natgillin/translations-raw huggingface dataset:
Axura oral solution is presented as a clear, colourless to light yellowish solution.
Axura peroralna raztopina je prozorna, brezbarvna do svetlo rumenkasta raztopina.
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets The 5 mg film-coated tablets are white to off-white, oval-oblong film-coated tablets with imprint ‘5' on one side and imprint ‘MEM' on the other side.
Axura 5 mg+10 mg+15 mg+20 mg filmsko obložene tablete 5 mg filmsko obložene tablete so bele do belkaste, ovalno podolgovate, filmsko obložene tablete z vtisnjeno številko "5" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations).
Pri bolnikih z zmerno okvaro delovanja ledvic (očistek kreatinina 30-49 ml/min) naj bo dnevni odmerek 10 mg (1 ml raztopine, kar ustreza dvema pritiskoma navzdol).
The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, and magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171) and iron oxide yellow (E 172) all in the tablet coating.
Pomožne snovi so: mikrokristalna celuloza, premrežen natrijev karmelozat,brezvoden koloidni silicijev dioksid in magnezijev stearat, vse v jedru tablete; in hipromeloza, makrogol 400, titanov dioksid (E 171) in rumeni železov oksid (E 172), vse v oblogi tablete.
EU/1/02/218/010 1000 film-coated tablets (20 packs of 50) EU/1/02/218/015 980 film-coated tablets (10 packs of 98) EU/1/02/218/030 840 film-coated tablets (20 packs of 42)
EU/1/02/218/010 1000 filmsko obloženih tablet (20 x 50) EU/1/02/218/015 980 filmsko obloženih tablet (10 x 98) EU/1/02/218/030 840 filmsko obloženih tablet (20 x 42)
Talk to your doctor or pharmacist before taking Axura - if you have a history of epileptic seizures - if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).
- če ste v preteklosti imeli epileptične napade - če ste pred kratkim preboleli srčni infarkt (srčna kap), imate kongestivno srčno odpoved ali neurejeno hipertenzijo (visok krvni tlak).
EU/1/02/218/012 14 film-coated tablets EU/1/02/218/007 28 film-coated tablets EU/1/02/218/001 30 film-coated tablets EU/1/02/218/013 42 film-coated tablets EU/1/02/218/002 50 film-coated tablets EU/1/02/218/008 56 film-coated tablets EU/1/02/218/014 98 film-coated tablets EU/1/02/218/003 100 film-coated tablets EU/1/02/218/009 112 film-coated tablets
EU/1/02/218/012 14 filmsko obloženih tablet EU/1/02/218/007 28 filmsko obloženih tablet EU/1/02/218/001 30 filmsko obloženih tablet EU/1/02/218/013 42 filmsko obloženih tablet EU/1/02/218/002 50 filmsko obloženih tablet EU/1/02/218/008 56 filmsko obloženih tablet EU/1/02/218/014 98 filmsko obloženih tablet EU/1/02/218/003 100 filmsko obloženih tablet EU/1/02/218/009 112 filmsko obloženih tablet
Always take Axura exactly as your doctor has told you.
Jemljite zdravilo Axura tako dolgo, kot vam.
From Week 4 on: The patient should take one 20 mg film-coated tablet per day.
Bolnik naj jemlje eno 20 mg filmsko obloženo tableto na dan.
Axura 20 mg film-coated tablets
Axura 20 mg filmsko obložene tablete
<1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
(≥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 pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study - activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
(3-14 točk na lestvici Kratkega preskusa spoznavnih sposobnosti (KPSS oz. MMSE »Mini-mental State Examination«)) ob vključitvi je zdravljenje z memantinom v monoterapiji pokazalo izboljšanje v primerjavi s placebom, v obdobju 6 mesečnega zdravljenja (analiza opazovanih bolnikov, lestvice Vtis sprememb na osnovi kliničnega intervjuja (CIBIC-plus oz. »Clinician's Interview-Based Impression of Change Plus Caregiver Input«): p=0,025; Vprašalnik vsakodnevnih aktivnosti (ADCS-ADLsev) (»Alzheimer's Disease Consortium Studies Activities of Daily Living-modified for severe dementia«): p=0,003; Baterije za hudo prizadetost (SIB oz. »Severe Impairment Battery«): p=0,002).
Axura 5 mg film-coated tablets Axura 10 mg film-coated tablets Axura 15 mg film-coated tablets Axura 20 mg film-coated tablets Memantine hydrochloride
Axura 5 mg filmsko obložene tablete Axura 10 mg filmsko obložene tablete Axura 15 mg filmsko obložene tablete Axura 20 mg filmsko obložene tablete memantinijev klorid
Axura 10 mg film-coated tablets
Axura 10 mg filmsko obložene tablete
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets
Axura 5 mg+10 mg+15 mg+20 mg filmsko obložene tablete
NN:
Uporabno do:
Axura 15 mg 7 film-coated tablets.
Axura 15 mg 7 filmsko obloženih tablet.
Axura 5 mg, 10 mg, 15 mg, 20 mg film-coated tablets Memantine hydrochloride
Axura 5 mg, 10 mg, 15 mg, 20 mg filmsko obložene tablete memantinijev klorid
From Week 4 on: The patient should take two 10 mg film-coated tablets (20 mg) per day.
Bolnik naj jemlje dve 10 mg filmsko obloženi tableti (20 mg) na dan. Vzdrževalni odmerek
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets Axura 20 mg film-coated tablets
Axura 5 mg+10 mg+15 mg+20 mg filmsko obložene tablete Axura 20 mg filmsko obložene tablete
Axura 5 mg, 10 mg, 15 mg, 20 mg tablets
Axura 5 mg, 10 mg, 15 mg, 20 mg filmsko obložene tablete
Axura film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 42 tablets, 56 tablets, 98 tablets or in multipacks of 840 (20 x 42) tablets.
Axura filmsko obložene tablete se nahajajo v pretisnih omotih v škatlicah s 14 tabletami, 28 tabletami, 42 tabletami, 56 tabletami, 98 tabletami.
Axura 10 mg 7 film-coated tablets.
Axura 10 mg 7 filmsko obloženih tablet.
Axura 5 mg 7 film-coated tablets.
Axura 5 mg 7 filmsko obloženih tablet.
Axura film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 30 tablets, 42 tablets, 50 tablets, 56 tablets, 98 tablets, 100 tablets, 112 tablets and multipacks of 840 (20 packs of 42) tablets, 980 (10 packs of 98) tablets or 1000 (20 packs of 50) tablets.
Axura filmsko obložene tablete se nahajajo v pretisnih omotih v škatlicah s 14 tabletami, 28 tabletami, 30 tabletami, 42 tabletami, 50 tabletami, 56 tabletami, 98 tabletami, 100 tabletami, 112 tabletami.
Axura 10 mg film-coated tablets Memantine hydrochloride
Axura 10 mg filmsko obložene tablete memantinijev klorid
Axura 20 mg film-coated tablets Memantine hydrochloride
Axura 20 mg filmsko obložene tablete memantinijev klorid
Do not use Axura after the expiry date which is stated on the carton and the blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Axura 5 mg film-coated tablets are presented as white to off-white, oval-oblong with imprint ‘5' on one side and imprint ‘MEM' on the other side.
Axura 5 mg filmsko obložene tablete so bele do belkaste, ovalne in podolgovate z vtisnjeno številko "5" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
Multipack 840 (20 packs of 42) film-coated tablets Multipack 980 (10 packs of 98) film-coated tablets Multipack 1000 (20 packs of 50) film-coated tablets
Večkratno pakiranje z 980 (10 pakiranj po 98) filmsko obloženimi tabletami
Titanium dioxide (E 171) Iron oxide yellow and red (E 172)
rumeni in rdeči železov oksid (E 172)
Axura 15 mg film-coated tablets are presented as orange to grey-orange, oval-oblong with imprint ‘15' on one side and imprint ‘MEM' on the other side.
Axura 15 mg filmsko obložene tablete so oranžne do sivo oranžne, ovalne in podolgovate z vtisnjeno številko "15" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
Axura 5 mg/pump actuation, oral solution
Axura 5 mg/pritisk peroralna raztopina
Each pump actuation delivers 0.5 ml solution which contains 5 mg of memantine hydrochloride which is equivalent to 4.16 mg memantine.
Vsaka aktivacija črpalke (en pritisk navzdol) dovede 0,5 ml raztopine, ki vsebuje 5 mg memantinijevega klorida, kar ustreza 4,16 mg memantina.
Axura 5 mg/pump actuation, oral solution Memantine hydrochloride
Axura 5 mg/pritisk peroralna raztopina memantinijev klorid
Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet (10 mg) per day for 7 days.
2. teden (8.-14. dan): Bolnik naj 7 dni jemlje eno 10 mg filmsko obloženo tableto na dan (bledo rumena do rumena, ovalna).
You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine) as your doctor may need to adjust the dose of your medicine.
Obvestite svojega zdravnika, če ste pred kratkim spremenili ali če nameravate bistveno spremeniti prehrano (npr. če preidete iz običajne hrane na strogo vegetarijansko prehrano), ali če imate ledvično tubularno acidozo (preveliko količino kislih spojin v krvi zaradi renalne disfunkcije (slabo delovanje ledvic)) ali če ste zboleli zaradi hudega vnetja sečil (strukture po kateri se prenaša seč).
Axura 20 mg film-coated tablets are presented as are pale red to grey-red, oval-oblong with imprint ‘20' on one side and imprint ‘MEM' on the other side.
Axura 20 mg filmsko obložene tablete so bledo rdeče do sivo rdeče, ovalne in podolgovate z vtisnjeno številko "20" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
Pack sizes of 14, 28, 42, 56, 98 or multipacks containing 840 (20 x 42) film-coated tablets are presented.
Na voljo so pakiranja s 14, 28, 42, 56, 98 filmsko obloženimi tabletami in večkratna pakiranja z
Axura film-coated tablets are presented as pale red to grey-red, oval-oblong film-coated tablets with imprint ‘20' on one side and imprint ‘MEM' on the other side.
Axura filmsko obložene tablete so bledo rdeče do sivo rdeče, ovalno podolgovate, filmsko obložene tablete z vtisnjeno številko "20" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
Vascular disorders
Peroralna raztopina.
The 10 mg film-coated tablets are pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side.
10 mg filmsko obložene tablete so bledo rumene do rumene, ovalne, z razdelilno zarezo in vtisnjeno številko "1 0" na eni strani in vtisnjeno besedo "M M" na drugi strani.
Axura film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side.
Axura filmsko obložene tablete so bledo rumene do rumene, ovalne, filmsko obložene tablete z razdelilno zarezo in vtisnjeno številko "1 0" na eni strani in besedo "M M" na drugi strani.
How to store Axura
Shranjevanje zdravila Axura
In patients with severe renal impairment (creatinine clearance 5-29 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations) per day.
5-29 ml/min) naj bo dnevni odmerek 10 mg (1 ml raztopine, kar ustreza dvema pritiskoma navzdol).
Axura 10 mg film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side The tablet can be divided into equal halves.
Axura 10 mg filmsko obložene tablete so bledo rumene do rumene, ovalne, z razdelilno zarezo in vtisnjeno številko "1 0" na eni strani in vtisnjeno besedo "M M" na drugi strani.
A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3 - 14) included a total of 252 outpatients.
V temeljni klinični študiji pri skupini 252 bolnikov z zmerno do hudo Alzheimerjevo boleznijo (3-14 točk na lestvici Kratkega preskusa spoznavnih sposobnosti (KPSS oz. MMSE ali "Mini-mental State Examination")) ob vključitvi je zdravljenje z memantinom v monoterapiji pokazalo izboljšanje v primerjavi s placebom, v obdobju 6 mesečnega zdravljenja (analiza opazovanih bolnikov, lestvice Vtis sprememb na osnovi kliničnega intervjuja (CIBIC-plus - "Clinician's Interview-Based Impression of
Week 1 (day 1-7): The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
Bolnik naj sedem dni jemlje eno in pol 10 mg filmsko obloženo tableto (15 mg) na dan. Od 4. tedna dalje:
Week 3 (day 15-21): The patient should take 1.5 ml solution (15 mg) equivalent to three pump actuations per day for 7 days.
Bolnik mora sedem dni jemati 1,5 ml raztopine (15 mg) na dan, kar ustreza trem navpičnim pritiskom navzdol.
Week 3 (day 15-21): The patient should take one and a half 10 mg film-coated tablet (15 mg) per day for 7 days.
Bolnik naj sedem dni jemlje eno 10 mg na dan filmsko obloženo tableto (10 mg) na dan. 3. teden (15.-21. dan):
If the pump does not function properly, consult your doctor or a pharmacist.Lock the dosing pump after using Axura.
Po uporabi zdravila Axura zaklenite odmerno črpalko.
EXP {MM/YYYY} See embossed stamp.
Uporabno do: {MM/LLLL} Glejte odtis na robu.
EMEA Number Invented Name Strength Pharmaceutical Form
Št. EMEA Trgovsko ime Moč Farmacevtska oblika
Packaging Content Package size Withdraw al period
Vsebina Velikost pakiranja
Route of administration
Način dajanja Pakiranje
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration and marketing authorisation holders in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila in imetnikov dovoljenja za promet z zdravilom v državah članicah
2730-097 Barcarena Portugal
2730-097 Barcarena
4 days (including the day of administration)
4 dni (vključno z dnem apliciranja)
Control, N = 10
kontrolna skupina, N = 10
• Some medicine may be present in your tears.
• se nekaj zdravila lahko izloči v vaše solze.
Study 301 was an open-label, randomised, controlled study.
Študija 301 je bila odprta, randomizirana in kontrolirana študija.
Phase 3 study
Študija faze 3
31 subjects were enrolled, 13 males and 18 females.
Vključenih je bilo 31 preiskovancev, 13 moških in 18 žensk.
It is important that you take this medicine according to the instructions given.
Zelo pomembno je, da to zdravilo jemljete v skladu z danimi navodili.
30 June 2030
30. junij 2030
• Tell your doctor if you have an active infection of any sort.
• povejte zdravniku, če imate kakršno koli vrsto aktivne okužbe.
10 subjects were randomised to the control (non-intervention) group.
10 preiskovancev so randomizirali v kontrolno (neintervencijsko) skupino.
The effects of this medicine on pregnancy and the unborn child are not known.
Učinkov tega zdravila na nosečnost in nerojenega otroka ne poznamo.
Your doctor will talk to you about the anaesthesia and how it will be given to you.
Vaš zdravnik vam bo povedal vse potrebno o anesteziji in o tem, kako vam jo bodo dali.
Vertical dotted lines represent additional 25% above and below the box.
Navpične črtkane črte predstavljajo nadaljnjih 25 % vrednosti nad oziroma pod okvirjem.
System organ class / Frequency
Organski sistem / pogostnost
Do not stop taking the medicine without first talking to your doctor.
Ne prenehajte jemati tega zdravila, ne da bi se prej posvetovali s svojim zdravnikom.
The testing of each subject was videotaped and assessed by independent graders.
Izvajanje testa vsakega preiskovanca so dokumentirali na videoposnetek, vse pa so ocenili neodvisni ocenjevalci.
• Summary of Product Characteristics (SmPC);
• Povzetek glavnih značilnosti zdravila (SmPC),
What Luxturna is and what it is used for
Kaj je zdravilo Luxturna in za kaj ga uporabljamo
This medicinal product must not be administered by intravitreal injection.
Tega zdravila se ne sme aplicirati z intravitrealno injekcijo.
Your doctor may be able to help reduce any discomfort caused by these temporary disturbances.
Morda vam bo lahko pomagal zmanjšati neprijetne občutke, ki jih lahko povzročijo te prehodne motnje.
There are no known clinically significant interactions.
S tem zdravilom ni nobenih znanih klinično pomembnih interakcij.
Immunomodulatory regimen
Imunomodulatoren režim
The interval between injection to the eyes for each subject was from 6 to 18 days.
Časovni interval med injekcijama v eno in drugo oko pri posameznem preiskovancu je bil od 6 do 18 dni.
This will be repeated on your other eye at least 6 days afterwards.
Celoten postopek bo ponovil še na drugem očesu po najmanj 6 dneh.
Patients may resume swimming and strenuous activity, after a minimum of one to two weeks, on the advice of their healthcare professional.
S plavanjem in naporno telesno dejavnostjo lahko bolniki spet začnejo po najmanj enem ali dveh tednih po posvetu z zdravstvenim delavcem.
If you are given more Luxturna than you should be As this medicine is given to you by a doctor, it is unlikely that you will be given too much.
Če bi prejeli večji odmerek zdravila Luxturna, kot bi smeli Ker vam bo to zdravilo dajal vaš zdravnik, je malo verjetno, da ga boste prejeli preveč.
Any exposed wounds should be covered before handling.
Vse odprte rane je treba pred rokovanjem z zdravilom pokriti.
The adverse reactions are listed by system organ class and frequency using the following convention: 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).
Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti po naslednjem dogovoru: 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).
Serious adverse reactions related to the administration procedure were reported in three subjects during the clinical programme.
O resnih neželenih učinkih v povezavi s postopkom apliciranja so poročali pri treh osebah v poteku programa kliničnih študij.
You should follow these precautions for 14 days.
Ta previdnostni ukrep morate upoštevati 14 dni.
No dose adjustment is required in these patients (see section 5.2).
Prilagajanje odmerjanja pri teh bolnikih ni potrebno (glejte poglavje 5.2).
Information on how to obtain the special formats will be provided in the patient card.
Informacije o možnosti dostopanja do vsebin v posebnih oblikah bodo navedene na bolnikovi kartici.
Please talk to your doctor before travelling.
Pred potovanjem se pogovorite z zdravnikom.
The average age was 15 years (range 4 to 44 years), including 64% paediatric subjects (n=20, age from 4 to 17 years) and 36% adults (n=11).
Povprečna starost preiskovancev je bila 15 let (od 4 do 44 let), pri čemer je bilo 64 % preiskovancev pediatričnih bolnikov (n=20, v starosti od 4 do 17 let), 36 % pa je bilo odraslih (n=11).
The qualified staff (i.e. vitreoretinal surgeons and pharmacists) at the treatment centres should be provided with educational materials including:
Kvalificiranemu osebju (to je vitreoretinalnim kirurgom in farmacevtom) v terapevtskih centrih je treba priskrbeti izobraževalno gradivo, kar vključuje:
• You should avoid air travel or other travel to high elevations until advised by your doctor.
• se morate izogibati potovanju z letalom in drugim potovanjem v kraje z visoko nadmorsko višino, dokler vam to odsvetuje zdravnik.
The virus used to deliver the gene does not cause disease in humans.
Virus, ki je v zdravilu uporabljen kot prenašalec gena, pri ljudeh ne povzroča bolezni.
Damage to the tissues of the eye may be accompanied by bleeding and swelling and an increased risk of infection.
Poškodbo očesnih tkiv pri posegu lahko spremlja krvavitev in oteklina ter povečano tveganje za okužbo.
Patients and their caregivers should be provided with the patient information pack, including:
Bolnikom in njihovim negovalcem je treba priskrbeti informacijski komplet za bolnika, ki vključuje:
Ocular or periocular infection.
Okužba očesa ali periokularna okužba.
Voretigene neparvovec has minor influence on the ability to drive and use machines.
Voretigen neparvovek ima blag vpliv na sposobnost vožnje in upravljanja strojev.
These steps are critical in the biological conversion of a photon of light into an electrical signal within the retina.
Ti koraki so bistvenega pomena za biološko pretvorbo fotona svetlobe v električni signal v mrežnici.
One subject in the control group withdrew consent and was discontinued from the study.
En preiskovanec iz kontrolne skupine je odstopil od privolitve v sodelovanje in je izstopil iz študije.
If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before being treated with Luxturna.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali medicinsko sestro, preden prejmete zdravilo Luxturna.
In the Phase 3 study, the MLMT used seven levels of illumination ranging from 400 lux to 1 lux (corresponding to, for example, a brightly lit office down to a moonless summer night).
V študiji faze 3 so pri testiranju MLMT uporabili sedem stopenj osvetlitve od 400 luksov do 1 luksa (kar ustreza osvetlitvi na primer v dobro osvetljeni pisarni do zmanjšanja osvetlitve na raven poletne noči brez mesečine).
• Change of the electrical activity of the heart
• motnje električne aktivnosti srca
Patients treated with Luxturna should not donate blood, organs, tissues and cells for transplantation.
Bolniki, ki prejmejo zdravilo Luxturna, ne smejo darovati krvi, organov, tkiv ali celic za presaditev.
Each box represents the middle 50% of distribution of MLMT score change.
Vsak okvir predstavlja srednjih 50 % distribucije sprememb ocene pri testu MLMT.
Your doctor may delay your treatment until your infection is gone because this medicine may make it more difficult for you to fight an infection.
Zdravnik bo verjetno odložil vaše zdravljenje, dokler okužba ne bo odpravljena, saj se zaradi tega zdravila telo težje bori proti okužbi.
D30, D90, D180: 30, 90 and 180 days after start of study;
D30, D90, D180: 30, 90 oziroma 180 dni po začetku študije;
No clinical data on the effect of the medicinal product on fertility are available.
Na voljo ni nobenih kliničnih podatkov o vplivu zdravila na plodnost.
Precaution to be taken before manipulating or administering the medicinal product This medicinal product contains genetically modified organisms.
Previdnostni ukrepi, potrebni pred rokovanjem z zdravilom ali dajanjem zdravila To zdravilo vsebuje gensko spremenjene organizme.
After receiving Luxturna:
Po prejemu zdravila Luxturna:
All participants had a clinical diagnosis of Leber congenital amaurosis, and some may have also had prior or additional clinical diagnoses, including retinitis pigmentosa.
Vsi preiskovanci so imeli klinično diagnozo Lebrove kongenitalne amavroze, nekateri pa so lahko imeli tudi že prej postavljene oziroma druge klinične diagnoze, med drugim pigmentno retinopatijo.
BL: baseline;
BL (Baseline) = izhodišče;
Before Luxturna treatment is started, your doctor may prescribe a medicine that will suppress your immune system (the body's natural defences) so that it will not try to fight the Luxturna when it is given.
Pred začetkom zdravljenja z zdravilom Luxturna vam bo zdravnik verjetno predpisal zdravilo, ki bo zavrlo delovanje vašega imunskega sistema (naravno obrambo telesa), da se ta ne bi poskušal obrniti proti zdravilu Luxturna, ko ga boste prejeli.
Children and adolescents Luxturna has not been studied in children under four years of age.
Otroci in mladostniki Zdravila Luxturna niso proučevali pri otrocih, ki so bili stari manj kot štiri leta.