Human Normal Immunoglobulin (100-200mg per ml)

Registered South African indications:

100mg/ml

• Replacement therapy in primary immunodeficiency syndromes (PID) such as:
  - Congenital agammaglobulinaemia and hypogammaglobulinaemia
  - Common variable immunodeficiency syndrome
  - Severe combined immunodeficiency syndrome
  - Wiskott-Aldrich syndrome
• Replacement therapy in secondary immune defects (SID) in patients with severe or recurring infections, ineffective antimicrobial treatment and either confirmed insufficient increase of antibodies from vaccinations (PSAF*) or IgG serum levels of <4g/L

*PSAF = Absence of a minimum two-fold increase of the IgG antibody concentration against pneumococcal polysaccharides and polypeptide antigen vaccine (PSAF = proven specific antibody failure)

• Immunomodulation
  - Primary immune thrombocytopenia (ITP) in children or adults at high risk of bleeding or prior to surgery to correct platelet count
  - Guillain-Barré syndrome
  - Kawasaki’s disease
  - Chronic inflammatory demyelinating polyneuropathy (CIDP)
  - Multifocal motor neuropathy (MMN)

200mg/ml

Indications for subcutaneous administration (SCIg)

• Replacement therapy in adults, and children and adolescents (0 to 18 years) in:
  - Primary immunodeficiency syndromes with impaired antibody production
  - Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4g/l

*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines

100mg/ml Thrombosis, Renal Dysfunction and Acute Renal Failure Thrombosis may occur with immune globulin products, including human normal immunoglobulin 100mg/ml. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of oestrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients

 

200mg/ml Thromboembolism Thromboembolism may occur with immune globulin products, including human normal immunoglobulin 200mg/ml. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors For patients at risk of thromboembolism, administer human normal immunoglobulin 200mg/ml at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thromboembolism and assess blood viscosity in patients at risk of hyperviscosity

Registered South African contraindications

100mg/ml

• Hypersensitivity to the active ingredient or to any of its excipients
• Hypersensitivity to human immunoglobulins, especially in patients with lgA deficiency when these patients have antibodies to lgA
• Hyperprolinaemia type I or ll
  - Hyperprolinaemia is a very rare disease affecting only individual families worldwide

200mg/ml

• Hypersensitivity to the active ingredient or to any of its excipients
• Severe IgA deficiency and a history of hypersensitivity to human immunoglobulin treatment
• Human normal immunoglobulin must not be given intravascularly or intramuscularly

Contraindications registered in other jurisdictions

100mg/ml

• Hypersensitivity to the active ingredient or to any of its excipients
• Patients with selective IgA deficiency who developed antibodies to IgA, as administering an IgA-containing product can result in anaphylaxis

200mg/ml

• Hypersensitivity to the active ingredient or to any of its excipients
• Human normal immunoglobulin must not be given intravascularly or intramuscularly
• Patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin
• IgA deficient patients with antibodies against IgA and history of hypersensitivity to human immune globulin treatment

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment (100mg/ml) (South African recommendations)
• Hepatic impairment (200mg/ml)
• Elderly (100mg/ml) (South African recommendations)
• Elderly (200mg/ml)
• Risk factors for thromboembolism and thrombotic events
  - Advanced age
  - Hypertension
  - Diabetes mellitus
  - History of vascular disease or thrombotic episodes
  - Acquired or inherited thrombophilic disorders
  - Prolonged periods of immobilization
  - Severely hypovolemic patients
  - Diseases which increase blood viscosity
  - Use of oestrogens (South African recommendations) 
  - Indwelling vascular catheters (South African recommendations) 
  - Hyperviscosity (South African recommendations) 
  - Cardiovascular risk factors (South African recommendations) 
• Administration into a blood vessel
• Human normal immunoglobulin naive patient 
• Switch in human normal immunoglobulin product 
• Long interval since the previous infusion
• Prolonged containment of product in siliconized syringes
• Patients with anti-IgA antibodies
• Risk factors for renal complications
  - Pre-existing renal insufficiency
  - Diabetes mellitus
  - Hypovolemia
  - Coadministration with nephrotoxic medicinal agents
  - Older than 65
  - Sepsis
  - Hyperviscosity
  - Paraproteinemia
• Females
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: inj

South African registered indications and dosages

100mg/ml

The dosage and intervals between infusions depend on the indication

Replacement therapy in primary immunodeficiency syndromes (PID) such as:
- Congenital agammaglobulinaemia and hypogammaglobulinaemia
- Common variable immunodeficiency syndrome
- Severe combined immunodeficiency syndrome
- Wiskott-Aldrich syndrome

In replacement therapy, the dosage should be individually adjusted depending on the clinical response. The following dosages are given as a recommendation:

• IV: Dosage regimen must be selected, under which IgG trough levels (determination of IgG serum levels immediately prior to the next infusion) of at least 5 to 6g/L are achieved; After initiation of treatment, 3 to 6 months are needed until a steady-state concentration is reached; Recommended initial dose: 0.4 to 0.8g/kg body weight (BW); Followed by at least 0.2g/kg BW every 3 to 4 weeks; Maintenance (dose required to maintain an IgG trough level of 5 to 6g/L): 0.2 to 0.8g/kg BW/month; After the steady-state concentration has been reached, the dosing interval is 3 to 4 weeks; To establish the required dose and correct dosing interval, IgG trough levels should be determined

Replacement therapy in secondary immune defects (SID) in patients with severe or recurring infections, ineffective antimicrobial treatment and either confirmed insufficient increase of antibodies from vaccinations (PSAF*) or IgG serum levels of <4g/L
*PSAF = Absence of a minimum two-fold increase of the IgG antibody concentration against pneumococcal polysaccharides and polypeptide antigen vaccine (PSAF = proven specific antibody failure)

In replacement therapy, the dosage should be individually adjusted depending on the clinical response. The following dosages are given as a recommendation:

• IV: Recommended dose: 0.2 to 0.4g/kg BW every 3 to 4 weeks; IgG trough levels should be measured and assessed in connection with the incidence of infection; The dose should be adapted as needed to achieve optimum protection against infections; Dose increase may be necessary in patients with persistent infections; Dose reduction may be considered if the patient remains free of infections

Immunomodulation
- Primary immune thrombocytopenia (ITP) in those at high risk of bleeding or prior to surgery to correct platelet count

• IV: Acute episode: First day: 0.8 to 1g/kg BW; Treatment can be repeated once within 3 days; Alternatively: 0.4g/kg BW is admin. on 2 to 5 consecutive days; In the event of a second decrease in the platelet count, treatment can be repeated

- Guillain-Barré syndrome

• IV: 0.4g/kg BW/day; Treatment duration: 5 days

- Kawasaki’s disease

• IV: 1.6 to 2g/kg BW spread over 2 to 5 days OR 2g/kg BW as a single dose; Patients should receive acetylsalicylic acid as co-medication

- Chronic inflammatory demyelinating polyneuropathy (CIDP)

• IV: Recommended starting dose: 2g/kg BW, divided into several doses, admin. on 2 to 5 consecutive days; Maintenance: 1g/kg BW admin. on one day or spread over 2 consecutive days, every 3 weeks; Long-term treatment beyond 25 weeks is guided by the response to maintenance therapy; The lowest effective maintenance dose and dosage regimen must be adjusted according to the individual course of the disease

- Multifocal motor neuropathy (MMN)

• IV: Starting dose: 2g/kg BW for 2 to 5 consecutive days; Maintenance dose: 1g/kg BW every 2 to 4 weeks OR 2g/kg BW every 4 to 8 weeks over 2 to 5 days; If an insufficient response to the treatment is determined after 6 months, the treatment should be terminated; If the treatment is effective, the necessity of long-term treatment should be evaluated by the physician based on the patient’s response; The dosage and the intervals may have to be adapted to the individual course of disease

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Human normal immunoglobulin 100mg/ml must be administered intravenously

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To ensure the traceability of the biological medicinal products it is recommended to document the brand name and the lot number for each treatment

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Method of administration: see additional prescribing points

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BW = body weight

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200mg/ml

The dose and dose regimen are dependent on the indication

Indications for subcutaneous administration (SCIg)

Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency

Replacement therapy in primary immunodeficiency syndromes with impaired antibody production

In replacement therapy the dose may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. Dose based on body weight may require adjustment in underweight or overweight patients. The following dose regimens are given as a guideline:

• SC: Dose regimen should achieve a trough level of IgG (measured before the next infusion) of at least 5 to 6g/l; Aim to be within the reference interval of serum IgG for age; Loading dose: At least 0.2 to 0.5g/kg (1 to 2.5ml/kg) body weight may be required; This may need to be divided over several days; Max: 0.1 to 0.15g/kg/24hrs

- Maintenances doses

• SC: After steady state IgG levels have been attained, maintenance doses are administered at repeated intervals to reach a cumulative monthly dose of the order of 0.3 to 1.0g/kg; Each single dose may need to be injected at different anatomic sites

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Trough levels should be measured and assessed in conjunction with the incidence of infection. To reduce the rate of infection, it may be necessary to increase the dose and aim for higher trough levels

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Replacement therapy in secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4g/l
(*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines)

In replacement therapy the dose may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. Dose based on body weight may require adjustment in underweight or overweight patients. The following dose regimens are given as a guideline:

• SC: The recommended dose admin. at repeated intervals is to reach a cumulative monthly dose to the order of 0.2 to 0.4g/kg; Each single dose may need to be injected at different anatomic sites

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IgG trough levels should be measured and assessed in conjunction with the incidence of infection. Dose should be adjusted as necessary to achieve optimal protection against infections, an increase may be necessary in patients with persisting infection; a dose decrease can be considered when the patient remains infection-free

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Human normal immunoglobulin 200mg/ml should be administered via the subcutaneous route

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Method of administration: See additional prescribing points

Paed. forms avail. in SA and covered in this monograph: inj

South African registered indications and dosages

100mg/ml

The dosage and intervals between infusions depend on the indication

Replacement therapy in primary immunodeficiency syndromes (PID) such as:
- Congenital agammaglobulinaemia and hypogammaglobulinaemia
- Common variable immunodeficiency syndrome
- Severe combined immunodeficiency syndrome
- Wiskott-Aldrich syndrome
Replacement therapy in secondary immune defects (SID) in patients with severe or recurring infections, ineffective antimicrobial treatment and either confirmed insufficient increase of antibodies from vaccinations (PSAF*) or IgG serum levels of <4g/L
*PSAF = Absence of a minimum two-fold increase of the IgG antibody concentration against pneumococcal polysaccharides and polypeptide antigen vaccine (PSAF = proven specific antibody failure)

• See adult dosage

Immunomodulation
- Primary immune thrombocytopenia (ITP) in those at high risk of bleeding or prior to surgery to correct platelet count
- Kawasaki’s disease
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Multifocal motor neuropathy (MMN)

• See adult dosage

- Guillain-Barré syndrome

• Experience in children is limited

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The dosage for children and adolescents (0 to 18 years) does not differ from that of adults, as the dosage for each indication is based on body weight and adjusted according to the clinical course of the relevant diseases

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200mg/ml

The dose and dose regimen are dependent on the indication

Indications for subcutaneous administration (SCIg)

Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency

Replacement therapy in primary immunodeficiency syndromes with impaired antibody production
Replacement therapy in secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4g/l
(*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines)

• See adult dosage

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The posology in children and adolescents (0 - 18 years) is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the above-mentioned indications. No clinical trials have been conducted with human normal immunoglobulin 200mg/ml in children at age 0-<2years, but experience with immunoglobulins suggests that no harmful effects on treatment of children at age 0-< 2 years with human normal immunoglobulin 200mg/ml are to be expected

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Method of administration: See additional prescribing points

Pregnancy

100mg/ml

South African recommendations

• Caution
• There are no controlled clinical data on the use of human normal immunoglobulin 100mg/ml in pregnant women
• Caution is therefore advised if used during pregnancy
• IVIg products cross the placenta, especially during the last pregnancy trimester
• However, long-standing clinical experience with immunoglobulins indicates that no harmful effects are to be expected on the course of pregnancy, the foetus or neonate
• Animal experiments with the excipient L-proline show no direct or indirect toxicity with respect to pregnancy, embryonic development and foetal development

Recommendations in other jurisdictions
 

• Caution
• The safety of human normal immunoglobulin 100mg/ml for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women
• IVIg products have been shown to cross the placenta, increasingly during the third trimester
• Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are expected

200mg/ml

Recommendations below are applicable to South Africa and other jurisdictions

• Caution
• The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women
• Immunoglobulin products have been shown to cross the placenta, increasingly during the third trimester
• Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected
• Health care professionals must balance the potential risk and only prescribe human normal immunoglobulin if clearly needed (South African recommendations)

Breastfeeding

100mg/ml

South African recommendations

• Caution
• Immunoglobulins are excreted in breast milk and can contribute to protecting the neonate from pathogens with a mucosal point of entry

Recommendations in other jurisdictions

• Caution
• The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to breastfeeding mothers
• Immunoglobulins are excreted into human milk
• No negative effects on the breastfed newborns/infants are anticipated

200mg/ml

Recommendations below are applicable to South Africa and other jurisdictions

• Caution
• Should only be given with caution in breastfeeding mothers
• Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry
• Health care professionals must balance the potential risk and only prescribe human normal immunoglobulin if clearly needed (South African recommendations)

Fertility

100mg/ml & 200mg/ml

Recommendations below are applicable to South Africa and other jurisdictions

• Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected

100mg/ml

South African recommendations

• Caution; dose adjustment recommended
  In patients at risk of acute renal failure, IVIg preparations should be administered at the lowest possible infusion rate and lowest possible dose that is practicable on clinical judgement
  Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients
  Pre-existing renal insufficiency has been identified as a risk factor
  In the event of renal impairment, discontinuation of IVIg preparations should be considered

Recommendations in other jurisdictions

• Caution; no dose adjustment recommended
  No dose adjustment unless clinically warranted
  Cases of acute renal failure have been reported in patients receiving IVIg therapy. In most cases, risk factors have been identified, such as pre-existing renal insufficiency
  Renal parameters should be assessed prior to infusion of IVIg, particularly in patients judged to have a potential increased risk for developing acute renal failure, and again at appropriate intervals
  In patients at risk for acute renal failure, IVIg products should be administered at the minimum rate of infusion and dose practicable. In case of renal impairment, IVIg discontinuation should be considered

200mg/ml

Recommendations below are applicable to South Africa and other jurisdictions

• Caution; no dose adjustment recommended
  Patients with renal impairment should be monitored, in particular patients with preexisting renal insufficiency or risk of acute renal failure
  Severe renal adverse reactions have been reported in patients receiving immune globulin treatment, particularly those products containing sucrose (this product does not contain sucrose). These include acute renal failure, acute tubular necrosis, proximal tubular nephropathy and osmotic nephrosis
  Factors that increase the risk of renal complications include but are not limited to pre-existing renal insufficiency

100mg/ml

South African recommendations

• Caution; no information available

Recommendations in other jurisdictions

• No dose adjustment recommended
  No evidence is available to require a dose adjustment

200mg/ml

Recommendations below are applicable to South Africa and other jurisdictions

• Caution; no information available

100mg/ml

South African recommendations

• Caution; no information available
  Cases of acute renal failure have been described in patients receiving intravenous immunoglobulin therapy. In most cases, risk factors have been identified, e.g. age over 65

Recommendations in other jurisdictions

• No dose adjustment recommended
  No dose adjustment unless clinically warranted
  Cases of acute renal failure have been reported in patients receiving IVIg therapy. In most cases, risk factors have been identified, such as age over 65

200mg/ml

South African recommendations

• Caution; no information available
  Factors that increase the risk of renal complications include, but are not limited to age over 65

Recommendations in other jurisdictions

• Caution; no dose adjustment recommended
  As the dose is given by body weight and adjusted to the clinical outcome of the mentioned conditions, the dose in the elderly population is not considered to be different from that in patients 18 to 65 years of age
  In clinical studies human normal immunoglobulin was evaluated in 5 subjects with PID >65 years of age and no specific dose adjustments were necessary to achieve the desired serum IgG levels

Central Nervous System Disorders

• Headache
• Dizziness
• Burning sensation
• Migraine
• Somnolence
• Fatigue
• Aseptic meningitis
• Paraesthesia
• Tremor

Cardiovascular Disorders

• Hypotension
• Tachycardia
• Myocardial infarction
• Stroke
• Thromboembolism (See additional prescribing points)
  - Deep venous thrombosis

Respiratory Disorders

• Dyspnoea
• Laryngospasm
• Chest discomfort
• Pulmonary embolism

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea
• Abdominal pain
  - Lower abdominal pain

Musculoskeletal Disorders

• Arthralgia
• Lower back pain 
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Chills
• Fever 
• Allergic reactions 
• Anaphylactic shock
• Local reactions at infusion site
  - Swelling
  - Pain
  - Erythema
  - Induration
  - Local heat
  - Local pain
  - Urticaria
  - Oedema
  - Bruising
  - Rash
  - Pruritis
  - Itching
• Positive Anti-GAD antibody

Others

• Pain 
• Positive Coombs direct test

• Live attenuated virus vaccines
• Measles vaccine
• Rubella vaccine
• Mumps vaccine
• Varicella vaccine

Other interactions

• Serological testing (See additional prescribing points)
  - Hepatitis A, hepatitis B, measles, and varicella
  - Red cell antibodies e.g. direct antiglobulin test (DAT, direct Coombs test)
• Assays dependent on beta-D-glucans for diagnosis of fungal infections

• Renal function
• Urine output
• IgG concentrations
• Haemoglobin
• Haematocrit
• Volume status 
• Blood pressure

Specific cases may require

• Platelets
• Blood viscosity
• Presence of antineutrophil antibodies
• IgG trough levels

Additional observations

• Infusion- or injection-related adverse reactions
• Anaphylaxis
• Signs and symptoms of thrombosis
• Signs and symptoms of haemolysis
• Neurologic symptoms
• Pulmonary adverse reactions
• Clinical response

100mg/ml

Method of administration

• Human normal immunoglobulin 100mg/ml must be administered intravenously
• Infusion rate
  • Human normal immunoglobulin 100mg/ml should be infused at an initial infusion rate of 0.3ml/kg BW/hour (over approximately 30 minutes). If well tolerated, the infusion rate can be gradually increased to 4.8ml/kg BW/hour
  • In patients with immunodeficiency syndromes and good tolerability to human normal immunoglobulin 100mg/ml replacement therapy, the infusion rate can be increased gradually to a maximum value of 7.2ml/kg BW/hour

Instructions for handling

• Human normal immunoglobulin 100mg/ml is a ready-to-use solution
• The product should be at room or body temperature prior to administration
• For administration, a standard infusion set with an integrated filter should be used
• The vial stopper must always be pierced at its centre, within the marked area. If necessary, human normal immunoglobulin can be diluted with 5% glucose solution under aseptic conditions. Human normal immunoglobulin 100mg/ml must not be mixed with physiological saline solution. However, the rinsing of infusion tubes with physiological saline solution is permitted
• The solution must be clear or slightly opalescent. Solutions showing cloudiness or precipitates must not be used

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200mg/ml

Method of administration

• For subcutaneous use only
• Human normal immunoglobulin should be inspected visually for particulate matter and discoloration prior to administration. Do not use if particulate matter and/or discoloration is observed
• The infusion must be started immediately upon transfer of human normal immunoglobulin into the syringe
• The administration is foreseen to take up to two hours. Should an administration shorter than two hours not be possible due to required dose or administration rate of human normal immunoglobulin, the required dose is to be portioned and administered at different infusion sites
• If human normal immunoglobulin remains in siliconized syringes for more than two hours, visible particles may form
• Human normal immunoglobulin must not be diluted
• Subcutaneous infusion should be commenced and initially monitored by a healthcare professional experienced in the guidance of patients for home treatment with regular follow-ups
• Infusion pumps appropriate for subcutaneous administration of immunoglobulins can be used
• The patient or caregiver must be instructed in the use of a syringe driver, the infusion techniques, the keeping of treatment diary, recognition of and measures to be taken in case of severe adverse reactions
• Human normal immunoglobulin 200mg/ml may be injected into sites such as abdomen, thigh, upper arm, and lateral hip. Adjustment of the infusion rate and infusion volume per site is based on subject tolerability

Infusion rate

• Human normal immunoglobulin 200mg/ml can be infused using:
  • an infusion device, or
  • by manual administration using a syringe
• The recommended initial infusion rate depends on the individual patient’s needs. An increase in the infusion rate of successive infusions may be considered at the discretion of the patient and based on the healthcare professionals’ judgement

Device-assisted infusion

• It is recommended to use an initial administration speed of 10ml/hr/infusion site. If well tolerated, the rate of administration may be increased at intervals of at least 10 minutes to a maximum of 20ml/hr/infusion site for the initial two infusions
• For further infusions, the infusion rate may be increased as tolerated
• More than one pump can be used simultaneously. The amount of product infused into a particular site varies. In infants and children, infusion site may be changed every 5-15ml
• In adults’ doses over 30ml may be divided according to patient preference. There is no limit to the number of infusion sites

Manual administration infusion

• Human normal immunoglobulin 200mg/ml may be administered using a syringe at a single infusion site. If administration at additional sites is required, a new sterile injection needle should be used
• The proposed maximum infusion rate is approximately 1-2ml per minute
• The rate of administration should be adjusted for each patient’s local tolerance which may depend on the site of each subcutaneous infusion and the amount of the individual patient’s subcutaneous tissue at that site
• The amount of product infused into a particular site varies. In infants and children, infusion site may be changed every 5-15ml. In adults doses over 30ml may be divided according to patient preference

Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. Human normal immunoglobulin contains the IgG antibodies present in the normal population. It is usually prepared from pooled plasma from not fewer than 1000 donations. It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma. Adequate doses of this medicinal product may restore abnormally low immunoglobulin G levels to the normal range. 

Injection (per ml) 200mg

• Cuvitru (Takeda) originator