natgillin/translations-raw huggingface dataset:
Date of renewal:
Datum podaljšanja dovoljenja za promet:
Ziagen 20 mg/ ml oral solution
Ziagen 20 mg/ ml peroralna raztopina
Oral solution containing 20 mg/ ml of abacavir (as sulfate).
Peroralna raztopina vsebuje 20 mg abakavirja (v obliki sulfata).
Sorbitol (E420)340 mg/ ml Methyl parahydroxybenzoate (E218) 1.5 mg/ ml Propyl parahydroxybenzoate (E216) 0.18 mg/ ml
sorbitol (E420) 340 mg/ ml metilparahidroksibenzoat (E218) 1, 5 mg/ ml propilparahidroksibenzoat (E216) 0, 18 mg/ ml
The demonstration of the benefit of Ziagen is mainly based on results of studies performed in treatment-naïve adult patients on combination therapy with a twice daily regimen (see section 5.1).
Prikaz prednosti zdravila Ziagen v glavnem temelji na rezultatih študij, ki so bile pri režimu odmerjanja dvakrat na dan izvedene pri odraslih bolnikih, ki še niso bili zdravljeni s kombinirano terapijo (glejte poglavje 5. 1).
Adults and adolescents: the recommended dose of Ziagen is 600 mg daily (30 ml).
Priporočeni odmerek zdravila Ziagen znaša 600 mg (30 ml) na dan.
This may be administered as either 300 mg (15 ml) twice daily or 600 mg (30 ml) once daily (see sections 4.4 and 5.1).
Priporočeni odmerek se lahko jemlje kot 300 mg (15 ml) dvakrat na dan ali kot 600 mg (30 ml) enkrat na dan (glejte poglavji 4. 4 in 5. 1).
Patients changing to the once daily regimen should take 300 mg (15 ml) twice a day and switch to 600 mg (30 ml) once a day the following morning.
Bolniki, ki bodo prešli na režim odmerjanja enkrat na dan, morajo jemati 300 mg (15 ml) dvakrat na dan, nato pa naslednje jutro preiti na 600 mg (30 ml) enkrat na dan.
Where an evening once daily regimen is preferred, 300 mg (15 ml) of Ziagen should be taken on the first morning only, followed by 600 mg (30 ml) in the evening.
Če želijo, pri režimu odmerjanja enkrat na dan, jemati odmerek zvečer, morajo prvo jutro vzeti zdravilo Ziagen v odmerku 300 mg (15 ml) in nato zvečer 600 mg (30 ml).
When changing back to a twice daily regimen, patients should complete the day's treatment and start 300 mg (15 ml) twice a day the following morning.
Pri prehajanju nazaj na režim odmerjanja dvakrat na dan, morajo bolniki prejeti celoten dnevni odmerek in nato naslednje jutro pričeti z jemanjem 300 mg (15 ml) dvakrat na dan.
Children from three months to 12 years: the recommended dose is 8 mg/ kg twice daily up to a maximum of 600 mg (30 ml) daily.
Priporočeni odmerek znaša 8 mg/ kg dvakrat na dan, do skupno največ 600 mg (30ml) na dan.
19 Children less than three months: the data available on the use of Ziagen in this age group are very limited (see section 5.2).
Podatkov o uporabi zdravila Ziagen pri tej starostni skupini je zelo malo (glejte poglavje 5. 2).
As a consequence, before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin.
Posledično je pred uvedbo zdravljenja z abakavirjem pri vsakem bolniku, okuženim z virusom HIV, treba opraviti presejalni test za prisotnost alela HLA- B* 5701, ne glede na rasno poreklo.
Therefore, even in the absence of HLA-B*5701 allele, it is important to permanently discontinue abacavir and not rechallenge with abacavir if a hypersensitivity reaction cannot be ruled out on clinical grounds, due to the potential for a severe or even fatal reaction.
Zaradi možne hude in celo usodne
Skin patch testing was used as a research tool for the PREDICT-1 study but has no utility in the clinical
21 reakcije je torej tudi v primeru odsotnosti alela HLA- B* 5701 pomembno, da se zdravljenje z abakavirjem trajno prekine in se ga nikoli več ne uvede, če se preobčutljivostne reakcije na klinični osnovi ne more izključiti.
20 management of patients and therefore should not be used in the clinical setting.
V študiji PREDICT- 1 so kot raziskovalno orodje uporabljali kožni test z obliži, ki pa je za klinično obravnavo bolnikov brez koristi in se ga zato v klinični praksi ne sme uporabljati.
This recurrence is usually more severe than on initial presentation, and may include life-threatening hypotension and death.
Rekurenca je navadno še hujša kot prvi pojav preobčutljivosti in lahko povzroči življenjsko ogrožujočo hipotenzijo in smrt.
To avoid a delay in diagnosis and minimise the risk of a life-threatening hypersensitivity reaction, Ziagen must be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible (respiratory diseases, flu-like illness, gastroenteritis or reactions to other medications).
Kadar ne moremo izključiti preobčutljivosti, in da bi se izognili zamudi pri diagnosticiranju ter čimbolj zmanjšali tveganje za pojav življenjsko nevarne preobčutljivostne reakcije, moramo z dajanjem zdravila Ziagen trajno prenehati, čeprav bi bile možne tudi druge diagnoze (respiratorne bolezni, gripi podobna obolenja, gastroenteritis ali reakcije na druga zdravila).
Special care is needed for those patients simultaneously starting treatment with Ziagen and other medicinal products known to induce skin toxicity (such as non-nucleoside reverse transcriptase inhibitors - NNRTIs).
Še zlasti je treba paziti pri tistih bolnikih, ki sočasno začenjajo zdravljenje z zdravilom Ziagen in z drugimi zdravili, za katera je znano, da povzročajo toksične reakcije na koži (npr. nenukleozidni inhibitorji reverzne transkriptaze – NNRTI).
This is because it is currently difficult to differentiate between rashes induced by these products and abacavir related hypersensitivity reactions.
To je pomembno zato, ker trenutno težko ločimo med izpuščaji, ki se pojavijo zaradi teh zdravil, in preobčutljivostnimi reakcijami, povezanimi z abakavirjem.
• Management after an interruption of Ziagen therapy
22 • Ukrepi v primeru prekinitve zdravljenja z zdravilom Ziagen
Moreover, on very rare occasions hypersensitivity reactions have been reported in patients who have restarted therapy, and who had no preceding symptoms of a hypersensitivity
Preobčutljivostne reakcije so bile v redkih primerih opažene tudi pri bolnikih, ki so znova začeli z zdravljenjem, a pred tem niso imeli nobenih simptomov preobčutljivostne reakcije.
They
- Vsakega bolnika je treba spomniti, naj prebere navodilo za uporabo, ki je priloženo škatlici
should be reminded of the importance of removing the Alert Card included in the pack, and keeping it with them at all times.
Spomniti jim je treba tudi na to, kako zelo pomembno je, da iz škatlice vzamejo opozorilno kartico in jo vedno nosijo s seboj.
Early symptoms (symptomatic hyperlactatemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/ or deep breathing) or neurological symptoms (including motor weakness).
Zgodnji simptomi (simptomatska hiperlaktemija) so blagi prebavni simptomi (slabost, bruhanje in bolečine v trebuhu, nespecifičen občutek neugodja, izguba teka, izguba telesne mase, respiratorni simptomi (hitro in/ ali globoko dihanje) ali nevrološki simptomi (vključno z gibalno šibkostjo).
Treatment with nucleoside analogues should be discontinued in the setting of symptomatic hyperlactatemia and metabolic/ lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
23 Zdravljenje z nukleozidnimi analogi je treba prekiniti ob pojavu simptomov hiperlaktatemije in presnovne acidoze/ laktacidoze, progresivne hepatomegalije ali hitrega porasta koncentracije aminotransferaze.
Whether the
Poročali so o nekaterih primerih nevroloških motenj, ki nastopijo kasneje (hipertonija, konvulzije, nenormalno obnašanje).
22 neurological disorders are transient or permanent is currently unknown.
Trenutno ni znano ali so te nevrološke motnje prehodne ali trajne.
Once daily administration (abacavir 600 mg): the benefit of abacavir as a once daily regimen is mainly based on a study performed in combination with efavirenz and lamivudine, in antiretroviral- naïve adult patients (see section 5.1).
Korist odmerjanja abakavirja enkrat na dan v glavnem temelji na študiji, ki je bila izvedena v kombinaciji z efavirenzom in lamivudinom pri odraslih bolnikih, ki še niso bili zdravljeni s protiretrovirusnimi zdravili (glejte poglavje 5. 1).
Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
24 Bolniki z že obstoječimi motnjami v delovanju jeter, vključno z aktivnim kroničnim hepatitisom, imajo med kombiniranim protiretrovirusnim zdravljenjem povečano pogostnost nenormalnosti jetrne funkcije in jih moramo nadzorovati v skladu s standardno prakso.
Ziagen oral solution contains 340 mg/ ml of sorbitol.
Zdravilo Ziagen peroralna raztopina vsebuje 340 mg/ ml sorbitola.
When taken according to the dosage recommendations each 15 ml dose contains approximately 5 g of sorbitol.
Po priporočilih za odmerjanje vsebuje vsak odmerek (15 ml) 5 g sorbitola.
23 problems of fructose intolerance should not take this medicine.
Bolniki z redkimi dednimi težavami intolerance za fruktozo tega zdravila ne smejo jemati.
The calorific value of sorbitol is 2.6 kcal/ g.
Kalorična vrednost sorbitola je 2, 6 kcal/ g.
Based on the results of in vitro experiments and the known major metabolic pathways of abacavir, the potential for P450 mediated interactions with other medicinal products involving abacavir is low.
Na podlagi rezultatov in vitro preskušanj, ter znanih glavnih presnovnih poti abakavirja obstaja le majhna verjetnost, da bo prišlo do interakcij z drugimi zdravili na P450.
P450 does not play a major role in the metabolism of abacavir, and abacavir does not inhibit metabolism mediated by CYP 3A4.
P450 pri presnovi abakavirja ne igra pomembne vloge in abakavir ne zavira presnove na CYP3A4.
Therefore, there is little potential for interactions with antiretroviral PIs and other medicinal products metabolised by major P450 enzymes.
25 interakcij s protiretrovirusnimi zaviralci proteaze in drugimi zdravili, ki se presnavljajo z glavnimi encimi P450.
Methadone: in a pharmacokinetic study, coadministration of 600 mg abacavir twice daily with methadone showed a 35% reduction in abacavir Cmax and a one hour delay in tmax but the AUC was unchanged.
V farmakokinetični študiji se je po sočasnem dajanju 600 mg abakavirja dvakrat dnevno z metadonom za 35% zmanjšal abakavirjev Cmax in za eno uro podaljšal tmax, medtem ko je AUC ostal nespremenjen.
24 Retinoids: retinoid compounds are eliminated via alcohol dehydrogenase.
Retinoidi se izločajo s pomočjo alkoholne dehidrogenaze.
This reaction is characterised by the appearance of symptoms indicating multi- organ/ body-system involvement.
Za to reakcijo je značilen pojav simptomov, ki nakazujejo prizadetost več telesnih organov/ sistemov.
Almost all patients developing hypersensitivity reactions will have fever and/ or rash (usually maculopapular or urticarial) as part of the syndrome, however reactions have occurred without rash or fever.
Skoraj pri vseh bolnikih s preobčutljivostnimi reakcijami se, kot del sindroma, pojavi vročina in/ ali izpuščaj (navadno makulopapulozni in/ ali urtikarijski), pri nekaterih pa so se pojavile reakcije tudi brez izpuščaja ali vročine.
The signs and symptoms of this hypersensitivity reaction are listed below.
26 Znake in simptome takšne preobčutljivostne reakcije navajamo spodaj.
Fever, lethargy, malaise, oedema, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis
Drugo Vročina, letargija, slabo počutje, edemi, limfadenopatija, hipotenzija, konjunktivitis, anafilaksa
25 Musculoskeletal
Mišičnoskeletni
Rash (81% vs 67% respectively) and gastrointestinal manifestations (70% vs 54% respectively) were more frequently reported in children compared to adults.
Izpuščaj (81% v primerjavi s 67 54%) so se pogosteje pojavljale
To avoid a delay in diagnosis and minimise the risk of a life-threatening hypersensitivity reaction, Ziagen must be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible (respiratory diseases, flu-like illness, gastroenteritis or reactions to other medications).
Kadar ne moremo izključiti preobčutljivosti in da bi se izognili zamudi pri diagnosticiranju in čimbolj zmanjšali tveganje za pojav življenjsko nevarne preobčutljivostne reakcije, moramo z dajanjem zdravila Ziagen prenehati, čeprav bi bile možne tudi druge diagnoze (respiratorne bolezni, gripi podobna obolenja, gastroenteritis ali reakcije na druga zdravila).
Hypersensitivity reactions with rapid onset, including life-threatening reactions have occurred after restarting Ziagen in patients who had only one of the key symptoms of hypersensitivity (skin rash, fever, gastrointestinal, respiratory or constitutional symptoms such as lethargy and malaise) prior to stopping Ziagen.
27 Pri bolnikih, ki so imeli pred prenehanjem jemanja zdravila Ziagen samo enega od ključnih simptomov preobčutljivosti (kožni izpuščaj, vročino, gastrointestinalne, respiratorne ali konstitucionalne simptome, kakor sta letargija in slabo počutje), so po ponovnem začetku jemanja zdravila Ziagen naglo nastopile preobčutljivostne reakcije, vključno z življenjsko nevarnimi reakcijami.
Many of those listed below occur commonly (nausea, vomiting, diarrhoea, fever, lethargy, rash) in patients with abacavir hypersensitivity.
Mnogi od spodaj navedenih (slabost, bruhanje, driska, vročina, letargija, izpuščaj) se pogosto pojavijo pri bolnikih preobčutljivih za abakavir.
26 Many of the adverse reactions have not been treatment limiting.
Večina neželenih učinkov ni terjala omejitve zdravljenja.
Cases of lactic acidosis, sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of nucleoside analogues(see section 4.4).
Pri uporabi nukleozidnih analogov so poročali o primerih laktacidoze, včasih smrtne, običajno povezane z hudo hepatomegalijo in jetrno steatozo (glejte poglavje 4. 4).
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Sočasno zdravljenje z več protiretrovirusnimi zdravili je povezano z presnovnimi motnjami, kot so hipertrigliceridemija, hiperholesterolemija, inzulinska rezistenca, hiperglikemija in povišana koncentracija laktata v krvi (glejte poglavje 4. 4).
In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART) an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
28 Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - "combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe (glejte poglavje 4. 4).
In a meta-analysis of six clinical trials, TAMs were not selected by regimens containing abacavir without zidovudine (0/ 127), but were selected by regimens containing abacavir and the thymidine analogue zidovudine (22/ 86, 26%)..
V metaanalizi šestih kliničnih preskušanj pri režimu, ki je vseboval abakavir brez zidovudina (0/ 127), selekcije mutacij timidinskih analogov niso ugotovili, ugotovili pa so jo pri režimih, ki so vsebovali abakavir in timidinski analog zidovudin (22/ 86, 26%).
In a meta-analysis of five clinical trials where abacavir was added to intensify therapy, of 166 subjects, 123 (74%) had M184V/ I, 28 50 (30%) had T215Y/ F, 45 (27%) had M41L, 30 (18%) had K70R and 25 (15%) had D67N.
V metaanalizi petih kliničnih preskušanj, v katerih je bil abakavir dodan 166 osebam zaradi stopnjevanja zdravljenja, je 123 oseb (74%) imelo M184V/ I, 50 oseb (30%) T215Y/ F, 45 oseb (27%) M41L, 30 oseb (18%) K70R in 25 oseb (15%) D67N.
Week 4 Baseline (n = 166) Reverse
30 4. teden
29 One randomised, double blind, placebo controlled clinical study in adults has compared the combination of abacavir, lamivudine and zidovudine to the combination of indinavir, lamivudine and zidovudine.
V randomizirani, dvojno slepi in s placebom kontrolirani študiji na odraslih bolnikih so primerjali kombinacijo abakavirja, lamivudina in zidovudina s kombinacijo indinavirja, lamivudina in zidovudina.
In a multicentre, double-blind, controlled study (CNA30024), 654 HIV-infected, antiretroviral therapy-naïve patients were randomised to receive either abacavir 300 mg twice daily or zidovudine 300 mg twice daily, both in combination with lamivudine 150 mg twice daily and efavirenz 600 mg once daily.
V multicentrični, dvojno slepi, nadzorovani študiji (CNA30024) je bilo 654 z virusom HIV okuženih bolnikov, ki še niso bili zdravljeni s protiretrovirusnimi zdravili randomiziranih tako, da so bodisi prejemali abakavir v odmerku 300 mg dvakrat na dan bodisi zidovudin v odmerku 300 mg dvakrat na dan.
Virologic failure (HIV 32 weeks RNA > 200 copies/ ml) 144 weeks
Virološki neuspeh (HIV RNA > 200 kopij/ ml)
Virologic success (48 weeks HIV RNA < 50 copies/ ml)
Virološki uspeh (48 tednov HIV RNA < 50 kopij/ ml)
• Therapy naïve children
• Predhodno še nezdravljeni otroci
30 • Therapy experienced patients
32 • Predhodno že zdravljeni bolniki
In study ESS30008, 260 patients with virologic suppression on a first line therapy regimen containing abacavir 300 mg plus lamivudine 150 mg, both given twice daily and a PI or NNRTI, were randomised to continue this regimen or switch to abacavir/ lamivudine FDC plus a PI or NNRTI for 48 weeks.
260 bolnikov, pri katerih je pri predhodnem zdravljenju z abakavirjem v odmerku 300 mg dvakrat na dan in lamivudinom v odmerku 150 mg dvakrat na dan ter PI ali NNRTI prišlo do virusne supresije, je bilo nato v študiji ESS30008 randomiziranih tako, da so 48 tednov bodisi nadaljevali z opisanim režimom zdravljenja bodisi jim je bilo za isto obdobje uvedeno zdravljenje s kombinacijo abakavir/ lamivudin v fiksnem odmerku in PI ali NNRTI.
Results indicate that the FDC group was associated with a similar virologic outcome (non- inferior) compared to the abacavir plus lamivudine group, based on proportions of subjects with HIV- 1 RNA < 50 copies/ ml (90% and 85% respectively, 95% CI -2.7, 13.5).
Rezultati kažejo, da je bil v skupini, ki je prejemala kombinacijo abakavir/ lamivudin v fiksnem odmerku, virusni odziv podoben (enakovreden) odzivu v skupini, ki je prejemala abakavir in lamivudin (izhajajoč iz odstotka oseb s HIV- 1 RNA < 50 kopij/ ml (90% oziroma 85%; interval zaupanja 95%; - 2, 7; 13, 5)).
Additional information:
33 Dodatne informacije:
31 Abacavir penetrates the cerebrospinal fluid (CSF) (see section 5.2), and has been shown to reduce HIV-1 RNA levels in the CSF.
Abakavir prehaja v cerebrospinalno tekočino (CSF – » cerebrospinal fluid «) (glejte poglavje 5. 2) in izkazalo se je, da zmanjšuje raven HIV- 1 RNK v CSF.
In a crossover study in 27 HIV-infected patients, intracellular carbovir-TP exposures were higher for the abacavir 600 mg once daily regimen (AUC24, ss + 32%, Cmax24, ss + 99% and Ctrough + 18%) compared to the 300 mg twice daily regimen.
V navzkrižni študiji pri 27 bolnikih, okuženih z virusom HIV, je bila znotrajcelična izpostavljenost karbovir- TP- ju večja pri režimu odmerjanja abakavirja 600 mg enkrat na dan (AUC24, ss + 32%, Cmax24, ss + 99% in Ctrough + 18%) kot pri režimu odmerjanja 300 mg dvakrat
32 Special populations
Posebne populacije:
The majority of these tumours occurred at the highest abacavir dose of 330 mg/ kg/ day in mice and 600 mg/ kg/ day in rats.
Večina teh tumorjev se je razvila pri dajanju najvišjih odmerkov, to je 330 mg/ kg/ dan pri miših in 600 mg/ kg/ dan pri podganah.
The systemic exposure at the no effect level in mice and rats was equivalent to 3 and 7 times the human systemic exposure during therapy.
Sistemska izpostavljenost, ki na miših in podganah ni imela še nobenega karcinogenega učinka, je bila ekvivalentna 3 in 7- kratni vrednosti sistemske izpostavljenosti pri človeku med zdravljenjem.
There is no evidence from clinical studies that abacavir is hepatotoxic.
V kliničnih študijah ni dokazov, da bi bil
33 In reproductive toxicity studies, embryo and foetal toxicity have been observed in rats but not in rabbits.
V študijah reproduktivne toksičnosti so opazili embrionalno in fetalno toksičnost pri podganah, ne pa tudi pri kuncih.
Sorbitol 70% (E420) Saccharin sodium Sodium citrate Citric acid anhydrous Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Propylene glycol (E1520) Maltodextrin Lactic acid Glyceryl triacetate Natural and artificial strawberry and banana flavours Purified water Sodium hydroxide and/ or hydrochloric acid for pH adjustment.
sorbitol 70% (E420) natrijev saharinat natrijev citrat brezvodna citronska kislina metilparahidroksibenzoat (E218) propilparahidroksibenzoat (E216) propilenglikol (E1520) maltodekstrin mlečna kislina gliceriltriacetat naravna in umetna aroma jagode in banane prečiščena voda natrijev hidroksid in/ ali klorovodikova kislina za uravnavanje pH
A 10 ml polypropylene oral dosing syringe and a polyethylene adapter are also included in the pack.
Priložena je tudi 10 ml odmerna brizga za peroralno odmerjanje in polietilenski nastavek.
6.6 Special precautions for disposal and other handling
36 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
35 ANNEX II
37 DODATEK II
36 A.
A.
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Priory Street Ware Herts SG12 0DJ United Kingdom
Glaxo Wellcome UK Ltd (trading as Glaxo Wellcome Operations) Priory Street Ware Hertfordshire SG12 0DJ Velika Britanija
Medicinal product subject to restricted medical prescription (See Annex I Summary of Product Characteristics, 4.2).
Povzetek glavnih značilnosti zdravila, 4. 2).
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 02 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici 02 načrta za obvladovanje tveganja (RMP – Risk Management Plan), predstavljenem v
37 As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
39 modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
- When new information is received that may impact on the current Safety Specification,
- kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na
Pharmacovigilance Plan or risk minimisation activities
trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja;
- Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
- v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z
The Marketing Authorisation Holder will submit Periodic Safety Update Reports and other safety information annually.
Imetnik dovoljenja za promet bo letno pošiljal redna posodobljena poročila o varnosti zdravila (PSUR) in druge informacije povezane z varnostjo zdravila..
38 ANNEX III
40 DODATEK III
Each film-coated tablet contains abacavir 300 mg (as sulfate).
Vsaka filmsko obložena tableta vsebuje 300 mg abakavirja (v obliki sulfata)
“ Pull here” (with Alert card attached)
“ Povlecite tukaj ” (z pritrjeno opozorilno kartico)
41 ALERT CARD TEXT
43 BESEDILO NA OPOZORILNI KARTICI
IMPORTANT - ALERT CARD ZIAGEN (abacavir sulfate) Tablets Carry this card with you at all times
POMEMBNO - OPOZORILNA KARTICA ZIAGEN (abakavirjev sulfat) tablete To kartico vedno nosite s seboj