TESTONE CIK- testosterone cypionate, alcohol kit

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

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Prenos Lastnosti izdelka (SPC)
17-11-2022

Aktivna sestavina:

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

Dostopno od:

Asclemed USA, Inc.

INN (mednarodno ime):

Testosterone Cypionate

Sestava:

Testosterone Cypionate 200 mg in 1 mL

Pot uporabe:

INTRAMUSCULAR

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Testosterone Cypionate Injection, USP, is available as follows: 200 mg/mL Store vials at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light.

Status dovoljenje:

unapproved drug other

Lastnosti izdelka

                                TESTONE CIK- TESTOSTERONE CYPIONATE, ALCOHOL
ASCLEMED USA, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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TESTOSTERONE CYPIONATE INJECTION, USP CIII
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 is a white or creamy white crystalline powder,
odorless or nearly
so and stable in air. 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)-, (17β)-. Its molecular formula is C
H
O , and the molecular weight
412.61.
The structural formula is represented below:
Testosterone Cypionate Injection, USP, is available as 200 mg/mL
testosterone
cypionate.
Each mL of the 200 MG/ML solution contains:
Testosterone cypionate
200 mg
Benzyl benzoate
0.2 mL
Cottonseed oil
560 mg
Benzyl alcohol (as preservative)
9.9 mg
CLINICAL PHARMACOLOGY
Endogenous androgens are responsible for normal growth and development
of the male
sex organs and for maintenance of secondary sex characteristics. These
effects include
growth and maturation of the prostate, seminal vesicles, penis, and
scrotum;
development of male hair distribution, such as beard, pubic, chest,
and axillary hair;
laryngeal enlargement, vocal cord thickening, and alterations in body
musculature and
fat distribution. Drugs in this class also cause retention of
nitrogen, sodium, potassium,
and phosphorous, and decreased urinary excretion of calcium. Androgens
have been
reported to increase protein anabolism and decrease protein
catabolism. Nitrogen
27
40
3
balance is improved only when there is sufficient intake of calories
and protein.
Androgens are responsible for the growth spurt 
                                
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