Faslodex solution for injection 250 mg syringe 5 ml No. 2

Fazlodex injection solution is indicated for the treatment of estrogen receptor-positive locally advanced or metastatic breast cancer in postmenopausal women:

Composition

1 pre-filled syringe (5 ml) contains (active substance) fulvestrant 250 mg.

Excipients: ethanol 96%, benzyl alcohol, benzyl benzoate, castor oil.

Contraindication

Method of application

Adult women (including the elderly): the recommended dose is 500 mg at one-month intervals, with an additional 500 mg dose administered two weeks after the first injection.

Application features

Children

The safety and effectiveness of the drug "Fazlodex" for children in the age category from birth to 18 years have not been established.

Drivers

"Fazlodex" has no or negligible influence on the ability to drive and use machines. However, since very common cases of asthenia have been reported during treatment with "Fazlodex", patients who develop this adverse reaction while driving or using machines should exercise caution.

Overdose

There are isolated reports of overdose with the drug "Fazlodex" in humans. In case of overdose, symptomatic supportive treatment is recommended. In animal studies, high doses of the drug "Fazlodex" did not produce effects other than those directly or indirectly related to antiestrogenic action.

Side effects

The most commonly reported adverse reactions are injection site reactions, asthenia, nausea and increased liver enzymes (ALT (alanine aminotransferase), AST (aspartame aminotransferase), ALT (alkaline phosphatase)).

Storage conditions

Store at 2°C to 8°C, out of the reach of children. Store pre-filled syringes in the original package in order to protect from light.

Temperature fluctuations within the range of 2°C to 8°C should be limited. In this case, storage at temperatures above 30°C should be avoided and should not exceed a 28-day period during which the average storage temperature of the product is below 25°C (but above 2-8°C). After temperature fluctuations, the product should be immediately returned to the recommended storage conditions (storage and transportation in a refrigerator at a temperature of 2°C to 8°C). Temperature fluctuations have a cumulative effect on the quality of the product, and the 28-day period should not be exceeded during the 4-year shelf life of the drug "Fazlodex". Exposure to temperatures below 2°C does not lead to damage to the product, provided that the product is not stored at a temperature below -20°C.

Shelf life - 4 years.