RELFYDESS

The treatment interval should be no more frequently than every twelve weeks. The efficacy and safety of the repeated administration of this product has not been studied for more than 52 weeks. Consideration of the cumulative dose is necessary if other botulinum toxin products are being or have been used to treat other indications for those products.

Posology The potency units are specific to Relfydess and are not interchangeable with other preparations of botulinum toxin. 1 mL and no reconstitution is required. 1 mL) for combined GL and LCL General information In the event of treatment failure or diminished effect following repeat injections, alternative treatment methods should be employed.

g. incorrect muscles injected, inappropriate injection technique, and formation of toxin-neutralising antibodies. • Re-evaluation of the relevance of treatment with botulinum toxin A. Paediatric population The safety and efficacy of Relfydess in children aged up to 18 years have not been established.

The use of Relfydess is not recommended in patients under 18 years. Elderly population There is limited phase 3 clinical data with Relfydess in patients 65 years and older. Method of administration Relfydess should only be administered by health care professionals with appropriate qualifications and expertise in this treatment and having the required equipment, in accordance with national guidelines and legislation.

Intramuscular use. Dosing and treatment intervals depend on assessment of the individual patient’s response, but dosing should not exceed maximum doses allowed and the treatment interval should be at least 12 weeks. Each vial should be used for a single patient during a single treatment session only.

Any residual product after the treatment should be discarded. Use aseptic technique and standard practice to prevent cross-infections. 6. The median time to onset is 2 to 3 days, with some patients reporting an effect within 1 day. Treatment effect has been demonstrated for 6 months, with up to 75% of patients not returning to baseline.

1 mL per injection) into each of the 5 intramuscular injection sites (see Figure 1): 2 injections on each side at the corrugator muscle and 1 injection at the procerus muscle near the nasofrontal angle. The anatomical landmarks can be more readily identified if palpated and observed at patient maximum frown.

Summary of safety profile The majority of adverse reactions reported after one treatment with Relfydess in subjects receiving ≥ 50 units in all placebo-controlled studies in the development program were of mild to moderate intensity.

The most frequently reported adverse reactions were injection site reactions and headache occurring in approximately 7% and 5% of subjects, respectively. In general, treatment/injection technique-related reactions occurred within the first month following injection and were transient.

When glabellar lines and lateral canthal lines were treated in combination, the nature and frequency of adverse reactions were comparable to what was observed when patients were treated for the individual indications. Tabulated list of adverse reactions The frequency of undesirable reactions is classified 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 2:

Moderate to severe glabellar lines The following adverse reactions were observed in patients that were administered Relfydess for the temporary improvement in the appearance of moderate to severe glabellar lines. g. bruising, swelling, pruritus, pain, discomfort, haematoma, hypersensitivity and warmth) Table 3: Moderate to severe lateral canthal lines The following adverse reactions were observed in patients that were administered Relfydess for the temporary improvement in the appearance of moderate to severe lateral canthal lines.

g. erythema, pain, and bruising) 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.

General Relfydess should not be injected into a blood vessel. As with all intramuscular injections, use of Relfydess is not recommended in patients who have a prolonged bleeding time. Patients treated with the recommended dose may experience exaggerated muscle weakness.

Each vial of Relfydess must be used for a single patient treatment during a single session. 6. 6). 8). These reactions include anaphylaxis, serum sickness, urticaria, soft tissue oedema, and dyspnoea. Equipment and medications (including adrenaline) needed to treat anaphylaxis should therefore be readily available.

If such a reaction occurs, further injection of Relfydess should be discontinued, and appropriate medical therapy immediately instituted. 8). Cases of iatrogenic botulism have been reported following injection of botulinum toxin products.

In addition, adverse reactions possibly related to the spread of toxin effect distant from the site of injection have been reported very rarely with botulinum toxin and may include asthenia, generalised muscle weakness, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties.

These symptoms are consistent with the mechanism of action of botulinum toxins and have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death related to spread of toxin effects.

Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. More specifically, following treatment with botulinum toxin, very rare cases of death have been reported in the context of patients who have dysphagia, pneumopathy, or significant asthenia.

Therefore, Relfydess is not recommended in such patients. 9). Pre-existing neuromuscular disorders Relfydess should be used with caution in patients with a risk of, or clinical evidence of, marked defective neuro-muscular transmission.

1. Presence of infection at the proposed injection sites. Presence of myasthenia gravis, Eaton Lambert Syndrome or amyotrophic lateral sclerosis.