Medicine information OMNITROPE 3.3mg / ml solution for injection

Product code:
W52345001
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
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 OMNITROPE 3.3mg / ml

Substance:
somatropin
Date of latest medicines list:
01-10-2026
Product code:
W52345001
Strength:
3.3mg / ml
Pharmaceutical form:
solution for injection
Pack volume:
1,5ml
Product type:
Generic medicine
Price:
404.73 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
SANDOZ GMBH - AUSTRIA
Holder:
SANDOZ GMBH - AUSTRIA
Number:
332/2007/01
Shelf life:
2 years

Strengths 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

Official documents

The SmPC text is not displayed because a match to this medicine, strength and pharmaceutical form has not been confirmed.

Added to database:
02/04/2008
Source record updated:
05/08/2025

Warnings:

Glaucoma warning

Use caution if you have glaucoma or increased eye pressure.

Anticholinergic effects

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

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Use during pregnancy only on medical advice.

Elderly warning

Older people may have an increased risk of side effects.

Reimbursement lists for OMNITROPE 3.3mg / ml Sandoz

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

Price
404.73 RON
Copayment
348.04 RON
Patient payment
56.69 RON

NHP 6.7 (C2) - Prader Willi Syndrome

Price
404.73 RON
Copayment
404.73 RON
Patient payment
0.00 RON