Profilnine Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing Local Product Insert

Concise Prescribing Info

Contents

Solvent detergent treated/nanofiltered factor IX complex

Indications/Uses

Prevention & control of bleeding in patients w/ factor IX deficiency due to hemophilia B.

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Dosage/Direction for Use

IV Individualized dose based on body wt & desired increase in factor IX.

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Warnings

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Special Precautions

Discontinue use if symptoms of hypersensitivity reaction occur. Not to be administered at >10 mL/min rate. Risk of transmitting infectious agents, eg, viruses, & Creutzfeldt-Jakob disease. Patients undergoing surgery, w/ thrombosis or disseminated intravascular coagulation (DIC). Consider hepatitis A & B vaccination in patients w/ hemophilia at birth or diagnosis. Liver disease. Pregnancy. Ped ≤16 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Urticaria, fever, chills, nausea, vomiting, headache, somnolence, lethargy, flushing or tingling. DIC or thrombosis.

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Caution For Usage

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Storage

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Description

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Action

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MIMS Class

Haemostatics

ATC Classification

B02BD04 - coagulation factor IX ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.

Thai FDA Category

Presentation/Packing

Form

Profilnine inj 500 IU

Packing/Price

1's

Profilnine

factor ix complex

Manufacturer:

Grifols

Distributor:

DKSH