PROVIRON Tablet Ref.[51091] Active ingredients: Mesterolone

Source: Web Search  Revision Year: 2020  Publisher: Bayer Israel Ltd., 36 Hacharash St.,Hod Hasharon 45240 Manufacturer: Bayer Weimar GmbH und CO. KG., Germany

4.1. Therapeutic indications

Androgen deficiency or male infertility when associated with primary or secondary male hypogonadism.

Reduced efficiency in middle and advanced age

Complaints attributable to androgen-deficiency, such as reduced efficiency, easy fatigability, lack of concentration, weak memory, disturbances of libido and potency, irritability, disturbances of sleep, depressive moods, and general vegetative complaints, can be overcome or improved by the use of Proviron tablets.

Potency disturbances

Potency disorders based on an androgen deficiency are eliminated by administration of Proviron. If other factors are the sole cause or if they contribute to the disorders, Proviron may be administered in support of other therapeutic measures.

Hypogonadism

Growth, development and function of androgen-dependent target organs are stimulated by Proviron. It promotes development of secondary male sex characteristics in cases of prepuberal androgen-deficiency. Proviron eliminates deficiency symptoms in cases where a loss of gonadal function has occurred postpuberally.

Infertility

Oligozoospermia and deficient Leydig-cell secretion may be the cause of infertility. With Proviron, sperm count and sperm quality as well as the fructose concentration in the ejaculate can be improved or normalized, thus increasing the chances of procreation.

4.2. Posology and method of administration

The tablets should be swallowed whole with some liquid.

The following dosages are recommended:

Reduced efficiency and potency disturbances:

Commencement of treatment:

1 Proviron tablet 3 times per day.

After satisfactory clinical improvement, it can be tried to reduce the dose.

Continuation of treatment:

1 Proviron tablet twice or once per day.

According to the type and severity of the complaints, the dose for further treatment is to be adjusted to individual requirements. Continuous treatment over a period of several months is recommended.

Hypogonadism requires continuous therapy:

For development of secondary male sex characteristics, 1-2 Proviron tablets 3 times per day for several months.

As maintenance dose, 1 Proviron tablet 2-3 times per day will often be sufficient.

Infertility – for the improvement of sperm quantity and quality:

1 Proviron tablet 2-3 times per day for a cycle of spermatogenesis, i.e. for about 90 days. If necessary, Proviron treatment is to be repeated after an interval of several weeks.

To achieve a higher fructose concentration in the ejaculate in cases of postpuberal Leydig-cell insufficiency: 1 Proviron tablet twice per day over several months.

4.9. Overdose

Acute toxicity studies using single administration showed that Proviron is to be classified as non-toxic. No risk of toxicity is to be expected even after inadvertent single administration of a multiple of the dose required for therapy.

6.3. Shelf life

The expiry date of the product is indicated on the packaging materials.

6.4. Special precautions for storage

No special storage conditions are required, is it recommended to keep at room temperature.

6.5. Nature and contents of container

Blister of polyvinyl chloride and aluminum, heat-sealed.

6.6. Special precautions for disposal and other handling

This medicinal product does not require any special storage conditions.

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