natgillin/translations-raw huggingface dataset:
Taking Axura with food and drink 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.
V teh primerih bo vaš zdravnik morda prilagodil odmerek vašega zdravila.
83 At the beginning of treatment you will start by using Axura 5 mg film-coated tablets once a day.
82 Na začetku boste zdravljenje začeli z jemanjem zdravila Axura 5 mg filmsko obložene tablete enkrat dnevno.
Duration of treatment Continue to take Axura as long as it is of benefit to you.
Trajanje zdravljenja Jemljite zdravilo Axura tako dolgo, kot vam.
Common (affects 1 to 10 users in 100): • Headache, sleepiness, constipation, dizziness and high blood pressure Uncommon (affects 1 to 10 users in 1,000): • Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism) Very Rare (affects less than 1 user in 10,000): • Seizures Not known (frequency cannot be estimated from the available data): • Inflammation of the pancreasand psychotic reactions
Občasni (prizadanejo 1 od 10 uporabnikov od 1. 000): • utrujenost, glivična okužba, zmedenost, halucinacije, bruhanje, neobičajna hoja, odpoved srca in krvni strdki v venah (tromboza/ tromboembolija)
84 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
83 Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek. ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
- Keep out of the reach and sight of children.
- Zdravilo shranjujte nedosegljivo otrokom in izven njihovega vidnega polja!
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.
Izgled zdravila Axura in vsebina pakiranja 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.
Axura film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 42 tablets, 56 tablets, 98 tablets or 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 ali 840 (20 x 42) tabletami.
België/Belgique/Belgien Merz Pharmaceuticals GmbH
België/ Belgique/ Belgien Merz Pharmaceuticals GmbH
Hanff Frères
Hanff Frères
Eckenheimer Landstraße 100
Eckenheimer Landstraße 100 D- 60318 Frankfurt Duitsland/ Allemagne/ Deutschland Tél/ Tel: +49 (0) 69 1503 – 1
B.P.
B. P.
France Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt
France Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D- 60318 Frankfurt Allemagne
România Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt
România Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D- 60318 Frankfurt Germania
86 Allemagne Tél: +49 (0)69 1503 – 1
Tél: +49 (0) 69 1503 – 1
Germania Tel.: +49 (0)69 1503 – 1
Tel.: +49 (0) 69 1503 – 1
Azarga is an eye drop suspension that contains two active substances, brinzolamide and timolol.
Zdravilo Azarga je suspenzija kapljic za oko, ki vsebuje dve zdravilni učinkovini, brinzolamid in timolol.
Azarga is used to reduce intra-ocular pressure (IOP, pressure inside the eye).
Zdravilo Azarga se uporablja za zniževanje intraokularnega tlaka (tlaka v očesu).
It is used in adults with open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) or ocular hypertension (when the pressure in the eye is higher than normal).
Uporablja se pri odraslih, ki imajo glavkom odprtega zakotja (bolezen, pri kateri se tlak v očesu zviša, ker tekočina ne more iztekati iz očesa) ali očesno hipertenzijo (tlak v očesu je višji od običajnega).
Azarga is used when treatment with a medicine containing only one active substance has been tried but has not reduced the IOP sufficiently.
Zdravilo Azarga se uporablja, kadar se pri zdravljenju z zdravilom, ki vsebuje samo eno zdravilno učinkovino, intraokularni tlak ne zniža dovolj.
Azarga is given as one drop into the affected eye(s) twice a day.
Zdravilo Azarga se daje kot ena kapljica v prizadeto oko dvakrat dnevno.
The suspension needs to be shaken well before use.
Pred uporabo je treba suspenzijo dobro pretresti.
Raised IOP causes damage to the retina (the light-sensitive surface at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Zvišan intraokularni tlak poškoduje mrežnico (membrana na zadnji strani zrkla, ki je občutljiva za svetlobo) in vidni živec, ki pošilja signale iz očesa v možgane.
This can result in serious vision loss and even blindness.
To lahko povzroči resno izgubo vida in celo slepoto.
Azarga contains two active substances, brinzolamide and timolol.
Zdravilo Azarga vsebuje dve zdravilni učinkovini: brinzolamid in timolol.
The two substances work by reducing the production of the aqueous humour (the watery fluid in the eye) in different ways.
Učinkovini delujeta tako, da na različne načine zmanjšujeta raven tvorjenja prekatne vodke (nizko viskozne tekočine v očesu).
Brinzolamide is a carbonic anhydrase inhibitor that works by blocking an enzyme called carbonic anhydrase, which produces bicarbonate ions in the body.
Brinzolamid je zaviralec karbonske anhidraze, ki deluje tako, da blokira encim, imenovan karbonska anhidraza, ki tvori bikarbonatne ione v telesu.
Bicarbonate is required for the production of the aqueous humour.
Bikarbonat je potreben za tvorjenje prekatne vodke.
Brinzolamide has been authorised in the European Union (EU) as Azopt since 2000.
Brinzolamid je v Evropski uniji (EU) odobren kot zdravilo Azopt od leta 2000.
Timolol is a beta-blocker that has been commonly used to treat glaucoma since the 1970s.
Timolol je zaviralec receptorjev beta, ki je v splošni uporabi za zdravljenje glavkoma od sedemdesetih let prejšnjega stoletja.
The combined effect of the two substances is greater than either substance used alone.
Kombiniran učinek obeh zdravilnih učinkovin presega učinek posamezne učinkovine.
The effects of Azarga were first tested in experimental models before being studied in humans.
Učinki zdravila Azarga so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Reproduction is authorised provided the source is acknowledged. the combination of timolol and dorzolamide (another carbonic anhydrase inhibitor) in 437 patients.
Zdravilo Azarga je bilo raziskano v dveh glavnih študijah, ki sta vključevali skupaj 960 odraslih z glavkomom odprtega zakotja ali očesno hipertenzijo.
In both studies, the main measure of effectiveness was the change in IOP over the first six months of treatment.
V prvi študiji, ki je trajala šest mesecev, so pri 523 bolnikih zdravilo Azarga primerjali z brinzolamidom in timololom kot samostojnima zdraviloma.
IOP was measured in ‘ millimetres of mercury’ (mmHg).
Intraokularni tlak so merili v „ milimetrih živega srebra “ (mmHg).
Azarga was more effective than either of the active substances used alone and was as effective as the combination of timolol and dorzolamide.
Zdravilo Azarga je bilo učinkovitejše od obeh zdravilnih učinkovin, uporabljenih samostojno, in je bilo tako učinkovito kot kombinacija timolola in dorzolamida.
In the first study, IOP fell from around 21 mmHg by 8.0 to 8.7 mmHg in the patients using Azarga.
V prvi študiji je intraokularni tlak bolnikov, ki so uporabljali zdravilo Azarga, s približno 21 mmHg upadel za 8, 0 do 8, 7 mmHg.
This compared with 5.1 to 5.6 mmHg in those using brinzolamide and 5.7 to 6.9 mmHg in those using timolol.
Ta izid zdravljenja so primerjali z upadoma za 5, 1 do 5, 6 mmHg pri tistih, ki so uporabljali brinzolamid, in za 5, 7 do 6, 9 mmHg pri tistih, ki so uporabljali timolol.
In the second study, IOP had fallen from around 26 mmHg by around 8.3 mmHg after six months in both groups of patients.
V drugi študiji je intraokularni tlak po šestih mesecih v obeh skupinah bolnikov upadel s približno 26 mmHg za približno 8, 3 mmHg.
The most common side effects with Azarga (seen in between 1 and 10 patients in 100) are dysgeusia (a bitter or unusual taste in the mouth), blurred vision, eye pain, eye irritation and the sensation of a foreign body in the eyes.
Najpogostejši neželeni učinki zdravila Azarga (opaženi pri več kot 1 bolniku izmed 100) so disgevzija (grenak ali nenavaden okus v ustih), zamegljen vid, bolečina v očesu, draženje očesa in občutek tujka v očesu.
For the full list of all side effects reported with Azarga, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Azarga, glejte navodilo za uporabo.
Azarga should not be used in patients who may be hypersensitive (allergic) to the active substances, any of the other ingredients, other beta-blockers (such as some heart medicines) or sulphonamides (such as some antibiotics).
Zdravila Azarga ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zdravilne učinkovine, druge sestavine, druge zaviralce receptorjev beta (kot so nekatera zdravila za srce) ali sulfonamidi (kot so nekateri antibiotiki).
It must not be used by patients who:  have had asthma;  have severe chronic obstructive pulmonary disease (a disease causing narrowing of the airways);  have certain heart problems;  have a severe allergy affecting the nose and airways;  have hyperchloraemic acidosis (excess acid in the blood caused by too much chloride);  have severe kidney problems.
Ne smejo ga uporabljati bolniki, ki:  imajo astmo,  imajo hudo kronično obstruktivno pljučno bolezen (bolezen, pri kateri se zožijo dihalne poti),  imajo določene težave s srcem,  imajo hudo alergijo, ki vpliva na nos in dihalne poti,  imajo hiperkloremično acidozo (presežek kisline v krvi, ki ga povzroča preveč klorida),  imajo hude težave z ledvicami.
Azarga contains benzalkonium chloride, which is known to discolour soft contact lenses.
Zdravilo Azarga vsebuje benzalkonijev klorid, ki lahko razbarva mehke kontaktne leče.
Therefore, care should be taken by people who wear soft contact lenses.
Zaradi tega morajo biti osebe, ki uporabljajo mehke kontaktne leče, previdne.
The Committee for Medicinal Products for Human Use (CHMP) noted that combining the two active substances in Azarga simplifies therapy and helps patients to stick to their treatment.
Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da kombinacija dveh zdravilnih učinkovin v zdravilu Azarga poenostavi zdravljenje in pomaga bolnikom, da se držijo zdravljenja.
The Committee decided that Azarga’ s benefits are greater than its risks for the decrease of IOP in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.
Odbor je zaključil, da so koristi zdravila Azarga pri zniževanju intraokularnega tlaka pri odraslih bolnikih z glavkomom odprtega zakotja ali okularno hipertenzijo, pri katerih monoterapija intraokularnega tlaka ne zniža dovolj, večje od z njim povezanih tveganj.
The Committee recommended that Azarga be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Azarga odobri dovoljenje za promet.
Other information about Azarga:
Druge informacije o zdravilu Azarga:
The European Commission granted a marketing authorisation valid throughout the EU for Azarga to Alcon Laboratories (UK) Ltd. on 25 November 2008.
Evropska komisija je dovoljenje za promet z zdravilom Azarga, veljavno po vsej Evropski uniji, odobrila družbi Alcon Laboratories (UK) Ltd. dne 25. novembra 2008.
The full EPAR for Azarga can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Azarga je na voljo tukaj.
name
Izmišljeno ime
administration
Pot uporabe
Packaging
Vsebnik
EU/ 1/ 08/ 482/ 001
EU/ 1/ 08/ 482/ 001 EU/ 1/ 08/ 482/ 002
AZARGA
AZARGA AZARGA
10 mg/ ml + 5 mg/ ml
10 mg/ ml + 5 mg/ ml 10 mg/ ml + 5 mg/ ml
Eye drops, suspension
kapljice za oko, suspenzija kapljice za oko, suspenzija
Eye drops, suspension
okularna uporaba okularna uporaba
Bottle (PE)
steklenička (LDPE) 5 ml steklenička (LDPE) 5 ml
3 bottles
1 steklenička 3 stekleničke
What is AZILECT?
Kaj je zdravilo AZILECT?
AZILECT is a medicine containing the active ingredient rasagiline.
AZILECT je zdravilo, ki vsebuje zdravilno učinkovino razagilin.
It is available as white round tablets (1 mg).
Na voljo je v obliki belih, okroglih tablet (1 mg).
What is AZILECT used for?
Za kaj se zdravilo AZILECT uporablja?
AZILECT is used for the treatment of Parkinson’ s disease.
Zdravilo AZILECT se uporablja za zdravljenje Parkinsonove bolezni.
Parkinson’ s disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Parkinsonova bolezen je napredujoča možganska bolezen, ki povzroča tresenje, upočasnjeno izvajanje gibov in otrdelost mišic.
AZILECT can be used either alone, or as an add-on to levodopa (another medicine used in Parkinson’ s disease) in patients who are having ‘ fluctuations’ towards the end of the period between levodopa doses.
Zdravilo AZILECT se lahko uporablja samostojno ali kot dodatek levodopi (drugemu zdravilu, ki se uporablja pri Parkinsonovi bolezni) pri bolnikih z nihanji proti koncu obdobja med dvema odmerkoma levodope.
Fluctuations are linked with a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘ on’ and able to move, and being ‘ off’ and immobile.
Nihanja so povezana z zmanjšanjem učinkov levodope, ko bolnik občuti nenadne preskoke med stanji „ vklopa “, ko se lahko giblje, in stanji „ izklopa “, ko je negiben.
AZILECT can only be obtained with a prescription.
Zdravilo AZILECT se dobi samo na recept.
How is AZILECT used?
Kako se zdravilo AZILECT uporablja?
The standard dose of AZILECT is one tablet once a day, taken with or without food.
Standardni odmerek zdravila AZILECT je ena tableta enkrat dnevno, ki se jemlje s hrano ali brez nje.
AZILECT should not be used in patients who have severe problems with their liver and it should be avoided in those with moderate liver problems.
Zdravila AZILECT se pri bolnikih s hudimi težavami z jetri ne sme uporabljati, pri bolnikih z zmernimi težavami z jetri pa se je uporabi tega zdravila treba izogibati.
Patients with mild liver problems should use AZILECT with caution and should stop treatment if their liver problems get worse.
Bolniki z blagimi težavami z jetri morajo zdravilo AZILECT uporabljati previdno ter morajo prenehati z zdravljenjem, če se njihove težave z jetri povečajo.
How does AZILECT work?
Kako zdravilo AZILECT deluje?
The active substance in AZILECT, rasagiline, is a monoamine oxidase-B inhibitor.
Zdravilna učinkovina zdravila AZILECT je razagilin, zaviralec monoaminooksidaze tipa B.
It blocks the enzyme monoamine oxidase type B, which breaks down the ‘ neurotransmitter’ dopamine in the brain.
Razagilin blokira encim monoaminooksidaza tipa B, ki razgrajuje živčni prenašalec dopamin v možganih.
By increasing levels of dopamine in the parts of the brain that control movement and co-ordination, AZILECT improves the signs and symptoms of Parkinson’ s disease, such as stiffness and slowness of movement.
S povečevanjem ravni dopamina v delih možganov, ki nadzorujejo gibe in koordinacijo, zdravilo AZILECT lajša znake in simptome Parkinsonove bolezni, kot sta okornost in počasnost gibov.
How has AZILECT been studied?
Kako je bilo zdravilo AZILECT raziskano?
The effects of AZILECT were first tested in experimental models before being studied in humans.
Učinki zdravila AZILECT so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged In the first study, the effects of two different doses of AZILECT taken alone were compared to those of placebo (a dummy treatment) in 404 patients with early-stage disease.
V prvi študiji so učinke dveh različnih odmerkov zdravila AZILECT, dajanega samostojno, primerjali z učinki placeba (zdravila brez zdravilne učinkovine) pri 404 bolnikih z boleznijo v zgodnji fazi.
The main measure of effectiveness was the change in symptoms over 26 weeks, as assessed on a standard scale (Unified Parkinson’ s Disease Rating Scale, UPDRS).
Glavno merilo učinkovitosti je bila sprememba simptomov po 26 tednih, ki je bila ocenjena s standardno lestvico (Združeno ocenjevalno lestvico Parkinsonove bolezni - Unified Parkinson’ s Disease Rating Scale, UPDRS).
The other two studies involved a total of 1,159 patients with later stage disease, where AZILECT was added to the patients’ existing treatment including levodopa.
V drugi dve študiji je bilo vključenih skupno 1159 bolnikov z boleznijo v kasnejši fazi, pri katerih se je zdravilo AZILECT dodajalo k bolnikovemu obstoječemu zdravljenju, ki je vključevalo levadopo.
It was compared with placebo or entacapone (another medicine for Parkinson’ s disease).
Primerjali so ga s placebom ali entakaponom (drugim zdravilom za Parkinsonovo bolezen).
The studies lasted 26 and 18 weeks, respectively.
18 tednov.
The main measure of effectiveness was the time spent in the ‘ off’ state during the day, as recorded in patient diaries.
Glavno merilo učinkovitosti je bil čas, preživet v stanju „ izklopa “ v teku dneva, ki se je beležil v dnevnikih bolnikov.
What benefit has AZILECT shown during the studies?
Kakšne koristi je zdravilo AZILECT izkazalo med raziskavami?
AZILECT was more effective than placebo in all studies.
Zdravilo AZILECT je bilo v vseh študijah učinkovitejše od placeba.
In the study where AZILECT was used alone, patients taking 1 mg of the medicine once a day had an average fall in UPDRS score of 0.13 points over the 26-week study from a starting value of 24.69.
V študiji, v kateri je bilo zdravilo AZILECT dajano samostojno, je bilo pri bolnikih, ki so prejemali 1 mg zdravila enkrat dnevno, po 26 - tedenski študiji ugotovljeno povprečno zmanjšanje po lestvici UPDRS za 0, 13 točke glede na začetno vrednost 24, 69 točk.
This was compared with a rise of 4.07 points in the patients taking placebo from a starting value of 24.54.
To so primerjali s povečanjem za 4, 07 točke glede na začetno vrednost 24, 54 točk pri bolnikih, ki so jemali placebo.
When used as an add-on to levodopa, 1 mg AZILECT reduced the time in the ‘ off’ state more than placebo did.
Zdravilo AZILECT 1 mg, uporabljeno kot dodatek levodopi, je zmanjšalo čas v stanju „ izklopa “ bolj kot placebo.
In both studies, patients adding AZILECT spent an average of around one hour less in the ‘ off’ state than those adding placebo.
V obeh študijah so bolniki, ki so dodatno prejemali zdravilo AZILECT, preživeli v povprečju približno eno uro manj v stanju „ izklopa “ kot bolniki, ki so dodatno prejemali placebo.
A similar decrease in time spent in the ‘ off’ state was seen in patients taking entacapone.
Podobno zmanjšanje časa v stanju „ izklopa “ je bilo opaženo pri bolnikih, ki so prejemali entakapon.
What is the risk associated with AZILECT?
Kakšna tveganja so povezana z zdravilom AZILECT?
The most common side effect with AZILECT (seen in more than 1 patient in 10) is headache.
Najpogostejši neželeni učinek pri jemanju zdravila AZILECT (opažen pri več kot 1 bolniku izmed 10) je glavobol.
For the full list of all side effects reported with AZILECT, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila AZILECT, glejte Navodilo za uporabo.
AZILECT should not be used in people who may be hypersensitive (allergic) to rasagiline or any of the other ingredients.
Zdravila AZILECT se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) razagilin ali katerokoli drugo sestavino zdravila.
AZILECT should not be used with other monoamine oxidase inhibitors or pethidine (a painkiller).
Zdravila AZILECT se ne sme uporabljati v kombinaciji z drugimi zaviralci monoaminooksidaz ali petidinom (zdravilom proti bolečinam).
There should be at least 14 days between stopping treatment with AZILECT and starting treatment with another monoamine oxidase inhibitor or with pethidine.
Med prenehanjem zdravljenja z zdravilom AZILECT in začetkom zdravljenja z drugim zaviralcem monoaminooksidaz ali petidinom mora preteči najmanj 14 dni.
AZILECT should not be used in patients who have severe problems with their liver.
Zdravila AZILECT ne smejo uporabljati bolniki, ki imajo hude težave z jetri.
Caution is also needed by patients taking AZILECT at the same time as other medicines.
Previdnost je potrebna tudi pri bolnikih, ki jemljejo zdravilo AZILECT sočasno z drugimi zdravili.
See the Package Leaflet for more information.
Za več informacij glejte Navodilo za uporabo.
Why has AZILECT been approved?
Zakaj je bilo zdravilo AZILECT odobreno?
The Committee for Medicinal products for Human Use (CHMP) decided that AZILECT’ s benefits are greater than its risks for the treatment of idiopathic Parkinson’ s disease as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila AZILECT pri zdravljenju idiopatske Parkinsonove bolezni kot monoterapija (brez levodope) ali kot dodatna terapija (z levodopo) pri bolnikih z nihanji končnih odmerkov, večje od z njim povezanih tveganj.
The Committee recommended that AZILECT be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo AZILECT odobri dovoljenje za promet.
Other information about AZILECT:
Druge informacije o zdravilu AZILECT:
The European Commission granted a marketing authorisation valid throughout the European Union for AZILECT to Teva Pharma GmbH on 21 February 2005.
Evropska komisija je dovoljenje za promet z zdravilom AZILECT, veljavno po vsej Evropski uniji, odobrila družbi Teva Pharma GmbH dne 21. februarja 2005.
The full EPAR for AZILECT can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo AZILECT je na voljo tukaj.
Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Pretisni omoti (Alu/ Alu)
Blisters (Alu/ Alu) Blisters (Alu/ Alu) Blisters (Alu/ Alu) Blisters (Alu/ Alu) Blisters (Alu/ Alu) Blisters (Alu/ Alu) Bottles (HDPE)
Pretisni omoti (Alu/ Alu)
White to off-white, round, flat, bevelled tablets, debossed with “ GIL” and “ 1” underneath on one side and plain on the other side.
Bele do belkaste, okrogle, ploščate, prirezane tablete, z vtisnjenim » GIL « in » 1 « spodaj na eni strani in brez odtisov na drugi strani.
AZILECT is indicated for the treatment of idiopathic Parkinson’ s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
AZILECT je indiciran za zdravljenje idiopatske Parkinsonove bolezni (PB) kot monoterapija (brez levodope) ali kot dodatna terapija (z levodopo) pri bolnikih z nihanji končnih odmerkov.
No change in dosage is required for elderly patients.
Starejši: za starejše bolnike ni potrebno spreminjanje odmerjanja.
Not recommended as the safety and efficacy have not been established in this population.
Otroci in mladostniki (< 18 let): ni priporočljivo, saj varnost in učinkovitost v tej populaciji nista bili ugotovljeni.
Rasagiline use in patients with severe hepatic impairment is contraindicated (see section 4.3).
Uporaba razagilina pri bolnikih s hudo jetrno okvaro je kontraindicirana (glejte poglavje 4. 3).
Caution should be used when initiating treatment with rasagiline in patients with mild hepatic insufficiency.
Ob začetku zdravljenja z razagilinom je pri bolnikih z blago jetrno insuficienco potrebna previdnost.