natgillin/translations-raw huggingface dataset:
The compatibility of voriconazole with diluents other than described above or in section 6.2 is unknown.
Združljivost vorikonazola z drugimi razredčili razen tistih, navedenih zgoraj oz. v poglavju 6. 2, ni znana.
EU/ 1/ 02/ 212/ 025
EU1/ 02/ 212/ 025
VFEND 40 mg/ ml powder for oral suspension
VFEND 40 mg/ ml prašek za peroralno suspenzijo.
Each ml of oral suspension contains 40 mg of voriconazole when reconstituted with water (see section 6.6).
En mililiter peroralne suspenzije po pripravi z vodo vsebuje 40 mg/ ml vorikonazola (glejte poglavje 6. 6).
White to off-white powder
Bel do belkast prašek
VFEND is also available as 50 mg and 200 mg film-coated tablets and 200 mg powder for solution for injection.
Zdravilo VFEND je na voljo tudi v obliki 50 mg in 200 mg filmsko obloženih tablet in praška za raztopino za infundiranje 200mg.
64 Detailed information on dosage recommendations is provided in the following table:
64 Podrobne informacije o priporočilih za odmerjanje prikazuje naslednja preglednica:
Oral Suspension
peroralna suspenzija
Patients less than 40 kg
bolniki z manj kot 40 kg
400 mg (10 ml) every
400 mg (10ml) vsakih 12
200 mg (5 ml) every 12
200 mg (5 ml) vsakih 12
(for the first 24 hours)
(prvih 24 ur)
hours (for the first 24
(v prvih 24 urah)
(first 24 hours)
(v prvih 24 urah)
24 hours)
(v prvih 24 urah)
200 mg (5 ml) twice
200 mg (5 ml) dvakrat na
100 mg (2.5 ml) twice
100 mg (2, 5 ml) dvakrat
(after first 24 hours)
(po prvih 24 urah)
A four hour haemodialysis session does not remove a sufficient amount of voriconazole to warrant dose adjustment.
Štiri urna hemodializa ne odstrani toliko vorikonazola, da bi bilo treba prilagoditi odmerek.
65 It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh A and B) receiving VFEND (see section 5.2).
Pri bolnikih z blago do zmerno cirozo jeter (Child- Pugh A in B), ki dobivajo zdravilo VFEND, je priporočljivo uporabiti standardno polnilno odmerjanje, vzdrževalni odmerek pa prepoloviti (glejte poglavje 5. 2).
VFEND has been associated with elevations in liver function tests and clinical signs of liver damage, such as jaundice, and must only be used in patients with severe hepatic impairment if the benefit outweighs the potential risk.
65 Zdravilo VFEND je bilo povezano z zvišanjem testov jetrne funkcije in kliničnimi znaki okvare jeter, kot na primer ikterusom, zato ga smemo pri bolnikih s hudo jetrno okvaro uporabiti le, če korist odtehta možno tveganje.
Loading Dose Regimen
Polnilno odmerjanje
Oral Suspension**
Peroralni odmerek **
It is therefore recommended to use the oral suspension formulation in children 2- < 12.
Upoštevaje domnevno omejeni gastro- enterični čas prehoda pri pediatričnih bolnikih je mogoče, da je absorpcija iz tablet pri pediatričnih bolnikih drugačna kot pri odraslih.
66 Coadministration of ergot alkaloids (ergotamine, dihydroergotamine), which are CYP3A4 substrates, is contraindicated since increased plasma concentrations of these medicinal products can lead to ergotism (see section 4.5).
Sočasna uporaba alkaloidov ergot (ergotamina, dihidroergotamina), ki so substrati CYP3A4, je kontraindicirana, ker lahko povečana koncentracija teh zdravil v plazmi povzroči ergotizem (glejte poglavje 4. 5).
The concomitant use of voriconazole with St John’ s Wort is contraindicated (see section 4.5).
66 Sočasna uporaba vorikonazola in šentjanževke je kontraindicirana (glejte poglavje 4. 5).
67 Monitoring of pancreatic function:
Nadzor delovanja pankreasa:
In addition VFEND has been associated with photosensitivity skin reaction especially during long-term therapy.
67 Poleg tega je bilo zdravilo VFEND povezano s fotosenzitivnostnimi kožnimi reakcijami, zlasti med dolgotrajnim zdravljenjem.
Concomitant use of voriconazole and phenytoin should be avoided unless the benefit outweighs the risk (see section 4.5).
Vorikonazola in fenitoina se ne smeuporabljati sočasno, razen če korist odtehta tveganje (glejte poglavje 4. 5).
Careful monitoring of full blood counts and adverse reactions to rifabutin (e. g. uveitis) is recommended when rifabutin is coadministered with voriconazole.
Med sočasno uporabo rifabutina in vorikonazola je priporočljivo natančno nadziranje celotne krvne slike in neželenih učinkov rifabutina (npr. uveitisa).
Reduction in the dose of alfentanil and other short acting opiates similar in structure to alfentanil and metabolised by CYP3A4 (e. g. alfentanyl and sufentanil) should be considered when co-administered with voriconazole (see section 4.5).
Med sočasno uporabo z vorikonazolom pride v poštev zmanjšanje odmerka alfentanila in drugih kratkodelujočih opiatov, ki so po zgradbi podobni alfentanilu in se presnavljajo s CYP3A4 (npr. fentanila in sufentanila) (glejte poglavje 4. 5).
Ritonavir (Potent CYP450 inducer; CYP3A4 inhibitor and substrate):
Ritonavir (močan induktor CYP450; zaviralec in substrat CYP3A4):
VFEND oral suspension contains sucrose and should not be given to patients with rare hereditary problems of fructose intolerance, sucrase-isomaltase deficiency or glucose-galactose malabsorption.
VFEND peroralna suspenzija vsebuje saharozo, zato je ne smejo jemati bolniki z redkimi dednimi težavami, kot so fruktozna intoleranca, pomanjkanje saharoze- izomaltaze ali malabsorpcijo glukoze in galaktoze.
68 This section addresses the effects of other medicinal products on voriconazole, the effects of voriconazole on other medicinal products and two-way interactions.
To poglavje se dotika učinkov drugih zdravil na vorikonazol, učinkov vorikonazola na druga zdravila in dvosmernih interakcij.
Rifampicin (CYP450 inducer):
68 Rifampicin (induktor CYP450):
Rifampicin (600 mg once daily) decreased the Cmax (maximum plasma concentration) and AUCτ (area under the plasma concentration time curve within a dose interval) of voriconazole by 9 3% and 96%, respectively.
Rifampicin (600 mg enkrat na dan) je Cmax (največjo koncentracijo v plazmi) vorikonazola zmanjšal za 93% in AUCτ (površino pod krivuljo plazemske koncentracije po času v odmernem intervalu) vorikonazola za 96%.
One outlier subject with raised voriconazole levels was identified in each of the ritonavir interaction studies. Coadministration of voriconazole and ritonavir (400 mg and above twice daily) is contraindicated.
Sočasna uporaba vorikonazola in višjih odmerkov ritonavirja (400 mg in več dvakrat na dan) je kontraindicirana.
69 Effects of voriconazole on other medicinal products
Učinki vorikonazola na druga zdravila
When there is also a potential for voriconazole to increase the plasma levels of substances metabolised by CYP3A4 isoenzymes (certain antihistamines, quinidine, cisapride, pimozide) co-administration is contraindicated (see section 4.3).
Kadar obstaja možnost, da bi vorikonazol zvišal plazemsko koncentracijo snovi, ki se presnavljajo preko izoencima CYP3A4 (določeni antihistaminiki, kinidin, cisaprid, pimozid), je sočasno dajanje vorikonazola kontraindicirano.
Sirolimus (CYP3A4 substrate):
69 Sirolimus (substrat CYP3A4):
Steady-state administration of oral voriconazole increased the AUC∞ of a single dose of alfentanil by 6-fold.
Uporaba peroralnega vorikonazola v stanju dinamičnega ravnovesja je 6- krat povečala AUCτ posamičnega odmerka alfentanila.
Reduction in the dose of alfentanil and other short acting opiates similar in structure to alfentanil and metabolised by CYP3A4 (e. g. fentanyl and sufentanil) should be considered when coadministered with voriconazole (see section 4.4).
Med sočasno uporabo z vorikonazolom pride v poštev zmanjšanje odmerka alfentanila in drugih kratkodelujočih opiatov, ki so po zgradbi podobni alfentanilu in se presnavljajo s CYP3A4 (npr. fentanila in sufentanila) (glejte poglavje 4. 4).
70 Oral anticoagulants:
Peroralni antikoagulanti:
It is recommended that dose adjustment of the statin be considered during coadministration.
70 razmisliti o prilagoditvi odmerka statina.
Concomitant use of voricoazole and phenytoin should be avoided unless the benefit outweighs the risk.
Sočasni uporabi vorikonazola in fenitoina se je treba izogniti, razen če korist odtehta tveganje.
71 increased to 5 mg / kg intravenously twice daily or from 200 mg to 400 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see section 4.2.
Fenitoin se lahko uporablja sočasno z vorikonazolom, če se vzdrževalni odmerek vorikonazola poveča na 5 mg/ kg intravensko dvakrat na dan ali z 200 mg na 400 mg peroralno dvakrat na dan (s 100 mg na 200 mg peroralno dvakrat na dan pri bolnikih, lažjih od 40 kg); glejte poglavje 4. 2.
Rifabutin (300 mg once daily) decreased the Cmax and AUCτ of voriconazole at 200 mg twice daily by 69% and 78%, respectively.
Rifabutin (300 mg enkrat na dan) je Cmax vorikonazola, uporabljenega v odmerku 200 mg dvakrat na dan, zmanjšal za 69%, njegovo AUCτ pa za 78%.
Careful monitoring of full blood counts and adverse reactions to rifabutin (e. g. uveitis) is recommended when rifabutin is coadministered with voriconazole.
Med sočasno uporabo rifabutina in vorikonazola je priporočljivo natančno nadzirati celotno krvno sliko in neželene učinke rifabutina (npr. uveitis).
Omeprazole (CYP2C19 inhibitor; CYP2C19 and CYP3A4 substrate):
71 Omeprazol (zaviralec CYP2C19; substrat CYP2C19 in CYP3A4):
Omeprazole (40 mg once daily) increased voriconazole Cmax and AUCτ by 15% and 41%, respectively.
Omeprazol 40 mg enkrat na dan) je Cmax vorikonazola povečal za 15%, njegovo AUCτ pa za 41%.
In the
Efavirenz (400 mg peroralno enkrat na dan) je v stanju dinamičnega ravnovesja pri zdravih preiskovalcih zmanjšal Cmax vorikonazola v stanju dinamičnega ravnovesja za povprečno 61% in njegovo AUCτ v stanju dinamičnega ravnovesja za povprečno 77%.
72 same study voriconazole at steady state increased the steady state Cmax and AUCτ of efavirenz by an average of 38% and 44% respectively, in healthy subjects.
V isti študiji je vorikonazol v stanju dinamičnega ravnovesja pri zdravih preiskovalcih zmanjšal Cmax efavirenza v stanju dinamičnega ravnovesja za povprečno 38% in njegovo AUCτ v stanju dinamičnega ravnovesja za povprečno 44%.
In a separate study in healthy subjects, voriconazole dose of 300 mg BID in combination with low dose efavirenz (300 mg once daily) did not lead to sufficient voriconzole exposure.
V ločeni študiji pri zdravih preiskovancih vorikonazol v odmerku 300 mg dvakrat na dan v kombinaciji z nizkim odmerkom efavirenza (300 mg enkrat na dan) ni povzročil zadostne izpostavljenosti vorikonazolu.
When voriconazole is coadministered with efavirenz, voriconazole maintenance dose should be increased to 400 mg twice daily and the efavirenz dose should be reduced by 50%, i. e. to 300 mg once daily (See section 4.2).
Če vorikonazol uporabljamo sočasno z efavirenzem, je treba vzdrževalni odmerek vorikonazola povečati na 400 mg dvakrat na dan, odmerek efavirenza pa zmanjšati za 50%, tj. na 300 mg enkrat na dan (glejte poglavje 4. 2).
Non-nucleoside reverse transcriptase inhibitors (NNRTI) (CYP3A4 substrates, inhibitors or CYP450 inducers):
72 Zaviralci nenukleozidne reverzne transkriptaze (NNRTI – » Non- nucleoside reverse transcriptase inhibitors «) (substrati, zaviralci CYP3A4 ali induktorji CYP450):
This represents a heterogeneous population, containing patients with haematological malignancy, HIV infected patients with oesophageal candidiasis and refractory 73 fungal infections, non-neutropenic patients with candidaemia or aspergillosis and healthy volunteers.
Gre za heterogeno populacijo, ki zajema bolnike s hematološkimi malignomi, s HIV okužene bolnike s kandidiazo požiralnika in refraktarnimi glivičnimi okužbami, nenevtropenične bolnike s kandidemijo ali aspergilozo ter zdrave prostovoljce.
Undesirable effects reported in subjects receiving voriconazole:
73 Neželeni učinki, opisani pri bolnikih, ki so prejemali vorikonazol Organski sistem Preiskave
Rare
Ušesne bolezni, vključno z
Retinal haemorrhage, optic atrophy, oculogyration, corneal opacity
motnjami labirinta
74 Ear and labyrinth disorders Rare Hypoacusis, tinnitus
Redki Hipakuza, tinitus
Skin and subcutaneous tissue disorders Very common Common
74 Bolezni kože in podkožja Zelo pogosti Pogosti
75 Immune system disorders Common Uncommon
Bolezni imunskega sistema Pogosti Občasni
Psychiatric disorders
Psihiatrične motnje Pogosti Redki
Depression, anxiety, hallucination Insomnia
Depresija, anksioznost, halucinacije Nespečnost
Altered taste perception In the combined data from three bioequivalence studies using the powder for oral suspension formulation, treatment related taste perversion was recorded in 12 (14%) of subjects.
Spremenjeno zaznavanje okusa V kombiniranih podatkih iz treh bioekvivalenčnih študij, kjer so uporabljali prašek za peroralno suspenzijo so zabeležili pri 12 osebah (14%) spremenjeno zaznavanje okusa, povezano z zdravljenjem.
Visual disturbances In clinical trials, voriconazole treatment-related visual disturbances were very common.
Motnje vida Motnje vida, povezane z zdravljenjem z vorikonazolom, so zelo pogoste.
In these studies, short-term as well as long-term treatment, approximately 30% of subjects experienced altered/ enhanced visual perception, blurred vision, colour vision change or photophobia.
Motnje vida so prehodne in
These visual disturbances were transient and fully reversible, with the majority spontaneously resolving within 60 minutes and no clinically significant long-term visual effects were observed.
75 popolnoma reverzibilne; večina jih spontano mine v 60 minutah, niso opazili nobenih klinično pomembnih dolgotrajnih učinkov na vid.
There was evidence of attenuation with repeated doses of voriconazole.
Obstajajo dokazi o njihovem zmanjševanju s ponavljajočimi odmerki vorikonazola.
Voriconazole has been infrequently associated with cases of serious hepatic toxicity in patients with other serious underlying conditions.
Vorikonazol je bil pri bolnikih z drugimi hudimi že obstoječimi boleznimi redko povezan hudimi hepatotoksičnimi učinki.
76 Paediatric Use The safety of voriconazole was investigated in 245 paediatric patients aged 2 to < 12 years who were treated with voriconazole in pharmacokinetic studies (87 paediatric patients) and in compassionate use programs (158 paediatric patients).
Pediatrična uporaba Varnost vorikonazola so raziskali pri 245 pediatričnih bolnikih, starih od 2 do < 12 let, ki so vorikonazol dobivali v farmakokinetičnih študijah (87 pediatričnih bolnikov) in programih sočutne uporabe (158 pediatričnih bolnikov).
Microbiology Clinical efficacy (with partial or complete response, see below under Clinical Experience) has been demonstrated for Aspergillus spp. including A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans, Candida spp., including C. albicans, C. glabrata, C. krusei, C. parapsilosis and C. tropicalis and limited numbers of C. dubliniensis, C. inconspicua, and C. guilliermondii, Scedosporium spp., including S. apiospermum, S. prolificans and Fusarium spp.
Klinična učinkovitost (z delnim ali popolnim odzivom, glejte "Klinične izkušnje", spodaj) je bila dokazana za Aspergillus spp., vključno z A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans, za Candida spp., vključno s C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis in omejenim številom C. dubliniensis, C. inconspicua, in C. guilliermondii, za Scedosporium spp., vključno s S. apiospermum in S. prolificans ter za Fusarium spp.
77 Other treated fungal infections (with often partial or complete response) included isolated cases of Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp. including P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis and Trichosporon spp. including T. beigelii infections.
Med drugimi zdravljenimi glivičnimi okužbami (pogosto z delnim ali popolnim odzivom) so bili posamezni primeri Alternarie spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp., vključno s P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis ter Trichosporon spp., vključno z okužbami s T. beigelii.
In vitro activity against clinical isolates has been observed for Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp., Histoplasma capsulatum, with most strains being inhibited by concentrations of voriconazole in the range 0.05 to 2µg/ ml.
In vitro so opažali delovanje proti kliničnim izolatom Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp., Histoplasma capsulatum; večino sevov je zavrla koncentracija vorikonazola v območju od 0, 05 do 2 g/ ml.
A satisfactory global response (complete or partial resolution of all attributable symptoms/ signs, radiographic/ bronchoscopic abnormalities present at baseline) was seen in 53% of voriconazole-treated patients compared to 31% of patients treated with comparator.
Zadovoljiv globalni odziv (popolno ali delno izginotje vseh izhodiščno prisotnih pripisljivih simptomov, znakov, rentgenoloških/ bronhoskopskih nenormalnosti) so ugotovili pri 53% bolnikov, zdravljenih z vorikonazolom, in pri 31% bolnikov, zdravljenih s primerjalnim zdravilom.
The efficacy of voriconazole compared to the regimen of amphotericin B followed by fluconazole in the primary treatment of candidaemia was demonstrated in an open, comparative study.
Kandidemija pri nenevtropeničnih bolnikih Učinkovitost vorikonazola v primerjavi s shemo amfotericina B, ki mu je sledil flukonazol (shema amfotericin B/ flukonazol), je v primarnem zdravljenju kandidemije dokazala odprta primerjalna študija.
In the primary analysis, successful response as assessed by a Data Review Committee (DRC) blinded to study medication was defined as resolution/ improvement in all clinical signs and symptoms of infection with eradication of Candida from blood and infected deep tissue sites at 12 weeks after the
V primarni analizi je bil uspešen odziv (kot ga je ocenil Odbor za pregled podatkov [OPP], slepljen za proučevano zdravilo) opredeljen kot izginotje/ izboljšanje vseh kliničnih znakov in simptomov okužbe ter odstranitev Candide iz krvi in okuženih mest v globokih tkivih 12 tednov po koncu terapije (KT).
Timepoint _
časovna točka
Experience in paediatric patients Sixty-one paediatric patients aged 9 months up to 15 years who had definite or probable invasive fungal infections, were treated with voriconazole.
Izkušnje pri pediatričnih bolnikih Z vorikonazolom je bilo zdravljenih 61 pediatričnih bolnikov, starih od 9 mesecev do 15 let, ki so imeli potrjeno ali verjetno invazivno glivično okužbo.
79 The majority (57/ 61) had failed previous antifungal therapies.
Pri večini (57/ 61) prejšnje antimikotične terapije niso bile uspešne.
Bioequivalence was established between the 200mg tablet and the 40 mg/ ml oral suspension when administered as a 200 mg dose.
Bioekvivalenca je bila dokazana med 200 mg tabletami in 40 mg/ ml peroralno suspenzijo, dano kot 200 mg odmerek.
When multiple doses of voriconazole oral suspension are administered with high fat meals, Cmax and AUCτ are reduced by 58% and 37% respectively.
Če se večkratne odmerke vorikonazola peroralne suspenzije uporablja z zelo mastnimi obroki, se Cmax zmanjša za 58% in AUCτ za 37%.
80 In vivo studies indicated that CYP2C19 is significantly involved in the metabolism of voriconazole.
Študije in vivo nakazujejo, da je CYP2C19 pomembno vpleten v presnovo vorikonazola.
Pharmacokinetic-Pharmacodynamic analyses of clinical trial data identified positive associations between plasma voriconazole concentrations and both liver function test abnormalities and visual disturbances.
80 Farmakokinetično- farmakodinamične analize podatkov kliničnih preskušanj so odkrile pozitivno povezavo med koncentracijo vorikonazola v plazmi ter nenormalnostmi testov jetrne funkcije in motnjami vida.
81 In the therapeutic studies no dosage adjustment was made on the basis of age.
V terapevtskih študijah odmerjanja niso prilagajali glede na starost.
A relationship between plasma concentrations and age was observed. The safety profile of voriconazole in young and elderly patients was similar and, therefore, no dosage adjustment is necessary for the elderly (see section 4.2).
Varnostni profil vorikonazola je bil pri mladih in starejših bolnikih podoben, zato pri starejših odmerka ni treba prilagajati (glejte poglavje 4. 2).
No pharmacokinetic data are available for patients with severe hepatic cirrhosis (Child-Pugh C).
81 bolnike s hudo cirozo jeter (Child- Pugh C) ni.
Sucrose Silica, Colloidal Titanium Dioxide (E171) Xanthan Gum Sodium Citrate Sodium Benzoate (E211) Citric Acid Natural Orange Flavour (containing orange oil, maltodextrin and tocopherol)
saharoza koloidni silicijev dioksid titanov dioksid (E171) ksantanski gumi natrijev citrat natrijev benzoat (E211) citronska kislina naravna pomarančna aroma (ki vsebuje olje pomaranče, maltodekstrin in tokoferol)
This medicinal product must not be mixed with other medicinal products except those mentioned in 6.6.
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so navedena v poglavju 6. 6.
It is not intended that the suspension be further diluted with water or other vehicles.
Suspenzije ne smemo dodatno redčiti z vodo ali drugimi topili.
The shelf-life of the constituted suspension is 14 days.
Rok uporabnosti za že pripravljeno suspenzijo je 14 dni.
Constituted suspension:
Pripravljena suspenzija:
Do not store above 30°C, do not refrigerate or freeze.
Shranjujte pri temperaturi do 30˚C, ne shranjujte v hladilniku ali zamrzujte.
Store at 2°C -8°C (in a refrigerator) before constitution.
Prašek za peroralno suspenzijo: pred pripravo shranjujte pri temperaturi med 2˚C - 8˚C (v hladilniku).
For storage conditions of the constituted suspension see section 6.3.
Za pogoje shranjevanja že pripravljene suspenzije glejte poglavje 6. 3.
A measuring cup (graduated to indicate 23 ml), 5 ml oral syringe and a press-in bottle adaptor are also provided.
82 Priložena je tudi merica (označena, da kaže 23 ml), 5 ml peroralna brizga in potisni nastavek za plastenko.
Any remaining suspension should be discarded 14 days after constitution.
Morebiten ostanek suspenzije morate zavreči 14 dni po pripravi.
Tap the bottle to release the powder.
Rahlo udarite po plastenki, da sprostite prašek.
Measure 23 ml of water by filling the measuring cup to the top of the marked line.
S pomočjo merice odmerite 23 ml vode, tako da napolnite merico do vrha označene črte.
Add the water to the bottle.
Dodajte vodo v plastenko.
Using the cup measure another 23 ml of water and add this to the bottle.
S pomočjo merice odmerite še enkrat 23 ml vode ter jo dodajte v plastenko.
Write the date of expiration of the constituted suspension on the bottle label (the shelf-life of the constituted suspension is 14 days).
Na nalepko plastenke napišite rok uporabnosti že pripravljene suspenzije (rok uporabnosti pripravljene suspenzije je 14 dni).
83 Instructions for use:
Navodilo za uporabo:
84 ANNEX II
83 DODATEK II
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release
84 A IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Tablets Pfizer Manufacturing Deutschland GmbH Heinrich-Mack-Str.
Tablete Pfizer Manufacturing Deutschland GmbH Heinrich- Mack- Str.
Powder for solution for infusion and powder for oral suspension:
Prašek za raztopino za infundiranje in prašek za peroralno suspenzijo:
Pfizer PGM Zone Industrielle 29 Route des Industries 37530 Pocé-Sur-Cisse France
Pfizer PGM Zone Industrielle 29 Route des Industries 37530 Pocé- Sur- Cisse Francija
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
 POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM