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HSA Approval

PENTAGLOBIN INJECTION 50 mg/ml

SIN11205P

PENTAGLOBIN INJECTION 50 mg/ml

PENTAGLOBIN INJECTION 50 mg/ml

October 29, 1999

ESHCOL PHARMACEUTICAL GROUP SINGAPORE PTE LTD

GRIFOLS ASIA PACIFIC PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantESHCOL PHARMACEUTICAL GROUP SINGAPORE PTE LTD
Licence HolderGRIFOLS ASIA PACIFIC PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION

**Dosage instructions and method of administration** The dosage is dependent on the patient's immune status and on the severity of the disease. The following dosage suggestions may be used as reference: 1. **Neonates and infants:** 5 ml (0.25 g)/kg body weight daily on 3 consecutive days. Further infusions may be required depending on the clinical course. 2. **Children and adults:** 1. Therapy of severe bacterial infections: 5 ml (0.25 g)/kg body weight daily on 3 consecutive days. Further infusions may be required depending on the clinical course. 2. Immunoglobulin substitution in immunocompromized patients: 3 – 5 ml (0.15 – 0.25 g)/kg body weight. Repetition at weekly intervals if necessary. Pentaglobin should be infused intravenously at the following rates: in neonates and infants:1.7 ml/kg/hour by infusion pumpin children and adults:0.4 ml/kg/hour**alternatively:**the first 100 ml at 0.4 ml/kg/hourthen 0.2 ml/kg/hour continuouslyuntil 15 ml/kg is reached within 72 hours![Pentaglobin Dosage Table 1](https://cdn.medpath.com/drug/dosage/20240520/58d849a9cb09aaa72f612f2a99d5a20d.png) **Method of administration** Intravenous use. Pentaglobin should be brought to room or body temperature before use.

INTRAVENOUS

Medical Information

**Indications** Adjuvant therapy of severe bacterial infections additional to antibiotic therapy. Product is only intended for use in high risk patients with proven bacterial sepsis and who are unlikely to have underlying IgA deficiency. Immunoglobulin substitution in immunocompromised patients.

**Contraindications** Hypersensitivity to the active substance or to any of the excipients listed above – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA.

J06BA02

immunoglobulins, normal human, for intravascular adm.

Manufacturer Information

GRIFOLS ASIA PACIFIC PTE. LTD.

BIOTEST AG

Active Ingredients

IMMUNOGLOBULIN (HUMAN)

50 mg/ml

Documents

Package Inserts

Pentaglobin Injection 50mg per mL PI.pdf

Approved: January 3, 2019

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