LUCRIN Depot Solution for injection (2022)
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Περιεχόμενα
1. Name of the medicinal product
LUCRIN DEPOT 3,75 Lyophilised microspheres for injection. LUCRIN DEPOT DILUENT Sterile diluent for injection.
2. Qualitative and quantitative composition
<u>LUCRIN DEPOT 3,75:</u> Each single-dose vial contains leuprolide acetate 3,75 mg. Contains mannitol (sugar-alcohol). For full lists of excipients, see section 6.1. <u>LUCRIN DEPOT DILUENT:</u> Each ...
3. Pharmaceutical form
LUCRIN DEPOT 3,75 Lyophilised microspheres for injection. LUCRIN DEPOT DILUENT Sterile diluent for injection.
4.1. Therapeutic indications
LUCRIN DEPOT 3,75 is indicated in: Endometriosis The management of endometriosis, including pain relief and reduction of endometriotic lesions, in women of 18 years of age and older, for a period of 6 ...
4.2. Posology and method of administration
LUCRIN DEPOT 3,75 must be administered under the supervision of a medical practitioner. Endometriosis The recommended dose of LUCRIN DEPOT 3,75 in the treatment of endometriosis is 3,75 mg. Prostate Cancer ...
4.3. Contraindications
LUCRIN DEPOT 3,75 is contraindicated in: Patients with known hypersensitivity to leuprolide acetate or similar nonapeptides or to any of the excipients in LUCRIN DEPOT 3,75. Patients with undiagnosed, ...
4.4. Special warnings and precautions for use
All Populations During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the natural stimulatory effect of LUCRIN DEPOT 3,75. Therefore, an increase in clinical ...
4.5. Interaction with other medicinal products and other forms of interaction
Pharmacokinetic-based interaction studies have not been conducted with LUCRIN DEPOT 3,75. However, due to LUCRIN DEPOT 3,75 being a peptide that is primarily degraded by peptidase and not by cytochrome ...
4.6. Fertility, pregnancy and lactation
Pregnancy LUCRIN DEPOT 3,75 is contraindicated during pregnancy or lactation (see section 4.3). The safety of leuprolide acetate in pregnancy has not been established. Breastfeeding Mothers on LUCRIN DEPOT ...
4.7. Effects on ability to drive and use machines
LUCRIN DEPOT 3,75 may cause convulsions, blurred vision or dizziness that may impair the patients ability to drive or to use machinery.
4.8. Undesirable effects
Women The most common adverse events in women are associated with the pharmacological actions of LUCRIN on the steroidogenesis: SYSTEM ORGAN CLASS ADVERSE EVENTS Metabolism and nutrition disorders Weight ...
4.9. Overdose
In overdose, side effects would be exacerbated and exaggerated (see section 4.4 and section 4.8). Treatment is symptomatic and supportive.
5.1. Pharmacodynamic properties
A 21.10 Tropic hormones Leuprolide acetate is a synthetic nonapeptide analogue of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). Leuprolide acetate, a GnRH agonist, acts as an inhibitor ...
5.2. Pharmacokinetic properties
Leuprolide acetate is not active when given orally. Bioavailability of leuprolide acetate following subcutaneous administration is comparable to that after intramuscular administration. Absorption Following ...
6.1. List of excipients
LUCRIN DEPOT 3,75 Lyophilised microspheres for injection: Copoly (DL-Lactic acid/glycolic acid) (PLGA) Mannitol Gelatin
6.2. Incompatibilities
No other fluid should be used for reconstitution of LUCRIN DEPOT 3,75 mg.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store at room temperature (below 25°C).
6.5. Nature and contents of container
LUCRIN DEPOT 3,75 is available in a single dose administration kit containing one vial of sterile lyophilised microspheres of leuprolide acetate (3,75 mg); one ampoule of diluent, one syringe with two ...
6.6. Special precautions for disposal and other handling
Reconstitution The lyophilised microspheres are to be reconstituted and administered monthly as a single intramuscular or subcutaneous injection in accordance with the following directions: Using a syringe ...
7. Marketing authorization holder
AbbVie (Pty) Ltd, Abbott Place, 219 Golf Club Terrace, Constantia Kloof, 1709
8. Marketing authorization number(s)
LUCRIN DEPOT 3,75: 27/21.10/0370 LUCRIN DEPOT DILUENT: 27/34/0371
9. Date of first authorization / renewal of the authorization
05/07/1993
10. Date of revision of the text
03/08/2022
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