Zinplava

1). 6). 4). 2). 2). 2). Paediatric population There is no relevant use of bezlotoxumab in children under 1 year of age for the indication of prevention of CDI. 2 micron to 5 micron in-line or add-on filter. ZINPLAVA should not be administered as an intravenous push or bolus.

• The diluted solution can be infused via a central line or peripheral catheter. • ZINPLAVA must not be co-administered with other medicinal products simultaneously through the same infusion line. 6.

Summary of the safety profile The safety profile of ZINPLAVA was assessed in two Phase 3 clinical studies in adults. The most common adverse reactions following treatment with ZINPLAVA (reported in ≥ 4 % of patients within the first 4 weeks of infusion) were nausea, diarrhoea, pyrexia and headache.

These adverse reactions were reported at a similar frequency in placebo treated patients compared with ZINPLAVA-treated patients. Tabulated list of adverse reactions Table 1 presents the adverse reactions reported within 4 weeks of infusion in ZINPLAVA-treated patients and listed by System Organ Class.

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).

Within each frequency grouping, adverse reactions are presented in order of decreasing frequency.

Table 1:

Adverse Reactions with ZINPLAVA MedDRA System Organ Class Frequency Adverse Reaction(s) Nervous system disorders Common Headache Gastrointestinal disorders Common Nausea, diarrhoea General disorders and administration site conditions Common Pyrexia Injury, poisoning and procedural complications Common Infusion related reactions† † See Description of selected adverse reactions below.

5 Description of selected adverse reactions Serious adverse reactions In clinical studies, serious adverse reactions occurring within 12 weeks following infusion were reported in 29 % of ZINPLAVA-treated patients and 33 % in patients receiving placebo.

Infusion related reactions Overall, 10 % of subjects in the ZINPLAVA group experienced one or more infusion specific adverse reactions on the day of, or the day after, the infusion compared to 8 % in the placebo group. 5 % of subjects receiving ZINPLAVA and at a frequency greater than placebo were nausea (3 %), fatigue (1 %), pyrexia (1 %), dizziness (1 %), headache (2 %), dyspnoea (1 %) and hypertension (1 %).

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. ZINPLAVA is not a treatment for CDI and has no effect on the current CDI episode.

ZINPLAVA should be administered during the course of antibacterial therapy for CDI. There is no data regarding the efficacy of ZINPLAVA if given after the initial 10- to 14-days of antibacterial therapy for CDI. ZINPLAVA should not be administered as an intravenous push or bolus.

There is no experience with repeat administration of ZINPLAVA in patients with CDI. 1). 1 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

1.