MEPACT Powder for concentrate for dispersion for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
MEPACT 4 mg powder for concentrate for dispersion for infusion.
Qualitative and quantitative composition
Each vial contains 4 mg mifamurtide*. After reconstitution, each mL of suspension in the vial contains 0.08 mg mifamurtide. * fully synthetic analogue of a component of Mycobacterium sp. cell wall. For ...
Pharmaceutical form
Powder for concentrate for dispersion for infusion. White to off-white homogeneous cake or powder.
Therapeutic indications
MEPACT is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination ...
Posology and method of administration
Mifamurtide treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of osteosarcoma. Posology The recommended dose of mifamurtide for all patients ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concurrent use with ciclosporin or other calcineurin inhibitors (see section 4.5). Concurrent use with high-dose ...
Special warnings and precautions for use
Respiratory distress In patients with a history of asthma or other chronic obstructive pulmonary disease, consideration should be given to administration of bronchodilators on a prophylactic basis. Two ...
Interaction with other medicinal products and other forms of interaction
Limited studies of the interaction of mifamurtide with chemotherapy have been conducted. Although these studies are not conclusive, there is no evidence of interference of mifamurtide with the anti-tumour ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of mifamurtide in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Mifamurtide is not recommended for use ...
Effects on ability to drive and use machines
MEPACT has a moderate influence on the ability to drive and use machines. Dizziness, vertigo, fatigue and blurred vision have shown as very common or common undesirable effects of mifamurtide treatment. ...
Undesirable effects
Summary of the safety profile Mifamurtide was studied as a single agent in 248 patients with mostly advanced malignancies during the early, single arm phase I and II clinical studies. The most frequent ...
Overdose
The maximum tolerated dose in phase I studies was 4-6 mg/m² with a high variability of adverse reactions. Signs and symptoms that were associated with higher doses and/or were dose limiting were not life-threatening, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunostimulants, Other immunostimulants ATC code: L03AX15 Mechanism of action Mifamurtide (muramyl tripeptide phosphatidyl ethanolamine, MTP-PE) is a fully synthetic derivative ...
Pharmacokinetic properties
The pharmacokinetics of mifamurtide have been characterised in healthy adult subjects following a 4 mg intravenous infusion and in paediatric and adult patients with osteosarcoma following a 2 mg/m² intravenous ...
Preclinical safety data
In sensitive species (rabbit and dog) the highest daily dose of liposomal mifamurtide that did not cause adverse effects was 0.1 mg/kg, corresponding to 1.2 and 2 mg/m², respectively. The no-adverse-effect ...
List of excipients
1-Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS)
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Unopened vial of powder: 30 months. Reconstituted suspension: Chemical and physical stability has been demonstrated for 6 hours up to 25ºC. From a microbiological point of view, immediate use ...
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 reconstitution of the medicinal product, see section 6.3. ...
Nature and contents of container
50 mL type I glass vial with a grey butyl rubber stopper, aluminium seal and plastic flip-off cap, containing 4 mg of mifamurtide. Each carton contains 1 vial and 1 single-use, non-pyrogenic, sterile filter ...
Special precautions for disposal and other handling
MEPACT must be reconstituted, filtered using the filter provided and further diluted using aseptic technique, prior to administration. Each vial should be reconstituted with 50 mL of sodium chloride 9 ...
Marketing authorization holder
Takeda France SAS, 112 avenue Kléber, 75116, Paris, France
Marketing authorization number(s)
EU/1/08/502/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 6 March 2009 Date of latest renewal: 20 February 2019
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