- 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
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Available formulations
No information is present at this moment.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Dosages
| Prevention of recurrence of Clostridium difficile infection |
|---|
|
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
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.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
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.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
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.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
| Immunoglobulins, normal human | ||
|---|---|---|
| J06BA02 | ||
| J06BA01 | ||
| Specific immunoglobulins | ||
|---|---|---|
| J06BB01 | ||
| J06BB04 | ||
| J06BB02 | ||
| J06BB03 | ||
| IMMUNOGLOBULINS, NORMAL HUMAN | ||
|---|---|---|
| J06BA02 | ||
| J06BA01 | ||
| Antiviral monoclonal antibodies | ||
|---|---|---|
| J06BD07 | ||
| J06BD08 | ||
| J06BD01 | ||
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Reference
- Merck Sharp & Dohme B.V., SmPC Zinplava (EU/1/16/1156/001-2) Rev 10; 18-07-2023, www.ema.europa.eu
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Changes
Changes
