IVERGALEN Tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Ivergalen 3 mg, tablet.
2. Qualitative and quantitative composition
1 tablet contains 3 mg of ivermectin. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. The tablets are round, white or almost white, flat chamfered with a diameter of 5.5 mm and thickness of 2.1 mm.
4.1. Therapeutic indications
Treatment of gastrointestinal strongyloidiasis (anguillulosis). Treatment of suspected or diagnosed microfilaraemia in patients with lymphatic filariasis due to Wuchereria bancrofti. Treatment of human ...
4.2. Posology and method of administration
Posology Treatment of gastrointestinal strongyloidiasis The recommended dosage is one single oral dose of 200 micrograms of ivermectin per kg body weight. For guidance, the dose, as determined by the patient ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
4.4. Special warnings and precautions for use
Special warnings Efficacy and dosing regimen of ivermectin in immunocompromised patients being treated for intestinal strongyloidiasis have not been established by adequate clinical studies. There have ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Pregnancy During mass treatment of onchocerciasis, data on a limited number (approximately 300) of pregnant women indicated no adverse effects such as congenital anomalies, spontaneous abortions, stillbirths ...
4.7. Effects on ability to drive and use machines
The effect of Ivergalen on the ability to drive and use machines has not been studied. The possibility in some patients of side effects such as dizziness, somnolence, vertigo and tremor, which may affect ...
4.8. Undesirable effects
Tabulated list of adverse reactions The adverse reactions are classified by System Organ Class and frequency, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 ...
4.9. Overdose
Cases of accidental overdose with ivermectin have been reported, but none have resulted in fatalities. In cases of accidental intoxication with unknown doses of products destined for veterinary use (oral ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Anthelmintics <b>ATC code:</b> P02CF01 Ivermectin is derived from avermectins isolated from fermentation broths of Streptomyces avermitilis. It has high affinity with ...
5.2. Pharmacokinetic properties
Absorption The mean peak plasma concentration of the major component (H2B1a) observed about 4 hours after oral administration of a single 12 mg dose of ivermectin in tablet form is 46.6 (± 21.9) ng/mL. ...
5.3. Preclinical safety data
Single-dose toxicity studies conducted in animals showed toxicity to the central nervous system, as manifested by the appearance of mydriasis, tremors and ataxia at high doses in several species (mice, ...
6.1. List of excipients
Cellulose, microcrystalline (E460) Pregelatinised maize starch Butylhydroxyanisole (E320) Magnesium stearate (E470b)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
18 months.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original packaging in order to protect from light.
6.5. Nature and contents of container
Do not store above 25°C. Store in the original packaging in order to protect from light.
6.6. Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Galenicum Derma, S.L., Ctra. N-1, Km 36, 28750 San Agustin de Guadalix (Madrid), Spain
8. Marketing authorization number(s)
Ivergalen 3 mg, tablet: RVG 125826
9. Date of first authorization / renewal of the authorization
18 november 2020
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