natgillin/translations-raw huggingface dataset:
Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3022) during clinical development.
Med kliničnim razvojem zdravila so pri majhnem številu bolnikov, ki so jemali brivaracetam (9/3022) poročali o reakcijah, ki so kazale na takojšnjo preobčutljivost (tip I).
As in adults, brivaracetam solution for injection/infusion is an alternative route of administration for patients when oral administration is temporarily not feasible.
Kot pri odraslih je raztopina brivaracetama za injiciranje/infundiranje alternativna pot dajanja bolnikom, ko peroralna uporaba ni izvedljiva.
In the clinical studies, although the numbers were limited, there was no observed benefit of brivaracetam versus placebo in patients taking levetiracetam concurrently.
V kliničnih študijah, kljub njihovemu omejenemu številu, niso opazili koristi brivaracetama v primerjavi s placebom pri bolnikih, ki so sočasno jemali levetiracetam.
Briviact may be diluted with the following solutions: sodium chloride 9 mg/ml (0.9 %), glucose 50 mg/ml (5 %) solution for injection or lactated Ringer's solution.
Zdravilo Briviact lahko razredčite z naslednjimi raztopinami: natrijev klorid 9 mg/ml (0,9 %), glukoza 50 mg/ml (5 %) raztopina za injiciranje ali Ringerjeva raztopina z laktatom.
In vitro, Brivaracetam inhibits OAT3 with a half maximal inhibitory concentration 42-fold higher than the Cmax at the highest clinical dose.
Brivaracetam zavira OAT3 s polovico največje zaviralne koncentracije, ki je 42-krat večja kot Cmax pri največjem kliničnem odmerku.
Briviact contains lactose
Zdravilo Briviact vsebuje laktozo
briviact 10 mg/ml (Only for outer carton)
briviact 10 mg/ml (Samo za škatlo.)
No human data on the effect of brivaracetam on fertility are available.
O vplivu brivaracetama na plodnost pri ljudeh ni podatkov.
Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous.
Vsebuje premrežen natrijev karmelozat, laktozo monohidrat in brezvodno laktozo.
Co-administration of brivaracetam (100 mg/day) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg) did not influence the pharmacokinetics of either substance.
Sočasno dajanje brivaracetama (100 mg/dan) in peroralnih kontraceptivov, ki so vsebovali etinilestradiol (0,03 mg) in levonorgestrel (0,15 mg), ni vplivalo na farmakokinetiko nobene od učinkovin.
Antiepileptic drugs
Antiepileptiki
Findings not observed in clinical studies, but seen in the repeated-dose toxicology dog studies at exposure similar to the clinical plasma AUC, were hepatotoxic effects (mainly porphyria).
Pri študijah toksikologije s ponavljajočimi se odmerki pri psih, z izpostavljenostjo podobno klinični plazemski AUC, so ugotovili hepatotoksične učinke (predvsem porfirijo), vendar tega v kliničnih študijah niso opazili.
Brivaracetam solution for injection/infusion is an alternative for patients when oral administration is temporarily not feasible.
Raztopina brivaracetama za injiciranje/infundiranje je alternativa za bolnike, ko peroralno dajanje začasno ni mogoče.
There are limited clinical data on the use of brivaracetam in patients with pre-existing hepatic impairment.
Kliničnih podatkov o uporabi brivaracetama pri bolnikih z obstoječo okvaro jeter ni veliko.
Currently, no clinical data are available in neonates.
Trenutno kliničnih podatkov za novorojenčke ni na voljo.
The recommended maintenance dose is 100 mg/day.
Priporočeni vzdrževalni odmerek je 100 mg/dan.
The other ingredients are: sodium acetate (trihydrate), acetic acid, glacial, sodium chloride, water for injection.
Druge sestavine zdravila so: natrijev acetat (trihidrat), koncentrirana ocetna kislina (ledocet), natrijev klorid, voda za injekcije.
When brivaracetam was coadministered at a dose of 400 mg/day (twice the recommended maximum daily dose) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg), a reduction in estrogen and progestin AUCs of 27 % and 23 %, respectively, was observed without impact on suppression of ovulation.
Pri sočasnem dajanju brivaracetama v odmerku 400 mg/dan (dvakratni največji priporočeni dnevni odmerek) s peroralnimi kontraceptivi, ki so vsebovali etinilestradiol (0,03 mg) in levonorgestrel (0,15 mg), so opazili zmanjšanje AUC za estrogen in progestin za 27 % oz. 23 %, vendar to ni vplivalo na zaustavitev ovulacije.
The solution for injection/infusion contains 0.83 mmol (or 19.14 mg) sodium per vial.
Raztopina za injiciranje/infundiranje vsebuje 0,83 mmol (ali 19,14 mg) natrija na vialo.
Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day and 4 mg/kg/day.
Na podlagi odziva posameznega bolnika je mogoče odmerek prilagajati v razponu učinkovitega odmerka 1 mg/ kg/dan in 4 mg/kg/dan.
The minimum extractible volume is 0.25 ml which is 2.5 mg of brivaracetam.
Najmanjša količina, ki jo je mogoče izvleči, je 0,25 ml, kar pomeni 2,5 mg brivaracetama.
None a based on a study involving the administration of a supratherapeutic dose of 400 mg/day brivaracetam
Nič a temelji na študiji, ki vključuje dajanje brivaracetama, kot supraterapevtskega odmerka 400 mg/dan Karbamazepin
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgija
From entry into the randomized studies,5.3 % of the subjects exposed to brivaracetam for 6 months (n=1,500) were seizure free compared to 4.6 % and 3.7 % for subjects exposed for 12 months (n=1,188) and 24 months (n=847), respectively.
Od začetka sodelovanja v randomiziranih študijah je bilo 5,3 % preskušancev, ki so bili izpostavljeni brivaracetamu 6 mesecev (n=1500), brez napadov, v primerjavi s 4,6 % oziroma 3,7 % za preskušance, ki so bili izpostavljeni 12 mesecev (n=1188) oziroma 24 mesecev (n=847).
Briviact solution for injection/infusion contains 0.83 mmol (or 19.14 mg) sodium per vial.
Zdravilo Briviact raztopina za injiciranje/infundiranje vsebuje 0,83 mmol (ali 19,14 mg) natrija na vialo.
Somnolence and fatigue (8.2 %) were reported at a higher incidence with increasing dose.
Z večanjem odmerka so poročali o povečani incidenci somnolence in utrujenosti (8,2 %).
In vitro studies have shown that brivaracetam exhibits little or no inhibition of CYP450 isoforms except for CYP2C19.
Študije in vitro so pokazale, da brivaracetam malo zavira ali ne zavira, izooblike CYP450 razen CYP2C19.
Oral dosing syringe (10 ml graduated every 0.25 ml) with an adaptor, recommended for use by patients weighing more than 20 kg or needing a dose between 50 mg and 100 mg (5 ml to 10 ml) brivaracetam per administration.
Peroralna odmerna brizga (10 ml graduirana na vsaki 0,25 ml) z adapterjem se priporoča za uporabo pri bolnikih s telesno maso več kot 20 kg ali bolnikih, ki potrebujejo odmerek med 50 mg in 100 mg (5 ml do 10 ml) brivaracetama na dajanje.
Take the daily dose in two equal divided doses - one in the morning and one in the evening at about the same time each day.
Dnevni odmerek vzemite razdeljen na dva enaka odmerka - enega zjutraj in enega zvečer, vsak dan ob približno enakem času.
Allée de la Recherche 60 (address only for outer carton) B-1070 Brussels
Allée de la Recherche 60 (naslov samo za škatlo) B-1070 Brussels
1 mg/kg/day (or 2 mg/kg/day)*
1 mg/kg/dan (ali 2 mg/kg/dan)*
Dose taken twice daily for children from 4 years of age weighing less than 50 kg.
Odmerek se jemlje dvakrat na dan za otroke od 4 leta starosti,
A 40 % decrease in steady-state plasma concentration has been estimated across a body weight range from 46 kg to 115 kg.
Pri razponu telesne mase od 46 do 115 kg so ocenili približno 40 % zmanjšanje plazemske koncentracije v dinamičnem ravnovesju.
Convulsion, vertigo
Konvulzije, vrtoglavica
Contains sodium citrate, carmellose sodium, methyl parahydroxybenzoate (E218), sorbitol liquid and glycerol (E422).
Vsebuje natrijev citrat, natrijev karmelozat, metilparahidroksibenzoat (E218), tekoči sorbitol in glicerol (E422).
It is recommended to parent and care giver to administer Briviact oral solution with the measuring device (10 ml or 5 ml oral dosing syringe) provided in the carton box.
Priporoča se, da starš ali negovalec zdravilo Briviact peroralno raztopino aplicira z merilnim pripomočkom, priloženim v škatli (peroralna odmerna brizga z 10 ml ali 5 ml).
Treatment of an overdose should include general supportive measures.
Specifičnega antidota za preveliko odmerjanje brivaracetama ni. Zdravljenje prevelikega odmerka naj vključuje splošne podporne ukrepe.
Briviact 10 mg/ml solution for injection/infusion 5 ml vial is packed in a carton box of 10 vials.
Zdravilo Briviact 10 mg/ml raztopina za injiciranje/infundiranje je na voljo v 5 ml vialah, v škatli s po 10 vialami.
Improvement in the median percent reduction in seizure frequency per 28 days has been observed in patients with type IC seizure (secondary generalized tonic-clonic seizures) at baseline treated with brivaracetam (66.6 % (n=62), 61.2 % (n=100) and 82.1 % (n=75) of the patients on brivaracetam 50 mg/day, 100 mg/day and 200 mg/day respectively as compared to placebo 33.3 % (n=115)).
Pri bolnikih z napadi tipa IC (sekundarni generalizirani tonično-klonični napadi), zdravljenih z brivaracetamom, so v primerjavi z izhodiščem opazili izboljšanje v mediani odstotka zmanjšanja pogostnosti napadov na 28 dni (pri 66,6 % (n=62), 61,2 % (n=100) in 82,1 % (n=75) bolnikov, ki so prejemali 50 mg/dan, 100 mg/dan in 200 mg/dan, v primerjavi s 33,3 % (n=115) bolnikov, ki so prejemali placebo).
The medicine is injected slowly into your vein or given as an infusion (drip) over 15 minutes.
Zdravilo boste prejeli s počasnim injiciranjem v žilo ali pa s 15-minutnim infundiranjem (s kapanjem).
• Packs of 14 x 1 and 100 x 1 film-coated tablet in PVC/PCTFE - Aluminium blisters
• Pakiranje po 14 x 1 in 100 x 1 filmsko obložena tableta v pretisnih omotih PVC/PCTFEaluminij.
There is limited clinical experience with brivaracetam overdose in humans.
Klinične izkušnje s prevelikim odmerjanjem brivaracetama pri ljudeh so omejene.
Brivaracetam film-coated tablets contain lactose.
Filmsko obložene tablete brivaracetama vsebujejo laktozo.
Brivaracetam has not been studied in patients undergoing hemodialysis (see section 4.2).
Brivaracetama pri bolnikih, ki so na hemodializi, niso preučevali (glejte poglavje 4.2).
If you are not sure, talk to your doctor or pharmacist before taking Briviact.
Če niste prepričani, se pred jemanjem zdravila Briviact posvetujte z zdravnikom ali farmacevtom.
- Do not drive, cycle or use any tools or machines until you know how the medicine affects you.
- Dokler ne veste, kako to zdravilo vpliva na vas, ne smete voziti avtomobila ali kolesa oziroma upravljati z orodji ali stroji.
Croscarmellose sodium, lactose monohydrate, betadex, lactose anhydrous, magnesium stearate
Jedro premrežen natrijev karmelozat, laktoza monohidrat, betadeks, brezvodna laktoza, magnezijev stearat
As from the 1 ml graduation mark, each graduation corresponds to 0.25 ml which is 2.5 mg of brivaracetam.
Od graduacijske oznake 1 ml naprej vsaka graduacijska oznaka ustreza 0,25 ml, kar je 2,5 mg brivaracetama.
The minimum extractible volume is 1 ml which is 10 mg of brivaracetam.
Najmanjša količina, ki jo je mogoče izvleči, je 1 ml, kar pomeni 10 mg brivaracetama.
What you need to know before you use Briviact 3.
Kaj morate vedeti, preden boste uporabili zdravilo Briviact 3.
50 - 200 mg/day
50-200 mg/dan
Children (≥4 years) and adolescents ≥50 kg Administered in 2 equally divided doses
Otroci (≥ 4 leta) in mladostniki ≥ 50 kg odmerja se razdeljen na 2 enaka odmerka
Oral dosing syringe (5 ml graduated every 0.1 ml) with an adaptor, recommended for use by patients weighing less than 20 kg or needing a maximum of 50 mg (5 ml) brivaracetam per administration.
Peroralna odmerna brizga (5 ml graduirana na vsaki 0,1 ml) z adapterjem se priporoča za uporabo pri bolnikih s telesno maso manj kot 20 kg ali bolnikih, ki potrebujejo največ 50 mg (5 ml) brivaracetama na dajanje.
Diluents - Sodium chloride 9 mg/ml (0.9 %) solution for injection - Glucose 50 mg/ml (5 %) solution for injection - Lactated Ringer's solution for injection.
Raztopine: - natrijev klorid 9 mg/ml (0,9 %) raztopina za injiciranje - glukoza 50 mg/ml (5 %) raztopina za injiciranje - Ringerjeva raztopina z laktatom za injiciranje
n= 96 n= 101
n = 101
Allée de la Recherche 60 B-1070 Brussels Belgium
Allée de la Recherche 60 B-1070 Brussels Belgija
In the open label, uncontrolled, long-term studies suicidal ideation was reported in 4.7 % of paediatric patients (more common in adolescents) compared with 2.4 % of adults and behavioural disorders were reported in 24.8 % of paediatric patients compared with 15.1 % of adults.
Varnostni profil za brivaracetam, ki so ga opazili pri otrocih, je bil skladen z varnostnim profilom, ki so ga opazili pri odraslih.V odprtih, nenadzorovanih, dolgoročnih študijah so o samomorilnih mislih poročali pri 4,7 % pediatričnih bolnikov (pogosteje pri mladostnikih) v primerjavi z 2,4 % odraslih in o vedenjskih motnjah so poročali pri 24,8 % pediatričnih bolnikov v primerjavi s 15,1 % odraslih.Večina dogodkov je bila po intenzivnosti blagih ali zmernih, dogodki niso bili resni in zaradi njih ni bilo treba prekiniti jemanja študijskega zdravila.
Gender There are no clinically relevant differences in the pharmacokinetics of brivaracetam by gender.
Spol Pri farmakokinetiki brivaracetama ni klinično pomembnih razlik med spoloma.
No clinical data are available in neonates.
Klinični podatki za novorojenčke niso na voljo.
50 mg/5 ml 10 vials solution for injection/infusion
50 mg/5 ml 10 vial raztopine za injiciranje/infundiranje
Driving and using machines - You may feel sleepy, dizzy or tired while taking Briviact.
Vpliv na sposobnost upravljanja vozil in strojev - Ko jemljete zdravilo Briviact, boste morda zaspani, omotični ali utrujeni.
Nausea, vomiting, constipation
Navzeja, bruhanje, zaprtost
The other ingredients are: sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), carmellose sodium, sucralose, sorbitol liquid, glycerol (E422), raspberry flavour, water, purified.
Druge sestavine so: natrijev citrat, brezvodna citronska kislina, metilparahidroksibenzoat (E218), natrijev karmelozat, sukraloza, tekoči sorbitol, glicerol (E422), aroma maline, prečiščena voda.
Each millilitre (ml) contains 10 milligrams (mg) brivaracetam.
En mililiter (ml) vsebuje 10 miligramov (mg) brivaracetama.
How to store Briviact 6.
Shranjevanje zdravila Briviact 6.
Common: may affect up to 1 in 10 people - flu - feeling very tired (fatigue) - convulsion, a feeling of ‘spinning' (vertigo) - feeling and being sick, constipation - pain or discomfort at the injection or infusion site - depression, anxiety, not being able to sleep (insomnia), irritability - infections of the nose and throat (such as the ‘common cold'), cough - decrease appetite
Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov - gripa - občutek hude utrujenosti - konvulzija, občutek vrtenja (vrtoglavica) - občutek slabosti in bruhanje, zaprtost - bolečina ali nelagodje na mestu injiciranja ali infundiranja - depresija, tesnoba, nespečnost (insomnija), razdražljivost - okužbe nosu in grla (npr. prehlad), kašelj - zmanjšanje apetita
People with liver problems If you have problems with your liver: - As an adult, adolescent or child weighing 50 kg or more, the maximum dose you will take is 75 mg twice a day.
Bolniki, ki imajo težave z jetri Če imate težave z jetri: - Kot odrasli, mladostnik ali otrok, ki tehta 50 kg ali več, je največji odmerek, ki ga lahko vzamete, 75 mg dvakrat na dan. - Kot otrok ali mladostnik, ki tehta manj kot 50 kg, je največji odmerek, ki ga lahko vzamete, 1,5 mg za vsak kg telesne mase dvakrat na dan.
The pharmacokinetics of brivaracetam was not significantly affected by race (Caucasian, Asian) in a population pharmacokinetic modeling from epilepsy patients.
Rasa (belci, Azijci) ni pomembno vplivala na farmakokinetiko brivaracetama v modeliranju populacijske farmakokinetike pri bolnikih z epilepsijo.
Type I hypersensitivity
Preobčutljivost tipa I
In monkeys, CNS signs (prostrate, loss of balance, clumsy movements) occurred at 64 fold the clinical Cmax, these effects being less apparent over time.
Pri opicah so se znaki vpliva na centralni živčni sistem (ležanje, izguba ravnotežja, nerodni gibi) pojavili pri 64-krat višji od kliničnega Cmax.
What Briviact looks like and contents of the pack Briviact 10 mg are white to off-white, round, film-coated tablets of 6.5 mm in diameter and debossed with ‘u10' on one side.
Izgled zdravila Briviact in vsebina pakiranja Tablete zdravila Briviact 10 mg so bele do umazano bele, okrogle, filmsko obložene tablete s premerom 6,5 mm in vtisnjeno oznako u10 na eni strani.
The 300 ml glass bottle of Briviact is packed in a cardboard box containing a 10 ml oral syringe and a 5 ml oral syringe and an adaptor for the syringe.
300 ml steklenica zdravila Briviact je na voljo v škatli, ki vsebuje 10-ml peroralno brizgo in 5-ml peroralno brizgo in adapter za brizgo.
In the table below, adverse reactions, which were identified based on review of the three placebocontrolled, fixed-dose studies safety database in subjects ≥ 16 years of age, are listed by System Organ Class and frequency.
Spodnja preglednica prikazuje neželene učinke, ki so bili ugotovljeni po pregledu baze podatkov o varnosti iz treh s placebom nadzorovanih kliničnih študij s stalnim odmerkom pri preskušancih, starih ≥ 16 let.
For children weighing 50 kg or greater the brivaracetam starting dose was 50 mg/day and depending on response and tolerability, the dose was increased up to a maximum of 200 mg/day by weekly increments of 50 mg/day.
Za otroke, ki so tehtali 50 kg ali več, je bil začetni odmerek brivaracetama 50 mg/dan, ki so ga glede na odziv in prenašanje povečali do največ 200 mg/dan v tedenskih korakih po 50 mg/dan.
10 mg/ml solution for injection/infusion is packed in 6 ml nominal capacity glass vials (type I) with siliconized bromobutyl rubber stoppers and sealed with an aluminium/polypropylene tear off cap. Each single use vial contains an extractable volume of not less than 5.0 ml of solution for injection/infusion.
Raztopina za injiciranje/infundiranje, 10 mg/ml, je na voljo v stekleni viali (tip I) z nominalno prostornino 6 ml, z zamaškom iz silikonizirane brombutilne gume, zaprtim z zaporko na poteg iz aluminij/polipropilena.
The dose should be administered in two equally divided doses, once in the morning and once in the evening.
Odmerek je treba dajati razdeljen na dva enaka odmerka, enkrat zjutraj in enkrat zvečer.
Children and adolescents weighing less than 50 kg - The recommended dose is from 0.5 mg to 2 mg for each kg of bodyweight, taken twice a day.
Otroci in mladostniki, ki tehtajo manj kot 50 kg - Priporočeni odmerek je od 0,5 mg do 2 mg za vsak kg telesne mase dvakrat na dan.
Adults, adolescents and children weighing 50 kg or more - The recommended dose is from 25 mg to 100 mg taken twice a day.
Odrasli, mladostniki in otroci, ki tehtajo 50 kg ali več - Priporočeni odmerek je od 25 mg do 100 mg dvakrat na dan.
- Briviact may be diluted before it is injected by your doctor or nurse.
- Zdravilo Briviact lahko zdravnik ali medicinska sestra razredči pred injiciranjem.
Suicidal ideation, psychotic disorder, aggression, agitation Nervous system disorders Very common Dizziness, somnolence Common
Samomorilno razmišljanje, psihotične motnje, agresija, agitacija
n = 252 n = 249
n = 252
Briviact is used in adults, adolescents and children from 4 years of age.
Za kaj uporabljamo zdravilo Briviact - Zdravilo Briviact se uporablja pri odraslih, mladostnikih in otrocih od 4. leta starosti.
- You have liver problems - your doctor may need to adjust your dose.
Če imate kadar koli take misli, se takoj posvetujte z zdravnikom; - imate težave z jetri vam bo zdravnik morda moral prilagoditi odmerek.
Pharmacokinetic/pharmacodynamics relationship
Povezava med farmakokinetiko/farmakodinamiko
Suicidal ideation has been reported in 0.3 % (3/1099) brivaracetam patients and 0.7 % (3/459) placebo patients.
O samomorilnem razmišljanju so poročali pri 0,3 % (3/1099) bolnikov, ki so jemali brivaracetam, in pri 0,7 % (3/459) bolnikov, ki so jemali placebo.
Table 1: Pharmacokinetic interactions between brivaracetam and other AEDs AED coadministered Influence of AED on brivaracetam plasma concentration
Preglednica 1: Farmakokinetične interakcije med brivaracetamom in drugimi antiepileptiki Sočasno uporabljeni antiepileptiki
Briviact oral solution is provided with a 5 ml and a 10 ml oral dosing syringe with their adaptor.
Peroralna raztopina zdravila Briviact je na voljo s peroralno odmerno brizgo 5 ml in 10 ml z adapterjem.
The efficacy of brivaracetam in monotherapy has not been established.
Učinkovitost brivaracetama pri samostojnem zdravljenju ni bila ugotovljena.
- Then take your next dose at the time you would normally take it. - Do not take a double dose to make up for a forgotten dose.
- Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Neutropenia has been reported in 0.5 % (6/1099) brivaracetam patients and 0 % (0/459) placebo patients.
O nevtropeniji so poročali pri 0,5 % (6/1099) bolnikov, ki so jemali brivaracetam, in pri 0 % (0/459) bolnikov, ki so jemali placebo.
No dose adjustment is needed in patients with impaired renal function (see section 5.2).
Za bolnike z okvarjenim delovanjem ledvic prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
The discontinuation rate due to adverse reactions was 3.5 %, 3.4 % and 4.0 % for patients randomized to brivaracetam at respectively the dose of 50 mg/day, 100 mg/day and 200 mg/day and 1.7% for patients randomized to placebo.
Stopnja prekinitve zdravljenja zaradi neželenih učinkov je bila 3,5 %, 3,4 % in 4,0 % pri bolnikih, randomiziranih na brivaracetam z odmerki 50 mg/dan, 100 mg/dan in 200 mg/dan, in 1,7 % pri bolnikih, ki so bili randomizirani na zdravljenje s placebom.
Based on individual patient response, the dose may be adjusted in the effective dose range of 50 mg/day and 200 mg/day.
Na podlagi odziva posameznega bolnika je mogoče odmerek prilagajati v razponu učinkovitega odmerka 50 mg/dan in 200 mg/dan.
How to use Briviact
Kako uporabljati zdravilo Briviact
In rats, there was no effect on fertility with brivaracetam (see section 5.3).
Pri podganah brivaracetam ni vplival na plodnost (glejte poglavje 5.3).
What you need to know before you take Briviact 3.
Kaj morate vedeti, preden boste vzeli zdravilo Briviact 3.
A nasogastric tube or a gastrostomy tube may be used when administering brivaracetam oral solution.
Za dajanje peroralne raztopine brivaracetama se lahko uporablja nazogastrična sonda ali sonda za gastrostomijo.
Common: may affect up to 1 in 10 people - flu - feeling very tired (fatigue) - convulsion, a feeling of ‘spinning' (vertigo) - feeling and being sick, constipation - depression, anxiety, not being able to sleep (insomnia), irritability - infections of the nose and throat (such as the ‘common cold'), cough - decreased appetite
Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov - gripa - občutek hude utrujenosti - konvulzija, občutek vrtenja (vrtoglavica) - občutek slabosti in bruhanje, zaprtost - depresija, tesnoba, nespečnost (insomnija), razdražljivost - okužbe nosu in grla (npr. prehlad), kašelj
Briviact contains sodium
Zdravilo Briviact vsebuje natrij
In clinical studies, brivaracetam was used as adjunctive therapy and when it was used with carbamazepine, it induced a dose-related increase in the concentration of the active metabolite, carbamazepine-epoxide (see section 4.5).
Če so ga uporabili skupaj s karbamazepinom, je sprožil z odmerkom povezano povečanje koncentracije aktivnega presnovka, karbamazepin epoksida (glejte poglavje 4.5).
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