SAIZEN 5MG (15IU)
PRODUCT DESCRIPTION :
Saizen 5Mg Injection is meant for hormonal therapy. It is used for hormone related growth deficiency disorders, certain intestinal disorders or HIV –related weight loss, stunted growths. It may also be administered for children with genetic disorder who are unable to attain an increase in their height. You must take proper consultation from the doctor regarding the dosage of the medicine especially if you are pregnant, planning a pregnancy any time soon or a breastfeeding mother. You must make the doctor aware of any allergies that you may be having, your medical history if you have suffered from any liver, kidney, lungs or cardiac problems. You must inform the doctor if you are taking any other prescription drugs, or dietary supplements. Saizen 5Mg Injection may react with other drugs and cause health complications, therefore you must make sure you have taken the necessary precautions. The medicine may be injected intravenously or just under the skin according to the needs of the patient. Some common side effects of this medicine may include persistent headaches, nausea, vomiting, dizziness, extreme fatigue, abnormal weight gain, unusually increased thirst, some unexplained pain in the body, numbness of hands and feet or sudden cramps. You may also face serious side effects such as lowering of the rate of heartbeats.
SIDE EFFECTS :
Increased mortality in patients with acute critical illness
Fatalities in children with Prader-Willi syndrome
Glucose intolerance and diabetes mellitus
Slipped capital femoral epiphysis in pediatric patients
Progression of preexisting scoliosis in pediatric patients
For subcutaneous injection.
SAIZEN 5mg therapy should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth hormone deficiency or adult patients with either childhood-onset or adult-onset growth hormone deficiency.
Pediatric Growth Hormone Deficiency (GHD)
SAIZEN dosage and administration schedule should be individualized for each patient. The recommended weekly dosage is 0.18 mg/kg of body weight by subcutaneous injection. It should be divided into equal doses given either on 3 alternate days, 6 times per week or daily.
Response to somatropin therapy in pediatric patients tends to decrease with time. However, in pediatric patients, the failure to increase growth rate, particularly during the first year of therapy, indicates the need for close assessment of compliance and evaluation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age and antibodies to recombinant human growth hormone.
Treatment with SAIZEN of growth failure due to growth hormone deficiency should be discontinued when the epiphyses are fused.
Adult Growth Hormone Deficiency (GHD)
Either of two approaches to SAIZEN dosing may be followed: a weight-based regimen or a non-weightbased regimen.
Based on the dosing utilized in the original pivotal study described herein, the recommended dosage at the start of therapy is not more than 0.005 mg/kg given as a daily subcutaneous injection. The dosage may be increased to not more than 0.01 mg/kg/day after 4 weeks according to individual patient requirements. Clinical response, side effects, and determination of age-and gender-adjusted serum insulin-like growth factor (IGF-1) levels may be used as guidance in dose titration.
Alternatively, taking into account more recent literature, a starting dose of approximately 0.2 mg/day (range, 0.15-0.30 mg/day) may be used without consideration of body weight. This dose can be increased gradually every 1 to 2 months by increments of approximately 0.1 to 0.2 mg/day, according to individual patient requirements based on the clinical response and serum IGF-1 concentrations. During therapy, the dose should be decreased if required by the occurrence of adverse reactions and/or serum IGF-1 levels above the age-and gender-specific normal range. Maintenance dosages vary considerably from person to person.
A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of somatropin than younger individuals. In addition, obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen. In order to reach the defined treatment goal, estrogen-replete women may need higher doses than men. Oral estrogen administration may increase the dose requirements in women.