TESTOSTERONE CYPIONATE injection, solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

TESTOSTERONE CYPIONATE (UNII: M0XW1UBI14) (TESTOSTERONE - UNII:3XMK78S47O)

متاح من:

Eugia US LLC

طريقة التعاطي:

INTRAMUSCULAR

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Testosterone Cypionate Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. - Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. - Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of Testosterone Cypionate Injection in men with “age­-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. 1.   Known hypersensitivity to the drug 2.   Males with carcinoma of the breast 3.   Males with known or suspected carcinoma of the prostate gland 4.   Women who are pregnant (see PRECAUTIONS, Pregnancy ) 5.   Patients with serious cardiac, hepatic or renal disease (see WARNINGS ) Testosterone cypionate injection contains testosterone, a Schedule III c

ملخص المنتج:

Testosterone Cypionate Injection, USP is a clear, pale yellow to yellowish oily solution and is available as follows: 1,000 mg per 10 mL (100 mg / mL) 10 mL multiple-dose vials packaged individually             NDC 55150-276-01 200 mg per mL 1 mL single-dose vials packaged individually                   NDC 55150-277-01 2,000 mg per 10 mL (200 mg / mL) 10 mL multiple-dose vials packaged individually             NDC 55150-278-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. The vial stopper is not made with natural rubber latex. Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520   Manufactured by: Eugia Pharma Specialities Limited Hyderabad – 500032  India Revised: August 2023

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

TESTOSTERONE CYPIONATE - TESTOSTERONE CYPIONATE INJECTION, SOLUTION
EUGIA US LLC
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TESTOSTERONE CYPIONATE INJECTION, USP CIII
RX ONLY
DESCRIPTION
Testosterone Cypionate Injection USP, for intramuscular injection,
contains testosterone
cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate
ester of the
androgenic hormone testosterone.
Testosterone cypionate USP is a white or creamy white crystalline
powder. It is insoluble
in water, freely soluble in alcohol, chloroform, dioxane, ether, and
soluble in vegetable
oils.
The chemical name for testosterone cypionate is androst-4-en-3-one,
17-(3-cyclopentyl-
1-oxopropoxy)-, (17ß)-. Its molecular formula is C
H
O , and the molecular weight
412.61.
The structural formula is represented below:
Testosterone Cypionate Injection, USP is a clear, pale yellow to
yellowish oily solution and
is available in two strengths, 100 mg/mL and 200 mg/mL testosterone
cypionate.
Each mL of the 100 MG/ML solution contains:
Testosterone cypionate
USP................................................................................
100 mg
(equivalent to 69.90 mg Testosterone)
Benzyl benzoate
...................................................................................................
0.1 mL
Cottonseed oil
......................................................................................................
736 mg
Benzyl alcohol (as preservative)
........................................................................
9.45 mg
Each mL of the 200 MG/ML solution contains:
Testosterone cypionate
USP.................................................................................
200 mg
27
40
3
(equivalent to 139.8 mg Testosterone)
Benzyl benzoate
...................................................................................................
0.2 mL
Cottonseed oil
......................................................................................................
560 mg
Benzyl alcohol (as preservative)
..................................................................