Vulvovaginitis and cervicovaginitis of all types.

Preoperative and postoperative treatment in gynecological surgery.

Active ingredient: ibuprofen;
100 ml of solution contains ibuprofen isobutanolammonium 0.1 g, equivalent to ibuprofen 0.0698 g.

Excipients:
2-phenoxyethanol, methyl- ethyl- propyl- butyl p-hydroxybenzoates (unde-benzophen), polysorbate 20, propylene glycol, floral extract, deionized water.

Розчин вагінальний

Упаковка.

Vaginal solution.

Description: clear, colorless solution.

Pharmacodynamics

Ginenorm contains ibuprofen isobutanolammonium as the active substance.
The medicinal product is a non-steroidal anti-inflammatory drug (NSAID).
Its mechanism of action is based on the inhibition of the enzyme cyclooxygenase, which is responsible for prostaglandin synthesis.

Pharmacokinetics

Bioavailability studies have shown that local administration does not lead to plasma changes of clinical and/or toxicological relevance.
Plasma levels are very low, near the analytical detection limit.
Preclinical data indicate no specific risk for humans based on studies of safety, repeated-dose toxicity, genotoxicity, carcinogenic potential, or reproductive toxicity.

Hypersensitivity to the active substance or to any excipient.

Pregnancy and breastfeeding.

Severe specific or non-specific vulvovaginitis.

Children. Not used.

Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), which may be life-threatening or fatal, have been reported with ibuprofen use (see “Adverse reactions”).
Most of these reactions occurred within the first month of treatment.
At the first signs or symptoms of these reactions, ibuprofen should be discontinued immediately and alternative therapy considered if necessary.
Prolonged use of topical medicinal products may cause hypersensitivity reactions.
Patients should be informed about early symptoms of such skin reactions and monitored closely for their development.
This medicinal product must not be used in cases of severe specific or non-specific vulvovaginitis.
Use only as directed by a physician.
Important information about excipients:
The product contains parabens (p-hydroxybenzoates) and propylene glycol, which may cause allergic reactions (possibly delayed).
Propylene glycol may also cause skin irritation.

Use during pregnancy and lactation
There are no clinical data on the use of topical ibuprofen-containing preparations during pregnancy.
Although systemic exposure following topical administration is lower than after oral use, it is unknown whether such exposure may harm the embryo or fetus.
During the first and second trimesters, ibuprofen should not be used unless absolutely necessary. If used, the dose should be as low and the duration of treatment as short as possible.
During the third trimester, systemic use of prostaglandin synthesis inhibitors, including ibuprofen, may cause cardiopulmonary and renal toxicity in the fetus.
At the end of pregnancy, prolonged bleeding in both the mother and the newborn, and delayed labor may occur.
Therefore, Ginenorm is contraindicated during pregnancy and lactation (see “Contraindications”).

Effects on ability to drive and use machines
Ginenorm has no influence on the ability to drive or operate machinery.

All adverse reactions are listed by system organ class and frequency:
Very common (≥1/10), common (≥1/100–<1/10), uncommon (≥1/1,000–<1/100), rare (≥1/10,000–<1/1,000), very rare (<1/10,000), frequency not known.

Immune system disorders: very rare – serious allergic reactions (some fatal), including exfoliative dermatitis, bullous reactions, Stevens–Johnson syndrome, and toxic epidermal necrolysis have been reported in association with NSAID use.
Patients appear to be at highest risk for these reactions at the beginning of therapy.

Skin and subcutaneous tissue disorders:
Very rare – severe cutaneous adverse reactions (including erythema multiforme, exfoliative dermatitis, Stevens–Johnson syndrome, and toxic epidermal necrolysis).
Frequency not known – photosensitivity reactions, acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).

If skin rash, mucosal lesions, or any signs of hypersensitivity occur, treatment must be discontinued immediately.

General disorders and administration site conditions:
Local hypersensitivity reactions may occur, especially with prolonged use. Treatment should be discontinued and appropriate therapy initiated if necessary.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important to monitor the benefit/risk balance.
Healthcare professionals and patients (or their legal representatives) should report any suspected adverse reactions or lack of efficacy via the Automated Pharmacovigilance Information System at:
🔗 https://aisf.dec.gov.ua

Use the ready-to-use solution according to the severity of inflammation and the physician’s recommendations.
It is recommended to perform 1–2 vaginal irrigations per day using the bottle containing the ready-to-use solution.

The solution may be used at room temperature. If desired, the temperature can be slightly increased by holding the bottle under warm running water.

Instructions for use:

1.Press the protruding part of the cap sideways to open.

2.Remove the sterile cannula from its protective package, insert it into the bottle, and ensure it is firmly attached.

3.Gently insert the cannula into the vagina and squeeze the bottle until it is completely emptied.

4.Retain the liquid in the vagina for several minutes to allow therapeutic action.

Pediatric population: not for use in children.

Store at a temperature not exceeding 25°C.
Keep out of the reach of children.

No cases of overdose have been reported.
In cases of severe intoxication, metabolic acidosis may occur.

3 years