LYMPHOSEEK Kit for radiopharmaceutical preparation (2020)
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Περιεχόμενα
1. Name of the medicinal product
Lymphoseek 50 micrograms kit for radiopharmaceutical preparation.
2. Qualitative and quantitative composition
Each vial contains 50 micrograms of tilmanocept. The radionuclide is not part of the kit. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Kit for radiopharmaceutical preparation. The vial contains a sterile, non-pyrogenic, white to off-white lyophilized powder.
4.1. Therapeutic indications
This medicinal product is for diagnostic use only. Radiolabelled Lymphoseek is indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with ...
4.2. Posology and method of administration
This medicinal product is restricted to hospital use only. The medicinal product should only be administered by trained healthcare professionals with technical expertise in performing and interpreting ...
4.3. Contraindications
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to any of the components of the radiolabelled product.
4.4. Special warnings and precautions for use
Potential for hypersensitivity or anaphylactic reactions The possibility of hypersensitivity including severe life-threatening fatal anaphylactic/anaphylactoid reactions must always be considered. If hypersensitivity ...
4.5. Interaction with other medicinal products and other forms of interaction
Adding very large volumes of tracing agents or other injectants temporally or anatomically proximal to Lymphoseek could affect the in vivo disposition of Lymphoseek. Additional tracing agents should not ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant. Any woman who ...
4.7. Effects on ability to drive and use machines
Lymphoseek has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of safety profile In clinical trials with 553 patients, the most common adverse reactions were: Injection site irritation (0.7%; 4 of 553 patients) Injection site pain (0.2%; 1 of 553 patients) ...
4.9. Overdose
The total injection amount should not exceed 50 micrograms tilmanocept, with a total maximum radioactivity of 74 MBq per dose. Chronic or acute overdose is unlikely to occur given the total injection amount. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> diagnostic radiopharmaceutical, tumour detection <b>ATC Code:</b> V09IA09 Mechanism of action Lymphoseek is a receptor-targeted radiopharmaceutical that is designed to ...
5.2. Pharmacokinetic properties
Two Phase 1 clinical trials in breast cancer patients and one Phase 1 study in melanoma patients have been completed. The purpose of the studies included the radiopharmacokinetic evaluation of Lymphoseek. ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, and genotoxicity.
6.1. List of excipients
Trehalose dihydrate Glycine (E640) Sodium ascorbate (E301) Stannous chloride dihydrate (E512) Sodium hydroxide (E524) Hydrochloric acid, dilute (E507)
6.2. Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6 and 12.
6.3. Shelf life
<u>Unopened vial:</u> 18 months. <u>After radiolabelling:</u> 6 hours. Do not store above 25°C. Store using appropriate radiation shielding. From a microbiological point of view, the product should be ...
6.4. Special precautions for storage
Do not store above 25°C. Store the vial in the outer carton in order to protect from light. For storage conditions after radiolabelling of the medicinal product, see section 6.3. Storage of radiopharmaceuticals ...
6.5. Nature and contents of container
8 mL type I glass vial with a butyl rubber stopper sealed with a flip-off seal. Each vial contains 50 micrograms tilmanocept. Pack-size of 1 and 5 vials.
6.6. Special precautions for disposal and other handling
General warning Radiopharmaceuticals should be received, used, and administered only by authorised persons in designated clinical settings. Their receipt, storage, use, transfer, and disposal are subject ...
7. Marketing authorization holder
Navidea Biopharmaceuticals Europe Ltd., Kilminion South, Ballinroad, Dungarvan, Co. Waterford, X35 WP70, Ireland
8. Marketing authorization number(s)
EU/1/14/955/002 EU/1/14/955/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 19 November 2014 Date of latest renewal: 16 September 2019
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