- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Er is geen informatie over de farmacokinetische parameters bij kinderen.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
On-label
Licensed use Licensed useA second drug has not been selected yet.
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Available formulations
Inj.vlst. (acetaat) 20 mg/ml; 40 mg/ml
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Dosages
| Relapsing Remitting Multiple Sclerose (RRMS) |
|---|
|
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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.
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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
Adult Side Effects
Zeer vaak (> 10%): reacties op de injectieplaats zoals overgevoeligheid, roodheid van de huid, pijn, zwelling, jeuk, ontsteking en oedeem; een 'Onmiddellijke (binnen enkele minuten optredende) Postinjectiereactie' met één of meer van de volgende systemische symptomen: vasodilatatie, pijn (op de borst), dyspneu, palpitaties of tachycardie. Misselijkheid, angst, depressie, hoofdpijn, griep, infectie, rugpijn, artralgie, asthenie.
Vaak (1-10%): bronchitis, herpes simplex, tandproblemen, cystitis, gastro-enteritis, otitis, rinitis, vaginale candidiasis, benigne neoplasma van de huid, lymfadenopathie, anorexie, gewichtstoename, nervositeit, smaakverandering, duizeligheid, slaperigheid, hypertonie, tremor, syncope, spraakstoornis, oog-, ooraandoening, hoest, constipatie, fecale incontinentie, braken, abnormale leverfunctietest, bloeduitstorting, hyperhidrose, jeuk, huidaandoening, mictiestoornis, urineretentie, rillingen, oedeem in het gezicht. Atrofie op de injectieplaats.
Soms (0,1-1%): abces, furunculosis, herpes zoster, pyelonefritis, huidcarcinoom, leukocytose, leukopenie, miltvergroting, trombocytopenie, struma, hyperthyreoïdie, alcoholintolerantie, jicht, hyperlipidemie, verhoogde natriumspiegel in het bloed, verlaagde serumferritinespiegel, abnormale dromen, euforie, hallucinatie, vijandigheid, manie, zelfmoordneiging, cognitieve stoornis, convulsie, dyslexie, spierkramp, nystagmus, stupor, gezichtsveldstoornis, oogbloeding, optische atrofie, droge ogen, extrasystolen, sinusbradycardie, spataderen, apneu, hyperventilatie, longaandoening, ademhalingsstoornis, (entero)colitis, oesofageale zweer, periodontitis, rectale bloeding, vergroting van de speekselklier, cholelithiasis, leververgroting, geneesmiddelgeïnduceerde leverbeschadiging en toxische hepatitis, angio-oedeem, erythema nodosum, artritis, bursitis, spieratrofie, osteoartritis, hematurie, nefrolithiase, urinewegaandoening, abortus, erectiestoornis, priapisme, prostaataandoening, gespannen borsten, vaginale bloeding, necrose op de injectieplaats, hypothermie.
Zelden (< 0,01–0,1%): anafylactische reacties, lipoatrofie, huidnecrose.
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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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| Colony stimulating factors | ||
|---|---|---|
| L03AA02 | ||
| L03AA14 | ||
| Interferons | ||
|---|---|---|
| L03AB05 | ||
| L03AB11 | ||
| L03AB10 | ||
| Other immunostimulants | ||
|---|---|---|
| L03AX15 | ||
| L03AX16 | ||
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Reference
- TEVA GmBH, SmPC Copaxone (RVG 30086) 10-01-2019, www. geneesmiddeleninformatiebank.nl
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Changes
Changes
