Pineamin 10 mg 10 pcs. lyophilisate for preparation of solution for intramuscular administration
pharmachologic effect
The active ingredient of the drug Pineamin® is a complex of low molecular weight water-soluble polypeptide fractions isolated from the pineal gland of cattle.
The drug optimizes the epiphyseal-hypothalamic relationship, normalizes the function of the anterior pituitary gland and the balance of gonadotropic hormones.
In experiments on laboratory animals with age-related decline in fertility in groups receiving the drug Pineamin®, there was a tendency to increase libido and increase reproductive capacity, and a slight calming effect on the psycho-emotional state of animals was noted.
In a double-blind, placebo-controlled study of the drug in a population of postmenopausal women, a significant decrease in the severity of menopausal disorders was found according to the Kupperman index due to the positive effect of the drug on the neurovegetative manifestations of menopausal syndrome, such as hot flashes, hyperhidrosis, headaches, and palpitations at rest. , increased excitability, sleep disturbances.
Toxicological studies have proven the non-toxicity of Pineamin®. When studying acute toxicity, it was not possible to achieve lethal effects when using the drug in maximum doses exceeding the therapeutic dose for humans by 10,000 times. Subacute (30 days) and chronic (90 days) daily intramuscular administration of the drug Pineamin® to experimental animals did not have a negative effect on the main systems (nervous, cardiovascular, hematopoietic, urinary and respiratory), as well as on metabolism and general condition body.
Composition and release form Pineamin 10 mg 10 pcs. lyophilisate for preparation of solution for intramuscular administration
Lyophilisate - 1 vial: bovine pineal gland polypeptides* 10 mg.
* a complex of water-soluble polypeptide fractions of the pineal gland (pineal gland) of cattle not older than 12 months of age, isolated from dry extract Pineamin® (GEROPHARM LLC, Russia), containing glycine as a stabilizer (AJINOMOTO CO., INC., Japan; Panreac, Spain) in a ratio of 1:2.
30 mg - colorless glass bottles with a capacity of 5 ml (5) - contour cell packaging (2) - cardboard packs.
Description of the dosage form
Lyophilisate for the preparation of a solution for intramuscular administration in the form of a powder or porous mass of white or white with a yellowish tint.
Directions for use and doses
The drug is administered intramuscularly.
Before injection, the contents of the bottle are dissolved in 1-2 ml of a 0.5% solution of procaine (novocaine), water or 0.9% sodium chloride solution and administered once daily at a dose of 10 mg for 10 days.
If necessary, repeat the course after 3-6 months.
If an injection is missed, it is not recommended to administer a double dose, but to administer the next injection as usual on the scheduled day.
Pharmacodynamics
The active ingredient of the PINEAMIN® preparation is a complex of low molecular weight water-soluble polypeptide fractions isolated from the pineal gland of cattle.
The drug optimizes the epiphyseal-hypothalamic relationship, normalizes the function of the anterior pituitary gland and the balance of gonadotropic hormones.
In experiments on female rats with age-related decline in fertility in groups receiving the drug PINEAMIN®, a tendency to increase libido and an increase in reproductive capacity was observed, and a slight calming effect on the psycho-emotional state of the animals was noted.
In a double-blind, placebo-controlled study of the drug in a population of postmenopausal women, a significant decrease in the severity of menopausal disorders according to the Kupperman index was established due to the positive effect of the drug on the neurovegetative manifestations of menopausal syndrome, incl. hot flashes, hyperhidrosis, headaches, palpitations at rest, increased excitability, sleep disturbances.
Toxicological studies have proven the non-toxicity of PINEAMIN®. When studying acute toxicity, it was not possible to achieve lethal effects when using maximum doses exceeding the therapeutic human dose by tens of thousands of times. Subacute (30 days) and chronic (90 days) daily intramuscular administration of the drug PINEAMIN® to experimental animals did not have a negative effect on the main systems (nervous, cardiovascular, hematopoietic, urinary and respiratory), as well as on metabolism and general condition body.
Pharmacokinetics
The composition of the drug Pineamin®, the active substance of which is a complex of polypeptide fractions, does not allow for conventional pharmacokinetic analysis of individual components.
Indications for use Pineamin 10 mg 10 pcs. lyophilisate for preparation of solution for intramuscular administration
Neurovegetative disorders in menopausal syndrome in women with contraindications to hormone replacement therapy (3HT) or refusal to carry it out.
Contraindications
- Metrorrhagia (bloody discharge from the genital tract of unknown origin);
- precancerous or malignant diseases, incl. estrogen-dependent tumors of the reproductive system and breast;
- pregnancy;
- breastfeeding period;
- children and adolescents up to 18 years of age;
- hypersensitivity to the components of the drug.
Application Pineamin 10 mg 10 pcs. lyophilisate for preparing a solution for intramuscular administration during pregnancy and lactation
The drug is not intended for use during pregnancy and breastfeeding.
Use in children
The use of the drug is contraindicated in children and adolescents under 18 years of age.
special instructions
Pineamin® should be used only as directed by a physician.
The drug does not affect the concentration of sex hormones in the blood plasma. However, it is recommended to use it with caution in case of leiomyoma and endometriosis.
Due to the possibility of individual hypersensitivity to the components of the drug, it is recommended that a test injection be performed before starting therapy.
The drug solution must be prepared immediately before use. The prepared solution cannot be stored.
No special precautions are required when disposing of unused medicinal products.
Impact on the ability to drive vehicles and operate machinery
The effect of the drug on the performance of potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions has not yet been identified.
Overdose
No cases of overdose have been identified.
Symptoms: in case of overdose, bloody discharge from the vagina and an increase in the concentration of estradiol in the blood are possible.
Treatment: if symptoms of overdose occur, discontinuation of the drug and symptomatic therapy are necessary.
Side effects Pineamin 10 mg 10 pcs. lyophilisate for preparation of solution for intramuscular administration
Allergic reactions are possible in case of individual hypersensitivity to the components and the drug.
In the clinical study conducted, isolated cases of the development of adverse reactions listed below were recorded (MedDRA classification).
From the genital organs and breast: often (≥1%, but
From the skin and subcutaneous tissues: rarely (≥0.01%, but
If these side effects occur, the patient should consult a doctor.
If any of the side effects indicated in the instructions worsen or any other side effects not listed in the instructions occur, the patient should inform the doctor.
Drug interactions
Drug interactions with other drugs have not yet been identified.
Pharmaceutical incompatibility
The Pineamin® solution is not recommended to be mixed with other solutions.
Pineamin lyophilis for the preparation of intramuscular solution 10 mg bottle N 10
Dosage form
Lyophilisate for preparation. solution for intramuscular administration of 10 mg: 10 pcs.
Release form, packaging and composition of the drug
Lyophilisate for the preparation of a solution for intramuscular administration in the form of a powder or porous mass of white or white with a yellowish tint.
bovine pineal gland polypeptides 10 mg
a complex of water-soluble polypeptide fractions of the epiphysis (pineal gland) of cattle not older than 12 months of age, isolated from dry Pineamin® extract
Pharmacotherapeutic group:
Antimenopausal agent
pharmachologic effect
The active ingredient of the drug Pineamin® is a complex of low molecular weight water-soluble polypeptide fractions isolated from the pineal gland of cattle.
The drug optimizes the epiphyseal-hypothalamic relationship, normalizes the function of the anterior pituitary gland and the balance of gonadotropic hormones.
In experiments on laboratory animals with age-related decline in fertility in groups receiving the drug Pineamin®, there was a tendency to increase libido and increase reproductive capacity, and a slight calming effect on the psycho-emotional state of animals was noted.
In a double-blind, placebo-controlled study of the drug in a population of postmenopausal women, a significant decrease in the severity of menopausal disorders was found according to the Kupperman index due to the positive effect of the drug on the neurovegetative manifestations of menopausal syndrome, such as hot flashes, hyperhidrosis, headaches, and palpitations at rest. , increased excitability, sleep disturbances.
Toxicological studies have proven the non-toxicity of Pineamin®. When studying acute toxicity, it was not possible to achieve lethal effects when using the drug in maximum doses exceeding the therapeutic dose for humans by 10,000 times. Subacute (30 days) and chronic (90 days) daily intramuscular administration of the drug Pineamin® to experimental animals did not have a negative effect on the main systems (nervous, cardiovascular, hematopoietic, urinary and respiratory), as well as on metabolism and general condition body.
Pharmacokinetics
The composition of the drug Pineamin®, the active substance of which is a complex of polypeptide fractions, does not allow for conventional pharmacokinetic analysis of individual components.
Indications for the drug Pineamin®
— neurovegetative disorders in menopausal syndrome in women with contraindications to hormone replacement therapy (3HT) or refusal to carry it out.
Dosage regimen
The drug is administered intramuscularly.
Before injection, the contents of the bottle are dissolved in 1-2 ml of a 0.5% solution of procaine (novocaine), water or 0.9% sodium chloride solution and administered once daily at a dose of 10 mg for 10 days.
If necessary, repeat the course after 3-6 months.
If an injection is missed, it is not recommended to administer a double dose, but to administer the next injection as usual on the scheduled day.
From the genital organs and breast: often (≥1%, but <10% of prescriptions) - bloody vaginal discharge.
From the skin and subcutaneous tissues: rarely (≥0.01%, but <0.1% of prescriptions) - infiltrate at the site of intramuscular administration of the drug.
If these side effects occur, the patient should consult a doctor.
If any of the side effects indicated in the instructions worsen or any other side effects not listed in the instructions occur, the patient should inform the doctor.
Contraindications for use
metrorrhagia (bloody discharge from the genital tract of unknown origin);
precancerous or malignant diseases, incl. estrogen-dependent tumors of the reproductive system and breast;
pregnancy;
breastfeeding period;
children and adolescents up to 18 years of age;
hypersensitivity to the components of the drug.
Use during pregnancy and breastfeeding
The drug is not intended for use during pregnancy and breastfeeding.
Use in children
The use of the drug is contraindicated in children and adolescents under 18 years of age.
special instructions
Pineamin® should be used only as directed by a physician.
The drug does not affect the concentration of sex hormones in the blood plasma. However, it is recommended to use it with caution in case of leiomyoma and endometriosis.
Due to the possibility of individual hypersensitivity to the components of the drug, it is recommended that a test injection be performed before starting therapy.
The drug solution must be prepared immediately before use. The prepared solution cannot be stored.
No special precautions are required when disposing of unused medicinal products.
Impact on the ability to drive vehicles and operate machinery
The effect of the drug on the performance of potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions has not yet been identified.
Overdose
No cases of overdose have been identified.
Symptoms: in case of overdose, bloody discharge from the vagina and an increase in the concentration of estradiol in the blood are possible.
Treatment: if symptoms of overdose occur, discontinuation of the drug and symptomatic therapy are necessary.
Drug interactions
Drug interactions with other drugs have not yet been identified.
Pharmaceutical incompatibility
The Pineamin® solution is not recommended to be mixed with other solutions.
Storage conditions for the drug Pineamin®
The drug should be stored in a place protected from light, out of reach of children, at a temperature of 2° to 20°C.
Shelf life of the drug Pineamin®
Shelf life: 3 years. Do not use after the expiration date stated on the package.
Terms of sale
The drug is available with a prescription.
Pineamin®
PINEAMIN ®
Group name: polypeptides of the pineal gland of cattle. Dosage form: lyophilisate for the preparation of a solution for intramuscular administration. Composition: The drug PINEAMIN®, lyophilisate for the preparation of a solution for intramuscular administration of 10 mg, is a complex of water-soluble polypeptide fractions of the pineal gland (pineal gland) of cattle not older than 12 months of age, isolated from the dry extract of Pineamin (GEROPHARM LLC, Russia ), containing glycine as a stabilizer (Ajinomoto Co. Inc., Japan; Panreac, Spain) in a ratio of 1: 2. Description of the drug: Powder or porous mass of white or white with a yellowish tint. Pharmacotherapeutic group of the drug: Anticlimacteric. ATX code: G02CX. Pharmacodynamics: When taken, the drug optimizes the epiphyseal-hypothalamic relationship, normalizes the function of the anterior pituitary gland and the balance of gonadotropic hormones. In a double-blind, placebo-controlled study of the drug in a population of postmenopausal women, it was found that with its use, a significant decrease in the severity of menopausal disorders according to the Kupperman index occurs due to the positive effect of the drug on the neurovegetative manifestations of menopause. Previously, in preclinical studies on experimental animals, long-term (30 and 90 days) intramuscular administration of the drug Pineamin did not reveal its negative effects on the main systems (nervous, cardiovascular, hematopoietic, urinary and respiratory), as well as on metabolism and general condition body. Indications for use: Neurovegetative disorders in menopausal syndrome in women with contraindications to hormone replacement therapy (HRT) or refusal to carry it out. Contraindications: Hypersensitivity or intolerance to any of the components of the drug, children under 18 years of age, pregnancy and breastfeeding, metrorrhagia (bloody discharge from the genital tract of unknown origin). Precancerous and malignant diseases, including estrogen-dependent tumors of the reproductive system and breast. With caution: The drug does not affect the concentration of sex hormones in the blood plasma. However, it is recommended to use it with caution in cases of uterine leiomyoma and endometriosis. Use during pregnancy and breastfeeding: The drug is not indicated for use during pregnancy and breastfeeding. Method of administration and dosage: The drug is administered intramuscularly. Before injection, the contents of the bottle are dissolved in 1-2 ml of 0.5% solution of procaine (novocaine), water for injection or 0.9% sodium chloride solution and administered once daily at a dose of 10 mg for 10 days. If necessary, repeat the course after 3-6 months. If an injection is missed, it is not recommended to administer a double dose, but to administer the next injection as usual on the scheduled day. Side effects: Possible side effects of Pineamin are allergic reactions in case of individual hypersensitivity to the components contained in the drug. In the clinical study conducted, isolated cases of the development of such adverse reactions as (MedDra classification) were registered:
| MedDra class | Adverse reaction | Frequency (according to WHO classification) |
| Disorders of the genital organs and mammary glands | Bloody vaginal discharge | Common (≥ 1% but < 10% of prescriptions) |
| Skin and subcutaneous tissue disorders | Infiltration at the site of intramuscular injection of the drug | Rare (≥ 0.01% but < 0.1% of prescriptions) |
If these side effects occur, you should consult a doctor. If the phenomena indicated in the instructions worsen or other side effects not mentioned occur, you must inform your doctor. Overdose: No cases of overdose have been identified. Possible symptoms of a drug overdose are bloody vaginal discharge and an increase in the concentration of estradiol in the blood. In these cases, discontinuation of the drug and symptomatic therapy are necessary. Interaction with other drugs: Drug interactions with other drugs have not yet been identified. Incompatibility: PINEAMIN® solution is not recommended to be mixed with other solutions. Special instructions: PINEAMIN® should be used only as prescribed by a doctor! In view of the possibility of individual hypersensitivity to individual components contained in the drug, it is recommended to administer it as a test injection before starting therapy. The bottle with the drug solution cannot be stored or used after storage. No special precautions are required when disposing of unused medicine. Effect on the ability to drive vehicles and machinery: The effect of the drug Pineamin for medical use on the performance of potentially hazardous activities that require increased concentration and speed of psychomotor reactions has not yet been identified. Release form: Lyophilisate Pineamin for the preparation of solution for intramuscular administration 10 mg. Bottles made of colorless glass with a capacity of 5 ml, with aluminum caps with a tear-off plastic lining of pink or orange color with a raised inscription: “GEROPHARM”, 5 bottles each in a blister pack made of polyvinyl chloride film and aluminum foil. 1 or 2 blister packs with instructions for use in a cardboard pack. Storage conditions: In a place protected from light at a temperature of 2 to 20 ° C. Keep out of the reach of children. Shelf life: 3 years. Conditions for dispensing from pharmacies: Dispensed by prescription. Registration number of Pineamin: LP-003202 Manufacturer: GEROPHARM LLC, Russia 191144, St. Petersburg, Degtyarny lane, 11, lit. B Telephone (multi-channel) Fax Hotline telephone: 8-800-333-4376 (calls within Russia are free)
