Leaflet SAIZEN 8mg / ml solution for injection

Indicated for: growth hormone deficiency

Route of administration: injectable

Substance: somatropin (growth hormone)

ATC: H01AC01 (Systemic hormonal preparations, excluding sex hormones and insulins | Anterior pituitary lobe hormones and analogues | Somatropin and somatropin agonists)

Precautions:
Glaucoma warning
Glaucoma warning

Use caution if you have glaucoma or increased eye pressure.

Anticholinergic effects
Anticholinergic effects

May cause dry mouth, constipation, urinary retention, or blurred vision.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Elderly warning
Elderly warning

Older people may have an increased risk of side effects.

Somatropin is a recombinant human growth hormone used to treat growth disorders and growth hormone deficiency. It is indicated for conditions such as growth hormone deficiency in children and adults, Turner syndrome, chronic kidney failure in children, Prader-Willi syndrome, and for children born small for gestational age who have not caught up in growth.

It is administered via subcutaneous injection, usually once daily, with the dose adjusted based on body weight and the patient's response.

Common side effects include pain at the injection site, edema, joint or muscle pain, and, in some cases, increased blood sugar levels. Rarely, it may cause intracranial hypertension or allergic reactions.

Somatropin is contraindicated in patients with active tumors, acute critical illnesses, or allergies to the product's components. Regular medical monitoring is required to assess its effectiveness and safety.

General data about SAIZEN 8mg / ml

  • Substance: somatropin
  • Date of latest medicines list: 01-08-2019
  • Product code: W66037002
  • Concentration: 8mg / ml
  • Pharmaceutical form: solution for injection
  • Quantity: 5
  • Product type: Original
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: MERCK SERONO S.P.A. - ITALIA
  • Holder: MERCK ROMANIA SRL - ROMANIA
  • Number: 13318/2020/02
  • Shelf life: 18 months; Dupa prima deschidere a cartusului - 28 days

Concentrations available for somatropin

  • 1.3mg/ml
  • 10mg/1.5ml
  • 10mg/2ml
  • 10mg/ml
  • 15mg/1.5ml
  • 16UI/ml(5.3mg/ml)
  • 3.3mg/ml
  • 4mg
  • 5.3mg/ml (16ui)
  • 5.83mg/ml
  • 5mg/1.5ml
  • 5mg/ml
  • 6.7mg/ml
  • 8mg/ml