Leaflet PROLUTEX 25mg solution for injection


Indicated for: disorders associated with progesterone deficiency

Route of administration: injectable

Substance: progesterone (progestogen)

ATC: G03DA04 (Genito urinary system and sex hormones | Progestogens | Pregnen (4) derivatives)

Progesterone is a natural hormone used in the treatment of menstrual disorders, infertility, and other conditions associated with progesterone deficiency. It plays a crucial role in regulating the menstrual cycle and maintaining pregnancy.

The medication is administered orally, by injection, or as a vaginal gel, as directed by a doctor. It is important for patients to follow the treatment regimen and inform the doctor about any other medications being used.

Patients should be aware of potential side effects, such as headaches, nausea, or breast tenderness. It is important to inform the doctor of any unusual symptoms.

Common side effects include headaches, nausea, and breast tenderness. In rare cases, severe reactions such as thrombosis or allergic reactions may occur. Patients should be informed of these risks before use.

General data about PROLUTEX 25mg

  • Substance: progesterone
  • Date of last drug list: 01-05-2026
  • Commercial code: W67640002
  • Concentration: 25mg
  • Pharmaceutical form: solution for injection
  • Quantity: 7
  • Product type: original
  • Price: 175.18 RON
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: IBSA FARMACEUTICI ITALIA SRL - ITALIA
  • Holder: IBSA FARMACEUTICI ITALIA SRL - ITALIA
  • Number: 13574/2020/02
  • Shelf life: 2 years-dupa ambalare pt. comericalizare;after the first opening of the bottle-it is used immediately

Concentrations available for progesterone

  • 1%
  • 100mg
  • 10mg/g
  • 200mg
  • 25mg
  • 400mg
  • 80mg/g

Compensation lists for PROLUTEX 25mg IBSA Farmaceutici Italia

B - Sublist B with 50% discount from the reference price

Price

Copayment

Patient

175.18 RON

87.59 RON

87.59 RON