- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Simulated mean (SD) of the pharmacokinetic parameters using a population based PK-Analysis (SmPC Xydalba)
| Age | Preterm Neonate (GA 26 - < 37 weeks) | Term Neonate (Birth -1 month) |
Young infant (1 month - < 3 months) |
Infant (3 months - < 2 years) |
Toddler (2 years - < 6 years) | Child (6 years - < 12 years) | adolescent (12 years - < 18 Jahre) | ||||||
| Dose | 22,5 mg/kg | 22,5 mg/kg | 22,5 mg/kg | 22,5 mg/kg | 22,5 mg/kg | 18 mg/kg | 18 mg/kg | ||||||
| Cmax (mg/L) |
231 (89) | 306 (130) | 306 (130) | 307 (130) | 304 (130) | 259 (110) | 251 (110) | ||||||
| AUC0-120 uur (mg*h/l) | 6620 (2000) | 9000 (2900) | 9080 (3000) | 9490 (3100) | 10.200 (3200) | 8870 (2900) | 9060 (3100) |
The antibacterial activity of dalbavancin correlates most strongly with the ratio of area under the unbound plasma concentration-time curve to the minimum inhibitory concentration (fAUC/MIC).
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Infections of the skin and skin structures |
|---|
|
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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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 is similar to that in adults.
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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.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Glycopeptide antibacterials | ||
|---|---|---|
| J01XA02 | ||
| J01XA01 | ||
| Polymyxins | ||
|---|---|---|
| J01XB01 | ||
| Steroid antibacterials | ||
|---|---|---|
| J01XC01 | ||
| Nitrofuran derivatives | ||
|---|---|---|
| J01XE01 | ||
| Other antibacterials | ||
|---|---|---|
| J01XX09 | ||
| J01XX08 | ||
| J01XX01 | ||
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References
- AbbVie Deutschland GmbH & Co. KG, SmPC Xydalba (EU/1/14/986/001) Rev15. 14-12-2022, www.ema.europa.eu
- AbbVie Deutschland GmbH & Co. KG, SmPC Xydalba (EU/1/14/986/001) Rev 20. 23-05-2025, www.ema.europa.eu
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Changes
Changes
