natgillin/translations-raw huggingface dataset:
Kontrollér visuelt, at kanylen er helt inde i kanylebeskyttelseshylsteret.
Risperidone was not teratogenic in animal studies but other types of reproductive toxicity were seen (see section 5.3).
Kassér straks på passende måde.
The potential risk for humans is unknown.
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
Therefore, RISPERDAL CONSTA should not be used during pregnancy unless clearly necessary.
43 7.
Lactation
[Se Bilag I - udfyldes nationalt]
There are no data available on adverse effects in breast-feeding infants.
{Navn og adresse}
26 4.7 Effects on ability to drive and use machines
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
RISPERDAL CONSTA has minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects (see section 4.8).
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/ FORNYELSE AF TILLADELSEN
Therefore, patients should be advised not to drive or operate machinery until their individual susceptibility is known.
[Udfyldes nationalt]
4.8 Undesirable effects
DATO FOR ÆNDRING AF TEKSTEN
The most frequently reported adverse drug reactions (ADRs) (incidence ≥ 1/ 10) are:
RISPERDAL CONSTA og associerede navne (se Bilag I) 12, 5 mg pulver og solvens til depotinjektionsvæske, suspension til intramuskulær injektion
Insomnia, anxiety, headache, upper respiratory tract infection, parkinsonism, depression, and akathisia.
ANGIVELSE AF AKTIVT STOF/ AKTIVE STOFFER
The following are all the ADRs that were reported in clinical trials and postmarketing.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE)
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/ 1,000), very rare (< 1/ 10,000), and not known (cannot be estimated from the available clinical trial data).
[Udfyldes nationalt]
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Kun til intramuskulær brug.
27 Adverse Drug Reactions by System Organ Class and Frequency Category Investigations Common
ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
Electrocardiogram abnormal, Blood prolactin increaseda, Blood glucose increased, Hepatic enzyme increased, Transaminases increased, Gamma-glutamyltransferase increased, Weight increased, Weight decreased
Opbevares utilgængeligt for børn.
Uncommon Cardiac disorders
EVENTUELLE ANDRE SÆRLIGE ADVARSLER
Electrocardiogram QT prolonged
UDLØBSDATO
Common Uncommon
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
Atrioventricular block, Tachycardia Bundle branch block, Atrial fibrillation, Bradycardia, Sinus bradycardia, Palpitations
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
Blood and lymphatic system disorders Common Uncommon Not known
[Se Bilag I – udfyldes nationalt]
Anaemia Thrombocytopenia, Neutropenia Agranulocytosis
{Navn og adresse}
Nervous system disorders Very common Common
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
Parkinsonismb, Akathisiab, Headache Dizziness, Sedation, Somnolence, Tremor, Dystoniab, Tardive dyskinesia, Dyskinesiab
[Udfyldes nationalt]
Uncommon Eye disorders
GENEREL KLASSIFIKATION FOR UDLEVERING
Convulsion, Syncope, Dizziness postural, Hypoaesthesia, Paraesthesia, Lethargy, Hypersomnia
[Udfyldes nationalt]
Common Not known
INSTRUKTIONER VEDRØRENDE ANVENDELSEN
Vision blurred, Conjunctivitis Retinal artery occlusion
INFORMATION I BRAILLE- SKRIFT
Ear and labyrinth disorders Common Uncommon
[Udfyldes nationalt]
Vertigo Ear pain
47 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
Respiratory, thoracic and mediastinal disorders Common Rare
Ydre karton (pakning med 3- nåls- system)
Dyspnoea, Cough, Nasal congestion, Pharyngolaryngeal pain Sleep apnea syndrome
LÆGEMIDLETS NAVN
Gastrointestinal disorders Common
RISPERDAL CONSTA og associerede navne (se Bilag I) 12, 5 mg pulver og solvens til depotinjektionsvæske, suspension til intramuskulær injektion
Vomiting, Diarrhoea, Constipation, Nausea, Abdominal pain, Dyspepsia, Toothache, Dry mouth, Stomach discomfort, Gastritis
Risperidon
Rare
ANGIVELSE AF AKTIVT STOF/ AKTIVE STOFFER
Intestinal obstruction, Pancreatitis
LISTE OVER HJÆLPESTOFFER
Renal and urinary disorders Common
[Udfyldes nationalt]
Urinary incontinence
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE)
Skin and subcutaneous tissue disorders Common Uncommon
Pulver og solvens til depotinjektionsvæske, suspension.
Rash, Eczema Angioedema, Pruritus, Acne, Alopecia, Dry skin
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ( E)
Musculoskeletal and connective tissue disorders Common Uncommon Endocrine disorders
Kun til intramuskulær brug.
Arthralgia, Back pain, Pain in extremity, Myalgia Muscular weakness, Neck pain, Buttock pain, Musculoskeletal chest pain
6.
Rare
Opbevares utilgængeligt for børn.
Inappropriate antidiuretic hormone secretion
EVENTUELLE ANDRE SÆRLIGE ADVARSLER
Metabolism and nutrition disorders Uncommon Very rare Not known
SÆRLIGE OPBEVARINGSBETINGELSER
Increased appetite, Decreased appetite Diabetic ketoacidosis Water intoxication
[Udfyldes nationalt]
Infections and infestations Very common Common
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF
Upper respiratory tract infection Pneumonia, Influenza, Lower respiratory tract infection, Bronchitis, Urinary tract infection, Ear infection, Sinusitis, Viral infection
48 UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
Uncommon
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
Cystitis, Gastroenteritis, Infection, Localised infection, Subcutaneous abscess
[Se Bilag I – udfyldes nationalt]
28 Injury, poisoning and procedural complications
{Navn og adresse}
Common Uncommon
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
Fall Procedural pain
[Udfyldes nationalt]
Vascular disorders
FREMSTILLERENS BATCHNUMMER
Common Uncommon
GENEREL KLASSIFIKATION FOR UDLEVERING
Hypertension, Hypotension Orthostatic hypotension
INSTRUKTIONER VEDRØRENDE ANVENDELSEN
General disorders and administration site conditions
16.
Common
49 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
Pyrexia, Peripheral oedema, Chest pain, Fatigue, Pain, Injection site pain, Asthenia, Influenza like illness
LÆGEMIDLETS NAVN
Uncommon
RISPERDAL CONSTA og associerede navne (se Bilag I) 12, 5 mg pulver og solvens til depotinjektionsvæske, suspension til intramuskulær injektion
Feeling abnormal, Chest discomfort, Induration, Injection site induration, Sluggishness, Injection site reaction
[Se Bilag I – udfyldes nationalt]
Rare
Risperidon
Hypothermia
ANGIVELSE AF AKTIVT STOF/ AKTIVE STOFFER
Immune system disorders
[Udfyldes nationalt]
Uncommon Not known
LISTE OVER HJÆLPESTOFFER
Hypersensitivity Anaphylactic reaction
[Udfyldes nationalt]
Hepatobiliary disorders
4.
Rare
[Udfyldes nationalt]
Jaundice
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ( E)
Reproductive system and breast disorders
Kun til intramuskulær brug.
Common Uncommon Not known
ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
Amenorrhoea, Erectile dysfunction, Galactorrhoea Sexual dysfunction, Gynaecomastia Priapism
Opbevares utilgængeligt for børn.
Psychiatric disorders
7.
a
UDLØBSDATO EXP:
Very common Common Uncommon
SÆRLIGE OPBEVARINGSBETINGELSER
Depression, Insomnia, Anxiety Agitation, Sleep disorder Mania, Libido decreased, Nervousness
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF
Hyperprolactinemia can in some cases lead to gynaecomastia, menstrual disturbances, amenorrhoea, galactorrhea. b Extrapyramidal disorder may occur:
50 UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
Tremor includes tremor and parkinsonian rest tremor.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
It should be noted that a broader spectrum of symptoms are included, that do not necessarily have an extrapyramidal origin.
[Se Bilag I – udfyldes nationalt]
The following is a list of additional ADRs associated with risperidone that have been identified as ADRs during clinical trials investigating the oral risperidone formulation (RISPERDAL) but were not determined to be ADRs in the clinical trials investigating RISPERDAL CONSTA.
{Navn og adresse}
Additional Adverse Drug Reactions Reported With Oral RISPERDAL but not With RISPERDAL CONSTA by System Organ Class Investigations Body temperature increased, Eosinophil count increased, White blood cell count decreased, Haemoglobin decreased, Blood creatine phosphokinase increased, Body temperature decreased Infections and Infestations Tonsillitis, Cellulitis, Otitis media, Eye infection, Acarodermatitis, Respiratory tract infection, Onychomycosis, Otitis media chronic Blood and Lymphatic Disorders Granulocytopenia
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
29 Immune System Disorders Drug hypersensitivity Metabolism and Nutrition Disorders Anorexia, Polydipsia Psychiatric Disorders Confusional state, Listless, Anorgasmia, Blunted affect Nervous System Disorders Unresponsive to stimuli, Loss of consciousness, Neuroleptic malignant syndrome, Diabetic coma, Cerebrovascular accident, Depressed level of consciousness, Cerebral ischemia, Cerebrovascular disorder, Transient ischemic attack, Dysarthria, Disturbance in attention, Balance disorder, Speech disorder, Coordination abnormal, Movement disorder Eye Disorders Ocular hyperemia, Eye discharge, Eye swelling, Dry eye, Lacrimation increased, Photophobia, Visual acuity reduced, Eye rolling, Glaucoma Ear and Labyrinth Disorders Tinnitus Vascular Disorders Flushing Respiratory, Thoracic, and Mediastinal Disorders Wheezing, Pneumonia aspiration, Pulmonary congestion, Respiratory disorder, Rales, Epistaxis, Respiratory tract congestion, Hyperventilation, Dysphonia Gastrointestinal Disorders Dysphagia, Faecal incontinence, Faecaloma, Lip swelling, Cheilitis Skin and Subcutaneous Tissue Disorders Skin lesion, Skin disorder, Skin discoloration, Seborrheic dermatitis, Hyperkeratosis, Dandruff, Erythema Musculoskeletal, Connective Tissue, and Bone Disorders Rhabdomyolysis, Joint swelling, Posture abnormal, Joint stiffness Renal and Urinary Disorders Enuresis, Dysuria, Pollakiuria Reproductive System and Breast Disorders Ejaculation disorder, Vaginal discharge, Menstrual disorder General Disorders and Administration Site Conditions Generalised oedema, Face oedema, Gait disturbance, Thirst, Chills, Peripheral coldness, Drug withdrawal syndrome
[Udfyldes nationalt]
Class effects
FREMSTILLERENS BATCHNUMMER
As with other antipsychotics, very rare cases of QT prolongation have been reported postmarketing with risperidone.
LOT:
Weight gain
GENEREL KLASSIFIKATION FOR UDLEVERING
In the 1-year, open-label study of RISPERDAL CONSTA, changes in body weight in individual patients were generally within ±7% from baseline; 25% of patients had an increase in body weight of ≥ 7%.
[Udfyldes nationalt]
4.9 Overdose
INSTRUKTIONER VEDRØRENDE ANVENDELSEN
While overdose is less likely to occur with parenteral than with oral medicinal products, information pertaining to oral is presented.
[Udfyldes nationalt]
30 Symptoms
51 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
In general, reported signs and symptoms have been those resulting from an exaggeration of the known pharmacological effects of risperidone.
Hætteglas med pulver til suspension til injektion (alle pakninger)
These include drowsiness and sedation, tachycardia and hypotension, and extrapyramidal symptoms.
LÆGEMIDLETS NAVN, STYRKE OG/ ELLER ADMINISTRATIONSVEJ( E)
In overdose, QT-prolongation and convulsions have been reported.
RISPERDAL CONSTA og associerede navne (se Bilag I) 12, 5 mg pulver til depotinjektionsvæske, suspension til intramuskulær injektion
Torsade de Pointes has been reported in association with combined overdose of oral RISPERDAL and paroxetine.
[Se Bilag I – udfyldes nationalt]
In case of acute overdose, the possibility of multiple drug involvement should be considered.
Risperidon
Treatment
ANVENDELSESMÅDE
Establish and maintain a clear airway and ensure adequate oxygenation and ventilation.
Læs indlægssedlen inden brug.
There is no specific antidote to RISPERDAL.
UDLØBSDATO
PHARMACOLOGICAL PROPERTIES
BATCHNUMMER
5.1 Pharmacodynamic properties
LOT:
Pharmacotherapeutic group:
INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
Other antipsychotics, ATC code:
ANDET
N05AX08
[Udfyldes nationalt]
Mechanism of action
52 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
It has a high affinity for serotoninergic 5-HT2 and dopaminergic D2 receptors.
Fyldt injektionssprøjte (alle pakninger)
Clinical efficacy The effectiveness of RISPERDAL CONSTA (25 mg and 50 mg) in the management of the manifestations of psychotic disorders (schizophrenia/ schizoaffective disorder) was established in one 12-week, placebo-controlled trial in adult psychotic inpatients and outpatients who met the DSM-IV criteria for schizophrenia.
LÆGEMIDLETS NAVN, STYRKE OG/ ELLER ADMINISTRATIONSVEJ( E)
Over time efficacy was maintained with RISPERDAL CONSTA (Figure 1).
BATCHNUMMER
31 Figure 1.
INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
Mean in total PANSS score over time (LOCF) in patients with schizophrenia.
[Udfyldes nationalt]
90 Placebo RIS 25 mg RIS 50 mg
ANDET
85 80 Mean
1.
75 70 65
Risperidon
Base
10.
10
12.
12
LOT:
Endpt
15.
Week
INFORMATION I BRAILLE- SKRIFT
5.2 Pharmacokinetic properties
55 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
Absorption The absorption of risperidone from RISPERDAL CONSTA is complete.
RISPERDAL CONSTA og associerede navne (se Bilag I) 25 mg pulver og solvens til depotinjektionsvæske, suspension til intramuskulær injektion
After a single intramuscular injection with RISPERDAL CONSTA, the release profile consists of a small initial release of risperidone (< 1% of the dose), followed by a lag time of 3 weeks.
3.
The main release of risperidone starts from Week 3 onwards, is maintained from 4 to 6 weeks, and subsides by Week 7.
LISTE OVER HJÆLPESTOFFER
Oral antipsychotic supplementation should therefore be given during the first 3 weeks of RISPERDAL CONSTA treatment (see section 4.2).
[Udfyldes nationalt]
The combination of the release profile and the dosage regimen (intramuscular injection every two weeks) results in sustained therapeutic plasma concentrations.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE)
Therapeutic plasma concentrations remain until 4 to 6 weeks after the last RISPERDAL CONSTA injection.
[Udfyldes nationalt]
After repeated intramuscular injections with 25 or 50 mg RISPERDAL CONSTA every two weeks, median trough and peak plasma concentrations of the active antipsychotic fraction fluctuated between 9.9-19.2 ng/ ml and 17.9-45.5 ng/ ml respectively.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ( E)
No accumulation of risperidone was observed during long term use (12 months) in patients who were injected with 25– 50 mg every two weeks.
Læs indlægssedlen inden brug.
Distribution Risperidone is rapidly distributed.
Kun til intramuskulær brug.
The volume of distribution is 1-2 l/ kg.
ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
In plasma, risperidone is bound to albumin and alpha-1-acid glycoprotein.
Opbevares utilgængeligt for børn.
The plasma protein binding of risperidone is 90%; that of the active metabolite 9-hydroxy-risperidone is 77%.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER
Biotransformation and elimination Risperidone is metabolised by CYP 2D6 to 9-hydroxy-risperidone, which has a similar pharmacological activity as risperidone.
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF
Risperidone plus 9-hydroxy-risperidone form the active antipsychotic fraction.
56 UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
CYP 2D6 is subject to genetic polymorphism.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
Extensive CYP 2D6 metabolisers convert risperidone rapidly into 9-hydroxy-risperidone, whereas poor CYP 2D6 metabolisers convert it much more slowly.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
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.
FREMSTILLERENS BATCHNUMMER
32 Another metabolic pathway of risperidone is N-dealkylation.
GENEREL KLASSIFIKATION FOR UDLEVERING
One week after oral risperidone administration, 70% of the dose is excreted in the urine and 14% in the faeces.
INSTRUKTIONER VEDRØRENDE ANVENDELSEN
In urine, risperidone plus 9-hydroxy-risperidone represent 35-45% of the orally administered dose.
INFORMATION I BRAILLE- SKRIFT
The remainder is inactive metabolites.
Ydre karton (pakning med Alaris og separat opbevaring til solvens)
The elimination phase is complete approximately 7 to 8 weeks after the last RISPERDAL CONSTA injection.
RISPERDAL CONSTA og associerede navne (se Bilag I) 25 mg pulver og solvens til depotinjektionsvæske, suspension til intramuskulær injektion
Linearity The pharmacokinetics of risperidone following single doses of RISPERDAL CONSTA are linear in the dose range of 12.5-75 mg.
ANGIVELSE AF AKTIVT STOF/ AKTIVE STOFFER
The pharmacokinetics of risperidone are also linear in the dose range of 25-50 mg injected every 2 weeks.
[Udfyldes nationalt]
Elderly, hepatic and renal impairment A single-dose pharmacokinetic study with oral risperidone 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.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE)
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.
[Udfyldes nationalt]
Risperidone plasma concentrations were normal in patients with liver insufficiency, but the mean free fraction of risperidone in plasma was increased by about 35%.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ( E)
Pharmacokinetic/ pharmacodynamic relationship There was no relationship between the plasma concentrations of the active antipsychotic fraction and the change in total PANSS (Positive And Negative Syndrome Scale) and total ESRS (Extrapyramidal Symptom Rating Scale) scores across the assessment visits in any of the phase-III trials where efficacy and safety was examined.
Kun til intramuskulær brug.
Gender, race and smoking habits A population pharmacokinetic analysis revealed no apparent effect of gender, race or smoking habits on the pharmacokinetics of risperidone or the active antipsychotic fraction.
Opbevares utilgængeligt for børn.
5.3 Preclinical safety data
EVENTUELLE ANDRE SÆRLIGE ADVARSLER
Similar to the (sub)chronic toxicity studies with oral risperidone in rats and dogs, the major effects of treatment with RISPERDAL CONSTA (up to 12 months of intramuscular administration) were prolactin-mediated mammary gland stimulation, male and female genital tract changes, and central nervous system (CNS) effects, related to the pharmacodynamic activity of risperidone.
SÆRLIGE OPBEVARINGSBETINGELSER
Risperidone was not teratogenic in rat and rabbit.
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF
In rat reproduction studies with risperidone, adverse effects were seen on mating behaviour of the parents, and on birth weight and survival of the offspring.
58 UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
In rats, intrauterine exposure to risperidone was associated with cognitive deficits in adulthood.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
Other dopamine antagonists, when administered to pregnant animals, have caused negative effects on learning and motor development in the offspring.
[Se Bilag I – udfyldes nationalt]
RISPERDAL CONSTA administration to male and female rats for 12 and 24 months produced osteodystrophy at a dose of 40 mg/ kg/ 2 weeks.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
No osteodystrophy was observed in dogs treated for 12 months with RISPERDAL CONSTA up to 20 mg/ kg/ 2 weeks.
GENEREL KLASSIFIKATION FOR UDLEVERING
This dose yielded plasma exposures up to 14 times the maximum recommended human dose.
INSTRUKTIONER VEDRØRENDE ANVENDELSEN
There was no evidence of genotoxic potential.
59 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
33 As expected for a potent dopamine D2-antagonist, in oral carcinogenicity studies of risperidone in rats and mice, increases in pituitary gland adenomas (mouse), endocrine pancreas adenomas (rat), and mammary gland adenomas (both species) were seen.
Hætteglas med pulver til suspension til injektion (alle pakninger)
These tumours observed upon oral and intramuscular dosing can be related to prolonged dopamine D2 antagonism and hyperprolactinaemia.
LÆGEMIDLETS NAVN, STYRKE OG/ ELLER ADMINISTRATIONSVEJ( E)
Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
RISPERDAL CONSTA og associerede navne (se Bilag I) 25 mg pulver til depotinjektionsvæske, suspension til intramuskulær injektion
Hypercalcemia, postulated to contribute to an increased incidence of adrenal medullary tumours in RISPERDAL CONSTA-treated rats, was observed in both dose groups.
[Se Bilag I – udfyldes nationalt]
There is no evidence to suggest that hypercalcemia might cause phaeochromocytomas in humans.
2.
Renal tubular adenomas occurred in male rats treated with RISPERDAL CONSTA at 40 mg/ kg/ 2 weeks.
ANVENDELSESMÅDE
There are no data suggesting kidney-related changes in dogs treated chronically with RISPERDAL CONSTA.
Læs indlægssedlen inden brug.
The relevance of the osteodystrophy, the prolactin-mediated tumours and of the presumed rat substrain-specific renal tumours in terms of human risk is unknown.
UDLØBSDATO
In a 24-month intramuscular carcinogenicity study in rats, no increased incidence of injection site tumours was seen in either the vehicle or active groups.
EXP:
In vitro and in vivo, animal models show that at high doses risperidone may cause QT interval prolongation, which has been associated with a theoretically increased risk of torsade de pointes in patients.
BATCHNUMMER
PHARMACEUTICAL PARTICULARS
INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
6.1 List of excipients
ANDET
6.2 Incompatibilities
Fyldt injektionssprøjte (alle pakninger)
6.3 Shelf life
Solvens til RISPERDAL CONSTA 25 mg og associerede navne (se Bilag I) [Se Bilag I – udfyldes nationalt]
[To be completed nationally]
ANVENDELSESMÅDE
6.4 Special precautions for storage
UDLØBSDATO
[To be completed nationally]
INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
34 6.5 Nature and contents of container
ANDET
6.6 Special precautions for disposal and other handling Instructions for Three Needle System
Opbevar den fyldte injektionssprøjte i yderkartonen.
Do not substitute any components in the dose pack.
61 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
To assure that the intended dose of risperidone is delivered, the full contents from the vial must be administered.
Ydre karton (pakning med Alaris)
Administration of partial contents may not deliver the intended dose of risperidone.
RISPERDAL CONSTA og associerede navne (se Bilag I) 37, 5 mg pulver og solvens til depotinjektionsvæske, suspension til intramuskulær injektion
Remove the dose pack of RISPERDAL CONSTA from the refrigerator and allow it to come to room temperature prior to reconstitution.
[Se Bilag I – udfyldes nationalt]
Contents of the dose pack:
Risperidon
• One vial containing RISPERDAL CONSTA extended release microspheres • Two Hypoint 20G 2” TW needles for reconstitution • One prefilled syringe containing the solvent for RISPERDAL CONSTA • One Needle-Pro needle for intramuscular injection (safety 20G 2” TW needle with needle protection device)
ANGIVELSE AF AKTIVT STOF/ AKTIVE STOFFER
Flip off the plastic coloured cap from the vial.
LISTE OVER HJÆLPESTOFFER
Open the prefilled syringe by breaking the seal of the closure and remove the white cap together with the rubber tip cap inside.
4.
35 3.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE)
Open the cover of one reconstitution needle.