GENERIC NAME OF THE MEDICINAL PRODUCT:
2. Miltefosine capsules 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Miltefosine……………..…………………..10mg
Excipients…………………………………..………q.s.
2. Each Hard Gelatin Capsules contains:
Miltefosine……………..…………………..50mg
Excipients…………………………………..………q.s.
THERAPEUTIC INDICATIONS:
CAUTION & SCHEDULE:
SCHEDULE: SCHEDULE H: Not to be sold by retail without the prescription of a Registered medical practitioner.
STORAGE & DOSAGE:
Dosage: As directed by the Physician.
Miltefosine capsules 50mg Technical Specification:
| Product Name: | Miltefosine capsules 50mg |
| Brand Name: | Impataj |
| Strength: | 10mg, 50mg |
| Dosage Form: | Capsules |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antiprotozoal |
| Indication: | Miltefosine belongs to class of drugs called antimicrobial agent. It interacts with essential proteins and chemicals which are required for growth and survival of parasite, thereby causing death. |
| Storage: | Store in a cool, dry & dark place. Do not store in the bathroom. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Miltefosine capsules 10mg
- Miltefosine capsules 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Each Hard Gelatin Capsules contains:
Miltefosine……………..…………………..10mg
Excipients…………………………………..………q.s. - Each Hard Gelatin Capsules contains:
Miltefosine……………..…………………..50mg
Excipients…………………………………..………q.s.
THERAPEUTIC INDICATIONS:
Miltefosine is used to treat certain types of leishmaniasis , including visceral leishmaniasis ( affects the internal organs) , cutaneous leishmaniasis (affects the skin ) , or mucosal leishmaniasis (affects the skin ) , or mucosal leishmaniasis(affects the nose , mouth , or throat).
CAUTION & SCHEDULE:
CAUTION: Miltefosine must not be used during pregnancy , and women of child bearing potential should have a negative pregnancy test before starting the medication.
SCHEDULE: SCHEDULE H: Not to be sold by retail without the prescription of a Registered medical practitioner.
STORAGE & DOSAGE:
Storage: Store in a cool, dry & dark place. Do not store in the bathroom.
Dosage: As directed by the Physician.






