Bezlotoxumab
Generic name
Bezlotoxumab
Brand name
ATC Code
J06BC03
- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
| 1-4 years (n=20) | 4-7 years (n=13) | 7-12 years (n=21) | 12-18 years (n=37) | |
| Geometric mean (%CV) | ||||
| Cmax (mcg/ml) | 112 (37,4%) | 136 (32,2 %) | 143 (24,0 %) | 155 (28,2 %) |
| T1/2 (days) | 18,4 (32 %) | 17,6 (36,6 %) | 18,2 (35,3 %) | 21,7 (22,1 %)* |
| Clearance (l/day) | 0,07 (33,2 %) | 0,116 (44,2 %) | 0,171 (45 %) | 0,24 (33,7 %)* |
| Volume of distribution (l) | 1,85 (39,1 %) | 2,95 (36,8 %) | 4,51 (27,7 %) | 7,5 (33,3 %)* |
*- n=36; FK parameters, except Cmax, could not be determined in one person due to an
incomplete concentration-time profile
Source: SmPC Zinplava
dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
Available formulations
No information is present at this moment.
Dosages
| Prevention of recurrence of Clostridium difficile infection |
|---|
|
Renal impaiment in children > 3 months
GFR ≥10 ml/min/1.73m2: Dose adjustment not required.
GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.
The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
The safety profile in children matches that of adults.
The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions
No information available on specific warnings and precautions in children.
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
IMMUNOGLOBULINS
This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.
| Immunoglobulins, normal human | ||
|---|---|---|
| J06BA02 | ||
| J06BA01 | ||
| Specific immunoglobulins | ||
|---|---|---|
| J06BB01 | ||
| J06BB04 | ||
| J06BB02 | ||
| J06BB03 | ||
| IMMUNOGLOBULINS, NORMAL HUMAN | ||
|---|---|---|
| J06BA02 | ||
| J06BA01 | ||
| Antiviral monoclonal antibodies | ||
|---|---|---|
| J06BD07 | ||
| J06BD08 | ||
| J06BD01 | ||
Reference
- Merck Sharp & Dohme B.V., SmPC Zinplava (EU/1/16/1156/001-2) Rev 10; 18-07-2023, www.ema.europa.eu
Changes
Therapeutic Drug Monitoring
Overdose
