Leaflet TIGECICLINA ROMPHARM 50mg powder for solution for infusion

Indicated for: bacterial infections

Route of administration: infusion

Substance: tigecycline (tetracycline antibiotic)

ATC: J01AA12 (Antiinfectives for systemic use | Tetracyclines)

Precautions:
Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Anaphylaxis
Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Colitis / severe diarrhea
Colitis / severe diarrhea

Seek medical advice if severe or persistent diarrhea occurs.

Contraindicated in children
Contraindicated in children

Do not give to children for whom it is contraindicated.

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.

Photosensitivity
Photosensitivity

Avoid excessive exposure to sunlight or UV radiation.

Tigecycline is an antibiotic from the glycylcycline class used for the treatment of complicated bacterial infections, including intra-abdominal infections, skin and soft tissue infections, and hospital-acquired pneumonia. It works by inhibiting bacterial protein synthesis and has a broad spectrum of activity against gram-positive, gram-negative, and anaerobic bacteria.

The medication is administered intravenously, as directed by a doctor, and the dosage is adjusted based on the severity of the infection and the patient's condition. It is primarily used for infections caused by bacteria resistant to other antibiotics.

Patients should be monitored for potential side effects, such as nausea, vomiting, diarrhea, or injection site reactions. It is important for patients to inform their doctor of any unusual symptoms.

Common side effects include nausea, vomiting, diarrhea, and abdominal pain. In rare cases, severe reactions such as pancreatitis or superinfections may occur. Patients should be informed of these risks before starting treatment.

General data about TIGECICLINA ROMPHARM 50mg

  • Substance: tigecycline
  • Date of latest medicines list: 01-06-2026
  • Product code: W68708002
  • Concentration: 50mg
  • Pharmaceutical form: powder for solution for infusion
  • Quantity: 10
  • Product type: Generic medicine
  • Price: 1478.11 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: 14375/2022/02
  • Shelf life: 2 years-after packing for marketing;after reconstitution-it is used immediately

Concentrations available for tigecycline

  • 10mg/ml
  • 50mg