SOS MECTIN^®-3

COMPOSITION: Each film-coated tablet contains:

Ivermectin............................................... 3.0 mg

Excipients: Microcrystalline cellulose, Pregelatinised starch, Citric acid, Magnesium stearate, Talc, Opadry II white, Tartrazine yellow.

INDICATIONS

SOS MECTIN^®-3 is indicated for adult patients and children ≥ 15 kg:

• Treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus.
• The treatment of Strongyloidiasis of the intestinal tract.

DOSAGE & ADMINISTRATION

Method of Administration: SOS MECTIN^®-3 should be taken with water on empty stomach or at any time without meals taken 2 hours before and after administration.

Dosage:

Adults and children ≥ 15 kg and above 5 years:

• Onchocerciasis due to Onchocerca: a single oral dose of 0.15 mg/ kg. Higher doses may increase adverse reactions without an increase of efficacy. Re-treatment is required every 3-12 months until the symptoms disappear.
• Strongyloidiasis due to Strongyloides stercoralis: a single oral dose of 0.2 mg/ kg. Stool examination should be performed.  Other dosage: 0.2 mg/kg/day for 2 days.
• Ascariasis due to Ascaris lumbricoides: a single oral dose of 0.15 – 0.2 mg/kg.
• Cutaneous Larva Migrans due to Ancylostoma braziliense:2 mg/kg/day, for 1-2 day(s).
• Filariasis due to Mansonella ozzardi: a single oral dose of 0.2 mg/kg.
• Filariasis due to Mansonella streptocerca: a single oral dose of 0.15 mg/kg.
• Filariasis due to Wucheria bancrofti: a single oral dose of 15 mg/kg with albendazole.

Dosage guidelines for ivermectin based on body weight:

Required dosage: 0.15 mg/kg

Required dosage: 0.2 mg/kg

CONTRAINDICATIONS

• Patients who are hypersensitive to ivermectin or any components of this product.
• Filariasis due to Loa loa as potentiality of severe encephalopathies.

WARNINGS  AND PRECAUTIONS

• Severe encephalopathies have been reported in patients treated onchocerciasis with ivermectin in Loa loa endemic areas (microfilarie in the blood).
• Safety and effectiveness in pediatric patients weighing < 15 kg have not been established. Use of children weighing < 15 kg and under 2 years of age do not recommend because the blood-brain barrier may be less developed than in older patients.
• Community treatment should exclude pregnant women, children weighing < 15 kg and patients who are seriously ill.
• Ivermectin might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis.
• In immunocompromised patients, repeated courses of therapy may be required.
• Since ivermectin is a GABA agonist, there is a concern over CNS effects of ivermectin in patients with impaired blood-brain barrier (e.g. meningitis, Trypanosomiasis).
• Treatment with ivermectin in patients with hyperreactive onchodermatitis, experience severe adverse reactions, especially edema and aggravation of onchodermatitis may be more likely than others.

Pregnancy

Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Ivermectin should not be used during pregnancy.

Breast feeding

Ivermectin is excreted in human milk in low concentrations (less than 2% of therapeutic dose). Safety in nursing infants has not been established, therefore treatment of mothers who intend to breastfeed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Ivermectin may cause dizziness. Patients should be warned not to drive or operate machinery if they experience dizziness or related symptoms. The use food of alcohol may be limited.

PRESENTATION: Blisters of 4 film-coated tablets, Box of 1 blisters.

Keep out of reach of children

Read the package insert carefully before use

Ask your doctor for further information

Use upon doctor’s prescription only

Manufactured and distributed by: AMPHARCO U.S.A. - PJSC

Nhon Trach 3 I.P., Hiep Phuoc, Nhon Trach, Dong Nai.

Tel: 02513 566 202    -     Fax: 02513 566 203