Immunorel 10gm Injection 100ml may be used for:

• Primary immunodeficiency disorders

• Kawasaki disease

• Idiopathic thrombocytopenic purpura (ITP)

• B-cell chronic lymphocytic leukaemia

• Paediatric HIV-1 infection

• Haemopoietic stem-cell transplantation in elderly patients

Human Normal Immunoglobulin may also be used in certain immune-mediated conditions, including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy, based on clinical experience and the treating physician's judgement.

Immunorel contains Human Normal Immunoglobulin, which is mainly made up of IgG antibodies collected from the plasma of healthy human donors. These antibodies can replace or supplement antibodies that are deficient in people with certain immunodeficiency disorders, helping the body defend itself against infections.

When used for immune-mediated conditions, immunoglobulin can also modify several parts of the immune response. It can influence immune cells and antibody-mediated inflammatory pathways, helping reduce abnormal immune activity. The exact mechanism varies according to the condition being treated.

Tell your doctor about all medicines, supplements and vaccines you are receiving before treatment with Immunorel.

• Live attenuated vaccines: Immunoglobulin can interfere with the immune response to some live viral vaccines, particularly measles, mumps, rubella and varicella vaccines. Tell your doctor or vaccination provider if you have recently received Immunorel so that the appropriate vaccination interval can be determined.

• Laboratory tests: The antibodies transferred through immunoglobulin therapy can affect the interpretation of some blood tests and other antibody-based tests. Inform your doctor that you have recently received immunoglobulin before undergoing investigations.

• Other medicines: Tell your doctor about all prescription medicines, over-the-counter medicines and supplements you use. Immunorel should be administered separately from other intravenous medicines unless specifically advised by the healthcare professional.

• Store Immunorel 10gm Injection 100ml in a refrigerator between 2°C and 8°C.

• Do not freeze.

• Keep the product in its carton to protect it from light.

• Do not use the solution if it appears turbid or contains visible particles.

• Once the vial has been penetrated, the remaining contents should be used within 24 hours as stated on the product packaging. Any unused portion should be discarded.

The product should be handled according to the instructions on the pack and by the healthcare professional administering the infusion.

Immunorel 10gm Injection 100ml is given only by intravenous infusion by a qualified healthcare professional. The dose is calculated according to the condition being treated, body weight, clinical response and other relevant patient factors.

The infusion is generally started at a slower rate and may be increased gradually if tolerated. Your doctor will determine the appropriate infusion rate and duration. Patients may be monitored during and after the infusion for signs of an infusion-related reaction.

Do not attempt to administer Immunorel yourself.

Like other medicines, Immunorel can cause side effects, although not everyone experiences them. Some reactions may occur during or shortly after the infusion.

Common or infusion-related side effects

• Headache

• Fever

• Chills

• Fatigue

• Dizziness

• Nausea

• Vomiting

• Flushing

• Back pain

• Muscle or joint pain

• Changes in blood pressure

• Infusion-related reactions

These reactions may sometimes be related to the infusion rate and usually improve when the infusion is slowed or stopped as directed by the healthcare professional.

Serious side effects

Seek immediate medical attention if you develop:

• Severe allergic reaction, including swelling of the face, lips, tongue or throat, wheezing or difficulty breathing

• Severe headache with neck stiffness, fever, nausea or sensitivity to light, which may indicate aseptic meningitis

• Reduced urine output or other signs of kidney problems

• Symptoms of a blood clot, such as sudden chest pain, difficulty breathing, swelling or pain in a limb

• Signs of haemolysis, such as unusual tiredness, rapid heartbeat, yellowing of the skin or eyes or dark-coloured urine

• Severe or persistent breathing difficulty

Serious reactions associated with intravenous immunoglobulin therapy can include hypersensitivity, thrombosis, renal complications, haemolysis and aseptic meningitis.

• Immunorel should be administered only under the supervision of a healthcare professional.

• Tell your doctor if you have a history of kidney disease, heart disease, blood clots or conditions associated with increased blood viscosity.

• Adequate hydration may be advised before and during treatment, particularly in people at increased risk of kidney complications.

• Your doctor may monitor kidney function and other blood parameters during treatment when clinically required.

• Tell your doctor about recent or planned vaccinations because immunoglobulin can interfere with the response to certain live vaccines.

• Inform your doctor about any previous severe reaction to human immunoglobulin or blood products.

• Do not use the product if the solution appears turbid or contains visible particles.

• Once the vial has been penetrated, follow the storage and disposal instructions printed on the pack.