natgillin/translations-raw huggingface dataset:
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja izpuščaj urtikarija pogosti pogosti
Discard the needle and empty vials per local requirements.
Injekcijsko iglo in prazne viale odstranite v skladu z lokalnimi zahtevami.
Periodically inspect the infusion system during the infusion for signs of leakage or delivery failure.
Med infundiranjem redno preverjajte, ali kaže infuzijski sistem znake puščanja ali odpovedi dovajanja.
Common side effects: pain rash hives head dropping (so that the chin drops towards the chest) stomach pain leakage of the device mouth or tongue blisters swelling or redness of the eyelid and the white part of the eye feeling nervous disorder of the stomach or intestines
bolečina v trebuhu puščanje pripomočka mehurčki v ustih ali na jeziku oteklina ali rdečina očesne veke in beločnice občutek živčnosti bolezni trebuha ali prebavil
Remove the green flip-off caps from both Brineura vials.
Z obeh vial zdravila Brineura odstranite zeleno dvižno zaporko.
Intracerebroventricular access device-related infections, including sub-clinical infections and meningitis, have been observed in patients treated with Brineura.
Pri bolnikih, zdravljenih z zdravilom Brineura, so opazili okužbe, povezane s pripomočkom za intracerebroventrikularni dostop, vključno s subkliničnimi okužbami in meningitisom.
Solution for infusion.
raztopina za infundiranje
Place the syringe containing the flushing solution into the syringe pump and program the pump to deliver an infusion rate of 2.5 ml per hour.
Injekcijsko brizgo z raztopino za izpiranje vstavite v črpalko za injekcijsko brizgo in črpalko programirajte tako, da bo dovajala s hitrostjo infundiranja 2,5 ml na uro.
CE marked intracerebroventricular access devices, and disposable components listed below or equivalent should be used to deliver Brineura.
Za dovajanje zdravila Brineura je treba uporabiti pripomočke za intracerebroventrikularni dostop z oznako CE in spodaj naštete komponente za enkratno uporabo ali enakovredne.
Healthcare professionals should be aware of the possible symptoms of anaphylaxis such as: generalized hives, pruritus or flushing, swollen lips, tongue, and/or uvula, dyspnoea, bronchospasm, stridor, hypoxemia, hypotonia, syncope, or incontinence.
generalizirana koprivnica, pruritus ali pordevanje, otekle ustnice, jezik in/ali uvula, dispneja, bronhospazem, stridor, hipoksemija, hipotonija, sinkopa ali inkontinenca.
There were no patients with advanced disease progression at treatment initiation who were included in clinical trials and no clinical data is available in children < 2 years.
Pediatrična populacija Bolnikov z napredovalo obliko bolezni ob začetku zdravljenja niso vključili v klinična preskušanja,
Initiate infusion of Brineura at a rate of 2.5 ml per hour.
Z infundiranjem zdravila Brineura začnite s hitrostjo 2,5 ml na uro.
The MAH shall ensure that in each MS where BRINEURA is marketed, all HCPs who are expected to handle / administer the product are provided with an educational programme (i.e. a dosing and administration guide), aiming at preventing and/or minimising the important identified risk of Device issues (infection/blockage/dislocation), containing information about: - How to store BRINEURA; - The device-related complications (i.e. infections, device's leakage and/or failure; the integrity of the device should be confirmed by a neurosurgeon); - How to prepare BRINEURA and the flushing solution; - A detailed step-by step description of BRINEURA intra-cerebro-ventricular infusion and the administration of the flushing solution (provided after BRINEURA infusion is complete) - How to monitor the patients receiving BRINEURA.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo BRINEURA trži, vsi zdravstveni delavci, za katere se pričakuje, da bodo z zdravilom rokovali ali ga dajali, prejeli izobraževalno gradivo (tj. vodnik za odmerjanje in dajanje zdravila), ki je namenjeno preprečevanju in/ali zmanjševanju pomembnega ugotovljenega tveganja glede težav s pripomočkom (okužba/zapora/premik), in vsebuje naslednje informacije:
p-valueb
vrednost pb
Brineura and flushing solution should be clear to slightly opalescent and colourless to pale yellow.
Zdravilo Brineura in raztopina za izpiranje morata biti bistra do nekoliko opalescentna in brezbarvna do bledorumena.
Brineura and flushing solution Sodium phosphate dibasic heptahydrate Sodium dihydrogen phosphate monohydrate Sodium chloride
Zdravilo Brineura in raztopina za izpiranje dvobazni natrijev fosfat heptahidrat natrijev dihidrogenfosfat monohidrat natrijev klorid kalijev klorid magnezijev klorid heksahidrat kalcijev klorid dihidrat voda za injekcije
Your doctor may adjust you or your child's dose or the amount of time the medicine is given if the infusion is not tolerated, there is an allergic reaction or there is a possible increase of pressure in the brain.
Zdravnik lahko ob neprenašanju infuzije, alergijski reakciji ali možnem povečanju tlaka v možganih prilagodi vaš ali otrokov odmerek ali čas dajanja zdravila.
It is not known if Brineura impacts human fertility.
Ni znano, ali zdravilo Brineura vpliva na sposobnost razmnoževanja pri ljudeh.
Thawed Brineura and flushing solution should be used immediately.
2 leti Odtaljeno zdravilo Brineura in raztopino za izpiranje je treba uporabiti takoj.
Not known (frequency cannot be estimated based on available data) device is displaced and does not function correctly when preparing for infusion inflammation of the brain due to device-related infection
pripomoček se je premaknil in med pripravo na infundiranje ni deloval pravilno vnetje možganov zaradi okužb, povezanih s pripomočkom
Device-related complications
Zapleti, povezani s pripomočkom
Withdraw flushing solution
Izvlek raztopine za izpiranje
Apply gentle pressure and bandage the infusion site per institution standard of care.
Z nežnim pritiskom povijte mesto v skladu s standardom nege, uveljavljenim v ustanovi.
Remove the port needle.
Odstranite iglo za pristopno odprtino.
Animal reproduction studies have not been conducted using Brineura.
Študij o vplivu zdravila Brineura na sposobnost razmnoževanja pri živalih niso izvedli.
Each vial of Brineura contains 150 mg of cerliponase alfa* in 5 ml of solution.
Ena viala zdravila Brineura vsebuje 150 mg cerliponaze alfa* v 5 ml raztopine.
Rating
Ocenjevanje
Withdraw Brineura
Izvlek zdravila Brineura
The most frequent (>20%) adverse reactions observed during Brineura clinical trials include pyrexia, low CSF protein, ECG abnormalities, vomiting, upper respiratory tract infections, and hypersensitivity.
zmanjšano vrednost beljakovin v CSL, nenormalnosti na EKG, bruhanje, okužbe zgornjih dihal in preobčutljivost.
Table 5: Pharmacokinetic properties following first Intracerebroventricular infusion (approximately 4 hours in duration) of 300 mg cerliponase alfa in CSF
Preglednica 5: Farmakokinetične lastnosti po prvem intracerebroventrikularnem infundiranju
How to store Brineura
Kako se daje zdravilo Brineura
Thaw Brineura and flushing solution
Odtajanje zdravila Brineura in raztopine za izpiranje
Brineura and the flushing solution are solutions for infusion.
Zdravilo Brineura in raztopina za izpiranje sta raztopini za infundiranje.
Verify that the “Brineura” syringe in the syringe pump is empty after the infusion is complete.
Ko je infundiranje zaključeno, se prepričajte, da je injekcijska brizga z zdravilom Brineura v črpalki za injekcijsko brizgo prazna.
Very common side effects (may affect more than 1 in 10 people): fever vomiting feeling irritable convulsions (seizures) reactions during or shortly after being given the medicine, such as hives, itching or flushing, swollen lips, tongue and/or throat, shortness of breath, hoarseness, turning blue around finger tips or lips, low muscle tone, fainting or incontinence
reakcije med dajanjem zdravila ali tik po tem, kot so koprivnica, srbenje ali pordevanje, otekle ustnice, jezik in/ali žrelo, zasoplost, hripavost, pomodrenje okoli konic prstov ali ustnic, slab mišični tonus, omedlevanje ali inkontinenca
Initiate infusion of the flushing solution at a rate of 2.5 ml per hour.
Z infundiranjem raztopine za izpiranje začnite s hitrostjo 2,5 ml na uro.
Talk to your doctor or nurse immediately if you experience any of the following:
Takoj se posvetujte z zdravnikom ali medicinsko sestro, če imate kaj od naslednjega: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):
Cardiac disorders
Srčne bolezni bradikardija pogosti
Figure 2: CLN2 Score Mean Change from Baseline (Natural History Control Group vs Brineura treated patients, 300 mg every other week)
(kontrolna skupina z naravnim potekom v primerjavi z bolniki, zdravljenimi z zdravilom Brineura, 300 mg vsak drugi teden)
Potassium chloride
Vzorce CSL
Verify that the “flushing solution” syringe in the syringe pump is empty after the infusion is complete.
Ko je infundiranje zaključeno, se prepričajte, da je injekcijska brizga z raztopino za izpiranje v črpalki za injekcijsko brizgo prazna.
Brineura and flushing solution vials should be thawed prior to administration.
Viale z zdravilom Brineura in raztopino za izpiranje je treba pred dajanjem odtajati.
3 Grossly normal gait.
Večinoma normalna hoja.
Preparation for administration of Brineura and flushing solution
Priprava na dajanje zdravila Brineura in raztopine za izpiranje
Brineura and flushing solution excipients: Sodium phosphate dibasic heptahydrate; Sodium dihydrogen phosphate monohydrate; Sodium chloride;
Pomožne snovi v zdravilu Brineura in raztopini za izpiranje: dvobazni natrijev fosfat heptahidrat natrijev dihidrogenfosfat monohidrat natrijev klorid kalijev klorid magnezijev klorid heksahidrat kalcijev klorid dihidrat voda za injekcije
Median Min, Max 95% CI Limits a Patient rate of decline per 48 weeks: (baseline CLN2 score - last CLN2 score) / (time elapsed in units of 48 weeks) b p-value based on 1-sample T-test comparing rate of decline to the value 2 c Positive estimates indicate clinical decline; negative estimates indicate clinical improvement
a Stopnja upada bolnikov v 48 tednih: (izhodiščni rezultat CLN2 - zadnji rezultat CLN2) / (pretekel čas v enotah 48 tednov)
Language
Govor
Post-authorisation efficacy study (PAES): Study 190-203.
študija 190-203.
Administer the flushing solution provided after the Brineura infusion is complete.
Intracerebroventrikularno infundiranje raztopine za izpiranje Priloženo raztopino za izpiranje uporabite po koncu infundiranja zdravila Brineura.
CSF protein increased ECG abnormalities CSF protein decreased
Preiskave zvišana vrednost beljakovin v cerebrospinalnem likvorju nenormalnosti na EKG zmanjšana vrednost beljakovin v cerebrospinalnem likvorju zelo pogosti zelo pogosti zelo pogosti
Vomiting
Dojenje
Each vial of Brineura contains 150 mg of cerliponase alfa in 5 ml of solution.
Ena viala zdravila Brineura vsebuje 150 mg cerliponaze alfa v
Rash Urticaria
OVOJNINAH VIALA
Product issues
Težave z zdravilom
Device-related infectiona Meningitis
Bolezni imunskega sistema preobčutljivost zelo pogosti
Psychiatric disorders
Količina raztopine zdravila
Administer flushing solution after Brineura.
Raztopino za izpiranje aplicirajte po zdravilu Brineura.
If anaphylaxis occurs, caution should be exercised upon re-administration.
je pri ponovni uporabi zdravila potrebna previdnost.
This is further supported by the likely common mechanism of action.
To mnenje je podprto tudi z verjetnim skupnim mehanizmom delovanja.
The exposure to these substances is respectively estimated to 565,000 patient-years, 555,470 patient-years and 66,052 patient-years worldwide.
Ocena izpostavljenosti tem zdravilom po svetu je 565 000 bolnik-let, 555 470 bolnik-let in 66 052 bolnik-let.
The RMP of all these products should be updated accordingly.
V skladu s tem je treba posodobiti RMP za vsa ta zdravila.
Further, in a number of cases, blood glucose values were only moderately increased or normal.
Poleg tega so bile v številnih primerih vrednosti glukoze v krvi le zmerno zvišane ali normalne.
A safety warning on DKA was issued by the FDA for this therapeutic class in the same month.
Isti mesec je FDA izdala varnostno opozorilo o DKA za ta terapevtski razred.
No definite conclusion could be drawn regarding dose relationship or protective or exacerbating effect of concomitant medicines.
Dokončnih zaključkov o povezavi z odmerkom ali o zaščitnih ali poslabševalnih učinkih sočasnih zdravil ni bilo mogoče podati.
The MAHs are required to submit the final study report to the EMA as they become available.
Imetniki dovoljenj za promet z zdravili morajo predložiti končno poročilo o študiji agenciji EMA, takoj ko bo na voljo.
Taking into account the severity of these cases and the general pattern seen across these medicinal products, the European Commission requested, on the 10 of June 2015 and pursuant to Article 20 of Regulation No 726/2004, the opinion of the Agency on whether the marketing authorisation of canagliflozin-, dapagliflozin- and empagliflozin-containing medicinal products, should be maintained, varied, suspended or revoked.
Z upoštevanjem resnosti teh primerov in splošnega vzorca, ki je razviden pri vseh teh zdravilih, je Evropska komisija 10. junija 2015 v skladu s členom 20 Uredbe št. 726/2004 zahtevala mnenje agencije o tem, ali naj se dovoljenja za promet z zdravili, ki vsebujejo kanagliflozin, dapagliflozin in empagliflozin, ohranijo, spremenijo, začasno umaknejo ali razveljavijo.
SGLT2 is expressed in the proximal renal tubules and is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen.
SGLT2 se izraža v proksimalnih ledvičnih tubulih in je odgovoren za večji del ponovne absorpcije filtrirane glukoze iz lumna tubulov.
Although the MAHs estimated slightly different incidence rates, these were not all calculated according to the international standards for computation of incidence rate.
Čeprav so bile ocene pojavnosti, ki so jih navedli imetniki dovoljenj za promet z zdravili, nekoliko drugačne, vse niso bile izračunane po mednarodnih standardih za izračun stopnje pojavnosti.
Those studies are expected to enable better characterisation of the risk of DKA and its mechanism and should be included in the RMP of those products.
S temi študijami naj bi bolje opredelili tveganje za DKA in njen mehanizem, kar je treba vključiti tudi v RMP za ta zdravila.
In addition treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses.
Poleg tega je treba pri bolnikih, ki so hospitalizirani zaradi večjih kirurških posegov ali hude akutne bolezni, zdravljenje prekiniti.
In the EU, three SGLT2 inhibitors are currently authorised as monocomponent and as fixed dose combination with metformin: canagliflozin (Invokana and Vokanamet), dapagliflozin (Forxiga and Xigduo) and empagliflozin (Jardiance and Synjardy).
V EU so trenutno odobreni trije zaviralci SGLT2 v monokomponentni obliki in v kombinaciji z metforminom s fiksnim odmerkom: kanagliflozin (zdravili Invokana in Vokanamet), dapagliflozin (zdravili Forxiga in Xigduo) in empagliflozin (zdravili Jardiance in Synjardy).
Overall the reported cases were poorly documented and the MAHs are requested to implement targeted follow up questionnaires, in order to document consistent information on the cases.
Na splošno so bili primeri, o katerih so poročali, slabo dokumentirani, zato morajo imetniki dovoljenj za promet z zdravili uvesti ciljno usmerjene vprašalnike za spremljanje, s katerimi bodo dosledno dokumentirali informacije o primerih.
Diabetic ketoacidosis (DKA) is a serious, often life-threatening condition, which usually develops in diabetic patients when insulin levels are too low.
Diabetična ketoacidoza (DKA) je resno, pogosto življenjsko nevarno stanje, ki se običajno pojavi pri bolnikih s sladkorno boleznijo, kadar je raven insulina prenizka.
A search in Eudravigilance (EV) database was performed by the EMA on 19 May 2015 for the three SGLT2 inhibitors.
Agencija EMA je 19. maja 2015 za omenjene tri zaviralce SGLT2 opravila iskanje v podatkovni bazi Eudravigilance (EV).
Ketone bodies have a low pKa and therefore their accumulation in the blood lead to acidosis.
Ketonska telesa imajo nizko vrednost pKa, zato njihovo kopičenje v krvi povzroča acidozo.
• The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for SGLT2 inhibitors-containing medicinal products.
• odbor PRAC je obravnaval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004, ki je bil na podlagi farmakovigilančnih podatkov sprožen za zdravila, ki vsebujejo zaviralce SGLT2.
In view of the above, the PRAC considered that the benefit-risk balance of Forxiga, XigDuo, Invokana, Vokanamet, Jardiance and Synjardy remains favourable subject to the agreed amendments to the product information.
Glede na zgoraj navedeno je odbor PRAC menil, da je razmerje med tveganji in koristmi zdravil Forxiga, XigDuo, Invokana, Vokanamet, Jardiance in Synjardi še naprej ugodno, pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu.
By blocking the action of SGLT2, these substances cause more glucose to be removed via the urine, thereby reducing the levels of glucose in the blood via an insulinindependent mechanism.
Te snovi z zaviranjem delovanja SGLT2 povzročijo večje izločanje glukoze z urinom, s čimer se znižajo ravni glukoze v krvi s pomočjo mehanizma, ki je neodvisen od insulina.
Based on the data available, the PRAC considered that there was no indication of a different risk between the products.
Na podlagi razpoložljivih podatkov je odbor PRAC menil, da se zdravila med seboj ne razlikujejo po tveganju.
Moreover, risk factors reported in the cases are consistent with those previously reported in the literature and the risks factors inherent to the patient population (e.g. patients with low beta-cell function reserve, restricted food intake or severe dehydration, sudden reduction in insulin dose and increased insulin requirements due to acute medical illness, surgery or alcohol abuse).
Dejavniki tveganja, o katerih poročajo v teh primerih, so skladni z dejavniki, o katerih so poročali že v literaturi, in dejavniki tveganja, povezanimi z določenimi populacijami bolnikov (npr. bolniki z majhno rezervo delovanja celic beta, omejenim vnosom hrane ali hudo dehidracijo, nenadnim zmanjšanjem odmerka insulina in povečanimi potrebami po insulinu zaradi akutne bolezni, kirurškega posega ali čezmernega uživanja alkohola).
The glucose is partially excreted via the urine, leading to polyuria, dehydration, and compensatory thirst and polydipsia.
Glukoza se delno izloča z urinom, kar povzroča poliurijo, dehidracijo, kompenzacijsko žejo in kompenzacijsko polidipsijo.
In a study that reported population-based rates of DKA, the incidence rate of DKA in T2DM patients, requiring hospital admission, was reported to be 0.5 per 1,000 patient-years.
V študiji, kjer so poročali o populacijski pojavnosti DKA, je bila pojavnost DKA pri bolnikih s sladkorno boleznijo tipa 2, ki so potrebovali hospitalizacijo, 0,5 na 1 000 bolnik-let.
In addition, the low levels of insulin along with a rise in plasma glucagon levels lead to the release of glucose by the liver.
Poleg tega nizke ravni insulina in dvig ravni glukagona v plazmi povzročajo sproščanje glukoze iz jeter.
In order to minimise this risk, the PRAC considered that physicians and patients should be warned through the PI to consider the risk of atypical DKA in the occurrence of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Da bi to tveganje čim bolj zmanjšali, je odbor PRAC menil, da je treba zdravnike in bolnike v informacijah o zdravilu opozoriti na upoštevanje tveganja za atipično DKA pri pojavu nespecifičnih simptomov, kot so navzeja, bruhanje, anoreksija, bolečine v trebuhu, čezmerna žeja, težave z dihanjem, zmedenost, neobičajna utrujenost ali zaspanost.
DKA most commonly occurs in patients with type 1 diabetes mellitus (T1DM) and is usually accompanied by high blood glucose levels (>250 mg/dL).
DKA se najpogosteje pojavlja pri bolnikih s sladkorno boleznijo tipa 1, po navadi pa jo spremljajo zvišane ravni glukoze v krvi (> 250 mg/dl).
DKA cases were reported in all three SGLT2 currently authorised in the EU, suggestive of a class effect.
O primerih DKA so poročali pri vseh treh zaviralcih SGLT2, ki so trenutno odobreni v EU, kar kaže na učinek razreda zdravil.
In absence of insulin the metabolism switches from using glycogenolysis to lipolysis as a source of energy, which produces ketone bodies.
V odsotnosti insulina presnova preklopi z glikogenolize na lipolizo kot vir energije, pri čemer nastajajo ketonska telesa.
In addition, a DUS, ideally based on secondary observational data via existing databases, is also required to be undertaken by the MAH of canagliflozin-containing products.
Poleg tega morajo študijo o uporabi zdravila, v idealnem primeru na podlagi sekundarnih podatkov opazovanj iz obstoječih podatkovnih baz, izvesti tudi imetniki dovoljenj za promet z zdravili, ki vsebujejo kanagliflozin.
Sodium-glucose co-transporter 2 (SGLT2) inhibitors are used together with diet and exercise in patients with type 2 diabetes, either alone or in combination with other diabetes medicines.
Zaviralci natrijevih glukoznih koprenašalcev 2 (SGLT2) se uporabljajo poleg diete in telesne vadbe pri bolnikih s sladkorno boleznijo tipa 2, bodisi samostojno bodisi v kombinaciji z drugimi zdravili za sladkorno bolezen.
• The PRAC therefore, was of the view that the risk of DKA should be minimised by its inclusion in the product information with a warning highlighting to healthcare professional and patients the possible atypical presentation of DKA to be considered in the occurrence of non-specific symptoms, together with the risk factors, and recommendations regarding treatment discontinuation.
• Zato je odbor PRAC menil, da je treba tveganje za DKA čim bolj zmanjšati in ga vključiti v informacije o zdravilu, z opozorilom, naj zdravstveni delavci in bolniki upoštevajo morebitno atipično sliko DKA pri pojavu nespecifičnih simptomov, skupaj z dejavniki tveganja in priporočili za prekinitev zdravljenja.
Planned and ongoing Drug Utilisation Studies (DUS) for dapagliflozin- and empagliflozincontaining products are expected to generate more information on the extent and nature of the offlabel use.
Pričakuje se, da bodo načrtovane in potekajoče študije o uporabi zdravil (DUS) za zdravila, ki vsebujejo dapagliflozin in empagliflozin, zagotovile več informacij o obsegu in naravi uporabe, ki ni v skladu z odobrenimi indikacijami.
Considering the above, the PRAC was of the view that DKA should be included in the product information of all SGLT2 inhibitors with the frequency rare.
Z upoštevanjem zgoraj navedenega je odbor PRAC menil, da je treba DKA vključiti v informacije o zdravilu za vse zaviralce SGLT2 s pogostnostjo „redko".
In a number of these reports, the presentation of the condition was atypical with only moderately increased blood glucose levels observed.
Pri številnih od teh poročil se je stanje kazalo z atipično sliko, z le zmerno povišanimi ravnmi glukoze v krvi.
The relatively long time-to-onset observed in clinical trials is suggestive of contributing factors triggering the development of DKA.
Sorazmerno dolg čas do pojava, ki so ga opazili v kliničnih preskušanjih, kaže, da k sprožitvi razvoja DKA prispevajo tudi drugi dejavniki.
Moreover, the MAHs should explore the feasibility of collecting plasma hormones in new or ongoing trials with the aim to identify patterns of hormone derangement that could further explain the mechanism of action of SGLT2 inhibitors in ketoacidosis.
Imetniki dovoljenj za promet z zdravili morajo v novih ali potekajočih preskušanjih tudi proučiti možnost odvzema plazemskih hormonov, da bi s tem določili vzorce hormonskih motenj, ki bi lahko nadalje pojasnili mehanizem delovanja zaviralcev SGLT2 pri ketoacidozi.