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PENTAGLOBIN INJECTION 50 MG/ML [SIN11205P]

Active ingredients: PENTAGLOBIN INJECTION 50 MG/ML

Last updated 26 October 2025

Product Info

PENTAGLOBIN INJECTION 50 MG/ML

[SIN11205P]

Product information

Active Ingredient and Strength

IMMUNOGLOBULIN (HUMAN) - 50 MG/ML

Dosage Form

INJECTION

Manufacturer and Country

BIOTEST AG - GERMANY

Registration Number

SIN11205P

Licence Holder

GRIFOLS ASIA PACIFIC PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

J06BA02

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.

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:

Table caption

in neonates and infants:

1.7 ml/kg/hour by infusion pump

in children and adults:

0.4 ml/kg/hour

alternatively:

the first 100 ml at 0.4 ml/kg/hour


then 0.2 ml/kg/hour continuously


until 15 ml/kg is reached within 72 hours

Pentaglobin Dosage Table 1



Method of administration
Intravenous use.
Pentaglobin should be brought to room or body temperature before use.

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.