QUADRAMET Solution for injection (2015)
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Περιεχόμενα
1. Name of the medicinal product
Quadramet 1.3 GBq/mL solution for injection.
2. Qualitative and quantitative composition
Each ml of solution contains 1.3 GBq Samarium (<sup>153</sup>Sm) lexidronam pentasodium at the reference date (corresponding to 20 to 80 µg/ml of samarium per vial) Samarium specific activity is approximately ...
3. Pharmaceutical form
Solution for injection. Clear, colourless to light amber solution with pH ranging between 7.0 and 8.5.
4.1. Therapeutic indications
Quadramet is indicated for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases which take up technetium (<sup>99m</sup>Tc)-labelled biphosphonates on bone scan. ...
4.2. Posology and method of administration
Quadramet should only be administered by physicians experienced in the use of radiopharmaceuticals and after full oncological evaluation of the patient by qualified physicians. Posology The recommended ...
4.3. Contraindications
Hypersensitivity to the active substance (ethylenediaminetetramethylenephosphonate (EDTMP) or similar phosphonates) or to any of the excipients excipients listed in section 6.1. In pregnant women (See ...
4.4. Special warnings and precautions for use
In absence of clinical data, the injected activity should be adapted to the renal function. Use of Quadramet in patients with evidence of compromised bone marrow reserve from previous therapy or disease ...
4.5. Interaction with other medicinal products and other forms of interaction
Because of the potential for additive effects on bone marrow, the treatment should not be given concurrently with chemotherapy or external beam radiation therapy. Quadramet may be given subsequent to either ...
4.6. Pregnancy and lactation
Pregnancy Quadramet is contra-indicated (see 4.3) in pregnancy. The possibility of pregnancy must strictly be ruled out. Women of childbearing potential have to use effective contraception during the treatment ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. Undesirable effects
Decreases in white blood cell and platelet counts and anaemia were observed in patients receiving Quadramet. In clinical trials white blood cell and platelet counts decreased to a nadir of approximately ...
4.9. Overdose
The product should only be administered by qualified personnel in authorised settings. The possibility of pharmacological overdose is therefore remote. The risks to be expected are associated with the ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Various pain palliation radiopharmaceuticals <b>ATC Code:</b> V10BX02 Mechanism of action Quadramet has an affinity for skeletal tissue and concentrates in areas of bone ...
5.2. Pharmacokinetic properties
Absorption Total skeletal uptake of Quadramet in studies of 453 patients with a variety of primary malignancies was 65.5 ± 15.5 % of the administered activity. A positive correlation was found between ...
5.3. Preclinical safety data
The radiolysis products of Sm-EDTMP showed a renal toxicity in rats and dogs with a no effect level of 2.5 mg/kg. Repeated dose administration of samarium (<sup>153</sup>Sm)-EDTMP to dogs indicated a slightly ...
6.1. List of excipients
Total EDTMP (as EDTMP.H2O) Calcium-EDTMP sodium salt (as Ca) Total sodium (as Na) Water for Injections
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with the other medicinal products.
6.3. Shelf life
1 day from the activity reference time stated on the label. Use within 6 hours of thawing. After thawing, do not freeze again.
6.4. Special precautions for storage
Quadramet is delivered frozen in dry ice. Store in a freezer at -10°C to -20°C in the original package. Storage procedures should be in accordance with local regulations for radioactive substances.
6.5. Nature and contents of container
15 ml colourless European Pharmacopoeia Type I drawn glass vial closed with Teflon-coated chlorobutyl/natural rubber stopper and aluminium flip-off overseal. Each vial contains 1.5 ml (2 GBq at calibration) ...
6.6. Special precautions for disposal and other handling
The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting etc. Radiation protection precautions in accordance with ...
7. Marketing authorization holder
CIS bio international, Boîte Postale 32, F-91192 GIF-SUR-YVETTE Cedex, FRANCE
8. Marketing authorization number(s)
EU/1/97/057/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 05 February 1998 Date of latest renewal: 12 December 2007
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