RISPERDAL CONSTA Powder and solvent for suspension for injection (2018)
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Περιεχόμενα
Name of the medicinal product
RISPERDAL CONSTA 25 mg powder and solvent for prolonged-release suspension for injection.
Qualitative and quantitative composition
1 vial contains 25 mg risperidone. 1 ml reconstituted suspension contains 12.5 mg of risperidone. Excipients with known effect: 1 ml reconstituted suspension contains 3 mg sodium. For the full list of ...
Pharmaceutical form
Powder and solvent for prolonged-release suspension for injection. Vial with powder: White to off-white free flowing powder. Prefilled syringe of solvent for reconstitution: Clear, colourless aqueous solution. ...
Therapeutic indications
RISPERDAL CONSTA is indicated for the maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics.
Posology and method of administration
Posology Adults Starting dose For most patients the recommended dose is 25 mg intramuscular every two weeks. For those patients on a fixed dose of oral risperidone for two weeks or more, the following ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
For risperidone-naïve patients, it is recommended to establish tolerability with oral risperidone prior to initiating treatment with RISPERDAL CONSTA (see section 4.2). Elderly with dementia RISPERDAL ...
Interaction with other medicinal products and other forms of interaction
The interactions of RISPERDAL CONSTA with co-administration of other drugs have not been systematically evaluated. The drug interaction data provided in this section are based on studies with oral RISPERDAL. ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of risperidone in pregnant women. Risperidone was not teratogenic in animal studies but other types of reproductive toxicity were seen (see section 5.3). ...
Effects on ability to drive and use machines
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). Therefore, patients should be advised not ...
Undesirable effects
The most frequently reported adverse drug reactions (ADRs) (incidence ≥1/10) are: insomnia, anxiety, headache, upper respiratory tract infection, parkinsonism, and depression. The ADRs that appeared to ...
Overdose
While overdose is less likely to occur with parenteral than with oral medicinal products, information pertaining to oral is presented. Symptoms In general, reported signs and symptoms have been those resulting ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other antipsychotics ATC code: N05AX08 Mechanism of action Risperidone is a selective monoaminergic antagonist with unique properties. It has a high affinity for serotoninergic ...
Pharmacokinetic properties
Absorption The absorption of risperidone from RISPERDAL CONSTA is complete. After a single intramuscular injection with RISPERDAL CONSTA, the release profile consists of a small initial release of risperidone ...
Preclinical safety data
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 ...
List of excipients
Powder: [poly-(d, l-lactide-co-glycolide) Solvent: Polysorbate 20 Carmellose sodium Disodium hydrogen phosphate dihydrate Citric acid anhydrous Sodium chloride Sodium hydroxide Water for injection
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life: 3 years at 2-8°C. After reconstitution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. ...
Special precautions for storage
The entire dose pack should be stored in the refrigerator (2-8°C). If refrigeration is unavailable, RISPERDAL CONSTA can be stored at temperatures not exceeding 25°C for no more than 7 days prior to administration. ...
Nature and contents of container
Needle-free vial access device One vial containing powder. One vial adapter for reconstitution. One prefilled syringe containing the solvent for RISPERDAL CONSTA. Two Terumo SurGuard3 needles for intramuscular ...
Special precautions for disposal and other handling
Important information RISPERDAL CONSTA requires close attention to these step-by-step Instructions for Use to help ensure successful administration. Use components provided: The components in this dose ...
Marketing authorization holder
Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG, UK
Marketing authorization number(s)
PL 00242/0375
Date of first authorization / renewal of the authorization
Date of first authorisation: 08 August 2002 Date of latest renewal: 30 April 2017
Date of revision of the text
September 2018
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