DOTAGRAF gadoteric acid 16.76g/60 mL solution for injection bottle

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

gadoteric acid, Quantity: 279.32 mg/mL

متاح من:

Bayer Australia Ltd

الشكل الصيدلاني:

Injection, solution

تركيب:

Excipient Ingredients: meglumine; tetraxetan; water for injections

طريقة التعاطي:

Intravenous

الوحدات في الحزمة:

10 x 60 mL

نوع الوصفة الطبية :

Not Scheduled after consideration by Committee

الخصائص العلاجية:

DOTAGRAF is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging (see Section 5.1 Pharmacodynamic properties ? Clinical trials).

ملخص المنتج:

Visual Identification: Clear, colourless to yellow solution for injection supplied in glass bottle; Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

الوضع إذن:

Registered

تاريخ الترخيص:

2022-10-19

نشرة المعلومات

DOTAGRAF®
1
DOTAGRAF®
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.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I GIVEN DOTAGRAF?
DOTAGRAF contains the active ingredient gadoteric acid. DOTAGRAF is a
contrast agent used during a magnetic resonance
imaging (MRI) examination.
For more information, see Section 1. Why am I given DOTAGRAF? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN DOTAGRAF?
Do not use if you have ever had an allergic reaction to DOTAGRAF or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR, RADIOGRAPHER OR NURSE 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 am
given DOTAGRAF? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DOTAGRAF and affect how it works.
TELL YOUR DOCTOR, RADIOGRAPHER OR NURSE IF YOU ARE TAKING A
BETA-BLOCKER ORE ANOTHER MEDICINE USED TO TREAT HIGH BLOOD
PRESSURE OR A HEART CONDITION.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW AM I GIVEN DOTAGRAF?
DOTAGRAF is injected into your vein by a doctor, radiographer or nurse
immediately before or during your MRI examination.
More instructions can be found in Section 4. How am I given DOTAGRAF?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE RECEIVING DOTAGRAF?
THINGS YOU
SHOULD DO
Tell your doctor, radiographer or nurse if you:
•
experience any of the severe symptoms such as loss of consciousness or
heart attack, increase in heart
rate, difficulty breathing, low blood pressure and swelling of the
face, lips or tongue leading to severe
breathing difficulties and shock
•
have very poor kidney function or severe kidney problems
•
had a liver

خصائص المنتج

221019 DOTAGRAF PI
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION
DOTAGRAF
® (GADOTERIC ACID) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Gadoteric acid.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DOTAGRAF solution for injection contains gadoteric acid 0.5 mM/mL.
Each vial or bottle contains the active ingredient gadoteric acid
279.32 mg/mL (0.5 M).
Gadoteric acid is a complex of the paramagnetic ion gadolinium oxide
90.62 mg/mL with
tetraxetan (DOTA;
1,4,7,10-tetraazacyclododecane-N,N’,N’’,N’’’-tetraacetic
acid) 202.46 mg/mL.
DOTAGRAF has the following chemical physical properties:
osmolality 1350 mOsmol/kg
viscosity at 20°C: 3.2 mPa.s
viscosity at 37°C: 2.0 mPa.s
pH: 6.5 to 8.0.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
DOTAGRAF is a sterile, preservative-free, clear, colourless to yellow
solution for injection free of
visible particles and packaged in glass vials or bottles for
intravenous injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DOTAGRAF is indicated, in adults and children, for use with magnetic
resonance imaging to
provide contrast enhancement for intracranial and spinal lesions with
abnormal blood brain
barrier or abnormal vascularity, and for whole body imaging (see
Section 5.1 Pharmacodynamic
properties – Clinical trials).
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The lowest effective dose should be used. The dose should be
calculated based on the patient’s
body weight and should not exceed the recommended dose per kilogram of
body weight
detailed in this section.
ADULTS (≥ 18 YEARS)
The maximum recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg for
adults.
221019 DOTAGRAF PI
Page 2 of 12
PAEDIATRICS (0 TO 18 YEARS)
The maximum recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg for
children and infants.
METHOD OF ADMINISTRATION
DOTAGRAF is intended for intravenous administration only.
Volumes required for doses of 0.1 mmol/kg are shown below.
WEIGHT (KG)
VOLUME (ML) REQUIRED FOR A DOSE
OF 0.