Omlyclo TM
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.
Active ingredients: omalizumab
Brand name
(ARTG)
: OMLYCLO omalizumab (rch) 75 mg/0.5 mL solution for injection in a pre-filled syringe with needle guardConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to less than 12 years of age,In children aged 6 to less than 12 years, Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents equal to or greater than 12 years of age,Omlyclo is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Omlyclo is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION) .,Chronic Spontaneous Urticaria (CSU),Omlyclo is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, colourless to pale brownish-yellow solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 10 pack
- 6 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: OMLYCLO omalizumab (rch) 150 mg/ mL solution for injection in a pre-filled syringe with needle guardConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to less than 12 years of age,In children aged 6 to less than 12 years, Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents equal to or greater than 12 years of age,Omlyclo is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Omlyclo is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION) .,Chronic Spontaneous Urticaria (CSU),Omlyclo is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, colourless to pale brownish-yellow solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 10 pack
- 6 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: OMLYCLO omalizumab (rch) 75 mg/0.5 mL solution for injection in a pre-filled syringe with needle guardConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to less than 12 years of age,In children aged 6 to less than 12 years, Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents equal to or greater than 12 years of age,Omlyclo is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Omlyclo is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION) .,Chronic Spontaneous Urticaria (CSU),Omlyclo is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, colourless to pale brownish-yellow solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 10 pack
- 6 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: OMLYCLO omalizumab (rch) 75 mg/0.5 mL solution for injection in a pre-filled syringe with needle guardConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to less than 12 years of age,In children aged 6 to less than 12 years, Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents equal to or greater than 12 years of age,Omlyclo is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Omlyclo is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION) .,Chronic Spontaneous Urticaria (CSU),Omlyclo is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, colourless to pale brownish-yellow solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 10 pack
- 6 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: OMLYCLO omalizumab (rch) 150 mg/ mL solution for injection in a pre-filled syringe with needle guardConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to less than 12 years of age,In children aged 6 to less than 12 years, Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents equal to or greater than 12 years of age,Omlyclo is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Omlyclo is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION) .,Chronic Spontaneous Urticaria (CSU),Omlyclo is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, colourless to pale brownish-yellow solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 10 pack
- 6 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: OMLYCLO omalizumab (rch) 150 mg/ mL solution for injection in a pre-filled syringe with needle guardConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to less than 12 years of age,In children aged 6 to less than 12 years, Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents equal to or greater than 12 years of age,Omlyclo is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Omlyclo is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION) .,Chronic Spontaneous Urticaria (CSU),Omlyclo is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, colourless to pale brownish-yellow solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 10 pack
- 6 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: OMLYCLO omalizumab (rch) 150 mg/ mL solution for injection pre-filled penWhat this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to less than 12 years of age,In children aged 6 to less than 12 years, Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents equal to or greater than 12 years of age,Omlyclo is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Omlyclo is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION) .,Chronic Spontaneous Urticaria (CSU),Omlyclo is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, colourless to pale brownish-yellow solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 10 pack
- 4 pack
- 6 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: OMLYCLO omalizumab (rch) 150 mg/ mL solution for injection pre-filled penWhat this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to less than 12 years of age,In children aged 6 to less than 12 years, Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents equal to or greater than 12 years of age,Omlyclo is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Omlyclo is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION) .,Chronic Spontaneous Urticaria (CSU),Omlyclo is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, colourless to pale brownish-yellow solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 10 pack
- 4 pack
- 6 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: OMLYCLO omalizumab (rch) 150 mg/ mL solution for injection pre-filled penWhat this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to less than 12 years of age,In children aged 6 to less than 12 years, Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents equal to or greater than 12 years of age,Omlyclo is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Omlyclo is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION) .,Chronic Spontaneous Urticaria (CSU),Omlyclo is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, colourless to pale brownish-yellow solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 10 pack
- 4 pack
- 6 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: OMLYCLO omalizumab (rch) 75 mg/0.5 mL solution for injection pre-filled penWhat this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to less than 12 years of age,In children aged 6 to less than 12 years, Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents equal to or greater than 12 years of age,Omlyclo is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Omlyclo is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION) .,Chronic Spontaneous Urticaria (CSU),Omlyclo is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, colourless to pale brownish-yellow solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 10 pack
- 6 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: OMLYCLO omalizumab (rch) 75 mg/0.5 mL solution for injection pre-filled penWhat this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to less than 12 years of age,In children aged 6 to less than 12 years, Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents equal to or greater than 12 years of age,Omlyclo is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Omlyclo is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION) .,Chronic Spontaneous Urticaria (CSU),Omlyclo is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, colourless to pale brownish-yellow solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 10 pack
- 6 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: OMLYCLO omalizumab (rch) 75 mg/0.5 mL solution for injection pre-filled penWhat this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to less than 12 years of age,In children aged 6 to less than 12 years, Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents equal to or greater than 12 years of age,Omlyclo is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Omlyclo is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION) .,Chronic Spontaneous Urticaria (CSU),Omlyclo is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, colourless to pale brownish-yellow solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 10 pack
- 6 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems