PRIALT Solution for infusion (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Prialt 25 micrograms/ml solution for infusion.
Qualitative and quantitative composition
One ml solution contains 25 μg ziconotide (as acetate). Each 20 ml vial contains 500 μg ziconotide (as acetate). For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for infusion (infusion). Clear, colourless solution.
Therapeutic indications
Ziconotide is indicated for the treatment of severe, chronic pain in adults who require intrathecal (IT) analgesia.
Posology and method of administration
Treatment with ziconotide should only be undertaken by physicians experienced in intrathecal (IT) administration of medicinal products. Posology Adults (including the elderly ≥65 years of age) Dosing of ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Combination with IT chemotherapy (see section 4.5).
Special warnings and precautions for use
Long-term use Although ziconotide has been studied in long-term, open label efficacy and safety clinical trials, controlled studies of longer than 3 weeks duration have not been conducted (see section ...
Interaction with other medicinal products and other forms of interaction
Specific clinical medicinal product interaction studies have not been conducted with ziconotide. However, low plasma ziconotide concentrations, metabolism by ubiquitous peptidases and relatively low plasma ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of ziconotide in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Ziconotide is not recommended during ...
Effects on ability to drive and use machines
Ziconotide has moderate influence on the ability to drive and use machines. Ziconotide may cause confusion, somnolence and other neurological adverse reactions, therefore patients must be advised not to ...
Undesirable effects
Summary of the safety profile The safety of ziconotide administered as a continuous intrathecal infusion has been evaluated in more than 1,400 patients participating in acute and chronic pain clinical ...
Overdose
In intravenous infusion studies, healthy male volunteers received ziconotide at doses of up to70,000 μg/day or 3,200 times the maximum recommended daily intrathecal infusion dose. Postural hypotension ...
Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics, other analgesics and antipyretics ATC code: N02BG08 Mechanism of action Ziconotide is a synthetic analogue of a ω-conopeptide, MVIIA, found in the venom of the Conus ...
Pharmacokinetic properties
The CSF pharmacokinetics of ziconotide have been studied following one-hour IT infusions of 1-10 μg of ziconotide in patients with chronic pain. The plasma pharmacokinetics following intravenous doses ...
Preclinical safety data
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. In subchronic continuous intrathecal ...
List of excipients
Methionine Sodium chloride Water for injections Hydrochloric acid (pH adjuster) Sodium hydroxide (pH adjuster)
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life: 4 years. In-use shelf-life (diluted product): Chemical and physical in use stability has been demonstrated for 60 days at 37°C. From a microbiological point of view, if the product is diluted ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
Type I glass vials with butyl rubber stoppers coated with fluorinated polymer. Each vial contains 20 ml solution for infusion. One vial per carton.
Special precautions for disposal and other handling
If dilution is required, Prialt must be diluted aseptically with preservative-free sodium chloride 9 mg/ml (0.9%) solution for injection before use. The concentration of the solution used in the infusion ...
Marketing authorization holder
RIEMSER Pharma GmbH, An der Wiek 7, 17493, Greifswald-Insel Riems, Germany
Marketing authorization number(s)
EU/1/04/302/004 – 20 ml solution for infusion
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 February 2005 Date of latest renewal: 18 September 2014
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