Minisem^® (Drops) Instructions for Use

Instructions
Dosage forms

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

Minisem^® affects processes related to memory formation and learning.

Minisem^® enhances selective attention during learning and information analysis, improves memory functions; improves the body’s adaptation to hypoxia, cerebral ischemia, anesthesia, and other damaging effects.

Under conditions of neuropsychic exhaustion, Minisem^® facilitates concentration, improves operator activity and mental performance.

Pharmacokinetics

Absorption from the nasal mucosa is 60-70%.

It is rapidly distributed to all organs and tissues, penetrates the blood-brain barrier.

The unchanged drug and/or its metabolites are not detected in daily urine.

Indications

For the treatment of intellectual-mnestic disorders in children with vascular brain lesions;
For delayed psychomotor development of perinatal origin in young children (from 3 months and older);
For the treatment of neurotic and cognitive impairments in preschool and primary school-age children;
To increase the adaptive capabilities of the child’s body.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
F07	Personality and behavioral disorders due to disease, damage or dysfunction of the brain
F79	Unspecified intellectual disabilities
F83	Mixed specific developmental disorders
R62	Lack of expected normal physiological development

ICD-11 code	Indication
6A00.Z	Disorders of intellectual development, unspecified
6A0Z	Neurodevelopmental disorders, unspecified
6E68	Secondary emotionally labile personality disorder
6E6Z	Unspecified secondary mental or behavioral syndromes
MG44.1Z	Lack of expected normal physiological development, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Drops

Minisem^® is used intranasally, using a dropper bottle.

Each drop of the standard solution contains 5 mcg of the active substance.

The drug solution is instilled with a pipette in an amount of no more than 3 drops (15 mcg) per administration into each nasal passage 2-3 times a day at intervals of 3-4 hours.

A single dose ranges from 1 to 3 drops (5-15 mcg) fractionally at intervals of 10-15 minutes until the therapeutic dose of 18 drops (90 mcg) is reached.

The drug is prescribed daily for 3-5 days. The duration of the course application of the drug is 14 days.

If necessary, the course of treatment can be repeated after 4 weeks.

Adverse Reactions

With increased sensitivity to the drug, irritation of the nasal mucosa, skin rash, sleep disturbance, increased excitability, irritability, increased blood pressure, and allergic reactions may occur.

Contraindications

Individual intolerance to the drug;
Acute psychotic conditions;
Pregnancy;
Breastfeeding period;
Tendency to convulsions;
Children under 3 months (due to lack of data).

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated in children under 3 months.

Drug Interactions

Concomitant use with intranasal drugs with local vasoconstrictive action is not advisable.

Storage Conditions

In a place protected from light at a temperature not exceeding +10°C (50°F). Do not allow freezing. Keep out of reach of children.

Shelf Life

Shelf life – 1 year.

Dispensing Status

By prescription.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Minisem^® [Institute of Molecular Genetics of the Russian Academy of Sciences State Institution (Russia)]
Nasal drops 0.01%: 3 ml bottle

Marketing Authorization Holder

Institute of Molecular Genetics of the Russian Academy of Sciences State Institution (Russia)

On Behalf Of

PIK-PHARMA, LLC (Russia)

Dosage Form

Minisem^®

Nasal drops 0.01%: 3 ml bottle

Dosage Form, Packaging, and Composition

Nasal drops 0.01% colorless, transparent.

	1 drop	1 ml
Synthetic peptide compound containing 7 amino acid residues (methionyl-glutamyl-histidyl-phenylalanyl-prolyl-glycyl-proline)	5 mcg	100 mcg

3 ml – plastic bottles (1) with a dropper cap – cardboard packs.

Minisem^® [Peptogen Innovation Scientific And Production Center, JSC (Russia)]
Nasal drops 0.01%: 3 ml bottle