THALIDOMIDE CELGENE Hard capsule (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Thalidomide Celgene 50 mg hard capsules.
Qualitative and quantitative composition
Each capsule contains 50 mg of thalidomide. For the full list of excipients, see section 6.1.
Pharmaceutical form
Hard capsule. White opaque capsules marked Thalidomide Celgene 50 mg.
Therapeutic indications
Thalidomide Celgene in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥65 years or ineligible for high dose chemotherapy. ...
Posology and method of administration
Treatment must be initiated and monitored under the supervision of physicians with expertise in managing immunomodulatory or chemotherapeutic agents and a full understanding of the risks of thalidomide ...
Contraindications
Hypersensitivity to thalidomide or to any of the excipients listed in section 6.1. Women who are pregnant (see section 4.6). Women of childbearing potential unless all the conditions of the Pregnancy Prevention ...
Special warnings and precautions for use
Teratogenic effects Thalidomide is a powerful human teratogen, inducing a high frequency of severe and life-threatening birth defects. Thalidomide must never be used by women who are pregnant or by women ...
Interaction with other medicinal products and other forms of interaction
Thalidomide is a poor substrate for cytochrome P450 isoenzymes and therefore clinically important interactions with medicinal products that are inhibitors and/or inducers of this enzyme system are unlikely. ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females Women of childbearing potential must use one effective method of contraception for at least 4 weeks before start of treatment, during ...
Effects on ability to drive and use machines
Thalidomide Celgene as per the recommended posology has minor or moderate influence on the ability to drive and use machines. Thalidomide may cause fatigue (very common), dizziness (very common), somnolence ...
Undesirable effects
Summary of the safety profile Most patients taking thalidomide can be expected to experience adverse reactions. The most commonly observed adverse reactions associated with the use of thalidomide in combination ...
Overdose
Eighteen cases of overdose have been reported in the literature concerning doses up to 14.4 grams. In thirteen of these cases, patients took thalidomide alone; amounts ranged from 350 mg to 4000 mg. These ...
Pharmacodynamic properties
Pharmacotherapeutic group: immunosuppressants, other immunosuppressants ATC code: L04AX02 Thalidomide has a chiral centre and is used clinically as a racemate of (+) - (R) and (-) - (S)-thalidomide. The ...
Pharmacokinetic properties
Absorption Absorption of thalidomide is slow after oral administration. The maximum plasma concentrations are reached 1-5 hours after administration. Co-administration of food delayed absorption but did ...
Preclinical safety data
In the male dog, after one year of dosing, reversible bile plugs in canaliculi were observed at exposures greater than 1.9-fold the human exposure. Decreased platelet counts were noted in the mouse and ...
List of excipients
<u>Capsule contents:</u> Starch, pregelatinised Magnesium stearate <u>Capsule shell:</u> Gelatin Titanium dioxide (E171) <u>Printing ink:</u> Shellac Black iron oxide (E172) Propylene glycol
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC/PCTFE/aluminium blister containing 14 capsules. Pack sizes: 28 capsules (two blisters) in a wallet card.
Special precautions for disposal and other handling
Capsules should not be opened or crushed. If powder from thalidomide makes contact with the skin, the skin should be washed immediately and thoroughly with soap and water. If thalidomide makes contact ...
Marketing authorization holder
Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands
Marketing authorization number(s)
EU/1/08/443/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 16 April 2008 Date of latest renewal: 08 February 2018
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