Biocure® Gel Cream HBS (formerly Regederm) - Precautions and Warnings

PRECAUTIONS AND WARNINGS

Even when following all safety criteria, sensitivities and allergies that have not yet been identified may occur.

User safety should always come first. Even without a history of latex allergy, and with Biocure® Gel Cream HBS (formerly Regederm) being a topical product designed to minimize potential allergenic reactions (as with any healthcare product), it is recommended to monitor for signs of dermatitis (such as heat, redness, itching) on and around the wound site during the use of Biocure® Gel Cream HBS. If these signs and symptoms occur at any time during application or any phase of treatment, discontinue use immediately and seek medical guidance and assistance promptly for proper diagnosis and treatment.

Biocure® is a topical product that can be applied to wounds and the periwound skin (edge/margin). It should not be ingested. Do not apply to the eyes, eyelids, or regions close to the eyes. Do not apply to fistulas. In case of suspected fistula, seek a definitive diagnosis. Do not apply directly to viscera and organs in anatomical cavities (abdominal cavity, thoracic cavity), inner ear, and central nervous system, as there are no studies supporting these indications.

Some patients and wounds may require complementary and/or adjunct treatments. There are no studies regarding the use of Biocure® Gel Cream HBS (formerly Regederm) on wounds in patients undergoing hyperbaric oxygen therapy (HBOT), nor on the stability of the gel-cream’s components in such environments. Additionally, there are no studies on the concurrent use of Biocure® Gel Cream HBS with negative pressure wound therapy (NPWT).  

It is suggested to have medical monitoring to assess systemic conditions that influence wound healing, such as anemia, malnutrition, dehydration, diabetes and hyperglycemia, hypothyroidism, chronic renal failure, hypoxia, smoking, hypotension (systolic BP < 100 mmHg and diastolic BP < 60 mmHg), use of vasoactive drugs, chronic use of systemic corticosteroids, chemotherapy, radiotherapy, which may interfere with wound healing and increase the local risk of infection.

If there is an infection at the wound site, it should be treated and monitored by a medical professional before starting treatment with the product. The use of Biocure® Gel Cream HBS (formerly Regederm) should begin only after the infection has improved or responded to treatment.

Over the days of use, as Biocure® Gel Cream HBS (formerly Regederm) stimulates tissue growth, the nerve endings around the treated wound may become more active, resulting in increased local sensitivity. Monitor these symptoms, which should subside as the wound epithelializes.

Do not mix Biocure® Gel Cream HBS (formerly Regederm) with other ointments, creams, or gels. If you are using another ointment, cream, or gel, it is recommended to remove any remaining residue before applying Biocure® Gel Cream HBS.

If you were using Biocure® Gel Cream HBS (formerly Regederm) and noticed sudden pain or burning with hypersensitivity to the product, it is recommended to discontinue treatment and consult a doctor.

In case of an excessive odor that was not present before using Biocure® Gel Cream HBS (formerly Regederm), it is recommended to consult a doctor.

Exercise caution when applying Biocure® Gel Cream HBS (formerly Regederm) to patients with bleeding at the wound site. While Biocure® Gel Cream HBS does not stimulate bleeding, it is advised to control any bleeding before application. Otherwise, wait until there is no active bleeding from the wound.

In cases of secondary infestation by myiasis (fly larvae) in the wound, it is recommended to remove the larvae, perform systemic treatment as directed by a doctor (if necessary), and treat the site before starting treatment with Biocure® Gel Cream HBS.

There are no studies regarding the use of Biocure® Gel Cream HBS (formerly Regederm) on ulcers in patients with sickle cell anemia. The use of Biocure® Gel Cream HBS in these cases is at the discretion of the physician.

In the case of burns (of any origin), seek immediate medical attention before applying Biocure® or any other product to the affected area.

Biocure® Gel Creme HBS (antes Regederm) é um produto para uso em humanos.

Keep out of reach of children.

Carefully follow the instructions for use.

At low temperatures, gel-creams tend to have a thicker consistency. At higher temperatures, gel-creams tend to have a thinner consistency. In principle, under both conditions, there is no interference with the action of the main component of the formula.

The use of the empty packaging for other purposes is not recommended.

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