GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Hard Gelatin Capsule contains:
Miltefosine ………………50mg
Excipients ……………………. q.s.
Approved colours are used in empty
capsule shell: Brilliant Blue FCF
THERAPEUTIC INDICATIONS:
Miltefosine use to treat a certain infection called leishmaniasis. It works by stopping the growth of certain n parasites.
CAUTION & WARNING:
Read enclosed leaflet before use.
Take one tablet by mouth three times daily.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
EMBRYO-FETAL TOXICITY
KEEP MEDICINE OUT OF REACH OF CHILDREN.
STORAGE & DOSAGE:
Do not store in the bathroom.
Dosage: Adolescent/adult patients aged 12-65 years received Impataj orally for 28 days. Impataj target dose was 2.5 mg/kg/day.
Daily dosage to 150mg (3 capsules).
Attach dispensing label as per end country. < /br>
Miltefosine capsules 50mg Technical Specification:
| Product Name: | Miltefosine capsules |
| Brand Name: | Impataj |
| Strength: | 50mg |
| Dosage Form: | Hard Gelatin Capsule |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-leishmaniasis Agents |
| Indication: | Miltefosine capsules is an antibiotic. It is used in the treatment of kala-azar (a parasitic disease spread by the bite of infected sand files). It inhibits the growth of parasite and kills it, thus relieving your infection. Miltefosine use to treat a certain infection called leishmaniasis. It works by stopping the growth of certain n parasites. |
| Storage: | Store in a cool, dry & dark place. Do not store in the bathroom. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Miltefosine capsules 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Miltefosine capsules 50mg
Each Hard Gelatin Capsule contains:
Miltefosine ………………50mg
Excipients ……………………. q.s.
Approved colours are used in empty
capsule shell: Brilliant Blue FCF
THERAPEUTIC INDICATIONS:
Miltefosine capsules is an antibiotic. It is used in the treatment of kala-azar (a parasitic disease spread by the bite of infected sand files). It inhibits the growth of parasite and kills it, thus relieving your infection.
Miltefosine use to treat a certain infection called leishmaniasis. It works by stopping the growth of certain n parasites.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
Take one tablet by mouth three times daily.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
EMBRYO-FETAL TOXICITY
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Store in a cool, dry & dark place. Do not store in the bathroom.
Dosage: Adolescent/adult patients aged 12-65 years received Impataj orally for 28 days. Impataj target dose was 2.5 mg/kg/day.
Daily dosage to 150mg (3 capsules).
Attach dispensing label as per end country.
