Depo-Testosterone

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Testosterone cipionate 100 mg/mL (101mg with manucturers overage.)

Tilgængelig fra:

Pfizer New Zealand Limited

INN (International Name):

Testosterone cipionate 100 mg/mL (101mg with manucturers overage.)

Dosering:

100 mg/mL

Lægemiddelform:

Solution for injection

Sammensætning:

Active: Testosterone cipionate 100 mg/mL (101mg with manucturers overage.) Excipient: Benzyl alcohol Benzyl benzoate Cottonseed oil

Enheder i pakken:

Vial, 10 mL

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Pharmacia & Upjohn Company LLC

Terapeutiske indikationer:

DEPO-TESTOSTERONE Sterile Solution is indicated for replacement therapy in males in conditions associated with symptoms of deficiency or absence of endogenous testosterone.

Produkt oversigt:

Package - Contents - Shelf Life: Vial, - 10 mL - 36 months from date of manufacture stored at or below 25°C protect from light

Autorisation dato:

1969-12-31

Produktets egenskaber

Version: pfdtesti10221
Supercedes: pfdtesti10119
Page 1 of 10
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
DEPO-TESTOSTERONE
®
100mg/mL Solution for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL solution for injection contains 100 mg/mL testosterone
cypionate.
Excipients with known effects:

Benzyl alcohol
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for Injection
DEPO-TESTOSTERONE is a slightly yellow viscous solution
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DEPO-TESTOSTERONE
is
indicated
for
replacement
therapy
in
males
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)-idiopathic
gonadotropin or LHRH
deficiency, or pituitary-hypothalamic injury from tumours, trauma, or
radiation.
4.2 DOSE AND METHOD OF ADMINISTRATION
Prior to initiating DEPO-TESTOSTERONE, confirm the diagnosis of
hypogonadism by
ensuring that serum testosterone concentrations have been measured in
the morning on at least
two separate days and that these serum testosterone concentrations are
below the normal range.
DEPO-TESTOSTERONE is for intramuscular use only.
It should not be given intravenously. Intramuscular injections should
be given deep in the
gluteal muscle.
DOSE
The suggested dosage for DEPO-TESTOSTERONE varies depending on the
age, sex, and
diagnosis of the individual patient. Dosage is adjusted according to
the patient’s response and
the appearance of adverse reactions.
Version: pfdtesti10221
Supercedes: pfdtesti10119
Page 2 of 10
Various dosage regimens have been used to induce pubertal changes in
hypogonadal males;
some experts have advocated lower dosages initially, gradually
increasing the dose as puberty
progresses, with or without a decrease to maintenance levels. Other
experts emphasise that
higher dosages a