CRESEMBA isavuconazole (as isavuconazonium sulfate) 100 mg capsule blister pack

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

isavuconazonium sulfate, Quantity: 186.3 mg (Equivalent: isavuconazole, Qty 100 mg)

MAH:

Pfizer Australia Pty Ltd

pharmaceutical_form:

Capsule

composition:

Excipient Ingredients: potassium acetate; gellan gum; iron oxide red; sodium lauryl sulfate; titanium dioxide; hypromellose; disodium edetate; magnesium citrate; microcrystalline cellulose; purified talc; colloidal anhydrous silica; stearic acid; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; Shellac; strong ammonia solution; ethanol absolute; iron oxide black; potassium hydroxide

administration_route:

Oral

units_in_package:

14

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

CRESEMBA is indicated in adults for the treatment of ? invasive aspergillosis ? mucormycosis in patients for whom amphotericin B is inappropriate (see Section 4.4 Special warnings and precautions for use and Section 5.1 Pharmacodynamic properties),Consideration should be given to official guidance on the appropriate use of antifungal agents.

leaflet_short:

Visual Identification: Swedish Orange (reddish-brown) capsule body marked with 100 in black ink and a white cap marked with C in black ink.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

authorization_status:

Registered

authorization_date:

2019-05-17

PIL

CRESEMBA
®
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING CRESEMBA?
CRESEMBA contains the active ingredient isavuconazole. CRESEMBA is
used to treat fungal infections such as invasive
aspergillosis and invasive mucormycosis. This medicine works by
preventing the growth of the fungal organisms causing your
infection.
For more information, see Section 1. Why am I using CRESEMBA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CRESEMBA?
Do not use if you have ever had an allergic reaction to isavuconazole
or any of the ingredients listed at the end of the CMI, or any
other similar medicines such as ketoconazole, fluconazole,
itraconazole, voriconazole or posaconazole.
Do not use CRESEMBA if you are taking any of the medicine listed in
section 3. What if I am taking other medicines?
Do not take this medicine if you have familial short QT syndrome
(Disorder of the heart).
CRESEMBA should not be taken during pregnancy or breastfeeding, unless
indicated by your doctor. Effective contraception should
be used in woman of childbearing potential.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant
or are breastfeeding. For more information, see Section 2. What should
I know before I use CRESEMBA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CRESEMBA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE CRESEMBA?
CRESEMBA is available as capsules for oral use or as an IV powder for
injection. CRESEMBA capsules should be swallowed
whole with a full glass of water. Do not chew, crush, dissolve or open
the capsules. CRESEMBA IV Injection is

SPC

Version : pfpcrema10922
Supersedes: pfpcrema10122
Page 1 of 28
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN
PRODUCT
INFORMATION
–
CRESEMBA®
(ISAVUCONAZOLE)
POWDER
FOR INJECTION AND CAPSULES
1.
NAME OF THE MEDICINE
Isavuconazole (as isavuconazonium sulfate).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
POWDER FOR INJECTION
Each vial contains 200 mg isavuconazole (as 372.6 mg isavuconazonium
sulfate).
CAPSULES
Each capsule contains 100 mg isavuconazole (as 186.3 mg
isavuconazonium sulfate).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
POWDER FOR INJECTION
Powder for injection; white to yellow powder for intravenous
administration following
reconstitution and dilution.
CAPSULES
Swedish Orange (reddish-brown) capsule body marked with “100” in
black ink and a white
cap marked with “C” in black ink. For oral administration.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CRESEMBA is indicated in adults for the treatment of
•
invasive aspergillosis
•
mucormycosis in patients for whom amphotericin B is inappropriate (see
Section 4.4
Special warnings and precautions for use and Section 5.1
Pharmacodynamic properties)
Consideration should be given to official guidance on the appropriate
use of antifungal agents.
▼
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Version : pfpcrema10922
Supersedes: pfpcrema10122
Page 2 of 28
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Therapy may be instituted before the results of the cultures and other
laboratory studies are
known. However, once these results become available, antifungal
therapy should be adjusted
accordingly.
The recommended loading and maintenance dose for both the powder for
injection and capsule
formulations are shown in Table 1 below.
TABLE 1. DOSAGE REGIMEN FOR CRESEMBA
LOADING DOSE
MAINTENANCE DOSE
A
CRESEMBA Powder for
injection (