qanastek/EMEA-V3 huggingface dataset:
There are no adequate data from the use of risperidone in pregnant women.
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ risperidone waqt it- tqala.
Consequently newborns should be monitored carefully.
Konsegwentement trabi tat- twelid għandhom jiġu mmonitorjati b’ attenzjoni.
Risperidone was not teratogenic in animal studies but other types of reproductive toxicity were seen (see section 5.3).
Risperidone ma kienx teratoġeniku fi studji fuq l- annimali iżda intwerew tipi oħra ta ’ ħsara fuq is- sistema riproduttiva (ara sezzjoni 5. 3).
Therefore, RISPERDAL should not be used during pregnancy unless clearly necessary.
Għalhekk, RISPERDAL m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
Lactation
65 Effetti fuq il- ħalib tas- sider
In animal studies, risperidone and 9-hydroxy-risperidone are excreted in the milk.
Fi studji fuq l- annimali, risperidone u 9- hydroxy- risperidone joħorġu mal- ħalib tas- sider.
There are no data available on adverse reactions in breast-feeding infants.
M’ hemmx tagħrif disponibbli dwar ir- reazzjonijiet avversi jekk tredda ’ lit- trabi.
Therefore, the advantage of breast- feeding should be weighed against the potential risks for the child.
Għalhekk il- vantaġġ tat- treddigħ għandu jitqies skond ir- riskji li jista ’ jkun hemm għat- tarbija.
61 4.7 Effects on ability to drive and use machines
4. 7 Effetti ħuq il- ħila biex issuq u tħaddem magni
RISPERDAL can have minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects (see section 4.8).
RISPERDAL jista ’ jkollu effett żgħir jew moderat fuq il- ħila li ssuq u tħaddem magni minħabba l - effetti li jista ’ jkollu fuq is- sistema nervuża u l- vista (ara sezzjoni 4. 8).
Therefore, patients should be advised not to drive or operate machinery until their individual susceptibility is known.
Għalhekk il- pazjenti għandhom jingħataw il- parir li ma jsuqux u jħaddmu makkinarju sakemm ikun magħruf kemm huma suxxettibbli.
4.8 Undesirable effects
4. 8 Effeti mhux mixtieqa
The most frequently reported adverse drug reactions (ADRs) (incidence ≥ 10%) are:
L- aktar reazzjonijiet avversi għall- mediċina (ADRs) irrappurtati b’ mod frekwenti (inċidenza ≥ 10%) huma:
Parkinsonism, headache, and insomnia.
Parkinsoniżmu, uġigħ ta ’ ras, u insomnja.
The following terms and frequencies are applied: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1000), very rare (< 1/ 10,000), and not known (cannot be estimated from the available clinical trial data).
Dawn it- termini u l- frekwenzi li ġejjin huma użati: komuni ħafna (≥ 1/ 10), komuni (≥ 1/ 100 sa < 1/ 10), mhux komuni (≥ 1/ 1000 sa < 1/ 100), rari (≥ 1/ 10, 000 sa < 1/ 1, 000), rari ħafna (< 1/ 10, 000), u mhux magħrufa (ma jistgħux jiġu stmati mid- dejta disponibbli mill- provi kliniċi).
Adverse Drug Reactions by System Organ Class and Frequency Investigations
Reazzjonijiet Avversi skond is- Sistema tal- Klassifikazzjoni ta ’ l- Organi u l- Frekwenza Investigazzjonijiet Żieda tal- prolactin fid- demma, Żieda fil- piż Komuni
Blood prolactin increaseda, Weight increased Electrocardiogram QT prolonged, Electrocardiogram abnormal, Blood glucose increased, Transaminases increased, White blood cell count decreased Body temperature increased, Eosinophil count increased, Haemoglobin decreased, Blood creatine phosphokinase increased
QT ta ’ l- elettrokardjogramm imtawwal, Elettrokardjogramm mhux normali, Żieda taz- zokkor fid- demm, Żieda fit- transaminases, Tnaqqis fl- għadd taċ - ċelluli bojod tad- demm, Żieda fit- temperatura tal- ġisem, Żieda fl- għadd ta ’ eosinofils, Tnaqqis fl- emoglobina, Żieda tal- creatine phosphokinase fid- demm
Cardiac disorders
Rari Disturbi fil- qalb
Blood and lymphatic system disorders
Tnaqqis fit- tempertura tal- ġisem
Uncommon Rare Not known
Komuni Mhux komuni
Anaemia, Thrombocytopenia Granulocytopenia Agranulocytosis
Takikardija Imblokk atrijoventikulari, Imblokk tal- fergħa bundle, Fibrillazzjoni ta ’ l- atriju, Bradikardija tas- sinus, Palpitazzjonijiet
Nervous system disorders
Disturbi tad- demm u tas- sistema limfatika
Very common Common
Mhux komuni Rari Mhux magħrufa
Parkinsonismb, Headache Akathisiab, Dizziness, Tremorb, Dystoniab, Somnolence, Sedation, Lethargy, Dyskinesiab
Anemija, Troboċitpenija Granuloċitopenija Agranuloċitożi
Unresponsive to stimuli, Loss of consciousness, Syncope, Depressed level of consciousness, Cerebrovascular accident, Transient ischaemic attack, Dysarthria, Disturbance in attention, Hypersomnia, Dizziness postural, Balance disorder, Tardive dyskinesia, Speech disorder, Coordination abnormal, Hypoaesthesia
Disturbi fis- sistema nervuża Parkinsoniżmub, Uġigħ ta ’ ras Komuni ħafna Akatisjab, Sturdament, Rogħdab, Distonjab, Ħedla tan- ngħas, Sedazzjoni, Komuni Letarġija, Diskajneżjab
Rare
Mhux komuni
Neuroleptic malignant syndrome, Diabetic coma, Cerebrovascular disorder, Cerebral ischaemia, Movement disorder
Mingħajr rispons għall- istimuli, Telf ta ’ koxjenza, Sinkope, Livell imnaqqas ta ’ koxjenza, Aċċident ċerebrovaskulari, Attakk iskemiku għaddieni, Disartrija, Disturb fl- attenzjoni, Ipersomnja, Sturdament mal- waqfien, Disturb fil- bilanċ, Diskajeżja tardiva, Disturb fit- taħdid, Koordinazzjoni mhux normali, Ipoesteżija
Common Uncommon
Rari Disturbi fl- għajnejn
Vision blurred Conjunctivitis, Ocular hyperaemia, Eye discharge, Eye swelling, Dry eye, Lacrimation increased, Photophobia
Sindrome Newrolettiku Malinn, Koma dijabetika, Disturb ċerebrovaskulari, Iskemija ċerebrali, Disturb fil- moviment
Rare
66
Ear pain, Tinnitus
Komuni Mhux komuni
Respiratory, thoracic and mediastinal disorders
Vista mċajpra Konġunktivite, Iperemja okulari, Tnixxija mill- għajnejn, Nefħa fl- għajnejn, Għajnejn xotti, Żieda fid- dmugħ, Fotofobja
Dyspnoea, Epistaxis, Cough, Nasal congestion, Pharyngolaryngeal pain
Rari Disturbi fil- widnejn u Mhux komuni Disturbi respiratorji, Komuni Mhux komuni
Wheezing, Pneumonia aspiration, Pulmonary congestion, Respiratory disorder, Rales, Respiratory tract congestion, Dysphonia
Tnaqqis fl- akutezza tal- vista, Dawrien ta ’ l- għajnejn, Glawkoma fis- sistema labirintika Uġigħ fil- widnejn, Tinnitus toraċiċi, u medjastinali Qtugħ ta ’ nifs, Epistażi, Sogħla, Konġestjoni nażali, Uġigħ faringolarinġali, Tħarħir, Pulmonite minħabba aspirazzjoni, Konġestjoni tal- pulmun, Disturb respiratorju, Ħsejjes tal- pulmun, Konġestjoni ta ’ l- apparat tan- nifs, Disfonja
Sleep apnea syndrome, Hyperventilation
Sindrome ta ’ waqfien tan- nifs waqt l- irqad, Iperventilazzjoni
Vomiting, Diarrhoea, Constipation, Nausea, Abdominal pain, Dyspepsia, Dry mouth, Stomach discomfort
Rimettar, Dijarea, Stitikezza, Dardir, Uġigħ fl- addome, Dispepsja, Ħalq xott, Skomfort fl- istonku
Dysphagia, Gastritis, Faecal incontinence, Faecaloma Intestinal obstruction, Pancreatitis, Lip swelling, Cheilitis
Disfaġja, Gastrite, Inkontinenza ta ’ l- ippurgar, Fikaloma Sadd fl- imsaren, Pankrejatite, Nefħa fix- xoffa, Kejlite
Renal and urinary disorders Common Uncommon
Disturbi fil- kliewi u fis- sistema urinarja Komuni Mhux komuni
Enuresis Dysuria, Urinary incontinence, Pollakiuria
Enuresi Disurja, Inkontinenza ta ’ l- awrina, Pollakijurja
Rash, Erythema Angioedema, Skin lesion, Skin disorder, Pruritus, Acne, Skin discolouration, Alopecia, Seborrhoeic dermatitis, Dry skin, Hyperkeratosis
Raxx, Eritema Anġjoedima, Ferita fil- ġilda, Disturb fil- ġilda, Ħakk, Akne, Telf ta ’ kulur fil - ġilda, Alopeċja, Dermatite tas- saborrea, Ġilda xotta
Dandruff
Brija
Musculoskeletal and connective tissue disorders Common Uncommon
Disturbi muskolu- skelettrali u tal- connective tissue Komuni Mhux komuni
Arthralgia, Back pain, Pain in extremity Muscular weakness, Myalgia, Neck pain, Joint swelling, Posture abnormal, Joint stiffness, Musculoskeletal chest pain
Artralġja, Uġigħ fid- dahar, Uġigħ fl- idejn u fis- saqajn Dgħjufija tal- muskoli, Majalġja, Uġigħ fl- għonq, Nefħa fil- ġogi, Pożizzjoni tal- ġisem mhux normali, Ebusija fil- ġogi, Uġigħ muskoluskelettrali fis- sider
Rhabdomyolysis
Rabdomijaliżi
Endocrine disorders Rare Inappropriate antidiuretic hormone secretion Metabolism and nutrition disorders Common Uncommon Very rare Not known
Disturbi fis- sistema endokrinarja Rari Tnixxija mhux adattata ta ’ ormon antidijuretiku Disturbi fil- metaboliżmu u n- nutrizzjoni Komuni Mhux komuni Rari ħafna Mhux magħrufa
Increased appetite, Decreased appetite Anorexia, Polydipsia Diabetic ketoacidosis Water intoxication
Żieda fl- aptit, Tnaqqis fl- aptit Anoressja, Polidipsja Ketoaċidożi dijabetika Intossikazzjoni ta ’ ilma
Pneumonia, Influenza, Bronchitis, Upper respiratory tract infection, Urinary tract infection
Pulmonite, Influwenza, Bronkite, Infezzjoni tal- parti tan- naħa ta ’ fuq ta ’ l - apparat tan- nifs, Infezzjoni ta ’ l- apparat ta ’ l- awrina
Sinusitis, Viral infection, Ear infection, Tonsillitis, Cellulitis, Otitis media, Eye infection, Localised infection, Acarodermatitis, Respiratory tract infection, Cystitis, Onychomycosis
Sinożite, Infezzjoni virali, Infezzjoni fil- widnejn, Tonsillite, Ċellulite, Infezzjoni tal- widna tan- nofs, Infezzjoni fl- għajnejn, Infezzjoni lokalizzata, Akarodermatite, Infezzjoni fl- apparat tan- nifs, Ċistite, Onikomikożi
Otitis media chronic
Infezzjoni kronika tal- widna tan- nofs
Hypotension, Orthostatic hypotension, Flushing
Pressjoni baxxa, Pressjoni baxxa mal- waqfien, Fwawar
General disorders and administration site conditions Common Uncommon
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata Komuni Mhux komuni
Pyrexia, Fatigue, Peripheral oedema, Asthenia, Chest pain Face oedema, Gait disturbance, Feeling abnormal, Sluggishness, Influenza like illness, Thirst, Chest discomfort, Chills
Deni, Għejja, Edima ta ’ l- idejn u tas- saqajn, Astenja, Uġigħ fis- sider Edima fil- wiċċ, Disturb fil- mixi, Ma tħossokx normali, Indolenza, Mard bħal ta ’ l- influwenza, Għatx, Skomfort fis- sider, Tkexkix ta ’ bard
Generalised oedema, Hypothermia, Drug withdrawal syndrome, Peripheral coldness
Edima mifruxa, Ipotermja, Sindrome ta ’ twaqqif tal- mediċina, Kesħa fil - priferiji
Immune system disorders Uncommon Rare Not known
Disturbi fis- sistema immuni Mhux komuni Rari Mhux magħrufa
Hypersensitivity Drug hypersensitivity Anaphylactic reaction
Sensittività eċċessiva Sensittività eċċessivia għall- mediċina Reazzjoni anafilattika
Hepatobiliary disorders Rare Jaundice Reproductive system and breast disorders Uncommon
Disturbi fil- fwied u fil- marrara
Amenorrhoea, Sexual dysfunction, Erectile dysfunction, Ejaculation disorder, Galactorrhoea, Gynaecomastia, Menstrual disorder, Vaginal discharge,
Rari
Not known
Suffejra
Priapism
Mhux komuni
Psychiatric disorders 63
Mhux magħrufa Disturbi psikjatriċi
a
Priapiżmu
Very common Common Uncommon Rare
Komuni ħafna Komuni Mhux komuni Rari a
Insomnia Anxiety, Agitation, Sleep disorder Confusional state, Mania, Libido decreased, Listless, Nervousness Anorgasmia, Blunted affect
Insomnja Ansjetà, Aġitazzjoni, Disturb fl- irqad Stat konfużjonali, Manija, Tnaqqis fil- libido, Bla ħeġġa, Nervożiżmu Anorgażmija, Effett ta ’ nuqqas ta ’ sensittività
Tremor includes tremor and parkinsonian rest tremor.
Parkinsoniżmu (ipersekrezzjoni ta ’ bżiq, ebusija muskolu - skeletrali, parkinsoniżmu, tlegħib, riġidità bħal tar- roti f’ magna, bradikajniżja, ipokineżja, espressjoni tal- wiċċ bħal maskra, tagħfis fil- muskoli, akineżja, riġidità ta ’ raqbet l- għonq, riġidità fil - muskoli, mixi parkinsonjan, rifless glabellari mhux normali) akatiżja (akatiżja, nuqqas ta ’ kwiet, iperkajneżja u sindrome ta ’ sieq bla kwiet) rogħda, diskajneżja (diskajneżja, kontrazzjoni tal- muskoli għall- għarrieda, koreoatetożi, atetożi u mijoklonus), distonja Distonja tinkludi distonja, spażmi fil - muskoli, ipertonija, tortikollis, kontrazzjonijiet involuntarji tal- muskoli, kontrazzjoni tal- muskoli, blefarospażmu, għajnejn iduru, paraliżi fl- ilsien, spażmu fil- wiċċ, spażmu fil- larinġi, mijotonija, opistotonus, spażmu orofarinġali, plewrototonus, spażmu fl- ilsien, u trismu. Rogħda jinkludi rogħda u rogħda parkinsonjan waqt il- mistrieħ..
The following is a list of additional ADRs associated with risperidone that have been identified as ADRs during clinical trials investigating the long-acting injectable risperidone formulation (RISPERDAL CONSTA) but were not determined to be ADRs in the clinical trials investigating oral RISPERDAL.
Din li ġejja hija lista ta ’ ADRs addizzjonali assoċjati ma ’ risperidone li kienu identifikati bħala ADRs waqt provi kliniċi li kienu qed jinvestigaw il- formulazzjoni ta ’ risperidone li jiġi injettat u jaħdem fuq tul ta ’ żmien (RISPERIDAL CONSTA) iżda ma ġewx determinati li kienu ADRs fil- provi kliniċi li kienu qed jinvestigaw RISPERDAL li jittieħed mill- ħalq.
This table excludes those ADRs specifically associated with the formulation or injection route of administration of RISPERDAL CONSTA.
Din it- tabella teskludi dawk l- ADRs assoċjati speċifikament mal- formulazzjoni jew mar- rotta ta ’ mnejn tingħata l- injezzjoni ta ’ RISPERDAL CONSTA.
Additional Adverse Drug Reactions Reported With RISPERDAL CONSTA but Not With Oral RISPERDAL by System Organ Class Investigations Weight decreased, Gamma-glutamyltransferase increased, Hepatic enzyme increased Cardiac Disorders Bradycardia Blood and Lymphatic Disorders Neutropenia Nervous System Disorders Paresthesia, Convulsion Eye Disorders Blepharospasm Ear and Labyrinth Disorders Vertigo Gastrointestinal Disorders Toothache, Tongue spasm Skin and Subcutaneous Tissue Disorders Eczema Musculoskeletal, Connective Tissue, and Bone Disorders Buttock pain Infections and Infestations Lower respiratory tract infection, Infection, Gastroenteritis, Subcutaneous abscess Injury and Poisoning Fall Vascular Disorders Hypertension General Disorders and Administration Site Conditions Pain Psychiatric Disorders Depression
Reazzjonijiet Avversi Addizzjonali għall- Mediċina Rappurtati b’ RISPERDAL CONSTA iżda mhux B’ RISPERDAL li Jittieħed mill- Ħalq skond il- Klassifikazzjoni tas- Sistema ta ’ l- Organi Investigazzjonijiet Tnaqqis fil- piż, Żieda fil- Gamma- glutamyltransferase, Żieda fl- enzimi tal- fwied Disturbi fil- Qalb Bradikardija Disturbi tad- Demm u tas- Sistema Limfatika Newtropenja Disturb fis- Sistema Nervuża Parestesija, Aċċessjonijiet Disturbi fl- Għajnejn Blefarospażmu Distrurbi fil- Widnejn u fis- Sistema Labirintika Vertigo Disturbi Gastro- intestinali Uġigħ fis- snien, spażmu fl- ilsien Disturbi fil- Ġilda u fit- Tessuti ta ’ Taħt il- Ġilda Ekżema Disturbi Muskolu- skeletrali, tal- Connective Tissue u fl- Għadam Uġigħ fil- warrani Infezzjonijiet u infestazzjonijiet
64 Class effects
Effetti tal- klassi
As with other antipsychotics, very rare cases of QT prolongation have been reported postmarketing with risperidone.
Bħal antipsikotiċi oħrajn, każi rari ħafna ta ’ QT imtawwal kienu rrappurtati b’ risperidone wara t - tqegħid fis- suq.
Other class-related cardiac effects reported with antipsychotics which prolong QT interval include ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest and Torsades de Pointes.
Effetti oħra tal- qalb li huma relatati mal- klassi rrappurtati b’ antipsikotiċi li jtawwlu l - intervall QT jinkludu arritmija tal- ventrikulu, fibrillazzjoni tal- ventirikulu, takikardija tal- ventrikulu, mewt zoptu, waqfien tal- qalb, u Torsades de Pointes.
The proportions of RISPERDAL and placebo-treated adult patients with schizophrenia meeting a weight gain criterion of ≥ 7% of body weight were compared in a pool of 6- to 8-week, placebo-controlled trials, revealing a statistically significantly greater incidence of weight gain for RISPERDAL (18%) compared to placebo (9%).
Il- proporzjonijiet ta ’ pazjenti adulti bi skizofrenja kkurati b’ RISPERDAL u bi plaċebo li ssodisfaw il - kriterju ta ’ żieda fil- piż ta ’ ≥ 7% tal- piż tal- ġisem kienu mqabbla f’ pool ta ’ 6- sa 8- ġimgħat, ta ’ provi kkontrollati bi plaċebo, fejn urew inċidenza statistikament sinifikanti ogħla ta ’ żieda fil- piż b’ RISPERDAL (18%) meta mqabbel ma ’ plaċebo (9%).
In a pool of placebo-controlled 3-week studies in adult patients with acute mania, the incidence of weight increase of ≥ 7% at endpoint was comparable in the RISPERDAL (2.5%) and placebo (2.4%) groups, and was slightly higher in the active-control group (3.5%).
F’ pool ta ’ studji ta ’ 3- ġimgħat ikkontrollati bi plaċebo f’ pazjenti adulti b’ manija akuta, l- inċidenza ta ’ żieda fil- piż ta ’ ≥ 7% fl- aħħar ta ’ l- istudju kienet tixxiebah fil- grupppi ta ’ RISPERDAL (2. 5%) u plaċebo (2. 4%), u kienet ftit ogħla fil- ġrupp ta ’ kontroll attiv (3. 5%).
In a population of children and adolescents with conduct and other disruptive behaviour disorders, in long- term studies, weight increased by a mean of 7.3 kg after 12 months of treatment.
F’ popolazzjoni ta ’ tfal u adoloxxenti b’ disturbi ta ’ l- imġieba u ta ’ komportament diżordnat ieħor, fi studji fuq tul ta ’ żmien, il- piż żdied b’ medja ta ’ 7. 3 kg wara 12- il xahar ta ’ kura.
The expected weight gain for normal children between 5-12 years of age is 3 to 5 kg per year.
Iż- żieda fil- piż mistennija minn tfal normali fl- età ta ’ bejn 5- 12- il sena hija ta ’ 3 sa 5 kg fis- sena.
From 12-16 years of age, this magnitude of gaining 3 to 5 kg per year is maintained for girls, while boys gain approximately 5 kg per year.
Mill- età ta ’ 12- 16- il sena, din iż- żieda ta ’ 3 sa 5 kg fis- sena tinżamm fit- tfal bniet, filwaqt li s- subien jiżdiedu bejn wieħed u ieħor 5 kg fis- sena.
Additional information on special populations
Informzzjoni Addizzjonali dwar Popolazzjonijiet Speċjali
Adverse drug reactions that were reported with higher incidence in elderly patients with dementia or paediatric patients than in adult populations are described below:
Reazzjonijiet avversi tal- mediċina li kienu rrappurtati b’ inċdenza ogħla f’ pazjenti anzjani bid - dimenzja jew f’ pazjenti tfal milli f’ popolazzjonijiet adulti huma deskritti hawn taħt:
Elderly patients with dementia
Pazjenti anzjani bid- dimenzja
Transient ischaemic attack and cerebrovascular accident were ADRs reported in clinical trials with a frequency of 1.4% and 1.5%, respectively, in elderly patients with dementia.
Attakk iskemiku għaddieni u aċċident ċerebrovaskulari kienu ADRs irrappurtati fi provi kliniċi bi frekwenza ta ’ 1. 4% u 1. 5%, rispettivament, f’ pazjenti anzjani bid- dimenzja.
In addition, the following ADRs were reported with a frequency ≥ 5% in elderly patients with dementia and with at least twice the frequency seen in other adult populations: urinary tract infection, peripheral oedema, lethargy, and cough.
Flimkien ma ’ dan, l - ADRs li ġejjin kienu rrappurtati bi frekwenza ta ’ ≥5% f’ pazjenti anzjani bid- dimenzja u bi frekwenza mill- anqas id- doppju ta ’ dak li ntwera f’ popolazzjonijiet adulti oħra: infezzjoni fl- apparat ta ’ l- awrina, edima periferali, ħedla, u sogħla.
Paediatric patients
Tfal
The following ADRs were reported with a frequency ≥ 5% in paediatric patients (5 to 17 years) and with at least twice the frequency seen in clinical trials in adults: somnolence/ sedation, fatigue, headache, increased appetite, vomiting, upper respiratory tract infection, nasal congestion, abdominal pain, dizziness, cough, pyrexia, tremor, diarrhoea, and enuresis.
L- ADRs li ġejjin kienu rrappurtati bi frekwenza ≥5% fi tfal (5 sa 17- il sena) u bi frekwenza mill - anqas id- doppju ta ’ dak li ntwera fi provi kliniċi fl- adulti: ngħas/ sedazzjoni, għeja, uġigħ ta ’ ras, żieda fl- aptit, rimettar, infezzjoni fil- parti ta ’ fuq ta ’ l- apparat tan- nifs, koġestjoni nażali, uġigħ fl- addome, sturdament, sogħla, deni, rogħda, dijarea, u enuresi.
4.9 Overdose
69 4. 9 Doża eċċessiva
In overdose, QT-prolongation and convulsions have been reported.
F’ każ ta ’ doża eċċessiva, QT imtawwal u aċċessjonijiet kienu rrappurtati.
Torsade de Pointes has been reported in association with combined overdose of RISPERDAL and paroxetine.
Torsade de Pointes kien irrappurtat b’ doża eċċessiva ta ’ RISPERDAL flimkien ma ’ paroxetine.
In case of acute overdose, the possibility of multiple drug involvement should be considered.
Fil- każ ta ’ doża eċċessiva akuta, għandha tiġi kkunsidrata l- possibiltà li ntużat aktar minn mediċina waħda.
Gastric lavage (after intubation, if the patient is unconscious) and administration of activated charcoal together with a laxative
Lavaġġ gastriku (wara l- intubazzjoni, jekk il- pazjent hu mitluf minn sensih) u l- għoti ta ’ charcoal attivat flimkien ma ’ lassativ għandu jiġi kkunsidrat biss meta l- mediċina tkun ittieħdet anqas minn siegħa qabel.
Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
Il - monitoraġġ kardjovaskulari għandu jibda mill- ewwel u għandu jinkludi monitoraġġ kontinwu elettrokardjografiku għal osservazzjoni tal- possibilità ta ’ arritmiji.
There is no specific antidote to RISPERDAL.
M’ hemm l- ebda antidot speċifiku għal RISPERDAL.
Therefore, appropriate supportive measures should be instituted.
Għaldaqstant, għandhom jinbdew miżuri xierqa ta ’ sapport.
In case of severe extrapyramidal symptoms, an anticholinergic medicinal product should be administered.
F’ każ ta ’ sintomi ekstrapiramidali qawwija, għanda tingħata prodott mediċinali antikolinerġika.
Close medical supervision and monitoring should continue until the patient recovers.
Superviżjoni medika mill- qrib u monitoraġġ għandu jitkompla sakemm il- pazjent jirkupra.
Although risperidone is a potent D2 antagonist, which is considered to improve the positive symptoms of schizophrenia, it causes less depression of motor activity and induction of catalepsy than classical antipsychotics.
Għalkemm risperidone huwa antagonist potenti ta ’ D2, li huwa kkunsidrat li jtejjeb sintomi pożittivi ta ’ skizofrenja, huwa jikkawża anqas dipressjoni u induzzjoni ta ’ katalessi minn antipsikotiċi klassiċi.
Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.
Antagoniżmu ċentrali ibbilanċjat ta ’ serotonin u dopamine jista ’ jnaqqas it- tendenza għal effetti sekondarji ekstrapiramidali u jkabbar l- attività terapewtika għas- sintomi negattivi u affettivi ta ’ l- iskizofrenja.
Pharmacodynamic effects
Effetti farmakodinamiċi.
The efficacy of risperidone in the short-term treatment of schizophrenia was established in four studies, 4- to 8-weeks in duration, which enrolled over 2500 patients who met DSM-IV criteria for schizophrenia.
L- effikaċja ta ’ risperidone f’ kura għal żmien qasir kienet stabbilita f’ erba ’ studji, li damu bejn 4 u 8 ġimgħat, li għalih kienu rreġistrati aktar minn 2500 pazjent li ssodisfaw il- kriterji DSM- IV għall - iskizofrenja.
In a 6- week, placebo-controlled trial involving titration of risperidone in doses up to 10 mg/ day administered twice daily, risperidone was superior to placebo on the Brief Psychiatric Rating Scale (BPRS) total score.
Fi prova ta ’ 6- ġimgħat ikkontrollata bi plaċebo li kienet tinvolvi titrazzjoni ta ’ risperidone f’ dożi sa 10 mg/ kuljum mogħtija darbtejn kuljum, risperidone kien superjuri għall- placebo mill- punteġġ totali miksub fuq l- iSkala tal- Klassifika Psikjatrika fil- Qosor (BPRS).
In an 8- week, placebo-controlled trial involving four fixed doses of risperidone (2, 6, 10, and 16 mg/ day, administered twice daily), all four risperidone groups were superior to placebo on the Positive and Negative Syndrome Scale (PANSS) total score.
Fi prova ta ’ 8 - ġimgħat ikkontrollata bi plaċebo li kienet tinvolvi erba ’ dożi fissi ta ’ risperidone ((2, 6, 10, u 16 mg/ kuljum, mogħtija darbtejn kuljum), l- erba ’ gruppi ta ’ risperidone kienu superjuri għall- plaċebo fil -
In an 8-week, dose comparison trial involving five fixed doses of risperidone (1, 4, 8, 12, and 16 mg/ day administered twice-daily), the 4, 8, and 16 mg/ day risperidone dose groups were superior to the 1 mg risperidone dose group on PANSS total score.
Fi prova ta ’ 8- ġimgħat ta ’ tqabbil tad- doża li kien jinvolvi ħames dożi fissi ta ’ risperidone (1, 4, 8, 12, u 16 mg/ kuljum, mogħtija darbtejn kuljum), il- gruppi ta ’ risperidone b’ dożi ta ’ 4, 8, u 16 mg/ kuljum kienu superjuri għall- grupp ta ’ risperidone b’ doża ta ’ 1mg fuq fil- punteġġ totali miksub f’ PANSS.
In a 4-week, placebo- controlled dose comparison trial involving two fixed doses of risperidone (4 and 8 mg/ day administered once daily), both risperidone dose groups were superior to placebo on several PANSS measures, including total PANSS and a response measure (> 20% reduction in PANSS total score).
Fi prova ta ’ tqabbil tad- doża ta ’ 4 ġimgħat ikkontrollata bi plaċebo li kienet tinvolvi żewġ dożi fissi ta ’ risperidone (4 u 8 mg/ kuljum mogħtija darba kuljum), iż- żewġ gruppi bid- doża ta ’ risperidone kienu superjuri għall - plaċebo fuq għadd ta ’ miżuri PANSS, inkluż it- total PANSS u t- tkejjil ta ’ rispons (tnaqqis ta ’ > 20% fil- punteġġ totali miksub f’ PANSS).
In a longer-term trial, adult outpatients predominantly meeting DSM-IV criteria for schizophrenia and who had been clinically stable for at least 4 weeks on an antipsychotic medicinal product were randomised to risperidone 2 to 8 mg/ day or to haloperidol for 1 to 2 years of observation for relapse.
Fi prova li tieħu aktar fit- tul, pazjenti adulti li ma ’ joqodux l - isptar u li l- maġġoranza tagħhom issodisfaw il- kriterji DSM- IV għal skiżofrenja u li kienu klinikament stabbli għal mill- anqas 4 ġimgħat fuq prodott mediċinali antipsikotika kienu randomised għal risperidone 2mg sa 8mg/ kuljum jew għal haloperidol għal bejn sena u sentejn biex jiġu osservati jekk jerġawx jirkadu.
Patients receiving risperidone experienced a significantly longer time to relapse over this time period compared to those receiving haloperidol.
Pazjenti li kienu qed jirċievu risperidone damu sinifikament aktar biex jirkadu f’ dan il- perjodu ta ’ żmien meta mqabbla ma ’ dawk li ħadu haloperidol.
Manic episodes in bipolar disorder
Episodji manijaċi f’ disturb bipolari
The efficacy of risperidone monotherapy in the acute treatment of manic episodes associated with bipolar I disorder was demonstrated in three double-blind, placebo-controlled monotherapy studies in approximately 820 patients who had bipolar I disorder, based on DSM-IV criteria.
L- effikaċja ta ’ monoterapija b’ risperidone fil- kura akuta ta ’ episodji ta ’ manija assoċjati ma ’ disturb bipolari I intweriet fi tliet studji ta ’ monoterapija double- blind ikkontrollati bi plaċebo f’ bejn wieħed u ieħor 820 pazjent li kellhom disturb bipolari I, ibbażat fuq il- kriterji DSM- IV.
In the three studies, risperidone 1 to 6 mg/ day (starting dose 3 mg in two studies and 2 mg in one study) was shown to be significantly superior to placebo on the pre-specified primary endpoint, i. e., the change from baseline in total Young Mania Rating
Fit- tliet studji, risperidone 1 sa 6 mg kuljum (doża tal- bidu ta ’ 3 mg f’ żewġ studji u ta ’ 2 mg fi studju wieħed) intwera li kien sinifikament superjuri għall- plaċebo fuq l- aħħar stadju ewlieni speċifikat minn qabel, i. e., il- bidla mill- linja bażi fil- Ġimgħa 3 fil- punti fuq l- iSkala tal- Klassifika tal- Manija fiż- Żgħar (YMRS).
Secondary efficacy outcomes were generally consistent with the primary outcome.
Ir- riżultat ta ’ l- effikaċja sekondarja kien ġeneralment konsistenti mar- riżultat primarju.
The percentage of patients with a decrease of ≥ 50% in total YMRS score from baseline to the 3-week endpoint was significantly higher for risperidone than for placebo.
Il - perċentwali ta ’ pazjenti bi tnaqqis ta ’ ≥ 50% tal- punteġġ totali YMRS mill- linja bażi sa l- aħħar stadju tat- 3- ġimgħa kien sinifikament ogħla għal risperidone milli għall- plaċebo.
One of the three studies included a haloperidol arm and a 9-week double-blind maintenance phase.
Wieħed mit- tliet studji kien jinkludi fergħa għal haloperidol u fażi ta ’ manteniment double- blind ta ’ 9- ġimgħat.
Efficacy was maintained throughout the 9-week maintenance treatment period.
L- effikaċja kienet miżmuma matul id- 9- ġimgħat tal- perjodu tal- manteniment tal- kura.
Change from baseline in total YMRS showed continued improvement and was comparable between risperidone and haloperidol at Week 12.
Bidla mill- linja bażi tat- total YMRS wera titjib kontinwu u kien kumparabbli bejn risperidone u haloperidol fil- Ġimgħa 12.
The efficacy of risperidone in addition to mood stabilisers in the treatment of acute mania was demonstrated in one of two 3-week double-blind studies in approximately 300 patients who met the DSM-IV criteria for bipolar I disorder.
L- effikaċja ta ’ risperidone flimkien ma ’ stabilizzaturi tal- burdata fil- kura ta ’ manija akuta ntweriet f’ wieħed minn żewġ studji double blind ta ’ 3- ġimgħat f’ bejn wieħed u ieħor 300 pazjent li ssodisfaw il- kriterji DSM- IV għal disturb bipolari I.
In one 3-week study, risperidone 1 to 6 mg/ day starting at 2 mg/ day in addition to lithium or valproate was superior to lithium or valproate alone on the pre-specified primary endpoint, i. e., the change from baseline in YMRS total score at Week 3.
F’ wieħed mill- istudji ta ’ 3- ġimgħat, risperidone bejn 1 sa 6 mg / kuljum mibdi b’ 2 mg/ kuljum flimkien ma ’ lithium jew valproate kien superjuri għal lithium jew valproate waħedhom fuq l- aħħar stadju ewlieni speċifikat minn qabel i. e., il- bidla mill- linja bażi tal - punteġġ totali ta ’ YMRS fil- Ġimgħa 3.
In a second 3-week study, risperidone 1 to 6 mg/ day starting at 2 mg/ day, combined with lithium, valproate, or carbamazepine was not superior to lithium, valproate, or carbamazepine alone in the reduction of YMRS total score.
Fit- tieni studju ta ’ 3- ġimgħat, risperidone bejn 1 sa 6 mg/ kuljum mibdi b’ 2 mg/ kuljum, mogħti flimkien ma ’ lithium, valproate, jew carbamazepine ma kienx superjuri għal lithium, valproate, jew carbamazepine mogħtija waħedhom fit- tnaqqis tal - punteġġ totali YMRS.
A possible explanation for the failure of this study was induction of risperidone and 9-hydroxy-risperidone clearance by carbamazepine, leading to subtherapeutic levels of risperidone and 9-hydroxy-risperidone.
Tifsira li jista ’ jkun hemm għall- falliment ta ’ dan l- istudju kienet l- induzzjoni tat- tneħħija ta ’ risperidone u ta ’ 9- hydroxy- risperidone minn carbamazepine li wassal għal livelli sottoterapewtiċi ta ’ risperidone u 9- hydroxy- risperidone.
When the carbamazepine group was excluded in a post-hoc analysis, risperidone combined with lithium or valproate was superior to lithium or valproate alone in the reduction of YMRS total score.
Meta l- grupp ta ’ carbamazepine ġie eskluż f’ analiżi post- hoc, risperidone mogħti flimkien ma ’ lithium jew valproate kien superjuri għal lithium jew valproate waħdu fit- tnaqqis tal- punteġġ totali YMRS.
Persistent aggression in dementia
Aggressjoni persistenti fid- dimenzja
The efficacy of risperidone in the treatment of Behavioural and Psychological Symptoms of Dementia (BPSD), which includes behavioural disturbances, such as aggressiveness, agitation, psychosis, activity, and affective disturbances was demonstrated in three double-blind, placebo-controlled studies in 1150 elderly patients with moderate to severe dementia.
L- effikaċja ta ’ risperidone fil- kura tas- Sintomi tal- Komportament u Psikoloġiċi tad- Dimenzja (BPSD), li jinkludu disturbi fil- komportament, bħal aggressjoni, aġitazzjoni, psikosi, disturbi ta ’ l- attività u affettivi intwerew fi studji double- blind u kkontrollati bi plaċebo, f’ 1150 pazjent anzjan bid- dimenzja moderata sa qawwija.
One study included fixed risperidone doses of 0.5, 1, and 2 mg/ day.
Studju wieħed kien jinkludi dożi fissi ta ’ risperidone ta ’ 0. 5, 1, u 2 mg/ kuljum.
Two flexible-dose studies included risperidone dose groups in the range of 0.5 to 4 mg/ day and 0.5 to 2 mg/ day, respectively.
Żewġ studji b’ doża flessibbli inkludew gruppi ta ’ dożi ta ’ risperidone fuq medda ta ’ 0. 5 sa 4 mg/ kuljum u 0. 5 sa 2 mg/ kuljum rispettivament.
Risperidone showed statistically significant and clinically important effectiveness in treating aggression and less consistently in treating agitation and psychosis in elderly dementia patients (as measured by the Behavioural Pathology in Alzheimer’ s Disease Rating Scale [BEHAVE-AD] and the Cohen-Mansfield Agitation Inventory [CMAI]).
Risperidone wera effett statistikament sinifikanti u klinikament importanti fil- kura ta ’ aggressjoni u b’ anqas konsistenza fil- kura ta ’ aġitazzjoni u psikosi f’ pazjenti anzjani bid- dimenzja (kif imkejjel fuq l- iSkala li Tikklassifika il- Patologija tal - Komportament fil- Marda ta ’ Alzheimer [BEHAVE- AD] u l- Inventarju ta ’ Agitazzjoni Cohen - Mansfield [CMAI]).
The treatment effect of risperidone was independent of Mini-Mental State Examination (MMSE) score (and consequently of the severity of dementia); of sedative properties of risperidone; of the presence or absence of psychosis; and of the type of dementia, Alzheimer’ s, vascular, or mixed.
71 sedattivi ta ’ risperidone; mill- preżenza jew nuqqas ta ’ psikosi; u mit- tip ta ’ dimenzja, ta ’ Alzheimer, vaskulari, jew imħallta.
(See also section 4.4)
(Ara wkoll sezzjoni 4. 4)
Conduct disorder
Disturbi ta ’ l- imġiba
The efficacy of risperidone in the short-term treatment of disruptive behaviours was demonstrated in two double-blind placebo-controlled studies in approximately 240 patients 5 to 12 years of age with a DSM-IV diagnosis of disruptive behaviour disorders (DBD) and borderline intellectual functioning or mild or moderate mental retardation/ learning disorder.
L- effikaċja ta ’ risperidone fil- kura għall- żmien qasir ta ’ komportamenti diżordnati intweriet f’ żewġ studji double- blind ikkontrollati bi plaċebo f’ madwar 240 pazjent minn 5 sa 12- il sena b’ dijanjosi DSM- IV ta ’ disturbi ta ’ komportament diżordnat (DBD) u funzjoni intellettwali kemm kemm normali jew ritardar mentali/ disturb fit- tgħalim ħafif jew moderat.
In the two studies, risperidone 0.02 to 0.06 mg/ kg/ day was significantly superior to placebo on the pre-specified primary endpoint, i. e., the change from baseline in the Conduct Problem subscale of the Nisonger-Child Behaviour Rating Form (N-CBRF) at Week 6.
Fiż- żewġ studji, risperidone 0. 02 sa 0. 06 mg/ kg/ kuljum kien sinifikament superjuri għall- plaċebo fl- aħħar stadju ewlieni speċifikat minn qabel, i. e., il- bidla mill- linja bażi fis- sottoskala ta ’ Problema ta ’ Imġieba tal- Formola ta ’ Klassifika Nisonger ta ’ Komportament tat- Tfal (N- CBRF) fis- 6 Ġimgħa.
RISPERDAL orodispersible tablets and oral solution are bio-equivalent to RISPERDAL film-coated tablets.
Il- pilloli RISPERDAL li inħallu fil- ħalq u s- soluzzjoni orali huma bio- ekwivalenti għall- pilloli RISPERDAL miksijin b’ rita.
Risperidone is metabolised to 9-hydroxy-risperidone, which has a similar pharmacological activity to risperidone (see Biotransformation and Elimination).
Risperidone jiġi mmetabolizzat għal 9- hydroxy- risperidone li għandu attività farmakoloġika tixbah lil dik ta ’ risperidone (ara Biotrasformazzjoni u Eliminazzjoni).
67 Absorption
Assorbiment
Risperidone is completely absorbed after oral administration, reaching peak plasma concentrations within 1 to 2 hours.
Risperidone jiġi assorbit kompletament wara li jittieħed mill- ħalq u jilħaq l- ogħla konċentrazzjonijiet fil- plażma fi żmien siegħa sa sagħtejn.
The absolute oral bioavailability of risperidone is 70% (CV=25%).
Il- biodisponibbiltà orali assoluta ta ’ risperidone hija 70% (CV=25%).
The relative oral bioavailability of risperidone from a tablet is 94% (CV=10%) compared with a solution.
Il- biodisponibbiltà orali relattiva minn pillola hija 94% (CV=10%) meta mqabbla mas - soluzzjoni.
The absorption is not affected by food and thus risperidone can be given with or without meals.
L- istat fiss ta ’ risperidone jintlaħaq fi żmien jum fil- biċċa l- kbira tal- pazjenti.
Steady-state of 9-hydroxy-risperidone is reached within 4-5 days of dosing.
L- istat fiss ta ’ 9- hydroxy- risperidone jintlaħaq wara 4- 5 ijiem ta ’ dożi mogħtija kuljum.
Risperidone is rapidly distributed.
Risperidone jiġi distribwit malajr.
In plasma, risperidone is bound to albumin and alpha1-acid glycoprotein.
Fil- plażma, risperidone jeħel ma ’ l- albumin u ma ’ alpha1- acid glycoprotein.
The plasma protein binding of risperidone is 90%, that of 9-hydroxy- risperidone is 77%.
It- twaħħil ta ’ risperidone mal- proteini tal- plażma huwa ta ’ 90%, dak ta ’ 9- hydroxy- risperidone huwa 77%.
Biotransformation and elimination
Biotransformazzjoni u eliminazzjoni
Risperidone is metabolised by CYP 2D6 to 9-hydroxy-risperidone, which has a similar pharmacological activity as risperidone.
Risperidone huwa immetabolizzat minn CYP 2D6 f’ 9- hydroxy- risperidone, li għandu attività farmakoloġika tixbah dik ta ’ risperidone.
Although extensive metabolisers have lower risperidone and higher 9-hydroxy-risperidone concentrations than poor metabolisers, the pharmacokinetics of risperidone and 9-hydroxy-risperidone combined (i. e., the active antipsychotic fraction), after single and multiple doses, are similar in extensive and poor metabolisers of CYP 2D6.
Minkejja li metabolizzaturi estensivi jkollhom konċentrazzjonijiet ta ’ risperidone aktar baxxi u ta ’ 9- hydroxy- risperidone aktar għoljin minn metabolizzaturi nieqsa, il - farmakokinetika ta ’ risperidone u ta ’ 9- hydroxy- risperidone flimkien (i. e., il- porzjon antipsikotiku attiv), wara doża waħda u ħafna dożi, jixtiebhu f’ metabolizzatturi ta ’ CYP 2D6 estensivi u nieqsa.
Another metabolic pathway of risperidone is N-dealkylation.
Mogħdija metabolika oħra ta ’ risperidone hija N- dealkylation.
In vitro studies in human liver microsomes showed that risperidone at clinically relevant concentration does not substantially inhibit the metabolism of medicines metabolised by cytochrome P450 isozymes, including CYP 1A2, CYP 2A6, CYP 2C8/ 9/ 10, CYP 2D6, CYP 2E1, CYP 3A4, and CYP 3A5.
Studji in vitro fil- mikrosomi tal- fwied uman urew li risperidone f’ konċentrazzjoni klinika rilevanti ma ’ jimpedixxix b’ mod sostanzjali l - metaboliżmu tal- mediċini mmetabolizzati bl- isozimi taċ- ċitokroma P450, inkluż CYP 1A2, CYP 2A6, CYP 2C8/ 9/ 10, CYP 2D6, CYP 2E1, CYP 3A4, u CYP 3A5.
One week after administration, 70% of the dose is excreted in the urine and 14% in the faeces.
Ġimgħa wara l- għoti 70% tad- doża titneħħa fl- awrina u 14% ma ’ l- ippurgar.
In urine, risperidone plus 9-hydroxy-risperidone represent 35-45% of the dose.
Fl- awrina, risperidone flimkien ma ’ 9- hydroxy- risperidone jirrapreżentaw 35- 45% tad- doża.
After oral administration to psychotic patients, risperidone is eliminated with a half-life of about 3 hours.
Wara li jingħata mill- ħalq lill- pazjenti psikotiċi, risperidone jiġi eliminat b’ half- life ta ’ madwar 3 sigħat.
The elimination half-life of 9-hydroxy-risperidone and of the active antipsychotic fraction is 24 hours.
Il- half- life ta ’ eliminazzjoni ta ’ 9- hydroxy- risperidone u tal- porzjon antipsikotiku attiv hija 24 siegħa.
Linearity
72 Linearità
Risperidone plasma concentrations are dose-proportional within the therapeutic dose-range.
Konċentrazzjonijiet ta ’ risperidone fil- plażma huma fi proporzjon mad- doża fil- medda tad- doża terapewtika.
Elderly, hepatic and renal impairment
Anzjani, indeboliment epatiku u renali
A single-dose study showed on average a 43% higher active antipsychotic fraction plasma concentrations, a 38% longer half-life and a reduced clearance of the active antipsychotic fraction by 30% in the elderly. Higher active antipsychotic fraction plasma concentrations and a reduced clearance of the active antipsychotic fraction by on average 60% were observed in patients with renal insufficiency.
Konċentrazzjonijiet ogħla tal- porzjon antipsikotiku attiv fil- plażma u tnaqqis fit - tneħħija tal- porzjon antipsikotiku attiv b’ medja ta ’ 60% kienu osservati f’ pazjenti b’ insuffiċjenza renali.
The pharmacokinetics of risperidone, 9-hydroxy-risperidone and the active antipsychotic fraction in children are similar to those in adults.
Il- farmakokinetika ta ’ risperidone, 9- hydroxy- risperidone u tal- porzjon antipsikotiku attiv fit- tfal tixbah lill dik fl- adulti.
68 Gender, race and smoking habits
Sess, razza u tipjip
A population pharmacokinetic analysis revealed no apparent effect of gender, race or smoking habits on the pharmacokinetics of risperidone or the active antipsychotic fraction.
Analiżi farmakokinetika ta ’ popolazzjoni ma wriet l- ebda effett evidenti ta ’ sess, razza jew tipjip fuq il- farmakokinetika ta ’ risperidone jew il- porzjon antipsikotiku attiv.
In (sub)chronic toxicity studies, in which dosing was started in sexually immature rats and dogs, dose- dependant effects were present in male and female genital tract and mammary gland.
Fi studji tossikoloġiċi (sotto) kroniċi, fejn inbdew dożi fi klieb u firien sesswalment immaturi, effetti dipendenti mid- doża kienu preżenti fil- passaġġ ġenitali u l- glandoli mammarji ta ’ l- irġiel u tan- nisa.
These effects were related to the increased serum prolactin levels, resulting from the dopamine D2-receptor blocking activity of risperidone.
Dawn l- effetti kellhom x’ jaqsmu ma ’ livelli ta ’ prolactin ogħla fis- serum, li kienu ġejjin mill- attività ta ’ imblukkar tar- riċetturi D2 tad- dopamine ta ’ risperidone.
In addition, tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Flimkien ma ’ dan studji fuq kolturi ta ’ tessuti issuġġerew li t- tkabbir taċ- ċelluli fit- tumuri tas- sider uman jistgħu jkunu stimulati minn prolactin.
Risperidone was not teratogenic in rat and rabbit.
Risperidone ma kienx teratoġeniku fil- far u fil- fenek.
In rat reproduction studies with risperidone, adverse effects were seen on mating behaviour of the parents, and on the birth weight and survival of the offspring.
Fi studji ta ’ riproduzzjoni fil- firien b’ risperidone, ġew osservati effetti avversi fuq l- imġiba ta ’ tgħammir tal- ġenituri, u fuq il- piż tat - twelid u s- sopravivenza tal- frieħ.
In rats, intrauterine exposure to risperidone was associated with cognitive deficits in adulthood.
Fil- firien, esponiment fl- utru għal risperidone kien assoċjat ma ’ defiċjenzi konoxxittivi meta dawn saru adulti.
Risperidone was not genotoxic in a battery of tests.
Risperidone ma kienx ġenotossiku f’ serje ta ’ testijiet.
These tumours can be related to prolonged dopamine D2 antagonism and hyperprolactinaemia.
Dawn it - tumuri jista ’ jkollhom x’ jaqsmu ma ’ antagoniżmu fit- tul għad- dopamina D2 u iperprolaktinimja.
The relevance of these tumour findings in rodents in terms of human risk is unknown.
Ir - rilevanza ta ’ dawn l- osservazzjonijiet ta ’ tumuri f’ annimal gerriema f’ termini ta ’ riskju lill- bniedem mhix magħrufa.
6.3 Shelf life
73 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Oro-dispersible Tablets (see section 4.2)
Pilloli li Jinħallu fil- Ħalq (ara sezzjoni 4. 2)
The bottle comes with a child- resistant cap, and should be opened as follows: – Push the plastic screw cap down while turning it counter clockwise. – Remove the unscrewed cap.
Il- flixkun jiġi b’ tapp li ma jinfetaħx mit- tfal, u għandu jinfetaħ kif ġej: – Agħfas it- tapp tal- plastik li fih kamin l- isfel filwaqt li ddawwru lejn il- lemin. – Neħħi t- tapp miftuħ.
Insert the pipette into the bottle.
Daħħal il- pipetta fil- flixkun.
While holding the bottom ring, pull the top ring up to the mark that corresponds to the number of millilitres or milligrams you need to give.
Filwaqt li żżomm iċ- ċirku ta ’ taħt iġbed iċ- ċirku ta ’ fuq sal- marka li taqbel man- numru ta ’ millilitri jew milligrammi li għandek bżonn tagħti.
Holding the bottom ring, remove the entire pipette from the bottle.
Filwaqt li żżomm iċ- ċirku ta ’ taħt neħħi l- pipetta kollha mill- flixkun.
Empty the pipette into any non- alcoholic drink, except for tea, by sliding the upper ring down.
Battal il- pipetta f’ xarba mhux alkoħolika, minbarra fit- té, billi żżeraq iċ- ċirku ta ’ fuq l- isfel.
Close the bottle.
Agħlaq il- flixkun.
Rinse the pipette with some water.
Laħlaħ il - pipetta bi ftit ilma.
See Annex I - To be completed nationally
Ara Anness I - Biex timtela mill- pajjiż partikolari.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
70 LABELLING
75 TIKKETTA
Carton for PVC-PE-PVDC/ Al blister
Kartuna għall- folja PVC- PE- PVDC/ Al
RISPERDAL and associated names (see Annex I) 0.25 mg film-coated tablets
RISPERDAL u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 0. 25 mg miksijin b’ rita
72 {Name and Address}
{Isem u indirizz}
[To be completed nationally]
Biex timtela mill- pajjiż partikolari]
RISPERDAL and associated names (see Annex I) 0.5 mg film-coated tablet
RISPERDAL u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 0. 5 mg miksijin b’ rita
74 {Name and Address}
{Isem u indirizz}
RISPERDAL and associated names (see Annex I) 1 mg film-coated tablets
RISPERDAL u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 1 mg miksijin b’ rita
76 {Name and Address}
{Isem u indirizz}
77 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
82 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
RISPERDAL and associated names (see Annex I) 2 mg film-coated tablets
RISPERDAL u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 2 mg miksijin b’ rita
[To be completed nationally].
[Biex timtela mill- pajjiż partikolari.]
78 {Name and Address}
{Isem u indirizz}
RISPERDAL and associated names (see Annex I) 3 mg film-coated tablets
RISPERDAL u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 3 mg miksijin b’ rita
80 {Name and Address}
{Isem u indirizz}
81 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
86 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
RISPERDAL and associated names (see Annex I) 4 mg film-coated tablets
RISPERDAL u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 4 mg miksijin b’ rita
82 {Name and Address}
{Isem u indirizz}
[To be completed nationally]
[Biex timtela mill- pajjiż partikolari
83 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
88 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
RISPERDAL and associated names (see Annex I) 6 mg film-coated tablets
RISPERDAL u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 6 mg miksijin b’ rita
84 {Name and Address}
{Isem u indirizz}
85 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
90 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
PVC-PE-PVDC/ Al blister
Folja PVC- PE- PVDC/ Al
RISPERDAL and associated names (see Annex I) 0.25 mg film-coated tablets RISPERDAL and associated names (see Annex I) 0.5 mg film-coated tablets RISPERDAL and associated names (see Annex I) 1 mg film-coated tablets RISPERDAL and associated names (see Annex I) 2 mg film-coated tablets RISPERDAL and associated names (see Annex I) 3 mg film-coated tablets RISPERDAL and associated names (see Annex I) 4 mg film-coated tablets RISPERDAL and associated names (see Annex I) 6 mg film-coated tablets
RISPERDAL u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 0. 25 mg miksijin b’ rita RISPERDAL u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 0. 5 mg miksijin b’ rita RISPERDAL u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 1 mg miksijin b’ rita RISPERDAL u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 2 mg miksijin b’ rita RISPERDAL u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 3 mg miksijin b’ rita RISPERDAL u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 4 mg miksijin b’ rita RISPERDAL u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 6 mg miksijin b’ rita
PVC-PE-PVDC/ Al blister [6 mg calendar pack only]
Folja PVC- PE- PVDC/ Al [pakkett bil- ġranet tal- ġimgħa ta ’ 6 mg biss]
[Abbreviation for 7 days of the week.]
[Taqsira għas- 7 ġranet tal- ġimgħa.]
87 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
92 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Plastic bottle
Flixkun tal- plastik
RISPERDAL and associated names (see Annex I) 0.5 mg film-coated tablets
RISPERDAL u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 0. 5 mg miksijin b’ rita
Film-coated tablet [To be completed nationally.]
Pillola miksija b’ rita [Biex timtela mill- pajjiż partikolari]
88 [To be completed nationally.]
[Biex timtela mill- pajjiż partikolari]
89 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
94 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Film-coated tablet [To be completed nationally.]
[Biex timtela mill- pajjiż partikolari]
91 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
96 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT