Pineamin^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Geropharm, LLC (Russia)

ATC Code

G02CX (Other drugs used in gynecology)

Active Substance

Cattle pineal gland polypeptides (Grouping name)

Dosage Form

Pineamin®

Lyophilisate for the preparation of solution for intramuscular administration 10 mg: vial 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for the preparation of solution for intramuscular administration in the form of a powder or porous mass of white or white with a yellowish tint color.

* a complex of water-soluble polypeptide fractions of the pineal gland of cattle not older than 12 months of age, isolated from the dry extract of Pineamin^® (Geropharm, LLC, Russia), containing glycine (AJINOMOTO Co. Inc., Japan; Panreac, Spain) as a stabilizer in a ratio of 1:2.

30 mg – vials of colorless glass with a capacity of 5 ml (5) – contour cell packaging (1) – cardboard boxes.
30 mg – vials of colorless glass with a capacity of 5 ml (5) – contour cell packaging (2) – cardboard boxes.

Clinical-Pharmacological Group

Anticlimacteric drug

Pharmacotherapeutic Group

Other agents used in gynecology

Pharmacological Action

A complex of low molecular weight water-soluble polypeptide fractions isolated from the pineal gland of cattle.

It optimizes pineal-hypothalamic relationships, normalizes the function of the anterior pituitary gland and the balance of gonadotropic hormones.

In women in the postmenopausal period, a decrease in the severity of menopausal disorders according to the Kupperman index has been established due to the positive effect of this agent on the neurovegetative manifestations of menopausal syndrome, such as hot flashes, hyperhidrosis, headaches, sensation of palpitations at rest, increased excitability, and sleep disorders.

Indications

Neurovegetative disorders in menopausal syndrome in women in the presence of contraindications to MHT or refusal to undergo it.

ICD codes

Dosage Regimen

Administer intramuscularly only.

Reconstitute the lyophilisate immediately before administration using the provided solvent or water for injection.

The recommended dose is 10 mg once daily.

Administer injections at approximately the same time each day.

The standard course of treatment is 10 consecutive days.

If a scheduled injection is missed, do not administer a double dose.

Resume the regimen with the next scheduled injection.

If necessary, a repeated course can be conducted after an interval of 3 to 6 months.

The decision on the need for a repeat course must be made by a physician.

Adverse Reactions

Possible allergic reactions.

In some cases bloody vaginal discharge, infiltration at the injection site.

Contraindications

Hypersensitivity to the components of the agent; metrorrhagia (bloody discharge from the genital tract of unclear genesis); precancerous or malignant diseases, including estrogen-dependent tumors of the reproductive system and mammary gland; pregnancy, period of breastfeeding; childhood and adolescence under 18 years.

Use in Pregnancy and Lactation

The agent is contraindicated for use during pregnancy and during lactation (breastfeeding).

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

This agent does not affect the concentration of sex hormones in the blood plasma. However, it is recommended to use it with caution in leiomyoma and endometriosis.

Due to the possibility of individual hypersensitivity to the components of the agent, it is recommended to perform a test injection before starting therapy.

In case of a missed injection, it is not recommended to administer a double dose, but to perform the next injection as usual on the scheduled day.

Drug Interactions

This agent is not recommended to be mixed with other solutions.

Storage Conditions

Store at 2°C (36°F) to 15°C (59°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.