NEURONTIN Capsule, hard (2018)
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Περιεχόμενα
Name of the medicinal product
Neurontin 100 mg hard capsules.
Qualitative and quantitative composition
Each 100 mg hard capsule contains 100 mg of gabapentin. Excipients with known effect: Each 100 mg hard capsule contains 13 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. ...
Pharmaceutical form
Capsule, hard. A two-piece, white opaque hard gelatin capsule, imprinted with Neurontin 100 mg and PD and containing a white to off-white powder.
Therapeutic indications
Epilepsy Neurontin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1). Neurontin ...
Posology and method of administration
Posology For all indications a titration scheme for the initiation of therapy is described in Table 1, which is recommended for adults and adolescents aged 12 years and above. Dosing instructions for children ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) Severe, life-threatening, systemic hypersensitivity reactions such as Drug rash with eosinophilia and systemic symptoms (DRESS) have been reported ...
Interaction with other medicinal products and other forms of interaction
There are spontaneous and literature case reports of respiratory depression and/or sedation associated with gabapentin and opioid use. In some of these reports, the authors considered this a particular ...
Fertility, pregnancy and lactation
Pregnancy Risk related to epilepsy and antiepileptic medicinal products in general The risk of birth defects is increased by a factor of 2–3 in the offspring of mothers treated with an antiepileptic medicinal ...
Effects on ability to drive and use machines
Gabapentin may have minor or moderate influence on the ability to drive and use machines. Gabapentin acts on the central nervous system and may cause drowsiness, dizziness or other related symptoms. Even, ...
Undesirable effects
The adverse reactions observed during clinical studies conducted in epilepsy (adjunctive and monotherapy) and neuropathic pain have been provided in a single list below by class and frequency: very common ...
Overdose
Acute, life-threatening toxicity has not been observed with gabapentin overdoses of up to 49 g. Symptoms of the overdoses included dizziness, double vision, slurred speech, drowsiness, loss of consciousness, ...
Pharmacodynamic properties
Pharmacotherapeutic groups: Other antiepileptics ATC code: N03AX12 Mechanism of action Gabapentin readily enters the brain and prevents seizures in a number of animal models of epilepsy. Gabapentin does ...
Pharmacokinetic properties
Absorption Following oral administration, peak plasma gabapentin concentrations are observed within 2 to 3 hours. Gabapentin bioavailability (fraction of dose absorbed) tends to decrease with increasing ...
Preclinical safety data
Carcinogenesis Gabapentin was given in the diet to mice at 200, 600, and 2000 mg/kg/day and to rats at 250, 1000, and 2000 mg/kg/day for two years. A statistically significant increase in the incidence ...
List of excipients
Each hard capsule contains the following excipients: Lactose monohydrate Maize starch Talc Capsule shell: Gelatin Purified water Sodium laurilsulfate The 100 mg hard capsules contain the colouring E171 ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
PVC/PVDC/aluminium foil blister packs Supplied in packs of 20, 30, 50, 60, 84, 90, 98, 100, 200, 500 or 1000 capsules. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/0853
Date of first authorization / renewal of the authorization
28<sup>th</sup> May 2007
Date of revision of the text
09/2018
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