EGRIFTA Powder for solution fot injection (2015)
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Περιεχόμενα
Name of the medicinal product
EGRIFTA.
Summary product information
Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients Subcutaneous injection Lyophilized powder for injection / 1 mg tesamorelin, as tesamorelin acetate, per vial ...
Indications and clinical use
EGRIFTA is indicated for the treatment of excess visceral adipose tissue (VAT), as assessed by waist circumference ≥95 cm for males and ≥94 cm for females, and confirmed by a VAT level >130 cm² by CT scan, ...
Contraindications
EGRIFTA should not be administered to patients: with known hypersensitivity to tesamorelin and/or mannitol (excipient) with disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, ...
Warnings and precautions
A 1.0 cm reduction in waist circumference should be considered as the minimal acceptable decrease for a satisfactory response following a 6-month treatment with EGRIFTA. Carcinogenesis and Mutagenesis ...
Adverse reactions
Adverse Drug Reaction Overview During the initial 26-week treatment period (Main Phase) of both placebo-controlled studies combined, the most frequently observed adverse drug reactions were those thought ...
Drug interactions
Drug-Drug Interactions Published data indicate that GH may modulate cytochrome P450 (CYP450) activity. Simvastatin The effect of multiple dose administration of EGRIFTA (2 mg) on the pharmacokinetics of ...
Dosage and administration
Recommended Dose and Dosage Adjustment The recommended dose of EGRIFTA is 2 mg injected subcutaneously (SC) once a day. The recommended injection site is the abdomen. Injection sites should be rotated ...
Overdosage
No data is available. For management of a suspected drug overdose, contact your regional Poison Control Centre.
Action and clinical pharmacology
Mechanism of Action <em>In vitro</em>, tesamorelin binds and stimulates human Growth Hormone-Releasing Factor (hGRF) receptors with similar potency as the natural GRF. Tesamorelin mimics the pharmacology ...
Storage and stability
EGRIFTA vials should be protected from light and be kept in the original box. Nonreconstituted EGRIFTA must be stored under refrigeration at 2°C to 8°C. Sterile Water for Injection, syringes and needles ...
Special handling instructions
EGRIFTA solution should not be administered if it contains particles or is not clear. Any unused product or waste should be disposed of in accordance with local requirements.
Dosage forms, composition and packaging
EGRIFTA is available in single-dose strengths of 1 mg and 2 mg vials supplied in packages comprised of 1 month supply: <u>1 mg Vials:</u> Box 1 of 2: Medication box with 60 vials containing (each) 1 mg ...
Pharmaceutical information
Drug Substance <u>Common name:</u> tesamorelin acetate <u>Chemical name:</u> [N-trans-3-Hexenoyl] Human Growth Hormone-Releasing Factor (1-44), Acetate <u>Molecular formula and molecular mass:</u> C<sub> ...
Detailed pharmacology
Animal Pharmacology <em>In Vitro</em> <em>In vitro</em> pharmacology studies demonstrated that tesamorelin did not act as a prodrug in porcine anterior pituitary cells in either the presence or absence ...
Clinical trials
Two multicenter, randomized, double-blind, placebo-controlled studies were conducted in HIVinfected patients with lipodystrophy and excess abdominal fat (abdominal lipohypertrophy). Both studies (Study ...
Microbiology
This section is not applicable.
Toxicology
Single-Dose Studies Single-dose intravenous toxicity studies were conducted in mice, rats and dogs. The maximum tolerated dose was <100 mg/kg in mice (due to mortality at 100 and 200 mg/kg), between 100 ...
Marketing authorization holder
Theratechnologies Inc., 2015 Peel St. 5<sup>th</sup> Floor, Montreal, QC, Canada, H3A 1T8, www.theratech.com
Submission control number
177087
Date of revision
March 26, 2015
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