(and dosage form):
Combined intramuscular estrogen-androgen preparation (oily solution)
1 mL contains estradiol valerate (estra-1,3,5(10)-triene-3,17beta-diol17-valerate) 4,0 mg and testosterone enantate (17beta-hydroxyandrost-4-en-3-one heptanoate) 90,3 mg in oily solution.
A. 21.9 Androgen-estrogen combinations.
Primodian Depot contains long-acting esters of the naturally occurring estrogen, estradiol, and the naturally occurring androgen, testosterone. Estrogens and androgens have partly synergistic and partly antagonistic actions in the organism.
Their proportion in Primodian Depot has been especially selected so that their desirable effects are brought to the fore, and the undesirable effects are to a large extent suppressed.
Primodian Depot has a favourable influence especially on the severe deficiency symptoms of the female climacteric. Above all psychic complaints respond very well to treatment. Furthermore, Primodian Depot has proved effective in the treatment of osteoporosis during the climacteric. The effect of Primodian Depot usually begins to show a few days after the injection and lasts on the average 3-6 weeks or even longer.
Typical deficiency symptoms of the female climacteric or following oophorectomy or radiological castration for non-carcinomatous diseases (eg hot flushes, bouts of perspiration, sleep disturbances, depressive moods, irritability, headaches, dizziness). Furthermore, Primodian Depot has a favourable influence on bladder irritation - a not infrequent occurrence in the climacteric - signs of cutaneous and mucosal involution (particularly in the genital region) which normally occur with advancing age, and on osteoporotic complaints.
Pregnancy, existing or suspected hormone-dependent tumours of the uterus or mammae, disturbances of lipometabolism, otosclerosis with deterioration in previous pregnancies.
DOSAGE AND DIRECTIONS FOR USE
Before starting the use of Primodian Depot a thorough general medical and gynaecological examination (including the breasts) should be carried out.
Like all oily solutions Primodian Depot must be injected intramuscularly.
One ampoule Primodian Depot intramuscularly every 3-6 weeks, depending individually on the duration of freedom from symptoms. Intervals of less than 3 weeks between injections should be avoided because of the increased risk of virilisation.
As with all estrogen-containing preparations for the treatment of climacteric symptoms, treatment should be discontinued from time to time (approximately every 6 months) in order to verify the persistence of complaints requiring treatment. During treatment pregnancy must not occur (cf "Special notes").
SIDE EFFECTS AND SPECIAL PRECAUTIONS
In rare cases, increased libido, a feeling of tension in the breasts, increase or decrease in body weight, uterine bleeding and signs of virilisation can occur.
The patient should inform her doctor if she suffers from any of the following disorders: diabetes, high blood pressure, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany.
If uterine bleeding occurs the patient must consult her doctor in order to clarify the cause.
The treatment may lead to signs of virilisation such as acne, hirsutism, voice changes. If treatment is continued in spite of easy fatigability of the voice, hoarseness or huskiness, an irreversible deepening of the voice may result. Before treatment, the possibility of voice changes should be pointed out particularly to patients who use their voice professionally.
During treatment pregnancy must not occur. Depending on the individual situation, patients who are still having menstrual periods should therefore practise contraception with non-hormonal methods. If during treatment with Primodian Depot menstrual bleeding at the accustomed intervals fails to occur, pregnancy must be considered despite the protective measures. The treatment must then be interrupted until the situation has been clarified by differential diagnosis.
Not for use during pregnancy.
An increased incidence of endometrial uterine carcinoma, related to the continuous use of estrogens in the post-menopausal period has been reported.
Gynaecological check-ups should be carried out at about 6-month intervals.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
With overdosage of Primodian Depot the symptoms mentioned under "Side effects and special precautions" might occur. In such cases the physician has to decide whether treatment should be discontinued or not. There is no specific antidote.
Clear, pale yellowish, oily solution in 1 ml glass ampoules.
Ampoules of 1 mL.
Protect from light. For shelf-life please refer to the imprint on the pack. Store below 30°C. Keep out of reach of children.
G.3127 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/009072/07)
106 Sixteenth Road
P O Box 5278
Halfway House 1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT
6 February 1979
SCHERING (PTY) LTD
(Reg No: 1964/009072/07)
Schering AG Germany
Updated on this site: April 2003
Current: January 2005
Source: Pharmaceutical Industry
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