Ztalmy

Treatment should be initiated and supervised by physicians with experience in the treatment of epilepsy. Posology Children and adolescents ZTALMY should be titrated gradually to achieve individual clinical response and tolerability.

Any patient not tolerating the dosing steps shown in the tables below, can be maintained at the lower dose for additional days before advancing to the next dose. If the next dose is still not tolerated, patients can drop back to the previous lower dose.

ZTALMY must be administered 3 times a day. It is recommended that the total daily dose is administered in 3 equal doses throughout the day. , somnolence), provided that the total daily dose is administered. Patients weighing ≤ 28 kg The recommended maximum daily dose is 63 mg/kg/day given in three separate doses (every 8 hours).

A minimum dose of 33 mg/kg/day is generally required. 42 63 mg/kg Patients weighing > 28 kg The recommended maximum daily dose is 1 800 mg per day given in three separate doses (every 8 hours). A minimum dose of 900 mg/day is generally required.

The recommended titration schedule for patients weighing more than 28 kg is shown below: Week Dose (given 3 times a day) mL per single dose Total daily dose Week 1 150 mg 3 450 mg Week 2 300 mg 6 900 mg Week 3 450 mg 9 1 350 mg Week 4 – ongoing 600 mg 12 1 800 mg Adults The efficacy and safety of treatment initiation with ZTALMY in patients aged over 17 years have not yet been established.

In adolescents in whom a clear treatment benefit has been demonstrated, treatment may be continued into adulthood. 2) Discontinuation If ZTALMY must be discontinued, the dose should be decreased gradually. For patients weighing 28 kg or less, the decrease in total daily dose should be 15 mg/kg every four days.

For patients weighing more than 28 kg, the decrease in total daily dose should be 450 mg every four days. ZTALMY may be stopped immediately and without down-titration in the case of an emergency, however, a down-titration is recommended to minimize the risk of increased seizure frequency and status epilepticus.

Missed doses Missed doses may be taken up to 4 hours before the next scheduled dose. When the next dose is due in less than 4 hours, it is recommended to skip the dose and to continue with the next scheduled dose. 4 Special populations Elderly There is no information on the use of ZTALMY in patients with CDD who are 65 years of age and over.

5%). 5 days (N = 102) are listed in the table below by System Organ Class and frequency. The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 8 System organ class Very common Common Nervous system disorders Somnolence Sedation Hypersomnia Lethargy Drooling Gastrointestinal disorders Salivary hypersecretion General disorders and administration site conditions Pyrexia Description of selected adverse reactions Somnolence and sedation ZTALMY can cause somnolence and sedation.

9% respectively in patients treated with placebo. These adverse reactions appear early in treatment and are dose-related; symptoms may decrease with continued treatment. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

8). Other Central Nervous System (CNS) depressants, including concomitantly used anti-seizure medicinal products, opioids, antidepressants, and alcohol, could potentiate the somnolence and sedation effect. Suicidal behaviour and ideation Suicidal behaviour and ideation have been reported in patients treated with anti-epileptic drugs (AEDs) in several indications.

A meta-analysis of randomised placebo-controlled trials with AEDs has shown a small increased risk of suicidal behaviour and ideation. The mechanism of this risk is not known. The available data do not exclude the possibility of an increased risk with ganaxolone.

Patient’s caregivers should be advised to monitor for signs of suicidal behaviour and ideation, or self-harm behaviour during treatment and when changes in the treatment regimen become necessary. Caregivers should be advised to seek medical advice should any signs of suicidal behaviour and ideation, or self-harm emerge.

Alcohol use In animal models, ganaxolone has been shown to potentiate the effects of alcohol. 5). g. 5). 2). 2). 3). 3). 2). Excipients with known effect This medicinal product contains less than 1 mmol sodium (23 mg) per each daily dose, that is to say essentially ‘sodium-free’.

00068 mg benzoic acid in each mL. Benzoate salt and benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old). 00023 mg benzyl alcohol in each mL. Benzyl alcohol may cause allergic reactions.

Monitor patients less than 3 years of age for respiratory symptoms. Advise patients who are pregnant or breastfeeding of the potential risk from the excipient benzyl alcohol, which might accumulate over time and cause metabolic acidosis.

Use with caution in patients with hepatic or renal impairment, because of the potential risk from the excipient benzyl alcohol which may accumulate over time and cause metabolic acidosis. 2 mg propyl parahydroxybenzoate in each mL. Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

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