Qualitative and quantitative composition:
An ovule contains: semi-synthetic glycerides; lanolin; Aloe Vera oil; Calendula extract (Calendula ocinalis); colloidal silicon dioxide; vitamin E; sodium hyaluronate – 5 mg; xylitol – 3 mg.
Aspect of the device:
Homogeneous ovules, white or slightly yellow, without undissolved particles or air bubbles. Each box contains 2 blisters with 5 ovules. The weight of an ovule is 1.8 g
What it is and what it is used for:
Halova is indicated for adult women (including women at menopause).
What is used for:
Halova is used for the treatment of:
• disruption of vaginal pH and normal vaginal ora,
• dyspareunia,
• dysuria,
• vaginal dryness.
Indications:
Promotes and accelerates the hydration, healing, reepithelialization and soothing of injured, atrophic or irritated vaginal mucosa. Contributes to restoring the normal lubrication and helps maintain a normal pH and vaginal ora. Halova is indicated for:
• vaginal dryness caused by menopause or other causes, especially when estrogen treatment is contraindicated,
• imbalances of the normal vaginal ora,
• sensations of discomfort or pain during intercourse,
• disturbances of the normal vaginal pH.
The medical device can also be used for the prevention of various pathologies that occur due to dryness of the vaginal mucosa (vulvovaginitis).
Contraindications:
Do not use Halova in case of hypersensitivity to any of the components of the product.
Pregnancy and breastfeeding
Due to the absence of su cient clinical data, the administration of Halova ovules to pregnant women cannot be recommended. It is recommended to consult a specialist in this case. No precautions need to be taken when used during breastfeeding.
Effects on ability to drive and use machines
None of the components of the product a ect the ability to drive or use machines.
Interactions with other products:
Interactions with other products are not known, therefore it is recommended to consult a doctor before using Halova together with other medical devices or medicines for vaginal use.
Dosage and administration:
An ovule is administered intravaginally, preferably in the evening, before going to bed or according to the medical prescription. Remove one shell from the blister by tearing along the perforated line. Then open the shell by slowly pulling apart the two layers at the end where they are not sealed together. Push from the other end to get the ovule out. It is preferable to insert the ovule lying down. Insert the ovule as deep as possible inside the vagina. For the prevention of vulvovaginitis caused by vaginal dryness, the duration of administration is 10 – 15 days or according to the doctor’s instructions.
For pre-menopause and menopause, the duration of administration is 10 days per month for three months, or according to the doctor’s instructions. The treatment can be repeated to maintain the favorable results.
Special warnings and precautions for use:
Due to the composition of the product, no precautions are generally required.
• Sanitize your hands and intimate area well before administering the ovule.
• Do not use ovules with damaged alveoli or traces of substance on the outside of the alveoli.
• Do not use ovules that are uneven in appearance or that show traces of agglomerated particles.
• Do not divide the ovules.
• Keep out of reach and sight of children.
• The product is for vaginal use. Do not swallow.
• Avoid contact with the eyes.
• Do not use the product after the expiry date indicated on the package.
• Using the medical device can a ect the e ectiveness of condoms and latex diaphragms. • Inform your referring physician if you are planning a pregnancy.
Inform the manufacturer or the competent authorities of any serious incident related to the use of the Halova medical device
Side effects:
Using topical products for a long time may cause local irritation and sensitization. If side e ffects occur, stop the treatment and contact your doctor or pharmacist.
Any serious incident that occurred in relation to the medical device must be reported to the manufacturer and the competent authority of the Member State where the patient is established.
Overdose:
No cases of overdose are known. The substances contained are not absorbed systemically, they are naturally eliminated in maximum 24 hours after administration.
Expiration, storage and disposal:
Store at 2 – 25 ° C in the original package in order to protect from direct sunlight. The term of validity inscribed on the package refers to the product stored under the conditions provided by the manufacturer. The medical device should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medical devices that you no longer use.
Manufacturer:
Perfect Care Manufacturing SRL,
no. 82 Complexului street, 085200 Mihailesti city,
Giurgiu county, Romania
contact@perfectcare.ro
Edition 02 Revision 01
Date of issue: 08.04.2026
