ประเทศ: ออสเตรเลีย
ภาษา: อังกฤษ
แหล่งที่มา: Department of Health (Therapeutic Goods Administration)
human immunoglobulin G, Quantity: 9000 mg
Grifols Australia Pty Ltd
Solution
Excipient Ingredients: glycine; polysorbate 80; water for injections
Subcutaneous
50 mL
(S4) Prescription Only Medicine
Indications for subcutaneous administration (SCIg),Xembify? is indicated as replacement therapy in adult and paediatric patients for:,- Primary immunodeficiency diseases (PID),- Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.
Visual Identification: SCIg; Container Type: Vial; Container Material: Glass; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2022-06-30
Xembify® 1 XEMBIFY® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. This medicine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I USING XEMBIFY®? Xembify® contains the active ingredient normal immunoglobulin . Xembify® is used to help your body fight infections. For more information, see Section 1. Why am I using Xembify®? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE XEMBIFY®? Do not use if you have ever had an allergic reaction to normal immunoglobulin or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Xembify®? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Xembify® and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE XEMBIFY®? • The recommended dose and dosing schedule are established by your doctor. • Xembify® has to be infused under the skin (subcutaneous or SC administration). More instructions can be found in Section 4. How do I use Xembify®? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING XEMBIFY®? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Xembify® • Have routine blood tests to measure the level of immunoglobulin in your blood. THINGS YOU SHOULD NOT DO • Do not change the dose or the time interval to the next dose without talking to your doctor first. • Do not use this medicine after the expiry date which is stated on the label and carton • Do not use this medicine if you notice it is cloudy, discoloured, turbid, or if it has been frozen. DRIVING OR USING MACHINES • Your ability t อ่านเอกสารฉบับเต็ม
Xembify ® Product Information 1 This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION XEMBIFY ® NORMAL IMMUNOGLOBULIN (HUMAN) 20% SOLUTION FOR SUBCUTANEOUS INJECTION 1. NAME OF THE MEDICINE Normal Immunoglobulin (Human) 20% solution for subcutaneous injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Normal immunoglobulin One ml contains: Normal immunoglobulin 200 mg (purity of at least 98% human immunoglobulin G (IgG)) Produced from the plasma of human donors. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dosage form: Injection Solution for injection, for subcutaneous use. The solution is clear to slightly opalescent, and colourless or pale yellow or light brown. Xembify ® has an approximate osmolality range of 280 to 404 mOsmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indications for subcutaneous administration (SCIg) Xembify ® is indicated as replacement therapy in adult and paediatric patients for: Primary immunodeficiency diseases (PID) Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. 4.2 DOSE AND METHOD OF ADMINISTRATION Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency. Dosage The dose and dose regimen are dependent on the indication. ▼ 2 _Replacement therapy_ The product should be administered via the subcutaneous route. In replacement therapy the dose may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. The following dose regimens are given as a guideline. The dose regimen should achieve a trough level of IgG (measured before the next infusion) of at least 5 to 6 g/l and aim to be within the reference interval of serum IgG for age. A loading dose of at leas อ่านเอกสารฉบับเต็ม