Ingalin®
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT INHALIN®
Composition:
Active substances: 1 vial contains menthol 0.284 g, eucalyptus tincture 14.28 ml;
Excipients: ethanol 96%, glycerol.
Pharmaceutical form. Inhalation solution.
Main physicochemical properties: yellow-brown liquid with a characteristic odor. Precipitation may occur.
Pharmacotherapeutic group. Agents used for cough and colds. Expectorants.
ATC code R05C A10.
Pharmacological properties.
Pharmacodynamics.
Exhibits antiseptic activity (due to the oxidizing properties of the terpene component of eucalyptus tincture essential oil) and provides anti-inflammatory, expectorant, and mild analgesic effects (menthol).
Pharmacokinetics.
Not studied.
Clinical characteristics.
Indications.
As part of complex treatment of acute respiratory diseases of the upper respiratory tract, pharyngitis, tracheitis, bronchitis, and pneumonia.
Contraindications.
Hypersensitivity to the components of the drug. Bronchial asthma and bronchospasm.
Interaction with other medicinal products and other forms of interaction.
To date, no interactions of Ingalipt® with other medicinal products have been identified.
Special precautions for use.
During storage, precipitation of IngaliN® may occur; therefore, the contents of the vial should be shaken before use. IngaliN® should be used with a warm moist inhaler. Due to the possibility of reflex bronchospasm, the medication must be administered to children under the supervision of a physician or an adult. If shortness of breath, fever, or purulent sputum occurs, consult a physician.
Use during pregnancy or breastfeeding.
Use of the medication during pregnancy or breastfeeding is possible only after a physician has evaluated the risk-benefit ratio.
Ability to affect reaction rate when driving or operating machinery.
During treatment with IngaliN®, patients should refrain from driving vehicles or performing other tasks requiring heightened attention and rapid mental and motor reactions.
Administration and Dosage.
For inhalation, adults should use 10–20 drops of Ingallin® per 1 glass (200 ml) of warm water, and children aged 3 years and older should use 5–10 drops. Inhalations are recommended 3–4 times daily. The duration of treatment is determined by a physician, depending on the patient's condition and clinical response.
Children.
Do not use in children under 3 years of age.
Overdose.
With prolonged use in large doses, dizziness, confusion, muscle weakness, nausea, and diplopia may occur. In such cases, the drug should be discontinued. Symptomatic therapy is recommended.
Adverse reactions.
The product is usually well tolerated, but allergic reactions may occur, including skin rashes, itching, redness, sometimes contact dermatitis (in the lip area), Quincke's edema, urticaria; bronchospasm, laryngospasm, apnea. If pronounced reactions occur, the use of the product should be discontinued.
Shelf life. 3 years.
Storage conditions.
Store in a place protected from light and inaccessible to children, at a temperature not exceeding 25 °C.
Packaging.
40 ml in glass bottles, in a carton or without a carton.
40 ml in a polymer bottle, in a carton.
Availability. Over-the-counter.
Manufacturer/Marketing authorization holder.
LLC "Ternopharm".
Manufacturer's address and location of its business activities.
LLC "Ternopharm".
Ukraine, 46010, Ternopil, Fabrychna St., 4.
Tel./fax: (0352) 521-444, http://www.ternopharm.com.ua
INSTRUCTIONS
for medical use of the medicinal product
INGALIN®
Composition:
Active substances: 1 bottle contains menthol 0.284 g, eucalyptus tincture 14.28 ml;
Excipients: ethanol 96%, glycerin.
Pharmaceutical form. Inhalation solution.
Main physicochemical properties: yellow-brown liquid with a characteristic odor. Sediment formation is permissible.
Pharmacotherapeutic group. Medicinal products used for cough and colds. Expectorants.
ATC code R05C A10.
Pharmacological properties.
Pharmacodynamics.
Exhibits antiseptic activity (due to oxidative properties of the terpene component of eucalyptus tincture essential oil), provides anti-inflammatory, expectorant, and mild analgesic effects (menthol).
Pharmacokinetics.
Not studied.
Clinical characteristics.
Indications.
As part of complex treatment of acute respiratory tract infections of the upper respiratory tract, pharyngitis, tracheitis, bronchitis, pneumonia.
Contraindications.
Hypersensitivity to the components of the drug. Bronchial asthma and lung spasm.
Interaction with other medicinal products and other types of interactions.
Currently, no interactions of Ingalin® with other medicinal products have been identified.
Special precautions.
During storage of Ingalin®, sediment formation may occur; therefore, the bottle contents should be shaken before use. Ingalin® should be used with a warm moist inhaler. Due to the possibility of reflex bronchospasm, children should use the product under medical or adult supervision. If dyspnea, fever, or purulent sputum occurs, consult a physician.
Use during pregnancy or breastfeeding.
The use of the drug during pregnancy and breastfeeding is possible only after a physician evaluates the risk-benefit ratio.
Ability to affect reaction rate when driving or operating machinery.
During treatment with Ingalin®, patients should refrain from driving or operating vehicles and from performing other tasks requiring high attention, and rapid mental or motor reactions.
Method of administration and dosage.
For inhalation in adults, 10–20 drops of Ingalin® per 1 glass (200 ml) of warm water; for children aged 3 years and older, 5–10 drops. Inhalations are recommended 3–4 times daily. The duration of treatment is determined by the physician depending on the patient's condition and clinical response.
Children.
Do not use in children under 3 years of age.
Overdose.
With prolonged use in large doses, dizziness, confusion, muscle weakness, nausea, and blurred vision may occur. In such cases, discontinue use of the drug. Symptomatic therapy is recommended.
Adverse reactions.
The product is usually well tolerated, but allergic reactions may occur, including skin rashes, itching, sometimes contact dermatitis (in the lip area), Quincke's edema, urticaria; bronchospasm, laryngospasm, apnea. If pronounced reactions occur, the use of the product should be discontinued.
Shelf life. 3 years.
Storage conditions.
Store in a place protected from light and inaccessible to children, at a temperature not exceeding 25 °C.
Packaging.
40 ml in glass bottles, in a carton or without a carton.
40 ml in a polymer bottle, in a carton.
Availability. Over-the-counter.
Manufacturer/Marketing authorization holder.
LLC "Ternopharm".
Manufacturer's address and location of its business activities.
LLC "Ternopharm".
Ukraine, 46010, Ternopil, Fabrychna St., 4.
Tel./fax: (0352) 521-444, http://www.ternopharm.com.ua