qanastek/EMEA-V3 huggingface dataset:
If you are allergic to peanut or soya do not take these tablets.
Jekk għandek allerġija għall- karawett jew għas- soja tieħux dawn il- pilloli.
HOW TO TAKE OLANZAPINE MYLAN
KIF GĦANDEK TIEĦU OLANZAPINE MYLAN
Always take Olanzapine Mylan exactly as your doctor has told you.
Dejjem għandek tieħu OLANZAPINE MYLAN skond il- parir tat- tabib.
Your doctor will tell you how many Olanzapine Mylan tablets to take and how long you should continue to take them.
It- tabib tiegħek għandu jgħidlek kemm tieħu pilloli ta ’ OLANZAPINE MYLAN u kemm għandek iddum tieħodhom.
The daily dose of olanzapine is between 5 and 20 mg.
Id- doża ta 'kuljum ta ’ OLANZAPINE MYLAN hija bejn 5 u 20 mg.
Consult your doctor if your symptoms return but do not stop taking Olanzapine Mylan unless your doctor tells you to.
Ikkonsulta mat- tabib tiegħek jekk jerġgħu jiġuk is- sintomi imma tieqafx tieħu OLANZAPINE MYLAN sakemm ma jgħidlekx it- tabib tiegħek.
You should take your Olanzapine Mylan tablets once a day following the advice of your doctor.
Għandek tieħu l- pilloli OLANZAPINE MYLAN darba kuljum wara li tingħata parir mit- tabib tiegħek.
Try to take your tablets at the same time each day.
Ipprova ħu l- pilloli tiegħek kuljum fl- istess ħin.
It does not matter whether you take them with or without food.
Ma jimpurtax jekk teħodhom ma 'l- ikel jew fuq stonku vojt.
Olanzapine Mylan tablets are for oral use.
Il- pilloli miksija ta ’ OLANZAPINE MYLAN huma għall- użu orali.
You should swallow the Olanzapine Mylan tablets whole with water.
Għandek tibla 'l- pilloli OLANZAPINE MYLAN sħaħ bl- ilma.
Patients who have taken more olanzapine than they should have experienced the following symptoms: rapid beating of the heart, agitation/ aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Jekk tieħu OLANZAPINE MYLAN aktar milli suppost Pazjenti li ħadu iżjed OLANZAPINE MYLAN milli suppost kellhom dawn is- sintomi li ġejjin: tħabbit mgħaġġel tal- qalb, aġitazzjoni/ aggressività, problemi biex jitkellmu, movimenti mhux tas- soltu (speċjalment tal- ħalq u ta ’ l- ilsien) u tnaqqis fil- livell ta ’ koxjenza.
Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart.
Sintomi oħra jistgħu jkunu: konfużjoni akuta, aċċessjonijiet (epilessija), koma, taħlita ta ’ dawn is- sintomi, deni, nifs aktar mgħaġġel, għaraq, ebusija tal- muskoli u ħedla jew ngħas, tnaqqis fil- frekwenza ta ’ nifsijiet, aspirazzjoni, pressjoni tad- demm għolja jew baxxa, ritmi mhux normali tal- qalb.
Contact your doctor or hospital straight away.
Ikkuntatja lit- tabib tiegħek jew l- isptar mill- ewwel.
Show the doctor your pack of tablets.
Uri l- pakkett tal- pilloli tiegħek lit- tabib.
If you forget to take Olanzapine Mylan
Jekk tinsa tieħu OLANZAPINE MYLAN:
Take your tablets as soon as you remember.
Ħu l- pilloli tiegħek eżatt kif tiftakar.
Do not take two doses in one day.
Tieħux żewġ dożi f' ġurnata waħda.
If you stop taking Olanzapine Mylan Do not stop taking your tablets just because you feel better.
Jekk tieqaf tieħu ZYPREX Tieqafx tieħu l- pilloli tiegħek sempliċement għaliex tħossok aħjar.
It is important that you carry on taking Olanzapine Mylan for as long as your doctor tells you.
Huwa importanti li tibqa 'tieħu OLANZAPINE MYLAN sakemm jgħidlek it- tabib tiegħek.
If you suddenly stop taking Olanzapine Mylan, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Jekk tieqaf tieħu OLANZAPINE MYLAN f' daqqa, jista 'jkollok sintomi bħal għaraq, ma tkunx tista' torqod, rogħda, ansjetà jew tqalligħ u rimettar.
Your doctor may suggest you to reduce the dose gradually before stopping treatment.
It- tabib tiegħek jista 'jissuġġerilek li tnaqqas id- doża bil- mod qabel ma twaqqaf il- kura.
Like all medicines, Olanzapine Mylan can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, OLANZAPINE MYLAN jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side effects: affect 1 user in 10 • Weight gain. • Sleepiness. • Increases in the levels of prolactin in the blood.
Effetti sekondarji komuni ħafna: jaffettwaw 1 minn kull 10 pazjenti • Żieda fil- piż. • Ngħas. • Żidiet fil- livelli ta 'prolactin fid- demm.
Common side effects: affect 1 to 10 users in 100 123 • Changes in the levels of some blood cells and circulating fats. • Increases in the level of sugars in the blood and urine. • Feeling more hungry. • Dizziness. • Restlessness. • 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.
123 • Ebusija tal- muskoli jew spażmi (inklużi movimenti fl- għajnejn). • Problemi fil- mod kif titkellem. • Moviment mhux tas- soltu (speċjalment tal- wiċċ jew ta ’ l- ilsien). • Stitikezza. • 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.
This will usually pass on its own but if it does not, tell your doctor.
Dan normalment jgħaddi waħdu iżda jekk le għid lit- tabib tiegħek.
Uncommon side effects: affect 1 to 10 users in 1,000 • Slow heart rate. • Make you sensitive to sunlight. • Hair loss.
Effetti sekondarji mhux komuni: jaffettwaw 1 sa 10 minn kull 1, 000 pazjent • Il- qalb tħabbat bil- mod. • Issir sensittiv għad- dawl tax- xemx. • Jaqa 'x- xagħar.
Rare side effects: affect 1 to 10 users in 10,000 • Male or female breast enlargement.
Effetti sekondarji rari: jaffettwaw 1 sa 10 minn kull 10, 000 pazjent • Jikber is- sider fl- irġiel jew fin- nisa.
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, tegħreq, 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 mtawla 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.
Some fatal cases have been reported in this particular group of patients.
Xi każijiet fatali kienu rapportati f’ dan il- grupp partikolari ta ’ pazjenti.
In patients with Parkinson's disease Olanzapine Mylan may worsen the symptoms.
F' pazjenti li għandhom il- marda ta 'Parkinson, OLANZAPINE MYLAN tista' tagħmel is- sintomi agħar.
Rarely women taking medicines of this type for a long time have started to secrete milk and have missed periods or had irregular periods.
Rari nisa li kienu qed jieħdu mediċini ta 'dawn it- tip għal żmien twil bdew inixxu l- ħalib u tilfu xi pirjid jew kellhom pirjid rregolari.
If this persists tell your doctor.
Jekk dawn jippersistu għid lit- tabib tiegħek.
Very rarely babies born to mothers who have taken olanzapine 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 MYLAN fl- aħħar stadju tat- tqala (fl- aħħar tlett xhur) jista 'jkollhom rogħda, ngħas u ħedla.
124 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
HOW TO STORE OLANZAPINE MYLAN
KIF TAĦŻEN OLANZAPINE MYLAN
Keep out of the reach and sight of children.
Żomm fejn ma tintlaħaqx u ma tidhirx mit- tfal.
Do not use Olanzapine Mylan after the expiry date, which is stated on the carton.
Tużax OLANZAPINE MYLAN wara d- data ta ’ skadenza li tidher fuq il- kartuna
Do not store above 25 °C.
Taħżnux f’ temperatura ta ’ ‘ l fuq minn 25 °C.
Please return left over medicine to your pharmacist.
Jekk jogħġbok agħti lura l- mediċina li tibqalek lill- ispiżjar tiegħek.
What Olanzapine Mylan contains
X’ fiha OLANZAPINE MYLAN:
- The active substance is olanzapine.
Is- sustanza attiva hi l- olanżapin.
Each Olanzapine Mylan tablet contains either 2.5 mg, 5 mg,
Kull pillola ta ’ l- Olanzapine Mylan fiha jew 2. 5 mg, 5 mg, 7. 5 mg, 10 mg, 15 mg jew 20 mg tas- sustanza attiva.
The exact amount is shown on your Olanzapine Mylan tablet pack.
L- ammont preċiż hu mniżżel fuq il- pakkett ta ’ pilloli ta ’ l- Olanzapine Mylan.
- The other ingredients are
L- ingredjenti l- oħra huma (qalba tal- pillola) monoidrat tal- lattożju.
(tablet core) lactose monohydrate, maize starch, pregelatinised maize starch, crospovidone type A, magnesium stearate and (tablet coating) polyvinyl alcohol, titanium dioxide (E171), talc (E553b), lecithin (soya) (E322), xanthan gum (E415).
Lamtu tal- qamħirrum, lamtu tal- qamħirrum preġelatinizzat, crospovidone tip A, stjerejt tal- manjeżju u (qoxra tal- pillola) alkol polivinil, diossidu tat- titanju (E171), terra (E553b), leċitin (soja) (E322), gomma xantan (E415).
What Olanzapine Mylan looks like and contents of the pack
Id- Dehra ta ’ OLANZAPINE MYLAN u l- kontenuti tal- pakkett:
Olanzapine Mylan 2.5 mg, 5 mg, 7.5 mg and 10 mg are round, white, film-coated tablets.
L- Olanzapine Mylan 2. 5 mg, 5 mg, 7. 5 mg u 10 mg huma pilloli tondi, bojod, b’ kisja b’ rita.
Olanzapine Mylan 15 mg and 20 mg are elliptical, white, film-coated tablets.
L- Olanzapine Mylan 15 mg u 20 mg huma pilloli ellittiċi, bojod b’ kisja b- rita.
Olanzapine Mylan 2.5 mg, 5 mg, 7.5 mg, 15 mg and 20 mg are available in packs of 28, 35, 56 and 70 film-coated tablets.
L- Olanzapine Mylan tal- 2. 5 mg, 5 mg, 7. 5 mg, 15 mg u 20 mg jinbiegħu f’ pakketti ta ’ 28, 35, 56 u 70 pillola miksija b’ rita.
Olanzapine Mylan 10 mg are available in packs of 7, 28, 35, 56 and 70 film-coated tablets.
L- Olanzapine Mylan ta ’ l- 10 mg jinbieghu f’ pakketti ta ’ 7, 28, 35, 56 u 70 pillola miksija b’ rita.
Tablet containers:
Kontenituri tal- pilloli:
Olanzapine Mylan 2.5 mg and 5.0 mg are available in packs of 250 and 500 film-coated tablets.
L- Olanzapine Mylan tal- 2. 5 mg u tal- 5. 0 mg jinbiegħu f’ pakketti ta ’ 250 u 500 pillola miksija b’ rita.
OlanzapineMylan 7.5 mg, 15 mg and 20 mg are available in packs of 100 film-coated tablets.
L- OlanzapineMylan tal- 7. 5 mg, tal- 15 mg u tal- 20 mg jinbiegħu f’ pakketti ta ’ 100 pilloa miksija b’ rita.
Olanzapine Mylan 10 mg are available in packs of 100 and 500 film-coated tablets.
L- Olanzapine Mylan ta ’ l- 10 mg jinbiegħu f’ pakketti ta ’ 100 u ta ’ 500 pillola miksija b’ rita.
125 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
België/ Belgique/ Belgien Mylan bvba/ sprl Tél/ Tel: + 0032 02 686 07 11
125 België/ Belgique/ Belgien Mylan bvba/ sprl Tél/ Tel: + 0032 02 686 07 11
This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l' aħħar f '
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu.
Informazzjoni dettaljata fuq dan il- prodotti tinsab fuq is- sit eletroniku ta l- Agenzija Ewropeja tal - Medicine (EMEA) http: // www. emea. europa. eu.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tirid aktar informazzjoni abbażi tar- rakkomandazzjonijiet tas- CHMP, aqra d - Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Olanzapine Neopharma?
X’ inhu Olanzapine Neopharma?
Olanzapine Neopharma is a medicine containing the active substance olanzapine.
Olanzapine Neopharma huwa mediċina li fiha s- sustanza attiva olanzapine.
15 mg).
Huwa disponibbli bħala pilloli (bojod u tondi 2. 5, 5, 7. 5 u 10 mg; blu u ovali 15 mg).
Olanzapine Neopharma is a ‘ generic medicine’.
Olanzapine Neopharma huwa ‘ mediċina ġenerika ’.
This means that Olanzapine Neopharma is similar to a ‘ reference medicine’ already authorised in the European Union (EU) called Zyprexa.
Dan ifisser li Olanzapine Neopharma huwa simili għall - ‘ mediċina ta ’ referenza ’ diġa awtorizzata fl- Unjoni Ewropea (UE) li jisimha Zyprexa.
For more information on generic medicines, see the question-and-answer document here.
Għal aktar informazzjoni dwar mediċina ġenerika, ara d- dokument mistoqsija u tweġiba hawn.
What is Olanzapine Neopharma used for?
Għalxiex jintuża Olanzapine Neopharma?
Olanzapine Neopharma is used to treat adults with schizophrenia.
Olanzipine Neopharma jintuża fit- trattament ta ’ adulti bl- 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).
L- iskizofrenija hija marda mentali, li għandha numru ta ’ sintomi, inkluż disturbi fil- ħsieb u fid- diskors, alluċinazzjonijiet (il - pazjent jisma ’ jew jara affarijiet li ma jeżistux), suspetti u delirji (ħsibijiet żbaljati).
Olanzapine Neopharma is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Olanzine Neopharma huwa effikaċi wkoll biex iżomm it- titjib li jkun sar f’ pazjenti li jkunu rrispondew għal kors inizjali ta ’ trattament.
Olanzapine Neopharma is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Olanzine Neopharma jintuża wkoll fit- trattament ta ’ każijiet moderati jew severi tal- manija (burdata tajba b’ mod estrem) fl- adulti.
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 l- feġġa mill- ġdid (meta jerġgħu jibdew jitfaċċaw is- sintomi) ta ’ dawn l- episodji f’ adulti b’ disturbi bipolari (marda mentali b’ perjodi jalternaw bejn burdata tajba ħafna u depressjoni) u li jkunu rrispondew għal kors inizjali ta ’ trattament.
How is Olanzapine Neopharma used?
Kif jintuża Olanzapine Neopharma?
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.
Id- doża inizjali rrakomandata ta ’ Olanzapine Neopharma tiddependi mill- marda li tkun qed tiġi ttrattata: doża ta ’ 10 mg kuljum tintuża għall- iskizofrenija u fil- prevenzjoni ta ’ episodji manijaċi, u 15 - il 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 aġġustata skond kemm il- pazjent jirrispondi tajjeb għat- trattament u jkun jittolerah.
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.
Pazjenti li jkollhom iktar minn 65 sena u pazjenti li jkollhom problemi fil- fwied jew fil- kliewi tagħhom jista ’ jkollhom bżonn ta ’ doża iktar baxxa fil- bidu ta ’ 5 mg kuljum.
How does Olanzapine Neopharma work?
Kif jaħdem Olanzapine Neopharma?
The active substance in Olanzapine Neopharma, olanzapine, is an antipsychotic medicine.
Is- sustanza attiva f’ Olanzapine Neopharma, 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- snin ħamsin.
Reproduction is authorised provided the source is acknowledged. receptors on the surface of nerve cells in the brain.
Reproduction is authorised provided the source is acknowledged diversi riċetturi differenti fuq is- superfiċje taċ- ċelloli tan- nervituri tal- moħħ.
This disrupts signals transmitted between brain cells by ‘ neurotransmitters’, chemicals that allow nerve cells to communicate with each other.
Dan ifixkel is- sinjali trażmessi bejn iċ- ċelloli tal- moħħ permezz ta ’ ‘ newrotrażmettituri ’, sustanzi kimiċi li jippermettu liċ - ċelloli tal- moħħ jikkomunikaw ma ’ xulxin.
It is thought that olanzapine’ s beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine.
Hu maħsub li l- effett benefiku ta ’ olanzapine huwa dovut għall- imblokkar tar- riċetturi għan- newrotrażmettituri 5- idrossitripamina (5- hydroxytrypamine) (imsejħa wkoll serotonina) u dopamina.
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 jgħin fin- normalizzazzjoni ta ’ l- attività tal- moħħ, u b’ hekk inaqqas is- sintomi ta ’ dawn il- mardiet.
How has Olanzapine Neopharma been studied?
Kif ġie studjat Olanzapine Neopharma?
Because Olanzapine Neopharma is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine (i. e. that the two medicines produce the same levels of the active substance in the body).
Minħabba li Olanzapine Neopharma huwa mediċina ġenerika, l- istudji ġew limitati għal testijiet biex jintwera li hija bioekwivalenti għall- mediċina ta ’ referenza (jiġifieri li ż- żewġ mediċini jipproduċu l - istess livelli ta ’ sustanza attiva fil- ġisem).
What are the benefit and risk of Olanzapine Neopharma?
X’ inhu il- benefiċċju u r- riskju ta ’ Olanzapine Neopharma?
Because Olanzapine Neopharma is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Minħabba li Olanzapine Neopharma huwa mediċina ġenerika u huwa bijoekwivalenti għall- mediċina ta ’ referenza, il- benefiċċju u r- riskju tiegħu huma meqjusa li huma l- istess bħal dawk tal- mediċina ta ’ referenza.
Why has Olanzapine Neopharma been approved?
Għaliex ġie approvat Olanzapine Neopharma?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Olanzapine Neopharma has been shown to have comparable quality and to be bioequivalent to Zyprexa.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li, b’ mod konformi mal- ħtiġijiet ta ’ l- UE, ġie muri li Olanzine Neopharma għandu kwalità komparabbli ma ’ u li huwa bijoekwivlenti għall- Zyprexa.
The Committee recommended that Olanzapine Neopharma be given marketing authorisation.
Il- Kumitat irrakkomanda li Olanzapine Neopharma jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Olanzapine Neopharma:
Tagħrif ieħor dwar Olanzapine Neopharma:
The European Commission granted a marketing authorisation valid throughout the EU for Olanzapine Neopharma to Neopharma Limited on 14 November 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Olanzapine Neopharma valida fl- Unjoni Ewropea kollha lil Novartis Europharm Limited fl- 14 ta ’ Novembru 2007.
The full EPAR for Olanzapine Neopharma can be found here.
L- EPAR sħiħ għal Olanzapine Neopharma jista ’ jiġi ikkonsultat hawn.
The full EPAR for the reference medicine can also be found on the EMEA’ s website.
L- EPARs sħaħ għall- mediċina ta ’ referenza jista ’ jiġi ikkonsultat fuq il- websajt ta ’ l- EMEA wkoll.
2.5 mg 2.5 mg 5 mg 5 mg 7.5 mg 7.5 mg 10 mg 10 mg 10 mg 15 mg 15 mg
2. 5 mg 2. 5 mg 5 mg 5 mg 7. 5 mg 7. 5 mg 10 mg 10 mg 10 mg 15mg 15mg
Coated Tablet Coated Tablet Coated Tablet Coated Tablet Coated Tablet Coated Tablet Coated Tablet Coated Tablet Coated Tablet Coated Tablet Coated Tablet
Pillola miksija Pillola miksija Pillola miksija Pillola miksija Pillola miksija Pillola miksija Pillola miksija Pillola miksija Pillola miksija Pillola miksija Pillola miksija
Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alualu) Blister (alu)/ alu Blister (alualu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu)
Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alualu) Folja (alu) / alu Folja (alualu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu)
Olanzapine Neopharma 2.5 mg coated tablets
Olanzapine Neopharma 2. 5 mg pilloli miksija
Each coated tablet contains 80.7 mg lactose monohydrate
Kull pillola miksija fiha 2. 5 mg ta ’ olanzapine.
For a full list of excipients, see section 6.1.
Kull pillola miksija fiha 80. 7 mg lactose monohydrate Għal- lista kompleta ta ’ sustanzi mhux attivi, ara Sezzjoni 6. 1.
Coated tablet
Pillola miksija
White, round, biconvex, coated tablets with ‘ 2.5’ debossing on one side and ‘ OLZ’ on the other.
Pilloli bojod, tondi, bikonvessi, miksija b ’ ’ 2. 5 ’ imnaqqxa fuq naħa waħda u ‘ OLZ ’ fuq in- naħa l- oħra.
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 ndividwali minn 5 mg sa 20 mg/ ġurnata.
2 Children and adolescents 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.
2 Tfal u adolexxenti Olanzapine mhux irrakkomandat għall- użu fit- tfal u fl- adolexxenti ta ’ taħt it- 18- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
Elderly A lower starting dose (5 mg/ day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
Anzjani Doża anqas tal- bidu (5 mg/ ġurnata) mhux indikata normalment imma għandha tiġi kkunsidrata għal dawk li għandhom 65 jew fuqhom meta fatturi kliniċi jindikaw hekk (ara sezzjoni 4. 4).
Renal and/ or hepatic impairment A lower starting dose (5 mg) should be considered for such patients.
Indeboliment renali u/ jew epatiku Għandu jiġi kkunsidrat tnaqqis fid- doża inizjali (5 mg/ ġurnata) għal dawn il- pazjenti.
Gender The starting dose and dose range need not be routinely altered for female patients relative to male patients.
Sess Id- doża tal- bidu u l- firxa tad- doża m' għandhomx għalfejn jinbidlu normalment għall- pazjenti nisa f' paragun ma 'pazjenti rġiel.
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
Dawk li jpejpu Id- doża tal- bidu u l- medda tad- dożi m' għandhomx għalfejn jinbidlu normalment għal dawk li ma jpejpux f' paragun ma 'dawk li jpejpu.
(See sections 4.5 and 5.2)
(Ara sezzjonijiet 4. 5 u 5. 2)
Hypersensitivity to the active substance or to any of the excipients.
Sensittivita 'eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
Patients with known risk for narrow-angle glaucoma.
Pazjenti li għandhom ir - riskju ta 'glawkoma tat- tip narrow angle.
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.
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 dik fil- pazjenti ttrattati bil- plaċebo, indipendentement minn dawn il- fatturi ta ’ riskju.
In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
Fl- istess studji kliniċi, kienu rrapportati avvenimenti avversi ċerebro- vaskulari (CVAE eż puplesija, attakki iskemiċi momentanji) inklużi l- imwiet.
There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3% vs.
Kien hemm żieda ta ’ 3 darbiet akbar ta ’ CVAE
0.4%, respectively).
3 f’ pazjenti ttattati b' olanzapine, meta mqabblin ma ’ pazjenti ttrattati bil- plaċebo (1. 3% kontra 0. 4U%, rispettivament).
Age > 75 years and vascular/ mixed type dementia were identified as risk factors for
L- età ta ’ > 75 sena u d - demenzja tat- tip vaskulari jew imħallta kienu identifikati bħala fatturi ta ’ riskju għal CVAE f’ assoċjazzjoni ma ’ trattament b' olanzapine.
The efficacy of olanzapine was not established in these trials.
L- effikaċja ta ’ olanzapine ma kienitx stabbilita f’ dawn l- istudji.
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 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 effettiva tal- mediċini kontra l- marda ta ’ Parkinson (agonist ta ’ dopamine) u biex jibqgħu fuq l- istess mediċini u dożi 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 inbeda b '2. 5 mg/ ġurnata u żdied bil- mod għall- massimu ta' 15 mg/ ġurnata ibbażat fuq il- ġudizzju tar- riċerkatur.
If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic medicines, including olanzapine must be discontinued.
Jekk pazjent jiżviluppa sinjali u sintomi li huma indikattivi ta 'NMS, jew ikollu deni għoli bla ebda spjegazzjoni u mingħajr manifestazzjonijiet kliniċi oħra ta' NMS, għandhom jitwaqqfu l- mediċini antipsikotiċi kollha, inkluż olanzapine.
Hyperglycaemia and diabetes Hyperglycaemia and/ or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases (see section 4.8).
Ipergliċemija u dijabete Zokkor għoli fid- demm u/ jew żvilupp jew taħrix tad- dijabete xi kultant assoċjati ma 'ketoaċidozi jew koma kienu rrappurtati b’ mod rari, inklużi xi każijiet fatali (ara sezzjoni 4. 8).
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).
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
Tibdil fil- livell tal- lipidi għandu jiġi kkontrollat b’ mod klinikamet xieraq speċjalment f’ pazjenti b’ ammonti mhux normali ta ’ lipidi fid- demm u f’ pazjenti li għandhom fatturi ta ’ riskju għall- iżvilupp ta ’ disturbi fil- lipidi.
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.
4 myeloproliferative disease.
4 Newtropenja 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.
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.
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
Relazzjoni kawżali bejn l- okkorrenza ta ’ tromboemboliżmu fil- vini u l- kura b’ olanzapine ma ġietx stabbilita.
General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
Attività tas- CNS ġenerali Minħabba l- effetti primarji ta 'olanzapine fuq is- CNS għandha tittieħed kawtela meta dan jingħata flimkien ma' mediċini oħra li jaġixxu ċentralment u meta jittieħed ma 'l- alkoħol.
However the risk of tardive dyskinesia increases with long term exposure, and therefore if signs or symptoms of tardive dyskinesia appear in a patient on olanzapine, a dose reduction or discontinuation should be considered.
Madankollu, r- riskju ta 'diskajneżja tardiva jiżdied b' espożizzjoni għal żmien twil, u għalhekk jekk jidhru s- sinjali jew is- sintomi ta' diskajneżja tardiva f' pazjenti li qed jieħdu olanzapine, għandu jiġi kkunsidrat tnaqqis fid- doża jew il- waqfien.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Pressjoni baxxa mal- waqfien Pressjoni baxxa mal- waqfien ġiet osservata rari fl- anzjani fil- provi kliniċi ta 'olanzapine.
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
5 L- użu fit- tfal u fl- adolexxenti taħt it- 18- il sena Olanzapine mhux indikat għall- użu fil- kura tat- tfal u adolexxenti.
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- livelli ta 'prolactin.
Lactose OLANZAPINE NEOPHARMA tablets contain lactose.
Lactose Il- pilloli OLANZAPINE NEOPHARMA fihom l- lactose.
5 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma 'dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Interaction studies have only been performed in adults.
Studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott saru fl- adulti biss.
Potential interactions affecting olanzapine Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this isoenzyme may affect the pharmacokinetics of olanzapine.
Potenzjal t' interazzjonijiet ma 'olanzapine Minħabba li olanzapine hija metaboliżżata b' CYP1A2, sustanzi li jistgħu speċifikament jikkaġunaw jew jinibixxu din l- iżoenzima jistgħu jaffettwaw il- komportament farmakokinetiku ta 'olanzapine.
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Attivazzjoni ta 'CYP1A2 Il- metaboliżmu ta’ olanzapine jista' jiġi kkawżat mit- tipjip u b 'carbamazepine, li jistgħu jwasslu għal tnaqqis fil- konċentrazzjoni ta' olanzapine.
The clinical consequences are likely to be limited, but clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (see section 4.2).
Il- konsegwenzi kliniċi x' aktarx huma limitati, imma hija rrakkomandata l- osservazzjoni klinika u tista 'tiġi kkunsidrata żjieda fid- doża ta' olanzapine jekk din tkun meħtieġa (ara Sezzjoni 4. 2).
Inhibition of CYP1A2 Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Inibizzjoni ta 'CYP1A2 Fluvoxamine, inibitur speċifiku ta' CYP1A2, deher li jinibixxi sinifikatament il- metaboliżmu ta' olanzapine.
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non- smokers and 77% male smokers.
Iż- żjieda medja f ’ olanzapine Cmax wara t- teħid ta 'fluvoxamine kienet 54% fin- nisa li ma jpejpux u 77% fl- irġiel li jpejpu.
Decreased bioavailability Activated charcoal reduces the bioavailability of oral olanzapine by 50 to 60% and should be taken at least 2 hours before or after olanzapine.
Biodisponibbiltà mnaqqsa Faħam attivat inaqqas il- biodisponibilità ta 'olanzapine li tittieħed mill- ħalq b' 50 sa 60% u għandu jittieħed għal ta 'l- inqas sagħtejn qabel jew wara olanzapine.
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Il- potenzjal ta 'olanzapine biex jaffetwa prodotti mediċinali oħra Olanzapine jista' jantagonizza l- effetti ta 'l- antagonisti ta ’ dopamine diretti jew indiretti.
Olanzapine showed no interaction when co-administered with lithium or biperiden.
Olanzapine ma wera ebda reazzjoni meta ttieħed flimkien ma ’ lithium jew biperiden.
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Osservazzjoni terapewtika tal- livelli ta ’ valproate fil- plażma ma ndikatx li tibdil fid- dożaġġ tal- valproate huwa meħtieġ wara l- introduzzjoni ta 'olanzapine ukoll.
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
6 Attività tas- CNS ġenerali Għandha tittieħed kawtela f' pazjenti li jixorbu l- alkoħol jew li jieħdu prodotti mediċinali li jistgħu jikkawżaw depressjoni tas- sistema nervuża ċentrali.
Because olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.
Minħabba li olanzapine jista 'jikkawża sonnolenza u sturdament, il- pazjenti għandhom jiġu avżati dwar l- użu ta' magni, inklużi l- karozzi.
Adults The most frequently (seen in ≥ 1% of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
Adulti Fi studji kliniċi, l- aktar reazzjonijiet avversi li ġew irrapportati b' mod frekwenti (jidhru f '> 1% tal- pazjenti) u li huma assoċjati ma' l- użu ta 'l- olanzapine kienu sonnolenza, żieda fil- piż, eosinofilja, livelli għolja ta' prolactin, kolesterol, glucose u trigliċeridi (ara sezzjoni 4. 4), glukosurja, żieda fl- aptit, sturdament, akatiżja, parkinsoniżmu (ara sezzjoni 4. 4), diskineżja, pressjoni baxxa mal- waqfien, effetti antikolinerġiċi, żieda fil- livelli tat- transaminases tal- fwied li ma jurux sintomi u li huma momentanji (ara sezzjoni 4. 4), raxx, astenja, għeja u edima.
7 Very common
7
Common
Komuni ħafna Komuni
Leukopenia Neutropenia
Lewkopenja Newtropenja
Nervous system disorders Somnolence Cardiac disorders
Disturbi fis- sistema nervuża Sonnolenza Disturbi fil- qalb
Seizures where in most cases a history of seizures or risk factors for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
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
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
Epatite inkluż mard tal- fwied tat- tip epatoċellulari, kolestatiku jew tat- tnejn flimkien)
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 Livelli elevati ta' prolactin fil- plażma 8 1
Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Ġiet osservata żieda fil- piż, klinikament sinifikanti, fil- linja bażi ta ’ l- Indiċi tal- Massa tal- Ġisem (Body Mass Index - BMI), fil- kategoriji kollha.
Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17 - < 6.2 mmol) to high (≥ 6.2 mmol) were very common.
Tibdil fil- livelli tal- kolesterol totali waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 5. 17 mmol/ l - < 6. 2 mmol/ l) għal għoljin (≥ 6. 2 mmol/ l) kienu komuni ħafna.
Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/ l) to high (≥ 7 mmol/ l) were very common.
Tibdil fil- livelli taz- zokkor waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 5. 56 - < 7 mmol/ l) għal għoljin (≥ 7m mol/ l) kienu komuni ħafna.
Changes in fasting triglycerides from borderline at baseline (≥ 1.69 mmol/ l - < 2.26 mmol/ l) to high (≥ 2.26 mmol/ l) were very common.
Tibdil fit- trigliċeridi waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 1. 69 mmol/ l - < 2. 26 mmol/ l) għal għoljin (≥ 2. 26 mmol/ l) kienu komuni ħafna.
6 In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
6 Fi studji kliniċi, l- inċidenza tal- marda ta 'Parkinson u distonja f' pazjenti kkurati b ’ olanzapine kienet numerikament ogħla, imma statistikament mhux differenti b’ mod sinifikattiv mill- plaċebo.
In the absence of detailed information on the pre-existing history of individual acute and tardive extrapyramidal movement disorders, it can not be concluded at present that olanzapine produces less tardive dyskinesia and/ or other tardive extrapyramidal syndromes.
Fl- assenza ta 'tagħrif dettaljat dwar passat pri- ezistenti ta' disturbi akuti u movimenti tardivi ekstrapiramidali, fil- preżent ma jistax jiġi konkluż li olanzapine jipproduċi anqas diskineżja tardiva u/ jew sindromi ekstrapiramidali tardivi oħra.
9 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.
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).
Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥ 7% from baseline body weight in 39.9% of patients.
Trattament b’ olanzapine għal żmien twil (sa 12- il xahar) bl- għan ta 'prevenzjoni ta' episodju ieħor f' pazjenti b' mard bipolari kien assoċjat ma 'żieda ta' ≥ 7% mil- linja bażi tal- piż tal- ġisem f '39. 9% tal- pazjenti.
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.
Clinically significant weight gain (≥ 7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Żieda fil- piż klinikament sinifikanti (≥ 7%) tidher li sseħħ aktar frekwentement fil- popolazzjoni ta 'l- adolexxenti meta mqabbla ma ’ l- adulti li kellhom l- istess ammont ta ’ espożizzjoni għall- prodott.
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..
10 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 - < 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).
Changes in total fasting cholesterol levels from borderline at baseline (≥ 4.39 - < 5.17 mmol/ l) to high (≥ 5.17 mmol/ l) were very common.
Tibdil fil- livelli tal- kolesterol totali waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 4. 39 - < 5. 17 mmol/ l) għal għoljin (≥ 5. 17 mmol/ l) kienu komuni ħafna.
Signs and symptoms Very common symptoms in overdose (> 10% incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Sinjali u sintomi Sintomi komuni ħafna meta ittieħdet doża eċċessiva (> 10% inċidenza) jinkludu takikardija, aġitazzjoni/ aggressività, diżartrija, sintomi ekstrapiramidali varji, u telf tas- sensi li tvarja minn sedazzjoni sa koma.
Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias (< 2% of overdose cases) and cardiopulmonary arrest.
Sintomi oħra morbużi ta 'doża eċċessiva li huma medicament sinifikanti jinkludu d- delirju, il- konvulżjoni, koma, possibilment Sindromu Newrolettiku Malinn, depressjoni respiratorja, aspirazzjoni fil- passaġġ respiratorju, pressjoni tad- demm għolja jew baxxa, taħbit tal- qalb irregolari (< 2% tal- każijiet ta' doża eċċessiva) u arrest kardjopulmonari.
Fatal outcomes have been reported for acute overdoses as low as 450 mg but survival has also been reported following acute overdose of 1,500 mg.
Ġew rappurtati każijiet fatali b 'dożi akuti u eċċessivi baxxi daqs 450 mg iżda kien hemm ukoll każ fejn pazjent baqa ħaj wara doża eċċessiva akuta ta' 1, 500 mg.
Management of overdose There is no specific antidote for olanzapine.
L- Immaniġġar ta 'Doża Eċċessiva Ma hemm ebda antidotu speċifiku għal olanzapine.