MYCAMINE micafungin (as sodium) 100 mg powder for injection vial

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

micafungin sodium, Quantity: 101.73 mg (Equivalent: micafungin, Qty 100 mg)

제공처:

Astellas Pharma Australia Pty Ltd

INN (International Name):

Micafungin sodium

약제 형태:

Injection, powder for

구성:

Excipient Ingredients: citric acid; sodium hydroxide; lactose monohydrate

관리 경로:

Intravenous Infusion

패키지 단위:

1 vial, 10 vials

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

MYCAMINE is indicated for: ? treatment of invasive candidiasis in children and adults ? treatment of oesophageal candidiasis in adults, adolescents greater than or equal to 16 years of age and the elderly patients for whom intravenous therapy is appropriate ? prophylaxis of Candida infection in children and adult patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/?L) for 10 or more days.

제품 요약:

Visual Identification: White coloured powder for injection; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Registered

승인 날짜:

2013-05-08

환자 정보 전단

MYCAMINE
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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.
1.
WHY AM I USING MYCAMINE?
Mycamine contains the active ingredient micafungin (as sodium).
Mycamine is used to treat a number of different conditions
and illnesses (see Section 1. Why am I using MYCAMINE? in the CMI for
full detail). The most common uses are to treat a
serious fungal infection called invasive candidiasis; fungal infection
in the food pipe (oesophagus); Candida (yeast) infection while
undergoing a certain type of stem cell transplant or if you are
expected to have white blood cell counts below a certain level.
2.
WHAT SHOULD I KNOW BEFORE I USE MYCAMINE?
Do not use if you have ever had an allergic reaction to Mycamine or
any of the ingredients listed at the end of the CMI.
There are a number of circumstances in which a person should not use
this medicine or may need to use caution. It is important to
understand if these apply to you before taking Mycamine (see Section
2. What should I know before I use MYCAMINE? in the full
CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with MYCAMINE 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 MYCAMINE?
Mycamine must be prepared and given to you by a nurse or another
health care professional. Your doctor will decide how much
Mycamine you will receive each day.
More instructions can be found in Section 4. How do I use MYCAMINE? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MYCAMINE?
THINGS YOU
SHOULD DO
•
If you are about to be started on any new medicine, remind your doctor
and pharmacist that you are
receiving Mycamine.
•
Tell any other doctors, dentists, and pharmacists who treat you that
you are having this medicine.
•
If you are going to have surgery, tell the surgeon or anaesthetist
that you are having this medicine. It may
aff

제품 특성 요약

1
AUSTRALIAN PRODUCT INFORMATION
MYCAMINE
® (MICAFUNGIN) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Micafungin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MYCAMINE 50 mg contains 50.86 mg micafungin sodium, corresponding to
50 mg micafungin.
MYCAMINE 100 mg contains 101.73 mg micafungin sodium, corresponding to
100 mg
micafungin.
For the full list of excipients, refer to Section 6.1 – LIST OF
EXCIPIENTS
3
PHARMACEUTICAL FORM
Powder for injection vial.
MYCAMINE 50 mg and 100mg is a white coloured powder for injection.
The powder must be diluted with either sodium chloride 0.9% or glucose
5% solution prior to use
(refer to Section 4.2 - DOSE AND METHOD OF ADMINISTRATION).
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
MYCAMINE is indicated for:
•
Treatment of invasive candidiasis in children and adults
•
Treatment of oesophageal candidiasis in adults, adolescents ≥ 16
years of age and the
elderly patients for whom intravenous therapy is appropriate
•
Prophylaxis of Candida infection in children and adult patients
undergoing allogeneic
haematopoietic stem cell transplantation or patients who are expected
to have neutropenia
(absolute neutrophil count < 500 cells/µL) for 10 or more days
4.2
D
OSE AND METHOD OF ADMINISTRATION
MYCAMINE must be diluted with either sodium chloride 0.9% or glucose
5% solution prior to use.
MYCAMINE should be administered once daily by intravenous infusion.
The dosage depends on the
indication and body weight of the patient as shown in Tables 1, 2 and
3 below.
TABLE 1. DOSAGE FOR ADULTS, ADOLESCENTS ≥ 16 YEARS OF AGE AND THE
ELDERLY INDICATION
BODY WEIGHT > 40 KG
BODY WEIGHT ≤ 40 KG
Treatment of invasive candidiasis
100 mg/day*
2 mg/kg/day*
Treatment of oesophageal
150 mg/day
3 mg/kg/day
2
candidiasis
Prophylaxis of Candida infection
50 mg/day
1 mg/kg/day
* If the patient’s response is inadequate, e.g. persistence of
cultures or if clinical condition does not improve, the dose may
be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day
in patients weig