LECTRUM Powder for suspension for injection (2019)
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Περιεχόμενα
1. Name of the medicinal product
Lectrum 3.75mg. Lectrum 7.50mg. Lectrum 11.25mg. Chemical name: 5-Oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-Larginyl-N-ethyl-L-prolinamide Molecular formula: C<sub>59</sub> ...
2. Qualitative and quantitative composition
Each vial with powder for suspension for injection contains 3.75mg; 7.5mg or 11.25mg of leuprolide acetate.
3. Pharmaceutical form
Powder for suspension for injection.
4.1. Therapeutic indications
Intramuscular and subcutaneous use. Use in adults and children. Prostate cancer Lectrum 3.75 mg; Lectrum 7.5 mg; Lectrum 11.25 mg are indicated in the palliative treatment of advanced prostate cancer, ...
4.2. Posology and method of administration
The doctor or nurse will give you an injection of Lectrum. The injection will normally be given in your arm, thigh, or abdomen. The injection site should be varied at regular intervals. Adults Prostate ...
4.3. Contraindications
The product is contraindicated in patients with a known hypersensitivity to leuprolide acetate, similar nonapeptides or any of the other excipients of the formulation. It has been reported in the medical ...
4.4. Special warnings and precautions for use
Prostate cancer Tumour flare Initially, Lectrum, like other GnRH agonists, causes increases in serum levels of testosterone to approximately 50% above baseline during the first weeks of treatment. Isolated ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Since androgen deprivation treatment may prolong the QT interval, the concomitant use of l Lectrum with medicinal products known to prolong the QT interval or ...
4.6. Pregnancy and lactation
Pregnancy category X (see section 4.3) Risk summary Based on findings in animal studies and mechanism of action, leuprorelin may cause foetal harm when administered to a pregnant woman. There are no available ...
4.7. Effects on ability to drive and use machines
Particularly sensitive patients, in whom medications can induce infrequent reactions, should be attentive for reactions that occur with the use of this medication before driving vehicles, operating machinery ...
4.8. Undesirable effects
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a medicinal product cannot be directly compared to rates in the clinical ...
4.9. Overdose
There is no experience of overdose in clinical trials. In rats, a single subcutaneous dose of 100 mg/kg (approximately 4,000 times the estimated daily human dose based on body surface area), resulted in ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Endocrine therapy, Hormones and related agents, Gonadotropin releasing hormone analogues <b>ATC code:</b> L02AE02 Leuprolide acetate, the active substance of the medicinal ...
5.2. Pharmacokinetic properties
Absorption Bioavailability by subcutaneous administration is comparable to that by intravenous administration. Distribution The volume of distribution in healthy male volunteers after a single intravenous ...
5.3. Preclinical safety data
Carcinogenesis, mutagenesis, fertility damage, teratogenesis Carcinogenicity studies conducted in animals (rats and mice) for a period of two years revealed that in rats there was a dose-related incidence ...
6.1. List of excipients
Excipients Lectrum 3.75 mg and Lectrum 7.5 mg Gelatine PLGA (copoly (DL-lactic acid/glycolic acid (75:25 mol %)) Mannitol <u>Each vial of diluent contains:</u> Sodium carboxymethylcellulose Mannitol Polysorbate ...
6.4. Special precautions for storage
Store below 30ºC. Protect from light. Do not freeze. Keep out of the reach and sight of children. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose ...
10. Date of revision of the text
25 March 2019
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