Leaflet BACLOFEN SINTETICA 0.5mg / ml solution for injection

Product code:
W69460001
Quantity:
1
Indicated for:
spasticity; muscle spasms
Route of administration:
injectable
Substance:
baclofen (muscle relaxant)
ATC
M03BX01 — Musculo-skeletal system | Muscle relaxants | Muscle relaxants, centrally acting agents | Other centrally acting agents
Baclofen is a muscle relaxant used in the treatment of spasticity associated with neurological conditions such as multiple sclerosis, spinal cord injuries, or cerebral palsy. It works by inhibiting exaggerated spinal reflexes, reducing muscle tone and painful spasms.

Baclofen is administered orally, usually 2-4 times daily, with the dose gradually adjusted to minimize side effects. In severe cases, it can be administered intrathecally via an implantable pump for more effective spasticity control.

Common side effects include drowsiness, dizziness, muscle weakness, and nausea. In rare cases, severe adverse reactions such as respiratory depression, confusion, or hypotension may occur. It is important to taper off the treatment gradually to avoid withdrawal symptoms.

Baclofen is a valuable therapeutic option for patients with severe spasticity, contributing to improved mobility and quality of life.

General data about BACLOFEN SINTETICA 0.5mg / ml

Substance:
baclofen
Date of latest medicines list:
01-04-2026
Product code:
W69460001
Concentration:
0.5mg / ml
Pharmaceutical form:
solution for injection
Quantity:
1
Product type:
Generic medicine
Prescription status:
P-6L — Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.

Marketing authorisation

Manufacturer:
SINTETICA GMBH - GERMANIA
Holder:
DIRECT PHARMA LOGISTICS S.R.L. - ROMANIA
Number:
783/2023/01
Shelf life:
5 years

Pharmaceutical forms available for baclofen

Concentrations available for baclofen

  • 0.05mg/ml
  • 0.5mg/ml
  • 10mg
  • 25mg
  • 2mg/ml