XYNTHA moroctocog alfa (rch) 2000IU powder for injection and diluent dual-chamber syringe
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
06-06-2022
Summary of Product characteristics
(SPC)
13-04-2021
Public Assessment Report
(PAR)
29-11-2017
Active ingredient:
Moroctocog alfa, Quantity: 2000 IU
Available from:
Pfizer Australia Pty Ltd
INN (International Name):
Moroctocog alfa
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: water for injections; sodium chloride
Administration route:
Intravenous
Units in package:
1's
Prescription type:
Not scheduled. Not considered by committee
Therapeutic indications:
The control and prevention of haemorrhagic episodes in patients with haemophilia A, including control and prevention of bleeding in surgical settings. XYNTHA does not contain von Willebrand factor and should not be used by patients with von Willebrand's disease.
Product summary:
Visual Identification: Clear, colourless liquid.; Container Type: Multiple containers; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2011-10-04
Patient Information leaflet
XYNTHA
®
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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 XYNTHA?
XYNTHA contains the active ingredient moroctocog alfa, a coagulation
factor VIII product. XYNTHA is used to control and treat
bleeding and prevent bleeding in people with haemophilia A. People
with haemophilia A are deficient in coagulation factor VIII.
For more information, see Section 1. Why am I using XYNTHA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE XYNTHA?
Do not use XYNTHA if you have had an allergic reaction to moroctocog
alfa, hamster proteins or any of the ingredients listed at the
end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, are on a low salt diet, or are pregnant or plan
to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
XYNTHA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with XYNTHA 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 XYNTHA?
•
XYNTHA comes in five dosage strengths. Your doctor will decide the
dosage strength and dose that you will receive.
•
XYNTHA is given by injection directly into your veins. It should be
injected using the infusion set provided in the pack.
•
XYNTHA is supplied as a freeze-dried powder. Before it can be injected
into your vein it must be mixed with 0.9% sodium
chloride solution.
•
Your doctor, nurse or pharmacist will show you how to prepare and give
an injection of XYNTHA.
More instructions can be found in Section 4. How do I use XYNTHA? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING XYNTHA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist and pharmacist you visit that you are using
XYNTHA.
•
Contact your doctor immediately if your bleeding does not stop as
expected.
•
Sto
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Summary of Product characteristics
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AUSTRALIAN
PRODUCT
INFORMATION
–
XYNTHA
®
(MOROCTOCOG
ALFA)
POWDER
FOR INJECTION
1.
NAME OF THE MEDICINE
moroctocog alfa
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
XYNTHA is formulated as a sterile, non-pyrogenic, lyophilised powder
for intravenous (IV)
injection. It is available in single use vials and in single use
prefilled dual chamber syringes
containing the labelled amount of factor VIII activity, expressed in
IUs.
Each vial contains nominally 250, 500, 1000 or 2000 IU of XYNTHA per
vial.
Each prefilled dual chamber syringe contains nominally 250, 500, 1000,
2000 or 3000 IU of
XYNTHA per syringe.
Each vial/prefilled dual chamber syringe of XYNTHA contains 1.23 mmol
(or 29 mg) sodium,
to be taken into consideration by patients on a controlled sodium
diet.
For the full list of excipients, see Section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
Powder for injection.
The product reconstituted with 4 mL Sodium Chloride Diluent [(9 mg/mL
(0.9%)] is a clear
colourless solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
XYNTHA is indicated for the control and prevention of haemorrhagic
episodes in patients with
haemophilia A, including control and prevention of bleeding in
surgical settings. XYNTHA
does not contain von Willebrand factor and should not be used by
patients with von
Willebrand’s disease.
4.2 DOSE AND METHOD OF ADMINISTRATION
Treatment with XYNTHA should be initiated under the supervision of a
physician experienced
in the treatment of haemophilia A.
Dosage and duration of treatment depend on the severity of the factor
VIII deficiency, the
location and extent of bleeding, and the patient’s clinical
condition. Individual patients may
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vary in their response to factor VIII, achieving different levels of
recovery and demonstrating
different half-lives. Doses administered should be titrated to the
patient's clinical response. In
the presence of an inhibitor, higher d
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