TESTIWELL® - peptide preparation for the restoration of spermatogenesis

TESTIWELL® is a complex of polypeptides isolated from the testes of mature cattle.

Dosage form:

Lyophilisate: lyophilised mass in the form of a tablet, whole, partially or completely crushed, white or with a yellowish tint. Reconstituted solution: clear, colorless or slightly yellowish solution.

Ingredients:

1 vial contains polypeptides of the testes of cattle - 5.0 mg. (active substance), glycine - 20.0 mg. (excipient:excipient).

Pharmacodynamics:

Testiwell is a complex of polypeptides isolated from the testes of mature cattle.
Being a peptide regulator, Testiwell has an organotropic effect on the male gonads, restoring spermatogenesis and improving spermogram parameters.
According to the results of clinical studies of Fertiwell, it was found that in 84% of men with oligoastenozoospermia, the preparation statistically significantly increases the number of spermatozoa and the proportion of their progressively mobile forms. In 36% of men with teratozoospermia, Testiwell increases the absolute number of morphologically normal forms of spermatozoa in the ejaculate (million/ml). The effect of Fertiwell on pregnancy rates has not been studied in clinical trials.

Pharmacokinetics:

The preparation Testiwell is an extract containing a complex of peptides and biologically active substances, which does not allow for the usual pharmacokinetic analysis of individual components. In tissues, peptides are cleaved by cellular proteases to amino acids; as a result, the therapeutic effect does not correlate with the determined amounts of peptides and metabolites.

Indications:

Complex therapy of spermatogenesis disorders (oligoastenozoospermia), accompanied by impaired fertility in men.

Contraindications:

Individual hypersensitivity to the drug or its components. Children's age up to 18 years (there is no experience of medical use). Use during pregnancy and during breastfeeding. The preparation is not intended for use in women.

Dosage and administration:

The preparation is administered intramuscularly.
Before injection, the contents of the vial are dissolved in 1-2 ml of 0.9% sodium chloride solution, directing the needle to the vial wall to avoid foaming.
The preparation is administered intramuscularly, 1 vial per day, 1 time per week for 10 weeks. The interval between two consecutive injections should be at least 4 days.
In case of missing an injection, it is not recommended to administer a double dose, the next injection is carried out on the scheduled day. Testiwell is injected intramuscularly into the upper outer quadrant of the gluteus maximus muscle, it is necessary to alternate the injection of the preparation into the left and right gluteal muscles.

Side effects:

Testiwell has demonstrated a favorable safety profile in clinical trials. Most reported adverse events (AEs) associated with taking Testiwell were of mild severity and did not require any corrective measures. No cases of serious adverse events have been reported.
The following are the adverse reactions observed during clinical studies, indicating the frequency of their development in accordance with the classification of the World Health Organization (WHO): very often (> 1/10); often (>1/100, <1/10), infrequently (>1/1000, <1/100), rarely (>1/10000, <1/1000) and very rarely (<1/10000), the frequency is unknown (according to the available data, it is not possible to establish the frequency of occurrence):
Reproductive system and mammary gland disorders:
infrequently: discoloration of the ejaculate, asthenozoospermia, teratozoospermia, increased viscosity of the ejaculate, increased pH of the ejaculate.
Laboratory and instrumental data:
infrequently: relative lymphocytosis, relative monocytosis, relative neutropenia.
General disorders and reactions at the injection site:
often: erythema at the injection site, pain at the injection site.

Special instructions:

The reconstituted solution of Testiwell should be administered immediately after dilution; storage of a vial with a dissolved preparation and delayed administration of the reconstituted solution is unacceptable.
Special precautions for the destruction of unused medicinal products are not required.
Before prescribing Testiwell, a thorough examination of the patient (including the determination of follicle-stimulating hormone (FSH), luteinizing hormone (LH), testosterone and prostate-specific antigen (PSA)) should be carried out and other causes of male infertility excluded.
There is no experience of repeated course use of Fertiwell.
With parenteral administration of preparations containing animal protein, the development of allergic / anaphylactic reactions is possible. If hypersensitivity reactions occur during the use of Testiwell, the administration of the drug should be discontinued and standard measures should be taken to treat the allergic reaction.
There is no experience of co-administration of Testiwell with other pharmacological and non-pharmacological methods for the treatment of spermatogenesis disorders in men.
Influence on the ability to drive vehicles, mechanisms: the preparation does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and psychomotor reactions.

Storage conditions:

To store in the dark place at a temperature from 2 to 25 °C.

Guaranteed authenticity and quality:

100% original product from PeptidPRO® and SAMSON-MED LLC (Russian Federation)

Development and production:

PeptidPRO®'s area of interest is in the development of preparations for the pathogenetic treatment of socially significant diseases. The company is currently issuing o the pharmaceutical market three injectable drugs that significantly affect the quality of life of patients.

Biopharmaceutical company Samson-Med LLC is one of the leaders of the Russian pharmaceutical market in the segment of development, research and production of peptide preparations. Center for Scientific and Technological Competences.

(Russian Federation)