Apo-Cilazapril

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Cilazapril monohydrate 1.0425mg equivalent to 1 mg Cilazapril

Tilgængelig fra:

Apotex NZ Ltd

INN (International Name):

Cilazapril monohydrate 1.0425 mg (equivalent to 1 mg Cilazapril)

Dosering:

1 mg

Lægemiddelform:

Film coated tablet

Sammensætning:

Active: Cilazapril monohydrate 1.0425mg equivalent to 1 mg Cilazapril Excipient: Hyprolose Hypromellose Iron oxide yellow Macrogol 8000 Maize starch Microcrystalline cellulose Purified water Sodium stearyl fumarate Titanium dioxide

Recept type:

Prescription

Fremstillet af:

Hetero Labs Limited

Terapeutiske indikationer:

APO-CILAZAPRIL is indicated in the treatment of all grades of essential hypertension and renovascular hypertension.

Produkt oversigt:

Package - Contents - Shelf Life: Bottle, White HDPE opaque round bottle with blue PP cap and lift N peel Al liner, Desiccant in caniste - 200 tablets - 24 months from date of manufacture stored at or below 25°C protect from light and moisture

Autorisation dato:

2016-05-25

Produktets egenskaber

NEW ZEALAND DATA SHEET
APO-CILAZAPRIL
1. APO-CILAZAPRIL (1MG, 2.5MG & 5MG FILM COATED TABLETS)
APO-CILAZAPRIL 1mg film coated tablets
APO-CILAZAPRIL 2.5mg film coated tablets
APO-CILAZAPRIL 5mg film coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Cilazapril monohydrate 1.0425mg (equivalent to Cilazapril 1mg)
Cilazapril monohydrate 2.606mg (equivalent to Cilazapril 2.5mg)
Cilazapril monohydrate 5.213mg (equivalent to Cilazapril 5mg)
Chemical Structure:
Molecular Formula:
C
22
H
31
N
3
O
5
.H
2
O
Molecular Mass:
435.50
Excipient(s) with known effect
APO-CILAZAPRIL contains corn starch.
APO-CILAZAPRIL is gluten free and lactose free
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
1mg APO-CILAZAPRIL Yellow, oval, biconvex, film coated tablet.
Engraved “CZ” over
European bisect “1” on one side, “APO” on the other side. Each
tablet typically weighs
82mg
2.5mg APO-CILAZAPRIL Dusty rose, oval, biconvex, film coated tablet.
Engraved “CZ”
over European bisect “2.5” on one side, ’APO” on the other
side. Each tablet typically
weighs 82mg.
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 14
APO-CILAZAPRIL
5mg APO-CILAZAPRIL Reddish-brown, oval, biconvex, film coated tablet.
Engraved “CZ”
over European bisect “5” on one side, “APO” on the other side.
Each tablet typically
weighs 82mg.
The tablet can be divided into equal doses
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
APO-CILAZAPRIL is indicated in the treatment of all grades of
essential hypertension
and renovascular hypertension.
•
APO-CILAZAPRIL is also indicated in the treatment of congestive heart
failure as an
adjunctive therapy with digitalis and/or diuretics.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
STANDARD DOSAGE
APO-CILAZAPRIL should be administered once daily. As food intake has
no clinically
significant influence on absorption, APO-CILAZAPRIL can be
administered before or after
a meal. The dose should always be taken at about the sa