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SEROSTIM is a brand name for Somatropin (also known as Somatotropin), supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .......................................................................... 3 CONTRAINDICATIONS ................................................................................................ 4 WARNINGS AND PRECAUTIONS .............................................................................. 4…
Verbatim from this product's HC label. Tap a section to expand.
SEROSTIM (somatropin for injection) is contraindicated and should not be administered in the following cases: • In patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or patients having acute respiratory failure.
Clinical studies demonstrated that high doses of growth hormone were associated with a significantly increased morbidity and mortality in those patients (see WARNINGS AND PRECAUTIONS). • In the presence of any progression of underlying intracranial tumour.
Intracranial tumour should be inactive and anti-malignancy treatment must be completed with evidence of remission prior to instituting therapy. SEROSTIM should be discontinued if there is evidence of recurrent activity. Patients should be examined frequently for progression or recurrence of the underlying disease process.
• In patients who are hypersensitive to or have a history of previous allergic reaction to somatropin or to any of the excipients. • In patients with active neoplasia (either newly diagnosed or recurrent). Any anti- tumour therapy should be completed prior to starting therapy with SEROSTIM, and should be discontinued if there is evidence of recurrent tumor growth.
• In patients with diabetes mellitus. • In patients with proliferative or preproliferative diabetic retinopathy. WARNINGS AND PRECAUTIONS General A significant increase in mortality was reported among growth hormone treated patients with acute critical illnesses in intensive care units due to complications following open heart surgery or abdominal surgery, multiple accidental trauma or acute respiratory failure compared with those receiving placebo (see CONTRAINDICATIONS and ADVERSE REACTIONS).
Serious Warnings and Precautions SEROSTIM (somatropin for injection) therapy should be carried out under the regular guidance of a physician who is experienced in the diagnosis and management of AIDS. Inadequate nutritional intake and hypogonadism, which are common in individuals with AIDS and which may contribute to catabolism and weight loss, should be corrected prior to initiation of SEROSTIM therapy.
Any substitution of Growth Hormone products should be made cautiously and only under medical supervision SEROSTIM shall only be used if, once reconstituted, the resulting solution is water- clear and devoid of particulate matter Serostim® Product Monograph Page 5 of 36 Fluid retention is expected during growth hormone therapy.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Somatropin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Oedema, joint swelling, arthralgias, myalgias, paresthesias may be clinical manifestations of fluid retention. However, these effects are dose dependent, and may resolve spontaneously with analgesic therapy, they usually resolve by reducing the total daily dose by 50% or the number of doses given per week.
It is recommended that SEROSTIM be administered using sterile, disposable syringes and needles(see PART III: CONSUMER INFORMATION). Patients should be thoroughly instructed in the importance of proper disposal and cautioned against any reuse of needles and syringes.
An appropriate container for the disposal of used needles and syringes should be used. To avoid transmission of disease, cartridge and prefilled syringe shall not be used by more than one person. When SEROSTIM is administered subcutaneously at the same site over a long period, local tissue atrophy may result.
This can be avoided by rotating the injection site daily. Carcinogenicity and Mutagenesis Carcinogenicity studies have not been conducted. There is no evidence from animal studies to date of SEROSTIM-induced mutagenicity. Treatment with growth hormone may have an increased risk of developing neoplasm.
Patients on SEROSTIM treatment should be monitored for the emergence of any new malignancy, particularly if they have a history of any neoplasm, and the product discontinued if a new tumour, signs of relapse or tumour progression are detected.
Kaposi's sarcoma, lymphoma, cervical cancer in women and other malignancies are common in AIDS patients. In clinical studies, the risk of developing new Kaposi sarcoma lesions and lymphomas were not found to be increased. The effect of SEROSTIM on the incidence of cervical cancer has not been assessed in clinical trials since the majority of patients included were male.
The potential effects of growth hormone on other malignancies are unknown. Evidence is available suggesting the possibility that growth hormone might increase the risk of development of cancers other than lymphoma, in particular colorectal cancer.
Although this evidence is not conclusive, the advisability of a regular screening program for colorectal cancer should be discussed with patients having known risk factors for this malignancy. Intracranial Hypertension (IH) No cases of intracranial hypertension (IH) have been observed among patients with AIDS wasting treated with SEROSTIM.
The syndrome of IH, with papilledema, visual changes, headache, nausea and/or vomiting has been reported in a small number of children with growth failure treated with growth hormone products. Symptoms usually occurred within the first eight weeks of initiation of growth hormone therapy.
Nevertheless, funduscopic evaluation of patients is recommended at the initiation and periodically during the course of SEROSTIM therapy. Idiopathic Intracranial Hypertension Idiopathic intracranial hypertension has been recognized as a complication (early in treatment usually) of growth hormone treatment.
The diagnosis is made on the basis of clinical symptoms Serostim® Product Monograph Page 6 of 36 such as severe, persistent or recurrent headache, visual problems, nausea and/or vomiting, papilloedema and temporal relationship to growth hormone.
Physicians and parents should be attentive to relevant symptoms such as headache and visual problems in patients under growth hormone therapy. Fundoscopic examination should be performed routinely before initiating treatment with growth hormones to exclude pre-existent […]