Pharmacokinetics in children

No information

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

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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

Transient voice changes in the initial phase.

Eye lid swelling and facial oedema are observed in (preterm) neonates [Kurnaz 2018; Ozturk 2014]

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 in children

Suitable pressure nebulizers/compressor systems are: Hudson T up-draft II/Pulmo Aide, Airlife Misty/Pulmo Aide, modified Respirgard/Pulmo Aide, Acorn II/Pulmo Aid, Pari LL/Inhalierboy, Pari LC/Inhalierboy or Master, Aiolos/2 Aiolos, Sidestream/CR50 or MobileAire or PortaNeb.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

• RESPIRATORY SYSTEM
• COUGH AND COLD PREPARATIONS

EXPECTORANTIA, EXCL COMB.PREP. MET HOESTPRIKKELDEMP.MIDD.

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

References

1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
2. McKenzie SG et al, Dornase alfa is well tolerated: data from the epidemiologic registry of cystic fibrosis., Pediatr Pulmonol, 2007, Oct;42(10), 928-37
3. Yang C, et al, Dornase alfa for Cystic Fibrosis, Cochrane Database Syst Rev., 2021, Mar 18;3 (3), CD001127
4. Roche Nederland BV, SmPC Pulmozyme (RVG 16734) 19-04-2017, www.geneesmiddeleninformatiebank.nl
5. Brand, PLP et al, Werkboek Kinderlongziekten, VU Uitgeverij, 2001
6. CBO, Richtlijn Diagnostiek en behandeling Cystic Fibrosis, www.cbo.nl, 2007, http://www.cbo.nl/Downloads/466/rl_cf_2007.pdf
7. Dilmen U, et al., Nebulized hypertonic saline and recombinant human DNase in the treatment of pulmonary atelectasis in newborns., Pediatr Int., 2011, 53(3), 328-31
8. Fedakar A, et al., Safety of recombinant human deoxyribonuclease as a rescue treatment for persistent atelectasis in newborns, Ann Saudi Med, 2012, 32(2), 131-6.
9. MacKinnon R, et al., Endotracheal DNase for atelectasis in ventilated neonates., J Perinatol, 2011, 31(12), 799-801
10. Altunhan H, et al., Comparing the efficacy of nebulizer recombinant human DNase and hypertonic saline as monotherapy and combined treatment in the treatment of persistent atelectasis in mechanically ventilated newborns., Pediatr Int., 2012, 54(1), 131-6
11. Merkus PJ, et al., DNase treatment for atelectasis in infants with severe respiratory syncytial virus bronchiolitis., Eur Respir J, 2001, 18(4), 734-7
12. El Hassan NO,et al., Rescue use of DNase in critical lung atelectasis and mucus retention in premature neonates., Pediatrics, 2001, 108(2), 468-70
13. Ozturk E, et al., The use of dornase alpha for post-operative pulmonary atelectasis after congenital heart surgery, Cardiol Young, 2014, 24(5), 807-12
14. Erdeve O,et al., Efficacy and safety of nebulized recombinant human DNase as rescue treatment for persistent atelectasis in newborns: case-series., Croat Med J., 2007, 48(2), 234-9
15. Küpeli S, et al., Use of recombinant human DNase in a premature infant with recurrent atelectasis., Pediatr Int, 2003, 45(5), 584-6
16. Kurnaz D, et al., Angioedema Associated With Nebulized Recombinant Human DNase in a Preterm Infant: Case Report., J Pediatr Pharmacol Ther., 2018, 23(3), 219-22

Changes

Therapeutic Drug Monitoring

Overdose