Leaflet SINDAXEL 6mg / ml concentrate for solution for infusion

Product code:
W64717004
Quantity:
1
Indicated for:
cancer
Route of administration:
infusion
Substance:
paclitaxel (taxane antineoplastic)
ATC
L01CD01 — Antineoplastic and immunomodulating agents | Plant alkaloids and other natural products | Taxanes

Precautions:

Fertility warning

Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment

Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Cytotoxic / special handling

Cytotoxic / special handling

Handle with special care.

Contraception required

Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding

Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy

Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity

Hepatotoxicity

This medicine may affect the liver.

Major drug interactions

Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis

Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring

Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests

Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions

Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.

Paclitaxel is a chemotherapy agent used in the treatment of various cancers, including breast, ovarian, and lung cancer. It works by inhibiting cell division, stabilizing microtubules, and preventing chromosome separation during mitosis.

The medication is administered intravenously, as directed by a doctor, usually once every three weeks. It is important for patients to follow the treatment regimen and undergo regular tests to monitor the therapy's effects.

Patients should be aware of potential side effects, such as nausea, hair loss, or peripheral neuropathy. It is important to inform the doctor of any unusual symptoms.

Common side effects include nausea, hair loss, and peripheral neuropathy. In rare cases, severe reactions such as myelosuppression or allergic reactions may occur. Patients should be informed of these risks before use.

General data about SINDAXEL 6mg / ml

Substance:
paclitaxel
Date of latest medicines list:
01-06-2026
Product code:
W64717004
Concentration:
6mg / ml
Pharmaceutical form:
concentrate for solution for infusion
Packing volume:
43,33ml
Product type:
Generic medicine
Price:
1032.01 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
SINDAN-PHARMA S.R.L. - ROMANIA
Holder:
TEVA B.V. - OLANDA
Number:
9154/2016/04
Shelf life:
3 years

Concentrations available for paclitaxel

  • 5mg/ml
  • 6mg/ml

Compensation lists for SINDAXEL 6mg / ml Teva

NHP 3 (C2) - NHP oncology

Price
1032.01 RON
Copayment
1032.01 RON
Patient
0.00 RON