- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No information is present at this moment.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| Chronic hepatitis B | ||||||||||||||||||||||||||||||||
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| Chronic hepatitis C | ||||||||||||||||||||||||||||||||
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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
(infection with HCV, combination therapy with ribavirin): Very common (> 10%): influenza-like symptoms (91%), sleeplessness, fatigue, irritability, reduced appetite. Headache (64%). Gastrointestinal disorders (56%). Pain in the skeletal muscles. Rash, itching, alopecia. Reaction at the injection site (45%). Common (1-10%): fever, influenza, infectious mononucleosis, pharyngitis or nasopharyngitis (due to Streptococcus), candidiasis, dental abscess, stye, (viral) gastroenteritis, urinary tract infection. Dizziness, disrupted attention, migraine. Abnormal behaviour, anger, aggression, ADHD, anxiety, depression, hallucination. Dyspnoea, nosebleed. (Aphthous) stomatitis, nausea, abdominal pain. Eye irritation, pain or itching in the eye, retina; exudates, reduced visual acuity, temporary blindness. Earache. Swollen face, fixed drug eruption. Dysuria, incontinence. Vaginal secretion. Back pain, pain in extremities. Anaemia. Hyperglycaemia, type 1 diabetes mellitus. Locally: haematoma at the injection site.
Also reported: growth inhibition. Reduction of haemoglobin, neutrophils and thrombocytes.
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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 in children
- children younger than 3 years (because of the risk of fatal toxic effect and anaphylactoid responses to benzyl alcohol in the liquid for injection).
- a pre-existing severe psychiatric condition (severe depression, suicidal behaviour) or a medical history of one in children and adolescents;
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
Using it in children results in weight loss and growth inhibition. In a number of patients, growth returned to their baseline growth curve (6 years after treatment). The amount of available data is not sufficient to conclude that the growth inhibition is always reversible. There is no data on the long-term effect on sexual maturation. These adverse effects before treatment are weighed against the child's disease characteristics such as evidence of disease progression (visible fibrosis), comorbidities that may affect the disease (such as HIV co-infection) and prognostic factors for a response (such as the HCV genotype and viral load). If possible, treat the child after the teenage growth spurt.
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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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| Colony stimulating factors | ||
|---|---|---|
| L03AA02 | ||
| L03AA14 | ||
| Interferons | ||
|---|---|---|
| L03AB05 | ||
| L03AB10 | ||
| Other immunostimulants | ||
|---|---|---|
| L03AX13 | ||
| L03AX15 | ||
| L03AX16 | ||
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Reference
- Roche Registration GmbH, SmPC Pegasys (EU/1/02/221) 26-03-2018
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Changes
Changes
