natgillin/translations-raw huggingface dataset:
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, the following additional adverse reactions were reported in > 2% of patients and in excess of placebo:
Pri diabetičnih bolnikih z visokim krvnim tlakom s kronično ledvično insuficienco in izraženo proteinurijo so pri > 2% bolnikov in več kot pri placebu dodatno poročali o naslednjih neželenih učinkih:
orthostatic dizziness
ortostatska omotica.
orthostatic hypotension
ortostatska hipotenzija.
Musculoskeletal, connective tissue and bone disorders:
Bolezni kosti, sklepov, mišic in vezivnega tkiva:
musculoskeletal pain
mišičnoskeletna bolečina.
Hyperkalaemia occurred more often in diabetic patients treated with irbesartan than with placebo.
Hiperkaliemija se je pojavljala pri diabetičnih bolnikih zdravljenih z irbesartanom pogosteje kot pri bolnikih, ki so dobivali placebo.
In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 29.4% (i. e. very common) of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
Pri diabetičnih bolnikih z visokim krvnim tlakom z mikroalbuminurijo in normalno ledvično funkcijo, se je hiperkaliemija (≥5, 5 mEq/ l) pojavila pri 29, 4% bolnikov (to je zelo pogosto), ki so prejemali 300 mg irbesartana in pri 22% bolnikov v skupini s placebom.
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 46.3% (i. e. very common) of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
Pri diabetičnih bolnikih z visokim krvnim tlakom s kronično ledvično insuficienco in izraženo proteinurijo, se je hiperkaliemija (≥5, 5 mEq/ l) pojavila pri 46, 3% bolnikov (to je zelo pogosto), ki so dobivali irbesartan in pri 26, 3% bolnikov v placebo skupini.
A decrease in haemoglobin, which was not clinically significant, has been observed in 1.7% (i. e. common) of hypertensive patients with advanced diabetic renal disease treated with irbesartan.
Znižanje hemoglobina, ki ni bilo klinično pomembno, so opazili pri 1, 7% bolnikov (to je pogosto) z visokim krvnim tlakom z napredovalo diabetično ledvično boleznijo, ki so jih zdravili z irbesartanom.
The following additional adverse reactions have been reported during post– marketing experience; they are derived from spontaneous reports for which incidences cannot be determined:
Po pridobitvi dovoljenja za promet so poročali o naslednjih dodatnih neželenih učinkih, ki izhajajo iz spontanih poročil, za katere pojavnosti ni bilo možno določiti:
As with other angiotensin-II receptor antagonists, rare cases of hypersensitivity reactions such as rash, urticaria, angioedema have been reported
Kot pri drugih antagonistih angiotenzina II, so poročali o redkih primerih preobčutljivostnih reakcij, kot so izpuščaj, koprivnica in angioedem.
Hyperkalaemia
Hiperkaliemija.
6 Nervous system disorders:
6 Bolezni živčevja:
Tinnitus
Tinitus.
Dysgeusia
Paragevzija.
Hepatitis, abnormal liver function
Hepatitis, nenormalno delovanje jeter.
Arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps
Artralgija, mialgija (v nekaterih primerih sta bili povezani z zvišanjem ravni kreatin- kinaze v plazmi), mišični krči.
No specific information is available on the treatment of overdose with Irbesartan BMS.
Specifični podatki o zdravljenju predoziranja z zdravilom Irbesartan BMS niso na voljo.
Activated charcoal may be useful in the treatment of overdose.
Aktivno oglje je lahko koristno pri zdravljenju predoziranja.
Angiotensin-II antagonists, plain.
Farmakoterapevtska skupina: antagonisti angiotenzina II, enokomponentna zdravila.
Mechanism of action: it is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II.
Mehanizem delovanja: pričakovani učinek je blokada vseh učinkov angiotenzina II, ki se prenašajo preko receptorja AT1, ne glede na izvor ali sintezno pot angiotenzina- II.
7 Clinical efficacy:
7 Klinična učinkovitost:
Once daily dosing with 150 mg produced trough and mean 24 hour responses similar to twice daily dosing on the same total dose.
Enkratno dnevno odmerjanje 150 mg povzroči podoben celoten in povprečni 24- urni odziv kot dvakrat dnevno odmerjanje istega celotnega odmerka.
The blood pressure lowering effect of Irbesartan BMS is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
Učinek zdravila Irbesartan BMS na znižanje krvnega tlaka je viden po 1- 2 tednih, največji učinek pa nastopi 4- 6 tednov po začetku zdravljenja.
In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/ day and serum creatinine ranging from 1.0-3.0 mg/ dl, the long-term effects (mean 2.6 years) of Irbesartan BMS on the progression of renal disease and all-cause mortality were examined.
Pri 1. 715 bolnikih z visokim krvnim tlakom z diabetesom tipa 2, proteinurijo ≥900 mg/ dan in serumskim kreatininom 1, 0- 3, 0 mg/ dl, so raziskovali dolgotrajne učinke zdravila Irbesartan BMS (povprečje 2, 6 let) na napredovanje ledvične bolezni in na celokupno smrtnost.
Patients were titrated from 75 mg to a maintenance dose of 300 mg Irbesartan BMS, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Bolnikom so postopoma povečevali odmerek zdravila Irbesartan BMS od 75 mg do vzdrževalnega odmerka 300 mg, odmerek amlodipina od 2, 5 do 10 mg, oziroma placeba, kot so ga prenesli.
Sixty per cent (60%) of patients in the placebo group reached this target blood pressure whereas this figure was 76% and 78% in the irbesartan and amlodipine groups respectively.
Irbesartan je pomembno znižal tveganje za primarno povezan izid podvojitve serumskega
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality.
8 kreatinina, zadnje faze ledvične bolezni (ESRD) in celokupne smrtnosti.
When the individual components of the primary endpoint were
Približno 33% bolnikov v skupini z irbesartanom je doseglo primarno povezan ledvični izid v primerjavi s 39% pri placebu in 41% v skupini z amlodipinom [20% relativno zmanjšanje tveganja v primerjavi s placebom (p = 0, 024) in 23% relativno zmanjšanje tveganja v primerjavi z amlodipinom (p = 0, 006)].
8 analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
Pri podrobnem proučevanju posameznih komponent primarnega izida, niso opazili učinka na celokupno smrtnost, pač pa pozitivno tendenco pri zniževanju ESRD in pomembno zmanjšanje podvojitve serumskega kreatinina.
The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Preskušanje delovanja irbesartana na mikroalbuminurijo pri bolnikih z visokim krvnim tlakom z diabetesom melitusom tipa 2 (IRMA 2), je pokazalo, da pri bolnikih z mikroalbuminurijo, 300 mg irbesartana odloži napredovanje do izražene proteinurije.
The study examined the long-term effects (2 years) of Irbesartan BMS on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/ day, and an increase in UAER of at least 30% from baseline).
V raziskavi so proučevali dolgotrajne učinke (2 leti) zdravila Irbesartan BMS na napredovanje v klinično proteinurijo (hitrost izločanja albuminov z urinom - “ urinary albumin excretion rate ” - UAER > 300 mg/ dan in povečanje UAER- a najmanj za 30% začetne vrednosti).
Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing.
Omejeno kopičenje irbesartana (< 20%) v plazmi so opazili ob ponovitvah enkrat -
9 However the terminal half-life was not significantly altered.
V študiji so opazili nekoliko večjo koncentracijo irbesartana pri bolnicah z visokim krvnim tlakom.
The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/ kg) up to a maximum daily dose of 150 mg for four weeks.
Farmakokinetiko irbesartana so ocenili pri 23 hipertenzivnih otrocih po uporabi posamičnega in večkratnih dnevnih odmerkov irbesartana (2 mg/ kg) do največjega dnevnega odmerka 150 mg štiri tedne.
Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Poloxamer 188
mikrokristalna celuloza premreženi natrijev karmelozat laktoza monohidrat magnezijev stearat koloidni hidratirani silicijev dioksid
10 6.2 Incompatibilities
10 predgelirani koruzni škrob poloksamer 188
14 tablets 28 tablets 56 tablets 98 tablets PVC/ PVDC/ Aluminium blisters
14 tablet 28 tablet 56 tablet 98 tablet PVC/ PVDC/ aluminijski pretisni omoti.
56 x 1 tablets PVC/ PVDC/ Aluminium perforated unit dose blisters
56 x 1 tablet PVC/ PVDC/ aluminijski perforirani pretisni omoti za enkratni odmerek.
BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - United Kingdom
BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - Velika Britanija
19 January 2007 Date of last renewal:
19. januar 2007 Datum zadnjega podaljšanja dovoljenja za promet:
Each tablet contains 150 mg irbesartan.
Vsaka tableta vsebuje 150 mg irbesartana.
12 Elderly patients: although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
12 Starejši bolniki: čeprav je treba pretehtati možnost uporabe začetnega odmerka 75 mg pri bolnikih starejših od 75 let, običajno pri starejših prilagajanje odmerka ni potrebno.
13 As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1).
13 Kot so že opazili pri zaviralcih ACE, so irbesartan in drugi antagonisti angiotenzina izrazito manj učinkoviti pri zniževanju krvnega tlaka pri temnopoltih ljudeh kot pri drugih ne- temnopoltih, verjetno zaradi večje prevalence stanj z nizko vrednostjo renina pri temnopoltih bolnikih z visokim krvnim tlakom (glejte poglavje 5. 1).
15 Respiratory, thoracic and mediastinal disorders:
15 Bolezni dihal, prsnega koša in mediastinalnega prostora:
16 Nervous system disorders:
16 Bolezni živčevja:
17 Clinical efficacy:
17 Klinična učinkovitost:
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality.
18 kreatinina, zadnje faze ledvične bolezni (ESRD) in celokupne smrtnosti.
18 analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
Pri podrobnem proučevanju posameznih komponent primarnega izida, niso opazili učinka na celokupno smrtnost, pač pa pozitivno tendenco pri zniževanju ESRD in pomembno zmanjšanje podvojitve serumskega kreatinina.
19 However the terminal half-life was not significantly altered.
V študiji so opazili nekoliko večjo koncentracijo irbesartana pri bolnicah z visokim krvnim tlakom.
20 6.2 Incompatibilities
20 predgelirani koruzni škrob poloksamer 188
Each tablet contains 300 mg irbesartan.
Vsaka tableta vsebuje 300 mg irbesartana.
22 Elderly patients: although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
22 Starejši bolniki: čeprav je treba pretehtati možnost uporabe začetnega odmerka 75 mg pri bolnikih starejših od 75 let, običajno pri starejših prilagajanje odmerka ni potrebno.
23 As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1).
23 Kot so že opazili pri zaviralcih ACE, so irbesartan in drugi antagonisti angiotenzina izrazito manj učinkoviti pri zniževanju krvnega tlaka pri temnopoltih ljudeh kot pri drugih ne- temnopoltih, verjetno zaradi večje prevalence stanj z nizko vrednostjo renina pri temnopoltih bolnikih z visokim krvnim tlakom (glejte poglavje 5. 1).
24 4.6 Pregnancy and lactation
24 4. 6 Nosečnost in dojenje
25 Respiratory, thoracic and mediastinal disorders:
25 Bolezni dihal, prsnega koša in mediastinalnega prostora:
26 Nervous system disorders:
26 Bolezni živčevja:
27 Clinical efficacy:
27 Klinična učinkovitost:
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality.
28 kreatinina, zadnje faze ledvične bolezni (ESRD) in celokupne smrtnosti.
28 analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
Pri podrobnem proučevanju posameznih komponent primarnega izida, niso opazili učinka na celokupno smrtnost, pač pa pozitivno tendenco pri zniževanju ESRD in pomembno zmanjšanje podvojitve serumskega kreatinina.
29 However the terminal half-life was not significantly altered.
V študiji so opazili nekoliko večjo koncentracijo irbesartana pri bolnicah z visokim krvnim tlakom.
30 6.2 Incompatibilities
30 predgelirani koruzni škrob poloksamer 188
Irbesartan BMS 75 mg film-coated tablets.
Irbesartan BMS 75 mg filmsko obložene tablete
Each film-coated tablet contains 75 mg irbesartan.
Vsaka filmsko obložena tableta vsebuje 75 mg irbesartana.
25.50 mg of lactose monohydrate per film-coated tablet.
25, 50 mg laktoze monohidtata na filmsko obloženo tableto.
32 Elderly patients: although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
32 Starejši bolniki: čeprav je treba pretehtati možnost uporabe začetnega odmerka 75 mg pri bolnikih starejših od 75 let, običajno pri starejših prilagajanje odmerka ni potrebno.
Hypersensitivity to the active substances or to any of the excipients (see section 6.1).
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte poglavje 6. 1).
33 As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1).
33 Kot so že opazili pri zaviralcih ACE, so irbesartan in drugi antagonisti angiotenzina izrazito manj učinkoviti pri zniževanju krvnega tlaka pri temnopoltih ljudeh kot pri drugih ne- temnopoltih, verjetno zaradi večje prevalence stanj z nizko vrednostjo renina pri temnopoltih bolnikih z visokim krvnim tlakom (glejte poglavje 5. 1).
34 4.6 Pregnancy and lactation
34 4. 6 Nosečnost in dojenje
AIIRAs therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). (see section 5.3).
Znano je, da izpostavljenost antagonistom angiotenzina II v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnij, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (odpoved ledvic, hipotenzija, hiperkaliemija) (glejte poglavje 5. 3).
flushing
rdečica
35 Respiratory, thoracic and mediastinal disorders:
35 Bolezni dihal, prsnega koša in mediastinalnega prostora:
nausea/ vomiting diarrhea, dyspepsia/ heartburn
slabost/ bruhanje driska, dispepsija / zgaga
fatigue chest pain
spremembe na mestu aplikacije: utrujenost bolečina v prsih
musculoskeletal pain
mišičnoskeletna bolečina
36 Nervous system disorders:
36 Bolezni živčevja:
Pharmacotherapeutic group: angiotensin-II antagonists, plain.
Farmakoterapevtska skupina: antagonisti angiotenzina II, enokomponentna zdravila.
37 Clinical efficacy:
37 Klinična učinkovitost:
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality.
38 kreatinina, zadnje faze ledvične bolezni (ESRD) in celokupne smrtnosti.
38 analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
Pri podrobnem proučevanju posameznih komponent primarnega izida, niso opazili učinka na celokupno smrtnost, pač pa pozitivno tendenco pri zniževanju ESRD in pomembno zmanjšanje podvojitve serumskega kreatinina.
Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects
Vrednosti AUC in Cmax irbesartana so bile pri starejših osebah (≥65 let) nekoliko večje kot pri mlajših (18- 40 let).
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate.
Jedro tablete: laktoza monohidrat mikrokristalna celuloza premreženi natrijev karmelozat hipromeloza silicijev dioksid
40 Film-coating:
40 magnezijev stearat
14 tablets 28 tablets 56 tablets 84 tablets 98 tablets PVC/ PVDC/ Aluminium blisters
14 tablet 28 tablet 56 tablet 84 tablet 98 tablet PVC/ PVDC/ aluminijski pretisni omoti.
Irbesartan BMS 150 mg film-coated tablets.
Irbesartan BMS 150 mg filmsko obložene tablete
Each film-coated tablet contains 150 mg irbesartan.
Vsaka filmsko obložena tableta vsebuje 150 mg irbesartana.
51.00 mg of lactose monohydrate per film-coated tablet.
51, 00 mg laktoze monohidtata na filmsko obloženo tableto.
43 Elderly patients: although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
43 Starejši bolniki: čeprav je treba pretehtati možnost uporabe začetnega odmerka 75 mg pri bolnikih starejših od 75 let, običajno pri starejših prilagajanje odmerka ni potrebno.
44 As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1).
44 Kot so že opazili pri zaviralcih ACE, so irbesartan in drugi antagonisti angiotenzina izrazito manj učinkoviti pri zniževanju krvnega tlaka pri temnopoltih ljudeh kot pri drugih ne- temnopoltih, verjetno zaradi večje prevalence stanj z nizko vrednostjo renina pri temnopoltih bolnikih z visokim krvnim tlakom (glejte poglavje 5. 1).
45 4.6 Pregnancy and lactation
45 4. 6 Nosečnost in dojenje
46 Respiratory, thoracic and mediastinal disorders:
46 Bolezni dihal, prsnega koša in mediastinalnega prostora:
47 Nervous system disorders:
47 Bolezni živčevja:
48 Clinical efficacy:
48 Klinična učinkovitost:
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality.
49 kreatinina, zadnje faze ledvične bolezni (ESRD) in celokupne smrtnosti.
49 analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
Pri podrobnem proučevanju posameznih komponent primarnega izida, niso opazili učinka na celokupno smrtnost, pač pa pozitivno tendenco pri zniževanju ESRD in pomembno zmanjšanje podvojitve serumskega kreatinina.
51 Film-coating:
51 magnezijev stearat
Irbesartan BMS 300 mg film-coated tablets.
Irbesartan BMS 300 mg filmsko obložene tablete
Each film-coated tablet contains 300 mg irbesartan.
Vsaka filmsko obložena tableta vsebuje 300 mg irbesartana.
102.00 mg of lactose monohydrate per film-coated tablet.
102, 00 mg laktoze monohidtata na filmsko obloženo tableto.
54 Elderly patients: although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
54 Starejši bolniki: čeprav je treba pretehtati možnost uporabe začetnega odmerka 75 mg pri bolnikih starejših od 75 let, običajno pri starejših prilagajanje odmerka ni potrebno.
55 As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1).
55 Kot so že opazili pri zaviralcih ACE, so irbesartan in drugi antagonisti angiotenzina izrazito manj učinkoviti pri zniževanju krvnega tlaka pri temnopoltih ljudeh kot pri drugih ne- temnopoltih, verjetno zaradi večje prevalence stanj z nizko vrednostjo renina pri temnopoltih bolnikih z visokim krvnim tlakom (glejte poglavje 5. 1).
56 4.6 Pregnancy and lactation
56 4. 6 Nosečnost in dojenje
57 Respiratory, thoracic and mediastinal disorders:
57 Bolezni dihal, prsnega koša in mediastinalnega prostora:
58 Nervous system disorders:
58 Bolezni živčevja:
59 Clinical efficacy:
59 Klinična učinkovitost:
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality.
60 kreatinina, zadnje faze ledvične bolezni (ESRD) in celokupne smrtnosti.
60 analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
Pri podrobnem proučevanju posameznih komponent primarnega izida, niso opazili učinka na celokupno smrtnost, pač pa pozitivno tendenco pri zniževanju ESRD in pomembno zmanjšanje podvojitve serumskega kreatinina.
62 Film-coating:
62 magnezijev stearat
64 ANNEX II
64 DODATEK II
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR IMPORT AND BATCH RELEASE
IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Names and addresses of the manufacturers responsible for import and batch release
Ime in naslov izdelovalca, odgovornega za sproščanje serije
66 ANNEX III
66 DODATEK III
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
68 PODATKI NA ZUNANJI OVOJNINI
EU/ 1/ 06/ 375/ 001 14 tablets EU/ 1/ 06/ 375/ 002 28 tablets EU/ 1/ 06/ 375/ 003 56 tablets EU/ 1/ 06/ 375/ 004 56 x 1 tablets EU/ 1/ 06/ 375/ 005 98 tablets
EU/ 1/ 06/ 375/ 001 14 tablet EU/ 1/ 06/ 375/ 002 28 tablet EU/ 1/ 06/ 375/ 003 56 tablet EU/ 1/ 06/ 375/ 004 56 x 1 tablet EU/ 1/ 06/ 375/ 005 98 tablet
70 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
70 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
EU/ 1/ 06/ 375/ 006 14 tablets EU/ 1/ 06/ 375/ 007 28 tablets EU/ 1/ 06/ 375/ 008 56 tablets EU/ 1/ 06/ 375/ 009 56 x 1 tablets EU/ 1/ 06/ 375/ 010 98 tablets
EU/ 1/ 06/ 375/ 006 14 tablet EU/ 1/ 06/ 375/ 007 28 tablet EU/ 1/ 06/ 375/ 008 56 tablet EU/ 1/ 06/ 375/ 009 56 x 1 tablet EU/ 1/ 06/ 375/ 010 98 tablet
73 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
73 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
EU/ 1/ 06/ 375/ 011 14 tablets EU/ 1/ 06/ 375/ 012 28 tablets EU/ 1/ 06/ 375/ 013 56 tablets EU/ 1/ 06/ 375/ 014 56 x 1 tablets EU/ 1/ 06/ 375/ 015 98 tablets
EU/ 1/ 06/ 375/ 011 14 tablet EU/ 1/ 06/ 375/ 012 28 tablet EU/ 1/ 06/ 375/ 013 56 tablet EU/ 1/ 06/ 375/ 014 56 x 1 tablet EU/ 1/ 06/ 375/ 015 98 tablet
76 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
76 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU