natgillin/translations-raw huggingface dataset:
It is therefore recommended that the marketing authorisation is suspended, and the product reformulated with a level of magnesium which is justified based on the most recent knowledge in the area.
Priporočil je, da se dovoljenje za promet z zdravilom začasno umakne, zdravilo pa reformulira z ravnijo magnezija, ki je upravičena na podlagi najsodobnejšega znanja na strokovnem področju.
Overall summary of the scientific evaluation of Numeta G13%E and Numeta G16%E by PRAC
Splošni povzetek znanstvenega vrednotenja zdravil Numeta G13%E in Numeta G16%E, ki ga je opravil odbor PRAC
Neonatal hypermagnesemia can also be caused by increased magnesium load such as with maternal magnesium sulphate administration for preeclampsia, newborn magnesium therapy, or decreased renal magnesium excretion due to prematurity and asphyxia (Hyun et al, 2011).
Hipermagneziemijo pri novorojenčkih lahko povzroči tudi povečano breme magnezija, kot je uporaba magnezijevega sulfata pri materi za zdravljenje preeklampsije, zdravljenje novorojenčka z magnezijem ali zmanjšano izločanje magnezija iz ledvic zaradi nedonošenosti ter asfiksije (Hyun in sod., 2011).
• The PRAC is of the opinion that there is a potential risk for hypermagnesaemia when Numeta G16%E is administered to term newborn infants and children up to two years, particularly in patients with reduced renal function, and newborn infants of mothers who were receiving supplemental magnesium prior to delivery;
• odbor PRAC je menil, da obstaja morebitno tveganje hipermagneziemije, kadar se zdravilo Numeta G16%E uporablja pri donošenčkih in otrocih, starih do dveh let, predvsem pri bolnikih s poslabšanim ledvičnim delovanjem, ter pri novorojenčkih mater, ki so pred porodom prejemale nadomestke magnezija;
Parenteral nutrition is essential in certain situations, and there are various methods available for preparation and delivery.
Na voljo so različne metode priprave ter dovajanja.
Based on the currently available information, the benefit-risk balance of Numeta G16%E is considered to remain favourable subject to the warnings, additional pharmacovigilance activities and additional risk minimisation measures agreed.
Na podlagi trenutno razpoložljivih podatkov menijo, da je razmerje med tveganji in koristmi zdravila Numeta G16%E še vedno ugodno, če se upoštevajo opozorila in uvedejo dogovorjene dodatne farmakovigilančne dejavnosti ter ukrepi za zmanjševanje tveganja.
Therefore, following the provisions under Article 107j(3) of Directive 2001/83/EC, the PRAC recommends the suspension of the marketing authorisations for Numeta G13%E.
Zato je v skladu z določbami člena 107j(3) Direktive 2001/83/ES priporočil začasen umik dovoljenj za promet z zdravilom Numeta G13%E.
• The PRAC considered the role of magnesium in the development of pre-term newborn infants and reviewed all available data on the risk of hypermagnesemia in this population, the available clinical guidelines on parenteral magnesium intake in preterm newborn infants and the content of magnesium in the current formulation of Numeta G13%E;
• odbor PRAC je upošteval vlogo magnezija pri razvoju nedonošenčkov in pregledal vse razpoložljive podatke o tveganju hipermagneziemije pri tej populaciji, razpoložljive klinične smernice o parenteralnem vnosu magnezija pri nedonošenčkih ter vsebnost magnezija v trenutni formulaciji zdravila Numeta G13%E;
• The PRAC considered the role of magnesium in the development of term newborn infants and children up to two years, all available guidance providing recommendation for parenteral magnesium intake in newborn infants and in children up to two years, and the content of magnesium in the current formulation of Numeta G16%E;
• odbor PRAC je upošteval vlogo magnezija pri razvoju donošenčkov in otrok, starih do dveh let, vse razpoložljive smernice o parenteralnem vnosu magnezija pri novorojenčkih ter otrocih, starih do dveh let, in vsebnost magnezija v trenutni formulaciji zdravila Numeta G16%E;
Therefore, the benefit-risk balance for Numeta G13%E as currently formulated is considered as not favourable.
Zato je ocenil, da razmerje med tveganji in koristmi zdravila Numeta G13%E v trenutni formulaciji ni ugodno.
The MAH should submit the protocol for the above mentioned study within the revised RMP submission.
Imetnik dovoljenja za promet z zdravilom mora protokol za zgoraj navedeno študijo predložiti skupaj s posodobljenim načrtom obvladovanja tveganja.
• The PRAC reviewed all available data from clinical studies, published literature, post-marketing experience on the safety and efficacy of Numeta G16%E in particular with regards to the risk of hypermagnesemia, as well as the stakeholder's submission and the PDCO advice;
• odbor PRAC je pregledal vse razpoložljive podatke iz kliničnih študij, objavljene literature, izkušenj iz obdobja trženja glede varnosti in učinkovitosti zdravila Numeta G16%E, predvsem v povezavi s tveganjem hipermagneziemije, ter prošnjo zainteresirane strani in nasvet odbora PDCO;
• The PRAC considered the procedure under Article 107i of Directive 2001/83/EC for Numeta G16%E;
• odbor PRAC je obravnaval postopek v skladu s členom 107i Direktive 2001/83/ES za zdravilo Numeta G16%E;
Having considered the overall submitted data provided by the MAH in writing, the stakeholder's submission and the PDCO advice, the PRAC concluded that the benefit-risk balance of Numeta G13%E for parenteral nutrition in preterm newborn infants when oral or enteral nutrition is not possible, insufficient or contraindicated is no longer favourable.
Na podlagi vseh podatkov, ki jih je v pisni obliki predložil imetnik dovoljenja za promet z zdravilom, prošnje zainteresirane strani in nasveta odbora PDCO je odbor PRAC sklenil, da razmerje med tveganji in koristmi zdravila Numeta G13%E za parenteralno prehranjevanje nedonošenčkov, kadar je peroralna ali enteralna prehrana nemogoča, nezadostna ali kontraindicirana, ni več ugodno.
For the suspension of the marketing authorisation to be lifted, the MAH should reformulate the product, to include a level of magnesium which is justified based on the most recent knowledge in the area.
Za preklic začasnega umika dovoljenja za promet z zdravilom mora imetnik dovoljenja za promet z zdravilom reformulirati zdravilo tako, da bo vsebovalo raven magnezija, ki temelji na najnovejšem znanju na strokovnem področju.
• The PRAC reviewed all available data from clinical studies, published literature, post-marketing experience on the safety and efficacy of Numeta G13%E in particular with regards to the risk of hypermagnesemia, as well as the stakeholder's submission and the PDCO advice;
• odbor PRAC je pregledal vse razpoložljive podatke iz kliničnih študij, objavljene literature, izkušenj iz obdobja trženja glede varnosti in učinkovitosti zdravila Numeta G13%E, predvsem v povezavi s tveganjem hipermagneziemije, ter prošnjo zainteresirane strani in nasvet odbora PDCO;
• The PRAC concluded that there is a risk for hypermagnesaemia when Numeta G13%E is administered to preterm newborn infants.
• odbor PRAC je zaključil, da je tveganje hipermagneziemije prisotno, kadar se zdravilo Numeta G13%E uporablja pri nedonošenčkih.
• The PRAC concluded that in view of the currently available safety data in order to maintain a favourable benefit-risk as parenteral nutrition in term newborn infants and children up to 2 years when oral or enteral nutrition is not possible, insufficient or contraindicated, additional warnings on the risk of hypermagnesemia should be introduced in the Product Information;
• odbor PRAC je na podlagi trenutno razpoložljivih varnostnih podatkov sklenil, da je treba za vzdrževanje ugodnega razmerja med tveganji in koristmi zdravila za parenteralno prehrano pri donošenčkih in otrocih, starih do dveh let, kadar je peroralna ali enteralna prehrana nemogoča, nezadostna ali kontraindicirana, v informacije o zdravilu vključiti dodatna opozorila o tveganju hipermagneziemije.
• The PRAC considered the procedure under Article 107i of Directive 2001/83/EC for Numeta G13%E;
• odbor PRAC je obravnaval postopek v skladu s členom 107i Direktive 2001/83/ES za zdravilo Numeta G13%E;
In order to facilitate its implementation at national level, the CMDh considered that clarification on the supervision of the appropriate procedure for the fulfilment of the condition to lift the suspension of Numeta G13%E should be provided and therefore the following was added to Annex III:
Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom Numeta G13%E so določeni v Prilogi III. Za uvedbo začasnega umika na nacionalni ravni je skupina CMDh menila, da je treba pripraviti pojasnitev za nadzorovanje ustreznega postopka za izpolnjevanje pogojev za preklic začasnega umika dovoljenj za promet z zdravilom Numeta G13%E, zato so Prilogi III dodali naslednje:
the first few months after birth and the immature kidney has limited adaptability in case of excess administrations of electrolytes, monitoring of serum magnesium levels should mitigate the potential risk, with initial monitoring at baseline and frequency of follow-up monitoring determined by the clinical circumstances and routine clinical practice.
Čeprav je glomerularna nezrelost v prvih nekaj mesecih po rojstvu še vedno prisotna in je prilagodljivost nezrelih ledvic ob čezmernem vnosu elektrolitov omejena, bo spremljanje ravni magnezija v serumu zmanjšalo morebitno tveganje - prvo spremljanje ob
A new safety concern with Numeta G13%E was identified based on a signal raised by the marketing authorisation holder (MAH) following receipt of case reports of hypermagnesaemia in preterm neonates.
Pri zdravilu Numeta G13%E so odkrili novo varnostno težavo, ki jo je po prejemu poročil o primerih hipermagneziemije pri nedonošenčkih izpostavil imetnik dovoljenja za promet z zdravilom.
• The PRAC also concluded that a prospective non-interventional post-authorisation safety study should be conducted to further evaluate magnesium levels observed in term newborn infants and children up to two years of age treated with Numeta G16%E in routine clinical practice.
• odbor PRAC je prav tako sklenil, da je treba opraviti prospektivno, neintervencijsko študijo varnosti po pridobitvi dovoljenja za promet z zdravilom, s katero bo nadalje ocenil ravni magnezija, opažene pri donošenčkih in otrocih, starih do dveh let, ki se zdravijo z zdravilom Numeta G16%E v rutinski klinični praksi.
In addition to these measures, it is also considered that the MAH should conduct a prospective noninterventional post-authorisation safety study to further evaluate magnesium levels observed in term newborn infants and children up to two years of age treated with Numeta G16%E in routine clinical practice.
Poleg teh ukrepov mora imetnik dovoljenja za promet z zdravilom po odobritvi dovoljenja za promet opraviti tudi prospektivno neintervencijsko študijo varnosti, s katero bo nadalje ocenil ravni magnezija, opažene pri donošenčkih in otrocih, starih do dveh let, ki se zdravijo z zdravilom Numeta G16%E v rutinski klinični praksi.
The PRAC, as a consequence, concluded that the benefit-risk balance for Numeta G16%E as parenteral nutrition in term newborn infants and children up to two years when oral or enteral nutrition is not possible, insufficient or contraindicated remains favourable subject to the warnings, additional pharmacovigilance activities and additional risk minimisation measures agreed.
Odbor PRAC je posledično zaključil, da razmerje med tveganji in koristmi zdravila Numeta G16%E za parenteralno prehrano pri donošenčkih in otrocih, starih do dveh let, kadar je peroralna ali enteralna prehrana nemogoča, nezadostna ali kontraindicirana, ostaja ugodno, če se upoštevajo opozorila in uvedejo dogovorjene dodatne farmakovigilančne dejavnosti ter ukrepi za zmanjševanje tveganja.
Numeta G16% Whereas,
Numeta G16% Ob upoštevanju naslednjega:
The PRAC concluded that the benefit-risk balance of Numeta G16%E for parenteral nutrition in term newborn infants and children up to two years when oral or enteral nutrition is not possible, insufficient or contraindicated remains favourable subject to the warnings, additional pharmacovigilance activities and additional risk minimisation measures agreed.
Odbor PRAC je sklenil, da razmerje med tveganji in koristmi zdravila Numeta G16%E za parenteralno prehrano pri donošenčkih in otrocih, starih do dveh let, kadar je peroralna ali enteralna prehrana nemogoča, nezadostna ali kontraindicirana, ostaja ugodno, če se upoštevajo opozorila in uvedejo dogovorjene dodatne farmakovigilančne dejavnosti ter ukrepi za zmanjševanje tveganja.
The MAH identified 14 case reports of hypermagnesaemia or increased magnesium associated with Numeta G13%E in their global safety database and 1 case associated with Numeta G16%.
Imetnik dovoljenja za promet z zdravilom je v svoji globalni varnostni podatkovni zbirki pri zdravilu Numeta G13%E odkril 14 poročil primerov hipermagneziemije ali povišane ravni magnezija, pri zdravilu Numeta G16%E pa en primer.
A prospective non-interventional post-authorisation safety study to further evaluate magnesium levels observed in term newborn infants and children up to two years of age treated with Numeta G16%E in routine clinical practice should be conducted.
Opraviti je treba prospektivno, neintervencijsko študijo varnosti po pridobitvi dovoljenja za promet z zdravilom, s katero se bodo nadalje ocenile ravni magnezija, opažene pri donošenčkih in otrocih, starih do dveh let, ki se zdravijo z zdravilom Numeta G16%E v rutinski klinični praksi.
The PRAC in accordance with Article 107j(3) of Directive 2001/83/EC, recommends by consensus that a. the marketing authorisation holders should sponsor a post-authorisation safety study together with the follow up evaluation of the results of that study (see Annex V - Conditions of marketing Authorisations);
a. imetniki dovoljenj za promet z zdravili sponzorirajo študijo varnosti zdravila v obdobju trženja in nadaljnje vrednotenje rezultatov študije (glejte Prilogo V - Pogoji dovoljenj za promet z zdravilom);
Numeta G16%E is indicated for parenteral nutrition in term newborn infants and children up to two years when oral or enteral nutrition is not possible, insufficient or contraindicated.
Zdravilo Numeta G16%E je indicirano za parenteralno prehrano pri donošenčkih in otrocih, starih do dveh let, kadar je peroralna ali enteralna prehrana nemogoča, nezadostna ali kontraindicirana.
Severe hypomagnesemia is uncommon but can cause seizures, drowsiness, cardiac ventricular defibrillation, hypokalemia and hypocalcemia (Whang et al, 1994).
Huda hipomagneziemija je redka, vendar lahko povzroči epileptične napade, zaspanost, srčno ventrikularno defibrilacijo, hipokaliemijo in hipokalciemijo (Whang in sod., 1994), zato je primerno, da raztopina za prehrano nedonošenčkov vsebuje magnezij kot en elektrolit, čeprav je treba količino uravnovesiti, da omogoči ustrezne ravni.
Numeta G13%E is specifically designed for preterm newborn infants for whom oral or enteral nutrition is not possible, insufficient or contraindicated.
Zdravilo Numeta G13%E je posebej zasnovano za nedonošenčke, pri katerih je peroralna ali enteralna prehrana nemogoča, nezadostna ali kontraindicirana.
Although no reports had been received for Numeta G16%E, the PRAC decided at its June 2013 meeting that this product would also be included in the scope of the referral because of its magnesium content and because of its use in neonates and infants/toddlers up to the age of 2 years, who may also be at risk of developing hypermagnesaemia.
Čeprav poročil glede zdravila Numeta G16%E ni bilo, se je odbor PRAC na svojem sestanku, ki je potekal junija 2013, odločil, da bo to zdravilo prav tako vključeno v sklop napotitvenega postopka,
No clinical symptoms relative to hypermagnesaemia have been reported with the use of Numeta G13%E or Numeta G16%E.
Pri uporabi zdravil Numeta G13%E in Numeta G16%E niso poročali o nobenih kliničnih simptomih, povezanih s hipermagneziemijo.
Numeta G13%E is indicated for PN in preterm newborn infants when oral or enteral nutrition is not possible, insufficient or contraindicated.
Zdravilo Numeta G13%E je indicirano za parenteralno prehrano nedonošenčkov, pri katerih je peroralna ali enteralna prehrana nemogoča, nezadostna ali kontraindicirana.
Information for healthcare professionals
Informacije za zdravstveno osebje
“For subcutaneous use only.
„Samo za subkutano uporabo.
Open wound
Odprta rana
Do not spray closer than the recommended distances.
Ne pršite bližje od priporočene razdalje.
Laparoscopic / minimally invasive procedures
Laparoskopski / minimalno invazivni posegi
Excessive clot thickness may negatively interfere with the product's efficacy and the wound healing process.
Predebel strdek lahko negativno vpliva na učinkovitost zdravila ter proces celjenja rane.
For spray application, see sections 4.4 and 6.6 for specific recommendations on the required pressure and distance from tissue per surgical procedure and length of applicator tips.”
Za nanos s pršenjem glejte poglavji 4.4 in 6.6 za posebna priporočila glede potrebnega tlaka in razdalje od tkiva pri posameznem kirurškem posegu ter dolžini nastavka aplikatorja.“
“In order to ensure optimal safe use of [PRODUCT NAME] by spray application the following recommendations should be followed:
„Da zagotovite optimalno varno uporabo zdravila [IME ZDRAVILA] s pršenjem upoštevajte naslednja priporočila:
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
PRILOGA III SPREMEMBE ZADEVNIH POGLAVIJ POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILO ZA UPORABO
How to use [PRODUCT NAME]
Kako uporabljati zdravilo [IME ZDRAVILA]
In minimally invasive/laparoscopic procedures - a pressure regulator device that delivers a maximum pressure of no more than 1.5 bar (22 psi) and uses carbon dioxide gas only should be used.
Pri minimalno invazivnih/laparoskopskih posegih - uporabite pripomoček z regulatorjem tlaka, katerega največji tlak ne presega 1,5 bar (22 psi) in uporablja izključno plin ogljikov dioksid.
[PRODUCT NAME] is not recommended for laparoscopic surgery.
Zdravilo [IME ZDRAVILA] ni priporočljivo za laparoskopske kirurške posege.
• Spray devices and the accessory tip provide instructions for use with recommendations for pressure ranges and to the spraying distance from the tissue surface.
• Pršilnim pripomočkom in ustreznemu nastavku je priloženo navodilo za uporabo s priporočenim razponom tlakov in priporočeno razdaljajo od površine tkiva.
Replaceable tip
Zamenljiv nastavek
[PRODUCT NAME] should only be reconstituted and administered according to the instructions and with the devices recommended for this product (see section 6.6).
Zdravilo [IME ZDRAVILA] lahko rekonstituirate in uporabite le v skladu z navodili in s pomočjo pripomočkov, ki so priporočeni za to zdravilo (glejte poglavje 6.6).
Beriplast P and associated names
Beriplast P (in povezana imena)
4.2.2 Method and route of administration
4.2.2 Postopek in pot uporabe zdravila
Take special care with [PRODUCT NAME]
Bodite posebno pozorni pri uporabi zdravila [IME ZDRAVILA]
When applying [PRODUCT NAME] using a spray device, be sure to use a pressure within the pressure range recommended by the spray device manufacturer (see table in section 6.6 for pressures and distances).
Pri uporabi zdravila [IME ZDRAVILA] s pršilnim pripomočkom izberite nastavitev tlaka znotraj razpona tlakov, ki ga priporoča izdelovalec pršilnega pripomočka (glejte preglednico v poglavju 6.6 za tlake in razdalje).
In order to ensure optimal safe use of [PRODUCT NAME] it should be sprayed using a pressure regulator device that delivers a maximum pressure of up to 2.0 bar (28.5 psi).
Da zagotovite optimalno varno uporabo zdravila [IME ZDRAVILA], ga pršite s pripomočkom z regulatorjem tlaka, katerega največji tlak ne presega 2,0 bar (28,5 psi).
• “[PRODUCT NAME] should not be used in laparoscopic surgery (keyhole surgery).
• „Zdravilo [IME ZDRAVILA] se ne sme uporabljati za laparoskopske kirurške posege.
This appears to be related to the use of the spray device at higher than recommended pressures and/or in close proximity to the tissue surface.
Izgleda, da je to povezano z uporabo pršilnega pripomočka, katerega nastavitev tlaka je višja od priporočenega, in/ali v bližini površine tkiva.
This event appears to be related to the use of the spray device at higher than recommended pressures and/or in close proximity to the tissue surface.
Izgleda, da je ta dogodek povezan z uporabo pršilnega pripomočka, katerega nastavitev tlaka je višja od priporočenega, in/ali v bližini površine tkiva.
This section of the Package Leaflet should include the following wording, in bold and underlined format where indicated:
To poglavje navodila za uporabo mora vsebovati naslednje besedilo, ki je tiskano krepko in podčrtano, kjer je to nakazano:
• [PRODUCT NAME] should be administered strictly according to the instructions and only with devices recommended for this product.
• Zdravilo [IME ZDRAVILA] se mora uporabljati natančno v skladu z navodili in le s pomočjo pripomočkov, ki so priporočeni za to zdravilo.
The risk appears to be higher when fibrin sealants are sprayed with air, as compared to CO2 and therefore cannot be excluded with [Product Name] when sprayed in open wound surgery.
Zdi se, da je tveganje večje, če so fibrinska lepila za tkiva pršena z zrakom v primerjavi s CO2, zato ga ne moremo izključiti pri pršenju zdravila [ime zdravila] pri operativnih posegih na odprtih ranah.
“Apply [PRODUCT NAME] as a thin layer.
„Zdravilo nanesite [PRODUCT NAME] v tankem sloju.
Tissucol and associated names
Tissucol in povezana imena
In open wound surgery - a pressure regulator device that delivers a maximum pressure of no more than 2.0 bar (28.5 psi) should be used.
Pri operativnih posegih na odprtih ranah - uporabite pripomoček z regulatorjem tlaka, katerega največji tlak ne presega 2,0 bar (28.5 psi).
[PRODUCT NAME] spray application should only be used if it is possible to accurately judge the spray distance as recommended by the manufacturer.
Za nanos zdravila [IME ZDRAVILA] s pršenjem se odločite samo, če lahko natančno ocenite razdalja pršenja po priporočilih izdelovalca.
Tisseel / Tissucol Spray Set
Pršilni komplet Tisseel / Tissucol
The product should only be reconstituted and administered according to the instructions and with the devices as provided with this product.”
Zdravilo se lahko rekonstituira in uporablja le v skladu z navodili in s pomočjo pripomočkov, ki so priloženi zdravilu.“
Tisseel and associated names
Tisseel in povezana imena
The risk appears to be higher when fibrin sealants are sprayed with air, as compared to CO2 and therefore cannot be excluded with [Product Name].
Zdi se, da je tveganje večje, če so fibrinska lepila za tkiva pršena z zrakom v primerjavi s CO2, zato ga ne moremo izključiti pri pršenju zdravila [IME ZDRAVILA] pri operativnih posegih na odprtih ranah.
Recommended pressure, distance and devices for spray application of [product name] Surgery Spray set to be used
Priporočeni tlak, razdalja in pripomoček za nanos zdravila [ime zdravila] s pršenjem Kirurški poseg Uporabljeni pršilni komplet
When applying [PRODUCT NAME] using a spray device be sure to use a pressure and a distance from the tissue within the range recommended by the manufacturer as follows:
Pri uporabi zdravila [IME ZDRAVILA] s pršilnim pripomočkom je treba uporabiti tlak in razdalja od tkiva znotraj razpona, ki ga priporoča izdelovalec, in sicer:
“When applying [PRODUCT NAME] using a spray device be sure to use a pressure and a distance from tissue within the ranges recommended by the manufacturer as follows:
„Pri uporabi zdravila [IME ZDRAVILA] s pršilnim pripomočkom uporabite tlak in razdalja od tkiva znotraj razponov, ki jih priporoča izdelovalec, in sicer:
Recommended pressure, distance and devices for spray application of [product name]
Priporočeni tlak, razdalja in pripomoček za nanos zdravila [ime zdravila] s pršenjem
The following changes should be made to the SmPC of Artiss:
V povzetek glavnih značilnosti zdravila Artiss je vnesti naslednje spremembe:
B. Package Leaflet The following changes should be made to the package leaflet of Beriplast P and associated names:
V navodilu za uporabo zdravila Beriplast P in povezana imena je treba vnesti naslednje spremembe: