natgillin/translations-raw huggingface dataset:
Xolair 150 mg powder and solvent for solution for injection omalizumab 
Xolair 150 mg prašek in vehikel za raztopino za injiciranje omalizumab
• Sharps disposal container. 
• zbiralnik za ostre predmete
Each pre-filled syringe of 1 ml solution contains 150 mg of omalizumab. 
Ena napolnjena injekcijska brizga z 1 ml raztopine vsebuje 150 mg omalizumaba.
Expel air, large bubbles, and any excess solution in order to obtain the required 0.6 ml dose. 
Izbrizgajte zrak, velike mehurčke in morebitno odvečno tekočino, da boste dobili potrebni odmerek 0,6 ml. Na površini raztopine v brizgi sme ostati tenka plast majhnih mehurčkov.
Expel air, large bubbles, and any excess solution in order to obtain the required 1.2 ml dose. 
Izbrizgajte zrak, velike mehurčke in morebitno odvečno tekočino, da boste dobili potrebni odmerek 1,2 ml. Na površini raztopine v brizgi sme ostati tenka plast majhnih mehurčkov.
Xolair 75 mg powder and solvent for solution for injection omalizumab 
Xolair 75 mg prašek in vehikel za raztopino za injiciranje omalizumab
Xolair 150 mg powder and solvent for solution for injection 
Xolair 150 mg prašek in vehikel za raztopino za injiciranje
Xolair 75 mg powder and solvent for solution for injection 
Xolair 75 mg prašek in vehikel za raztopino za injiciranje
Xolair 150 mg solution for injection in pre-filled syringe 
Xolair 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
You must look out for signs of these conditions while you use Xolair. 
V času uporabe zdravila Xolair morate biti pozorni na znake teh neželenih učinkov.
Your Xolair 150 mg pre-filled syringe 
Xolair 150 mg napolnjena injekcijska brizga
Clear to slightly opalescent, colourless to pale brownish-yellow solution. 
bistra do rahlo opalescentna in brezbarvna do bledo rjavorumeno obarvana raztopina
Each pre-filled syringe of 0.5 ml solution contains 75 mg of omalizumab*. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka napolnjena injekcijska brizga z 0,5 ml raztopine vsebuje 75 mg omalizumaba*.
Storage of the Xolair pre-filled syringe 
Shranjevanje zdravila Xolair v napolnjeni injekcijski brizgi
Administration of Xolair manufactured as a lyophilised or liquid formulation resulted in similar serum concentration-time profiles of omalizumab. 
Časovno spreminjanje koncentracije omalizumaba v serumu po aplikaciji zdravila Xolair poteka približno enako ne glede na to, ali je bilo zdravilo izdelano v liofilizirani ali v tekoči obliki.
WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING BLUE BOX) 
NALEPKA (Z “BLUE BOX” PODATKI) NA OVITKU SKUPNEGA PAKIRANJA Z VMESNIMI PAKIRANJI ZAVITIMI V FOLIJO
Xolair 150 mg powder for solution for injection omalizumab 
Xolair 150 mg prašek za raztopino za injiciranje omalizumab subkutana uporaba
Keep the plunger fully depressed while you carefully lift the needle straight out from the injection site. 
Medtem ko previdno vlečete iglo naravnost iz kože na mestu injiciranja, držite bat pritisnjen do konca.
One vial contains 75 mg of omalizumab*. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 75 mg omalizumaba*.
The liquid should be clear to slightly cloudy. 
Tekočina mora biti bistra do rahlo motna, barva tekočine pa lahko variira od brezbarvne do bledo rjavorumene.
Xolair 75 mg powder for solution for injection omalizumab 
Xolair 75 mg prašek za raztopino za injiciranje omalizumab subkutana uporaba
Study 2 
DRUGI PODATKI
Children (6 to less than 12 years of age) are not expected to inject Xolair themselves, however, if deemed appropriate by their doctor, a caregiver may give them their Xolair injection after proper training. 
Pri otrocih (ki so stari od 6 do manj kot 12 let) ni predvideno, da bi si zdravilo Xolair dajali sami.
1 x 75 mg vial 1 x 2 ml solvent ampoule 
prašek in vehikel za raztopino za injiciranje 1 x 75 mg viala
Injection site reactions such as swelling, erythema, pain, pruritus 
občasni znaki in simptomi dispepsije, driska, navzea
Keep taking your current medicine for CSU during Xolair treatment. 
Med zdravljenjem z zdravilom Xolair nadaljujte z uporabo zdravil, ki ste jih že prej uporabljali za zdravljenje kronične spontane urtikarije.
L-arginine hydrochloride L-histidine hydrochloride L-histidine 
L-argininijev klorid L-histidinijev klorid L-histidin polisorbat 20 voda za injekcije
1 x 150 mg vial 1 x 2 ml solvent ampoule 
prašek in vehikel za raztopino za injiciranje 1 x 150 mg viala
For subcutaneous administration only. 
Zdravilo je namenjeno samo za subkutano uporabo.
Omalizumab 300 mg 
placebo omalizumab 300 mg študija 1
It's important that you do this. 
Pomembno je, da to storite.
The reason is unclear. 
Razlog za to ni jasen.
You can take it with or without food. 
Vzamete ga lahko s hrano ali brez nje.
• when you first start treatment 
• ko prvič začnete zdravljenje
- The CHMP concluded that the data are supportive of the following indications: 
- CHMP je zaključil, da podatki podpirajo naslednje indikacije:
The dose you take will depend on: 
Odmerek, ki ga boste jemali, bo odvisen od:
However, based on interaction studies with other medicinal products, the following recommendations can be made: 
Vendar je mogoče na podlagi študij interakcij z drugimi zdravili podati naslednja priporočila:
Never take only part of a tablet. 
Nikdar ne vzemite le dela tablete.
Less than 10% is excreted unchanged in the urine. 
Manj kot 10 % se ga izloči nespremenjenega v urinu.
• if you are under 25 years old. 
• če ste mlajši od 25 let
Elderly (above 65 years) 
Starejši bolniki (nad 65 let)
• Drink all the liquid. 
• Popijte vso tekočino.
Watch out for important symptoms 
Bodite pozorni na pomembne simptome
Development in children 
Razvoj pri otrocih
Clinical worsening and suicide risk 
Klinično poslabšanje in tveganje za samomor
The results are shown in Table 7. 
Rezultati so prikazani v preglednici 7.
lupus-like reactions. 
lupusu podobne reakcije.
Other data sets have not confirmed this finding. 
Druge podatkovne zbirke tega niso potrdile.
105 Reykjavik Iceland 
105 Reykjavik Islandija
• difficulty in sleeping 
• težave s spanjem
Take them back to your pharmacist, who will dispose of them in a way that won't harm the environment. 
Vrnite jih farmacevtu, ki jih bo odstranil tako, da ne bo škodovalo okolju.
37135 Verona Italy 
37135 Verona Italija
Stevens-Johnson Syndrome. 
Stevens-Johnsonov sindrom.
• hallucinations (‘seeing' or ‘hearing' things that aren't really there) 
• halucinacije ("videnje" ali "slišanje" stvari, ki jih v resnici ni)
In addition Lamictal has been approved for use in bipolar patients in several EU member states except in the UK, Netherlands, France and Cyprus. 
Zdravilo Lamictal je odobreno tudi za uporabo pri bolnikih z bipolarno motnjo v številnih državah članicah EU, razen v Združenem kraljestvu, na Nizozemskem, v Franciji in na Cipru.
Î See a doctor as soon as possible. 
Î Čim prej pojdite k zdravniku.
MOM Park, Gesztenyes torony Hungary 
MOM Park, Gesztenyes torony Madžarska
Patients should be monitored with respect to this. 
Bolnike morate glede tega kontrolirati.
It is not yet known how Lamictal works in the brain to have this effect. 
Ni še znano, kako Lamictal v možganih doseže ta učinek.
28760 Tres Cantos Madrid Spain 
28760 Tres Cantos Madrid Španija
If you have an intolerance to lactose or any other sugars: 
Če imate intoleranco za laktozo ali kakšne druge sladkorje:
Clinical efficacy and safety in children aged 1 to 24 months 
Klinična učinkovitost in varnost pri otrocih v starosti od 1 do 24 mesecev
No dosage adjustment from the recommended schedule is required. 
Ni potrebna prilagoditev od priporočenega režima odmerjanja.
The volume of distribution is 0.92 to 1.22 L/kg. 
Volumen porazdelitve je od 0,92 do 1,22 l/kg.
In the event of overdosage, the patient should be admitted to hospital and given appropriate supportive therapy. 
V primeru prevelikega odmerjanja je treba bolnika sprejeti v bolnišnico in mu zagotoviti ustrezno podporno zdravljenje.
If necessary, the dose should be adapted. 
Če je potrebno, morate odmerek prilagoditi.
Approximately half of these cases have been reported as Stevens-Johnson syndrome (1 in 1000). 
Približno polovica teh primerov je bila opisana kot Stevens-Johnsonov sindrom (1 na 1000).
Ljubljana Knezov stradon 90 1000 Ljubljana Slovenia 
Ljubljana Knezov štradon 90 1000 Ljubljana Slovenija
They smell of blackcurrant. 
Imajo vonj po črnem ribezu.
• Always take the full dose that your doctor has prescribed. 
• Vedno vzemite celotni odmerek, ki vam ga je predpisal zdravnik.
• bupropion, used to treat mental health problems or to stop smoking Î Tell your doctor if you are taking any of these. 
• bupropion, ki se uporablja za zdravljenje težav z duševnim zdravjem ali za opustitev kajenja Î Povejte svojemu zdravniku, če jemljete katero od teh zdravil.
In addition, the assessment of quality issues has led to the harmonisation of the pharmaceutical forms (tablet and dispersible/chewable tablet) across the EU. 
Poleg tega je ocena vidikov kakovosti privedla do uskladitve farmacevtskih oblik (tableta in disperzibilna/žvečljiva tableta) po vsej EU.
Take your dose of Lamictal once or twice a day, as your doctor advises. 
Odmerek Lamictala vzemite enkrat ali dvakrat na dan, kot vam je svetoval zdravnik.
Laboratórios Wellcome de Portugal Lda. 
Portugalska Laboratórios Wellcome de Portugal Lda.
Suicidality analysis 
Analiza samomorilnosti
• loss of consciousness or coma. 
• izguba zavesti ali koma.
Some patients may experience severe seizures, which may cause serious health problems. 
Nekaterim bolnikom se lahko pojavijo hudi napadi,ki lahko povzročijo resne zdravstvene težave.
The greater the interval of time since the previous dose, the more consideration should be given to escalation to the maintenance dose. 
Daljši ko je presledek od prejšnjega odmerka, bolj je treba preučiti zviševanje do vzdrževalnega odmerka.
Grunwaldzka 189, 60-322 Poznan, Poland.> 
Grunwaldzka 189, 60-322 Poznan, Poljska.>
There are no data in children below 1 month of age. 
Podatkov za otroke do 1 meseca starosti ni.
Dose reductions of up to 90% were required in some patients at the end of week 2. 
Nekaterim bolnikom je bilo treba odmerek na koncu 2. tedna zmanjšati do 90 %.
The tablets may be slightly mottled. 
Tablete so lahko nekoliko lisaste.
• rifampicin, which is an antibiotic 
• rifampicin, ki je antibiotik,
The IC50 was approximately nine-times above the maximum therapeutic free concentration. 
IC50 je bila približno devetkrat nad največjo terapevtsko prosto koncentracijo.
You may need to drink a little water at the same time to help the tablet dissolve in your mouth. 
Morda boste morali hkrati popiti malo vode, da se vam bo tableta lažje raztopila v ustih.
The excipients used in the formulations of the drug product and manufacturing processes are standard for the proposed pharmaceutical forms. 
Pomožne snovi, uporabljene v formulacijah zdravila in proizvodnih procesih, so standardne za predlagane farmacevtske oblike.
If possible, show them the Lamictal packet. 
Če je mogoče, mu pokažite škatlico zdravila Lamictal.
If you plan to start using a hormonal contraceptive: 
Če nameravate začeti uporabljati hormonsko kontracepcijo:
Extremadura, 3, Poligono Industrial Allenduero, 09400 Aranda de Duero (Burgos), Spain.> 
Extremadura, 3, Poligono Industrial Allenduero, 09400 Aranda de Duero (Burgos), Španija.>
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidality emerge. 
Bolnikom (in skrbnikom bolnikov) je treba svetovati, naj poiščejo zdravniško pomoč, če bi se pojavili znaki samomorilnosti.
toxic epidermal necrolysis. 
toksična epidermalna nekroliza.
The CHMP concluded that conversion to monotherapy is not an indication but information on correct use of the product. 
CHMP je zaključil, da prehod na monoterapijo ni indikacija, temveč informacija o pravilni uporabi zdravila.
• Either stir to dissolve, or wait for about a minute, until the tablet is fully dissolved. 
• Premešajte, da se bo tableta raztopila, ali počakajte približno minuto, dokler ni tableta povsem raztopljena.
This text should be therefore moved to section 4.2, Posology and method of administration. 
To besedilo je zato treba premakniti v poglavje 4.2 „Odmerjanje in način uporabe“.
An effect of this magnitude is not generally expected to be clinically relevant. 
Praviloma ni mogoče pričakovati, da bi bil učinek tega velikostnega reda klinično pomemben.
Week 1 (beginning with withdrawal) 
1. teden (začetek opuščanja)
• if you have previously had thoughts about harming yourself or about suicide 
• če ste že kdaj razmišljali o samopoškodovanju ali o samomoru
Î Don't drive or operate machines unless you are sure you're not affected. 
Î Ne vozite in ne upravljajte strojev, dokler niste prepričani, da vam ne povzroča tega.
Therefore, patients should see how Lamictal therapy affects them before driving or operating machinery. 
Zato morajo bolniki ugotoviti, kako zdravljenje z Lamictalom vpliva nanje, preden vozijo ali upravljajo stroje.
Each bottle contains 30 tablets. 
Ena steklenička vsebuje 30 tablet.
Solna Sweden 
Solna Švedska
The efficacy of lamotrigine in combination with mood stabilisers has not been adequately studied. 
Učinkovitost lamotrigina v kombinaciji s stabilizatorji razpoloženja ni ustrezno raziskana.
The difference was not statistically significant: 26.3%, CI95% -2.6% <> 50.2%, p=0.07. 
Razlika ni bila statistično značilna: 26,3 %, 95% IZ: -2,6 % <> 50,2 %, p =
There are no data on the effect of lamotrigine on growth, sexual maturation and cognitive, emotional and behavioural developments in children. 
Ni podatkov o vplivu lamotrigina na rast, spolno dozorevanje ter kognitivni, čustveni in vedenjski razvoj otrok.
The effects of doses of lamotrigine other than 300 mg/day have not been studied and studies with other female hormonal preparations have not been conducted. 
Učinki ostalih odmerkov lamotrigina, razen 300 mg/dan, niso bili raziskani in študije z drugimi ženskimi hormonskimi pripravki niso bile izvedene.
Don't break, chew or crush them. 
Ne lomite jih, ne grizite in ne drobite.
The following convention has been utilised for the classification of undesirable effects:- Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000). 
Neželeni učinki so razvrščeni po naslednji klasifikaciji: Zelo pogosti (≥ 1/10), pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1000, < 1/100), redki (≥ 1/10.000, < 1/1000), zelo redki (< 1/10.000).
- The Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee 
- povzetki glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki jih je predlagal imetnik dovoljenja za promet, so bili ocenjeni na podlagi predložene dokumentacije in znanstvene razprave v okviru Odbora;
This referral is undertaken following concerns related to divergent decisions on approval of the bipolar indication for lamotrigine across EU Member States. 
Ta napotitev izhaja iz pomislekov v zvezi z razhajajočimi se odločitvami glede odobritve indikacije za bipolarno motnjo za lamotrigin v državah članicah EU.
Physiological changes during pregnancy may affect lamotrigine levels and/or therapeutic effect. 
Fiziološke spremembe med nosečnostjo lahko vplivajo na koncentracijo lamotrigina in/ali njegov terapevtski učinek.
Infants aged 2 to 26 months 
Dojenčki v starosti od 2 do 26 mesecev
Risk related to antiepileptic drugs in general 
Tveganje, povezano z antiepileptiki na splošno
DK-2605 Broendby 
DK-2605 Broendby Danska
• hormonal contraceptives, such as the Pill (see below). 
• hormonska kontracepcija, npr. kontracepcijske tablete (glejte spodaj).
Binding to plasma proteins is about 55%; it is very unlikely that displacement from plasma proteins would result in toxicity. 
Vezava ne beljakovine v plazmi je okoli 55 %; zelo malo je verjetno, da bi izpodrivanje z beljakovin v plazmi povzročilo toksične učinke.
Your doctor may also advise you to start or stop taking other medicines, depending on what condition you're being treated for and the way you respond to treatment. 
Zdravnik vam bo morda tudi svetoval začetek ali prenehanje jemanja drugih zdravil, odvisno od bolezni, zaradi katere se zdravite, in od vašega odziva na zdravljenje.
In the clinical practice, the approved drugs for Bipolar disorder generally need to be combined to achieve an acceptable control of the symptoms. 
V klinični praksi je treba v splošnem kombinirati odobrena zdravila za zdravljenje bipolarne motnje, da bi dosegli sprejemljiv nadzor simptomov.
Dose increases should not exceed this rate, unless the clinical response supports larger increases. 
Odmerka ne smete zviševati hitreje, razen če klinični odziv zahteva višje povečanje.
It should be also underlined that lamotrigine is not indicated for acute treatment. 
Poudariti je treba tudi, da lamotrigin ni indiciran za akutno zdravljenje.
80339 München 
80339 München Nemčija
Target Stabilisation Dose (Week 6)* 
1. in 2. teden 3. in 4. teden 5. teden Ciljni stabilizacijski odmerek (6. teden)*
- Clinical aspects 
- Klinični vidiki
Î Talk to your doctor, who will discuss suitable methods of contraception with you. 
Î Z zdravnikom se posvetujte o ustreznih načinih kontracepcije.
Lamictal belongs to a group of medicines called anti-epileptics. 
Lamictal spada v skupino zdravil, imenovanih antiepileptiki.
• whether you have problems with your kidneys or liver. 
• tega, ali imate kakšne težave z ledvicami ali jetri.
Î Contact a doctor or pharmacist immediately. 
Î Nemudoma se posvetujte z zdravnikom ali farmacevtom.
Albert-Schweitzer-Gasse 6 A-1140 Wien Austria 
Albert-Schweitzer-Gasse 6, A-1140 Dunaj Avstrija
* The Target stabilisation dose will alter depending on clinical response 
* Ciljni stabilizacijski odmerek se bo razlikoval glede na klinični odziv
In addition, the patients studied were diagnosed with Bipolar I disorder; therefore the results of these studies may not be extrapolated to Bipolar II disorder. 
Poleg tega so bili obravnavani bolniki diagnosticirani z bipolarno motnjo I, zato rezultatov teh študij ni mogoče ekstrapolirati v bipolarno motnjo II.
<Glaxo Wellcome GmbH & Co., Industriestrasse 32-36, 23843 Bad Oldesloe, Germany.> 
<Glaxo Wellcome GmbH & Co., Industriestrasse 32-36, 23843 Bad Oldesloe, Nemčija.>
In many cases, these symptoms will be signs of less serious side effects. 
V številnih primerih so našteti simptomi sicer znaki manj resnih neželenih učinkov.
The drug substance and the drug product have been appropriately described and generally satisfactory documentation has been provided. 
Zdravilna učinkovina in zdravilo sta bila ustrezno opisana, predložena je bila tudi v splošnem zadovoljiva dokumentacija.
It is likely that patients aged two to six years will require a maintenance dose at the higher end of the recommended range. 
Otroci od 2. do 6. leta starosti bodo predvidoma potrebovali vzdrževalni odmerek v zgornjem delu priporočenega območja.
These symptoms are more likely to happen during the first few months of treatment with Lamictal, especially if you start on too high a dose or if your dose is increased too quickly, or if you're taking Lamictal with another medicine called valproate. 
Verjetnost teh simptomov je večja v prvih mesecih zdravljenja z zdravilom Lamictal, zlasti če začnete s prevelikim odmerkom, če vam odmerek prehitro povečajo, ali če jemljete Lamictal skupaj z zdravilom, imenovanim valproat.
Week 1 (beginning with addition) 
1. teden (po dodatku)
A clinically significant worsening of seizure frequency instead of an improvement may be observed. 
Kaže se lahko tudi klinično pomembno poslabšanje pogostnosti krčev, namesto izboljšanja.
Medicines to treat depression and other mental health problems increase the risk of suicidal thoughts and behaviour in children and adolescents aged under 18 years. 
Zdravila za zdravljenje depresije in druge težave z duševnim zdravjem povečujejo tveganje za samomorilne misli in samomorilno vedenje med otroci in mladostniki, mlajšimi od 18 let.
Children below 2 years 
Otroci, mlajši od 2 let
Therefore lamotrigine serum concentrations should be monitored before, during and after pregnancy, as well as shortly after birth. 
Zato je treba serumsko koncentracijo lamotrigina kontrolirati pred nosečnostjo, med nosečnostjo in po njej, pa tudi kmalu po porodu.
• feeling ‘wobbly' or unsteady when you move about 
• občutek "majavosti" ali negotovosti, ko se gibljete naokoli
Monotherapy should be the most desirable achievement, as the safety concerns tend to be reduced when only one drug is used, but at the present it is rarely obtained. 
Monoterapija je najbolj zaželena, saj se varnostni pomisleki pri uporabi le enega zdravila zmanjšajo, vendar pa je trenutno redko dosegljiva.
The use of lamotrigine in the proposed harmonised indications has been generally well substantiated according to the available clinical data submitted by the Marketing Authorisation Holder. 
Uporaba lamotrigina pri predlaganih usklajenih indikacijah je bila z razpoložljivimi kliničnimi podatki, ki jih je predložil imetnik dovoljenja za promet z zdravilom, v splošnem primerno utemeljena.
Hungary GlaxoSmithKline Kft. 1124Bp. 
Madžarska GlaxoSmithKline Kft. 1124Bp.
People with bipolar disorder (sometimes called manic depression) have extreme mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or despair). 
Ljudje z bipolarno motnjo (včasih imenovanoo manično depresivno motnjo) doživljajo izredna nihanja razpoloženja, tako da se jim obdobja manije (vznemirjenja ali evforije) izmenjujejo z obdobji depresije (globoke žalosti ali obupa).
Although the disorder is a heterogeneous disease with contrasting therapeutic needs, it was recognised that depressive aspect is the most worrying and a drug able to prevent depressive episodes is therefore of value. 
Čeprav je motnja heterogena bolezen z nasprotujočimi se terapevtskimi potrebami, je bilo sprejeto, da je vidik depresije najbolj zaskrbljujoč, zato je zdravilo, ki bi lahko preprečevalo epizode depresije, pomembno.
GlaxoSmithKline Oy Piispansilta 9 A 02230 Espoo Finland 
GlaxoSmithKline Oy Piispansilta 9 A 02230 Espoo Finska
A similar effect was seen during a study of lamotrigine and oxcarbazepine in healthy adult volunteers, but dose reduction was not investigated. 
Podoben učinek so opazili med študijo lamotrigina in okskarbazepina pri zdravih odraslih prostovoljcih, toda zmanjšanja odmerka niso raziskali.
When valproate is withdrawn, double the stabilisation dose, not exceeding an increase of more than 100 mg/week 
Po ukinitvi valproata podvojite stabilizacijski odmerek, vendar ne prekoračite zviševanja odmerka po 100 mg/teden
There is considerable inter-individual variation in steady state maximum concentrations but within an individual, concentrations rarely vary. 
Obstaja občutna inter-individualna variabilnost največje koncentracije v stanju dinamičnega ravnovesja, toda pri posamezniku koncentracije le redko variirajo.
The target population will be Bipolar I patients, as these patients were included in the clinical studies. 
Ciljna skupina bodo bolniki z bipolarno motnjo I, saj so bili taki bolniki vključeni v klinične študije.
• a severe skin reaction, starting with a painful red area, developing into large blisters then peeling of layers of skin (toxic epidermal necrolysis) 
• huda kožna reakcija, ki se začne kot boleč rdeč predel, se razvije v velike mehurje in nato v odstopanje plasti kože (toksična epidermalna nekroliza)
Administration of lamotrigine resulted in a 15% increase in topiramate concentrations. 
Uporaba lamotrigina je povzročila 15 % povečanje koncentracije topiramata.
Not all listed pack sizes may be available in your country. 
V vaši državi morda na trgu ni vseh navedenih pakiranj.
To make a liquid medicine: 
Za pripravo tekočega zdravila:
These effects were observed at the expected clinical exposure. 
Te učinke so opazili pri odmerkih, enakih kot ob pričakovani klinični izpostavljenosti zdravilu.