EPISALVAN Gel Ref.[50043] Active ingredients: Betulin

Wound infection

Episalvan gel is sterile. However, wound infection is an important and serious complication that can occur during wound healing. In the case of infection, it is recommended to discontinue treatment with Episalvan. Additional standard treatment may be required (see section 4.5).

Wound size

The mean wound size treated with Episalvan in clinical studies in split-thickness skin graft donor site wounds was 40.7 cm² (range 8-300 cm²). In the Grade 2a burn wound study, the mean wound size treated with Episalvan was 108 cm² (range 23-395 cm²).

Duration of use

There is no information available on clinical use of Episalvan for more than 4 weeks.

Partial thickness burn wounds

Repeated critical assessment of burn depth and healing progression is needed. Wounds that are assessed as unable to heal within an acceptable time frame may need surgical measures (e.g., splitthickness skin grafting) to reduce the risk of hypertrophic scarring.

Other wound types

There is no clinical experience from the use of Episalvan for the treatment of chronic wounds, e.g. diabetic foot ulcers, venous leg ulcers or wounds in patients with epidermolysis bullosa.

Birch pollen allergy

Episalvan is safe to use for people who are allergic to birch pollen, as these allergens are not present in Episalvan.

No interaction studies have been performed. Since the systemic exposure of Episalvan following cutaneous application is negligible no interaction with systemic treatments is expected. Interactions with topical products have not been investigated in clinical trials. Other topical products should not be concomitantly used together with Episalvan but rather sequentially or alternatively depending on the clinical need.

Pregnancy

No studies in pregnant women have been conducted.

No effects during pregnancy are anticipated, since systemic exposure to Episalvan is negligible. Episalvan can be used during pregnancy.

Breast-feeding

No data are available to evaluate whether Episalvan is excreted into human milk.

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to Episalvan is negligible. Episalvan can be used during breast-feeding, unless the chest area is subject to treatment.

Fertility

Fertility studies have not been conducted. No effects on human fertility are anticipated, since the systemic exposure is negligible.

Episalvan has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

The most frequently observed adverse reactions were wound complication (in 2.9% of patients), pain of skin (2.5%) and pruritus (1.3%). Adverse reactions were administration site reactions only. Wound complication adverse reactions such as wound infection and wound necrosis are complications of healing of partial thickness skin wounds and can be serious (see section 4.4).

Tabulated list of adverse reactions

In the following table, adverse reactions are listed by MedDRA system organ class and preferred term. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Table 1. Adverse reactions reported in clinical trials:

^* Wound complication comprises different kinds of local complications such as post-procedural complications, wound necrosis, wound secretion, impaired healing, or inflammation of wound.

In addition, there is one case report of contact dermatitis reported from a literature in a patient after prolonged use of a topical birch bark extract containing cosmetic product.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Not applicable.