receive Glybera')
• Peroralna kontracepcijska sredstva (glejte poglavje 2 „Zdravila Glybera ne smete prejeti“)
1) on efficacy data such as biochemical markers as part of normal practice and frequency and severity of pancreatitis and 2) on safety including immunogenicity against Glybera and LPL.
1) o učinkovitosti, kot so biokemični označevalci, kot del normalne prakse in 2) o varnosti, vključno z imunogenostjo proti zdravilu Glybera in LPL.
Lipoprotein lipase (LPL) is a naturally occurring substance in the body (known as an enzyme) that controls the level of certain fats in the blood.
Lipoproteinska lipaza (LPL) je naravno prisotna snov v telesu (znana kot encim), ki nadzoruje raven nekaterih maščob v krvi.
The registry should be performed according to an agreed protocol.
Register je treba izvajati skladno z odobrenim protokolom.
Follow applicable local or international guidelines for prophylaxis (See also section 4.5).
Upoštevajte ustrezne lokalne in mednarodne smernice za profilakso (glejte tudi poglavje 4.5).
It is important that you ask your doctor about the side effects of these other medicines.
Pomembno je, da zdravnika vprašate o neželenih učinkih teh zdravil.
Do not use this medicine after the expiry date which is stated on the label after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake
If any of the above applies to you, or if you are unsure of any of the above, please talk to your doctor before you receive Glybera.
Če kar koli od navedenega velja za vas ali če niste prepričani glede česar koli zgoraj navedenega, se pred uporabo zdravila Glybera posvetujte z zdravnikom.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu .
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
The indication is restricted to patients with detectable levels of LPL protein (see section 4.4).
Indikacija je omejena na bolnike z določljivimi ravnmi proteina LPL (glejte poglavje 4.4).
This medicine contains genetically modified organisms and must be disposed of according to local rules for such medicines.
To zdravilo vsebuje gensko spremenjene organizme, zato ga je treba zavreči skladno z lokalnimi predpisi za taka zdravila.
3) Dietary diary and quality of life data should also be recorded.
3) Prav tako je treba zbirati tudi podatke o kakovosti življenja in voditi
• Oral contraceptive use (see section 4.6).
• Uporaba peroralnih kontracepcijskih sredstev (glejte poglavje 4.6).
The expiry date refers to the last day of that month.
Uporabno do. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
The clinical relevance of the antibody response is unknown (see section 4.2 on re-administration).
Klinična pomembnost odziva protiteles ni znana (glejte poglavje 4.2 o ponovni uporabi).
Unused medicine must be disposed of in compliance with the local rules for genetically modified organisms.
Neuporabljeno zdravilo je treba odstraniti skladno z lokalnimi predpisi za gensko spremenjene organizme.
Diabetes mellitus is common in patients who have the most severe symptoms of LPLD.
Sladkorna bolezen je pogosta pri bolnikih z najhujšimi simptomi LPLD.
Further follow-up of patients who took part in study CT-AMT-11-03 (to a median of 5.8 years after exposure to Glybera) has shown a reduction in hospital stay of 1 day per patient per year when compared to the same length of time prior to exposure.
Nadaljnje spremljanje bolnikov, ki so sodelovali v študiji CT-AMT-11-03 (do mediane 5,8 let po izpostavljenosti zdravilu Glybera) je pokazalo zmanjšanje hospitalizacije za 1 dan na bolnika na leto v primerjavi z enako časovno dolžino pred izpostavljenostjo.
Glybera should not be administered to pregnant women unless the possible benefit to the mother outweighs the possible risk to the foetus.
Zdravilo Glybera se ne sme uporabljati pri nosečnicah, razen če je morebitna korist za mater večja od morebitnega tveganja za plod.
The patient's weight should be divided by 3, then without rounding up this number multiplied by 2 and rounded up to the next higher whole number.
Bolnikovo telesno maso je treba deliti s 3, potem to število brez zaokroževanja pomnožiti z 2 in zaokrožiti na naslednje višje celo število.
In addition to being given Glybera, you will be given other medicines called immunosuppressants (see section 3 ‘How Glybera is used').
Poleg zdravila Glybera boste prejeli tudi druga zdravila, imenovana imunosupresivna sredstva (glejte poglavje 3 „Kako uporabljati zdravilo Glybera“).
In saliva vector DNA was still detectable up to 12 weeks; in urine up to 10 weeks and in semen up to 26 weeks.
V slini je bilo mogoče DNK vektorja zaznati do 12 tednov, v urinu do 10 tednov, v spermi pa do 26 tednov.
The assay to be used in the study needs to be agreed.
Test, ki se bo uporabil v študiji, mora biti odobren.
Treated patients should not donate blood, organs, tissues and cells for transplantation.
Zdravljeni bolniki ne smejo darovati krvi, organov, tkiv in celic za transplantacijo.
The PSUR cycle for the medicinal product should follow a half-yearly cycle until otherwise agreed by the CHMP.
Cikel PSUR za zdravilo mora slediti polletnemu ciklu, dokler CHMP ne določi drugače.
In a follow-up period of up to 3 years after treatment, there was a decreasing trend in the incidence and severity of pancreatitis in the 12 patients who had multiple attacks during their life time.
V obdobju sledenja, ki je trajalo do 3 leta po zdravljenju, so opazili zmanjševanje incidence in resnosti pankreatitisa pri 12 bolnikih, ki so imeli v življenju več napadov.
• bruises in the upper and lower leg muscle due to the injections.
• podplutbe na mišicah zgornjega in spodnjega dela nog zaradi injiciranja.
No interaction studies other than preclinical and clinical studies with mycophenolate mofetil and ciclosporin have been performed.
Študij medsebojnega delovanja, razen predkliničnih in kliničnih študij z mofetilmikofenolatom in ciklosporinom, niso izvedli.
• Use appropriate barrier contraception such as condoms to avoid becoming pregnant during treatment and for at least 12 months after treatment.
• Uporabljate ustrezno pregradno kontracepcijo, kot so kondomi, da preprečite zanositev med zdravljenjem in še vsaj 12 mesecev po njem.
Oral contraceptive use is contraindicated in LPLD patients (see section 4.3) as this may exacerbate the underlying disease.
Pri bolnikih z LPLD so peroralna kontracepcijska sredstva kontraindicirana (glejte poglavje 4.3), saj lahko poslabšajo osnovno bolezen.
2.2 Qualitative and quantitative composition
KAKOVOSTNA IN KOLIČINSKA SESTAVA
See also section 3, ‘How Glybera is used'.
Glejte tudi poglavje 3 „Kako uporabljati zdravilo Glybera“.
• Information on the use of Glybera and avoidance of pregnancy.
• Informacije o uporabi zdravila Glybera in preprečevanju nosečnosti.
Taking these medicines before receiving or at the same time as receiving Glybera, may cause unnecessary bruising or bleeding from the injection sites.
Jemanje teh zdravil pred prejemom zdravila Glybera ali v času njegovega injiciranja lahko povzroči nepotrebno podplutbo ali krvavitev mesta injiciranja.
Pre-clinical studies with doses ten times the recommended dose (1 x 1013 gc/kg) did not lead to any general systemic untoward signs or symptoms.
Predklinične študije z odmerki, ki so desetkrat večji od priporočenega odmerka (1 x 1013 gk/kg), niso pokazale nobenih sistemskih neželenih znakov ali simptomov.
Women of childbearing potential must be advised to use reliable barrier contraception methods in accordance with the guidelines for immunosuppressants for a minimum of 12 months from the start of therapy (9 months following cessation of immunosuppressants).
Kontracepcija pri moških in ženskah Ženskam v rodni dobi je treba svetovati, naj uporabljajo zanesljive pregradne kontracepcijske metode skladno s smernicami za imunosupresivna sredstva vsaj 12 mesecev od začetka zdravljenja (9 mesecev po ukinitvi imunosupresivnih sredstev).
A demonstrable improvement of postprandial CM metabolism was shown in 5/5 patients up to week 14 and in 3/3 patients who were followed up to 52 weeks.
CM so pokazali pri 5/5 bolnikov do 14. tedna in pri 3/3 bolnikov, ki so jih spremljali do 52. tedna.
The dose you will need is dependent on your weight and is calculated by your doctor.
Odmerek, ki ga potrebujete, bo odvisen od vaše telesne mase, izračunal pa ga bo vaš zdravnik.
The studies should be performed according to an agreed protocol.
Študiji je treba izvajati skladno z odobrenim protokolom.
• It is important that you tell your doctor if you have an active infection of any sort before you take the medicines you will be given to reduce your body's defences (immunosuppressants) and before you receive Glybera.
• Pomembno je, da zdravnika obvestite, če imate kakršno koli aktivno okužbo, preden prejmete zdravila za zmanjšanje odpornosti imunskega sistema (imunosupresivna sredstva) in preden prejmete zdravilo Glybera.
All patients treated with Glybera should be enrolled in the registry and systematic data collection carried out to enrich the database:
Vse bolnike, ki se zdravijo z zdravilom Glybera, je treba vključiti v register ter zbirati sistemske podatke za obogatitev zbirke podatkov:
Vials should be visually inspected for particulate matter and colour.
Viale preglejte za delce in barvo.
As expected, all animals developed antibodies to the AAV protein shell.
Kot je bilo pričakovati, so se pri vseh živalih razvila protitelesa proti beljakovinski kapsuli AAV.
No clinical data on the effect of Glybera on fertility are available.
Klinični podatki o učinku zdravila Glybera na plodnost niso na voljo.
All but two patients received immunosuppressant for 12 weeks.
Vsi preskušanci razen dveh so 12 tednov prejemali imunosupresivna sredstva.
Treatment with Glybera does not eliminate attacks of acute pancreatitis.
Prehrana Zdravljenje z zdravilom Glybera ne odpravi napadov akutnega pankreatitisa.
This medicine has been authorised under "exceptional circumstances”.
Zdravilo je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
2) Educational material for physicians and other healthcare professionals involved in the treatment of patients with Glybera including the following key safety elements:
2) Izobraževalno gradivo za zdravnike in druge zdravstvene delavce, vključene v zdravljenje bolnikov z zdravilom Glybera, vključno z naslednjimi ključnimi varnostnimi elementi:
Liver and kidney function, cytochrome P450 polymorphisms and ageing are not expected to influence the clinical efficacy or safety of Glybera.
Ni pričakovati, da bodo delovanje jeter in ledvic, polimorfizmi citokroma P450 in staranje vplivali na klinično učinkovitost ali varnost zdravila Glybera.
Alipogene tiparvovec is produced using insect cells and recombinant baculovirus technology.
Alipogentiparvovek je izdelan z uporabo celic žuželk in rekombinantne bakulovirusne tehnologije.
One patient developed myoglobinuria in association with raised serum creatine kinase activity.
Pri enem bolniku se je razvila mioglobinurija v povezavi s povečano aktivnostjo serumske kreatin kinaze.
LPL protein mass should be determined by ELISA or equivalent methods.
Maso proteina LPL je treba določiti s preiskavo ELISA ali enakovredno metodo.
You need to take this into consideration if you are on a controlled sodium diet.
To morate upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
After treatment with Glybera do not donate blood, organs, tissues and cells for transplantation to avoid spreading cells that contain your medicine.
Po zdravljenju z zdravilom Glybera ne smete darovati krvi, organov, tkiv in celic za transplantacijo, da preprečite širjenje celic, ki vsebujejo to zdravilo.
Study CT-AMT-011-03 was a combined retrospective and prospective study of subjects who had taken part in studies CT-AMT-10-01, CT-AMT-11-01, CT-AMT-11-02.
Študija CT-AMT-011-03 je bila kombinirana retrospektivna in prospektivna študija oseb, ki so sodelovale v študijah CT-AMT-10-01, CT-AMT-11-01, CT-AMT-11-02.
Re-evaluation of immune responses from all patients enrolled in study CT-AMT-011-01 by using a validated assay method should also be provided.
Prav tako je treba predložiti ponovno oceno imunskega odziva pri vseh bolnikih, vključenih v študijo CT-AMT-011-01, z uporabo validirane metode testiranja.
Information for health care professionals: The holder of this card has received Glybera, a gene therapy medicinal product for familial lipoprotein lipase deficiency, containing genetically modified organisms.
Informacije za zdravstvene delavce: Imetnik te kartice je prejel zdravilo Glybera, namenjeno genski terapiji pri družinskem pomanjkanju lipoproteinske lipaze, ki vsebuje gensko spremenjene organizme.
The MAH shall agree the details of a restricted access programme with the National Competent Authorities and must implement such programme nationally prior to launch.
Imetnik dovoljenja za promet z zdravilom se bo o podrobnostih programa z omejenim dostopom dogovoril z nacionalnimi pristojnimi organi in mora ta program uvesti nacionalno pred dajanjem zdravila v promet.
Glybera shall only be supplied if the healthcare professionals involved in the treatment of a patient have received the educational pack and if the prescriber confirms that the patient agrees to participate in the registry.
Zdravilo Glybera bo dostavljeno samo, če so zdravstveni delavci, vključeni v zdravljenje bolnika, prejeli izobraževalni komplet in če zdravnik, ki zdravilo predpiše, potrdi, da se bolnik strinja s sodelovanjem v registru.
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan and the Efficacy Follow-up Plan as agreed in the Risk Management Plan presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance in v načrtu spremljanja učinkovitosti, sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
Upon injection, Glybera was well tolerated in all animal studies performed with no notable clinical signs.
Injiciranje zdravila Glybera so živali dobro prenašale v vseh opravljenih študijah na živalih, saj niso opazili nobenih kliničnih znakov.
The calculated amount of syringes should be filled from the thawed vials, and they should be labelled and placed in a container protected from light suitable for transportation to the room where the patient will undergo the intramuscular injections.
Iz odtajanih vial je treba napolniti izračunano število injekcijskih brizg, ki jih je treba označiti in položiti v vsebnik, zaščiten pred svetlobo in primeren za transport v sobo, kjer bo bolnik prejel intramuskularno injiciranje.
In gonads and reproductive organs, vector DNA copies were found at low levels.
V gonadah in reproduktivnih organih so bile ravni kopij DNK vektorja nizke.
Compared to pre-administration, a transient and variable reduction in median triglyceride levels was recorded for all patients.
V primerjavi z obdobjem pred injiciranjem so pri vseh bolnikih opazili prehodno in spremenljivo znižanje mediane ravni trigliceridov.
To avoid any injection of particles from the stopper due to two withdrawals, one needle for the withdrawal from the vial (to be left inside the stopper) and a separate needle for each syringe must be used.
Da se izognete injiciranju delcev zamaška zaradi dveh polnjenj brizge, morate uporabiti eno iglo za polnjenje brizg iz viale (ki se pusti v zamašku) in ločeno iglo za vsako injekcijsko brizgo.
Two of these clinical trials were preceded by prospective observational studies to assess fasting triglycerides (TG) level and symptoms and signs of LPLD in subjects maintained on a low fat diet.
Pred dvema od teh kliničnih preskušanj so se opravile prospektivne opazovalne študije, s katerimi so ocenili raven trigliceridov (TG) na tešče ter simptome in znake LPLD pri preskušancih na dieti z majhnim vnosom maščob.
Glybera is not recommended for use in children and adolescents under 18 years of age.
Uporaba zdravila Glybera ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let.
Your doctor will weigh up the benefits to you against the risks to your baby of taking Glybera whilst you are pregnant.
Zdravnik bo pretehtal razmerje med koristmi za vas in tveganji za otroka pri uporabi zdravila Glybera med nosečnostjo.
The patient's weight should be divided by 3, and rounded up to the next higher whole number.
Bolnikovo telesno maso je treba deliti s 3 in zaokrožiti na naslednje višje celo število.