AKLONIL Tablet (2018)
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Περιεχόμενα
1. Name of the medicinal product
Aklonil 2 mg tablets.
2. Qualitative and quantitative composition
Each tablet contains 2 mg clonazepam. <u>Excipient with known effect:</u> lactose monohydrate. Each 2mg tablet contains 112.0mg lactose monohydrate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. Aklonil 2 mg tablets are white, round, flat, scored, uncoated tablets.
4.1. Therapeutic indications
Aklonil tablets are indicated for all clinical forms of epileptic seizures and disease in infants, children and adults, especially absence seizures (petit mal) including atypical absence; primary or secondarily ...
4.2. Posology and method of administration
Posology Adults Initial dosage should not exceed 1 mg/day. The maintenance dosage for adults normally falls within the range 4 to 8 mg. Elderly The elderly are particularly sensitive to the effects of ...
4.3. Contraindications
Hypersensitivity to benzodiazepines or to any of the excipients listed in section 6.1. Patients with acute pulmonary insufficiency; severe respiratory insufficiency, sleep apnoea syndrome, myasthenia gravis, ...
4.4. Special warnings and precautions for use
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomized placebo controlled trials of anti-epileptic drugs ...
4.5. Interaction with other medicinal products and other forms of interaction
Not recommended In combination with clonazepam, alcohol may modify the effects of the drug, compromise the success of therapy or give rise to unpredictable side-effects (see also section 4.4). See section ...
4.6. Pregnancy and lactation
Pregnancy Preclinical studies in animals have shown reproductive toxicity and from preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations ...
4.7. Effects on ability to drive and use machines
As a general rule, epileptic patients are not allowed to drive. Even when adequately controlled on clonazepam, it should be remembered that any increase in dosage or alteration in timings of dosage may ...
4.8. Undesirable effects
<b>The following have been observed:</b> <u>Immune system disorders</u> Allergic reactions and very rare cases of anaphylaxis have been reported to occur with benzodiazepines. Angioedema may occur in rare ...
4.9. Overdose
Symptoms The symptoms of overdosage or intoxication vary greatly from person to person depending on age, bodyweight and individual response. Benzodiazepines commonly cause drowsiness, ataxia, dysarthria ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Benzodiazepine derivatives <b>ATC Code:</b> N03AE01 Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, ...
5.2. Pharmacokinetic properties
Absorbtion Clonazepam is quickly and completely absorbed after oral administration. Peak plasma concentrations are reached in most cases within 1–4 hours after an oral dose. Bioavailability is 90% after ...
5.3. Preclinical safety data
Carcinogenicity Conventional studies of carcinogenic potential have not been conducted with clonazepam. However, in an 18-month chronic study in rats no treatment-related histopathological changes were ...
6.1. List of excipients
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Sodium lauryl sulphate Colloidal anhydrous silica Magnesium stearate
6.2. Incompatibilities
None known.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C, in the original package in order to protect from light and moisture.
6.5. Nature and contents of container
Aluminium foil-polyvinylchloride blisters in card carton with leaflet. Packs with 40 tablets are available. Dispensing packs of 100 and 500 tablets and boxes of 1000 tablets are available. Securitainers ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
MEDOCHEMIE LTD., 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
9040
9. Date of first authorization / renewal of the authorization
15.09.1983 / 12.07.2010
10. Date of revision of the text
26/04/2018
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