Cetrotide - Pharmaceutical Information, Clinical Trials, Detailed Pharmacology, Toxicology.
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Cetrotide - Scientific Information

Manufacture: EMD Serono, Inc
Country: Canada
Condition: Ovulation Induction
Class: Somatostatin and somatostatin analogs
Form: Liquid solution, Subcutaneous (SC)
Ingredients: cetrorelix acetate

Pharmaceutical Information

Drug Substance

Proper name: Cetrorelix Acetate
Other name: GnRH Antagonist
Chemical name: Ac-D-Nal-D-p-Cl-Phe-D-Pal-ser-Tyr-D-Cit-Leu-Arg-Pro-D-Ala-NH2
Structural formula:
Physical and Chemical Characteristics:
Physical form: white powder
Molecular weight: 1431.06 (base) ;
1490.11 (monoacetate); 1519.58 ( as base x 1.5 acetate)
Solubility:
Water 8 mg/ml
Water/Mannitol 5 mg/ml
Acetic acid (30%) 50 mg/ml
Sodium phosphate buffer pH 7.4 1 mg/ml
Dichloromethane Insoluble (<0.5 mg/ml)
Melting Point: 232.1 °C rsd = ± 0.69 % (n=6)
Polymorphism: amorphous (x-ray diffraction spectrum of cetrorelix acetate reference standard - evidence of chemical structure)
pH: 5.6 (0.1 % in water)

Composition

Cetrotide (cetrorelix for injection) 0.25 mg or 3 mg is a sterile lyophilized powder intended for subcutaneous injection after reconstitution with Sterile Water for Injection, Ph.Eur, that comes supplied in either a 1.0 mL (for 0.25 mg vial) or 3.0 mL (for 3 mg vial) pre-filled syringe. Each vial of Cetrotide (cetrorelix for injection) 0.25 mg (multiple dose regimen) contains 0.25 mg of cetrorelix as cetrorelix acetate and 54.80 mg of mannitol. Each vial of Cetrotide (cetrorelix for injection) 3 mg (single dose regimen) contains 3 mg of cetrorelix as cetrorelix acetate and 164.40 mg of mannitol.

Stability and Storage Recommendations

Store between 2°C and 25°C. Do not freeze. Keep the container in the outer carton to protect it from light. Do not use the product after the expiry date indicated on the label.

Reconstituted Solutions

Parenteral Products:
The reconstituted product is to be administered subcutaneously (see DOSAGE AND ADMINISTRATION). Use immediately after reconstitution.

As with all parenteral drug products, reconstituted solutions should be inspected visually for clarity, particulate matter, precipitate, discolouration and leakage prior to administration. Solution showing haziness, particulate matter, precipitate, discolouration or leakage should not be used. Discard unused portions.

Availability of Dosage Forms

Cetrotide (cetrorelix for injection) is supplied in a sterile, lyophilized form in a single dose vial containing cetrorelix acetate.

Cetrotide (cetrorelix for injection) 0.25 mg is available in a carton of one packaged tray. Each packaged tray contains: one glass vial containing 0.25 mg of cetrorelix base, one pre-filled glass syringe with 1 mL of Sterile Water for Injection, Ph.Eur., one 20 gauge needle (yellow), one 27 gauge needle (grey), and two alcohol swabs. After reconstitution with the solvent provided, each mL of solution contains 0.25 mg cetrorelix (base).

Cetrotide (cetrorelix for injection) 3 mg is available in a carton of one packaged tray. Each packaged tray contains: one glass vial containing 3 mg of cetrorelix base, one pre-filled glass syringe with 3 mL of Sterile Water for Injection, Ph.Eur., one 20 gauge needle (yellow), one 27 gauge needle (grey), and two alcohol swabs. After reconstitution with the solvent provided, each mL of solution contains 1 mg cetrorelix (base).

The reconstituted product is to be administered by subcutaneous injection only.

Cetrotide (cetrorelix for injection) does not contain latex.