Gohibic

Treatment should be initiated and monitored by a physician experienced in the management of patients treated in an intensive care unit (ICU) setting. Posology The recommended dose is 800 mg administered by intravenous infusion after dilution, for a maximum of 6 (six) doses over the treatment period as described below.

Treatment should be started within 48 hours of intubation (Day 1) followed by administration on Days 2, 4, 8, 15 and 22 as long as the patient is hospitalised, even if discharged from the intensive care unit (ICU). 2). 2). Elderly No dose adjustment is required in elderly patients.

Paediatric population The safety and efficacy of Gohibic in children under 18 years have not been established. No data are available. Method of administration For intravenous use after dilution. Once diluted, the solution must be administered as an infusion over 30 to 60 minutes.

Gohibic should not be infused concomitantly in the same intravenous line with other medicinal products. No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of Gohibic with other medicinal products.

6.

1%). Tabulated list of adverse reactions The safety of vilobelimab has been evaluated in a placebo-controlled, randomised study in which 175 patients receiving invasive mechanical ventilation with or without extracorporeal membrane oxygenation were treated.

However, the very small number of patients who received extracorporeal membrane oxygenation in the clinical trial (7 in the vilobelimab group and 9 in the placebo group) represents a limitation for the characterisation of the safety of vilobelimab in this subset of patients.

Adverse reactions are listed below by MedDRA system organ class and by frequency. Frequencies are 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).

5 Table 1. Adverse reactions System organ class Frequency Adverse reactions Infections and infestations very common pneumonia common sepsis, bronchopulmonary aspergillosis, herpes simplex Blood and lymphatic system disorders common thrombocytopenia Cardiac disorders common supraventricular tachycardia Skin and subcutaneous tissue disorders common rash 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.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity, including anaphylaxis and infusion-related reactions There is a possibility for hypersensitivity, including anaphylaxis and infusion-related reactions, to occur as the product is a monoclonal antibody.

Signs and symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnoea, wheezing, angioedema, rash, nausea, vomiting, diaphoresis and shivering. If symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, administration should be discontinued immediately and appropriate medical treatment and/or supportive care should be initiated.

Appropriate medical treatment and/or supportive care should be administered if an infusion-related reaction occurs. 8). A patient who develops a new infection during treatment with vilobelimab should undergo diagnostic investigations.

Appropriate treatment should be initiated and the patient should be closely monitored. The risk of vilobelimab-associated infections may be higher in elderly patients (>65 years). 8 mg sodium per dose of 4 vials, equivalent to 15% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

1.