Enbrel Pre-Filled Pen/Enbrel Pre-Filled Syringe / 恩利 - Hong Kong[香港药品]

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Enbrel Pre-Filled Pen/Enbrel Pre-Filled Syringe / 恩利

2014-04-06 07:41:22 来源: 作者: 【大中小】浏览:514次评论:0条

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Manufacturer

Pfizer

Distributor

Hong Kong: Zuellig/Macau: LF Asia (Macao)

Contents

Etanercept

Indications

In combination w/ methotrexate in the treatment of moderate to severe active RA in adults when response to disease-modifying antirheumatic drugs (DMARDs) has been inadequate. As monotherapy in case of intolerance to methotrexate or when continued treatment w/ methotrexate is inappropriate. Treatment of severe, active & progressive RA in adults not previously treated w/ methotrexate. As monotherapy or in combination w/ methotrexate to reduce progression rate of joint damage & improve physical function. Treatment of active & progressive psoriatic arthritis in adults when the response to previous DMARDs has been inadequate. Treatment of adults w/ severe active ankylosing spondylitis not responsive to conventional therapy. Treatment of adults w/ moderate to severe plaque psoriasis who failed to respond to, contraindicated to or intolerant of other systemic therapy including cyclosporine, methotrexate or PUVA. Treatment of chronic severe plaque psoriasis in childn & adolescents ≥8 yr inadequately controlled by or intolerant to other systemic therapies or phototherapies. Pre-filled syringe 25 mg Treatment of active polyarticular juvenile idiopathic arthritis in childn ≥4 yr w/ inadequate response or intolerant to methotrexate.
Click to view Enbrel Pre-Filled Pen/Enbrel Pre-Filled Syringe detailed prescribing infomation

Dosage

SC. Pre-filled pen & pre-filled syringe Adult 18-64 yr RA, psoriatic arthritis & ankylosing spondylitis 25 mg twice wkly or 50 mg once wkly. Plaque psoriasis 25 mg twice wkly or 50 mg once wkly or alternatively 50 mg twice wkly for up to 12 wk follwed by 25 mg twice wkly or 50 mg once wkly. Paed plaque psoriasis Childn ≥8 yr 0.8 mg/kg (max: 50 mg/dose) once wkly for up to 24 wk. Discontinue treatment if unresponsive after 12 wk. Pre-filled syringe Juvenile idiopathic arthritis Childn ≥4 yr 0.4 mg/kg (max: 25 mg/dose) twice wkly at 3-4 days interval.
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Overdosage

View Enbrel Pre-Filled Pen/Enbrel Pre-Filled Syringe overdosage for action to be taken in the event of an overdose.

Contraindications

Sepsis or risk of sepsis. Active infections eg chronic or localised infections.
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Special Precautions

Patient w/ a history of recurring or chronic infections or w/ underlying conditions which may predispose to infections. Discontinue if any serious allergic or anaphylactic reaction occurs. Moderate to severe alcoholic hepatitis. TB. HBV carriers. Diabetes. Malignancies (particularly Hodgkin's & non-Hodgkin's lymphomas), some fatal, among childn & adolescents. Perform skin exam for all patients who are at increased risk for non-melanoma skin cancer. Live vaccines should not be given concurrently. May result in the formation of autoimmune Ab. History of blood dyscrasias. eva luate risk/benefit before prescribing to patient w/ preexisting or recent onset of CNS demyelinating disease. CHF. Not for the treatment of Wegener's granulomatosis. Pregnancy & lactation. Childn <4 yr.
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Adverse Drug Reactions

Infections, inj site reactions; allergic reactions, auto Ab formation, pruritus, fever; worsening of CHF.
View ADR Monitoring Form

Drug Interactions

Combination w/ anakinra & abatacept is not recommended.
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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 1^st trimester (and there is no evidence of a risk in later trimesters).

Caution For Usage

For caution against possible variation of physical aspect of medicine... click to view Enbrel Pre-Filled Pen/Enbrel Pre-Filled Syringe detailed prescribing infomation

Storage

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Description

View Enbrel Pre-Filled Pen/Enbrel Pre-Filled Syringe description for details of the chemical structure and excipients (inactive components).

Mechanism of Action

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Presentation/Packing

Form

Packing

Photo

Enbrel Pre-Filled Pen/Enbrel Pre-Filled Syringe pre-filled pen

Enbrel Pre-Filled Pen/Enbrel Pre-Filled Syringe 50 mg x 4's