TRANEXAMIC INJECTION PHARMA-Q #N/A

מדינה: דרום אפריקה

שפה: אנגלית

מקור: South African Health Products Regulatory Authority (SAHPRA)

זמין מ:

Pharma-Q Holdings (Pty) Ltd

כמות:

Not Indicated

טופס פרצבטיות:

#N/A

הרכב:

None

מצב אישור:

Registered

עלון מידע

26 April 2022
Page 1 of 8
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
TRANEXAMIC INJECTION PHARMA-Q SOLUTION FOR INJECTION
TRANEXAMIC ACID
SUGAR FREE
_ _
READ
ALL
OF
THIS
LEAFLET
CAREFULLY
BEFORE
YOU
ARE
GIVEN
TRANEXAMIC
INJECTION PHARMA-Q
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or
other health care provider.
WHAT IS IN THIS LEAFLET
1. What TRANEXAMIC INJECTION PHARMA-Q is and what it is used for
2. What you need to know before you use TRANEXAMIC INJECTION PHARMA-
Q
3. How to use TRANEXAMIC INJECTION PHARMA-Q
4. Possible side effects
5. How to store TRANEXAMIC INJECTION PHARMA-Q
6. Contents of the pack and other information
1.
WHAT TRANEXAMIC INJECTION PHARMA-Q IS AND WHAT IT IS USED FOR
TRANEXAMIC INJECTION PHARMA-Q contains tranexamic acid which belongs
to the class of medicines called antifibrinolytics. TRANEXAMIC
INJECTION
PHARMA-Q is used to prevent or reduce bleeding in certain conditions,
minor
26 April 2022
Page 2 of 8
surgery such as dental surgery in people with hereditary blood
clotting disorders,
and bleeding inside the eye.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TRANEXAMIC INJECTION
PHARMA-Q
TRANEXAMIC INJECTION PHARMA-Q SHOULD NOT BE ADMINISTERED TO YOU:
•
If you are hypersensitive (allergic) to tranexamic acid or any of the
other
ingredients of TRANEXAMIC INJECTION PHARMA-Q (listed in section 6). _
_
•
If you have currently a disease leading to blood clots
•
If you have a condition called ‘consumption coagulopathy’ where
blood in the
whole body starts to clot
•
If you have kidney problems
•
If you have liver problems
•
If you have a history of convulsions
Due
to
the
risk
of
cerebral
oedema
and
convulsions,
intrathecal
and
intraventricular injection and intracerebral application are not
recommended.
If you think any of these apply to you, or if you are in any doubt at
all, tell your
doctor before TRANEXAMIC INJECTION PHARMA-Q is given to you.
WARNINGS AND PRECAUTIONS
Tell your docto

מאפייני מוצר

26 April 2022
Page 1 of 12
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S4
1
NAME OF THE MEDICINE
TRANEXAMIC INJECTION PHARMA-Q solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRANEXAMIC INJECTION PHARMA-Q contains tranexamic acid 100 mg/ml
Each 10 ml ampoule or vial contain 1 000 mg tranexamic acid
Sugar free
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution practically free from particles filled in
clear glass
ampoules and vials.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Short term use in the treatment of hyphaema and in patients with
established
coagulopathies who are undergoing minor surgery.
•
Management of dental extraction in haemophiliacs.
•
Hereditary angio-oedema.
26 April 2022
Page 2 of 12
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
TRANEXAMIC
INJECTION
PHARMA-Q
is
given
by
slow
intravenous
infusion/injection. Administration by injection is usually changed to
oral tranexamic
acid administration after a few days.
_TRAUMATIC HYPHAEMA _
1,0 to 1,5 g every 8 hours for six to seven days.
_PATIENTS WITH ESTABLISHED COAGULOPATHIES UNDERGOING MINOR SURGERY _
Conization of the cervix: 1,0 to 1,5 g every 8 to 12 hours for 12 days
post-
operatively.
_DENTAL OPERATIONS/EXTRACTIONS _
25 mg/kg two hours before the operation. Factor VIII and Factor IX
should be given
as well as tranexamic acid. After the operation, 25 mg/kg of
tranexamic acid is
given 3 to 4 times a day for 6 to 8 days.
_HEREDITARY ANGIO-OEDEMA _
Some patients are aware of the onset of illness; a suitable treatment
for these
patients is 1,0 -1,5 g two to three times daily for some days. Other
patients are
treated continually at this dosage.
METHOD OF ADMINISTRATION
TRANEXAMIC INJECTION PHARMA-Q is administered intravenously by slow
injection
over
a
period
of
at
least
five
minutes.
For
intravenous
infusion,
TRANEXAMIC INJECTION PHARMA-Q may be mixed with electrolyte solutions,
carbohydrate solutions, amino acid solutions, and dextran solutions.