natgillin/translations-raw huggingface dataset:
Zerit 20 mg hard capsule
Zerit 20 mg trde kapsule
Each hard capsule contains 20 mg of stavudine.
Vsaka trda kapsula vsebuje 20 mg stavudina.
The hard capsule is brown, opaque and imprinted with “ BMS” over a BMS code “ 1965” on one side and “ 20” on the other side.
Trda kapsula je rjava, neprozorna, z oznako "BMS" nad BMS kodo “ 1965 ” na eni strani in “ 20 ” na drugi strani.
13 inappropriate, dose reduction of stavudine may be considered, while the symptoms of peripheral neuropathy are under close monitoring and satisfactory virological suppression is maintained.
14 primerno, se lahko razmisli o zmanjšanju odmerka stavudina, pri čemer je treba zagotoviti skrben nadzor nad simptomi periferne nevropatije in zagotoviti zadovoljivo zaviranje razmnoževanja virusa.
Liver disease: hepatitis or liver failure, which was fatal in some cases, has been reported.
Opisani so primeri hepatitisa ali odpovedi jeter, ki je bila v nekaterih primerih usodna.
The safety and efficacy of stavudine has not been established in patients with significant underlying liver
Varnost in učinkovitost stavudina nista ugotovljeni pri bolnikih s pomembno osnovno boleznijo jeter.
Any child exposed in utero to nucleoside and nucleotide analogues, even HIV-negative children, should
Vse otroke, tudi HIV- negativne, ki so bili in utero izpostavljeni nukleozidnim in nukleotidnim analogom, je treba klinično in laboratorijsko spremljati ter jih v primeru relevantnih znakov ali simptomov glede možne mitohondrijske disfunkcije temeljito preiskati.
Lactose intolerance: the hard capsule contains lactose (180 mg).
Trda kapsula vsebuje laktozo (180 mg).
16 the same medications as given to the mother, was given to the new-born infant within 36 hours of delivery and continued for 6 weeks.
Novorojenčki so dobivali protiretrovirusno profilakso z istim zdravilom, kot ga je jemala mati; prvič so ga dobili v 36 urah po rojstvu in so ga prejemali 6 tednov.
17 Immune reactivation syndrome: 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).
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).
Endocrine disorders:
19 Bolezni endokrinega sistema:
18 *Lipoatrophy was observed in a long-term follow-up study of stavudine in combination with lamivudine and efavirenz (total follow-up: median 148 weeks ranging up to 207 weeks).
v kateri so dolgotrajno spremljali uporabo stavudina v kombinaciji z čas spremljanja: srednji čas 148 tednov; razpon do 207 tednov).
Relevant grade 3-4 laboratory abnormalities in the 91 stavudine treated infants were low neutrophils in 7%, low hemoglobin in 1%, ALT increase in 1% and no lipase abnormality.
20 stavudinom so bile: majhno število nevtrofilcev pri 7%, nizek hemoglobin pri 1% in zvišanje ALT pri 1%; nenormalnosti lipaze ni bilo.
Stavudine treatment can select for and/ or maintain mutations associated with zidovudine resistance.
21 Zdravljenje s stavudinom lahko selekcionira in/ ali ohrani mutacije, povezane z odpornostjo proti zidovudinu.
20 The results of AI455-099 and AI455-096 are presented in the table below:
Rezultati raziskav AI455- 099 in AI455- 096 so prikazani v spodnji tabeli:
In eight patients receiving 40 mg twice daily in the fasted state, steady-state AUC0-12h was 1284±227 ng⋅ h/ ml (18%) (mean ± SD [% CV]), Cmax was 536±146 ng/ ml (27%), and Cmin was 9±8 ng/ ml (89%).
22 Pri osmih bolnikih, ki so dobivali 40 mg dvakrat na dan na tešče, je bila AUC0- 12h v stanju dinamičnega ravnovesja 1284 ± 227 ng⋅ur/ ml (18%) (srednja vrednost ± SD [% IZ]), Cmax 536 ± 146 ng/ ml (27%) in Cmin 9 ± 8 ng/ ml (89%).
21 pharmacokinetic characteristics of stavudine is low, approximately 15% and 25%, respectively, after oral administration.
Intra - in interindividualne razlike v farmakokinetičnih značilnostih stavudina po peroralni uporabi so majhne (približno 15% intra - in 25% interindividualno).
Stavudine was carcinogenic in mice (liver tumours) and rats (liver tumours: cholangiocellular, hepatocellular, mixed hepatocholangiocellular, and/ or vascular; and urinary bladder carcinomas) at very high exposure levels.
23 Stavudin je bil pri zelo visoki ravni izpostavljenosti kancerogen pri miših (tumorji jeter) in podganah (tumorji jeter – holangiocelularni, hepatocelularni, mešani hepatoholangiocelularni – in/ ali žilni ter karcinomi sečnega mehurja).
Zerit 30 mg hard capsule
Zerit 30 mg trde kapsule
Each hard capsule contains 30 mg of stavudine.
Vsaka trda kapsula vsebuje 30 mg stavudina.
The hard capsule is light and dark orange, opaque and imprinted with “ BMS” over a BMS code “ 1966” on one side and “ 30” on the other side.
Trda kapsula je svetlo in temno oranžna, neprozorna, z oznako "BMS" nad BMS kodo “ 1966 ” na eni strani in “ 30 ” na drugi strani.
24 inappropriate, dose reduction of stavudine may be considered, while the symptoms of peripheral neuropathy are under close monitoring and satisfactory virological suppression is maintained.
26 primerno, se lahko razmisli o zmanjšanju odmerka stavudina, pri čemer je treba zagotoviti skrben nadzor nad simptomi periferne nevropatije in zagotoviti zadovoljivo zaviranje razmnoževanja virusa.
27 the same medications as given to the mother, was given to the new-born infant within 36 hours of delivery and continued for 6 weeks.
Novorojenčki so dobivali protiretrovirusno profilakso z istim zdravilom, kot ga je jemala mati; prvič so ga dobili v 36 urah po rojstvu in so ga prejemali 6 tednov.
28 Immune reactivation syndrome: 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).
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).
Endocrine disorders:
31 Bolezni endokrinega sistema:
29 *Lipoatrophy was observed in a long-term follow-up study of stavudine in combination with lamivudine and efavirenz (total follow-up: median 148 weeks ranging up to 207 weeks).
v kateri so dolgotrajno spremljali uporabo stavudina v kombinaciji z čas spremljanja: srednji čas 148 tednov; razpon do 207 tednov).
Relevant grade 3-4 laboratory abnormalities in the 91 stavudine treated infants were low neutrophils in 7%, low hemoglobin in 1%, ALT increase in 1% and no lipase abnormality.
32 stavudinom so bile: majhno število nevtrofilcev pri 7%, nizek hemoglobin pri 1% in zvišanje ALT pri 1%; nenormalnosti lipaze ni bilo.
30 4.9 Overdose
4. 9 Preveliko odmerjanje
Stavudine treatment can select for and/ or maintain mutations associated with zidovudine resistance.
33 Zdravljenje s stavudinom lahko selekcionira in/ ali ohrani mutacije, povezane z odpornostjo proti zidovudinu.
31 The results of AI455-099 and AI455-096 are presented in the table below:
Rezultati raziskav AI455- 099 in AI455- 096 so prikazani v spodnji tabeli:
In eight patients receiving 40 mg twice daily in the fasted state, steady-state AUC0-12h was 1284±227 ng⋅ h/ ml (18%) (mean ± SD [% CV]), Cmax was 536±146 ng/ ml (27%), and Cmin was 9±8 ng/ ml (89%).
34 Pri osmih bolnikih, ki so dobivali 40 mg dvakrat na dan na tešče, je bila AUC0- 12h v stanju dinamičnega ravnovesja 1284 ± 227 ng⋅ur/ ml (18%) (srednja vrednost ± SD [% IZ]), Cmax 536 ± 146 ng/ ml (27%) in Cmin 9 ± 8 ng/ ml (89%).
32 pharmacokinetic characteristics of stavudine is low, approximately 15% and 25%, respectively, after oral administration.
Intra - in interindividualne razlike v farmakokinetičnih značilnostih stavudina po peroralni uporabi so majhne (približno 15% intra - in 25% interindividualno).
Stavudine was carcinogenic in mice (liver tumours) and rats (liver tumours: cholangiocellular, hepatocellular, mixed hepatocholangiocellular, and/ or vascular; and urinary bladder carcinomas) at very high exposure levels.
35 Stavudin je bil pri zelo visoki ravni izpostavljenosti kancerogen pri miših (tumorji jeter) in podganah (tumorji jeter – holangiocelularni, hepatocelularni, mešani hepatoholangiocelularni – in/ ali žilni ter karcinomi sečnega mehurja).
Zerit 40 mg hard capsule
Zerit 40 mg trde kapsule
Each hard capsule contains 40 mg of stavudine.
Vsaka trda kapsula vsebuje 40 mg stavudina.
The hard capsule is dark orange, opaque and imprinted with “ BMS” over a BMS code “ 1967” on one side and “ 40” on the other side.
Trda kapsula je temno oranžna, neprozorna, z oznako "BMS" nad BMS kodo “ 1967 ” na eni strani in “ 40 ” na drugi strani.
35 inappropriate, dose reduction of stavudine may be considered, while the symptoms of peripheral neuropathy are under close monitoring and satisfactory virological suppression is maintained.
38 primerno, se lahko razmisli o zmanjšanju odmerka stavudina, pri čemer je treba zagotoviti skrben nadzor nad simptomi periferne nevropatije in zagotoviti zadovoljivo zaviranje razmnoževanja virusa.
Lactose intolerance: the hard capsule contains lactose (240 mg).
Trda kapsula vsebuje laktozo (240 mg).
38 the same medications as given to the mother, was given to the new-born infant within 36 hours of delivery and continued for 6 weeks.
Novorojenčki so dobivali protiretrovirusno profilakso z istim zdravilom, kot ga je jemala mati; prvič so ga dobili v 36 urah po rojstvu in so ga prejemali 6 tednov.
39 Immune reactivation syndrome: 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).
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).
Endocrine disorders:
43 Bolezni endokrinega sistema:
40 *Lipoatrophy was observed in a long-term follow-up study of stavudine in combination with lamivudine and efavirenz (total follow-up: median 148 weeks ranging up to 207 weeks).
v kateri so dolgotrajno spremljali uporabo stavudina v kombinaciji z čas spremljanja: srednji čas 148 tednov; razpon do 207 tednov).
Relevant grade 3-4 laboratory abnormalities in the 91 stavudine treated infants were low neutrophils in 7%, low hemoglobin in 1%, ALT increase in 1% and no lipase abnormality.
44 stavudinom so bile: majhno število nevtrofilcev pri 7%, nizek hemoglobin pri 1% in zvišanje ALT pri 1%; nenormalnosti lipaze ni bilo.
41 4.9 Overdose
4. 9 Preveliko odmerjanje
Stavudine treatment can select for and/ or maintain mutations associated with zidovudine resistance.
45 Zdravljenje s stavudinom lahko selekcionira in/ ali ohrani mutacije, povezane z odpornostjo proti zidovudinu.
42 The results of AI455-099 and AI455-096 are presented in the table below:
Rezultati raziskav AI455- 099 in AI455- 096 so prikazani v spodnji tabeli:
In eight patients receiving 40 mg twice daily in the fasted state, steady-state AUC0-12h was 1284±227 ng⋅ h/ ml (18%) (mean ± SD [% CV]), Cmax was 536±146 ng/ ml (27%), and Cmin was 9±8 ng/ ml (89%).
46 Pri osmih bolnikih, ki so dobivali 40 mg dvakrat na dan na tešče, je bila AUC0- 12h v stanju dinamičnega ravnovesja 1284 ± 227 ng⋅ur/ ml (18%) (srednja vrednost ± SD [% IZ]), Cmax 536 ± 146 ng/ ml (27%) in Cmin 9 ± 8 ng/ ml (89%).
43 pharmacokinetic characteristics of stavudine is low, approximately 15% and 25%, respectively, after oral administration.
Intra - in interindividualne razlike v farmakokinetičnih značilnostih stavudina po peroralni uporabi so majhne (približno 15% intra - in 25% interindividualno).
Stavudine was carcinogenic in mice (liver tumours) and rats (liver tumours: cholangiocellular, hepatocellular, mixed hepatocholangiocellular, and/ or vascular; and urinary bladder carcinomas) at very high exposure levels.
47 Stavudin je bil pri zelo visoki ravni izpostavljenosti kancerogen pri miših (tumorji jeter) in podganah (tumorji jeter – holangiocelularni, hepatocelularni, mešani hepatoholangiocelularni – in/ ali žilni ter karcinomi sečnega mehurja).
The powder contains 200 mg of stavudine.
Prašek vsebuje 200 mg stavudina.
Zerit powder appears as off-white to pale-pink, gritty powder.
Zerit prašek je sivobel do bledo rožnat zrnat prašek.
Patient weight < 60 kg ≥ 60 kg
Bolnikova telesna masa < 60 kg ≥ 60 kg
Zerit dosage 30 mg twice daily (every 12 hours) 40 mg twice daily (every 12 hours)
Odmerek zdravila Zerit 30 mg dvakrat na dan (na 12 ur) 40 mg dvakrat na dan (na 12 ur)
Adolescents, children and infants: the recommended dosage is:
Priporočeno odmerjanje je:
Patient age and/ or weight From birth* to 13 days old
Bolnikova starost in/ ali telesna masa od rojstva * do 13. dne starosti starost vsaj 14 dni in telesna masa < 30 kg ≥ 30 kg
Zerit dosage 0.5 mg/ kg twice daily (every 12 hours)
Odmerek zdravila Zerit 0, 5 mg/ kg dvakrat na dan (na 12 ur) 1 mg/ kg dvakrat na dan (na 12 ur) odmerjanje je enako kot za odrasle
*The reduced posology in neonates from 0 to 13 days is based on average study data and may not correspond to invidual variation in kidney maturation.
* Zmanjšano odmerjanje pri novorojenčkih, starih od 0 do 13 dni, temelji na povprečnih raziskovalnih podatkih, zato se lahko zgodi, da ne ustreza individualnim razlikam v dozorevanju ledvic.
For optimal absorption, Zerit should be taken on an empty stomach (i. e. at least 1 hour prior to meals) but, if this is not possible, it may be taken with a light meal.
Za optimalno absorpcijo je treba zdravilo Zerit vzeti na prazen želodec (tj. vsaj 1 uro pred obroki); če to ni mogoče, ga je mogoče vzeti z lahkim obrokom.
Instructions for preparation, see section 6.6.
Za navodila za pripravo glejte poglavje 6. 6.
In the rare cases when this is
Če se pojavijo simptomi periferne nevropatije (njena značilnost so ponavadi dolgotrajna omrtvelost, mravljinčenje ali bolečine v stopalih in/ ali dlaneh) (glejte poglavje 4. 4), je
46 inappropriate, dose reduction of stavudine may be considered, while the symptoms of peripheral neuropathy are under close monitoring and satisfactory virological suppression is maintained.
V redkih primerih, v katerih to ni primerno, se lahko razmisli o zmanjšanju odmerka stavudina, pri čemer je treba zagotoviti skrben nadzor nad simptomi periferne nevropatije in zagotoviti zadovoljivo zaviranje razmnoževanja virusa.
Treatment with NRTIs should be discontinued if there is symptomatic hyperlactatemia and metabolic/ lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Če se pojavijo simptomatska hiperlaktatemija in metabolična acidoza/ laktacidoza, napredujoča hepatomegalija ali hitro zviševanje aminotransferaz, je treba zdravljenje z zaviralci nukleozidne in nukleotidne reverzne transkriptaze prekiniti.
A connection between visceral lipomatosis and Protease Inhibitors and lipoatrophy and NRTIs has been hypothesised.
Domnevajo, da obstaja povezava med visceralno lipomatozo in zaviralci proteaz ter lipoatrofijo in nukleozidnimi in nukleotidnimi zaviralci reverzne transkriptaze.
Osteonecrosis: although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/ or long-term exposure to combination antiretroviral therapy (CART).
Bolnikom je
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
52 treba svetovati, naj poiščejo zdravniško pomoč, če se jim pojavijo bolečine v sklepih, togost sklepov ali težave z gibljivostjo.
Diabetic patients: the reconstituted powder for oral solution contains 50 mg sucrose per ml of reconstituted solution.
Pripravljeni prašek za peroralno raztopino vsebuje 50 mg saharoze na ml pripravljene raztopine.
Infants under the age of 3 months: safety data is available from clinical trials up to 6 weeks of treatment in 179 newborns and infants < 3 months of age (see section 4.6).
Na voljo so podatki o varnosti iz kliničnih preskušanj, ki so zajele do 6- tedensko zdravljenje pri 179 novorojenčkih in dojenčkih, mlajših od 3 mesecev (glejte poglavje 4. 8).
48 Some late-onset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour).
Poročali so o nekaterih primerih nevroloških motenj, ki nastopijo kasneje (hipertonija, konvulzije, nenormalno obnašanje).
Stavudine does not inhibit the major cytochrome P450 isoforms CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4; therefore, it is unlikely that clinically significant drug interactions will occur with drugs metabolised through these pathways.
53 Stavudin ne zavira glavnih izooblik citokroma P450 CYP1A2, CYP2C9, CYP2C19, CYP2D6 in CYP3A4, zato ni verjetno, da bi se pojavile klinično pomembne interakcije z zdravili, ki se presnavljajo po teh poteh.
Antiretroviral prophylaxis, the same medications as given to the mother, was given to the new-born infant within 36 hours of
Novorojenčki so dobivali protiretrovirusno profilakso z istim zdravilom, kot ga je jemala mati; prvič so ga dobili v 36 urah po rojstvu in so ga prejemali 6 tednov.
50 Immune reactivation syndrome: 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).
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).
Endocrine disorders:
55 Bolezni endokrinega sistema:
51 *Lipoatrophy was observed in a long-term follow-up study of stavudine in combination with lamivudine and efavirenz (total follow-up: median 148 weeks ranging up to 207 weeks).
* Lipoatrofijo so opazili v študiji, v kateri so dolgotrajno spremljali uporabo stavudina v kombinaciji z lamivudinom in efavirenzem (celoten čas spremljanja: srednji čas 148 tednov; razpon do 207 tednov).
Relevant grade 3-4 laboratory abnormalities in the 91 stavudine treated infants were low neutrophils in 7%, low hemoglobin in 1%, ALT increase in 1% and no lipase abnormality.
Pomembne laboratorijske nenormalnosti 3. do 4. stopnje pri 91 dojenčkih, zdravljenih s stavudinom so bile: majhno število nevtrofilcev pri 7%, nizek hemoglobin pri 1% in zvišanje ALT pri
52 4.9 Overdose
4. 9 Preveliko odmerjanje
It also inhibits viral DNA synthesis by causing DNA chain termination due to a lack of the 3’ -hydroxyl group necessary for DNA elongation.
Zavira tudi sintezo virusne DNA, ker povzroči zaključitev verige DNA zaradi pomanjkanja 3 ’ - hidroksilne skupine, potrebne za podaljševanje DNA.
Stavudine treatment can select for and/ or maintain mutations associated with zidovudine resistance.
57 Zdravljenje s stavudinom lahko selekcionira in/ ali ohrani mutacije, povezane z odpornostjo proti zidovudinu.
Study AI455-099 was a 48-week, randomised, double-blind study withZerit (40 mg twice daily), in combination with lamivudine (150 mg twice daily) plus efavirenz (600 mg once daily), in 391 treatment-naive patients, with a median CD4 cell count of 272 cells/ mm3 (range 61 to 1,215 cells/ mm3) and a median plasma HIV-1 RNA of 4.80 log10 copies/ ml (range 2.6 to 5.9 log 10 copies/ ml) at baseline.
Srednja vrednost števila celic CD4 v izhodišču je bila 272 celic/ mm3 (razpon od 61 do 1. 215 celic/ mm3), srednja vrednost HIV- 1 RNA v plazmi pa 4, 80 log10 kopij/ ml (razpon 2, 6 do 5, 9 log 10 kopij/ ml).
53 The results of AI455-099 and AI455-096 are presented in the table below:
Rezultati raziskav AI455- 099 in AI455- 096 so prikazani v spodnji tabeli:
Percent of Percent of
Srednja sprememba HIV RNA od
HIV RNA
kopij/ ml
CD4 Mean
kopij/ ml
AI455-099 (48 weeks) b
AI455- 099 (48 tednov) b
+182
- 2, 83 +182
+195
- 2, 64 +195
In eight patients receiving 40 mg twice daily in the fasted state, steady-state AUC0-12h was 1284±227 ng⋅ h/ ml (18%) (mean ± SD [% CV]), Cmax was 536±146 ng/ ml (27%), and Cmin was 9±8 ng/ ml (89%).
58 Pri osmih bolnikih, ki so dobivali 40 mg dvakrat na dan na tešče, je bila AUC0– 12h v stanju dinamičnega ravnovesja 1284 ± 227 ng⋅ur/ ml (18%) (srednja vrednost ± SD [% IZ]), Cmax 536 ± 146 ng/ ml (27%) in Cmin 9 ± 8 ng/ ml (89%).
54 pharmacokinetic characteristics of stavudine is low, approximately 15% and 25%, respectively, after oral administration.
Intra - in interindividualne razlike v farmakokinetičnih značilnostih stavudina po peroralni uporabi so majhne (približno 15% intra - in 25% interindividualno).
Stavudine was carcinogenic in mice (liver tumours) and rats (liver tumours: cholangiocellular, hepatocellular, mixed hepatocholangiocellular, and/ or vascular; and urinary bladder carcinomas) at very high exposure levels.
59 Stavudin je bil pri zelo visoki ravni izpostavljenosti kancerogen pri miših (tumorji jeter) in podganah (tumorji jeter – holangiocelularni, hepatocelularni, mešani hepatoholangiocelularni – in/ ali žilni ter karcinomi sečnega mehurja).
Cherry flavour Methylhydroxybenzoate (E218) Propylhydroxybenzoate (E216) Silicon dioxide Simethicone Sodium carmellose Sorbic acid Stearate emulsifiers Sucrose
aroma češnje metilparahidroksibenzoat (E218) propilparahidroksibenzoat (E216) silicijev dioksid simetikon natrijev karmelozat sorbinska kislina stearatni emulgatorji saharoza
55 After reconstitution, the prepared oral solution is stable for 30 days in a refrigerator (2°C-8°C).
Po rekonstituciji je pripravljena peroralna raztopina stabilna 30 dni, če se jo shranjuje v hladilniku (2°C - 8°C).
Do not store the dry powder above 30°C.
Suhi prašek shranjujte pri temperaturi do 30°C.
After reconstitution, store in a refrigerator (2°C-8°C).
Po rekonstituciji shranjujte v hladilniku (2°C - 8°C).
Instructions for preparation Reconstitute with water to a 200 ml deliverable volume solution (stavudine concentration of 1 mg/ ml): add 202 ml of water to the original bottle (when the patient makes up the solution, they should be instructed to fill to the mark).
V originalno stekleničko dodajte 202 ml vode (če raztopino pripravlja bolnik, mu je treba naročiti, naj napolni do oznake).
Shake the bottle well until the powder dissolves completely.
Stekleničko dobro pretresite, dokler se prašek povsem ne raztopi.
Dispense the solution with the measuring cup provided, or for doses less than 10 ml, dispense with a syringe.
Odmerite raztopino s priloženo odmerno čašo, odmerke, manjše od 10 ml, pa z brizgo.
The patient should be instructed to shake the bottle well prior to measuring each dose.
Bolniku je treba naročiti, da mora stekleničko pred vsakim odmerjanjem dobro pretresti.
Disposal Any unused product or waste material should be disposed of in accordance with local requirements.
60 Odstranjevanje Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
56 ANNEX II
61 DODATEK II
57 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
62 A IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Bristol-Myers Squibb, Champ “ Lachaud”, La Goualle, 19250 Meymac, France
Bristol- Myers Squibb, Champ “ Lachaud ”, La Goualle, 19250 Meymac, Francija
Periodic Safety Update Reports (PSUR’ s):
Redno poročilo o neželjenih, škodljivih učinkih zdravila (PSUR’ s):
The Marketing Authorisation Holder will submit yearly PSUR’ s
Imetnik dovoljenja za promet bo PSUR oddajal letno.
58 ANNEX III
63 DODATEK III