Gelangin flex spray mest.pr. 0.2% 40ml vial

Description

Composition
Active substance:
Hexetidine 2.0 mg
Excipients:
Propylene glycol 100.0 mg
Ethanol 95% (calculated as anhydrous) 43.33 mg
Polysorbate 20 10.0 mg
Anhydrous sodium calcium edetate 1.0 mg
Levomenthol 0.7 mg
Citric acid anhydrous 0.64 mg
Sodium saccharinate 0.6 mg
Eucalyptol 0.2 mg
1 M sodium hydroxide solution to pH 4.0-7.0
Nitrogen up to 5 bar
Water for injection to 1.0 ml
Description:
Transparent colorless or lightly colored liquid with a characteristic odor of menthol.
Product form:
Aerosol topical 0.2%.
40 ml cylinder with an internal spray coating.
According to one cylinder complete with a spray nozzle or spray nozzles four different colors together with instructions for use in a stack of cardboard.
Contraindications
• hypersensitivity to any component of the drug;
• deskvamoznye erosive lesions of the oral mucosa;
• Children up to age 3 years.
Dosage
2 mg / ml
Indications
As a symptomatic treatment.
• Symptomatic treatment of inflammatory and infectious diseases of the oral cavity and throat:
– tonsillitis, angina (including angina Plaut-Vincent, angina side rollers), pharyngitis, gingivitis, stomatitis, glossitis, periodontitis;
– fungal diseases;
• prevention of infectious complications before and after surgical interventions on the oral cavity and the larynx, and trauma, including infection prevention alveoli after tooth extraction;
• oral hygiene, including and for eliminating halitosis.
Overdose
It is unlikely that Hexetidine may have a toxic effect when used according to the instructions for use of the drug instructions.
Ingestion of large amounts of a formulation containing ethanol, can lead to signs / symptoms of alcohol intoxication.
In any case of overdose, consult your physician immediately. Treatment is symptomatic, as in drunkenness.
Gastric lavage required within 2 hours after ingestion of an overdose.
pharmachologic effect
Pharmacological group:
Antiseptic.
Pharmacodynamics:
The antimicrobial effect of the drug due to the suppression of oxidative metabolism Bacteria reactions (thiamin antagonist). The drug has a broad spectrum antibacterial and antifungal activity, particularly against gram-positive bacteria and fungi of the genus Candida. Hexetidine has a weak anesthetic effect on the mucous membrane.
The drug has antiviral activity against influenza A viruses, respiratory syncytial virus (RS virus), herpes simplex virus type 1, affecting the respiratory tract.
Pharmacokinetics:
Hexetidine very well adheres to the mucosa and practically not absorbed.
After a single application of active ingredient to exhibit its mucosal traces of gum for 65 h plaque active concentration maintained for 10 -. 14 hours after application.
Pregnancy and breast-feeding
Information about any adverse effects of the drug during pregnancy and breastfeeding is not. However, before prescribing medication pregnant or nursing women physician should carefully weigh the benefits and risks of treatment, given the lack of sufficient data on the penetration of the drug through the placenta and breast milk.
side effects
Adverse reactions revealed by post-registration application of the drug, were classified as follows: very often (> 1/10); often (> 1/100 and 1/1000, and 1/10000 and
Violations by the immune system.
Very rarely hypersensitivity reactions (including hives), angioedema.
Disorders of the nervous system
Very rare: ageusia, dysgeusia.
Violations of the respiratory system, organs, thoracic and mediastinal disorders
Very rare: cough, shortness of breath due to the appearance of hypersensitivity reactions.
Disorders of the gastrointestinal tract
Very rare: dry mouth, dysphagia, nausea, salivary gland enlargement, vomiting.
General disorders and injection site
Very rarely reaction at the site of application (including irritation of the oral mucosa and pharynx, burning sensation, paresthesia oral language change in color, change in color of the teeth, inflammation, blistering and ulceration).
If any specified in the instruction side effects are compounded or you notice other side effects, it is recommended to consult a doctor.
special instructions
No special requirements.
Children can use the drug to an age when there is no danger of uncontrolled swallowing it, or when they do not oppose foreign object (nozzle-spray) in the mouth when using aerosol and able to hold their breath when injecting the drug.
The ethanol content in the formulation is 5.15%.
One dose of the preparation contains 20.3 mg of ethanol (in terms of absolute alcohol).
The contents of the aerosol container is pressurized. Do not open, do not pierce or burn, even if the container is empty.
If the drug has come into disrepair or expiration date – do not pour it into the waste water and not be thrown into the street! Place the drug in the bag and place in the trash. These measures will help protect the environment!
The effect on the ability of control of vehicles and mechanisms
Drug Gelangin® flex, spray for topical use does not affect the ability to drive and engage in other potentially hazardous activities.
Storage conditions
At temperatures above 25 ° C.
Keep out of the reach of children.
After the first use – 6 months.
Dosing and Administration
Locally.
Children 3 to 6 years: the use of the drug may, after consultation with a medical professional.
Adults and children over 6 years: affected area was treated with a single breath, 1 injection for 1-2 seconds, 2 times a day.
Hexetidine adheres to the mucosa and thus enables stable effect. In connection with this drug should be used after a meal.
General recommendations for the introduction of • put on aerosol can spray nozzle;
• forward end of the spray nozzle to the affected area of ​​the oral cavity or pharynx;
• the balloon during insertion of the drug should be kept constantly in a vertical position as shown in the figure;
• enter the required amount of drug, pressing on the spray head nozzles for 1-2 seconds without breathe when administered aerosol.
Duration of treatment is determined by the doctor.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist