PDgrowth®

– Lyophilized vial: 4IU

– Solvent ampule: 1ml Distilled water for injection

– Lyophilized powder: Sterile and white

– Solvent: Colorless – Clear – Without particle

– Effect on Ability to Drive and Operate Machinery

Somatropin-containing products have no influence on the ability to drive and use machines.

– Overdosage

If you use too much PDgrowth^® you may need medical treatment right away. Too much PDgrowth^® can cause initial hypoglycemia, followed by hyperglycemia.

– If you forget to use PDgrowth^®:

If you miss a dose of PDgrowth^®, skip that dose and take your next dose at the next prescribed time. Do not take an extra dose or increase the amount of your next dose to make up for the one you missed.

– Inject PDgrowth^® right after reconstitution.

1. Long term treatment in pediatric patients showing growth retardation confirmed by inadequate secretion of the growth hormone.
2. Long term treatment in pediatric patients showing growth retardation confirmed by renal insufficiency.
3. Long term treatment in PWS pediatric patients.
4. Long term treatment in Turner syndrome pediatric patients.
5. Long term treatment in pediatric patients who were born smaller regarding their gestational age and who show growth retardation and lack of height recovery at two years of age.
6. Wasting syndrome in AIDS patients.
7. Replacement therapy in adults with pronounced growth hormone deficiency as diagnosed by a single dynamic test for growth hormone deficiency.
8. Idiopathic short stature.

The following recommendations are based on the applied dose in controlled clinical trials that demonstrated the efficacy of the treatment.

– GH deficiency in pediatric patients: by sub-cutaneous or intramuscular injection, 0.069–0.117 IU/kg daily or 0.7–1 mg/m² daily.

– Turner syndrome in pediatric patients: by subcutaneous injection, 0.135–0.15 IU/kg daily or 1.4 mg/m² daily.

– Prader-Willi syndrome in pediatric patients: by subcutaneous injection in children with growth velocity greater than 1 cm/year, in combination with energy-restricted diet, 0.105 IU/kg daily or 1 mg/m² daily; max. 2.7 mg daily.

– Small pediatric patients regarding their gestational age: by subcutaneous injection, 0.105 IU/kg daily or 1 mg/m² daily.

– Growth hormone deficiency in adult patients: by subcutaneous injection, initially 0.45–0.9 IU daily gradually increased if required to max. 3 IU daily; use minimum effective dose (requirements may decrease with age).

– Chronic renal insufficiency in pediatric patients: by subcutaneous injection, 0.135–0.15 IU/kg daily or 1.4 mg/m² daily (higher doses may be needed) adjusted if necessary after 6 months.

– Wasting syndrome in AIDS patients: 0.26-0.3 IU/Kg per day or 0.3 IU/kg given as a daily subcutaneous injection.

– Idiopathic short stature: by subcutaneous injection 1.11-1.41 IU/kg divided into equal doses 6-7 days per week.

1. PDgrowth^® should not be administrated when there is evidence of active neoplastic. If there are neoplasia antecedents, PDgrowth^® treatment should be initiated once the corresponding anti-neoplasia treatment is over.
2. Sensibility to the drug and other ingredients
3. Diabetic patients
4. Patients who show acute respiratory failure
5. Children patients with closed epiphysis
6. If there is evidence of active intracranial tumor in past 12 months
7. It is recommendable not to initiate PDgrowth^® treatment either in patients suffering complications from open-cast method, abdominal surgery or traumatism
8. In severely obese PWS patients or in those who show an important respiratory deterioration as confirmed through spirometry
9. Active proliferative or severe nonproliferative diabetic retinopathy

PDgrowth^® treatment should be indicated by a specialist physician who, based on appropriate tests, should verify the diagnosed growth hormone deficiency before treatment onset.

Under PDgrowth^® therapy, a through control should be performed in these conditions:

1. Patients with diabetes, family history of diabetes or obese patients
2. Patients with glucose intolerance
3. Some patients may develop hypothyroidism under PDgrowth^® treatment; thus patients should undergo regular controls regarding thyroid function.
4. Pediatric patients with endocrine disorders, including GHD, show a high incidence of luxation on femoral epiphysis. Under PDgrowth^® treatments, presence of limp or pain development on hips or knees should be careful evaluated.
5. Development of skin lesions, suspicious of malignity, should be monitored.
6. Patients with history of scoliosis should be monitored for illness progression risk.

It is not known if PDgrowth^® may harm your unborn child. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine, as PDgrowth^® should not be used during pregnancy. It is not known if the medicine in PDgrowth^® passes into your milk. PDgrowth^® should not be used if breast-feeding.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Adverse effects have been reported in less than 1% of the patients treated with the human recombinant growth hormone, mainly as transitorily reactions over the injection site.

1. Acromegalic features on the face, hands and feet
2. Diabetes
3. Arthrosclerosis
4. Arterial hypertension
5. Carpal tunnel syndrome
6. The development of antibodies
7. Otitis media or hearing conditions in patients with Turner syndrome
8. Gynecomastia
9. Headache
10. Articular and muscular pain
11. Peripheral Edema
12. Pancreatitis
13. Rash
14. Jaundice
15. Intracranial hypertension
16. Lypodystrophy on injection site
17. Hematuria
18. Hypothyroidism

1. The concomitant administration of glucocorticoids may inhibit PDgrowth^® effect growth. In case of associated ACTH production deficit, the treatment should be adjusted by means of glucocorticoids in order to minimize the inhibitory effect over growth.
2. In diabetic patients, may cause resistance to insulin
3. There is preliminary evidence of regulation of several cytochrome P 450 isoforms by the growth hormone. Potentially speaking, the growth hormone may alter the metabolism of some drugs which are metabolized by cytochrome p 450 systems. (Sexual hormones, Cyclosporin and Etc.)
4. Elevated glycosolated Hgb (14%); increased AST (13%); increased fasting serum insulin levels (10%); increased levels of alkaline phosphatase, inorganic phosphate, and parathyroid hormone.
5. Larger doses of somatropin may be required in women receiving oral estrogens.

Growth curve, Tanner staging (children), periodic thyroid function tests, bone age (annually), periodical urine testing for glucose, somatomedin C (IGF-I) levels; funduscopic examinations at initiation of therapy and periodically during treatment; serum phosphorus, alkaline phosphatase and parathyroid hormone. If growth deceleration is observed in children treated for growth hormone deficiency, and not due to other causes, evaluate for presence of antibody formation. Periodic blood glucose monitoring; strict blood glucose monitoring in patients with diabetes. Progression or recurrence of pre-existing tumors or malignant transformation of skin lesions.

CRI: Progression of renal osteodystrophy

Prader-Willi syndrome: Monitor for sleep apnea, respiratory infections, snoring (onset of or increased)

Turner syndrome: Ear disorders including otitis media; cardiovascular disorders

Noonan syndrome: Prior to use, verify short stature syndrome.

Mimics actions of naturally occurring growth hormone (GH) to stimulate linear and skeletal growth; increases number and size of skeletal muscle cells; increases RBC mass and internal organ size; increases cellular protein synthesis; reduces body fat stores and lipid mobilization, and increases plasma fatty acids. Somatropin, as well as the endogenous GH, functions by means of binding to specific receptors on the surface of numerous cells. The activation of these receptors triggers a cascade of intracellular events, particularly phosphorilations, which conclude on the regulation of the expression of several genes, at transcription level. The majority of somatropin anabolic effects are mediated by IGF-I, synthesized in the liver, and other tissues in response to the stimulation of GH receptors on its membrane, IGF-I concentrations are low in GHD pediatric patients, but they get to normal levels post somatropin treatment.

– Absorption : 70-90% in both injection route

– Half-life absorption : 2-4 hours ( depends on injection route )

– Distribution : about 1 L/Kg in adult patients

– Excretion: mainly excreted by renal and hepatic proteolysis. Approximately 0.1% of the dose excreted unaltered.

Reconstitute the content of a vial of PDgrowth^® with one ml of water for injection from the ampoule with the solvent, making it flow against the vial wall. After reconstitution, swirls the vial with a soft rotary motion until the content is completely dissolved. Do not agitate the solution during preparation. Before administration, the stopper should be cleaned with a swab embedded in alcohol in order to avoid contamination. The injection should be given subcutaneously and the site varied to prevent lipoatrophy.

1. Store in a refrigerator (2°^C – 8°^C)
2. Keep the container in the outer carton in order to protect from light
3. Keep out of the reach and sight of children. 
4. Do not use PDgrowth^® after the expiry date which is stated on the box and on the syringe label (EXP).  The expiry date refers to the last day of that month.
5. Do not freeze PDgrowth^® and do not use PDgrowth^® that has been frozen or improperly refrigerated.
6. Do not shake PDgrowth^®
7. Do not use PDgrowth^® if you notice particles in the solution, or if it is cloudy or colored.
8. PDgrowth^® should inject right after reconstitution.

– Each ampoule with lyophilized PDgrowth^® contains:

Somatropin – Glycine – Anhydrous sodium dibasic phosphate – Anhydrous sodium monobasic phosphate

– Each ampoule with diluent contains:

Distilled water for injection