natgillin/translations-raw huggingface dataset:
In vivo, in human subjects possessing ineffective mutations of CYP2C19, production of the hydroxy metabolite is decreased 10-fold while brivaracetam itself is increased by 22 % or 42 % in individuals with one or both mutated alleles.
Pri človeških preskušancih, ki so imeli neučinkovite mutacije CYP2C19, se je proizvodnja hidroksi presnovka in vivo zmanjšala za 10-krat, medtem ko se je brivaracetam povečal za 22 % oziroma 42 % pri posameznikih z mutacijo enega ali obeh alelov.
- Take the oral syringe out of the adaptor (figure 10).
- Vzemite peroralno brizgo iz adapterja (slika 10).
- Wash the oral syringe with water only (figure 13).
- Peroralno brizgo izperite samo z vodo (slika 13).
No additional safety or tolerability concerns were observed.
Prav tako niso ugotovili dodatnih zadržkov glede varnosti in prenašanja.
The physician should prescribe the most appropriate formulation and strength according to weight and dose.
Zdravnik mora predpisati najustreznejšo obliko in jakost glede na telesno maso ter odmerek.
No CYP3A4 induction was found in vivo (see midazolam above).
In vivo indukcije CYP3A4 niso opazili (glejte midazolam zgoraj).
Experience with epilepsy medicines suggests that the results of efficacy studies performed in adults can be extrapolated to children down to the age of 4 years provided the paediatric dose adaptations are established and safety has been demonstrated (see sections 5.2 and 4.8).
Izkušnje s protiepileptičnimi zdravili kažejo, da je mogoče rezultate študij učinkovitosti ekstrapolirati na otroke do starosti 4 let, če so bile prilagoditve na pediatrični odmerek določene in varnost dokazana (glejte poglavji 5.2 in 4.8).
Other enzyme inducers
Drugi induktorji encimov
Figure 1: Proportion of patients by category of seizure response for brivaracetam and placebo over 12 weeks across all three double-blind pivotal trials
Slika 1: Delež bolnikov po kategoriji odziva napadov na brivaracetam in placebo v obdobju 12 tednov v vseh treh dvojno slepih ključnih preskušanjih
When converting from oral to intravenous administration or vice versa, the total daily dose and frequency of administration should be maintained.
Pri prehodu s peroralne na intravensko uporabo ali obratno je treba obdržati skupni dnevni odmerek in pogostnost dajanja.
Figure 1 shows the percentage of patients (excluding patients with concomitant levetiracetam) by category of reduction from baseline in POS frequency per 28 days in all 3 studies.
Slika 1 prikazuje odstotek bolnikov (razen bolnikov, ki so sočasno prejemali levetiracetam) po kategoriji zmanjšanja glede na izhodišče in pogostnost parcialnih napadov na 28 dni v vseh 3 študijah.
Patients with rare heriditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorbcijo glukoze/galaktoze ne smejo jemati tega zdravila.
- Keep the bottle, the oral syringe, and the leaflet in the carton.
- Steklenico, peroralno brizgo in navodilo shranjujte v škatli.
Carcinogenicity studies did not indicate any oncogenic potential in rats, whereas increased incidences of hepatocellular tumors in male mice are considered to result of a non-genotoxic, mode of action linked to a phenobarbitonelike liver enzyme induction, which is a known rodent specific phenomenon.
Študije karcinogenosti na podganah niso pokazale onkogenega potenciala, medtem ko je bila povečana incidenca tumorjev jetrnih celic pri mišjih samcih smatrana kot rezultat negenotoksičnega mehanizma delovanja, povezanega z induciranjem jetrnih encimov, podobnega kot pri fenobarbitonu, kar je znan specifičen pojav za glodavce.
- Pull the plunger down to the millilitre (ml) dose marker on the oral syringe prescribed by your doctor (figure 8).
- Izvlecite bat navdol do oznake mililitrskega (ml) odmerka na peroralni brizgi, ki vam ga je predpisal vaš zdravnik,(slika 8).
Brivaracetam is rapidly and completely absorbed after oral administration and the absolute bioavailablity is approximately 100 %.
Brivaracetam se hitro in v celoti absorbira po peroralni uporabi, absolutna biološka razpoložljivost pa je približno 100 %.
- If you weigh less than 20 kg, you should use the 5 ml oral syringe provided in the carton to ensure accurate dosing.
- Če tehtate manj kot 20 kg, morate uporabljati 5-ml peroralno brizgo, priloženo v škatli, da zagotovite natančno odmerjanje.
Common: may affect up to 1 in 10 people - restlessness and hyperactivity (psychomotor hyperactivity)
Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov - nemir in hiperaktivnost (psihomotorična hiperaktivnost)
50% Responder rate
50 % delež odzivnosti
In a pharmacokinetic study with a 3-week evaluation period and weekly fixed 3-step up-titration using the brivaracetam oral solution, 99 subjects aged 1 month to <16 years were evaluated.
V farmakokinetični študiji s 3-tedenskim obdobjem ocenjevanja in tedenskim določenim titriranjem v 3 korakih s peroralno raztopino brivaracetama, je bilo ocenjenih 99 preskušancev, starih od 1 meseca do < 16 let.
All packs are available in PVC/PCTFE - Aluminium blisters.
Vsa pakiranja so na voljo v pretisnih omotih PVC/PCTFE-aluminij.
This is because stopping treatment could increase the number of fits you have.
To je pomembno zato, ker bi lahko prekinitev zdravljenja povečala število epileptičnih napadov, ki jih doživljate.
If brivaracetam has to be discontinued it is recommended to withdraw it gradually by 50 mg/day on a weekly basis.
Če je treba prekiniti jemanje brivaracetama, je priporočeno postopno zmanjševanje odmerka po 50 mg/dan na teden.
In children aged 4 years and older, partial onset seizures have a similar clinical expression to those in adolescents and adults.
Pri otrocih, starih 4 leta in več, se parcialni epileptični napadi klinično izražajo podobno kot pri mladoletnikih in odraslih.
- Pull the plunger down to fill the oral syringe with a small amount of solution (figure 6).
- Izvlecite bat navzdol, da napolnite peroralno brizgo z majhno količino raztopine (slika 6).
This plasma concentration is slightly above the median exposure obtained after brivaracetam doses of 50 mg/day.
Ta plazemska koncentracija je rahlo nad mediano izpostavljenosti, ki je bila dosežena pri odmerkih brivaracetama 50 mg/dan.
In a pharmacokinetic and pharmacodynamic interaction study between brivaracetam 200 mg single dose and ethanol 0.6 g/L continuous infusion in healthy subjects, there was no pharmacokinetic interaction but brivaracetam approximately doubled the effect of alcohol on psychomotor function, attention and memory.
V študiji farmakokinetičnih in farmakodinamičnih interakcij med enkratnim odmerkom brivaracetama 200 mg in neprekinjeno infuzijo etanola 0,6 g/l pri zdravih preskušancih ni bilo farmakokinetičnih interakcij, vendar je brivaracetam približno podvojil učinek alkohola na psihomotorične funkcije, pozornost in spomin.
A small number of people being treated with anti-epileptic medicines such as Briviact have had thoughts of harming or killing themselves.
Pri majhnem številu bolnikov, ki so se zdravili z antiepileptiki, kot je zdravilo Briviact, so se pojavile misli o samopoškodovanju ali samomoru.
There was no additive effect of brivaracetam and valproate on the AUC of carbamazepine epoxide.
Aditivnega učinka brivaracetama in valproata na AUC karbamazepin epoksida ni bilo.
Brivaracetam is a moderate reversible inhibitor of epoxide hydrolase resulting in an increased concentration of carbamazepine epoxide, an active metabolite of carbamazepine.
Brivaracetam je zmeren reverzibilni zaviralec epoksid-hidrolaze, kar povzroči povečano koncentracijo karbamazepin epoksida, aktivnega presnovka karbamazepina.
There is no experience with twice daily intravenous administration of brivaracetam for a period longer than 4 days.
Izkušenj z intravenskim odmerjanjem brivaracetama dvakrat na dan za obdobje, daljše kot 4 dni, ni.
Effects of other agents on the pharmacokinetics of brivaracetam In vitro data suggest that brivaracetam has a low interaction potential.
Učinki drugih zdravilnih učinkovin na farmakokinetiko brivaracetama Podatki in vitro kažejo, da ima brivaracetam nizek interakcijski potencial.
Component of a multipack, can't be sold separately.
Sestavni del večkratnega pakiranja, ni za ločeno prodajo.
In vitro, interaction studies to determine the potential inhibitory effects on transporters concluded that there were no clinically relevant effects, except for OAT3.
In vitro študije interakcij, kjer so ugotavljali potencialne zaviralne učinke na prenašalce so pokazale, da ni klinično pomembnih učinkov, razen na OAT3.
Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A), a transmembrane glycoprotein found at presynaptic level in neurons and in endocrine cells.
Brivaracetam kaže visoko in selektivno afiniteto do proteina sinaptičnega vezikla 2A (SV2A), transmembranskega glikoproteina, ki je prisoten na predsinaptični ravni v nevronih in endokrinih celicah.
Brivaracetam solution for injection/infusion is physically compatible and chemically stable when mixed with the following diluents
Raztopina brivaracetama za injiciranje/infundiranje je fizikalno kompatibilna in kemijsko stabilna, če jo zmešate z naslednjimi raztopinami.
Brivaracetam was evaluated in these patients in a short term openlabel pharmacokinetic study and an ongoing open-label extension study, in 16 subjects from 1 month to <4 years of age (see section 5.2).
Brivaracetam so pri teh bolnikih ocenjevali v kratkotrajni odprti študiji farmakokinetike in v odprti podaljšani študiji v teku pri 16 preskušancih, starih od 1 meseca do < 4 leta (glejte poglavje 5.2).
There are two ways in which you can choose to drink the medicine: - empty the contents of the syringe into water (or juice) by pushing the plunger to the bottom of the oral syringe (figure 11) - you will then need to drink all of the water (add just enough to make it easy to drink) or - drink the solution directly from the oral syringe without water - drink the whole contents of the syringe (figure 12).
Zdravilo lahko vzamete na dva načina: - vsebino brizge izpraznite v vodo (ali sok) tako, da pritisnete na bat na dnu peroralne brizge (slika 11) - nato spijte vso vodo (vode naj bo ravno dovolj, da boste lahko vse enostavno spili) ali
If you have more Briviact than you should If you think you have been given too much Briviact, tell your doctor straight away.
Če ste prejeli večji odmerek zdravila Briviact, kot bi smeli Če mislite, da ste prejeli preveč zdravila Briviact, takoj obvestite zdravnika.
There is a limited amount of data from the use of brivaracetam in pregnant women.
O uporabi brivaracetama pri nosečnicah je na voljo omejena količina podatkov.
Brivaracetam film-coated tablets, oral solution and solution for intravenous injection show the same AUC, while the maximum plasma concentration is slightly higher after intravenous administration.
Filmsko obložene tablete brivaracetama, peroralna raztopina in raztopina za intravensko injiciranje kažejo enak AUC, medtem ko je največja plazemska koncentracija po intravenski uporabi rahlo večja.
* Based on physician assessment of need for seizure control.
* Na podlagi zdravnikove ocene potrebe po obvladovanju epileptičnih napadov.
Other medicines and Briviact
Druga zdravila in zdravilo Briviact
Doses in patients from 4 years of age were defined by weight-based dose adaptations which have been established to achieve similar plasma concentrations to the ones observed in adults taking efficacious doses (section 5.2).
Odmerki pri bolnikih od 4. leta starosti so bili opredeljeni s prilagoditvijo odmerka na podlagi telesne mase, ugotovljeni tako, da so bile dosežene koncentracije v plazmi podobne tistim pri odraslih, ki so jemali učinkovite odmerke (glejte poglavje 5.2).
Due to its lipophylicity (Log P) brivaracetam has high cell membrane permeability.
Zaradi svoje lipofilnosti (log P) ima brivaracetam visoko sposobnost prehajanja skozi celično membrano.
Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Preobčutljivost na zdravilno učinkovino ali druge derivate pirolidona ali katero koli pomožno snov, navedeno v poglavju 6.1.
Risk related to brivaracetam
Tveganja, povezana z brivaracetamom
Your doctor may then decide to adjust your dose to find the best dose for you.
Zdravnik se lahko nato odloči, da vam prilagodi vaš odmerek tako, da najde odmerek, ki vam najbolj ustreza.
- St John's wort (also known as Hypericum perforatum) - a herbal medicine used to treat depression and anxiety as well as other conditions.
šentjanževka (znana tudi kot Hypericum perforatum) - ki je zdravilo rastlinskega izvora in se uporablja za zdravljenje depresije, tesnobe ter drugih stanj.
Levetiracetam None
Nič levetiracetam Nič
Briviact is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Zdravilo Briviact je indicirano za dopolnilno zdravljenje parcialnih epileptičnih napadov s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih in otrocih od 4. leta starosti z epilepsijo.
In rats, brivaracetam was shown to readily cross the placenta and to be excreted in milk of lactating rats with concentrations similar to maternal plasma levels.
Pri podganah se je izkazalo, da brivaracetam zlahka prehaja skozi placento in se izloča v mleko doječih podgan v koncentracijah, ki so podobne materinim ravnem v plazmi.
The daily dose of brivaracetam ranged from 5 to 200 mg/day across these studies.
Dnevni odmerek brivaracetama je bil v teh študijah od 5 do 200 mg/dan.
If you stop taking Briviact
Če ste prenehali jemati zdravilo Briviact
In vitro, brivaracetam was not an inhibitor of the CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 3A4, or the transporters P-gp, BCRP, BSEP MRP2, MATE-K, MATE-1, OATP1B1, OATP1B3, OAT1 and OCT1 at clinically relevant concentrations.
In vitro, pri klinično pomembnih koncentracijah, brivaracetam ni bil zaviralec CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 3A4 ali prenašalcev P-gp, BCRP, BSEP MRP2, MATE-K, MATE-1, OATP1B1, OATP1B3, OAT1 in OCT1.
The effect of the interactions on the plasma concentration is summarised in table 1 (increase is indicated as “↑” and decrease as “↓”, area under the plasma concentration versus time curve as “AUC”, maximum observed concentration as Cmax).
Učinek interakcij na plazemsko koncentracijo je povzet v preglednici 1 (povečanje je označeno z ↑, zmanjšanje z ↓, površina pod krivuljo plazemske koncentracije v odvisnosti od časa kot AUC, največja opažena koncentracija kot Cmax).
After 1 week of treatment at 50 mg/day, a final week of treatment at the dose of 20 mg/day is recommended.
Po 1 tednu zdravljenja s 50 mg/dan je v zadnjem tednu zdravljenja priporočen odmerek 20 mg/dan.
Brivaracetam plasma concentrations may increase when coadministered with CYP2C19 strong inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19-mediated interaction is considered to be low.
Plazemske koncentracije brivaracetama se lahko povečajo, če se ta daje sočasno z močnimi zaviralci CYP2C19 (npr. flukonazol, fluvoksamin), vendar se tveganje klinično pomembnih interakcij, posredovanih s CYP2C19, smatra za nizko.
Each film-coated tablet contains 10 mg, 25 mg, 50mg, 75 mg, or 100 mg brivaracetam.
Ena filmsko obložena tableta vsebuje 10 mg, 25 mg, 50 mg, 75 mg ali 100 mg brivaracetama.
- Intravenous infusion: brivaracetam may be diluted in a compatible diluent and administered as a 15-minute intravenous infusion (see section 6.6).
- Intravenska infuzija: brivaracetam lahko razredčite s kompatibilnim topilom in dajete kot 15minutno intravensko infuzijo (glejte poglavje 6.6).
- For the long term treatment with Briviact, your doctor will ask to you to take Briviact tablets or oral solution.
- Za dolgotrajno zdravljenje z zdravilom Briviact vam bo zdravnik naročil, da vzamete tablete ali peroralno raztopino zdravila Briviact.
In healthy subjects, coadministration with the strong enzyme inducer rifampicin (600 mg/day for 5 days), decreased brivaracetam area under the plasma concentration curve (AUC) by 45 %.
Pri zdravih preskušancih je sočasno dajanje z močnim induktorjem encimov rifampicinom (600 mg/dan, 5 dni) zmanjšalo površino pod krivuljo plazemske koncentracije (AUC - area under curve) brivaracetama za 45 %.
Brivaracetam 200mg/day may increase plasma concentrations of medicinal products transported by OAT3.
Brivaracetam 200 mg/dan lahko poveča plazemske koncentracije učinkovin, ki se prenašajo z OAT3.
- Turn the bottle upside down (figure 5).
- Steklenico obrnite navzdol (slika 5).
Therefore, starting or ending treatment with St John's wort should be done with caution.
Zato je treba previdno izvesti začetek ali konec zdravljenja s šentjanževko.
Coadministration with a high-fat meal slowed down the absorption rate (median tmax 3 h) and decreased the maximum plasma concentration (37 % lower) of brivaracetam, while the extent of absorption remained unchanged.
Sočasno jemanje z obrokom z visoko vsebnostjo maščob upočasni stopnjo absorpcije (mediana čas tmax je 3 h) in zniža največjo plazemsko koncentracijo (za 37 %) brivaracetama, medtem ko je obseg absorpcije nespremenjen.
In safety pharmacology studies, the predominant effects were CNS related (mainly transient CNS depression and decreased spontaneous locomotor activity) seen at multiples (greater than 50 fold) of the pharmacologically active dose of brivaracetam, 2 mg/kg.
V študijah varnostne farmakologije so bili poglavitni učinki povezani s centralnim živčnim sistemom (predvsem začasna depresija centralnega živčnega sistema in zmanjšana spontana lokomotorična dejavnost), ki je bila opažena pri večkratnikih (več kot 50-krat) farmakološko aktivnega odmerka brivaracetama 2 mg/kg.
The efficacy and tolerability of brivaracetam in paediatric patients less than 4 years of age have not been established (see section 4.2).
Učinkovitost in prenašanje brivaracetama pri pediatričnih bolnikih, starih manj kot 4 leta, nista bili ugotovljeni (glejte poglavje 4.2).
The primary endpoints in the phase 3 studies were the percent reduction in POS frequency over placebo and the 50 % responder rate based on 50 % reduction in POS frequency from baseline.
Primarni opazovani dogodek v študijah faze 3 je bilo odstotno zmanjšanje pogostnosti parcialnih napadov v primerjavi s placebom in 50 % stopnja odzivnosti na podlagi 50 % zmanjšanja pogostnosti parcialnih napadov glede na izhodišče.
n = randomised patients who received at least 1 dose of study medication ~ Dose not studied Statistically significant Approximately 20 % of the patients were on concomitant levetiracetam The primary outcome for N01252 did not achieve statistical significance based on the sequential testing procedure.
n = število randomiziranih bolnikov, ki so prejeli vsaj 1 odmerek preiskovanega zdravila ~ Odmerek, ki ga niso preučevali Statistično pomembno Približno 20 % bolnikov je sočasno prejemalo levetiracetam Primarni rezultat za N01252 ni dosegel statistično pomembnost, ki je temeljila na zaporednih testnih postopkih.
In the short-term clinical studies of brivaracetam in epilepsy patients, there were no cases of completed suicide and suicide attempt, however both have been reported in open-label extension studies (see section 4.4).
Pri kratkotrajnih kliničnih študijah brivaracetama pri bolnikih z epilepsijo niso zabeležili primerov izvedenih samomorov ali poskusov samomora, vendar so o obojem poročali pri podaljšanih odprtih študijah (glejte poglavje 4.4).
The 5 ml oral syringe must be used in patients weighing less than 20 kg to ensure accurate dosing as the 10 ml oral syringe does not allow accurate measurements of volumes <1 ml.
5-ml peroralna brizga se mora uporabiti pri bolnikih, ki tehtajo manj kot 20 kg, da se zagotovi natančno odmerjanje, saj natančnega odmerjanja količin <1 ml s peroralno brizgo 10 ml ni mogoče doseči.
Both metabolites, are further metabolised forming a common hydroxylated acid formed predominantly by hydroxylation of the propyl side chain on the carboxylic acid metabolite (mainly by CYP2C9).
Oba presnovka se nadalje presnavljata v skupno hidroksilirano kislino, ki se tvori predvsem s hidroksilacijo propilne stranske verige na presnovku karboksilne kisline (v glavnem s CYP2C9).
Do not stop taking this medicine unless your doctor tells you to.
Ne prenehajte jemati tega zdravila, razen če vam tako naroči zdravnik.
Physicians should discuss family planning and contraception with women of childbearing potential taking brivaracetam (see Pregnancy).
Zdravniki se morajo z ženskami v rodni dobi, ki jemljejo brivaracetam, pogovoriti o načrtovanju družine in kontracepciji (glejte Nosečnost).
Four of these subjects had decreased neutrophil counts at baseline, and experienced additional decrease in neutrophil counts after initiation of brivaracetam treatment.
Štirje od teh preskušancev so imeli že ob izhodišču zmanjšano število nevtrofilcev, po začetku zdravljenja z brivaracetamom pa je prišlo do dodatnega zmanjšanja števila nevtrofilcev.
Briviact tablets are packaged in blister packs supplied in cardboard boxes containing either 14, 56, 14 x 1 or 100 x 1 film-coated tablets or in multipacks containing 168 (3 packs of 56) film-coated tablets.
Tablete zdravila Briviact so pakirane v pretisne omote, ki se nahajajo v škatlah, ki vsebujejo po 14, 56, 14 x 1 ali 100 x 1 filmsko obloženo tableto, ali v večkratnih pakiranjih, ki vsebujejo 168 (3 pakiranja po 56) filmsko obloženih tablet.
Recommended starting dose 50 mg/day (or 100 mg/day)*
Priporočeni začetni odmerek 50 mg/dan (ali 100 mg/dan)*
- Turn the bottle the right way up (figure 9).
- Obrnite steklenico pokonci (slika 9).
In juvenile rats, brivaracetam exposure levels 6- to 15-fold the clinical AUC exposure at the maximum recommended dose induced developmental adverse effects (i.e. mortality, clinical signs, decreased body weight and lower brain weight).
Pri mladičih podgan je brivaracetam z ravnjo izpostavljenosti, ki je od 6- do 15-krat višja od klinične izpostavljenosti AUC pri največjem priporočenem odmerku, povzročal neželene razvojne učinke (tj. smrtnost, klinični znaki, manjša telesna masa in manjša masa možganov).
What Briviact is and what it is used for
Kaj je zdravilo Briviact in za kaj ga uporabljamo
Study N01253
Študija N01253
A study in subjects with severe renal impairment (creatinine clearance <30 ml/min/1.73 m² and not requiring dialysis) revealed that the plasma AUC of brivaracetam was moderately increased (+21 %) relative to healthy controls, while the AUC of the acid, hydroxy and hydroxyacid metabolites were increased 3-, 4-, and 21-fold, respectively.
Študija preskušancev s hudo okvaro ledvic (očistek kreatinina < 30 ml/min/1,73 m², niso potrebovali dialize) je pokazala, da je bil plazemski AUC brivaracetama zmerno povišan (+ 21 %) v primerjavi z zdravimi kontroliranimi preskušanci, medtem ko se je AUC kislinskih, hidroksi in hidroksikislinskih presnovkov povečal 3-, 4- oziroma 21-krat.
How to take Briviact oral solution - You can take Briviact oral solution on its own, or dilute it in water or juice shortly before swallowing.
Kako jemati zdravilo Briviact peroralna raztopina - Zdravilo Briviact peroralna raztopina lahko jemljete samo, ali pa jo razredčite z vodo ali sokom neposredno pred zaužitjem.
Brivaracetam plasma concentrations are decreased when coadministered with strong enzyme inducing AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required (see table 1).
Plazemske koncentracije brivaracetama se zmanjšajo pri sočasnem jemanju antiepileptikov, ki močno inducirajo encime (karbamazepin, fenobarbital, fentoin), vendar prilagoditev odmerka ni potrebna (glejte preglednico 1).
The oral solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).
Peroralna raztopina vsebuje metilparahidroksibenzoat (E218), ki lahko povzroči alergijske reakcije, (lahko zapoznele).
Follow these steps each time you take Briviact: - Put the oral syringe into the adaptor opening (figure 4).
Vsakič ko vzamete zdravilo Briviact, upoštevajte naslednje korake: - Vstavite peroralno brizgo v odprtino adapterja (slika 4).