Leaflet ACID ZOLEDRONIC ROMPHARM 4mg / 5ml concentrate for solution for infusion

Product code:
W71498001
Quantity:
1
Indicated for:
osteoporosis; bone metastases; tumor-induced hypercalcemia
Route of administration:
infusion
Substance:
zoledronic acid (bisphosphonate)
ATC
M05BA08 — Musculo-skeletal system | Drugs affecting bone structure and mineralization | Bisphosphonates

Precautions:

Take on an empty stomach

Take on an empty stomach

Take this medicine on an empty stomach.

Avoid milk, calcium, iron, or antacids

Avoid milk, calcium, iron, or antacids

Do not take with milk, calcium, iron, magnesium, or antacids if separation is recommended.

Zoledronic acid is a bisphosphonate given intravenously to strengthen bones and reduce bone loss. It is used in osteoporosis, Paget’s disease of bone, prevention of bone complications in some cancers with bone metastases, and treatment of cancer-related hypercalcaemia. It works by slowing down bone breakdown.

It is administered as an infusion into a vein, at intervals that depend on the indication: sometimes once yearly in osteoporosis, more often in oncology. Before treatment, kidney function, calcium and vitamin D are usually checked. Patients may receive calcium and vitamin D supplements and should be well hydrated unless the doctor advises otherwise.

Side effects may include fever, muscle or bone pain, chills and flu-like symptoms after the infusion, especially after the first dose. Low calcium, kidney injury, eye pain, rhythm problems or infusion-site reactions may occur. A rare but important risk is osteonecrosis of the jaw, especially in cancer patients.

Tell the doctor before treatment if you have kidney disease, dental problems, planned tooth extraction, low calcium, pregnancy or breastfeeding. Contact a doctor urgently if severe jaw pain, loose teeth, mouth sores, thigh or hip pain, muscle spasms, numbness, reduced urination or swelling occurs. Preventive dental assessment may be needed.

General data about ACID ZOLEDRONIC ROMPHARM 4mg / 5ml

Substance:
zoledronic acid
Date of latest medicines list:
01-06-2026
Product code:
W71498001
Concentration:
4mg / 5ml
Pharmaceutical form:
concentrate for solution for infusion
Quantity:
1
Product type:
Generic medicine
Price:
196.24 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
ROMPHARM COMPANY S.R.L. - ROMANIA
Holder:
ROMPHARM COMPANY S.R.L. - ROMANIA
Number:
16315/2025/01
Shelf life:
3 years-after packing for marketing;after the first opening of the bottle-it is used immediately

Concentrations available for zoledronic acid

  • 4mg
  • 4mg/100ml
  • 4mg/5ml
  • 5mg
  • 5mg/100ml

Compensation lists for ACID ZOLEDRONIC ROMPHARM 4mg / 5ml Rompharm

NHP 3 (C2) - NHP oncology

Price
196.24 RON
Copayment
142.60 RON
Patient
53.64 RON