SANDOGLOBULIN® NF Liquid201041723525 by lindayy


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									SANDOGLOBULIN® NF Liquid
Normal Immunoglobulin (Human) 12% (120 g/L) - intravenous injection

Product Information

Australia                                                                            In Idiopathic Thrombocytopenic Purpura (ITP), Sandoglobulin® NF Liquid was        immunoglobulin, causing a positive direct antiglobulin reaction and, rarely,
                                                                                     again compared with Sandoglobulin® lyophilised powder in a randomised             haemolysis. Haemolytic anaemia can develop subsequent to IVIg therapy due
NAME OF THE MEDICINE                                                                 trial. There were 16 patients in the Sandoglobulin® NF Liquid group and           to enhanced RBC sequestration (see ADVERSE EFFECTS). IVIg recipients
Normal immunoglobulin (Human) 12 % (120 g/L) - intravenous injection                 17 in the Sandoglobulin® lyophilised powder group. The mean age of patients       should be monitored for clinical signs and symptoms of haemolysis.
                                                                                     was 41 years (range 16-83) and about one-third were male. The dose of
DESCRIPTION                                                                          immunoglobulin was 400 mg/kg/day intravenously for up to 5 days. Patients         Thrombotic events have been reported in association with IVIg therapy.
Sandoglobulin® NF Liquid is a sterile, clear or slightly opalescent,                 were required to have a platelet count < 25 x 109/L on the day of screening.      Risk factors include advanced age, immobility, impaired cardiac output,
colourless or pale yellow solution of unmodified human immunoglobulin                The primary efficacy variable was platelet count response, defined as platelet    and conditions associated with increased plasma viscosity, such as
for intravenous injection.                                                           count ≥ 50 x 109/L within 29 days of the first dose of study medication.          hypertriglyceridaemia and monoclonal gammopathies.
                                                                                     Twelve (75 %) Sandoglobulin® NF Liquid patients responded, which was              An aseptic meningitis syndrome (AMS) has been reported to occur
Sandoglobulin® NF Liquid has a nominal osmolality of 360 mOsmol/kg and is
                                                                                     similar to the response in Sandoglobulin® lyophilised powder patients.            infrequently in association with IVIg treatment. The syndrome usually begins
approximately isotonic. The pH value of the ready-to-use solution is
5.3 and the solution contains no buffer substances. Sandoglobulin® NF Liquid         In an uncontrolled trial of Sandoglobulin NF Liquid in 6 children with acute
                                                                                                                               ®                                       within several hours to 2 days of treatment. It is characterised by symptoms
is supplied as a 50 mL or 100 mL solution containing 6 g or 12 g of human            ITP and platelet count ≤ 20 x 109/L, 4 children (67 %) achieved a platelet        and signs such as severe headache, nuchal rigidity, drowsiness, fever,
immunoglobulin respectively.                                                         count response. The response criterion was less rigid (platelet count ≥ 30 x      photophobia, painful eye movements, nausea and vomiting. Cerebrospinal
                                                                                     109/L within 5 days of the first dose of study medication) than that in the       fluid (CSF) frequently shows pleocystosis, predominantly granulocytic, and
The concentration of the active ingredient (unmodified immunoglobulin G                                                                                                elevated protein levels. Patients exhibiting such symptoms and signs should
                                                                                     previous trial. The mean age of patients was 5 years (range 4-7). The dose of
(IgG) of human origin) is 12 % (120 g/L). At least 96 % (typically 99 %) of                                                                                            receive a thorough neurological examination, including CSF studies, to rule
                                                                                     immunoglobulin was 400 mg/kg/day for up to 5 days.
the total protein is IgG (at least 90 % of it exists as monomers and dimers).                                                                                          out other causes of meningitis. AMS may occur more frequently with high
The product contains further small amounts of IgG fragments                          INDICATIONS                                                                       doses (2 g/kg) IVIg. Discontinuation of IVIg has resulted in remission of AMS
(≤ 10 %), aggregates (≤ 2 % - typically 0.5 %), albumin (≤ 3 %) and traces           Sandoglobulin® NF Liquid is indicated for replacement therapy in:                 within several days without sequalae.
of Immunoglobulin A (IgA) and Immunoglobulin M (IgM). The level of IgA in
the product is normally below 15 mg/L. The distribution of the IgG subclasses        • Primary immunodeficiency (PID) syndromes such as:                               Reactions to IVIg tend to be related to the infusion rate and are most likely
present in Sandoglobulin® NF Liquid closely resembles that in normal human             - congenital agammaglobulinaemia and hypogammaglobulinaemia                     to occur during the first hour of the infusion. It is recommended that the
plasma. The distribution of IgG subclasses present in Sandoglobulin® NF                                                                                                patient’s vital signs and general status are monitored regularly throughout
                                                                                       - common variable immunodeficiency
Liquid is, on the average, 64.5 % IgG1, 32.4 % IgG2, 2.3 % IgG3 and 0.8 %                                                                                              the infusion.
                                                                                       - severe combined immunodeficiency
IgG4. Prekallikrein activator (PKA) levels are less than 10 IU/mL.                                                                                                     Vitamin supplements containing high levels (≥ 250 mg) of niacin
                                                                                       - Wiskott-Aldrich syndrome                                                      (vitamin B3) or nicotinamide should not be taken at the time of
Sandoglobulin® NF Liquid contains the following stabilisers: proline,
isoleucine and nicotinamide.                                                         • Myeloma or chronic lymphocytic leukaemia with severe secondary                  administration of Sandoglobulin® NF Liquid or on the following day
                                                                                       hypogammaglobulinaemia and recurrent infections                                 because of the risk of adverse reactions including headache and nausea.
The stabilisers, in particular nicotinamide, minimise the formation of IgG           • Children with congenital Acquired Immunodeficiency Syndrome (AIDS) and
dimers, which is important for the tolerability of the product. The preparation                                                                                        No effects on the ability to drive and use machines have been observed.
                                                                                       recurrent infections.
contains traces of sodium chloride (≤ 10 mmol/L). Sandoglobulin® NF Liquid                                                                                             Pathogen Safety
contains no carbohydrates (for example sucrose or maltose) or antimicrobial          Sandoglobulin NF Liquid is indicated for immunomodulatory therapy in:
                                                                                                                                                                       This product is made from human plasma. Products made from human
preservatives.                                                                       • Idiopathic thrombocytopenic purpura (ITP) in children or adults at high         plasma may contain infectious agents, such as viruses and theoretically
PHARMACOLOGY                                                                            risk of bleeding or prior to surgery to correct the platelet count.            Creutzfeldt-Jacob Disease (CJD) agents that can cause disease. The risk
                                                                                     • Guillain-Barré Syndrome (GBS)                                                   that such products will transmit an infectious agent has been reduced by
Pharmacodynamic properties                                                           • Kawasaki Disease
                                                                                                                                                                       screening plasma donors for prior exposure to certain infectious agents and
Sandoglobulin® NF Liquid contains mainly IgG with a broad spectrum of                                                                                                  by testing for the presence of certain viral markers.
antibodies against infectious agents.                                                • Allogeneic bone marrow transplantation.
                                                                                                                                                                       In addition, virus removal and inactivation procedures are included in
Sandoglobulin® NF Liquid reflects the IgG antibodies present in the normal           CONTRAINDICATIONS                                                                 the manufacturing process. The current procedures applied in the
population. It is usually prepared from pooled plasma from not fewer than            Sandoglobulin NF Liquid is contraindicated in the following situations:
                                                                                                   ®                                                                   manufacture of this product are effective against enveloped viruses such
1000 donors. It has a distribution of IgG subclasses closely proportional to                                                                                           as human immunodeficiency virus (HIV), hepatitis B and hepatitis C viruses,
                                                                                     • Hypersensitivity to any of the components.                                      and against the non-enveloped hepatitis A virus. The measures taken may
that in native human plasma. Adequate doses of this medicinal product may
restore abnormally low IgG levels to the normal range. The mechanism of              • Hypersensitivity to homologous immunoglobulins, especially in very rare         be of limited value against other non-enveloped viruses such as parvovirus
action in indications other than replacement therapy is not fully elucidated,           cases of IgA deficiency when the patient has antibodies against IgA.           B19. However, the product contains specific antibodies directed against
but includes immunomodulatory effects.                                               • Sandoglobulin® NF Liquid contains the excipients isoleucine and proline         parvovirus B19.
Nicotinamide has been included in Sandoglobulin® NF Liquid as a stabiliser              and is contraindicated in patients with maple syrup urine disease (MSUD)       There is a reassuring clinical experience regarding the lack of hepatitis A
to help prevent IgG dimerisation. It may have pharmacological activity. It is a         and hyperprolinaemia.                                                          or parvovirus B19 transmission with immunoglobulins possibly because
water-soluble vitamin and a constituent of the normal human body, essential                                                                                            antibodies against these infections are contained in the product and are
in preventing pellagra at low doses. There is no known contraindication.             PRECAUTIONS                                                                       protective.
Higher serum levels of nicotinamide, such as those achieved with maximum             Certain adverse reactions may occur more frequently
doses of Sandoglobulin® NF Liquid, may be associated with adverse effects            • in the case of high rate of infusion,                                           Despite these measures, such products may still potentially transmit disease.
including headache and nausea.                                                                                                                                         There is also the possibility that other known or unknown infectious agents
                                                                                     • in patients with hypogammaglobulinaemia or agammaglobulinaemia                  may be present in such products.
Pharmacokinetic properties                                                               with or without IgA deficiency,
                                                                                                                                                                       Vaccination for patients in receipt of medicinal products from human plasma
Human normal immunoglobulin is immediately and completely bioavailable               • in patients who receive intravenous immunoglobulin (IVIg) for the first         should be considered where appropriate.
in the recipient’s circulation after intravenous administration. It is distributed       time or, in rare cases, when the human normal immunoglobulin product
relatively rapidly between plasma and extravascular fluid, after approximately           is switched or when there has been a long interval since the previous         Effects on fertility
3-5 days equilibrium is reached between the intra- and extravascular                     infusion.                                                                     No fertility studies have been conducted in animals on Sandoglobulin® NF
compartments.                                                                                                                                                          Liquid or any of its components.
                                                                                     True hypersensitivity reactions are rare. They can occur in the very rare cases
Sandoglobulin NF Liquid has a half-life of about 17.6 ± 8.5 days in healthy
                                                                                     of IgA deficiency with anti-IgA antibodies.
adults. In a controlled Primary Immuno-deficiency (PID) study (n = 17)                                                                                                 Use in pregnancy
comparing Sandoglobulin® NF Liquid with the lyophilised Sandoglobulin®               Rarely, human normal immunoglobulin can induce a fall in blood pressure           Animal reproduction studies have not been conducted with Sandoglobulin®
preparation using a dose of 0.3-0.8 g/kg body weight IgG per month,                  with anaphylactic reaction, even in patients who had tolerated previous           NF Liquid. It is also not known whether Sandoglobulin® NF Liquid can cause
comparable median half-lives were obtained: 34 days versus 41.5 days                 treatment with human normal immunoglobulin.                                       foetal harm when administered to pregnant women, or whether it can affect
respectively. These results are also comparable with published data. Half-life                                                                                         reproductive capacity. Sandoglobulin® NF Liquid should be given with caution
                                                                                     In a clinical study in paediatric patients with acute ITP, a transient            to a pregnant woman only if clearly indicated.
may vary from patient to patient, in particular in primary immunodeficiency.         slight-to-moderate decrease in Haemoglobin (Hb) levels has been observed in
IgG and IgG-complexes are broken down in cells of the reticuloendothelial            some children after administration of Sandoglobulin® NF Liquid.                   There was no evidence of a teratogenic effect of the excipients (nicotinamide,
system.                                                                              It was most likely caused by the underlying disease, by a dilution effect         isoleucine and proline) when administered to pregnant rats over the period
                                                                                     and/or by repeated blood sampling. In these patients, a follow-up of Hb is        of organogenesis at daily exposures (based on plasma Cmax values) of about
The nicotinamide component reached a mean serum concentration of                     recommended (see ADVERSE EFFECTS).                                                2.2, 0.7 and 0.9 times, respectively, that are expected in patients given the
0.64 mmol/L after an infusion of 1 g/kg body weight of Sandoglobulin® NF                                                                                               maximum recommended dose of Sandoglobulin® NF Liquid.
Liquid. Nicotinamide is mainly cleared by metabolism, with about 50 % to             Cases of acute renal failure have been reported in patients receiving IVIg
1-methyl-nicotinamide and 30 % to nicotinamide-N-oxide. Clearance is about           therapy. In most cases, risk factors have been identified, such as pre-existing   Use in lactation
1.5 mL/min/kg and half-life 9 h.                                                     renal insufficiency, diabetes mellitus, hypovolaemia, overweight, concomitant     Immunoglobulins are excreted into breast milk. Due to the level of
                                                                                     nephrotoxic medicinal products or age over 65 years.                              nicotinamide in Sandoglobulin® NF Liquid and because nicotinamide may
CLINICAL TRIALS                                                                                                                                                        be excreted in breast milk women should discontinue breast-feeding during
                                                                                     In case of renal insufficiency, IVIg discontinuation should be considered.
In primary immunodeficiency (PID) of X-linked agammaglobulinaemia,                                                                                                     treatment.
                                                                                     While these reports of renal dysfunction and acute renal failure have
common variable immunodeficiency or IgG subclass deficiency,
Sandoglobulin® NF Liquid was compared with Sandoglobulin® lyophilised                been associated with the use of many of the licensed IVIg products, those         Paediatric use
powder in a randomised trial over 6 months. There were 17 patients in each           containing sucrose as a stabiliser accounted for a disproportionate share
                                                                                                                                                                       Sandoglobulin® NF Liquid has been used in a small number of paediatric
group. The mean age of patients was 30 years (range 12-59) and about half            of the total number. In patients at risk, the use of IVIg products that do
                                                                                                                                                                       patients with PID (children n = 8, adolescents n = 8) and ITP (children n = 6).
were male. The dose of immunoglobulin was 300-800 mg/kg per month                    not contain sucrose may be considered. In addition, the product should be
                                                                                                                                                                       The safety and efficacy of Sandoglobulin® NF Liquid has not been established
intravenously at 2-4 week intervals. The dose was titrated to achieve a trough       administered at the minimum concentration and infusion-rate practicable.
                                                                                                                                                                       in children under 4 years of age.
serum IgG concentration of 4-6 g/L. Median days absent from school or                Sandoglobulin® NF Liquid contains no carbohydrates like sucrose or maltose.
work or unable to perform normal activities due to PID, the primary efficacy                                                                                           In paediatric patients with ITP the most frequent adverse events (AEs) were in
                                                                                     IVIg products can contain blood group antibodies which may act as
variable, was 0.3 (range 0-3.7) in the Sandoglobulin® NF Liquid group which                                                                                            the same body systems as in adults with ITP. However, there is evidence of an
                                                                                     haemolysins and induce in vivo coating of red blood cells (RBC) with
was similar to that in the Sandoglobulin® lyophilised powder group.                                                                                                    increase in frequency of gastrointestinal AEs in children compared to adults.
Use in the elderly                                                                                                                                                    licensed IVIg products, those containing sucrose as a stabiliser accounted for
Clinical studies of Sandoglobulin® NF Liquid did not include sufficient             Skin and                     Sweating Increase                                    a disproportionate share of the total number. In patients at risk, the use of
numbers of subjects aged 65 and over to determine whether they respond              Subcutaneous                                                                      IVIg products that do not contain sucrose may be considered. In addition, the
differently from younger subjects.                                                  Tissue Disorders                                                                  product should be administered at the minimum concentration and infusion-
                                                                                                                                                                      rate practicable. Sandoglobulin® NF Liquid contains no carbohydrates like
Sandoglobulin® NF Liquid should be used with caution in patients over               Musculoskeletal              Arthralgia              Arthralgia (common)          sucrose or maltose.
65 years of age and judged to be at increased risk of developing renal              and Connective               Back pain               Back pain (common)
insufficiency.                                                                      Tissue Disorders                                                                  Administration
                                                                                                                                                                      Patients naïve to human normal immunoglobulin, patients switched from an
Carcinogenicity                                                                                                                                                       alternative IVIg product or patients who have not received IVIg for a long
No carcinogenicity studies have been conducted with Sandoglobulin® NF                                                                                                 time should have vital signs and general status monitored regularly during
Liquid.                                                                             General and                  Fever                   Fever (common)               and for the first hour after the first infusion.
                                                                                    Administration Site          Rigors                  Chills (common)
Genotoxicity                                                                        Conditions                                                                        In all patients, IVIg administration requires:
No genotoxicity studies have been conducted with Sandoglobulin NF  ®                                             Fatigue
                                                                                                                 Influenza-like                                       • adequate hydration prior to the initiation of the infusion of IVIg,
Liquid. Genotoxicity assays are not required for plasma products such as
immunoglobulins. The excipients (nicotinamide, proline and isoleucine)                                           symptoms                                             • monitoring of urine output,
were not genotoxic in a standard array of genotoxicity tests.                                                    Malaise                                              • monitoring of serum creatinine levels,
Interactions with other medicines                                                                                Injection site                                       • avoidance of concomitant use of loop diuretics,
Live attenuated virus vaccines                                                                                                                                        • monitoring during infusion and for at least 20 minutes after infusion.
Immunoglobulin administration may impair the efficacy of live attenuated          Common: >1/100, < 1/10                                                              The recommended infusion rate given under DOSAGE AND
virus vaccines such as measles, mumps, rubella and varicella for a period of at                                                                                       ADMINISTRATION must be closely followed.
                                                                                  Rarely human normal immunoglobulins may cause a sudden fall in blood
least 6 weeks and up to 3 months. After administration of this product,
                                                                                  pressure and, in isolated cases, anaphylactic shock, even when the patient          Rapid infusion of Sandoglobulin® NF Liquid may cause adverse reactions.
an interval of 3 months should elapse before vaccination with live attenuated
                                                                                  has shown no hypersensitivity to previous administration.                           Reactions are most likely to occur during the first hour of the infusion.
virus vaccines. In the case of measles, this impairment may persist for up to
1 year. Therefore patients receiving measles vaccine should have their            Cases of reversible aseptic meningitis, isolated cases of reversible haemolytic     In case of adverse reaction, either the rate of administration must be reduced
antibody status checked.                                                          anaemia/haemolysis and rare cases of transient cutaneous reactions have             or the infusion stopped. The treatment required depends on the nature and
                                                                                  been observed with human normal immunoglobulin.                                     severity of the side effect.
Drug interactions
Patients treated with phenytoin concomitantly should be carefully monitored,      An increase in serum creatinine level and/or acute renal failure has been           In case of shock, the current medical standards for shock treatment should
as there has been a published report of hepatic toxicity with concurrent          observed with IVIg treatment.                                                       be observed.
administration of nicotinamide and phenytoin.                                     Very rarely: Thromboembolic reactions such as myocardial infarction, stroke,        Allow the product to reach room temperature before use. Do not shake.
                                                                                  pulmonary embolism, deep vein thrombosis.                                           Inspect the solution for particulate matter, turbidity and discolouration.
Nicotinamide may also interact with the metabolism of primidone and
carbamazepine.                                                                    DOSAGE AND ADMINISTRATION                                                           The solution should be clear or slightly opalescent. Slight yellow
                                                                                                                                                                      discolouration is of no concern and can be disregarded. Do not use if turbid.
It is possible that the hepatotoxic potential of alcohol is exacerbated by                                                                                            Do not mix other medicinal products in the same infusion line.
nicotinamide. It is recommended that patients limit their alcohol intake during   Dosage
treatment with Sandoglobulin® NF Liquid and on the following day.                 Sandoglobulin® NF Liquid replaces missing IgG antibodies in primary and             Each bottle of Sandoglobulin® NF Liquid is for use in one patient on one
                                                                                  secondary immunodeficiency syndromes and corrects functional disturbance            occasion only. It should be used immediately on opening and any unused
Formal interaction studies of nicotinamide with cardiac drugs such as             of the immune system e.g. in autoimmune diseases. The dose and dosage               product discarded in accordance with local requirements. It is strongly
ß-blockers and vasodilators have not been performed.                              regimen is dependent on the indication.                                             recommended that every time Sandoglobulin® NF Liquid is administered to a
Effect on laboratory tests                                                        The daily dose should not exceed 1 g/kg body weight.                                patient, the name and batch number of the product be recorded in order to
                                                                                                                                                                      maintain a link between the patient and the batch of the product.
Interference with serological testing                                             The dosage recommendations are summarised in the following table:
After injection of immunoglobulin the transitory rise of the various passively                                                                                        OVERDOSAGE
transferred antibodies in the patients blood may result in misleading positive                                                                                        Overdose may lead to fluid overload and hyperviscosity, particularly in
                                                                                    Indication                 Dose                        Frequency of
results in serological testing.                                                                                                                                       patients at risk, including elderly patients or patients with renal insufficiency.
Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D                                                                                              PRESENTATION AND STORAGE CONDITIONS
may interfere with some serological tests for red cell allo-antibodies              Replacement therapy:                                                              Sandoglobulin® NF Liquid is presented as a 12 % (120 g/L) solution for
(e.g. Coombs test).                                                                                                                                                   intravenous injection. The solution is dispensed into a clear glass bottle and
                                                                                    - Primary                  Starting dose: 0.4          every 2 to 4 weeks         closed with a rubber stopper and aluminium crimp cap, with a plastic flip-off
ADVERSE EFFECTS                                                                       immunodeficiency*        to 0.8 g/kg body            to obtain IgG trough       disk providing a tamper-evident seal.
Immunoglobulins have a well-established history of safety and efficacy in                                      weight                      level of at least 4
humans. The antibodies contained in Sandoglobulin® NF Liquid, representing                                     thereafter: 0.2 to 0.8      to 6 g/L                   The product is supplied in the following pack sizes:
endogenous IgG, are natural components of the human body and can                                               g/kg body weight                                       Sandoglobulin® NF Liquid 6 g: 50 mL solution in a 50 mL bottle
therefore be considered non-toxic.                                                                                                                                    Sandoglobulin® NF Liquid 12 g: 100 mL solution in a 100 mL bottle
The pharmacology, pharmacokinetics and toxicology of the excipient mixture          - Secondary                0.2 to 0.4 g/kg body        every 3 to 4 weeks
                                                                                      immunodeficiency         weight                      to obtain IgG trough       Store at +2 °C to +8 °C (Refrigerate. Do not freeze). Do not shake. Keep the
containing nicotinamide, isoleucine and proline were investigated with in                                                                                             vial in the outer carton in order to protect from light.
                                                                                                                                           level of at least 4
vitro and in vivo studies. The excipient mixture was generally well tolerated.
                                                                                                                                           to 6 g/L
                                                                                                                                                                      Shelf-life after first opening:
Adverse reactions from the PID and ITP trials and post marketing
experience, which have been identified to be at least possibly related to           - Children with AIDS       0.2 to 0.4 g/kg             every 3 to 4 weeks         Sandoglobulin® NF Liquid contains no antimicrobial preservative. The product
Sandoglobulin® NF Liquid are tabulated below. The studies were not powered                                     body weight                                            should be used immediately on opening and any unused portion discarded
to calculate or estimate frequencies of the reactions.                                                                                                                appropriately.
                                                                                    Immunomodulatory therapy:                                                         Do not use after the expiry date.
  System Organ Class              Adverse reaction Preferred Terms                  - Idiopathic               0.8 to 1 g/kg body          on day 1, possibly         NAME AND ADDRESS OF THE SPONSOR
                                                                                      Thrombocytopenic         weight                      repeated once within       CSL Limited ABN 99 051 588 348
                                                                                      Purpura                  or                          3 days                     Bioplasma Division
                              PID and ITP            Post marketing                                            0.4 g/kg body               for 2 to 5 days            189 - 209 Camp Road
                              Trials                 (Frequency)                                               weight /d                                              Broadmeadows VIC 3047
  Infection and               Pharyngitis                                           - Guillain-Barré           0.4 g/kg                    for 3 to 7 days
  Infestations                Rhinitis                                                Syndrome                 body weight /d                                         POISON SCHEDULE OF THE MEDICINE
  Blood and                   Leucopenia                                            - Kawasaki Disease         1.6 to 2 g/kg               in divided doses
                                                                                                               body weight                 over 2 to 5 days in        DATE OF APPROVAL
  Lymphatic System                                                                                                                                                    Approved by the Therapeutic Goods Administration on 31 August 2006
  Disorders                                                                                                                                association with
                                                                                                                                           acetylsalicylic acid       Date of last amendment: 07 December 2007
  Immune System               Aseptic                Allergic Reactions                                                                                               ®
                                                                                                                                                                          Registered trademark of Novartis AG, used under licence.
  Disorders                   Meningitis             (common)                       Allogeneic bone marrow transplantation:

                                                                                    - treatment of             0.5 g/kg body weight        every week from
  Psychiatric                 Nervousness                                             infections and                                       7 days before to
  Disorders                                                                           prophylaxis of graft                                 (up to) 3 months
                                                                                      versus host disease                                  after transplantation
  Nervous System              Headache               Headache (common)
  Disorders                                                                         - persistent lack of       0.5 g/kg body weight        every month until
                              Dizziness                                               antibody production                                  antibody levels return
                              Paraesthesiae                                                                                                to normal
                                                                                  *In replacement therapy the dosage may need to be individualised for each
  Eye Disorders               Conjunctivitis                                      patient dependent on the pharmacokinetic and clinical response
                                                                                  In patients not previously exposed to IVIg, Sandoglobulin® NF Liquid should
  Vascular Disorders          Hypertension           Low Blood Pressure           be infused at an initial rate of 0.3 mL/kg/h for 1 h. If well tolerated, the rate
                              Hypotension            (common)                     may be gradually increased to a maximum of 1 mL/kg/h.
                              postural                                            In patients who have been previously exposed to IVIg, Sandoglobulin® NF
                              Haematoma                                           Liquid should be infused at an initial rate of 0.5 mL/kg/h for 30 minutes. If
                              Flushing                                            well tolerated, the rate may be gradually increased to a maximum of                 CSL Limited, Bioplasma Division, 189-209 Camp Road Broadmeadows Victoria Australia 3047
                                                                                  1 mL/kg/h.                                                                                                              ABN 99 051 588 348
  Gastrointestinal            Abdominal pain         Abdominal pain                                                                                                                                Internet:
  Disorders                                          (common)                     Dosage adjustment in renal insufficiency
                              Nausea                                              In case of renal insufficiency, IVIg discontinuation should be considered.          For Medical/technical inquiries: 1800 067 140 For Customer Service inquiries: 1800 063 892
                              Vomiting               Nausea (common)                                                                                                  Email: Email: bioplasma.customer
                                                                                  While reports of renal dysfunction and acute renal failure
                                                     Vomiting (common)            (see PRECAUTIONS) have been associated with the use of many of the                                              Version: PI 2:00 CSL Bioplasma 969

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