CETROTIDE- cetrorelix acetate kit

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

CETRORELIX ACETATE (UNII: W9Y8L7GP4C) (CETRORELIX - UNII:OON1HFZ4BA)

Sẵn có từ:

EMD Serono, Inc.

INN (Tên quốc tế):

CETRORELIX ACETATE

Thành phần:

CETRORELIX 0.25 mg in 1 mL

Tuyến hành chính:

SUBCUTANEOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Cetrotide® (cetrorelix acetate for injection) is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation. Cetrotide® (cetrorelix acetate for injection) is contraindicated under the following conditions: - Hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol. - Known hypersensitivity to GnRH or any other GnRH analogs. - Known or suspected pregnancy, and lactation (see PRECAUTIONS). - Severe renal impairment

Tóm tắt sản phẩm:

Cetrotide® (cetrorelix acetate for injection) 0.25 mg is available in a carton of one packaged tray (NDC 44087-1225-1). Each packaged tray contains: one glass vial containing 0.26 - 0.27 mg cetrorelix acetate (corresponding to 0.25 mg cetrorelix), one pre-filled glass syringe with 1 mL of Sterile Water for Injection, one 20 gauge needle (yellow) and one 27 gauge needle (grey). Store Cetrotide® 0.25 mg refrigerated, 2-8°C (36-46°F). Store the packaged tray in the outer carton in order to protect from light.

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

CETROTIDE - CETRORELIX ACETATE
EMD SERONO, INC.
----------
CETROTIDE 0.25 MG
(CETRORELIX ACETATE FOR INJECTION)
FOR SUBCUTANEOUS USE ONLY
DESCRIPTION
Cetrotide (cetrorelix acetate for injection) is a synthetic
decapeptide with gonadotropin-
releasing hormone (GnRH) antagonistic activity. Cetrorelix acetate is
an analog of native
GnRH with substitutions of amino acids at positions 1, 2, 3, 6, and
10. The molecular
formula is
Acetyl-D-3-(2´-naphtyl)-alanine-D-4-chlorophenylalanine-D-3-(3´-pyridyl)-
alanine-L-serine-L-tyrosine-D-citruline-L-leucine-L-arginine-L-proline-D-alanine-amide,
and
the molecular weight is 1431.06, calculated as the anhydrous free
base. The structural
formula is as follows:
CETRORELIX ACETATE
(Ac-D-Nal
-_D_-Cpa -_D_-Pal
-Ser -Tyr -_D_-Cit -Leu -Arg -Pro -_D_-Ala
-NH )
Cetrotide (cetrorelix acetate for injection) 0.25 mg is a sterile
lyophilized powder
intended for subcutaneous injection after reconstitution with Sterile
Water for Injection,
that comes supplied in a 1.0 mL pre-filled syringe. Each vial of
Cetrotide 0.25 mg
contains 0.26-0.27 mg cetrorelix acetate, equivalent to 0.25 mg
cetrorelix, and 54.80
mg mannitol.
CLINICAL PHARMACOLOGY
GnRH induces the production and release of luteinizing hormone (LH)
and follicle
stimulating hormone (FSH) from the gonadotrophic cells of the anterior
pituitary. Due to
a positive estradiol (E2) feedback at midcycle, GnRH liberation is
enhanced resulting in an
LH-surge. This LH-surge induces the ovulation of the dominant
follicle, resumption of
oocyte meiosis and subsequently luteinization as indicated by rising
progesterone levels.
Cetrotide competes with natural GnRH for binding to membrane receptors
on pituitary
cells and thus controls the release of LH and FSH in a dose-dependent
manner. The
onset of LH suppression is approximately one hour with the 3 mg dose
and two hours
®
®
1
2
3
4
5
6
7
8
9
10
2
®
®
®
with the 0.25 mg dose. This suppression is maintained by continuous
treatment and
there is a more pronounced effect on LH than on FSH. An ini