natgillin/translations-raw huggingface dataset:
More than 1000 outcomes from second and third trimester exposure in pregnant women indicate no evidence of increased risk of malformative and foeto/neonatal negative effects.
Več kot 1.000 primerov izpostavljenosti nosečnic v drugem in tretjem trimesečju ne navaja dokazov o povečanem tveganju za deformacije in negativne učinke na plod/novorojenčka.
What you need to know before you take {product name} Warnings and precautions
Kaj morate vedeti, preden boste vzeli zdravilo {ime zdravila} Opozorila in previdnostni ukrepi
Direct acting antivirals (DAAV) indicated for the treatment of hepatitis C2 - Dysglycaemia (EPITT no 19234)
Neposredno delujoča protivirusna zdravila, indicirana za zdravljenje hepatitisa C2 - disglikemija (EPITT št. 19234)
Taking {product name} at the time of becoming pregnant or during the first twelve weeks of pregnancy, may increase the risk of a type of birth defect, called neural tube defect, such as spina bifida (malformed spinal cord).
Jemanje zdravila {ime zdravila} ob zanositvi ali v prvih dvanajstih tednih nosečnosti lahko poveča tveganje za prirojeno napako, imenovano okvara nevralne cevi, kot je spina bifida (nepravilno oblikovana hrbtenjača).
As neural tube defects occur within the first 4 weeks of foetal development (at which time the neural tubes are sealed) this potential risk would concern women exposed to dolutegravir at the time of conception and in early pregnancy.
Ker pride do okvare nevralne cevi v prvih štirih tednih razvoja ploda (ko se nevralne cevi zaprejo), se to morebitno tveganje nanaša na ženske, izpostavljene dolutegravirju ob spočetju in na začetku nosečnosti.
WOCBP who are taking dolutegravir should use effective contraception throughout treatment.
Ženske v rodni dobi, ki jemljejo dolutegravir, morajo skozi celotno zdravljenje uporabljati učinkovito kontracepcijo.
However, as the mechanism by which dolutegravir may interfere in human pregnancy is unknown, the safety in use during the second and third trimester cannot be confirmed.
Ker mehanizem morebitnega negativnega učinka dolutegravirja na nosečnost ni znan, varnosti uporabe v drugem in tretjem trimesečju ni mogoče potrditi.
Hormonal contraceptives3 - Suicidality with hormonal contraceptives following a recent publication (EPITT no
Hormonski kontraceptivi3 - samomorilnost pri hormonskih kontracepcijskih sredstvih po nedavni objavi (EPITT št. 19144)
Undesirable effects Tabulated list of adverse reactions Metabolism and nutrition disorders Frequency ‘Not known'': Dyslipidaemia
Preglednica neželenih učinkov Presnovne in prehranske motnje Pogostnost „neznana“: dislipidemija
Dolutegravir was shown to cross the placenta in animals.
Dokazano je bilo, da dolutegravir pri živalih prehaja skozi placento.
Teriflunomide - Dyslipidaemia (EPITT no 19227)
Teriflunomid - dislipidemija (EPITT št. 19227)
Warnings and precautions Talk to your doctor or pharmacist before taking this medicine if you: - Have diabetes.
Kaj morate vedeti, preden boste vzeli zdravilo {ime zdravila} Opozorila in previdnostni ukrepi Pred začetkom jemanja tega zdravila se posvetujte z zdravnikom ali farmacevtom, če: - imate sladkorno bolezen.
Dolutegravir - Evaluation of preliminary data from an observational study on birth outcomes in human immunodeficiency virus (HIV)-infected women (EPITT no
Dolutegravir - ocena predhodnih podatkov iz opazovalne študije otrok, ki so jih rodile ženske, okužene z virusom humane imunske pomanjkljivosti (HIV) (EPITT št. 19244)
Glucose levels of diabetic patients initiating {direct acting antiviral / DAA} therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary.
Pri sladkornih bolnikih, ki so se začeli zdraviti z {neposredno delujočim protivirusnim zdravilom}, je treba zlasti v prvih treh mesecih skrbno spremljati ravni krvnega sladkorja ter po potrebi prilagoditi zdravilo za zdravljenje sladkorne bolezni.
What you need to know before you take {product name} Pregnancy
Kaj morate vedeti, preden boste vzeli zdravilo {ime zdravila} Nosečnost
Women of childbearing potential (WOCBP) should undergo pregnancy testing before initiation of dolutegravir.
Ženske v rodni dobi morajo pred začetkom jemanja dolutegravirja opraviti test nosečnosti.
Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like {product name}.
Nekateri sladkorni bolniki so imeli po začetku zdravljenja z zdravili, kot je zdravilo {ime zdravila}, nizke ravni sladkorja v krvi (hipoglikemija).
Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV {direct acting antiviral / DAA} treatment.
Pri sladkornih bolnikih se lahko po začetku zdravljenja okužbe s HCV z { neposredno delujočim protivirusnim zdravilom} izboljša nadzor nad sladkorjem, kar ima lahko za posledico simptomatsko hipoglikemijo.
You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting {product name}.
Po začetku jemanja zdravila {ime zdravila} morda potrebujete skrbno spremljanje ravni sladkorja v krvi in/ali prilagoditev zdravila za zdravljenje sladkorne bolezni.
Tell your doctor immediately if you become pregnant or are planning to become pregnant.
Če ste zanosili ali načrtujete zanositev, o tem takoj obvestite zdravnika.
The physician in charge of the diabetic care of the patient should be informed when {direct acting antiviral / DAA} therapy is initiated.
O začetku zdravljenja z {neposredno delujočim protivirusnim zdravilom} je treba obvestiti zdravnika, odgovornega za zdravljenje sladkorne bolezni pri zadevnem bolniku.
-> Talk to your doctor about the risks and benefits of taking {product name}.
Če ste noseči, če ste zanosili ali če načrtujete zanositev: -> se posvetujte z zdravnikom o tveganjih in koristih jemanja zdravila {ime zdravila}.
Please open here.
Prosimo, odprite tu.
Date of first authorisation: 09/10/1998 Date of latest renewal: 09/10/2008
Datum prve odobritve: 09/10/1998 Datum zadnjega podaljšanja: 09/10/2008
• Risk Management Plan (RMP) Not applicable.
• Načrt za obvladovanje tveganj (RMP) Navedba smiselno ni potrebna.
Follow your doctor's instructions carefully.
Skrbno se ravnajte po zdravnikovih navodilih.
The overall safety profiles were similar in both groups.
Splošen varnostni profil je bil približno enak v obeh skupinah.
The terminal half-life was 7.23.2 days.
Končni razpolovni čas je bil 7,2 ± 3,2 dni.
Use in heart transplantation
Uporaba pri presaditvi srca
Breastfeeding must therefore be avoided.
Zato se je treba dojenju izogibati.
Powder: 3 years
Prašek: 3 leta.
No mutagenic potential was observed in vitro.
In vitro ni bil opažen nikakršni mutageni potencial.
It is very important to tell your doctor before your transplant if you are pregnant or you think that you may be pregnant.
Zelo pomembno je, da pred presaditvijo poveste svojemu zdravniku, da ste noseči ali mislite, da bi utegnili biti noseči.
Tell your doctor if you suspect you may have had an allergic reaction to any of these ingredients in the past.
Povejte zdravniku, če se vam zdi, da ste kdaj v preteklosti imeli alergijsko reakcijo na katerokoli od teh sestavin.
Centre de Biotechnologie 8 rue de l'Industrie 68330 Huningue France
Centre de Biotechnologie 8 rue de l'Industrie 68330 Huningue Francija
Your doctor will watch out for any effects on your immune system and treat them if necessary.
Zdravnik bo pozoren na možne učinke na vaš imunski sistem in jih bo po potrebi zdravil.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Preden dobite to zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Listing of adverse reactions from post-marketing spontaneous reports
Seznam neželenih učinkov iz postmarketinških spontanih poročil
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
Ker gre za spontano sporočene neželene učinke iz populacije nedoločljive velikosti, ni vedno mogoče zanesljivo oceniti njihove pogostnosti.
- if you are pregnant or breast-feeding.
- če ste noseči ali dojite.
The volume of distribution at steady state was 8.64.1 l. The extent and degree of distribution to various body compartments have not been fully studied.
Porazdelitveni prostor v stanju ravnovesja je 8,6 ± 4,1 l. Obseg in stopnja porazdelitve v različne telesne razdelke nista popolnoma proučena.
Simulect can be given to children and adolescents.
Zdravilo Simulect lahko dobijo otroci in mladostniki.
Infusion sets - Luer Lock, H. Noolens - Sterile vented i.v.
Infuzijski kompleti - Luer Lock, H. Noolens - Sterile vented i.v.
Simulect is given to stop your body from rejecting the new organ during the first 4 to 6 weeks after the transplant operation, when rejection is most likely.
Zdravilo Simulect boste dobili zato, da vašemu telesu prepreči zavrnitev novega organa v prvih 4 do 6 tednih po presaditveni operaciji, ko je zavrnitev najverjetnejša.
Total body clearance was 4119 ml/h.
Celotni telesni očistek je bil 41 ± 19 ml/h.
Children and adolescents (1-17 years)
Otroci in mladostniki (1-17 let)
The dose for children who weigh less than 35 kg will be smaller than the dose usually given to adults.
Odmerek za otroke, ki tehtajo manj od 35 kg, bo manjši kot odmerek, ki ga navadno prejmejo odrasli.
Your doctor will check this for you and discuss with you the possibility of repeated treatment with Simulect.
Zdravnik bo to preveril za vas in se pogovoril z vami o možnosti ponovnega zdravljenja z zdravilom Simulect.
Simulect may harm your baby.
Zdravilo Simulect lahko škoduje vašemu otroku.
As concentrations fall below this level, expression of the CD25 antigen returns to pretherapy values within 1-2 weeks.
Ko se koncentracije zmanjšajo pod to vrednost, se izraženost antigena CD25 v 1 do 2 tednih vrne na vrednosti pred zdravljenjem.
There is accumulating evidence that a subgroup of patients is at an increased risk of developing hypersensitivity reactions.
Nabirajo se dokazi, da je pri eni od podskupin bolnikov zvečano tveganje razvoja preobčutljivostnih reakcij.
Compatibility with a number of infusion sets has been verified.
Preverjena je združljivost z več infuzijskimi seti.
Clinical studies
Klinične raziskave
Extension studies also showed that patients who experienced an acute rejection episode during the first year after transplantation experienced more graft losses and deaths over the five-year follow-up period than patients who had no rejection.
Podaljšani raziskavi sta tudi pokazali, da se je pri bolnikih, ki so v prvem letu po presaditvi doživeli akutno zavrnitveno reakcijo, v petletnem obdobju spremljanja pojavilo več izgub presadkov in smrti kot pri bolnikih, ki niso imeli zavrnitve.
If you become pregnant during this time, despite the use of contraceptive measures, you should tell your doctor immediately.
Če kljub uporabi kontracepcije v tem času zanosite, morate o tem nemudoma obvestiti zdravnika.
Pregnancy and lactation (see section 4.6).
Nosečnost in dojenje (glejte poglavje 4.6).
These are patients in whom, following the initial administration of Simulect, the concomitant immunosuppression was discontinued prematurely due, for example, to abandoned transplantation or early loss of the graft.
To so bolniki, pri katerih je bila po začetni uporabi zdravila Simulect spremljajoča imunosupresija prezgodaj prekinjena, na primer zaradi odpovedane presaditve ali zgodnje izgube presadka.
Women of childbearing potential must use effective contraception during and up to 16 weeks after treatment.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in do 16 tednov po njem.
Paediatric population The efficacy and safety of basiliximab were evaluated in two paediatric studies.
Pediatrična populacija Učinkovitost in varnost baziliksimaba so ocenjevali v dveh pediatričnih študijah.
Your doctor may discuss this with you before you are given Simulect.
Mogoče se bo vaš zdravnik o tem pogovoril z vami, preden boste dobili zdravilo Simulect.
Adult patients
Odrasli bolniki
Acute rejection occurred in 14.6% of patients by 6 months post-transplantation, and in 24.3% by 12 months.
Do akutne zavrnitve je prišlo v 6 mesecih po presaditvi pri 14,6 % bolnikov, v 12 mesecih po presaditvi pa pri 24,3 %.
It is given in hospital to adults, adolescents and children who are having a kidney transplant.
V bolnišnici ga prejmejo odrasli, mladostniki in otroci ob presaditvi ledvice.
If you need to have a vaccination, seek your doctor's advice first.
Če se morate cepiti, se najprej posvetujte s svojim zdravnikom.
In clinical studies basiliximab has been administered to humans in single doses of up to 60 mg and multiple doses of up to 150 mg over 24 days with no acute undesirable effects.
V kliničnih raziskavah baziliksimaba so prejele osebe v enkratnem odmerku do 60 mg in v večkratnih odmerkih do 150 mg v 24 dneh brez akutnih neželenih učinkov.
What Simulect is and what it is used for
Kaj je zdravilo Simulect in za kaj ga uporabljamo
Pharmacotherapeutic group: Interleukin inhibitors, ATC code: L04AC02.
Farmakoterapevstka skupina: zaviralci interlevkinov, oznaka ATC: L04AC02.
Patients receiving Simulect must be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources, including medications for the treatment of severe hypersensitivity reactions.
Bolniki, ki dobivajo zdravilo Simulect, se morajo zdraviti v ustanovah, ki imajo ustrezne laboratorijske in podporne medicinske kapacitete s potrebno opremo in osebjem, vključno z zdravili za zdravljenje težkih preobčutljivostnih reakcij.
Simulect can be given to older patients, but the information available is limited.
Zdravilo Simulect lahko dobijo starejši bolniki, vendar je na voljo malo podatkov.
For information on preclinical toxicology see section 5.3.
Za podatke o predklinični toksikologiji glejte poglavje 5.3.
Inactivated vaccines may be administered to immunosuppressed patients; however, response to the vaccine may depend on the degree of the immunosuppression, therefore vaccination during treatment with Simulect may be less effective.
Bolnike z zmanjšanim imunskim odzivom je mogoče cepiti z inaktiviranim cepivom, vendar je odziv na cepljenje lahko odvisen od stopnje imunosupresije, tako da je cepljenje v času zdravljenja z zdravilom Simulect lahko manj učinkovito.
Of the 202 patients, 104 were randomised to basiliximab and 98 to placebo.
Izmed 202 bolnikov so bili 104 randomizirani tako, da so prejemali baziliksimab, 98 pa jih je prejemalo placebo.
Elderly (≥ 65 years)
Starostniki (≥ 65 let)
Simulect should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation.
Zdravilo Simulect naj predpisujejo le zdravniki, ki imajo izkušnje z uporabo imunosupresivnega zdravljenja po presaditvi organov.
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika, medicinsko sestro ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Children and adolescents (aged 1 to 17 years)
Otroci in mladostniki (stari 1 do 17 let)
Older patients (aged 65 years and over)
Starejši bolniki (stari 65 let ali več)
Complete and consistent blocking of the interleukin-2 receptor is maintained as long as serum basiliximab levels exceed 0.2 g/ml (usually up to 4-6 weeks after administration).
Popolna in dosledna zavora receptorja za interlevkin 2 traja, dokler serumska koncentracija baziliksimaba presega 0,2 g/ml (običajno do 4-6 tednov po uporabi).
Neoplasms and infections
Tumorji in okužbe
What do you need to know before you are given Simulect
Kaj morate vedeti, preden boste prejeli zdravilo Simulect
Distribution volume and clearance are reduced by about 50% compared to adult renal transplantation patients.
Porazdelitveni volumen in očistek sta bila v primerjavi z odraslimi bolniki z ledvičnim presadkom manjša za okrog 50 %.
There is no animal or human data available concerning excretion of basiliximab into breast milk.
Na voljo ni nobenih podatkov, pridobljenih na živalih ali pri ljudeh, o izločanju baziliksimaba v materino mleko.
Simulect is indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients (1-17 years) (see section 4.2).
Zdravilo Simulect je indicirano za profilakso akutne zavrnitve organa pri de novo alogeni presaditvi ledvice pri odraslih in pediatričnih bolnikih (1-17 let) (glejte poglavje 4.2).
These events were not influenced by basiliximab.
Na te dogodke baziliksimab ni vplival.
Overall the adverse event profile was consistent with general clinical experience in the paediatric renal transplantation population and with the profile in the controlled adult transplantation studies.
V celoti gledano se je profil neželenih dogodkov ujemal s splošnimi kliničnimi izkušnjami v populaciji pediatričnih prejemnikov ledvičnih presadkov in s profilom v kontroliranih raziskavah presaditev pri odraslih.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Če uporabnik zdravila, pripravljenega za uporabo, ne uporabi takoj, je za čas in pogoje shranjevanja odgovoren sam.
FOLDING BOX FOR 1 VIAL AND 1 AMPOULE AS UNIT PACK
ŠKATLA ZA 1 VIALO IN 1 AMPULO KOT ENOTA PAKIRANJA
Talk to your doctor, nurse or pharmacist before you are given Simulect: - if you have previously received a transplant that failed after only a short time or, - if you have previously been in the operating theatre for a transplantation that in the end was not performed.
Preden dobite zdravilo Simulect, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom: - če ste kdaj prej prejeli presadek, ki se je že čez kratek čas pokazal za neuspešnega, ali, - če ste bili kdaj prej že v operacijski dvorani zaradi presaditve, ki na koncu ni bila opravljena.
In this situation, you may have received Simulect.
Možno je, da ste v takem primeru prejeli zdravilo Simulect.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPLY AND USE
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
The relationship between serum concentration and receptor saturation was assessed in 13 patients and was similar to that characterised in adult renal transplantation patients.
Razmerje med serumsko koncentracijo in nasičenostjo receptorjev je bilo ocenjeno pri 13 bolnikih in je bilo podobno kot pri odraslih bolnikih po presaditvi ledvice.
What Simulect is and what it is used for What do you need to know before you are given Simulect How Simulect is given
Kaj je zdravilo Simulect in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Simulect Kako boste prejeli zdravilo Simulect Možni neželeni učinki
Disposition parameters were not influenced to a clinically relevant extent by age (1-11 years), body weight (9-37 kg) or body surface area (0.44-1.20 m
V tej starostni skupini niso na kazalce porazdelitve v klinično pomembnem obsegu vplivali starost (1-11 let), telesna teža (9-37 kg) ali telesna površina (0,44-1,20 m
Severe acute (less than 24 hours) hypersensitivity reactions have been observed both on initial exposure to Simulect and on re-exposure to a subsequent course of therapy.
Hude akutne preobčutljivostne reakcije (v manj kot 24 urah) so opažali tako pri prvi izpostavljenosti zdravilu Simulect kot pri ponovni izpostavljenosti ob kasnejši ponovitvi zdravljenja.
Safety data in paediatric patients have been obtained from one open-label pharmacokinetic and pharmacodynamic study in renal transplant recipients (41 patients).
Podatki o varnosti za pediatrične bolnike so bili pridobljeni iz ene odprte farmakokinetične in farmakodinamske raziskave na prejemnikih ledvičnih presadkov (41 bolnikov).
Other medicines and Simulect
Druga zdravila in zdravilo Simulect
No clinically relevant influence of body weight or gender on distribution volume or clearance has been observed in adult patients.
Pri odraslih bolnikih ni bil opažen klinično pomemben vpliv telesne teže ali spola na porazdelitveni volumen ali na očistek.
It is recommended that after reconstitution the colourless, clear to opalescent solution should be used immediately.
Priporočljivo je, da se brezbarvna, bistra do opalescenčna raztopina uporabi takoj po pripravi.
Simulect should be administered under qualified medical supervision.
Zdravilo Simulect naj se uporablja pod strokovnim medicinskim nadzorom.
Immunosuppressive regimens involving combinations of medications increase the susceptibility to infection, including opportunistic infections, fatal infections and sepsis; the risk increased with total immunosuppressive load.
Imunosupresivne sheme, ki vključujejo kombinacije zdravil, povečujejo dovzetnost za okužbe, vključno z oportunističnimi okužbami, s smrtnimi okužbami in sepso, pri čemer je tveganje večje pri večji imunosupresivni obremenitvi.
The incidence was 2/138 in patients not exposed to muromonab-CD3 (OKT3) and 4/34 in patients who received muromonab-CD3 concomitantly.
Incidenca je bila 2/138 pri bolnikih, ki niso bili izpostavljeni muromonabu-CD3 (OKT3), in 4/34 pri bolnikih, ki so sočasno dobili muromonab-CD3.
You must use adequate contraception to prevent pregnancy during treatment and up to 4 months after receiving the last dose of Simulect.
Za preprečevanje nosečnosti morate uporabljati ustrezno kontracepcijo v času zdravljenja in še 4 mesece po zadnjem odmerku zdravila Simulect.
Incidence of infectious episodes: The overall incidence and profile of viral, bacterial and fungal infections among patients treated with basiliximab or placebo in combination with dual and triple immunosuppressive therapy was comparable between the groups.
Incidenca okužb: Celotna incidenca in profil virusnih, bakterijskih in glivičnih okužb pri bolnikih, ki so bili zdravljeni z baziliksimabom ali s placebom v kombinaciji z dvotirnim ali tritirnim imunosupresivnim zdravljenjem, je bila primerljiva med obema skupinama.
Immunosuppressants reduce the body's response to anything that it sees as “foreign” - which includes transplanted organs.
Zdravila za zaviranje imunske odzivnosti zmanjšajo odgovor organizma na snovi, ki jih telo spozna za ”tujek” - to so med drugim tudi presajeni organi.
2.5 ml of the sterile water is used to dissolve the powder before it is given to you.
2,5 ml sterilne vode se uporabi, da se pred uporabo raztopi prašek.
However, based on the IgG1 nature of basiliximab, excretion into milk should be expected.
Ker pa je baziliksimab IgG1, lahko pričakujemo njegovo izločanje v mleko.
You will be given other medicines to help protect your new kidney during this time, such as ciclosporin and corticosteroids and after you leave hospital.
Prejeli boste še druga zdravila, kot so ciklosporin in kortikosteroidi, ki bodo pomagala obvarovati vašo novo ledvico v tem časovnem obdobju in tudi po zapustitvi bolnišnice.
Simulect belongs to a group of medicines called immunosuppressants.
Simulect spada v vrsto zdravil, ki se imenujejo zdravila za zaviranje imunske odzivnosti (imunosupresivi).
The incidence of acute rejection episode was substantially lower in patients receiving basiliximab and a triple drug immunosuppressive regimen.
Pogostost akutnih zavrnitvenih reakcij je bila bistveno manjša pri bolnikih, ki so dobivali baziliksimab in imunosupresivno shemo treh zdravil.
There are limited data available on the use of Simulect in the elderly, but there is no evidence that elderly patients require a different dosage from younger adult patients.
Glede zdravljenja starejših z zdravilom Simulect je na voljo malo podatkov, vendar ni dokazov, ki bi narekovali pri starejših bolnikih drugačne odmerke kot pri mlajših odraslih bolnikih.
The incidence of CMV infections was similar in both groups (14.6% vs. 17.3%), following either dual or triple therapy regimen (see section 4.4).
Incidenca okužb s citomegalovirusom (CMV) je bila podobna v obeh skupinah (14,6 % v primerjavi s 17,3 %) tako po dvotirnem kot po tritirnem zdravljenju (glejte poglavje 4.4).