natgillin/translations-raw huggingface dataset:
In study 4 patients who completed treatment in studies 1 and 2 with placebo were switched to ivacaftor while patients on ivacaftor continued to receive it for a minimum of 96 weeks, i.e., the length of treatment with ivacaftor was at least 96 weeks for patients in the placebo/ivacaftor group and at least 144 weeks for patients in the ivacaftor/ivacaftor group.
dolžina zdravljenja z ivakaftorjem je bila pri bolnikih v skupini s placebom in ivakaftorjem vsaj 96 tednov, v skupini z ivakaftorjem in ivakaftorjem pa vsaj 144 tednov.
common
Zmerne
Always take this medicine exactly as your doctor has told you to.
Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika.
Kalydeco granules are indicated for the treatment of babies and children aged 6 months and older and weighing 5 kg to less than 25 kg with cystic fibrosis (CF) who have one of the following gating mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
Zrnca Kalydeco so namenjena zdravljenju dojenčkov in otrok, starih 6 mesecev ali starejših, s telesno maso 5 kg do manj kot 25 kg, s cistično fibrozo (CF), ki imajo eno od naslednjih mutacij spreminjanja prehodnosti kanalčkov celične membrane na genu CFTR: G551D, G1244E, G1349D, G178R,
CYP3A inhibitors
Spodbujevalci CYP3A
Placebo
FEV1
MA (EU) number (Invented) name
Številka postopka EMA (Izmišljeno) ime
--¹ After reconstitution, 1 dose (0.5 ml) contains 50 micrograms of gE antigen1 adjuvanted with AS01B2.
--1 Po rekonstituciji 1 odmerek (0,5 ml) vsebuje 50 mikrogramov antigena gE1 z adjuvansom AS01B2.
1 vial (powder) + 1 vial (suspension)
1 viala (prašek) + 1 viala (suspenzija)
10 vials (powder) + 10 vials (suspension)
10 vial (prašek) + 10 vial (suspenzija)
2 AS01B Adjuvant System is composed of the plant extract Quillaja saponaria Molina, fraction 21 (QS-21) (50 micrograms) and 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota (50 micrograms)
1 glikoprotein E (gE) virusa varicella zoster, pridobljen iz celic jajčnika kitajskega hrčka s tehnologijo rekombinantne DNA 2 AS01B adjuvansni sistem je sestavljen iz rastlinskega izvlečka Quillaja saponaria Molina, frakcija 21 (QS-21) (50 mikrogramov) in 3-O-dezacil-4'monofosforillipida A (MPL) iz Salmonella minnesota (50 mikrogramov)
In certain cases treatment should be permanently stopped.
V določenih primerih je treba zdravljenje trajno ukiniti.
This overview was last updated in 06-2018.
Povzetek je bil nazadnje posodobljen 06-2018.
Further information on Alecensa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Alecensa so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Alecensa received a marketing authorisation valid throughout the EU on 16 February 2017.
Zdravilo Alecensa je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 16. februarja 2017.
The medicine is available as capsules (150 mg).
Zdravilo je na voljo v obliki kapsul (150 mg).
The European Medicines Agency decided that Alecensa's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Alecensa večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Response was maintained for an average of 14.9 months in the first study, and 15.2 months in the second study.
V prvi študiji je odziv trajal povprečno 14,9 meseca, v drugi pa 15,2 meseca.
In the second study, the complete or partial response rate at the time of analysis was 51% (62 out of 122 patients).
V drugi študiji je bil delež popolnega ali delnega odziva v času analize 51 % (62 od 122 bolnikov).
What measures are being taken to ensure the safe and effective use of Alecensa?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Alecensa?
As for all medicines, data on the use of Alecensa are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Alecensa stalno spremljajo.
The recommended usual dose is 4 capsules taken twice a day with food (1,200 mg in total).
Priporočeni običajni odmerek je štiri kapsule dvakrat na dan s hrano (skupaj 1 200 mg).
Response to treatment was assessed using body scans and standardised criteria for solid tumours, with complete response being when the patient had no remaining signs of the cancer.
Odziv na zdravljenje so ocenjevali s slikanjem telesa in standardiziranimi merili za čvrste tumorje; popoln odziv je pri tem pomenil, da bolnik nima nikakršnih preostalih znakov raka.
Genetic defects affecting ALK (‘ALK-positive' status) should be confirmed in advance by appropriate methods.
Genske okvare, ki vplivajo na anaplastično limfomsko kinazo (ALK-pozitivno stanje), je treba predhodno potrditi z ustreznimi metodami.
The most common side effects with Alecensa (which may affect more than 2 in 10 people) are constipation, muscle pain and oedema (swelling) including of the ankles and feet, the face, the eyelids and the area around the eyes.
Najpogostejši neželeni učinki zdravila Alecensa (ki se lahko pojavijo pri več kot 2 bolnikih od 10) so zaprtje, bolečine v mišicah in edem (otekanje), vključno z otekanjem gležnjev in stopal, obraza ter vek in predelov okrog oči.
Two main studies involved a total of 225 patients in whom the disease progressed despite previous treatment with Xalkori (crizotinib).
Dve glavni študiji sta skupaj vključevali 225 bolnikov, pri katerih je bolezen napredovala kljub predhodnemu zdravljenju z zdravilom Xalkori (krizotinib).
The safety profile of Alecensa was considered acceptable and in line with that of other ALK inhibitors.
Varnostni profil zdravila Alecensa je bil sprejemljiv in v skladu z drugimi ALK-zaviralci.
Why is Alecensa authorised in the EU?
Zakaj je zdravilo Alecensa odobreno v EU?
In the first study around 52% of patients given Alecensa (35 out of 67) were considered by the treating doctors to have shown a complete or partial response to the medicine at the time of analysis.
V prvi študiji so zdravniki za približno 52 % (35 od 67) bolnikov, ki so prejemali zdravilo Alecensa, presodili, da so v času analize dosegli popoln ali delen odziv na zdravilo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alecensa have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Alecensa upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Side effects reported with Alecensa are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Alecensa, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
An overview of Alecensa and why it is authorised in the EU
Pregled zdravila Alecensa in zakaj je odobreno v EU
Other information about Alecensa
Druge informacije o zdravilu Alecensa
What is Alecensa and what is it used for?
Kaj je zdravilo Alecensa in za kaj se uporablja?
What benefits of Alecensa have been shown in studies?
Kakšne koristi je zdravilo Alecensa izkazalo v študijah?
Patients whose disease progresses during or shortly after treatment with Xalkori currently have very limited treatment options and Alecensa can be of benefit in these patients.
Bolniki, pri katerih bolezen med zdravljenjem ali kmalu po zdravljenju z zdravilom Xalkori napreduje, imajo trenutno le malo možnosti za zdravljenje, zato jim lahko zdravilo Alecensa koristi.
Alecensa was compared with Xalkori and the main measure of effectiveness was how long patients lived without their disease getting worse.
Zdravilo Alecensa so primerjali z zdravilom Xalkori, glavno merilo učinkovitosti pa je bil čas preživetja bolnikov brez poslabšanja bolezni.
In both studies Alecensa was not compared with any other treatment or placebo (a dummy treatment).
V nobeni študiji zdravila Alecensa niso primerjali z nobenim drugim zdravilom ali placebom (zdravilom brez zdravilne učinkovine).
For more information about using Alecensa, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Alecensa glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Alecensa can only be obtained with a prescription and treatment must be started and supervised by a doctor who is experienced in using cancer medicines.
Predpisovanje in izdaja zdravila Alecensa je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
What are the risks associated with Alecensa?
Kakšna tveganja so povezana z zdravilom Alecensa?
After 1 year of treatment, 68% of patients receiving Alecensa lived without their disease getting worse compared with 49% of patients receiving Xalkori.
Po enem letu zdravljenja se bolezen še ni poslabšala pri 68 % bolnikov, ki so prejemali zdravilo Alecensa, in pri 49 % bolnikov, zdravljenih z zdravilom Xalkori.
For patients with severe liver impairment the recommended dose is 3 capsules taken twice a day with food (900 mg in total).
Za bolnike s hudo okvaro jeter je priporočeni odmerek tri kapsule dvakrat na dan (skupaj 900 mg).
The doctor may reduce the dose or stop treatment temporarily if side effects occur.
V primeru neželenih učinkov bo zdravnik morda zmanjšal odmerek ali zdravljenje začasno prekinil.
Alecensa is a cancer medicine used to treat adults with a lung cancer called non-small-cell lung cancer (NSCLC), when the disease is advanced and has not been treated before or has been treated before with a cancer medicine called Xalkori (crizotinib).
Alecensa je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje odraslih s pljučnim rakom, imenovanim nedrobnocelični pljučni rak (NSCLC), kadar je bolezen napredovala in prej še ni bila zdravljena ali je že bila zdravljena z drugim zdravilom za zdravljenje raka, imenovanim Xalkori (krizotinib).
The third study involved 303 patients whose ALK-positive NSCLC had not been treated before.
Tretja študija je vključevala 303 bolnike s predhodno nezdravljenim ALK-pozitivnim nedrobnoceličnim pljučnim rakom.
ALK belongs to a family of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them.
Anaplastična limfomska kinaza spada v skupino beljakovin, imenovanih receptorji tirozin-kinaze (RTK), ki sodelujejo pri rasti celic in razvoju novih krvnih žil, ki te celice oskrbujejo.
Alecensa is used on its own and only if the NSCLC is ‘ALK-positive', which means that the cancer cells have certain defects affecting the gene that makes a protein called ALK (anaplastic lymphoma kinase).
Zdravilo Alecensa se uporablja samostojno in le, če je nedrobnocelični pljučni rak ALK-pozitiven, kar pomeni, da imajo rakave celice določene okvare, ki vplivajo na gen, ki tvori beljakovino, imenovano anaplastična limfomska kinaza (ALK).
For the full list of side effects and restrictions with Alecensa, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Alecensa glejte navodilo za uporabo.
The active substance in Alecensa, alectinib, is an ALK inhibitor and works by blocking the activity of ALK, thereby reducing the growth and spread of the cancer.
Zdravilna učinkovina v zdravilu Alecensa, alektinib, je zaviralec anaplastične limfomske kinaze in deluje tako, da zavira njeno aktivnost ter s tem zmanjšuje rast in širjenje raka.
Alecensa was also better than Xalkori at treating previously untreated patients with ALK-positive NSCLC.
Zdravilo Alecensa je bilo tudi boljše od zdravila Xalkori pri zdravljenju predhodno nezdravljenih bolnikov z ALKpozitivnim nedrobnoceličnim pljučnim rakom.
Alecensa contains the active substance alectinib.
Zdravilo Alecensa vsebuje zdravilno učinkovino alektinib.
How does Alecensa work?
Kako zdravilo Alecensa deluje?
In patients with ALKpositive NSCLC, an abnormal form of ALK is produced that stimulates the cancer cells to divide and grow in an uncontrolled fashion.
Pri bolnikih z ALKpozitivnim nedrobnoceličnim pljučnim rakom nastaja nenormalna oblika anaplastične limfomske kinaze, ki rakave celice spodbuja k nenadzorovani delitvi in rasti.
How is Alecensa used?
Kako se zdravilo Alecensa uporablja?
Alecensa has been shown to be effective in treating ALK-positive NSCLC in three studies.
Zdravilo Alecensa se je v treh študijah izkazalo kot učinkovito pri zdravljenju ALK-pozitivnega nedrobnoceličnega pljučnega raka.
Date of first authorisation: 28th August 2015
Datum prve odobritve:28 avgust 2015
Nine weeks after exposure, this effect was no longer observable.
Devet tednov po izpostavitvi tega učinka ni bilo več možno opaziti.
Take your box or bottle of this medicine with you.
S seboj vzemite svojo škatlo ali plastenko tega zdravila.
If you are an elderly patient (over 65 years of age), you should take this medicine normally except if you have problems with your kidneys.
Če ste starejši bolnik (nad 65 let), lahko jemljete to zdravilo normalno, razen če imate težave z ledvicami.
• Inappropriate behaviour.
• neprimerno vedenje
Call your doctor or go to the nearest hospital emergency unit immediately.
Pokličite zdravnika ali nemudoma pojdite v ambulanto za nujno pomoč najbližje bolnišnice.
• Slow or reduced movement of the body.
• počasno ali okrnjeno gibanje telesa
Warnings and Precautions
Opozorila in previdnostni ukrepi
• Difficulties with erection.
• težave z erekcijo
Pregabalin Accord should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Zdravila Pregabalin Accord se ne sme uporabljati med nosečnostjo, razen če je nujno potrebno (če koristi za mater jasno prevladajo nad možnim tveganjem za plod).
Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, The Netherlands
Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, Nizozemska
Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki soopisaniv poglavjih 4.8, 5.1 in 5.2, vendar ni mogoče datipriporočil o odmerjanju.
It is important to take your medicine regularly at the same time each day.
Pomembno je, da to zdravilo jemljete redno, vsak dan ob istem času.
• Before taking this medicine you should tell your doctor if you have a history of alcoholism or any drug abuse or dependence.
• Pred uporabo tega zdravila morate zdravniku povedati, če ste imeli v preteklosti težave z alkoholizmom ali z zlorabo ali odvisnostjo od drog.
These estimated doses are approximately 7% of the total daily maternal dose on a mg/kg basis.
Ocenjena odmerka predstavljata približno 7 % skupnega dnevnega materinega odmerka v enotah mg/kg.
The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore, pregabalin should not be used in this age group.
Varnost in učinkovitost pri otrocih in mladostnikih(mlajših od 18 let) nista ugotovljeni, zato se pregabalina v tej starostni skupini ne sme uporabljati.
This should be considered when prescribing pregabalin in this condition.
To je treba upoštevati pri predpisovanju pregabalina za to indikacijo.
Pregabalin Accord is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Zdravilo Pregabalin Accordni namenjeno temu, da bi ga jemali samo, temveč ga je vedno treba uporabljati v kombinaciji z drugimi zdravili proti epilepsiji.
This medicine is used to treat long lasting pain caused by damage to the nerves.
To zdravilo se uporablja za zdravljenje dolgotrajne bolečine, nastale zaradi okvare živcev.
These symptoms may occur more commonly or severely if you have been taking this medicine for a longer period of time.
Ti znaki se lahko pojavljajo bolj pogosto in z večjo izrazitostjo, če ste to zdravilo jemali daljši čas.
If you experience swollen face or tongue or if your skin turns red and starts to blister or peel, you should seek immediate medical advice.
Če vam zateče obraz ali jezik ali če vaša koža postane rdeča in se na njej pojavijo mehurji ali se začne lupiti, morate nemudoma poiskati zdravniško pomoč.
Continue taking this medicine until your doctor tells you to stop.
To zdravilo jemljite, dokler vam zdravnik ne naroči, da nehajte.
Pregabalin Accord and certain other medicines may influence each other (interaction).
Zdravilo Pregabalin Accord in določena druga zdravila imajo lahko medsebojno delovanje (interakcije).
• Difficulty with writing properly.
• težave s pisanjem
• Coldness of hands and feet.
• hladne dlani in stopala
Efficacy has not been studied in other models of neuropathic pain.
Učinkovitosti niso raziskovali v drugih modelih nevropatske bolečine.
• The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg each day.
• Odmerek, prilagojen vam in vaši bolezni, bo praviloma med 150 mg in 600 mg na dan.
Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom
Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, Združeno kraljestvo
• Your doctor will tell you to take this medicine either twice or three times a day.
• To zdravilo morate vzeti dvakrat ali trikrat na dan.
• Painful menstrual periods.
• boleče menstruacije
Oxycodone - (used as a pain-killer) Lorazepam - (used for treating anxiety) Alcohol
oksikodon - (uporablja se kot zdravilo proti bolečinam) lorazepam - (uporablja se za zdravljenje tesnobe) alkohol
Inter-subject pharmacokinetic variability for pregabalin is low (< 20%).
Razlike v farmakokinetiki pregabalina od posameznika do posameznika so majhne (< 20 %).
• Difficulty with or painful urination, incontinence.
• težave z uriniranjem ali boleče uriniranje, inkontinenca
This medicine is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
To zdravilo se uporablja za zdravljenje določene oblike epilepsije (parcialnih napadov s sekundarno generalizacijo ali brez nje) pri odraslih.
In humans, the apparent volume of distribution of pregabalin following oral administration is approximately 0.56 L/kg.
Pri človeku je navidezni volumen porazdelitve pregabalina po peroralni uporabi približno 0,56 l/kg.
In table 2 below all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency (very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
V spodnji preglednici 2 so po organskih sistemih in pogostnosti navedeni vsi neželeni učinki, ki so se pojavili pri več kot enem bolniku in z incidenco, večjo kot pri placebu (zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000);neznana (ni mogoče oceniti iz razpoložljivih podatkov)).
See section 4.
Glejte poglavje4.
• Changes in the recording of electrical changes (ECG) in the heart which correspond to heart rhythm disturbances.
• spremembe zapisa elektrokardiograma (EKG), ki kažejo na motnje srčnega ritma
This medicine may be taken with oral contraceptives.
To zdravilo lahko jemljete s peroralnimi kontraceptivi.
If you stop taking Pregabalin Accord Do not stop taking this medicine unless your doctor tells you to.
Če ste prenehali jemati zdravilo Pregabalin Accord Ne prenehajte jemati tega zdravila, razen če vam to naroči zdravnik.
• This medicine may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary.
• Uporabatega zdravila lahko povzroči zamegljenost ali izgubo vida ali druge spremembe vida, med katerimi so mnoge začasne.
• Muscle damage.
• mišične poškodbe
Pregabalin Accord may be taken with or without food.
Zdravilo Pregabalin Accord se lahko jemlje s hrano ali brez nje.
• Increased appetite.
• zvečanje apetita
Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics ATC code: N03AX16
5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki, oznaka ATC: N03AX16.
• A small number of people being treated with anti-epileptics such as Pregabalin Accord have had thoughts of harming or killing themselves.
• Pri majhnem številu bolnikov, ki so se zdravili z antiepileptiki, kot je zdravilo Pregabalin Accord, so se pojavile misli na samopoškodovanje ali samomor.
In accordance with current clinical practice, if pregabalin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week independent of the indication (see sections 4.4 and 4.8).
Če je treba uporabo pregabalina prekiniti,ga je skladno s trenutno klinično prakso, ne glede na indikacijo, priporočljivo zmanjševati postopoma vsaj 1 teden (glejte poglavji 4.4 in 4.8).
If while taking this medicine you notice decreased urination, you should tell your doctor as stopping the medicine may improve this.
Če med jemanjem tega zdravila zasledite zmanjšano izločanje urina, morate to povedatizdravniku, saj se lahko s prenehanjem jemanja zdravila stanje izboljša.
• Vertigo, problems with balance, fall.
• vrtoglavica, težave z ravnotežjem, padec
In clinical trials up to 12 weeks for both peripheral and central neuropathic pain, a reduction in pain was seen by Week 1 and was maintained throughout the treatment period.
V kliničnih preskušanjih v trajanju 12 tednov so tako pri periferni kot centralni nevropatski bolečini že v prvem tednu opazili zmanjšanje bolečine, ki se je ohranilo ves čas zdravljenja.
What Pregabalin Accord is and what it is used for What you need to know before you take Pregabalin Accord How to take Pregabalin Accord Possible side effects
Kaj je zdravilo Pregabalin Accordin za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Pregabalin Accord Kako jemati zdravilo Pregabalin Accord Možni neželeni učinki
• Feeling drunk, abnormal style of walking.
• občutek pijanosti, nenormalna hoja
This medicine may produce dizziness, sleepiness and decreased concentration.
To zdravilo lahko povzroči omotico, zaspanost in poslabša sposobnost koncentracije.
If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Pregabalin Accord: če ste alergični na pregabalin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
The safety and efficacy of Pregabalin Accord in children below the age of 12 years and in adolescents (12-17 years of age) have not been established.
Varnost in učinkovitost zdravila Pregabalin Accord pri otrocih, starih do 12 let, in pri mladostnikih (12-17 let) nista bili dokazani.
Pregabalin steady-state pharmacokinetics are similar in healthy volunteers, patients with epilepsy receiving anti-epileptic medicinal products and patients with chronic pain.
Farmakokinetika pregabalina v stanju dinamičnega ravnovesja je podobna pri zdravih prostovoljcih, bolnikih z epilepsijo, ki dobivajo antiepileptična zdravila, in bolnikih s kroničnimi bolečinami.
Peripheral and central neuropathic pain, Epilepsy or Generalised Anxiety Disorder:
Periferna in centralna nevropatska bolečina, epilepsija ali generalizirana anksiozna motnja:
For twice a day take this medicine once in the morning and once in the evening, at about the same time each day.
Če jemljete to zdravilo dvakrat na dan, ga vzemite enkrat zjutraj in enkrat zvečer, in sicer vsak dan ob približno istem času.
The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3-(aminomethyl)-5-methylhexanoic acid].
Učinkovina pregabalin je analog gama-aminomaslene kisline[(S)-3-(aminometil)-5-metilheksanojska kislina].
This medicine should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor.
Tega zdravilane smete uporabljati med nosečnostjo ali dojenjem, razen če vam tako svetuje zdravnik.