Saizen solution for injection 5.83mg/ml (6mg in 1.03ml)

Merck Serono S.p.A (ITALY)🇸🇬 Health Sciences Authority

Approval Date: Nov 6, 2013
Approval ID: 169bee2ba70f7fb2
Company: Merck Serono S.p.A (ITALY)
Type: Therapeutic

Approval Details

Approval Id: 169bee2ba70f7fb2
Drug Name: Saizen solution for injection 5.83mg/ml (6mg in 1.03ml)
Product Name: Saizen solution for injection 5.83mg/ml (6mg in 1.03ml)
Approval Number: SIN14432P
Approval Date: 2013-11-06
Registrant: MERCK PTE. LTD.
Licence Holder: MERCK PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, SOLUTION
Dosage: Posology and method of administration Saizen® 5.83mg/ml and Saizen® 8mg/ml are intended for multiple dose use. Saizen® dosage should be individualised for each patient based on body surface area (BSA) or on body weight (BW). It is recommended that Saizen® be administered at bedtime according to the following dosage: Growth failure due to inadequate endogenous growth hormone secretion: 0.7–1.0 mg/m2 body surface area (BSA) per day or 0.025–0.035 mg/kg body weight (BW) per day by subcutaneous administration. Growth failure in girls due to gonadal dysgenesis (Turner Syndrome): 1.4 mg/m2 body surface area (BSA) per day or 0.045–0.050 mg/kg body weight (BW) per day by subcutaneous administration. Concomitant therapy with non-androgenic anabolic steroids in patients with Turner Syndrome can enhance the growth response. Growth failure in short children born small for gestational age (SGA): The recommended daily dose is 0.035 mg/kg body weight (or 1 mg/m2/day, equal to 0.1 international units/kg/day or 3 international units/m2/day) per day, by subcutaneous administration. Duration of treatment Treatment should be discontinued when the patient has reached a satisfactory adult height, or the epiphyses are fused. For growth disturbance in short children born SGA, treatment is usually recommended until final height is reached. Treatment should be discontinued after the first year if height velocity SDS is below +1. Treatment should be discontinued when final height is reached (defined as height velocity < 2 cm/year), and if confirmation is required if bone age is > 14 years (girls) or > 16 years (boys), corresponding to closure of the epiphyseal growth plates. Growth failure in prepubertal children due to chronic renal failure (CRF): 1.4 mg/m2 body surface area per day, approximately equal to 0.045–0.050 mg/kg body weight per day by subcutaneous administration. Growth disturbance due to idiopathic short stature (ISS): 0.067 mg/kg body weight per day, is injected 6 times subcutaneously per week (0.40 mg/kg/week). Growth Hormone Deficiency in adults: At the start of somatropin therapy, low doses of 0.15–0.3mg are recommended, given as a daily subcutaneous injection. The dose should be adjusted stepwise, controlled by Insulin-like Growth Factor 1 (IGF-1) values. The recommended final GH dose seldom exceeds 1.0mg/day. In general the lowest efficacious dose should be administered. Women may require higher doses than men, with men showing an increasing IGF-1 sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen replacement are under-treated while men are over-treated. In older or overweight patients, lower doses may be necessary. Method of administration For administration of the solution for injection of Saizen® follow the instructions given in the package leaflet and in the instruction manual provided with the Easypod® auto-injector or aluetta pen injector.
Route Of Administration: SUBCUTANEOUS
Indication Info: Therapeutic indications Saizen® (6 mg, 12 mg, and 20 mg) is indicated in the treatment of: <ul> <li>growth failure in children caused by decreased or absent secretion of endogenous growth hormone.</li> <li>growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal analysis.</li> <li>growth disturbance (current height SDS < -2.5 and parental adjusted height SDS < -1) in short children born small for gestational age (SGA) with a birth weight and/or length below – 2 SD, who failed to show catch-up growth (HV SDS < 0 during the last year) by 4 years of age or later.</li> <li>replacement therapy in adults with pronounced growth hormone deficiency as diagnosed by a single dynamic test for growth hormone deficiency. Patients must also fulfil the following criteria:</li> </ul> Childhood Onset: Patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with Saizen® is started. Adult Onset: Patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin. Saizen® (Only for 6 mg and 12 mg) is indicated in the treatment of: <ul> <li>growth failure in prepubertal children due to chronic renal failure (CRF).</li> <li>growth disturbance due to idiopathic short stature (ISS).</li> </ul>
Contraindications: Contra-indications Saizen® should not be used in children in whom epiphyseal fusion occurred. Saizen® is contraindicated in patients known to be hypersensitive to Somatropin and any of the excipients in the solution for injection. Saizen® is contraindicated in patients with active neoplasia. Any anti-tumor therapy must be completed prior to starting treatment with Somatropin. Saizen® should not be used in cases with evidence of any progression or recurrence of an underlying intra-cranial lesion. Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions should not be treated with Somatropin. (Regarding patients undergoing Somatropin therapy and becoming critically ill, see “Special warnings and special precautions for use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.) Saizen® is contraindicated in patients with proliferative or pre-proliferative diabetic retinopathy. Saizen® is contraindicated in pregnancy and lactation. In children with chronic renal disease, treatment with somatropin should be discontinued at renal transplantation.
Atc Code: H01AC01
Atc Item Name: somatropin
Pharma Manufacturer Name: MERCK PTE. LTD.

Active Ingredients

Somatropin

6 mg/1.03 ml

SOMATROPIN

6 MG/1.03 ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Nov 6, 2013

Approval ID

169bee2ba70f7fb2

Type

Therapeutic

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