APREPITANT COMBI PACK Capsules, hard 250/80 mg

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Aprepitant

Available from:

Eurolab (Pty) Ltd, SOUTH AFRICA

ATC code:

aprepitant

INN (International Name):

Aprepitant

Dosage:

250/80 mg

Pharmaceutical form:

Capsules, hard

Manufactured by:

Rontis Hellas S.A., Medical and Pharmaceutical Products, GREECE

Product summary:

Physical description: Repimend80; Opeque size 2 hard gelatine capsule with a white body and cap, containing white to off white pellets Repimend 125; Opeque size 1 hard gelatine capsule with a white body and cap, containing white to off white pellets; Local technical representative: BB PHARMA CONSULTANCY LTD (3955)

Authorization status:

Registered/Compliant

Authorization date:

2021-08-20

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Repimend 80 mg hard capsules
Repimend 125 mg hard capsules
Repimend 125 mg + 80 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Repimend_ 80 mg hard capsules _
Each hard capsule contains 80 mg of aprepitant.
Excipient with known effect
Each capsule contains 80 mg of sucrose (in the 80 mg capsule).
Repimend
_ 125 mg hard capsules _
Each hard capsule contains 125 mg of aprepitant.
Excipient with known effect
Each capsule contains 125 mg of sucrose (in the 125 mg capsule).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
_Repimend80 mg hard capsules _
Opaque hard gelatin capsules with a white body and cap, containing
white to off-white pellets.
_Repimend125 mg hard capsules _
Opaque hard gelatin capsules with a white body and pink cap,
containing white to off-white pellets.
4.
CLINICAL PARTICULARS
1. THERAPEUTIC INDICATIONS
Prevention nausea and vomiting associated with highly and moderately
emetogenic cancer
chemotherapy in adults and adolescents from the age of 12.
Repimend125 mg/80 mg is given as part of combination therapy (see
section 4.2).
2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Repimendis given for 3 days as part of a regimen that includes a
corticosteroid and a 5-HT
3
antagonist. The recommended dose is Repimend125 mg orally once daily
one hour before
start of chemotherapy on Day 1 and Repimend80 mg orally once daily on
Days 2 and 3 in the
morning.
The following regimens are recommended in adults for the prevention of
nausea and vomiting
associated with emetogenic cancer chemotherapy:
_ Highly Emetogenic Chemotherapy Regimen _
_ _
DEXAMETHASONE should be administered 30 minutes prior to chemotherapy
treatment on Day
1 and in the morning on Days 2 to 4. The dose of dexamethasone
accounts for active
substance interactions.
Day 1
Day 2
Day 3
Day 4
Aprepitant
125 mg
orally
80 mg
orally
80 mg
orally
none
Dexamethaso
ne
12 mg
orally
8 mg
orally
8 mg
orally
8 mg
orally
5-HT
3
an