GNH USA

Europe — EMA

Lionova

GNH USA supplies Lionova (Baclofen), a muscle relaxant for spasticity associated with multiple sclerosis, spinal cord injury and cerebral palsy.

Baclofen

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What is Baclofen?

Baclofen, the active ingredient in Lionova, is a muscle relaxant presented as an intrathecal infusion solution for intrathecal use. It is employed to reduce muscle spasticity in conditions such as multiple sclerosis, spinal cord injury, and cerebral palsy. It acts centrally to modulate neuronal activity and significantly improve functional mobility.

GNH USA supplies Lionova as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to EU quality standards and provides regulatory documentation for importers.

What is Baclofen used for?

Baclofen is used to manage spasticity disorders affecting the central nervous system.

- Multiple sclerosis: reduces muscle tone and improves mobility in patients with MS‑related spasticity. - Spinal cord injury: alleviates involuntary muscle contractions and facilitates rehabilitation. - Cerebral palsy: decreases spastic muscle activity to aid functional movement.

What are the side effects of Baclofen?

Baclofen may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects: - Drowsiness: feeling of sleepiness or reduced alertness. - Weakness: generalized muscle weakness or fatigue. - Nausea: mild gastrointestinal upset. - Dizziness: sensation of light‑headedness or imbalance.

Serious or Rare Side Effects: - Respiratory depression: slowed or shallow breathing requiring medical attention. - Seizures: occurrence of convulsive episodes. - Hypotension: marked drop in blood pressure.

What precautions apply to Baclofen?

When using intrathecal Baclofen, several precautions should be observed to ensure safety and efficacy.

- Patient assessment: evaluate spasticity severity and underlying neurological condition before initiation. - Dose titration: adjust infusion rate gradually under specialist supervision to avoid abrupt changes. - Renal function: monitor in patients with impaired kidney function as clearance may be affected. - Concomitant CNS depressants: use caution with alcohol, opioids, or benzodiazepines due to additive sedation. - Withdrawal risk: abrupt discontinuation can cause rebound spasticity and autonomic instability; taper slowly. - Store at ambient temperature: keep the solution below 25°C, protected from light and moisture in the original container.

What does Baclofen interact with?

Baclofen can interact with other medications, influencing its efficacy or safety profile.

Major Interactions (Avoid): - Opioids: combined use may enhance central nervous system depression and respiratory compromise. - Benzodiazepines: additive sedative effects increase risk of profound drowsiness. - Antihypertensives: may potentiate blood pressure lowering, leading to hypotension.

Moderate Interactions (Monitor Closely): - Anticonvulsants: may alter seizure threshold; monitor seizure control. - Alcohol: can increase sedation and dizziness. - Muscle relaxants: additive muscle weakness may occur.

Frequently asked questions

What is Lionova used for?+
Lionova contains baclofen and is indicated for the treatment of muscle spasticity in patients with multiple sclerosis, spinal cord injury, or cerebral palsy. By reducing involuntary muscle contractions, it helps improve mobility and comfort in these neurological conditions.
How does baclofen work?+
Baclofen acts as an agonist at GABA_B receptors in the central nervous system. Activation of these receptors inhibits excitatory neurotransmitter release and hyperpolarizes spinal neurons, which dampens reflex activity and lowers muscle tone, thereby alleviating spasticity.
What is the usual dose of Lionova?+
The dosing regimen for Lionova is individualized. A qualified prescriber determines the appropriate infusion rate and any adjustments based on the patient’s clinical response, severity of spasticity, and tolerability.
Is Lionova safe in pregnancy or breastfeeding?+
Safety data for intrathecal baclofen during pregnancy and lactation are limited. The product is classified as having an unknown pregnancy category, and clinicians should weigh potential benefits against risks before prescribing to pregnant or nursing individuals.
How do I order Lionova from GNH USA?+
To request Lionova, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.
How does Lionova compare with other antispastic agents?+
Lionova delivers baclofen directly to the intrathecal space, achieving higher spinal concentrations with lower systemic exposure compared with oral baclofen or other oral muscle relaxants such as tizanidine. This route often provides better spasticity control and fewer systemic side effects, especially in severe cases.
How should Lionova be stored and handled?+
Lionova should be stored at ambient temperature, preferably below 25 °C, in its original sealed container. Protect the solution from direct light, moisture and extreme temperature fluctuations to maintain stability before use.
How is Lionova administered?+
Lionova is supplied as an intrathecal infusion solution that is delivered via an implanted pump and catheter system directly into the cerebrospinal fluid. The infusion rate is programmed by a specialist and can be adjusted as needed to manage spasticity.
What are the most serious risks associated with Lionova?+
Serious risks include respiratory depression, severe hypotension, and the possibility of rebound spasticity or autonomic instability if the infusion is abruptly stopped. Patients should be monitored closely for these events, especially during dose changes or pump malfunction.
Who should not use Lionova?+
Lionova is contraindicated in individuals with known hypersensitivity to baclofen, severe uncontrolled epilepsy, or those with significant renal impairment that cannot be monitored. Caution is also advised for patients with unstable cardiovascular conditions or a history of severe hypotension.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Baclofen
Route
Intrathecal Use
Manufacturer
Alternova A/S
Origin
EU

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