Revision Year: 2015 Publisher: Megapharm Ltd, P.O. Box 514, Hod Hasharon, 4510501, Israel Manufacturer: Paesel + Lorei GmbH & Co. KG, Rheinberg, Germany
Impavido 10 mg hard capsules.
Impavido 50 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsules. Impavido 10 mg hard capsules: White powder in a red, opaque hard capsule of size 3 with a white imprint “PLB” on the body and “MILT 10” on the cap. Impavido 50 mg hard capsules: White powder in a red, opaque hard capsule of size 2 with a white imprint “PLB” on the body and “MILT 50” on the cap. |
1 hard capsule contains:
Impavido 10 mg: 10 mg Miltefosine.
Impavido 50 mg: 50 mg Miltefosine.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Miltefosine |
Miltefosine has a marked direct antileishmanial activity in vitro and in animal models. Leishmania donovani was the most sensitive species in promastigote and amastigote test systems. |
| List of Excipients |
|---|
|
Hard capsule content: Collodial anhydroussilica Hard capsule shell: Gelatin Printing ink: Consisting of shellac |
Impavido 10 mg: Pack with 56 hard capsulessealed in 8 aluminium/aluminium blisterstrips, each containing 7 hard capsules.
Impavido 50 mg: Packs with 28 and 56 hard capsulessealed in 4 and 8 aluminium/aluminium blister strips,respectively, each containing 7 hard capsules.
Megapharm Ltd, P.O. Box 514, Hod Hasharon, 4510501, Israel
Manufacturer: Paesel + Lorei GmbH & Co. KG, Rheinberg, Germany
Impavido 10 mg: 154-05-34311
Impavido 50 mg: 154-06-34313
June 2015
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