Leaflet GENOTROPIN 16UI/ml (5.3mg/ml) powder and solvent for solution for injection

Product code:
W64823002
Quantity:
1
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 GENOTROPIN 16UI/ml (5.3mg/ml)

Substance:
somatropin
Date of latest medicines list:
01-06-2026
Product code:
W64823002
Concentration:
16UI / ml(5.3mg / ml)
Pharmaceutical form:
powder and solvent for solution for injection
Quantity:
1
Product type:
Original
Price:
457.33 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
PFIZER MANUFACTURING BELGIUM NV - BELGIA
Holder:
PFIZER EUROPE MA EEIG - BELGIA
Number:
7081/2014/01
Shelf life:
3 years-after packing for marketing; after reconstitution - 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

Compensation lists for GENOTROPIN 16UI/ml (5.3mg/ml) Pfizer

A - Sublist A with 90% discount from the reference price

Price
457.33 RON
Copayment
379.89 RON
Patient
77.44 RON

NHP 6.7 (C2) - Prader Willi Syndrome

Price
457.33 RON
Copayment
457.33 RON
Patient
0.00 RON