qanastek/EMEA-V3 huggingface dataset:
95 • Tremor. • Muscle stiffness or spasm (including eye movements). • Problems with speech. • Unusual movement (especially of the face or tongue). • Constipation. • Dry mouth. • Rash. • Loss of strength. • Extreme tiredness. • Water retention leading to swelling of the hands, ankles or feet. • 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.
96 • Ħalq xott. • Raxx. • Titlef il- forzi. • Għeja esaġerata. • Retenzjoni ta 'l- ilma li twassal għal nefħa fl- idejn, għekiesi jew saqajn. • Fl- ewwel stadji tal- kura, xi persuni jistgħu jħossuhom sturduti jew mhux f' sikkithom (il- qalb tħabbat bil- mod), speċjalment waqt li jkunu qegħdin iqumu minn pożizzjoni mimduda jew minn bil- qiegħda.
Other possible side effects: frequency cannot be estimated from the available data. • Allergic reaction (e. g. swelling in the mouth and throat, itching, rash). • Diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma. • Lowering of normal body temperature. • Seizures, usually associated with a history of seizures (epilepsy). • Combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. • Spasms of the muscle of the eye causing rolling movement of the eye. • Abnormal rhythms of the heart. • Sudden unexplained death. • Blood clots such as deep venous thrombosis of the leg or blood clot on the lung. • Inflammation of the pancreas causing severe stomach pain, fever and sickness. • Liver disease appearing as yellowing of the skin and white parts of the eyes. • Muscle disease presenting as unexplained aches and pains. • Difficulty in passing urine. • Prolonged and/ or painful erection.
Effetti sekondarji oħra possibbli: ma tistax tiġi stmata frekwenza mill- informazzjoni disponibbli • Reazzjonijiet allerġiċi (eż. nefħa fil- ħalq u l- gerżuma, ħakk, raxx). • Dijabete jew dijabete li tmur għall- agħar, kultant assoċjata ma 'ketoaċidożi (ketoni fid- demm u fl- awrina) jew koma. • Titbaxxa t- temperatura normali tal- ġisem. • Aċċessjonijiet, normalment assoċjati ma' storja ta 'aċċessjonijiet (epilessija). • Taħlita ta' deni, nifs mgħaġġel, tagħriq, ebusija tal- muskoli u ħedla jew ngħas. • Spażmi tal- muskolu ta 'l- għajn li jikkawża taqlib ta' l- għajn. • Ritmi mhux normali tal- qalb. • Mewt għall- għarrieda u inspjegabbli. • Tagħqid tad- demm bħal trombożi fil- vini fondi tas- sieq jew tagħqid tad- demm fil- pulmun. • Infjammazjoni tal- frixa li tikkawża wġigħ qawwi fl- istonku, deni u taqlib. • Mard tal- fwied li jidher bħala sfurija tal- ġilda u ta 'l- abjad ta' l- għajnejn. • Mard tal- muskoli li jimmanifesta ruħu bħala wġigħ inspjegabbli. • Diffikultà biex tgħaddi l- awrina. • Erezzjoni mtawwla u/ jew bl- uġigħ.
While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking.
Waqt li qed jieħdu l- olanzapine, il- pazjenti anzjani bid- demenzja jistgħu jsofru minn puplesija, il- pnewmonja,, l- inkontinenza ta ’ l- awrina, waqgħat, għeja kbira, alluċinazzjonijiet viżivi, żjieda fit- temperatura tal- ġisem, ħmura fil- ġilda u jistgħu jkollhom problemi fil- mixi.
In patients with Parkinson's disease OLANZAPINE NEOPHARMA may worsen the symptoms.
F' pazjenti li għandhom il- marda ta 'Parkinson, OLANZAPINE NEOPHARMA tista' tagħmel is- sintomi agħar.
Very rarely babies born to mothers who have taken OLANZAPINE NEOPHARMA in the last stage of pregnancy (3rd trimester) may have tremors, be sleepy or drowsy.
Rarament ħafna trabi li jitwieldu lil ommijiet li ħadu OLANZAPINE NEOPHARMA fl- aħħar stadju tat- tqala (fl- aħħar tlett xhur) jista 'jkollhom rogħda, ngħas u ħedla.
HOW TO STORE OLANZAPINE NEOPHARMA COATED TABLETS 96 Keep out of the reach and sight of children.
KIF TAĦŻEN OLANZAPINE NEOPHARMA
Do not use Olanzapine Neopharma after the expiry date which is stated on the carton after Exp.
97 Tużax OLANZAPINE NEOPHARMA wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- kartun wara Jis.
Store below 30ºC.
Aħżen f’ temperaturi anqas minn 30ºC.
What Olanzapine Neopharma contains
X’ fih OLANZAPINE NEOPHARMA
- The active substance is olanzapine.
- Is- sustanza attiva hi olanzapine.
Each Olanzapine Neopharma coated tablet contains either
Kull OLANZAPINE NEOPHARMA pillola miksija fiha jew
2.5 mg, 5 mg, 7.5 mg, 10 mg or 15 mg of the active substance.
2. 5 mg, 5 mg, 7. 5 mg, 10 mg jew 15 mg tas- sustanza attiva.
- Tablet core: lactose monohydrate (See also end of section 2 – important information about some
- Il- qalba tal- pillola: lactose monohydrate (Ara wkoll it- tmien ta ’ sezzjoni 2 – Tagħrif importanti
of the ingredients of Olanzapine Neopharma), maize starch, hydroxypropyl cellulose, magnesium stearate.
dwar xi wħud mis- sustanzi ta ’ OLANZAPINE NEOPHARMA), maize starch, hydroxypropyl cellulose, magnesium stearate.
- Tablet coat:
- Il- kisja tal- pillola:
- 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets:
- Pilloli ta ’ 2. 5 mg, 5 mg, 7. 5 mg and 10 mg:
Opadry white containing hypromellose (E464),
Opadry white li fih hypromellose (E464), titanium
titanium dioxide (E171), lactose monohydrate, polyethylene glycol 3000 and glycerol triacetate
dioxide (E171), lactose monohydrate, polyethylene glycol 3000 u glycerol triacetate
- 15 mg tablets:
- Pilloli ta ’ 15 mg:
Opadry Blue containing hypromellose (E464), titanium dioxide (E171),
Opadry Blue li fih hypromellose (E464), titanium dioxide (E171),
polyethylene glycol 6000, indigo carmine aluminium lake (E132), brilliant blue FCF aluminium lake (E133) and iron oxide black (E172)
polyethylene glycol 6000, indigo carmine aluminium lake (E132), brilliant blue FCF aluminium lake (E133) u iron oxide black (E172)
What OLANZAPINE NEOPHARMA looks like and contents of the pack Olanzapine Neopharma 2.5 mg coated tablets are white, round, biconvex, coated tablets with ‘ 2.5’ debossed on one side and ‘ OLZ’ on the other.
Id- dehra ta ’ OLANZAPINE NEOPHARMA u l- kontenuti tal- pakkett OLANZAPINE NEOPHARMA 2. 5 mg pilloli miksija huma bojod, tondi, bikonvessi, miksija b’ rita b ’’ 2. 5 ’ imnaqqxa fuq naħa waħda u ‘ OLZ ’ fuq in- naħa l- oħra.
Olanzapine Neopharma 5 mg coated tablets are white, round, biconvex, coated tablets with ‘ OLZ 5’ debossed on one side and ‘ NEO’ on the other.
OLANZAPINE NEOPHARMA 5 mg pilloli miksija huma bojod, tondi, bikonvessi, miksija b’ rita b ’’ OLZ 5 ’ imnaqqxa fuq naħa waħda u ‘ NEO ’ fuq in- naħa l- oħra.
Olanzapine Neopharma 7.5 mg coated tablets are white, round, biconvex, coated tablets with ‘ OLZ 7.5’ debossed on one side and ‘ NEO’ on the other.
OLANZAPINE NEOPHARMA 7. 5 mg pilloli miksija huma bojod, tondi, bikonvessi, miksija b’ rita b ’’ OLZ 7. 5 ’ imnaqqxa fuq naħa waħda u ‘ NEO ’ fuq in- naħa l- oħra.
Olanzapine Neopharma 10 mg coated tablets are white, round, biconvex, coated tablets with ‘ OLZ 10’ debossed on one side and ‘ NEO’ on the other.
OLANZAPINE NEOPHARMA 10 mg pilloli miksija huma bojod, tondi, bikonvessi, miksija b’ rita b ’’ OLZ 10 ’ imnaqqxa fuq naħa waħda u ‘ NEO ’ fuq in- naħa l- oħra.
Olanzapine Neopharma 15 mg coated tablets are blue, elliptical, convex, coated tablets with ‘ NEO’ debossed on one side and plain on the other side.
OLANZAPINE NEOPHARMA 15 mg pilloli miksija huma blu, ellitiċi, konvessi, pilloli miksija b ’’ NEO ’ imnaqqxa fuq naħa waħda u xejn fuq in- naħa l- oħra.
Olanzapine Neopharma 2.5 mg, 5 mg, 7.5 mg and 15 mg coated tablets are available in 28 and 56 blister packs.
OLANZAPINE NEOPHARMA 2. 5 mg, 5 mg, 7. 5 mg u 15 mg pilloli miksija huma disponibbli fi 28 u 56 pakkett bil- folji.
Olanzapine Neopharma 10 mg coated tablets are available in 7, 28 and 56 blister packs.
OLANZAPINE NEOPHARMA 10 mg pilloli miksija huma disponibbli f’ 7, 28 u 56 pakkett bil- folji.
97 Marketing Authorisation Holder and Manufacturer
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- manifattur
Neopharma Limited, 57 High Street, Odiham, Hampshire, RG29 1LF, UK Tel: +44 (0)1256 704110 Fax: +44 (0)1256 701144
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Neolab Limited, 57 High Street, Odiham, Hampshire, RG29 1LF, UK Tel: +44 (0)1256 704110 Fax: +44 (0)1256 701144
Neopharma Limited, 57 High Street, Odiham, Hampshire, RG29 1LF, Renju Unit Tel: +44 (0) 1256 704110 Fax: +44 (0) 1256 701144
98
98 Manifattur:
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqa, biex jissodisfa ir- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ aktar informazzjoni dwar il- kondizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (huwa parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is Olanzapine Teva?
X’ inhu Olanzapine Teva?
Olanzapine Teva is a medicine containing the active substance olanzapine.
Olanzapine Teva huwa mediċina li fiha s- sustanza attiva olanzapine.
It is available as tablets (white and round:
Huwa disponibbli bħala pilloli (bojod u tondi:
2.5, 5, 7.5 and 10 mg; blue and oval:
2. 5, 5, 7. 5 u 10 mg; blu u ovali:
15 mg; green:
15 mg; roża u ovali: 20 mg) u bħala pilloli tondi ‘ orodispersibbli ’ (sofor: 5 u 10 mg, oranġjo: 15 mg, ħodor: 20 mg).
Orodispersible tablets are tablets that dissolve in the mouth.
Il- pilloli orodispersibbli huma pilloli li jinħallu fil- ħalq.
Olanzapine Teva is a ‘ generic medicine’.
Olanzapine Teva huwa ‘ mediċina ġenerika ’.
This means that Olanzapine Teva is similar to ‘ reference medicines’ already authorised in the European Union (EU) called Zyprexa and Zyprexa Velotab.
Dan ifisser li Olanzapine Teva huwa simili għall - ‘ mediċini ta ’ referenza ’ diġà awtorizzati fl- Unjoni Ewropea (UE) li jisimhom Zyprexa u Zyprexa Velotab.
For more information on generic medicines, see the question-and-answer document here.
Għal aktar informazzjoni dwar il- mediċini ġeneriċi, ara d- dokument mistoqsija u tweġiba hawn.
What is Olanzapine Teva used for?
Għal xiex jintuża Olanzapine Teva?
Olanzapine Teva is used to treat adults with schizophrenia.
Olanzipine Teva jintuża fit- trattament ta ’ l- iskizofrenija.
Schizophrenia is a mental illness that has a number of symptoms including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Din hija marda mentali, li għandha numru ta ’ sintomi, inkluż disturbi fil- ħsieb u fid- diskors, alluċinazzjonijiet (il- pazjent jisma ’ u jara affarijiet li ma jeżistux), suspetti u delirji (ħsibijiet żbaljati).
Olanzapine Teva is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Olanzapine Teva huwa effikaċi wkoll biex iżomm it - titjib li jkun sar f’ pazjenti li jkunu rrispondew għal kors inizjali ta ’ trattament.
Olanzapine Teva is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Olanzapine Teva jintuża wkoll fit- trattament ta ’ każijiet moderati jew gravi tal- manija (burdata estremament tajba).
It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness causing alternating periods of high mood and depression) who have responded to an initial course of treatment.
Jista ’ wkoll jintuża sabiex jipprevjeni (meta jerġgħu jibdew jitfaċċaw is- sintomi) li dawn l- episodji f’ pazjenti b’ disturbi bipolari (marda mentali b’ perjodi li jalternaw bejn burdata tajba ħafna u depressjoni) jerġgħu jfiġġu u li jkunu rrispondew għal kors inizjali ta ’ trattament.
How is Olanzapine Teva used?
Kif jintuża Olanzapine Teva?
The recommended starting dose of Olanzapine Teva depends on the disease being treated:
Id- doża rrakkomandata inizjali ta ’ Olanzapine Teva tiddependi mill- marda li tkun qed tiġi ttrattata:
10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Doża ta ’ 10 mg kuljum tintuża għall- iskizofrenija u fil- prevenzjoni ta ’ każijiet manijaċi, u 15 mg kuljum fit- trattament ta ’ każijiet manijaċi, sakemm ma tintużax ma ’ mediċini oħra, f’ liema każ id- doża tal- bidu tista ’ tkun ta ’ 10 mg kuljum.
The dose is adjusted depending on how well the patient responds to and tolerates the treatment.
Id- doża tiġi adattata skond kemm il- pazjent jirrispondi tajjeb għat- trattament u jittollerah.
The orodispersible tablets, which can be used as an alternative to the tablets, are taken by being placed on the tongue, where they disintegrate quickly in the saliva, or by mixing them in water before swallowing.
Il- pilloli orodispersabbli li jistgħu jintużaw bħala alternattiva għall- pilloli, jittieħdu billi jitpoġġew fuq l- ilsien, fejn jiddiżintegraw malajr fil- bżieq, jew inkella billi tħallathom ma ’ l- ilma qabel tiblagħhom.
Patients over 65 years of age and patients who have problems with their liver or kidneys may need a lower starting dose of 5 mg per day.
Il- pazjenti li jkollhom iktar minn 65 sena u pazjenti li jkollhom problemi fil- fwied jew fil- kliewi tagħhom jista ’ jkollhom bżonn ta ’ doża inizjali iktar baxxa ta ’ 5 mg kuljum.
How does Olanzapine Teva work?
Reproduction is authorised provided the source is acknowledged Kif jaħdem Olanzapine Teva?
The active substance in Olanzapine Teva, olanzapine, is an antipsychotic medicine.
Is- sustanza attiva f’ Olanzapine Teva, olanzapine, hija mediċina antipsikotika.
It is known as an ‘ atypical’ antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Hija magħrufa bħala antipsikotiku 'atipiku' minħabba li hija differenti mill- mediċini antipsikotiċi iktar antiki li ilhom disponibbli mill- ħamsinijiet.
Its exact mechanism of action is unknown, but it attaches to several receptors on the surface of nerve cells in the brain.
Mhux magħruf l- eżatt mekkaniżmu ta ’ l- azzjoni tagħha, iżda teħel ma ’ diversi riċetturi differenti fuq is- superfiċje taċ- ċelloli tan- nervituri tal- moħħ.
Since these neurotransmitters are involved in schizophrenia and bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Billi dawn in- newrotrażmettituri għandhom sehem fl - iskizofrenija u fid- disturbi bipolari, olanzapine tgħin fin- normalizzazzjoni ta ’ l- attività ċelebrali, u b’ hekk tnaqqas is- sintomi ta ’ dawn il- mardiet.
How has Olanzapine Teva been studied?
Kif ġie studjat Olanzapine Teva?
Because Olanzapine Teva is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicines (i. e. that the medicines produce the same levels of the active substance in the body).
Minħabba li Olanzapine Teva huwa mediċina ġenerika, l- istudji ġew limitati għal testijiet biex jintwera li huwa bijoekwivalenti għall- mediċini ta ’ referenza (jiġiferi li l- mediċini jipproduċu l- istess livelli ta ’ sustanza attiva fil- ġisem).
What are the benefit and risk of Olanzapine Teva?
X’ inhu l- benefiċċju u r- riskju ta ’ Olanzapine Teva?
Because Olanzapine Teva is a generic medicine and is bioequivalent to the reference medicines, its benefit and risk are taken as being the same as those of the reference medicines.
Minħabba li Olanzapine Teva huwa mediċina ġenerika u bijoekwivalenti għall- mediċini ta ’ referenza, il- benefiċċju u r- riskju tagħha huma meqjusa li huma analogi għal dawk tal- mediċini ta ’ referenza.
Why has Olanzapine Teva been approved?
Għaliex ġie approvat Olanzapine Teva?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Olanzapine Teva has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkunsidra li, b’ mod konformi mat- rekwiżiti ta ’ l- UE, intwera li Olanzapine Teva għandu kwalità komparabbli ma ’ u li huwa bijoekwivalenti għal Zyprexa u Zyprexa Velotab.
Therefore, the CHMP’ s view was that, as for Zyprexa and Zyprexa Velotab, the benefit outweighs the identified risk.
Għaldaqstant, il- fehma tas- CHMP kienet li, bħal f’ Zyprexa u Zyprexa Velotab, il- benefiċċju jegħleb r- riskju identifikat.
The Committee recommended that Olanzapine Teva be given marketing authorisation.
Il- Kumitat irrakkomanda li Olanzapine Teva jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Olanzapine Teva:
Tagħrif ieħor dwar Olanzapine Teva:
The European Commission granted a marketing authorisation valid throughout the EU for Olanzapine Teva to Teva Pharma BV on 12 December 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Olanzapine Teva valida fl - Unjoni Ewropea kollha lil Teva Pharma BV fit- 12 ta ’ Diċembru 2007.
The full EPAR for Olanzapine Teva can be found here.
L- EPAR sħiħ għal Olanzapine Teva jista ’ jiġi ikkonsultat hawn.
The full EPARs for the reference medicines can also be found on the EMEA’ s website.
L- EPARs sħaħ għall- mediċini ta ’ referenza jista ’ jiġi ikkonsultat fuq is- sit ta ’ l- internet ta ’ l- EMEA wkoll.
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Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja r (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja r (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al)
1/ 2 EU Number
1/ 2 Numru ta ’ l- EU
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet
Pilloli miksija b’ rita Pilloli miksija b’ rita Pilloli miksija b’ rita Pilloli miksija b’ rita Pilloli miksija b’ rita Pilloli miksija b’ rita Pilloli li jinħallu fil Pilloli li jinħallu fil Pilloli li jinħallu fil Pilloli li jinħallu fil Pilloli miksija b’ rita Pilloli miksija b’ rita Pilloli miksija b’ rita Pilloli miksija b’ rita Pilloli miksija b’ rita Pilloli miksija b’ rita Pilloli li jinħallu fil Pilloli li jinħallu fil Pilloli li jinħallu fil Pilloli li jinħallu fil
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
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Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al) Folja (OPA/ Al/ PVC/ Al)
Olanzapine Teva 2.5 mg film-coated tablets
Olanzapine Teva 2. 5 mg pilloli miksija b’ rita
Each film-coated tablet contains 71.3 mg lactose.
Kull pillola miksija b’ rita fiha 71. 3 mg lactose.
A white, biconvex, round tablet, with the inscription “ OL 2.5 ” on one side.
Pillola bajda tonda u mżaqqa li fuqha hemm miktub “ OL 2. 5 ” fuq naħa waħda.
Risk factors that may predispose this patient population to increased mortality include age > 65 years, dysphagia, sedation, malnutrition and dehydration, pulmonary conditions (e. g., pneumonia, with or without aspiration), or concomitant use of benzodiazepines.
Il- fatturi ta ’ riskju li jistgħu jippredisponu dan il- grupp ta ’ pazjenti għal żieda fil- mortalità jinkludu l- età ta ’ > 65 sena, id- diffikulta biex wieħed jibla ’, is- sedazzjoni, il- malnutriment u d- deidrazzjoni, kundizzjonijiet tal- pulmun (eż pulmonite, bil - jew fl- assenza ta ’ l- aspirazzjoni), jew l- użu konkomittanti ta 'benzodiazepines.
0.4%, respectively).
3 f’ pazjenti ttattati b' olanzapine, meta mqabblin ma ’ pazjenti ttrattati bil- plaċebo (1. 3% kontra 0. 4%, rispettivament).
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
Tibdil fil- livelli tal- lipidi Fi studji kliniċi kkontrollati bi plaċebo, ġie osservat tibdil mhux mixtieq fil- livell tal- lipidi f’ pazjenti kkurati b’ olanzapine (ara sezzjoni 4. 8).
Caution should be exercised in patients with elevated ALT and/ or AST, in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic medicines.
Għandha tittieħed kawtela f' pazjenti b 'ALT u/ jew AST elevati, f' pazjenti b' kundizzjonijiet li kienu hemm qabel, assoċjati b' riżerva funzjonali limitata tal - fwied, u f' pazjenti li qed ikunu trattati b' mediċini li jistu' jkunu tossiċi għall- fwied.
In the event of elevated ALT and/ or AST during treatment, follow- up should be organised and dose reduction should be considered.
Fil- każ ta 'ALT u/ jew AST elevati waqt it- trattament, għandha tiġi organiżżata investigazzjoni oħra u għandha tiġi kkunsidrata tnaqqis fid- doża.
Neutropenia Caution should be exercised in patients with low leukocyte and/ or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/ toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with
Newtropenja
4 myeloproliferative disease.
4 Għandha tittieħed kawtela f' pazjenti b 'numru baxx ta ’ lewkoċiti u/ jew numru baxx taċ- ċelluli newtrofili għal kwalunkwe raġuni, dawk il- pazjenti li qed jieħdu xi mediċini li huma magħrufa li jikkawżaw newtropenja, f' pazjenti b ’ passat ta' tnaqqis fil- funzjoni tal- mudullun jew tossiċità tal - mudullun minħabba t- teħid ta 'xi mediċina, f' pazjenti b' tnaqqis fil- funzjoni tal- mudullun minħabba xi marda konkomitanti, trattament bir- raġġi jew kimoterapija u f' pazjenti b' kundizzjonijiet b' numru għoli taċ- ċelluli eżinofili jew b' xi marda majeloproliferattiva.
QT interval In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
L- Intervall QT Fi studji kliniċi, żidiet fil- QTc li kienu klinikament sinifikanti (korrezzjoni fil- QT skond Fridericia [QTcF] > 500 millisekondi [msek] f’ kwalunkwe ħin wara l- valur bażiku f’ pazjenti b’ valur bażiku ta ’ QTcF < 500 msek) ma kienux komuni (0. 1% sa 1%) f’ pazjenti kkurati b’ olanzapine, b’ ebda differenza sinifikattiva fl- avvenimenti assoċjati kardijaċi meta mqabbla ma ’ plaċebo.
However, as with other antipsychotics, caution should be exercised when olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
Madankollu, bħal b' antipsikotiċi oħra, għandha tittieħed kawtela meta olanzapine jingħata ma 'mediċini oħra li huma magħrufa li jżidu l- intervall QTc, speċjalment fl- anzjani, f' pazjenti b' sindromu konġenitali ta' QT twil, insuffiċjenza tal- qalb konġestiva, ipertrofija tal- qalb, potassju baxx fid- demm jew manjesju baxx fid - demm.
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported..
Tromboemboliżmu B’ mod rari ħafna (< 0. 01%) ġiet irrapportata assoċjazzjoni temporali bejn il- kura b’ olanzapine u t - tromboemboliżmu fil- vini.
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
Studji f' pazjenti bejn it- 13 u s- 17- il sena wrew reazzjonijiet avversi varji, fosthom żieda fil- piż, tibdil fil- parametri metaboliċi u żieda fil -
Lactose Olanzapine Teva film-coated tablets contain lactose.
Lactose Il- pilloli miksija b’ rita ta ’ Olanzapine Teva fihom il- lattożju.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal gallattożju, b’ nuqqas tal- Lapp lactase jew b’ nuqqas ta ’ asssorbiment ta ’ glukożju - gallatożju m’ għandhomx jieħdu din il- mediċina.
The concomitant use of olanzapine with anti-Parkinsonian medicinal products in patients with Parkinson's disease and dementia is not recommended (see section 4.4).
6 Mhux rakkomandat l- użu konkomitanti ta 'olanzapine ma' prodotti mediċinali kontra l- Parkinson f' pazjenti bil- marda ta 'Parkinson u d- demenzja (ara sezzjoni 4. 4).
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
L- Intervall QTc Għandha tintuża l- kawtela jekk olanzapine qiegħed jingħata flimkien ma 'prodotti mediċinali magħrufa li jtawwlu l- intervall QTc (ara sezzjoni 4. 4).
6 olanzapine.
4. 6 Tqala u Treddigħ
Elevated cholesterol levels2,3 Elevated glucose levels4 Elevated triglyceride levels2,5 Glucosuria Increased appetite
Livelli għolja ta 'kolesterol2, 3 Livelli għolja ta' glucose4 Livelli għolja ta '
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
Żvilupp jew iggravar tad- dijabete, xi kultant assoċjata ma ’ ketoaċidożi jew koma inklużi xi każijiet fatali
Nervous system disorders Somnolence Cardiac disorders
trigliċeridi2, 5 Glikosurja Żieda fl- aptit
Dizziness Akathisia6 Parkinsonism6 Dyskinesia6
(ara sezzjoni 4. 4) Ipotermija
Vascular disorders
Disturbi fis- sistema nervuża Sonnolenza Disturbi fil- qalb
Bradycardia QTc prolongation (see section 4.4)
Sturdament Akatizja6 Parkinsoniżmu6 Diskineżja6
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
Aċċessjonijiet li fil - maġġoranza tagħhom kien rrappurtat passat mediku ta 'aċċessjonijiet jew fatturi tar- riskju għall - aċċessjonijiet Sindromu Newrolettiku Malinn (ara sezzjoni 4. 4) Distonja (tinkludi okuloġirazzjoni) Diskineżja tardiva Sintomi ta' twaqqif tal - kura7
Orthostatic hypotension
Disturbi vaskulari
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
Bradikardija QTc imtawwal (ara sezzjoni 4. 4)
Mild, transient anticholinergic effects including constipation and dry mouth
Takikardija / fibrillazzjoni ventrikulari, mewt għall - għarrieda (ara sezzjoni 4. 4)
Pancreatitis
Pressjoni baxxa mal - waqfien
Hepato-biliary disorders
Tromboemboliżmu (inkluż l- emboliżmu pulmonari u t- trombożi tal- vini fil- fond)
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
Disturbi gastro- intestinali Pankreatite Effetti antikolinerġiċi ħfief u li jgħaddu malajr inklużi stitikezza u ħalq xott Disturbi fil- fwied u fil- marrara Epatite inkluż mard Żieda ta 'transaminases tal- fwied tat- tip tal- fwied (ALT, AST) epatoċellulari, bla sintomi u li tgħaddi kolestatiku jew tat - malajr, speċjalmet fil - tnejn flimkien) bidu tal- kura (ara sezzjoni 4. 4)
8
8 Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda
Alopecia
Raxx
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels8 1
Disturbi muskolu- skeltrali u tal- connective tissue Rabdomijoliżi Disturbi fil- kliewi u fis- sistema urinarja Eżitazzjoni urinarja Disturbi fis- sistema riproduttiva u fis- sider Prijapiżmu Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Astenja Għeja Edima Investigazzjonijiet Żieda f' alkaline Livelli elevati ta' prolactin fil- plażma 8 1
2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
2 Iż- żidiet medji fil- livelli tal- lipidi waqt is- sawm (kolesterol totali, LDL kolesterol, u trigliċeridi) kienu ogħla f’ pazjent li fil- linja bażi ma wrewx evidenza ta ’ problemi fil- kontroll tal- lipidi.
Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
9 Espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 48 ġimgħa) Il- proporzjon ta ’ pazjenti li kellhom tibdil avvers, klinikament sinifikanti fiż- żieda fil- piż, fil- glucose, fil- kolesterol totali/ LDL/ HDL jew trigliċeridi żdied maż- żmien.
9 Additional information on special populations In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see also section 4.4).
Tagħrif addizzjonali dwar popolazzjonijiet speċjali Fi studji kliniċi f’ pazjenti anzjani bid- demenzja, trattament b' olanzapine kien assoċjat ma ’ inċidenza ogħla ta ’ mwiet u reazzjonijiet avversi ċerebro- vaskulari meta mqabbla mal- plaċebo (ara wkoll sezzjoni 4. 4).
Although no clinical studies designed to compare adolescents to adults have been conducted, data from the adolescent trials were compared to those of the adult trials.
Għalkemm ma ġewx imwettqa studji kliniċi magħmulin biex iqabblu l- adolexxenti ma 'l- adulti, informazzjoni mill - istudji ta' l- adolexxenti ġiet imqabbla ma 'dik ta' ’ l- istudji ta 'l- adulti.
The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
L- ammont ta ’ żieda fil- piż u l - proporzjon ta ’ pazjenti adolexxenti li kellhom żieda fil- piż klinikament sinifikanti kienu akbar b’ espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 24 ġimgħa) milli b’ espożizzjoni għal perijodu qasir ta’ żmien.
9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
10 9 Żieda fil- piż ta '≥ 7% mil- linja bażi tal- piż tal- ġisem (kg) kienet komuni ħafna u ta' ≥ 15% mil- linja bażi tal- piż tal- ġisem kienet komuni.
10 Observed for fasting normal levels at baseline (< 1.016 mmol/ l) which increased to high (≥ 1.467 mmol/ l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/ l - 10 < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
10 Innotat għal livelli normali waqt is- sawm fil- linja bażi (< 1. 016 mmol/ l) li żdiedu għal għoljin (≥ 1. 467 mmol/ l) u tibdil fit- trigliċeridi waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 1. 016 mmol/ l - < 1. 467 mmol/ l) għal għoljin (≥ 1. 467 mmol/ l).
Do not use epinephrine, dopamine, or other sympathomimetic agents with beta- agonist activity since beta stimulation may worsen hypotension.
Tużax epinephrine, dopamine, jew sustanzi oħra simpatomimatiċi b 'attività beta- agonista għax l - istimulazzjoni beta tista' taggrava l- pressjoni baxxa.
N05A H03.
Grupp farmako terapewtika: antipsikotiċi: diazepines, oxazepines u thiazepines, kodiċi ATC N05A H03.
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5 HT2A/ 2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors m1-m5; α 1 adrenergic; and histamine H1 receptors.
Studji fuq l- imġieba ta 'l- annimali li ingħataw
Animal behavioral studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
11 olanzapine indikaw antagoniżmu għal 5HT, għal dopamine, u għal dak kolinerġiku, konsistenti mal - profil tar- riċettur li jorbot.
11 In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5 HT2A than dopamine D2 receptor occupancy.
Fi studju b' doża waħda orali (10 mg) fejn intużat it- tomografija bl- Emissjoni tal- Pozitroni (PET) f' voluntiera b' saħħithom, olanzapine ipproduċa okkupanza ta '5HT2A ogħla mir- riċettur ta ’ dopamine D2.
In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p= 0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
F’ studju komparattiv, double- blind u multinazzjonali ta ’ skiżofrenija, ta ’ manifestazzjonijiet skiżoaffettivi u disturbi relatati oħra li kien jinkludi 1, 481 pazjent li kellhom gravità differenti ta ’ l - assoċjati sintomi dipressivi (medja ta ’ punteġg ta ’ 16. 6 meħud fil- bidu tal- kura skond l- iskala li tivvaluta d- dipressjoni ta ’ Montgomery- Asberg), analiżi prospettiva sekondarja tat- tibdil fil- punteġġ ta ’ l- atteġġament bejn il- bidu u fl- aħħar tal- kura wriet titjib statistikament sinifikanti (p= 0. 001) favur olanzapine (- 6. 0) kontra haloperidol (- 3. 1).
In a 12-month recurrence prevention study in manic episode patients who achieved remission on olanzapine and were then randomised to olanzapine or placebo, olanzapine demonstrated statistically significant superiority over placebo on the primary endpoint of bipolar recurrence.
Fi studju ta '12- il xahar ta' prevenzjoni ta 'rikorrenza f' pazjenti b' episodju ta' manija, li kienu diġà ikkontrollati b’ olanzapine, imbagħd kienu mogħtija mingħajr għażla olanzapine jew il- plaċebo, olanzapine wera superjorita sinifikanti u statistikament superjuri fuq il- plaċebo fuq l- għan ewlieni tar - rikorrenza bipolari.
In a second 12-month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence (olanzapine 30.0%, lithium 38.3%; p = 0.055).
Fit- tieni studju ta '12- il xhar dwar ir- rikorrenza preventiva f' pazjenti b' episodju ta' manija li kienu ikkontrollati b’ olanzapine u l- lithium flimkien, kienu mbgħad mqassmin mingħajr għażla u mogħtija olanzapine jew il- lithium waħdu. Olanzapine kien statistikament mhux inferjuri għall- lithium fuq l - għan ewlieni ta 'rikorrenza bipolari (olanzapine 30. 0%, lithium 38. 3%; p = 0. 055).
The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
M' hemmx
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
12 tagħrif dwar il- manteniment ta 'l- effett u hemm tagħrif limitat dwar is- sigurtà fit- tul (ara sezzjonijiet 4. 4 u 4. 8).
Cytochromes P450-
L - enżimi ċitokromju P450- CYP1A2 u P450- CYP2D6 jikkontrbwixxu għall- formazzjoni ta 'prodotti metaboliċi tat- tip N- desmethyl u 2- hydroxymethyl.
12 CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites, both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
It- tnejn dehru sinifikatament anqas f' attività farmakoloġika in vivo milli olanzapine fi studji fuq l- annimali.
Olanzapine is bound predominantly to albumin and α 1-acid-glycoprotein.
Olanzapine hija fil- biċċa ’ l kbira marbuta ma 'l- albumina u ∝1- aċid - glycoprotein.
13 Repeated-dose toxicity In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Tossiċità ta 'dożi repetuti Fi studji sa 3 xhur fil- ġrieden u sa sena fil- firien u fil- klieb, l- effetti li ippredominaw kienu d - depressjoni CNS, effetti antikolinerġiċi, u diżordnijiet periferali ematoloġiċi.
Lactose monohydrate Hydroxypropylcellulose Crospovidone type A Silica colloidal anhydrous Microcrystalline cellulose Magnesium stearate
Lactose monohydrate Hydroxypropylcellulose Crospovidone type A Silica, colloidal anhydrous Microcrystalline cellulose Magnesium stearate
Tablet coating:
14 Il- kisja tal- pillola:
Hypromellose Colour mixture white (polydextrose, hypromellose, glycerol diacetate, macrogol 8000, titanium dioxide E171)
Hypromellose Kulur ta ’ taħlita bajda (polydextrose, hypromellose, glycerol diacetate, macrogol 8000, titanium dioxide E171)
14 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Store in the original package in order to protect from light.
Aħżen fil- pakkett oriġinali biex tilqa ’ mid- dawl.
OPA/ Aluminium/ PVC-Aluminium blisters in cartons of 28, 30, 35, 56 and 70 film-coated tablets per carton.
Folji ta ’ OPA/ Aluminium/ PVC- Aluminium f’ kartun ta ’ 28, 30, 35, 56 jew 70 pillola miksija b’ rita f’ kull kartuna.
Teva Pharma BV, Computerweg 10, 3542 DR Utrecht, The Netherlands
Teva Pharma BV, Computerweg 10, 3542 DR Utrecht, L- Olanda
EU/ 1/ 07/ 427/ 001 – Olanzapine Teva – 2.5 mg – film-coated tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 002 – Olanzapine Teva – 2.5 mg – film-coated tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 038 – Olanzapine Teva – 2.5 mg – film-coated tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 003 – Olanzapine Teva – 2.5 mg – film-coated tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 048 – Olanzapine Teva – 2.5 mg – film-coated tablets – 70 tablets, per box
EU/ 1/ 07/ 427/ 048 – Olanzapine Teva – 2. 5 mg – pilloli miksija b’ rita – 70 pillola, kull kaxxa.
Olanzapine Teva 5 mg film-coated tablets
Olanzapine Teva 5 mg pilloli miksija b’ rita
Each film-coated tablet contains 68.9 mg lactose.
Kull pillola miksija b’ rita fiha 68. 9 mg lactose.
A white, biconvex, round tablet, with the inscription “ OL 5 ” on one side.
Pillola bajda tonda u mżaqqa li fuqha hemm miktub “ OL 5. 0 ” fuq naħa waħda
During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5- 20 mg/ day.
Waqt it- trattament għas- skiżofrenja, għal episodju ta 'manija u għall- prevenzjoni tar- rikorrenza fid - diżordni bipolari, d- dożaġġ ta' kuljum jista 'sussegwentement jiġi aġġustat fuq il- bażi ta' l- istat kliniku individwali minn 5 mg sa 20 mg/ ġurnata.
Gradual
Olanzapine tista 'tingħata fuq l- ikel jew fuq stonku vojt għax l -
16 tapering of the dose should be considered when discontinuing olanzapine.
It- tnaqqis gradwali tad- doża għandu jiġi kkunsidrat meta titwaqqaf olanzapine.
A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short term studies of adolescent patients than in studies of adult patients (see sections 4.4, 4.8, 5.1 and 5.2).
Fl- istudji ta ’ terminu qasir, ġie rrapportat ammont akbar ta ’ żieda fil- piż u tibdil fil- lipidi u prolactin f’ pazjenti adolexxenti milli fl- istudji ta ’ pazjenti adulti (ara sezzjonijiet 4. 4, 4. 8, 5. 1 u 5. 2).
Renal and/ or hepatic impairment A lower starting dose (5 mg) should be considered for such patients.
Indeboliment renali u/ jew epatiku Doża anqas tal- bidu (5 mg/ ġurnata) għandha tiġi kkunsidrata għal dawn il- pazjenti.
(See sections 4.5 and 5.2)
(Ara sezzjonijiet 4. 5 u 5. 2).
Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
Olanzapine mhux approvat għat- trattament tal- psikożi relatata mad- demenzja u/ jew disturbi fil - komportament, u mhux irrakkomandat għall- użu f’ dan il- grupp partikolari ta ’ pazjenti, dovut għal żieda fil- mortalità u r- riskju ta ’ inċident ċerebro- vaskulari.
In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5% vs.
Fi studji kliniċi kkontrollati bil- plaċebo (li damu minn 6 sa 12- il ġimgħa), fuq pazjenti anzjani (età medja 78 sena) li kelhom psikożi relatata mad- demenzja u/ jew disturbi fil- komportament, kien hemm żieda ta ’ darbtejn akbar fl- inċidenza ta ’ mwiet fil- pazjenti ttrattati b' olanzapine, mqabbla ma ’ pazjenti ttrattati bil- plaċebo (3. 5% kontra 1. 5%, rispettivament).
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
Madankollu, l - inċidenza ta ’ l- imwiet kienet ogħla f’ dawk ittrattati b' olanzapine minn dawk il- pazjenti ttrattati bil - plaċebo, indipendentement minn dawn il- fatturi ta ’ riskju.
0.4%, respectively).
Kien hemm żieda ta ’ 3 darbiet akbar ta ’ CVAE f’ pazjenti ttattati b' olanzapine, meta mqabblin ma ’ pazjenti ttrattati bil- plaċebo (1. 3% kontra 0. 4%, rispettivament).
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing
Il- pazjenti kollha ttrattati b' olanzapine jew bi plaċebo u li kellhom avveniment
17 risk factors.
17 ċerebro- vaskulari, kellhom fatturi ta ’ riskju li kienu jeżistu minn qabel.
In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
Fi studji kliniċi, id- deterjorament fis- sintomi tal- marda ta’ Parkinson u l- alluċinazzjonijiet kienu rrappurtati b’ mod komuni ħafna u aktar ta 'spiss milli bil - plaċebo (ara sezzjoni 4. 8), u olanzapine ma kienx aktar effettiv mill- plaċebo fit- trattament tas- sintomi psikotiċi.
In these trials, patients were initially required to be stable on the lowest effective dose of anti- Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.
F' dawn l- istudji, il- pazjenti inizjalment kellhom ikunu stabblizzati fuq id- doża l- aktar baxxa u effettiva tal- mediċini kontra l- marda ta ’ Parkinson (agonist ta ’ dopamine) u biex jibqgħu fuq l- istess dożi u mediċini kontra l- marda ta ’ Parkinson matul l- istudju.
Olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgement.
Olanzapine nbeda b '2. 5 mg/ ġurnata u żdied bil- mod għall- massimu ta' 15 mg/ ġurnata ibbażat fuq il- ġudizzju tar- riċerkatur.