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Pentaglobin

Pentaglobin

human normal immunoglobulin

Manufacturer:

Biotest

Distributor:

Biovalys

Marketer:

Biovalys
Concise Prescribing Info
Contents
Human Ig (Per mL: IgG 38 mg, IgA 6 mg, IgM 6 mg)
Indications/Uses
Adjuvant therapy of severe bacterial infections additional to antibiotic therapy. Ig substitution in immunocompromised patients & those suffering from severe secondary Ab deficiency syndrome (suppressed immune defence).
Dosage/Direction for Use
IV Adult & childn Therapy of severe bacterial infection 5 mL/kg daily on 3 consecutive days at a rate of 0.4 mL/kg/hr. Alternatively, 1st 100 mL at 0.4 mL/kg/hr then 0.2 mL/kg/hr continuously until 15 mL/kg is reached w/in 72 hr. Further infusion may be needed. Ig substitution 3-5 mL/kg. Repeat at wkly intervals if needed. Neonate & infant 5 mL/kg daily on 3 consecutive days at a rate of 1.7 mL/kg/hr by infusion pump. Further infusion may be needed.
Contraindications
Hypersensitivity. Patients w/ selective IgA deficiency who developed Abs to IgA.
Special Precautions
Anaphylaxis can develop in patients w/ undetectable IgA who have anti-IgA Abs; who had tolerated previous treatment w/ human normal Ig. Discontinue treatment immediately in case of pulmonary adverse reactions. Shock. Thromboembolic events eg, MI, CVA (stroke), pulmonary embolism & DVT. Acute renal failure. Aseptic meningitis syndrome. Haemolytic anaemia. Transient decrease in neutrophil count &/or episodes of neutropenia. Acute non-cardiogenic pulmonary oedema. Misleading +ve results in serological testing. Possibility of transmitting infective agents. Patients who receive human normal Ig for the 1st time or, is switched or when there has been long interval since previous infusion; w/ untreated infection or underlying chronic inflammation. Obese patients. Patients w/ pre-existing risk factors for thrombotic events (eg, advanced age, HTN, DM, history of vascular disease or thrombotic episodes, acquired or inherited thrombophilic disorders, prolonged periods of immobilisation, diseases which increase blood viscosity & severely hypovolemic patients); restricted Na diet. Monitor patients for any symptoms throughout whole infusion period; to detect potential adverse signs at the hospital during 1st infusion & for the 1st hr after 1st infusion in those naive to human normal Ig, those switched from alternative IVIg product or when there has been long interval since previous infusion; clinical signs & symptoms of haemolysis. Ensure adequate hydration prior to infusion. Monitor urine output; serum creatinine levels. Assess renal parameters prior to infusion. Perform neurologic exam including CSF studies in patients exhibiting signs & symptoms of aseptic meningitis syndrome. Avoid concomitant use w/ loop diuretics. Minor influence on ability to drive & use machines. Consider discontinuation in case of renal impairment. Pregnancy & lactation. Hypersensitivity in neonates & infants. Elderly >65 yr.
Adverse Reactions
Low BP, hypotension; nausea, vomiting; hyperhidrosis.
Drug Interactions
May impair efficacy of live attenuated virus vaccines eg, MMR & varicella. Avoid concomitant use w/ loop diuretics.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BA02 - immunoglobulins, normal human, for intravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.
Presentation/Packing
Form
Pentaglobin soln for infusion 50 mg/mL
Packing/Price
10 mL x 1's;50 mL x 1's
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/thailand/image/info/pentaglobin-soln-for-infusion-50-mg-ml/50-ml?id=bc9ee918-5d27-4835-a4c2-b29000894ecf
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