- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No information
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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
| Immunosuppression in kidney transplants |
|---|
|
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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
In children, rhinitis, pyrexia, hypertrichosis, urinary tract infection, hypertension, upper respiratory tract infection, viral infection, sepsis and constipation have been reported more often than in adults.[SmPC]
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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 in children
At the start of the treatment, hypersensitivity reactions have been reported: anaphylaxis.
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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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| Selective immunosuppressants | ||
|---|---|---|
| L04AA24 | ||
| L04AA32 | ||
| L04AA13 | ||
| L04AA02 | ||
| L04AA06 | ||
| L04AA31 | ||
| L04AA04 | ||
| L04AA44 | ||
| Other immunosuppressants | ||
|---|---|---|
| L04AX01 | ||
| L04AX03 | ||
| Tumor necrosis factor alpha (TNF-alpha) inhibitors | ||
|---|---|---|
| L04AB04 | ||
| L04AB01 | ||
| L04AB06 | ||
| L04AB02 | ||
| Interleukin inhibitors | ||
|---|---|---|
| L04AC03 | ||
| L04AC08 | ||
| L04AC13 | ||
| L04AC19 | ||
| L04AC10 | ||
| L04AC22 | ||
| L04AC07 | ||
| L04AC05 | ||
| Calcineurin inhibitors | ||
|---|---|---|
| L04AD01 | ||
| L04AD02 | ||
| Sphingosine-1-phosphate (S1P) receptor modulators | ||
|---|---|---|
| L04AE01 | ||
| Janus-associated kinase (JAK) inhibitors | ||
|---|---|---|
| L04AF02 | ||
| L04AF02 | ||
| L04AF08 | ||
| L04AF01 | ||
| Monoclonal antibodies | ||
|---|---|---|
| L04AG04 | ||
| Mammalian target of rapamycin (mTOR) kinase inhibitors | ||
|---|---|---|
| L04AH02 | ||
| L04AH01 | ||
| Complement inhibitors | ||
|---|---|---|
| L04AJ01 | ||
| L04AJ02 | ||
| Dihydroorotate dehydrogenase (DHODH) inhibitors | ||
|---|---|---|
| L04AK02 | ||
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References
- Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
- Novartis Europharm Limited, SPC Simulect (EU/1/98/084/001-002) 18-05-2018, www.ema.europa.eu
- Novartis, SmPC Simulect® 10mg, 20mg Pulv. u. Lsg.-mittel z. Herst. einer Inj.- od. Infusionslsg. (EU/1/98/084/002, EU/1/98/084/001), 02/2017
- Novartis Europharm Limited, SPC Simulect (EU/1/98/084/001-002) Rev 29; 18 December 2024, www.ema.europa.eu
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Changes
Changes
