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PRODUCT MONOGRAPH Saizen®Product Monograph Page 1 of 94 PRODUCT MONOGRAPH PrSaizen® Somatropin for Injection Lyophilized Powder for reconstitution 3. 33 mg/vial, 5 mg/vial PrSaizen®click. easy Somatropin for Injection Lyophilized Powder for reconstitution 8. 8 mg (5. 83 mg/mL) PrSaizen® Somatropin Solution for Injection in a CartridgeSaizen Prices, Coupons and Patient Assistance Programs. Saizen () is a member of the growth hormones drug class and is commonly used for Adult Human Growth Hormone Deficiency, Idiopathic Short Stature, Pediatric Growth Hormone Deficiency, and others. . The cost for Saizen injectable powder for injection 5 mg is around $766 for a supply of 1 powder for injection, depending on the pharmacy you visit. Saizen ® (somatropin), a recombinant human growth hormone (r-hGH), has been proven to mitigate growth disturbances in patients with growth hormone deficiency, growth failure due to Turner Syndrome in girls, growth failure in prepubertal children due to chronic renal failure (CRF), and short children born small for gestational age. 1 Specific indications vary across the 80 countries in which . Product Specifications Features SAIZEN is a recombinant human growth hormone Includes (1) vial of 8. 8 mg SAIZEN and 1 vial of Bacteriostatic Water for Injection, USP (0. 9% Benzyl Alcohol) Before reconstitution store at controlled room temperature of 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit)SAIZEN® Product Monograph Page 1 of 83. PRODUCT MONOGRAPH . PrSAIZEN ® Somatropin for Injection . Lyophilized Powder for reconstitution . 5 mg/vial . PrSAIZEN® Somatropin . Solution for Injection in a Cartridge . 6 mg (5. 83 mg/mL) 12 mg (8 mg/mL) 20 mg (8 mg/mL) Pharmaceutical Standard: Professed . Therapeutic Classification: Human Growth . One vial Saizen ® containing 8. 8 mg somatropin (approximately 26. 4 IU), 60. 2 mg sucrose, 2. 05 mg o-phosphoric acid and sodium hydroxide or o-phosphoric acid to adjust pH. One cartridge diluent containing 1. 51 mL 0. 3% (w/v) metacresol in Water for Injection. Exp. Date: [somatropin (rDNA origin) for injection] 8. 8 mgGeneric name: somatropin Dosage form: injection Drug class: Growth hormones J Code (medical billing code): J2941 (1 mg) Medically reviewed by Drugs. com. Last updated on Jun 25, 2023. On This Page Indications and Usage Dosage and Administration Dosage Forms and Strengths Contraindications Warnings and Precautions Adverse Reactions/Side EffectsThe reconstituted solution has a pH of 6. 5 to 8. 5. Saizen® is available in 5 mg and 8. 8 mg vials. The quantitative composition per vial is: 5 mg (approximately 15 IU) vial: Each vial contains 5. 0 mg somatropin (approximately 15 IU), 34. 2 mg sucrose and 1. 16 mg O-phosphoric acid. The pH is adjusted with sodium hydroxide or O-Medical Information Fax. +44 (0)208 818 7274. Saizen 8mg/ml solution for injection in cartridge - Patient Information Leaflet (PIL) by Merck. Saizen saizenprep 8. 8 mg/1. 51 mL (final conc. ) subcutaneous cartridge. Loading. View more photos. . Saizen , Serostim , Zorbtive. Uses. Various brands of this medication are used for the treatment of one of the following medical conditions: growth failure, growth hormone deficiency, intestinal disorder (short bowel syndrome) or HIV-related . Saizen® is a sterile, non-pyrogenic, white, lyophilized powder intended for subcutaneous or intramuscular injection after reconstitution with Bacteriostatic Water for Injection, USP (0. 9% Benzyl. 8. 8 mg somatropin and one cartridge diluent containing 1. 51 mL 0. 3% (w/v) metacresol in Sterile Water for Injection Most common adverse reactions are injection site reactions (such as pain, numbness, redness, and swelling), fluid retention, peripheralSaizen ® is indicated as a growth hormone replacement therapy for adults with pronounced GHD ‡ as diagnosed by a single dynamic test for GHD. Patients must also fulfil the following criteria:Saizen (somatropin [rDNA origin]) For Injection is a human growth hormone used to treat growth failure due to growth hormone deficiency. What Is Saizen? Common side effects of Saizen include: joint stiffness or pain, muscle pain, pain in your arms or legs, swelling, carpal tunnel syndrome, numbness and burning, headache, tiredness,SAIZEN (somatropin) is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone. 1. 2 Adult Patients SAIZEN is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria: Adult Onset02350149 SAIZEN 20 MG LIQUID CARTRIDGE (8MG/ML) 02350130 SAIZEN 12MG LIQUID CARTRIDGE (8MG/ML) 02350122 SAIZEN 6MG LIQUID CARTRIDGE (5. 83 MG/ML) 02272083 SAIZEN 8. 8MG VIAL 02237971 SAIZEN 5 MG VIAL 02215136 SAIZEN 3. 33 MG VIAL. About this Medication . How does this medication work? . Tell your doctor right away if you have any serious side effects, including: nausea/vomiting that doesn't stop, development of a limp, unusual tiredness, unusual/ unexplained weight gain, cold. SAIZEN lyophilized powder (to be reconstituted with Bacteriostatic Water for Injection): 5 mg per vial - 8. 8 mg per vial - saizenprep® reconstitution device: One vial SAIZEN containing 8. 8 mg . 4 CONTRAINDICATIONSSaizen is indicated in the treatment of: Children and adolescents: - Growth failure in children caused by decreased or absent secretion of endogenous growth hormone. - Growth failure in girls with gonadal dysgenesis (Turner syndrome), confirmed by chromosomal analysis. - Growth failure in prepubertal children due to chronic renal failure (CRF). Common side effects of Saizen may include: pain, itching, or skin changes where the medicine was injected; swelling, rapid weight gain; muscle or joint pain; numbness or tingling; stomach pain, gas; headache, back pain; or. cold or flu symptoms, stuffy nose, sneezing, sore throat, ear pain. This is not a complete list of side effects and others . Saizen Dosage Generic name: SOMATROPIN 5mg in 3mL; Dosage form: injection Drug class: Growth hormones Medically reviewed by Drugs. com. Last updated on Jun 19, 2023. For subcutaneous injection. For Cartridge: Saizen® cartridge is administered using easypod® or one. click®. For easypod® and one. click®, 8. 8 mg vials are reconstituted using eitherclick. easy® (for existing patients) or saizenprep® (for new patients as of May 1, 2017). How do you store Saizen®? Before, reconstitution, Saizen® can be stored in room temperature. pain, numbness, redness, and swelling), fluid retention, peripheral SAIZEN click. easy® reconstitution device: One vial SAIZEN containing 8. 8 mg somatropin and one cartridge diluent.
Saizen (EMD Serono, Inc. ): FDA Package Insert - MedLibrary. org DailyMed - SAIZEN- somatropin kit SAIZENPREP- somatropin kit PDF Saizen [somatropin (rDNA origin) for injection] For subcutaneous or . Saizen (somatropin) Product and Support Details - Merck Group Saizen: Package Insert / Prescribing Information - Drugs. com Saizen Prices, Coupons, Copay & Patient Assistance - Drugs. com Saizen Dosage Guide - Drugs. com Saizen saizenprep 8. 8 mg/1. 51 mL (final conc. ) subcutaneous cartridge PDF Saizen Prescribing Information - EMD Serono PDF Reference ID: 4094904 - Food and Drug Administration Saizen - Uses, Side Effects, Interactions - MedBroadcast. com Saizen (somatropin) Indication, Dosing and Drug Details - EMD Group Saizen 8mg/ml solution for injection in cartridge - medicines Saizen Subcutaneous: Uses, Side Effects, Interactions, Pictures . - WebMD PDF SAIZEN [somatropin (rDNA origin) for injection], NDA 19-764/S-020 DRAFT . Saizen (Somatropin Injection): Uses, Dosage, Side Effects . - RxList Serono Labs 44087108801 - McKesson Medical-Surgical PDF [Product Monograph Template - Schedule D] - EMD Serono PDF PRODUCT MONOGRAPH - pdf. hres. ca Saizen Uses, Side Effects & Warnings - Drugs. com Saizen 8mg/ml solution for injection in cartridge - medicines SAIZEN® - Ocean Breeze Healthcare PDF Saizen ®8. 8 mg click - Food and Drug Administration