HBVaxPro · 4.6 Fertility, pregnancy and lactation · 5

HOS-093132 · has-adverse-reaction-information · PDF-Seite 13

a. Summary of the safety profile The most common side effects seen are injection-site reactions: transient soreness, erythema, induration. b. Tabulated summary of adverse reactions The following undesirable effects have been reported following the widespread use of the vaccine. As with other hepatitis B vaccines, in many instances, the causal relationship to the vaccine has not been established. 13  Adverse reactions Frequency General disorders and administration site conditions Common Local reactions (injection site): Transient soreness, Erythema, Induration (≥1/100 to, <1/10) Fatigue, Fever, Malaise, Influenza-like symptoms Very rare (<1/10,000) Blood and the lymphatic system disorders Thrombocytopaenia, Lymphadenopathy Very rare (<1/10,000) Immune system disorders Serum sickness, Anaphylaxis, Polyarteritis nodosa Very rare (<1/10,000) Nervous system disorders Paresthesia, Paralysis (including Bell's palsy, facial paralysis), Peripheral neuropathies (polyradiculoneuritis, Guillain Barre Syndrome), Neuritis (including optical neuritis), Myelitis (including transverse Myelitis), Very rare (<1/10,000) Encephalitis, Demyelinating disease of the central nervous system, Exacerbation of multiple sclerosis, Multiple sclerosis, Seizure, Headache, Dizziness, Syncope Eye disorders Uveitis Very rare (<1/10,000) Vascular disorders Hypotension, Vasculitis Very rare (<1/10,000) Respiratory, thoracic and mediastinal disorders Bronchospasm-like symptoms Very rare (<1/10,000) Gastrointestinal disorders Vomiting, Nausea, Diarrhoea, Abdominal pain Very rare (<1/10,000) Skin and subcutaneous tissue disorders Rash, Alopecia, Pruritus, Urticaria, Erythema multiforme, Angioedema,

Auszug; vollständigen Abschnitt im Original lesen.

HOS-093138 · has-adverse-reaction-information · PDF-Seite 21

a. Summary of the safety profile The most common side effects seen are injection-site reactions: transient soreness, erythema, induration. b. Tabulated summary of adverse reactions The following undesirable effects have been reported following the widespread use of the vaccine. As with other hepatitis B vaccines, in many instances, the causal relationship to the vaccine has not been established. 21  Adverse reactions Frequency General disorders and administration site conditions Common Local reactions (injection site): Transient soreness, Erythema, Induration (≥1/100 to, <1/10) Fatigue, Fever, Malaise, Influenza-like symptoms Very rare (<1/10,000) Blood and the lymphatic system disorders Thrombocytopaenia, Lymphadenopathy Very rare (<1/10,000) Immune system disorders Serum sickness, Anaphylaxis, Polyarteritis nodosa Very rare (<1/10,000) Nervous system disorders Paresthesia, Paralysis (including Bell's palsy, facial paralysis), Peripheral neuropathies (polyradiculoneuritis, Guillain Barre Syndrome), Neuritis (including optical neuritis), Myelitis (including transverse Myelitis), Very rare (<1/10,000) Encephalitis, Demyelinating disease of the central nervous system, Exacerbation of multiple sclerosis, Multiple sclerosis, Seizure, Headache, Dizziness, Syncope Eye disorders Uveitis Very rare (<1/10,000) Vascular disorders Hypotension, Vasculitis Very rare (<1/10,000) Respiratory, thoracic and mediastinal disorders Bronchospasm-like symptoms Very rare (<1/10,000) Gastrointestinal disorders Vomiting, Nausea, Diarrhoea, Abdominal pain Very rare (<1/10,000) Skin and subcutaneous tissue disorders Rash, Alopecia, Pruritus, Urticaria, Erythema multiforme, Angioedema, Very rare (<1/10

Auszug; vollständigen Abschnitt im Original lesen.

HOS-093126 · has-adverse-reaction-information · PDF-Seite 5

a. Summary of the safety profile The most common side effects seen are injection-site reactions: transient soreness, erythema, induration. b. Tabulated summary of adverse reactions The following undesirable effects have been reported following the widespread use of the vaccine. As with other hepatitis B vaccines, in many instances, the causal relationship to the vaccine has not been established. 5  Adverse reactions Frequency General disorders and administration site conditions Common Local reactions (injection site): Transient soreness, Erythema, Induration (≥1/100 to, <1/10) Fatigue, Fever, Malaise, Influenza-like symptoms Very rare (<1/10,000) Blood and the lymphatic system disorders Thrombocytopaenia, Lymphadenopathy Very rare (<1/10,000) Immune system disorders Serum sickness, Anaphylaxis, Polyarteritis nodosa Very rare (<1/10,000) Nervous system disorders Paresthesia, Paralysis (including Bell's palsy, facial paralysis), Peripheral neuropathies (polyradiculoneuritis, Guillain Barre Syndrome), Neuritis (including optical neuritis), Myelitis (including transverse Myelitis), Very rare (<1/10,000) Encephalitis, Demyelinating disease of the central nervous system, Exacerbation of multiple sclerosis, Multiple sclerosis, Seizure, Headache, Dizziness, Syncope Eye Disorders Uveitis Very rare (<1/10,000) Vascular disorders Hypotension, Vasculitis Very rare (<1/10,000) Respiratory, thoracic and mediastinal disorders Bronchospasm-like symptoms Very rare (<1/10,000) Gastrointestinal disorders Vomiting, Nausea, Diarrhoea, Abdominal pain Very rare (<1/10,000) Skin and subcutaneous tissue disorders Rash, Alopecia, Pruritus, Urticaria, Erythema multiforme, Angioedema, Eczema Very rare (<1/10,000) Musculoskeletal, connective tissue and bone disorders Arthralgia, Arthritis, Myalgia, Pain in ex

Auszug; vollständigen Abschnitt im Original lesen.

HOS-093150 · has-adverse-reaction-information · PDF-Seite 36

a. Summary of the safety profile The most common side effects seen are injection-site reactions: transient soreness, erythema, induration. 36 b. Tabulated summary of adverse reactions The following undesirable effects have been reported following the widespread use of the vaccine. As with other hepatitis B vaccines, in many instances, the causal relationship to the vaccine has not been established. Adverse reactions Frequency General disorders and administration site conditions Common Local reactions (injection site): Transient soreness, Erythema, Induration (≥1/100 to, <1/10) Fatigue, Fever, Malaise, Influenza-like symptoms Very rare (<1/10,000) Blood and the lymphatic system disorders Thrombocytopaenia, Lymphadenopathy Very rare (<1/10,000) Immune system disorders Serum sickness, Anaphylaxis, Polyarteritis nodosa Very rare (<1/10,000) Nervous system disorders Paresthesia, Paralysis (including Bell's palsy, facial paralysis), Peripheral neuropathies (polyradiculoneuritis, Guillain Barre Syndrome), Neuritis (including optical neuritis), Myelitis (including transverse Myelitis), Very rare (<1/10,000) Encephalitis, Demyelinating disease of the central nervous system, Exacerbation of multiple sclerosis, Multiple sclerosis, Seizure, Headache, Dizziness, Syncope Eye Disorders Uveitis Very rare (<1/10,000) Vascular disorders Hypotension, Vasculitis Very rare (<1/10,000) Respiratory, thoracic and mediastinal disorders Bronchospasm-like symptoms Very rare (<1/10,000) Gastrointestinal disorders Vomiting, Nausea, Diarrhoea, Abdominal pain Very rare (<1/10,000) Skin and subcutaneous tissue disorders Rash, Alopecia, Pruritus, Urticaria, Erythema multiforme, Angioedema,

Auszug; vollständigen Abschnitt im Original lesen.

HOS-093144 · has-adverse-reaction-information · PDF-Seite 29

a. Summary of the safety profile The most common side effects seen are injection-site reactions: transient soreness, erythema, induration. b. Tabulated summary of adverse reactions The following undesirable effects have been reported following the widespread use of the vaccine. As with other hepatitis B vaccines, in many instances, the causal relationship to the vaccine has not been established. 29  Adverse reactions Frequency General disorders and administration site conditions Common Local reactions (injection site): Transient soreness, Erythema, Induration (≥1/100 to, <1/10) Fatigue, Fever, Malaise, Influenza-like symptoms Very rare (<1/10,000) Blood and the lymphatic system disorders Thrombocytopaenia, Lymphadenopathy Very rare (<1/10,000) Immune system disorders Serum sickness, Anaphylaxis, Polyarteritis nodosa Very rare (<1/10,000) Nervous system disorders Paresthesia, Paralysis (including Bell's palsy, facial paralysis), Peripheral neuropathies (polyradiculoneuritis, Guillain Barre Syndrome), Neuritis (including optical neuritis), Myelitis (including transverse Myelitis), Very rare (<1/10,000) Encephalitis, Demyelinating disease of the central nervous system, Exacerbation of multiple sclerosis, Multiple sclerosis, Seizure, Headache, Dizziness, Syncope Eye disorders Uveitis Very rare (<1/10,000) Vascular disorders Hypotension, Vasculitis Very rare (<1/10,000) Respiratory, thoracic and mediastinal disorders Bronchospasm-like symptoms Very rare (<1/10,000) Gastrointestinal disorders Vomiting, Nausea, Diarrhoea, Abdominal pain Very rare (<1/10,000) Skin and subcutaneous tissue disorders Rash, Alopecia, Pruritus, Urticaria, Erythema multiforme, Angioedema, Very rare (<1/10

Auszug; vollständigen Abschnitt im Original lesen.

HOS-093140 · has-contraindication-information · PDF-Seite 28

- History of hypersensitivity to the active substance, or to any of the excipients, or trace residuals (e.g. formaldehyde and potassium thiocyanate), see sections 6.1 and 6.2. - Vaccination should be postponed in individuals with a severe febrile illness or acute infection.

HOS-093128 · has-contraindication-information · PDF-Seite 12

- History of hypersensitivity to the active substance, or to any of the excipients, or trace residuals (e.g. formaldehyde and potassium thiocyanate), see sections 6.1 and 6.2. - Vaccination should be postponed in individuals with a severe febrile illness or acute infection.

HOS-093134 · has-contraindication-information · PDF-Seite 20

- History of hypersensitivity to the active substance, or to any of the excipients, or trace residuals (e.g. formaldehyde and potassium thiocyanate), see sections 6.1 and 6.2. - Vaccination should be postponed in individuals with a severe febrile illness or acute infection.

HOS-093122 · has-contraindication-information · PDF-Seite 4

- History of hypersensitivity to the active substance, or to any of the excipients, or trace residuals (e.g. formaldehyde and potassium thiocyanate), see sections 6.1 and 6.2. - Vaccination should be postponed in individuals with a severe febrile illness or acute infection.

HOS-093146 · has-contraindication-information · PDF-Seite 35

- History of hypersensitivity to the active substance, or to any of the excipients, or trace residuals (e.g. formaldehyde and potassium thiocyanate), see sections 6.1 and 6.2. - Vaccination should be postponed in individuals with a severe febrile illness or acute infection.

HOS-093121 · has-indication-information · PDF-Seite 2

HBVAXPRO is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis B virus. The specific at risk categories to be immunised are to be determined on the basis of the official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

HOS-093127 · has-indication-information · PDF-Seite 10

HBVAXPRO is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis B virus. The specific at risk categories to be immunised are to be determined on the basis of the official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

HOS-093133 · has-indication-information · PDF-Seite 18

HBVAXPRO is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis B virus. The specific at risk categories to be immunised are to be determined on the basis of the official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

HOS-093139 · has-indication-information · PDF-Seite 26

HBVAXPRO is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis B virus. The specific at risk categories to be immunised are to be determined on the basis of the official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

HOS-093145 · has-indication-information · PDF-Seite 34

HBVAXPRO is indicated for the active immunisation against hepatitis B virus infection caused by all known subtypes in predialysis and dialysis adult patients. It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

HOS-093148 · has-interaction-information · PDF-Seite 36

This vaccine can be administered: - with hepatitis B immunoglobulin, at a separate injection site. - to complete a primary immunisation course or as a booster dose in subjects who have previously received another hepatitis B vaccine. - concomitantly with other vaccines, using separate sites and syringes.

HOS-093136 · has-interaction-information · PDF-Seite 21

This vaccine can be administered: - with hepatitis B immunoglobulin, at a separate injection site. - to complete a primary immunisation course or as a booster dose in subjects who have previously received another hepatitis B vaccine. - concomitantly with other vaccines, using separate sites and syringes.

HOS-093130 · has-interaction-information · PDF-Seite 13

This vaccine can be administered: - with hepatitis B immunoglobulin, at a separate injection site. - to complete a primary immunisation course or as a booster dose in subjects who have previously received another hepatitis B vaccine. - concomitantly with other vaccines, using separate sites and syringes. The concomitant administration of pneumococcal conjugate vaccine (PREVENAR) given with hepatitis B vaccine using the 0, 1 and 6 and 0, 1, 2 and 12 month schedules has not been sufficiently studied.

HOS-093124 · has-interaction-information · PDF-Seite 5

This vaccine can be administered: - with hepatitis B immunoglobulin, at a separate injection site. - to complete a primary immunisation course or as a booster dose in subjects who have previously received another hepatitis B vaccine. - concomitantly with other vaccines, using separate sites and syringes. The concomitant administration of pneumococcal conjugate vaccine (PREVENAR) given with hepatitis B vaccine using the 0, 1 and 6 and 0, 1, 2 and 12 month schedules has not been sufficiently studied.

HOS-093142 · has-interaction-information · PDF-Seite 29

This vaccine can be administered: - with hepatitis B immunoglobulin, at a separate injection site. - to complete a primary immunisation course or as a booster dose in subjects who have previously received another hepatitis B vaccine. - concomitantly with other vaccines, using separate sites and syringes.

HOS-093143 · has-pregnancy-information · PDF-Seite 29

Fertility: HBVAXPRO has not been evaluated in fertility studies. Pregnancy: There is no clinical data on the use of HBVAXPRO on pregnant women. The vaccine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Breast-feeding: There is no clinical data on the use of HBVAXPRO on breast-feeding women.

HOS-093137 · has-pregnancy-information · PDF-Seite 21

Fertility: HBVAXPRO has not been evaluated in fertility studies. Pregnancy: There is no clinical data on the use of HBVAXPRO in pregnant women The vaccine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Breast-feeding: There is no clinical data on the use of HBVAXPRO on breast-feeding women.

HOS-093149 · has-pregnancy-information · PDF-Seite 36

Fertility: HBVAXPRO has not been evaluated in fertility studies. Pregnancy: There is no clinical data on the use of HBVAXPRO on pregnant women. The vaccine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Breast-feeding: There is no clinical data on the use of HBVAXPRO on breast-feeding women.

HOS-093125 · has-pregnancy-information · PDF-Seite 5

Fertility: HBVAXPRO has not been evaluated in fertility studies. Pregnancy: There is no clinical data on the use of HBVAXPRO on pregnant women. The vaccine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Breast-feeding: There is no clinical data on the use of HBVAXPRO on breast-feeding women.

HOS-093131 · has-pregnancy-information · PDF-Seite 13

Fertility: HBVAXPRO has not been evaluated in fertility studies. Pregnancy: There is no clinical data on the use of HBVAXPRO on pregnant women. The vaccine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Breast-feeding: There is no clinical data on the use of HBVAXPRO on breast-feeding women.

HOS-093141 · has-warning-information · PDF-Seite 28

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine (see section 4.8). This vaccine may contain traces of formaldehyde and potassium thiocyanate which are used during the manufacturing process. Therefore, hypersensitivity reactions may occur (see sections 2 and 4.8). Use caution when vaccinating latex-sensitive individuals since the syringe plunger stopper and tip cap contain dry natural latex rubber that may cause allergic reactions. For clinical or laboratory monitoring regarding immunocompromised individuals or individuals with known or presumed exposure to hepatitis B virus, see section 4.2. A number of factors have been observed to reduce the immune response to hepatitis B vaccines. These factors include older age, male gender, obesity, smoking, route of administration and some chronic underlying diseases. Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of HBVAXPRO. Additional doses may need to be considered for persons who do not respond or have a sub-optimal response to a course of vaccinations. Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination. The vaccine may not prevent hepatitis B infection in such cases. The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E and other pathogens known to infect the liver. Caution should be exercised when prescribing to pregnant or breast-feeding women (see section 4.6). Excipient(s) with known effect: 28 This medicinal product contains less than 1mmol sodium (23 mg) per dose, and is considered to be essentially sodium free.

HOS-093123 · has-warning-information · PDF-Seite 4

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine (see section 4.8). This vaccine may contain traces of formaldehyde and potassium thiocyanate, which are used during the manufacturing process. Therefore, hypersensitivity reactions may occur (see sections 2 and 4.8). Use caution when vaccinating latex-sensitive individuals since the vial stopper contains dry natural latex rubber that may cause allergic reactions. For clinical or laboratory monitoring regarding immunocompromised individuals or individuals with known or presumed exposure to hepatitis B virus, see section 4.2. The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity (see section 4.8). As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed. Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination. The vaccine may not prevent hepatitis B infection in such cases. The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E and other pathogens known to infect the liver. 4 Caution should be exercised when prescribing to pregnant or breast-feeding women (see section 4.6). Excipient(s) with known effect: This medicinal product contains less than 1mmol sodium (23 mg) per dose, and is considered to be essentially sodium free.

HOS-093147 · has-warning-information · PDF-Seite 35

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine (see section 4.8). This vaccine may contain traces of formaldehyde and potassium thiocyanate which are used during the manufacturing process. Therefore, hypersensitivity reactions may occur (see sections 2 and 4.8). Use caution when vaccinating latex-sensitive individuals since the vial stopper contains dry natural latex rubber that may cause allergic reactions. 35 A number of factors have been observed to reduce the immune response to hepatitis B vaccines. These factors include older age, male gender, obesity, smoking, route of administration and some chronic underlying diseases. Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of HBVAXPRO. Additional doses may need to be considered for persons who do not respond or have a sub-optimal response to a course of vaccinations. Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination. The vaccine may not prevent hepatitis B infection in such cases. The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E and other pathogens known to infect the liver. Caution should be exercised when prescribing to pregnant or breast-feeding women (see section 4.6). Excipient(s) with known effect: This medicinal product contains less than 1mmol sodium (23 mg) per dose, and is considered to be essentially sodium free.

HOS-093129 · has-warning-information · PDF-Seite 12

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine (see section 4.8). This vaccine may contain traces of formaldehyde and potassium thiocyanate which are used during the manufacturing process. Therefore, hypersensitivity reactions may occur (see sections 2 and 4.8). Use caution when vaccinating latex-sensitive individuals since the syringe plunger stopper and tip cap contain dry natural latex rubber that may cause allergic reactions. For clinical or laboratory monitoring regarding immunocompromised individuals or individuals with known or presumed exposure to hepatitis B virus, see section 4.2. The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity (see section 4.8). As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed. Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination. The vaccine may not prevent hepatitis B infection in such cases. 12 The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E and other pathogens known to infect the liver. Caution should be exercised when prescribing to pregnant or breast-feeding women (see section 4.6). Excipient(s) with known effect: This medicinal product contains less than 1mmol sodium (23 mg) per dose, and is considered to be essentially sodium free.

HOS-093135 · has-warning-information · PDF-Seite 20

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine (see section 4.8). This vaccine may contain traces of formaldehyde and potassium thiocyanate which are used during the manufacturing process. Therefore, hypersensitivity reactions may occur (see sections 2 and 4.8). Use caution when vaccinating latex-sensitive individuals since the vial stopper contains dry natural latex rubber that may cause allergic reactions. For clinical or laboratory monitoring regarding immunocompromised individuals or individuals with known or presumed exposure to hepatitis B virus, see section 4.2. A number of factors have been observed to reduce the immune response to hepatitis B vaccines. These factors include older age, male gender, obesity, smoking, route of administration and some chronic underlying diseases. Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of HBVAXPRO. Additional doses may need to be considered for persons who do not respond or have a sub-optimal response to a course of vaccinations. Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination. The vaccine may not prevent hepatitis B infection in such cases. The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E and other pathogens known to infect the liver. Caution should be exercised when prescribing to pregnant or breast-feeding women (see section 4.6). Excipient(s) with known effect: 20 This medicinal product contains less than 1mmol sodium (23 mg) per dose, and is considered to be essentially sodium free.