Generic drug of the therapeutic class: Haemostasis and blood
active ingredients: Alpha 1-antitrypsin
Powder and solvent for solution for injection
Box of 1 bottle of powder + 30 ml solvent bottle
This medicinal product is indicated for the substitution treatment of severe forms of primary alpha 1-antitrypsin deficiency in patients with phenotype PiZZ or PiSZ with pulmonary emphysema.
Dosage ALFALASTIN 1 g / 30 ml Powder and solvent for solution for injection Box of 1 vial of powder + vial of solvent of 30 ml
- The treatment is to be implemented as soon as possible from the moment when the first signs of emphysema appear.
- This treatment is to continue:
. continuously, especially in cases of highly progressive emphysema,
. or by discontinuous cures during bronchopulmonary infectious outbreaks.
- Continuous or recurrent exposure to aerocontaminants that may increase intrapulmonary protease load is the only known factor in the development of emphysema. Stopping smoking is therefore imperative and protection of the subject against potential professional air contaminants is strongly recommended.
- A dose of 60 mg / kg of ALFALASTIN injected once a week, intravenously, provides a sufficient plasma level of alpha 1-antitrypsin comparable to that of non-deficient subjects.
- Alpha 1-antitrypsin assays should be performed in patients treated once a month for the first six months of treatment and subsequently every three to four months. The doses to be injected will eventually be corrected so as to obtain the maintenance of a minimum plasma level of 0.50 to 0.70 g / liter.
Method and route of administration :
- ALFALASTIN is a powder to be reconstituted extemporaneously with water for injections, according to the modalities described in the paragraph instructions for use, handling and disposal.
- ALFALASTIN should be injected exclusively intravenously, all at once, immediately after reconstitution, without exceeding a flow rate of 4 ml / min.
- The solution is clear or slightly opalescent. Do not use a cloudy solution or a deposit.
Known hypersensitivity to one of the constituents of the preparation.
NOT RECOMMENDED :
The safety of ALFALASTIN in pregnant women has not been evaluated in controlled clinical trials. Animal testing is insufficient to establish safety with regard to reproduction, the course of pregnancy, the development of the embryo or fetus and postnatal development. Therefore, ALFALASTIN will only be prescribed if absolutely necessary during pregnancy and lactation.
Alfalastin side effects
- No adverse effects have been reported to date, however clinical experience is limited.
- In case of allergy or anaphylactic reaction, administration should be stopped immediately. In case of shock, symptomatic treatment of shock should be instituted.