natgillin/translations-raw huggingface dataset:
Stakeholders were also invited to submit any relevant information to support the assessment, and the Agency's Paediatric Committee (PDCO) was consulted for advice.
Prav tako je pozval zainteresirane strani k predložitvi kakršnih koli pomembnih informacij, ki bi bile v pomoč pri oceni, in se posvetoval z Odborom za zdravila za pediatrično uporabo (PDCO) pri agenciji.
They contain nutrients such as glucose (sugar), lipids (fats), aminoacids and other important substances including magnesium.
Vsebujejo hranilne snovi, kot so glukoza (sladkor), lipidi (maščobe), aminokisline in druge pomembne snovi, med katerimi je tudi magnezij.
The review of Numeta G13%E and Numeta G16%E was initiated on 13 June 2013 at the request of Sweden, under Article 107i of Directive 2001/83/EC, also known as the urgent Union procedure.
Pregled zdravil Numeta G13%E in Numeta G16%E se je začel 13. junija 2013 na zahtevo Švedske, v skladu s členom 107i Direktive 2001/83/ES, znanim tudi kot nujni postopek Unije.
• Severe hypermagnesaemia is rare but can have adverse clinical consequences.
• Huda hipermagneziemija je redka, vendar ima lahko neželene klinične posledice.
As the review only covers nationally authorised medicines, the PRAC recommendation was forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Ker so bila pregledana samo zdravila, odobrena na nacionalni ravni, je bilo priporočilo odbora PRAC predloženo Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončni sklep.
As the PRAC recommendations were endorsed by consensus by the CMDh, they will now be implemented directly in all Member States, according to an agreed timetable.
Ker je skupina CMDh soglasno podprla priporočila odbora PRAC, jih bodo odslej neposredno izvajale vse države članice v skladu z dogovorjenim časovnim razporedom.
Magnesium levels mainly ranged from 1.025 mmol/L to > 1.5 mmol/L and no clinical signs or symptoms were reported for any of the cases.
Koncentracije magnezija so bile večinoma v razponu od 1,025 mmol/l do > 1,5 mmol/l, v nobenem primeru pa niso poročali o kliničnih znakih ali simptomih.
Because the CMDh position was agreed by consensus, the agreement will be directly implemented by the Member States where the medicines are authorised.
Ker je skupina CMDh soglasno sprejela sklep, ga bodo neposredno izvajale države članice, v katerih sta zdravili odobreni.
Clinical signs may not be identifiable unless hypermagnesaemia is severe.
Kliničnih znakov včasih ni mogoče prepoznati, če hipermagneziemija ni huda.
Although this is within the recommendations reported in the literature as a whole, it is slightly more than suggested by some recognised guidelines1,2,3 (0.15-0.25 mmol/kg/day and 0.2 mmol/kg/day for term infant to one year of age, 0.15-0.25 mmol/kg/day and 0.1 mmol/kg/day for children from one year to two years of age).
Čeprav je ta vrednost znotraj priporočil, ki se na splošno pojavljajo v literaturi1,2,3, nekoliko presega vrednost, ki jo priporočajo nekatere priznane smernice (0,15-0,25 mmol/kg/dan in 0,2 mmol/kg/dan za donošenčke do 1. leta starosti, 0,15-0,25 mmol/kg/dan in 0,1 mmol/kg/dan za otroke od prvega do drugega leta starosti).
• The appropriate parenteral magnesium intake in preterm infants is uncertain.
• Kakšen je ustrezen parenteralni vnos magnezija pri nedonošenčkih, ni povsem jasno.
The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), a medicines regulatory body representing the European Union (EU) Member States, has endorsed by consensus the recommendation to suspend the marketing authorisation of Numeta G13%E because of a risk of hypermagnesaemia (high blood levels of magnesium).
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU), je soglasno podprla priporočilo, da se začasno umakne dovoljenje za promet z zdravilom Numeta G13%E zaradi tveganja za hipermagneziemijo (visoke koncentracije magnezija v krvi).
Parenteral nutrition is necessary in premature neonates and in some full-term babies in order to prevent complications such as growth retardation and breathing complications and to promote the normal development of the brain.
Parenteralno hranjenje je potrebno pri nedonošenčkih in nekaterih donošenčkih, da se preprečijo zapleti, kot sta zaostajanje v rasti in težave z dihanjem, ter spodbudi normalen razvoj možganov.
The product information should be revised accordingly and healthcare professionals should be informed in writing of the potential risk of hypermagnesaemia, which is increased in patients with impaired kidney function and those whose mothers were receiving supplemental magnesium before delivery, and of the measures to be taken to minimise this risk.
Informacije o zdravilu je treba ustrezno spremeniti, zdravstvene delavce pa je treba pisno obvestiti o možnem tveganju za hipermagneziemijo, ki se poveča pri bolnikih z okvarjenim delovanjem ledvic in pri tistih, katerih matere so pred porodom dobivale dodaten magnezij, ter o ukrepih, ki jih je treba sprejeti za zmanjšanje tega tveganja.
Safe Practices for Parenteral Nutrition JPEN 2004; 28: S 39 - S 70
Mirtallo in sod., „Varna praksa parenteralnega hranjenja“, JPEN, št. 28, 2004, str. S 39-S 70.
This risk is increased in patients with reduced renal function, and in newborn infants of mothers who were receiving supplemental magnesium prior to delivery.
Tveganje je večje pri bolnikih z zmanjšanim delovanjem ledvic in pri novorojenčkih mater, ki so pred porodom dobivale dodaten magnezij.
For Numeta G16%E, the PRAC concluded that although the magnesium content may result in a magnesium intake that is slightly higher than suggested in some guidelines, the proposed measures, including updating the product information and a further study, are sufficient to ensure the safe use of this product.
V zvezi z zdravilom Numeta G16%E je zaključil, da bi vsebnost magnezija sicer lahko povzročila vnos količin magnezija, ki so nekoliko večje od tistih, ki jih priporočajo nekatere smernice, vendar predlagani ukrepi, med katerimi sta tudi posodobitev informacij o zdravilu in dodatna študija, zadostujejo za zagotovitev varne uporabe tega zdravila.
Koletzko B, Goulet O, Hunt J, Krohn K, Shamir R. Guidelines on Paediatric Parenteral Nutrition of the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), and the European Society for Clinical Nutrition and Metabolism (ESPEN), Supported by the European Society of Paediatric Research (ESPR).
Koletzko, B., Goulet, O., Hunt, J., Krohn, K., Shamir, R., „Smernice za parenteralno prehrano otrok Evropskega združenja za pediatrično gastroenterologijo, hepatologijo in prehrano (ESPGHAN) in Evropskega združenja za klinično prehrano in metabolizem (ESPEN), ki jih je podprlo Evropsko združenje za pediatrične raziskave (ESPR)“, J Pediatric Gastroenterology Nutrition, št. 41, 2005, str. S1-S87.
In addition, the PRAC noted that this risk is further increased in premature newborns because their kidneys are immature and less able to clear the body of magnesium.
Poleg tega je ugotovil, da bi bilo to tveganje še večje pri nedonošenčkih, ker so njihove ledvice še nerazvite in zato težje izločijo magnezij iz telesa.
Numeta G13%E and Numeta G16%E (glucose, lipids, aminoacids and electrolytes) are parenteral nutrition solutions.
Numeta G13%E in Numeta G16%E (glukoza, lipidi, aminokisline in elektroliti) sta parenteralni hranilni raztopini.
The PRAC also noted the difficulty in identifying symptoms of hypermagnesaemia in premature newborns, which means that hypermagnesaemia may not be detected until it causes serious complications.
Ugotovil je tudi, da je težko prepoznati simptome hipermagneziemije pri nedonošenčkih, kar pomeni, da hipermagneziemije včasih ne odkrijejo, dokler ne povzroči resnih zapletov.
In addition, the PRAC recommended a study be carried out to further evaluate blood magnesium levels observed in term newborn infants and children up to two years of age following use of Numeta G16%E.
Poleg tega je odbor PRAC priporočil, da se opravi študija, v kateri bi nadalje ocenili koncentracije magnezija v krvi, opažene pri donošenčkih in otrocih do drugega leta starosti po uporabi zdravila Numeta G16%E.
• Doctors should also monitor patients for signs and symptoms of hypermagnesaemia such as nausea, vomiting and flushing, generalized weakness, respiratory failure, hypotension and arrhythmias.
• Zdravniki morajo bolnike spremljati tudi glede znakov in simptomov hipermagneziemije, kot so slabost, bruhanje in zardevanje, splošna oslabelost, odpoved dihal, hipotenzija in aritmije.
• The company identified one case of hypermagnesaemia associated with Numeta G16%E.
• Družba je zabeležila en primer hipermagneziemije, povezane z zdravilom Numeta G16%E.
For another nutrition preparation given into a vein, Numeta G16%E, used in full-term newborns and children up to 2 years, the CMDh agreed that the benefit-risk balance remains positive, provided that healthcare professionals monitor their patients' blood magnesium levels before giving the preparation and at appropriate intervals thereafter in accordance with routine clinical practice and the clinical needs of the individual patient.
Za drugi prehranski pripravek, ki se daje v veno, tj. Numeta G16%E, ki se uporablja pri donošenčkih in otrocih do 2. leta starosti, se je skupina CMDh strinjala, da je razmerje med tveganji in koristmi še vedno pozitivno, če zdravstveni delavci preverijo koncentracijo magnezija v krvi bolnikov, preden jim dajo pripravek in v rednih razmikih po tem, pri čemer morajo upoštevati vsakdanjo klinično prakso in klinične potrebe posameznega bolnika.
The review of Numeta G13%E and Numeta G16%E was carried out by the the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) following several reports of hypermagnesaemia (without clinical symptoms) in preterm infants.
Pregled zdravil Numeta G13%E in Numeta G16%E je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila, potem ko so poročali o več primerih hipermagneziemije (brez kliničnih simptomov) pri nedonošenčkih.
Having considered available guidelines and relevant literature and considering the magnesium content of Numeta, the PRAC concluded that the administration of Numeta G13%E could lead to a higher risk of hypermagnesaemia.
Potem ko je odbor PRAC proučil razpoložljive smernice in zadevno literaturo ter pregledal vsebnost magnezija v zdravilu Numeta, je zaključil, da bi se lahko pri uporabi zdravila Numeta G13%E povečalo tveganje za hipermagneziemijo.
As a precautionary measure, the manufacturer decided to voluntarily recall Numeta G13%E in the EU.
Izdelovalec se je odločil za previdnostni ukrep in prostovoljno odpoklical zdravilo Numeta G13%E s trgov EU.
• The benefit-risk balance of the nutrition preparation Numeta G16%E, used in full-term newborns and children up to 2 years, remains positive.
• Razmerje med tveganji in koristmi za prehranski pripravek Numeta G16%E, ki se uporablja pri donošenčkih in otrocih do 2. leta starosti, je še naprej pozitivno.
• The maximum total amount of magnesium that can be delivered to term infants using Numeta G16%E according to its product information is 0.3 mmol/kg/day.
• Največja skupna količina magnezija, ki jo lahko pri uporabi zdravila Numeta G16%E prejmejo donošenčki, glede na navedeno v informacijah o zdravilu znaša 0,3 mmol/kg/dan.
• The company marketing Numeta identified 14 case reports of hypermagnesaemia with Numeta G13%E.
• Družba, ki trži zdravilo Numeta, je zabeležila 14 poročil o primerih hipermagneziemije pri uporabi zdravila Numeta G13%E.
The PRAC assessed the available data on the risk of hypermagnesaemia with Numeta G13%E and Numeta G16%E preparations from clinical studies, post-marketing reports and the published literature and considered available treatment guidelines.
Odbor PRAC je ocenil razpoložljive podatke o tveganju za hipermagneziemijo pri uporabi pripravkov Numeta G13%E in Numeta G16%E, ki so na voljo iz kliničnih študij, poročil v obdobju trženja in objavljene literature, ter proučil razpoložljive smernice za zdravljenje.
In patients whose blood magnesium levels are elevated or signs of hypermagnesaemia are identified Numeta G16%E should be stopped or the infusion rate reduced.
Pri bolnikih, pri katerih se pojavijo zvišane koncentracije magnezija v krvi ali znaki hipermagneziemije, je treba prekiniti dajanje zdravila Numeta G16%E ali zmanjšati hitrost infundiranja.
Numeta preparations are given to provide nutritional support in children who cannot be fed by mouth or with a feeding tube.
Pripravki Numeta se dajejo za prehransko podporo pri otrocih, ki jih ni mogoče hraniti skozi usta ali po sondi za hranjenje.
• The nutrition preparation Numeta G16%E can continue to be used in full-term newborns and children up to 2 years, however the doctor will monitor the levels of magnesium in the child's blood before giving the preparation and at appropriate intervals thereafter.
• Prehranski pripravek Numeta G16%E se lahko še naprej uporablja pri donošenčkih in otrocih do 2. leta starosti, vendar morajo zdravniki preveriti koncentracije magnezija v krvi otroka, preden mu dajo pripravek in v ustreznih razmikih po tem.
The maximum total licensed amount of magnesium that can be delivered to preterm infants using Numeta G13%E is 0.55 mmol/kg/day which is above this recommended intake.
Največja skupna odobrena količina magnezija, ki jo lahko pri uporabi zdravila Numeta G13%E prejmejo nedonošenčki, je 0,55 mmol/kg/dan, kar je več od priporočenega vnosa.
• In case of hypermagnesaemia, the infusion of Numeta G16%E should be stopped or infusion rate reduced and alternative fluids, nutrition and electrolytes prescribed as deemed clinically appropriate.
• Če se pojavi hipermagneziemija, je treba prekiniti ali upočasniti infundiranje zdravila Numeta G16%E in predpisati druge tekočine, hranilne snovi in elektrolite, kot je klinično ustrezno.
However, widelyrecognised guidelines 1,2 recommend a parenteral magnesium intake of 0.15 - 0.25 mmol/kg/day.
Parenteralni vnos magnezija, ki ga priporočajo splošno priznane smernice1,2, je od 0,15-0,25 mmol/kg/dan.
Numeta G13%E, which is given into a vein to premature babies to provide nutritional support (intravenous nutrition or parenteral nutrition), will remain suspended until a re-formulated preparation is made available.
Zdravilo Numeta G13%E, ki se daje v veno pri nedonošenčkih kot prehranska podpora (intravenska prehrana oziroma parenteralna prehrana), bo začasno umaknjeno s trga, dokler ne bo na voljo pripravek z novo formulacijo.
Doctors will monitor newborns and children who are receiving Numeta G16%E for symptoms of hypermagnesaemia such as weakness, nausea and vomiting, breathing difficulties, hypotension (low blood pressure) and arrhythmias (irregular heart beat).
Zdravniki bodo spremljali novorojenčke in otroke, ki dobivajo pripravek Numeta G16%E, glede simptomov hipermagneziemije, kot so oslabelost, navzeja in bruhanje, težave z dihanjem, hipotenzija (nizek krvni tlak) in aritmije (nepravilno bitje srca).
Hypermagnesaemia is a serious condition and symptoms may include weakness, nausea and vomiting, breathing difficulties, hypotension (low blood pressure) and arrhythmias (irregular heart beat).
Hipermagneziemija je resna bolezen, katere simptomi so oslabelost, slabost in bruhanje, težave z dihanjem, hipotenzija (nizek krvni tlak) in aritmije (nepravilno bitje srca).
While Numeta G13%E is suspended, healthcare professionals should use alternative nutrition solutions which may include authorised standardised or individually prepared solutions.
V času, ko bo pripravek Numeta G13%E začasno umaknjen, naj zdravstveni delavci uporabljajo druge hranilne raztopine, ki so bodisi odobrene standardizirane ali individualno pripravljene raztopine.
Parenteral nutrition is the providing of nutrients and fluids through a vein in patients who cannot be fed by mouth or by enteral nutrition (the use of a feeding tube passed directly into the gut).
Parenteralno hranjenje pomeni, da bolniki, ki jih ni mogoče hraniti skozi usta ali z enteralno prehrano (uporabo sonde za hranjenje, ki se uvede neposredno v črevo), dobivajo hranilne snovi in tekočine skozi veno.
• When giving Numeta G16%E, doctors should monitor serum magnesium levels, along with other electrolyte levels at baseline and at appropriate intervals thereafter.
• Pri dajanju zdravila Numeta G16%E morajo zdravniki preveriti koncentracije magnezija in drugih elektrolitov v serumu ob izhodišču in nato še v rednih razmikih po tem.
• Because of the risk of hypermagnesaemia (high blood levels of magnesium), the nutrition preparation Numeta G13%E has been suspended until a re-formulated preparation is made available.
• Zaradi tveganja za hipermagneziemijo (visoke koncentracije magnezija v krvi) je bil prehranski pripravek Numeta G13%E začasno umaknjen s trga, dokler ne bo na voljo v obliki z novo formulacijo.
• Following several reports of hypermagnesaemia in preterm infants, the nutrition preparation Numeta G13%E has been suspended until a re-formulated preparation is made available.
• Potem ko so poročali o več primerih hipermagneziemije pri nedonošenčkih, je bil prehranski pripravek Numeta G13%E začasno umaknjen s trga, dokler ne bo na voljo v obliki z novo formulacijo.
Numeta G13%E is given into a vein to provide nutritional support in premature babies who cannot be fed by mouth or with a feeding tube.
Pripravek Numeta G13%E se daje v veno za prehransko podporo pri nedonošenčkih, ki jih ni mogoče hraniti skozi usta ali po sondi za hranjenje.
Canada T, Crill C, Guenter P. A.S.P.E.N.
Canada, T., Crill, C., Guenter, P., A.S.P.E.N., Priročnik za parenteralno hranjenje, Ameriško združenje za parenteralno in enteralno prehrano, Silver Spring, Maryland, 2009, str. 167.
The doctor will stop giving Numeta G16%E if magnesium levels are high, or will give Numeta at a slower rate.
V primeru visokih koncentracij magnezija bo zdravnik prekinil ali upočasnil dajanje pripravka Numeta G16%E.
List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicant in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila, predlagataljev, imetnikov dovoljenja za promet z zdravilom v državah članicah
Poland
Poljsko
Hungary
Madžarski
Lithuania
Litvo
Sweden
Danski
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
2700 AN, Zoetermeer The Netherlands
2700 AN, Zoetermeer Nizozemska
Via E. Folli 50 20134 Milano Italy
Via E. Folli 50 20134 Milano Italija
Via F. Sforza Palazzo Volta 20080 Basiglio (MI) Italy
Via F. Sforza Palazzo Volta 20080 Basiglio (MI) Italija
Via Lungo l'Ema 7 50015 Bagno a Ripoli (FI) Italy
Via Lungo l'Ema 7 50015 Bagno a Ripoli (FI) Italija
Laboratorio Tau, S.A. C/ Serrano Galvache, 56 Edificio Roble 28033 Madrid Spain
Laboratorio Tau, S.A. C/ Serrano Galvache, 56 Edificio Roble 28033 Madrid Španija
Netherlands AstraZeneca BV Postbus 599
Nizozemska AstraZeneca BV Postbus 599
Hungary AstraZeneca Kft. H-2045 Törökbálint, Park u. 3.
Madžarska AstraZeneca Kft. H-2045 Törökbálint, Park u.
Norway AstraZeneca AS, Postboks 200 Vinderen, 0319 OSLO
Norveška AstraZeneca AS, Postboks 200 Vinderen, 0319 OSLO
AstraZeneca Oy Luomanportti 3 FI-02200 Espoo Finland
AstraZeneca Oy Luomanportti 3 FI-02200 Espoo Finska
AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU United Kingdom
AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU Velika Britanija
4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens Greece
4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens Grčija
AstraZeneca UK Ltd., Silk Road Business Park ,SK10 2NA Macclesfield, Cheshire, United Kingdom
AstraZeneca UK Ltd., Silk Road Business Park ,SK10 2NA Macclesfield, Cheshire, Velika Britanija
DK-2620 Albertslund Denmark
DK-2620 Albertslund Danska
1, Place Renault 92844 RUEIL-MALMAISON Cedex
AstraZeneca 1, Place Renault 92844 RUEILMALMAISON Cedex Francija
AstraZeneca A/S Roskildevej 22 2620 Albertslund Denmark
AstraZeneca A/S Roskildevej 22 2620 Albertslund Danska
Germany AstraZeneca GmbH 22876 Wedel
AstraZeneca GmbH 22876 Wedel Nemčija
AstraZeneca AB, 151 85 Södertälje Sweden
AstraZeneca AB, 151 85 Södertälje, Švedska
Sweden AstraZeneca AB S-151 85 Södertälje Sweden
Romunija AstraZeneca AB, S-151 85 Södertälje Švedska
AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien
Schwarzenbergplatz 7, A-1037 Wien Avstrija
MUPS
Ciper
10 mg Film-coated gastroresistant tablets
10 mg Filmsko obložene gastrorezistentne tablete
10 mg Capsules
10 mg Kapsule
20 mg Capsules
20 mg Kapsule
Gastro-resistant, film-coated tablet
Gastrorezistentne filmsko obložene tablete
40 mg Powder for infusion
40 mg Prašek za infuzijo
Losec-Mups 40mg 40 mg Gastroresistant tablets
Losec MUPS 40 40 mg Gastrorazistentne tablete Peroralna uporaba NA
20 m Gastro-resistant tablets
20 m Gastrorezistentne tablete Peroralna uporaba NA
Losec-Mups 10mg 10 mg Gastroresistant tablets
Losec MUPS 10 10 mg Gastrorazistentne tablete Peroralna uporaba NA
40 mg Gastroresistant capsules
40 mg Trde gastrorezistentne kapsule
ANNEX I
Intravenska uporaba NA
Losec-Mups 20mg 20 mg Gastroresistant tablets
Losec MUPS 20 20 mg Gastrorazistentne tablete Peroralna uporaba NA
10 mg Gstroresistant capsules
10 mg Trde kapsule
20 mg Gastroresistant capsules
20 mg Trde gastrorezistentne kapsule
10 mg Hard Gastroresistant capsules Oral use
10 mg Gastrorezistentne kapsule Peroralna uporaba NA
20 mg Hard Gastroresistant capsules Oral use
20 mg Gastrorezistentne kapsule Peroralna uporaba NA
40 mg Hard Gastroresistant capsules Oral use
40 mg Gastrorezistentne kapsule Peroralna uporaba NA
Losec Capsules 20mg 20mg Hard gelatin capsules
LOSEC 20 mg 20 mg Trde gastrorezistentne kapsule
40 mg Gastroresistant tablets
40 mg Liofilizat za perfuzijo
40 mg Powder for solution for intravenous infusion
40 mg Prašek za raztopino za intravensko infuzijo
40 mg/ml Powder and Solvens for solution for injection
40 mg/ml Prašek in topilo za raztopino za injiciranje
40 mg Powder and solvent for injectable solution
40 mg Prašek in topilo za raztopino za injiciranje
The absolute risk reduction was 4.2%.
Absolutno zmanjšanje tveganja je bilo 4,2%.
Do not take a double dose to make up for the forgotten dose.
Ne vzemite dvojnega odmerka, da bi nadomestili pozabljeni odmerek.
Available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
Razpoložljivi podatki so opisani v poglavjih 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče podati.
United Kingdom EX31 3UD
Velika Britanija EX31 UD
About 4% of an oral dose is excreted unchanged in urine.
Približno 4% peroralnega odmerka se izloča nespremenjenega z urinom.
Food delayed absorption by approximately 1 hour, and increased plasma exposure by 20 to 30%.
Hrana je upočasnila absorpcijo za približno 1 uro in povečala izpostavljenost v plazmi za 20 do 30%.
2900 Komárom Hungary
2900 Komárom Madžarska
Therefore the intake of grapefruit juice should be avoided.
Pitju grenivkinega soka se je torej treba izogibati.
The absolute bioavailability of the film-coated tablets is around 40%, due to first-pass effect in the gut and liver.
Absolutna biološka uporabnost filmsko obloženih tablet znaša okoli 40% zaradi učinka prvega prehoda skozi črevesje in jetra.
All phosphenes resolved during or after treatment, of which a majority (77.5%) resolved during treatment.
Vsi fosfeni so ponehali med zdravljenjem ali po njem, in sicer večina med zdravljenjem (77,5%).
Applicable only for the outer packaging component: PC:
Samo za zunanjo ovojnino: PC:
Bradycardia was reported by 3.3% of patients particularly within the first 2 to 3 months of treatment initiation.
O bradikardiji so poročali pri 3,3% bolnikov, zlasti v prvih 2 do 3 mesecih po uvedbi zdravljenja.