Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
Levetiracetam
UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia
Medicine Registered
1 KEPPRA ® _ _oral solution (pronounced “KEPP-ruh”) _ _ _Contains the active ingredient levetiracetam (pronounced "LEE ve tye RA se tam") _ _ _ CONSUMER MEDICINE INFORMATION _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Keppra. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Keppra against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT KEPPRA IS USED FOR Keppra is used to control epilepsy. Epilepsy is a condition where you have repeated seizures. There are many different types of seizures, ranging from mild to severe. This medicine belongs to a group of medicines called antiepileptics. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. Keppra may be used alone, or in combination with other medicines, to treat your condition. Your doctor may have prescribed this medicine in addition to your current therapy. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. There is no evidence that this medicine is addictive. This medicine is available only with a doctor’s prescription. The safety and effectiveness of Keppra has not been established in patients less than 4 years of age. BEFORE YOU TAKE KEPPRA _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE KEPPRA IF YOU HAVE AN ALLERGY TO: • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty Прочитать полный документ
KEPPRA IV PI 18 th September 2012 (g2012-314) Page 1 of 22 PRODUCT INFORMATION KEPPRA (LEVETIRACETAM) CONCENTRATE SOLUTION FOR IV INFUSION NAME OF THE MEDICINE Non-proprietary name: Levetiracetam Chemical name: (S)- α-ethyl-2-oxo-1-pyrrolidineacetamide Chemical structure: Molecular formula: C 8 H 14 N 2 O 2 CAS number: 102767-28-2 DESCRIPTION Levetiracetam is a white to off-white powder with a faint odour and a bitter taste. It is very soluble in water (104 g/100mL). It is freely soluble in chloroform (65.3 g/100mL) and in methanol (53.6 g/100mL), soluble in ethanol (16.5 g/100mL), sparingly soluble in acetonitrile (5.7 g/100mL) and practically insoluble in n-hexane. KEPPRA concentrate solution for IV infusion contains 500 mg of levetiracetam (500 mg/5 mL). The excipients are sodium acetate, sodium chloride, acetic acid- glacial and water for injections. PHARMACOLOGY MECHANISM OF ACTION The precise mechanism of action by which levetiracetam induces seizure protection still remains to be fully elucidated, but appears to be unrelated to the mechanisms of current anti-epileptic drugs. _In vitro _ and _in vivo _experiments suggest that levetiracetam does not alter basic cell characteristics and normal neurotransmission. _In vitro_ studies show that levetiracetam affects intraneuronal Ca 2+ levels by partial inhibition of N- type Ca 2+ currents and by reducing the release of Ca 2+ from intraneuronal stores. In addition, it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β- carbolines. Furthermore, levetiracetam has been shown in _in vitro_ studies to bind to a specific site in rodent brain tissue. This binding site is the synaptic vesicle protein 2A, believed to be involved in vesicle fusion and neurotransmitter exocytosis. Levetiracetam and related analogues show a rank order of affinity for bi Прочитать полный документ