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See related Simponi inj information |
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Manufacturer |
Janssen |
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Distributor |
Hong Kong: DKSH/Macau: Four Star |
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Contents |
Golimumab |
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Indications |
In combination w/ methotrexate for the treatment of moderate to severe active RA. Alone or in combination w/ methotrexate for active psoriatic arthritis. Monotherapy for active ankylosing spondylitis. |
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Dosage |
50 mg SC once a mth. |
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Special Precautions |
eva luate for active TB & test for latent infection prior to & during therapy. Malignancies; serious infection including active TB, invasive fungal infections, bacterial, viral & opportunistic infections; HBV reactivation, CHF, demyelinating disorders, hematologic cytopenias, vaccinations. Concomitant abatacept, anakinra. Live vaccines. Pregnancy & lactation. Childn <18 yr, elderly. |
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Adverse Drug Reactions |
Serious infections, malignancies, liver enzyme elevations, autoimmune disorders & autoantibodies; new onset & exacerbations of psoriasis; immunogenicity, upper resp tract infection, nasopharyngitis; increased ALT, AST; inj site erythema, HTN, bronchitis, dizziness, sinusitis, flu, pharyngitis, rhinitis, pyrexia, oral herpes, paraesthesia.
View ADR Monitoring Form |
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Drug Interactions |
Biologic products for RA, psoriatic arthritis &/or ankylosing spondylitis; live vaccines, CYP450 substrates.
View more drug interactions with Simponi |
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Pregnancy Category (US FDA) |
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters). |
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ATC Classification |
L04AB06 - golimumab ; |
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Presentation/Packing |
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Form |
Packing |
Photo |
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Simponi injection |
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Simponi 50 mg/0.5 mL x 1's |
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Manufacturer: |
Janssen |
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Distributor: |
Hong Kong: DKSH
Macau: Four Star |
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