MEGACE Tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Megace 160 mg Tablets.
Qualitative and quantitative composition
Each tablet contains Megestrol Acetate 160 mg. Excipient with known effect: Each tablet contains 224.5 mg Lactose Monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablets. Off-white, oval, biconvex tablets with a break line, engraved 160 on one face. The break line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Therapeutic indications
Megace is a progestational agent, indicated for the treatment of certain hormone dependent neoplasms, such as breast cancer.
Posology and method of administration
Breast cancer: 160 mg/day taken once daily. At least two months of continuous treatment is considered an adequate period for determining the efficacy of Megace. Children Safety and effectiveness in paediatric ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Precautions Megace should be used with caution in patients with a history of thrombophlebitis and in patients with severe impaired liver function. This product should be used under the supervision of a ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Pregnancy and lactation
Megace is not recommended for women who are pregnant or who are breast feeding. Several reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy ...
Effects on ability to drive and use machines
There are no known effects of megestrol acetate on the ability to drive or operate machinery.
Undesirable effects
The main side-effect experienced by patients while taking megestrol acetate, particularly at high doses, is weight gain, which is usually not associated with water retention, but which is secondary to ...
Overdose
No acute toxicological effects have resulted from studies involving Megace (megestrol acetate) administered in dosages as high as 1600 mg/day for six months or more. Reports of overdose have also been ...
Pharmacodynamic properties
Megace (megestrol acetate) possesses pharmacological properties similar to those of natural progesterone. Its progestational activity is slightly greater than that of medroxyprogesterone acetate, norethindrone, ...
Pharmacokinetic properties
Peak plasma levels of tritiated megestrol acetate and metabolites occur one to three hours after oral administration. When 4 to 91mg of c-labelled megestrol acetate were administered orally to women, the ...
Preclinical safety data
Administration of megestrol acetate to female dogs for up to 7 years was associated with an increased incidence of both benign and malignant tumors of the breast. Comparable studies in rats and studies ...
List of excipients
Colloidal anhydrous silica Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone Sodium starch glycollate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 36 months Blister packs 36 months – Amber glass bottles
Special precautions for storage
Do not store Megace Tablets above 25°C. Store in the original package in order to protect from moisture.
Nature and contents of container
Amber glass bottles of 30, 60 or 100. Blister packs of 30 tablets.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
PharmaSwiss Česká republika s.r.o., Jankovcova 1569/2c, 170 00, Prague 7, Czech Republic
Marketing authorization number(s)
PL 33616/0001
Date of first authorization / renewal of the authorization
20 November 1985 / 25 April 2002
Date of revision of the text
03/2019
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