ESTIVA 600

INSTRUCTIONS for medical use of the medicinal product CALENDULA OINTMENT (Unguentum Calendulae)

Composition

active substance: calendula tincture; 1 g of ointment contains 0.1 g of calendula tincture; excipients: white soft paraffin, purified water, emulsifier T-2.

Pharmaceutical form

Ointment.

Main physical and chemical properties

Ointment of yellowish color.

Pharmacotherapeutic group

Preparations that promote wound healing. ATC code D03A X.

Pharmacological properties

Pharmacodynamics

Calendula ointment contains flavonoids, carotenoids, saponins, tannins, organic acids, and other compounds. It has antiseptic, anti-inflammatory, and reparative properties.

Clinical characteristics

Indications

Burns, cuts, skin cracks, purulent wounds.

Contraindications

Increased individual sensitivity to the components of the preparation.

Interaction with other medicinal products and other types of interactions

Not established.

Special instructions

Should not be used by individuals prone to allergic reactions to calendula preparations. Avoid getting the ointment in the eyes. If the ointment accidentally gets into the eyes, they should be rinsed with water and medical attention should be sought immediately.

Use during pregnancy or breastfeeding

The safety and clinical efficacy of the preparation during pregnancy or breastfeeding have not been studied, so it is not recommended to prescribe it to this category of patients.

Ability to affect reaction speed when driving vehicles or operating other mechanisms

Does not affect.

Method of application and dosage

The ointment should be applied in a thin layer to the affected areas (can be used under an occlusive dressing). The duration of the treatment course is determined by the doctor individually and depends on the nature and severity of the pathological process or the achieved effect.

Children

The safety and efficacy of the ointment in children under 12 years of age have not been established, so the preparation can be used in this category of patients only after a careful assessment of the risk/benefit ratio (as prescribed by a doctor).

Overdose

Not detected. Possible enhancement of adverse reaction symptoms.

Adverse reactions

In case of increased individual sensitivity, allergic reactions may occur, including skin redness, rash, itching, angioedema.

Shelf life

2 years 6 months.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C; freezing is not allowed. Store in a place inaccessible to children.

Packaging

40 g in containers, 20 g or 30 g in aluminum or laminated tubes.

1 tube in a pack or without a pack.

Release category

Without a prescription.

Manufacturer

Viola Pharmaceutical Factory, PrJSC.

Manufacturer's location and address of its business activity

69063, Ukraine, Zaporizhzhia, Akademika Amosova Street, 75.

Applicant

Viola Pharmaceutical Factory, PrJSC.

Applicant's location

69063, Ukraine, Zaporizhzhia, Akademika Amosova Street, 75.