OCTAGAM IV SOLUTION FOR INFUSION 5 g/50 mL

Active ingredient: 1 mL solution contains 100 mg protein (contains at least 95% human immunoglobulin G).

Excipients: Maltose, water for injection

▼This drug is subject to additional monitoring. This triangle will enable rapid identification of new safety information. You can help by reporting any side effects that occur. To learn how to report side effects, see the end of Chapter 4.

Before you start using this medicine, please read this INSTRUCTIONS FOR USE carefully, because it contains important information for you.

OCTAGAM belongs to a group of medicines called immunoglobulins.

These medicines contain human antibodies that are also found in your blood. Antibodies help your body fight microbial diseases (infections).

This group of drugs is used in replacement therapy (complementing the missing) in patients who do not have sufficient antibodies in their blood and are infected more frequently.

In addition, it can be used in patients who need more antibodies for the treatment of some inflammatory conditions (autoimmune diseases) caused by the immune system mistakenly developing against its own tissues.

OCTAGAM (100 mg/ml) contains all IgG activities found in the normal population. Appropriate doses of this product can restore abnormally low IgG levels to normal levels.

Instructions for proper use and dosage/frequency of administration

Your doctor will decide whether you need this medicine and its dosage. Your doctor will determine the dose of your medicine depending on your disease and ensure that it is administered to you.

The following information serves as a guide for the doses to be administered:

Replacement therapy in patients with congenitally deficient immune systems (primary immunodeficiency)

The dose of your medicine will be adjusted to ensure that the measured drug level is at least 600 mg/dL before the administration of the next dose. It takes 3-6 months from the start of treatment to achieve this balance.

Like all medicines, side effects may occur in people who are sensitive to the ingredients contained in OCTAGAM. However, these effects may not occur in everyone.

Frequency definitions for the following side effects are as follows:

If any of the following occur, immediately inform your doctor or go to the emergency department of your nearest hospital:

In some cases, your doctor may need to interrupt your treatment and reduce your dose or stop your treatment.

If any of the conditions listed above occur, consult your doctor immediately.

⚠️ Disclaimer: The information provided on this website is for informational purposes only and does not substitute professional medical advice. Always consult a healthcare provider before using any medication.