Selank nasal drops 0.15% 3ml
Compound
Active substance: Selanka® in terms of 100% substance (threonyl-lysyl-prolyl-arginyl-prolyl-glycyl-proline diacetate) - 1.5 mg.
Excipients: methyl parahydroxybenzoate (nipagin) - 1 mg, purified water up to 1 ml.
Pharmacokinetics
Selank® is administered intranasally (nasal drops). The absolute bioavailability of Selank® when administered to the nasal mucosa is 92.8%. The drug is quickly absorbed from the nasal mucosa and after 30 seconds is detected in the blood plasma, and then quickly distributed to various organs and tissues. Penetrates into brain tissue. Plasma concentrations decrease progressively over 5-5.5 minutes. Neither unchanged drug nor metabolites are detected in daily urine, which is due to the rapid degradation of Selank® under the influence of tissue peptidases.
Indications for use
Alarm states:
- unmotivated anxiety, restlessness;
- panic attacks;
- neurasthenia;
- asthenia;
- mood instability;
- sleep disorders;
- decreased willpower, initiation of activities, indecisiveness, difficulties in making decisions, lack of self-confidence;
- lack of confidence in communication;
- adaptation disorders.
Prevention and treatment of stress disorders.
Contraindications
- Individual intolerance to the drug.
- Pregnancy, breastfeeding (efficacy and safety studies have not been conducted).
- Children under 18 years of age (efficacy and safety studies have not been conducted).
Directions for use and doses
Selank® is administered intranasally, using a bottle sealed with a plastic screw cap or a dropper cap.
If the bottle is sealed with a plastic screw cap, upon initial use, remove the plastic screw cap and replace it with the included capped dropper.
Pipette the drug.
Squeeze the required number of drops of the drug onto the clean mucous membrane of the nasal passage, then close the nostril with your finger for a short time.
If the bottle is sealed with a dropper cap, carefully cut off the tip of the pipette and tightly cap the pipette. Before use, invert the bottle so that the liquid fills the entire pipette space. Remove the cap. Squeeze the required number of drops of the drug onto the clean mucous membrane of the nasal passage, then close the nostril with your finger for a short time.
Instillation of the drug into the nasal passages is carried out in a sitting position with the head slightly thrown back or tilted to one side, after which each nostril is pinched for a short time with a finger.
The effectiveness of absorption may be reduced in the presence of increased secretions from the nasal mucosa, therefore, before use (instillation), it is recommended to clear the nasal passage.
Dose: 2 drops in each nasal passage 3 times a day.
The duration of the course of use of the drug is 14 days. If necessary, the course of treatment can be repeated after 1-3 weeks, after consulting a doctor.
Use the drug only according to the method of use and in the doses indicated in the instructions. If necessary, please consult your doctor before using the medicine.
Storage conditions
Store in a place protected from light, at a temperature not exceeding 10 °C. Do not freeze. Store the opened bottle at a temperature not exceeding 25 °C for no more than 15 days.
Keep out of the reach of children.
Best before date
2 years. Do not use after the expiration date indicated on the package.
special instructions
Selank® does not cause drug dependence or addiction.
Description
Anxiolytic (tranquilizer).
Pharmacodynamics
Selank® is a synthesized analogue of the endogenous tuftsin peptide, which has an original mechanism of neurospecific action on the central nervous system.
Selank® has an anti-anxiety effect with an antidepressant effect; antiasthenic effect.
Relieves symptoms of restlessness, anxiety, fear, apathy, depression and asthenia.
It has a positive effect on cognitive functions, improves memory, speech, increases attention, activates learning processes, in particular, memorization, analysis and reproduction of information. Normalizes psychomotor reactions.
In case of stress, Selank® eliminates emotional and negative tension and stimulates the development of adaptive behavior aimed at achieving a useful result.
Side effects
With increased sensitivity to the perception of smell and taste, unpleasant taste sensations may appear when the drug gets from the nasal cavity onto the mucous membrane of the pharynx. It is possible to develop allergic reactions due to individual intolerance.
Use during pregnancy and breastfeeding
Pregnancy
Since controlled studies of the use of Selank® in pregnant women have not been conducted, it should not be used during pregnancy.
Breastfeeding period
If it is necessary to use the drug during lactation, you should refrain from breastfeeding.
Interaction
Selank® does not affect the effects of drugs that depress and stimulate the central nervous system - haloperidol, pentobarbital, hexobarbital, analeptics.
Selank® can be combined with any psycho- and neuroactive therapy.
Selank® is safe when used in combination with ethanol-containing products.
Overdose
No cases of overdose have been reported when using the drug Selank®.
Impact on the ability to drive vehicles and operate machinery
Does not affect the ability to drive vehicles and operate machinery.
Instructions
MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
Instructions for medical use of the drug Selank®
Read these instructions carefully before you start using this medicine because they contain information that is important to you. Save the instructions, you may need them again. If you have any questions, consult your doctor. The medicine you are using is for your own use and should not be given to others as it may harm them even if they have the same symptoms as you.
Registration number: LRS-003338/09 Trade name of the drug: Selank® Chemical name: threonyl-lysyl-prolyl-arginyl-prolyl-glycyl-proline-diacetate. Dosage form: nasal drops Composition per 1 ml: Active ingredient: Selanka® in terms of 100% substance (threonyl-lysyl-prolyl-arginyl-prolyl-glycyl-proline diacetate) – 1.5 mg. Excipients: methyl parahydroxybenzoate (nipagin) – 1 mg, purified water up to 1 ml. Description: colorless transparent liquid. Pharmacotherapeutic group: anxiolytic agent (tranquilizer). ATX code: N05BX
pharmachologic effect
Pharmacodynamics Selank® is a synthesized analogue of the endogenous tuftsin peptide, which has an original mechanism of neurospecific action on the central nervous system. Selank® has an anti-anxiety effect with an antidepressant effect; antiasthenic effect. Relieves symptoms of restlessness, anxiety, fear, apathy, depression and asthenia. It has a positive effect on cognitive functions, improves memory, speech, increases attention, activates learning processes, in particular, memorization, analysis and reproduction of information. Normalizes psychomotor reactions. In case of stress, Selank® eliminates emotional and negative tension and stimulates the development of adaptive behavior aimed at achieving a useful result.
Pharmacokinetics Selank® is administered intranasally (nasal drops). The absolute bioavailability of Selank® when administered to the nasal mucosa is 92.8%. The drug is quickly absorbed from the nasal mucosa and after 30 seconds is detected in the blood plasma, and then quickly distributed to various organs and tissues. Penetrates into brain tissue. Plasma concentrations decrease progressively over 5-5.5 minutes. Neither unchanged drug nor metabolites are detected in daily urine, which is due to the rapid degradation of Selank® under the influence of tissue peptidases.
Indications for use:
Alarm states:
- unmotivated anxiety, restlessness;
- panic attacks;
- neurasthenia;
- asthenia;
- mood instability;
- sleep disorders;
- decreased willpower, initiation of activities, indecisiveness, difficulties in making decisions, lack of self-confidence;
- lack of confidence in communication;
- adjustment disorders;
Prevention and treatment of stress disorders.
Contraindications
Individual intolerance to the drug. Pregnancy, breastfeeding (efficacy and safety studies have not been conducted). Children under 18 years of age (efficacy and safety studies have not been conducted).
Use during pregnancy and breastfeeding
Pregnancy Since controlled studies of the use of Selank® in pregnant women have not been conducted, it should not be used during pregnancy. Breastfeeding period If it is necessary to use the drug during lactation, you should refrain from breastfeeding.
Directions for use and doses
Selank® is administered intranasally, using a bottle sealed with a plastic screw cap or a dropper cap. If the bottle is sealed with a plastic screw cap, upon initial use, remove the plastic screw cap and replace it with the included capped dropper. Pipette the drug. Squeeze the required number of drops of the drug onto the clean mucous membrane of the nasal passage, then close the nostril with your finger for a short time. If the bottle is sealed with a dropper cap, carefully cut off the tip of the pipette and tightly cap the pipette. Before use, invert the bottle so that the liquid fills the entire pipette space. Remove the cap. Squeeze the required number of drops of the drug onto the clean mucous membrane of the nasal passage, then close the nostril with your finger for a short time. Instillation of the drug into the nasal passages is carried out in a sitting position with the head slightly thrown back or tilted to one side, after which each nostril is pinched for a short time with a finger. The effectiveness of absorption may be reduced in the presence of increased secretions from the nasal mucosa, therefore, before use (instillation), it is recommended to clear the nasal passage. Dose: 2 drops in each nasal passage 3 times a day. The duration of the course of use of the drug is 14 days. If necessary, the course of treatment can be repeated after 1–3 weeks, after consulting a doctor. Use the drug only according to the method of use and in the doses indicated in the instructions. If necessary, please consult your doctor before using the medicine.
Side effect
With increased sensitivity to the perception of smell and taste, unpleasant taste sensations may appear when the drug gets from the nasal cavity onto the mucous membrane of the pharynx. It is possible to develop allergic reactions due to individual intolerance. If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.
Overdose
No cases of overdose have been reported when using the drug Selank®.
Interaction with other drugs
Selank® does not affect the effects of drugs that depress and stimulate the central nervous system - haloperidol, pentobarbital, hexobarbital, analeptics. Selank® can be combined with any psycho- and neuroactive therapy. Selank® is safe when used in combination with ethanol-containing products. If you are taking other medications (including over-the-counter medications), consult your doctor before using Selank®.
special instructions
Selank® does not cause drug dependence or addiction.
Impact on the ability to drive vehicles and machinery
Does not affect the ability to drive vehicles or operate machinery.
Release form
Nasal drops of 3 ml in a glass bottle, sealed with a plastic pipette stopper, or in a glass bottle, sealed with a plastic screw cap with a pipette cap included. Each bottle with instructions for use is packaged in a cardboard box.
Storage conditions
Store in a place protected from light, at a temperature not exceeding 10oC. Do not freeze. Store the opened bottle at a temperature not exceeding 25oC for no more than 15 days. Keep out of the reach of children.
Best before date
2 years. Do not use after the expiration date.
Vacation conditions
Available without a prescription.
Manufacturer: Name and address of the manufacturer: CJSC Innovative Research and Production (CJSC INPC Peptogen). Russia, 123182, Moscow, pl. Academician Kurchatova, 2, building 1 Russia, 123458, Moscow, st. Tvardovskogo, 8 Tel./fax 8-499-686-05-50 E-mail
Quality claims are accepted by the manufacturer.
