natgillin/translations-raw huggingface dataset:
Opaque blue cap and opaque yellow body approximately 21.7 mm, imprinted in white ink with ‘MYLAN' over ‘DL 60' on both the cap and the body.
Rumena neprozorna kapsula z modrim neprozornim pokrovčkom, velikosti priližno 21,7 mm in z belim črnilom vtisnjeno oznako ‘MYLAN' preko 'DL 60', na pokrovčku in telesu kapsule.
• increased pressure in the eye (glaucoma)
• zvišan očesni tlak (glavkom)
60 mg capsules Each capsule contains 60 mg of duloxetine (as hydrochloride).
60 mg kapsule Ena kapsula vsebuje 60 mg duloksetina (v obliki duloksetinijevega klorida).
Duloxetine Mylan with food, drink and alcohol
Zdravilo Duloksetin Mylan skupaj s hrano, pijačo in alkoholom Zdravilo Duloksetin Mylan lahko vzamete s hrano ali brez nje.
60 mg capsules EU/1/15/1010/011 EU/1/15/1010/012 EU/1/15/1010/013 EU/1/15/1010/014 EU/1/15/1010/015
30 mg kapsule EU/1/15/1010/001 EU/1/15/1010/002 EU/1/15/1010/003 EU/1/15/1010/004 EU/1/15/1010/005 EU/1/15/1010/006 EU/1/15/1010/007
Each capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride).
Ena kapsula vsebuje 30 mg ali 60 mg duloksetina (v obliki duloksetinijevega klorida).
Opaque blue cap and opaque white body approximately 15.9 mm, imprinted in gold ink with ‘MYLAN' over ‘DL 30' on both the cap and the body.
Bela neprozorna kapsula z modrim neprozornim pokrovčkom, velikosti približno 15,9 mm in z zlatim črnilom vtisnjeno oznako ‘MYLAN' preko 'DL 30' na pokrovčku in telesu kapsule.
• blurred eyesight
• zamegljen vid
Adverse reactions may be more common during concomitant use of Duloxetine Mylan and herbal preparations containing St John's wort (Hypericum perforatum).
Ob sočasni uporabi zdravila Duloksetin Mylan in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so lahko neželeni učinki pogostejši.
What Duloxetine Mylan contains
Kaj vsebuje zdravilo Duloksetin Mylan
PVC/PE/PVdC/Aluminium perforated unit dose blister pack containing 7 x 1 and 28 x 1 hard gastro-resistant capsules.
PVC/PE/PVdC/aluminijevi perforirani enoodmerni pretisni omoti s po 7 x 1 in 28 x 1 trdo gastrorezistentno kapsulo.
Duloxetine Mylan 30 mg hard gastro-resistant capsules Duloxetine Mylan 60 mg hard gastro-resistant capsules duloxetine (as hydrochloride)
Duloksetin Mylan 30 mg trde gastrorezistentne kapsule Duloksetin Mylan 60 mg trde gastrorezistentne kapsule duloksetin (v obliki duloksetinijevega klorida)
Malaise
Midriaza
PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium perforated unit dose blister pack containing 28 x 1, 30 x 1 and 100 x 1 hard gastro resistant capsules PVC/PE/PVdC/Aluminium perforated unit dose blister pack containing 28 x 1 hard gastro-resistant capsules.
PVC/PCTFE/aluminijevi ali OPA/Al/PVC - aluminijevi perforirani enoodmerni pretisni omoti s po 28 x 1, 30 x 1, 100 x 1 trdo gastrorezistentno kapsulo.
How to store Duloxetine Mylan
Shranjevanje zdravila Duloksetin Mylan
Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin
Belo črnilo vsebuje šelak propilenglikol natrijev hidroksid povidon titanov dioksid (E171)
Duloxetine Mylan 60 mg hard gastro-resistant capsules duloxetine
Duloksetin Mylan 60 mg trde gastrorezistentne kapsule duloksetin
Anticoagulants and antiplatelet agents: Caution should be exercised when duloxetine is combined with oral anticoagulants or antiplatelet agents due to a potential increased risk of bleeding attributable to a pharmacodynamic interaction.
Zaradi možnega povečanega tveganja za krvavitev, ki ga lahko pripišemo farmakodinamični interakciji, je potrebna previdnost pri kombinaciji duloksetina s peroralnimi antikoagulanti ali antitrombotičnimi zdravili.
Duloxetine Mylan 30 mg hard gastro-resistant capsules duloxetine
Duloksetin Mylan 30 mg trde gastrorezistentne kapsule duloksetin
BLISTER INNER CARTON FOR MULTIPACK FOR 60 MG HARD GASTRO RESISTANT CAPSULES, WITHOUT BLUE BOX
VMESNA ŠKATLA SKUPNEGA PAKIRANJA ZA 60 MG TRDE GASTROREZISTENTNE KAPSULE (BREZ MODREGA OKENCA)
Duloxetine Mylan 30 mg hard gastro-resistant capsules Duloxetine Mylan 60 mg hard gastro-resistant capsules
Duloksetin Mylan 30 mg trde gastrorezistentne kapsule Duloksetin Mylan 60 mg trde gastrorezistentne kapsule
BLISTER INNER CARTON FOR MULTIPACK FOR 30 MG HARD GASTRO RESISTANT CAPSULES, WITHOUT BLUE BOX
VMESNA ŠKATLA SKUPNEGA PAKIRANJA ZA 30 MG TRDE GASTROREZISTENTNE KAPSULE (BREZ MODREGA OKENCA)
PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium blister pack containing 14, 28, 84, 98 and multipacks containing 98 (2 packs of 49) hard gastro resistant capsules.
PVC/PCTFE/aluminijevi ali OPA/Al/PVC - aluminijevi pretisni omoti s po 14, 28, 84, 98 in skupno pakiranje s po 98 (2 škatli po 49) trdih gastrorezistentnih kapsul.
There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake inhibitors (SNRIs), including duloxetine.
Pri selektivnih zaviralcih privzema serotonina (SSRI) in selektivnih zaviralcih privzema noradrenalina (SNRI), vključno z duloksetinom, so poročali o nenormalnih krvavitvah, kot so ekhimoze, purpure in krvavitve iz prebavil.
Propylene glycol Strong ammonia solution Yellow iron oxide (E172)
Zlato črnilo vsebuje šelak propilenglikol amoniak, koncetrirana raztopina rumeni železov oksid (E172)
Interstitial lung disease
Infekcijske in parazitske bolezni laringitis
PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium blister pack containing 7, 14, 28, 98 and multipacks containing 98 (2 packs of 49) hard gastro-resistant capsules.
PVC/PCTFE/aluminijevi ali OPA/AL/PVC - aluminijevi pretisni omoti s po 7, 14, 28, 98 in skupno pakiranje s po 98 (2 škatli po 49) trdih gastrorezistentnih kapsul.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Zdravilo Duloksetin Mylan vsebuje saharozo in natrij Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred jemanjem tega zdravila pogovorite z njim.
Each capsule contains 30 mg of duloxetine (as hydrochloride).
Ena kapsula vsebuje 30 mg duloksetina (v obliki duloksetinijevega klorida).
Somnolence
Krvavitev
PVC/PE/PVdC/Aluminium blister pack containing 7, 14, 28, 49, 98 and multipacks containing 98 (2 packs of 49) hard gastro resistant capsules.
PVC/PE/PVdC/aluminijevi pretisni omoti s po 7, 14, 28, 49, 98 in skupno pakiranje s po 98 (2 škatli po 49) trdih gastrorezistentnih kapsul.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Sestavni del skupnega pakiranja.
Each capsule contains 60 mg of duloxetine (as hydrochloride).
Ena kapsula vsebuje 60 mg duloksetina (v obliki duloksetinijevega klorida).
Duloxetine Mylan is for oral use.
Zdravilo Duloksetin Mylan jemljemo peroralno.
PVC/PE/PVdC/Aluminium blister pack containing 14, 28, 49, 98 and multipacks containing 98 (2 packs of 49) hard gastro-resistant capsules.
PVC/PE/PVdC/aluminijevi pretisni omoti s po 14, 28, 49, 98 in skupno pakiranje s po 98 (2 škatli po 49) trdih gastrorezistentnih kapsul.
Sugar spheres (sucrose, maize starch) Hypromellose
Vsebina kapsule sladkorne kroglice (saharoza, koruzni škrob) hipromeloza makrogol krospovidon smukec saharoza hipromelozaftalat dietilftalat
• contraction of the jaw muscle
• krčenje mišice čeljusti
BLISTER OUTER CARTON FOR MULTIPACK FOR 60 MG HARD GASTRO RESISTANT CAPSULES, WITH BLUE BOX
ŠKATLA ZA SKUPNO PAKIRANJE S PRETISNIMI OMOTI ZA 60 MG TRDE GASTROREZISTENTNE KAPSULE (VKLJUČNO Z MODRIM OKENCEM)
CLINICAL PARTICULARS
Posebne skupine bolnikov
BLISTER OUTER CARTON FOR MULTIPACK FOR 30 MG HARD GASTRO RESISTANT CAPSULES, WITH BLUE BOX
ŠKATLA ZA SKUPNO PAKIRANJE S PRETISNIMI OMOTI ZA 30 MG TRDE GASTROREZISTENTNE KAPSULE (VKLJUČNO Z MODRIM OKENCEM)
EU/1/15/1010/016 EU/1/15/1010/017 EU/1/15/1010/018 EU/1/15/1010/019 EU/1/15/1010/020 EU/1/15/1010/029 EU/1/15/1010/030 EU/1/15/1010/031 EU/1/15/1010/032 EU/1/15/1010/033 EU/1/15/1010/034 EU/1/15/1010/035 EU/1/15/1010/036 EU/1/15/1010/039 EU/1/15/1010/040 EU/1/15/1010/049 EU/1/15/1010/050 EU/1/15/1010/051 EU/1/15/1010/052 EU/1/15/1010/053 EU/1/15/1010/054
60 mg kapsule EU/1/15/1010/011 EU/1/15/1010/012 EU/1/15/1010/013 EU/1/15/1010/014 EU/1/15/1010/015 EU/1/15/1010/016 EU/1/15/1010/017 EU/1/15/1010/018 EU/1/15/1010/019 EU/1/15/1010/020 EU/1/15/1010/029 EU/1/15/1010/030 EU/1/15/1010/031 EU/1/15/1010/032 EU/1/15/1010/033 EU/1/15/1010/034 EU/1/15/1010/035 EU/1/15/1010/036 EU/1/15/1010/039 EU/1/15/1010/040 EU/1/15/1010/049 EU/1/15/1010/050 EU/1/15/1010/051 EU/1/15/1010/052 EU/1/15/1010/053 EU/1/15/1010/054
BOTTLE CARTON FOR 30 MG HARD GASTRO RESISTANT CAPSULES
ŠKATLA ZA PRETISNE OMOTE ZA 30 MG TRDE GASTROREZISTENTNE KAPSULE
BLISTER FOR 60 MG HARD GASTRO RESISTANT CAPSULES
PRETISNI OMOT ZA 60 MG TRDE GASTROREZISTENTNE KAPSULE
BOTTLE CARTON FOR 60 MG HARD GASTRO RESISTANT CAPSULES
ŠKATLA ZA PRETISNE OMOTE ZA 60 MG TRDE GASTROREZISTENTNE KAPSULE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Samo za pakiranje v plastenkah:
30 mg capsules EU/1/15/1010/001 EU/1/15/1010/002 EU/1/15/1010/003 EU/1/15/1010/004 EU/1/15/1010/005 EU/1/15/1010/006 EU/1/15/1010/007 EU/1/15/1010/008 EU/1/15/1010/009 EU/1/15/1010/010 EU/1/15/1010/021 EU/1/15/1010/022 EU/1/15/1010/023 EU/1/15/1010/024 EU/1/15/1010/025 EU/1/15/1010/026 EU/1/15/1010/027 EU/1/15/1010/028 EU/1/15/1010/037 EU/1/15/1010/038 EU/1/15/1010/041 EU/1/15/1010/042 EU/1/15/1010/043 EU/1/15/1010/044 EU/1/15/1010/045 EU/1/15/1010/046 EU/1/15/1010/047 EU/1/15/1010/048
EU/1/15/1010/008 EU/1/15/1010/009 EU/1/15/1010/010 EU/1/15/1010/021 EU/1/15/1010/022 EU/1/15/1010/023 EU/1/15/1010/024 EU/1/15/1010/025 EU/1/15/1010/026 EU/1/15/1010/027 EU/1/15/1010/028 EU/1/15/1010/037 EU/1/15/1010/038 EU/1/15/1010/041 EU/1/15/1010/042 EU/1/15/1010/043 EU/1/15/1010/044 EU/1/15/1010/045 EU/1/15/1010/046 EU/1/15/1010/047 EU/1/15/1010/048
Reproductive system and breast disorders Erectile dysfunction
dehidracija, hiponatremija, sindrom neustreznega izločanja antidiuretičnega hormona
BLISTER FOR 30 MG HARD GASTRO RESISTANT CAPSULES
PRETISNI OMOT ZA 30 MG TRDE GASTROREZISTENTNE KAPSULE
Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant
(mlajših od 25 let) z motnjami razpoloženja med zdravljenjem z antidepresivi obstaja večje tveganje za pojav samomorilnega vedenja
Dehydration Hyponatraemia SIADH
Zaviralci monoaminooksidaze (MAOI):
The main ingredient of Duloxetine Mylan, duloxetine, is used in other medicines for other conditions: • diabetic neuropathic pain, depression, anxiety and urinary incontinence
• bolečina diabetične nevropatije, depresije, anksioznosti in urinske inkontinence
• muscle tightness, muscle twitching
• mišična napetost, trzanje mišic
Breast feeding
PODATKI NA ZUNANJI OVOJNINI
28 x 1 hard gastro-resistant capsules 30 x 1 hard gastro-resistant capsules 100 x 1 hard gastro-resistant capsules
14 trdih gastrorezistentnih kapsul 28 trdih gastrorezistentnih kapsul 49 trdih gastrorezistentnih kapsul 84 trdih gastrorezistentnih kapsul 98 trdih gastrorezistentnih kapsul 28 x 1 trda gastrorezistentna kapsula 30 x 1 trda gastrorezistentna kapsula 100 x 1 trda gastrorezistentna kapsula
Not all pack sizes may be marketed.
Ni za posamezno prodajo.
List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicants and marketing authorisation holders in the member states
Dodatek I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
Concentrate for solution for infusion
Koncentrat za pripravo raztopine za infundiranje
1 mg/ml (5ml)
1 mg/ml (5ml) Raztopina za injiciranje
Solution for infusion Intravenous use
Raztopina za infundiranje
The European Commission issued a decision on 30 September 2010.
Evropska komisija je odločbo izdala dne 30. septembra 2010.
Further treatment can be given under medical supervision.
Nadaljnjo zdravljenje lahko poteka le pod zdravniškim nadzorom.
Jens Ersbøll (Denmark)
Jens Ersbøll (Danska)
The recommended treatment period for the ointment is four weeks.
Priporočeno obdobje zdravljenja z mazilom je štiri tedne.
Daivobet ointment was authorised in some Member States through a mutual recognition procedure and in others through national procedures.
Daivobet mazilo je bilo odobreno v nekaterih državah članicah s postopkom z medsebojnim priznavanjem, v drugih pa z nacionalnimi postopki.
The company that markets these medicines is Leo Pharmaceutical Products.
Družba, ki trži ti zdravili, je Leo Pharmaceutical Products.
Daivobet gel was authorised via a decentralised procedure.
Daivobet gel je bil odobren z decentraliziranim postopkom.
It is available as a gel and ointment and is used topically (applied on the skin).
Na voljo je v obliki gela in mazila in se uporablja topično (nanaša se na kožo).
Why was Daivobet reviewed?
Zakaj je bilo zdravilo Daivobet pregledano?
The European Medicines Agency has completed a review of Daivobet.
Evropska agencija za zdravila je zaključila pregled zdravila Daivobet.
The Committee also harmonised a list of contra-indications related to skin conditions, including viral lesions of the skin, fungal or bacterial skin infections, parasitic infections and skin problems caused by tuberculosis or syphilis.
Odbor je uskladil tudi seznam kontraindikacij v zvezi s stanjem kože, vključno z virusnimi lezijami kože, glivičnimi ali bakterijskimi okužbami kože, parazitnimi okužbami in težavami s kožo, ki jih povzročata tuberkuloza ali sifilis.
It must also not be used in patients with abnormal levels of calcium in their blood.
Prav tako ga ne smejo uporabljati bolniki z nenormalno vsebnostjo kalcija v krvi.
Daivobet is also available in the EU under the trade name Dovobet.
Zdravilo Daivobet je v EU na voljo tudi pod tržnim imenom Dovobet.
Questions and answers on Daivobet and associated names (calcipotriol/betamethasone gel and ointment, 50 micrograms/0.5 mg per g) EMA/CHMP/466386/2010
Vprašanja in odgovori v zvezi z zdravilom Daivobet in povezanimi imeni (kalcipotriol/betametazon gel in mazilo, 50 mikrogramov/0,5 mg na g) EMA/CHMP/466386/2010
Daivobet should be applied once a day on the affected areas of the skin.
Zdravilo Daivobet je treba nanesti enkrat dnevno na prizadete dele kože.
Because of this, there are some differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicines are marketed.
Zato se pojavljajo razlike v povzetkih glavnih značilnosti zdravila, označevanju in navodilih za uporabo v državah, v katerih se zdravili tržita.
What is Daivobet?
Kaj je zdravilo Daivobet?
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
CHMP je ob upoštevanju predloženih podatkov in znanstvenih razprav v okviru Odbora menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo uskladiti v celotni EU.
Questions and answers on Daivobet and associated names (calcipotriol/betamethasone gel and ointment, 50 micrograms/0.5 mg per g)
Vprašanja in odgovori v zvezi z zdravilom Daivobet in povezanimi imeni (kalcipotriol/betametazon gel in mazilo, 50 mikrogramov/0,5 mg na g)
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Daivobet in the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Daivobet.
No more than 15 g of the gel or ointment should be used in one day.
Na dan se lahko uporabi največ 15 g gela ali mazila.
The Committee also harmonised other sections of the SmPC, including the sections on special warnings, pregnancy and lactation and undesirable effects.
Odbor je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavjem s posebnimi opozorili ter poglavji o nosečnosti, dojenju in neželenih učinkih.
22 July 2010
22. julij 2010
Daivobet contains two active substances: calcipotriol and betamethasone.
Zdravilo Daivobet vsebuje dve zdravilni učinkovini: kalcipotriol in betametazon.
Calcipotriol, a substance derived from vitamin D, acts through receptors in the skin to prevent the multiplication of cells that cause the scaly patches in psoriasis.
Kalcipotriol, snov, pridobljena iz vitamina D, deluje prek receptorjev v koži in tako preprečuje razmnoževanje celic, ki povzročajo luskaste površine pri psoriazi.
The CHMP agreed that Daivobet ointment is to be used for the treatment of adults with plaque psoriasis where it is possible to use a topical medicine.
CHMP se je strinjal, da naj bi se Daivobet mazilo uporabljalo za zdravljenje odraslih bolnikov s psoriazo s plaki, kadar je možno zdravljenje z uporabo topičnih zdravil.
Daivobet should not be used in patients who may be hypersensitive (allergic) to the active substances or to any other ingredient.
Zdravila Daivobet ne smejo uporabljati bolniki, ki utegnejo biti preobčutljivi za (alergični na) zdravilni učinkovini ali katero koli drugo sestavino zdravila.
For the gel, the recommended treatment period is four weeks for scalp psoriasis and eight weeks for non-scalp psoriasis.
Priporočeno obdobje zdravljenja z gelom je štiri tedne pri psoriazi lasišča in osem tednov pri psoriazi, ki se ne pojavlja na lasišču.
Daivobet is used to treat adults with psoriasis (a disease causing red, scaly patches on the skin).
Zdravilo Daivobet se uporablja za zdravljenje odraslih bolnikov s psoriazo (boleznijo, ki povzroča rdeče, luskaste površine na koži).
Daivobet must not be used in patients who have some types of psoriasis that is red and flaking off or filled with pus.
Zdravila Daivobet ne smejo uporabljati bolniki z nekaterimi vrstami psoriaze, ki je rdeča in luskava ali ognojena.
Daivobet gel is for the treatment of psoriasis on the scalp or mild to moderate plaque psoriasis on other parts of the body.
Daivobet gel je namenjen zdravljenju psoriaze na lasišču ali blage do zmerne psoriaze s plaki na drugih delih telesa.
For the full list, see the harmonised SmPC.
Za celoten seznam glejte usklajen povzetek glavnih značilnosti zdravila.
On 10 March 2010, Leo Pharmaceutical Products referred Daivobet to the CHMP in order to harmonise the marketing authorisations for the product in the EU.
Da bi uskladila dovoljenja za promet z zdravilom Daivobet v EU, je družba Leo Pharmaceutical Products dne 10. marca 2010 zadevo napotila na CHMP.
Betamethasone is an anti-inflammatory medicine that helps to reduce the inflammation and itching that occur with psoriasis.
Betametazon je protivnetno zdravilo, ki pomaga zmanjševati vnetje in srbenje, ki se pojavljata pri psoriazi.
Company responses provided on: 16 June 2010 Opinion date:
Odgovori družbe, poslani dne:
Do not take two doses in one day.
Ne vzemite dveh odmerkov v enem dnevu.
Drink it straight away.
Napitek takoj spijte.
(See sections 4.5 and 5.2).
(Glejte poglavji 4.5 in 5.2.)
Information on long term safety is primarily limited to open-label, uncontrolled data.
Informacije o dolgoročni varnosti so primarno omejene na nenadzorovane podatke odprtih študij.
Common: Dry mouth
Pogosti: suha usta
This will usually pass on its own but if it does not, tell your doctor.
To običajno mine samo od sebe, če pa ne, povejte zdravniku.
You and your doctor should check your weight regularly.
Vi in vaš zdravnik morata redno spremljati vašo telesno maso.
With some drinks, the mixture may change colour and possibly become cloudy.
V nekaterih napitkih lahko mešanica spremeni barvo in postane motna.
This leaflet was last revised in {month XXXX}.
Navodilo je bilo nazadnje revidirano v {mesec LLLL}
People with this disease may also feel depressed, anxious or tense.
Ljudje s to boleznijo se lahko počutijo tudi depresivno, občutijo tesnobo ali napetost.
Your doctor may suggest you to reduce the dose gradually before stopping treatment.
Vaš zdravnik vam bo morda predlagal postopno nižanje odmerka pred ukinitvijo zdravljenja.
Increased total bilirubin
zvišan celokupni bilirubin
• If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
• če so vam v preteklosti ugotovili težave z očmi kot je določena vrsta glavkoma (povišan tlak v očesu).
No studies on the effects on the ability to drive and use machines have been performed.
Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
If this has happened to you, tell your doctor.
Če se vam je zgodilo kaj takega, povejte zdravniku.
• Medicines of this type may cause unusual movements mainly of the face or tongue.
• Tovrstna zdravila lahko povzročijo nenavadne zgibke predvsem v mišicah obraza ali jezika.
Discontinuation symptoms7, 12
odtegnitveni simptomi7, 12
Glucosuria Increased appetite
glikozurija povečan apetit
In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position.
Nekateri ljudje imajo lahko v začetnih obdobjih zdravljenja občutek omotice ali oslabelosti (z upočasnjenim srčnim utripom), zlasti pri vstajanju iz ležečega ali sedečega položaja.
Your doctor will tell you how many Olanzapine Apotex tablets to take and how long you should continue to take them.
Zdravnik vam bo povedal, koliko Olanzapin Apotex tablet morate vzeti in kako dolgo naj bi jih jemali.
Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Uporaba olanzapina ni priporočena pri otrocih in mladostnikih, mlajših od 18 let, zaradi pomanjkanja podatkov o varnosti in učinkovitosti.
• If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na (preobčutljivi za) olanzapin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Removal of the intact orodispersible tablet from the mouth is difficult.
Odstranitev cele orodisperzibilne tablete iz ust je težavna.
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 6 months.
Pri odraslih bolnikih, ki so zaključili 9-12 mesecev terapije, se je razmerje zvišanja povprečne glukoze v krvi upočasnilo po približno 4-6 mesecih.
The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
Naslednja tabela našteva neželene učinke in laboratorijske preiskave, ki so jih opazili iz spontanega poročanja in kliničnih preskušanj.
Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Apotex and regularly during treatment.
Vaš zdravnik mora opraviti krvni test za preiskavo sladkorja v krvi in nivo določenih maščob pred začetkom jemanja zdravila Olanzapin Apotex in redno tekom zdravljenja.
The frequency terms listed are defined as follows: 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).
Našteti izrazi pogostnosti so definirani kot sledi: 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).
Dose escalation, when indicated, should be conservative in such patients.
Višanje odmerka, kadar je to indicirano, naj bo pri takih bolnikih previdno.
Children and adolescents Olanzapine Apotex is not for patients who are under 18 years.
Otroci in mladostniki Zdravilo Olanzapin Apotex ni namenjeno bolnikom, mlajšim od 18 let.
You can also place the tablet in a full glass or cup of water, orange juice, apple juice, milk or or coffee and stir.
Tableto lahko date tudi v poln kozarec ali skodelico vode, oranžnega soka, jabolčnega soka, mleka ali kave in premešate.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred jemanjem tega zdravila posvetujte z zdravnikom.