Pineamine - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspLyophilizate for the preparation of solution for intramuscular injection.

Composition:Medicament PINEAMIN®, lyophilisate for the preparation of a solution for intramuscular administration of 10 mg, is a water-soluble complex of polypeptide fractions epiphysis [pineal] cattle aged 12 months of age, isolated from dry extract Pineamin® (OOO "GEROPHARM", Russia) , containing as a stabilizer glycine (Aginomoto Co. Inc., Japan, Panreac, Spain) in a ratio of 1: 2.

Description:Powder or porous mass of white or white with a yellowish hue.

Pharmacotherapeutic group:Anti-climacteric.

Pharmacodynamics:PINEAMIN® active substance preparation is a complex of low molecular weight water-soluble polypeptide fraction isolated from bovine pineal gland.
The drug optimizes the epiphyseal-hypothalamic relationship, normalizes the function of the anterior pituitary and the balance of gonadotropic hormones.
In experiments with laboratory animals with age-related decrease fertility in the groups receiving drug PINEAMIN®, tended to increase libido and increase reproductive ability, and easy noted psihoemotsialnoe soothing effect on animal performance.
In a double-blind, placebo-controlled study of the drug in the postmenopausal women's population, a significant decrease in the severity of menopausal disorders was revealed by the Kupperman index due to the positive effect of the drug on neurovegetative manifestations of menopausal syndrome, such as hot flushes, hyperhidrosis, headaches, increased excitability, sleep disorders, etc.
Toxicological studies have proved the non-toxicity of the drug PINEAMIN®. When studying acute toxicity, it was not possible to achieve lethal effects with maximal doses exceeding the therapeutic human dose of tens of thousands of times.
The subacute (30 days) and chronic (90 days) daily intramuscular injection of the preparation PINEAMIN® to the experimental animals had no negative effect on the main systems (nervous, cardiovascular, hematopoietic, urinary and respiratory), and also on metabolism and the general state of the organism.

Pharmacokinetics:The composition of the preparation PINEAMIN®, the active ingredient of which is a complex of polypeptide fractions, does not allow the usual pharmacokinetic analysis of individual components.

Indications:Neurovegetative disorders with climacteric syndrome in women in the presence of contraindications to hormone replacement therapy (HRT) or refusal to conduct it.

Contraindications:Hypersensitivity or intolerance to any of the
components of the drug, children under 18 years of age, pregnancy and the period of breastfeeding, metrorrhagia (bloody discharge from the genital tract of unknown origin).
Precancerous or malignant diseases, including estrogen-dependent tumors of the organs of the reproductive system and breast.

Carefully:The drug has no effect on the concentration of sex hormones in the blood plasma. However, it is recommended with caution to use it for uterine leiomyoma and endometriosis.

Pregnancy and lactation:The drug is not intended for use in pregnancy and during breastfeeding.

Dosing and Administration:The drug is administered intramuscularly.
The contents of the vial before injection 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 in 3-6 months.
In the case of missed injections, it is not recommended to administer a double dose, but to carry out the next injection as usual on the target day.

Side effects:Allergic reactions are possible in case of individual hypersensitivity to the components of the drug.
In the conducted clinical study, single cases of development of such undesirable reactions as (classification of MedDra) were recorded:

Class by MedDra	Unwanted reaction	Frequency (by classification WHO)
Violations of the genitals and mammary glands	Bloody discharge from the vagina	Often (≥ 1%, but <10% of prescriptions)
Disturbances from the skin and subcutaneous tissues	Infiltrate at the site of intramuscular injection of the drug	Rarely (≥ 0.01%, but <0.1% of prescriptions

If these side effects occur, consult a doctor.
If any of the side effects indicated in the manual are aggravated or any other side effects not indicated in the instructions occur, you should notify the doctor.

Overdose:Cases of overdose have not been identified.
Possible symptoms of drug overdose are spotting from the vagina, an increase in the concentration of estradiol of the blood.In these cases, it is necessary to cancel the drug, carry out symptomatic therapy.

Interaction:Drug interactions with other drugs have not been identified.
Incompatibility
The solution of PINEAMIN® is not recommended for mixing with other solutions.

Special instructions:The drug PINEAMIN® should only be used as directed by a doctor!
In view of the possibility of individual hypersensitivity to the components of the drug, it is recommended that a trial injection be performed before the start of therapy.
The drug solution must be prepared immediately before use.
Prepared solution can not be stored.
Special precautions for the destruction of unused medicinal product are not required.

Effect on the ability to drive transp. cf. and fur:Influence of medicinal product for medical use on the performance of potentially hazardous activities requiring an increased concentration of attention and speed of psychomotor reactions is currently not revealed.

Form release / dosage:Lyophilizate for solution for intramuscular injection 10 mg.

Packaging:30 mg of lyophilisate in the vials from the colorless glass capacity of 5 ml, sealed with stoppers rubber lyophilic with run-caps aluminum with peelable plastic plate pink or orange color with relief inscription "GEROPHARM" 5 vials in blisters of film polyvinylchloride or polyethylene terephthalate and a foil aluminum. For 1 or 2 contour squares with instructions for use in a pack of cardboard.

Storage conditions:In the dark place at a temperature of 2 to 20 ° C. Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003202

Date of registration:16.09.2015

Expiration Date:16.09.2020

The owner of the registration certificate:GEROPHARM, LLC GEROPHARM, LLC Russia

Manufacturer: & nbsp

GEROPHARM, LLC Russia

Information update date: & nbsp2016-12-16

Illustrated instructions

Instructions

Pineamine® (Pineamin)