Gelangin nova, 1% solution 200 ml

An antiseptic agent.

ATX code: A01AB12 Pharmacological properties

Pharmacodynamics

The antimicrobial action of the drug is associated with inhibition of oxidative reactions of bacterial metabolism (thiamine antagonist). The drug has a wide spectrum of antibacterial and antifungal activity, in particular against Gram-positive bacteria and fungi of genus Candida; the drug may also show effect in treatment of infections caused by e.g. Pseudomonas aeruginosa or Proteus spp. At a concentration of 100 mg/ml, the drug suppresses most strains of bacteria.

The development of resistance has not been observed. Hexatidine has a weak anesthetic effect on the mucous membranes. The drug has antiviral action against influenza A viruses, respiratory syncytial virus (PC-virus), herpes simplex virus type 1, affecting the respiratory tract.

PharmacokineticsHexetidine adheres very well to the mucous membranes and is practically not absorbed. After a single application of the active

the substance is detectable on the gum mucosa for 65 hours. In the plaque the active concentrations remain for 10-14 hours after application.

Indications

As a symptomatic agent.

• Symptomatic treatment of inflammatory and infectious diseases of the oral cavity and throat:
  – tonsillitis, tonsillitis (including Plauta-Vensana sore throat, sidelobacterial angina), pharyngitis, gingivitis, stomatitis, glossitis, periodontal disease;
  – fungal diseases.
• Prevention of alveolar infection after tooth extraction
• Mouth hygiene, including for treating bad breath

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Active ingredient

Hexatidine

Composition

1 ml of the drug contains:

Active ingredient:

Hexatidine – 1.0 mg

Excipients:

Propylene glycol – 100.00 mg

Ethanol 95% (in terms of anhydrous) – 43.33 mg

How to take, the dosage

Topically.

Children from 3 to 6 years:

Use of the drug is possible after consultation with a medical professional. Children can use the drug from such an age when there is no danger of uncontrolled swallowing when applying the solution.

Adults and children over 6 years:

Fill the measuring cup up to the mark 15 ml and gargle with 15 ml of non-diluted solution for at least 30 seconds 2-3 times a day.

Hexatidine adheres to the mucous membrane and so gives a persistent effect. In this regard, the drug should be used after meals.

Gelangin® nova, a solution for topical use, can only be used to rinse the mouth and throat. The solution must not be swallowed.

It is always necessary to use undiluted solution.

In the treatment of oral diseases the drug may also be applied with a tampon for 2-3 minutes.

Duration of treatment is determined by the doctor.

Special Instructions

The drug Gelangin® Nova, topical solution, may only be used to rinse the mouth and throat if the patient is able to spit out the solution after rinsing. Gelangin® nova, a solution for topical use, contains 4.3% ethanol. The content of absolute alcohol in one dose of the drug (15 ml) is 0.65 g.

If the medication has expired or is out of date, do not pour it down the drain or throw it outdoors! Place the medication in a bag and put it in the trash. These measures will help protect the environment!

Influence on driving and operating ability

The medicinal product Gelangin® Nova, topical solution, has no effect on the ability to drive vehicles and engage in other potentially dangerous activities.

Contraindications

• High sensitivity to any of the ingredients of the drug
• Erosive-desquamous lesions of the oral mucosa
• Children under 3 years.
  

Side effects

Frequency of adverse reactions: very frequent (≥1/10), frequent (≥1/100, < 1/10), infrequent (≥1/1000, < 1/100), rare (≥1/10000, < 1/1000), very rare (< 1/10000), frequency unknown (incidence cannot be estimated based on available data).

Immune system disorders.

Very rare: hypersensitivity reactions (including urticaria), angioedema.

Nervous system disorders.

Very rare: agueusia, dysgeusia.

Disorders of the respiratory system, thoracic and mediastinal organs.

Very rarely: cough, dyspnea caused by hypersensitivity reactions.

Gastrointestinal tract disorders.

Very rare: dry mouth, dysphagia, nausea, increased salivary glands, vomiting.

General disorders and disorders in the injection site.

Very rare: reactions at the application site (including irritation of the mucous membrane of the mouth and pharynx, burning sensation, oral paresthesia, discoloration of the tongue, discoloration of teeth, inflammation, blistering and ulceration).

If any side effects specified in the instructions worsen, or you notice other side effects, it is recommended to consult a doctor.

Overdose

It is unlikely that hexatidine may have a toxic effect when used according to the instructions for use of the drug.

Ingestion of large amounts of hexatidine solution containing ethanol may lead to signs/symptoms of alcohol intoxication.

In any cases of overdose consult a doctor immediately. Treatment is symptomatic as in alcohol intoxication. Gastric lavage is necessary within 2 hours after swallowing an excessive dose.

Pregnancy use

There are no reports of any adverse effects of Gelangin® nova in pregnancy and during breastfeeding. Nevertheless, before prescribing Gelangin® nova to pregnant or lactating women, the physician should carefully weigh the benefits and risks of treatment, taking into account the lack of sufficient data on penetration of the drug through the placenta and into the breast milk.

Similarities

Stopangin, Hexoral, Stomatidin, Maxicold, Maxicold Lore