Crusia-AFT Forte

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Enoxaparin sodium 150 mg/mL;  

Available from:

AFT Pharmaceuticals Ltd

Dosage:

150 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Enoxaparin sodium 150 mg/mL   Excipient: Water for injection

Prescription type:

Prescription

Therapeutic indications:

Treatment of venous thromboembolic disease.

Product summary:

Package - Contents - Shelf Life: Syringe, 1 mL Type 1 glass with chlorobutyl rubber stopper, with automatic safety - 10 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze - Syringe, 0.8 mL Type 1 glass with chlorobutyl rubber stopper, with automatic safety - 10 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze - Syringe, 1 mL Type 1 glass with chlorobutyl rubber stopper, without automatic safety - 10 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze - Syringe, 0.8 mL Type 1 glass with chlorobutyl rubber stopper, without automatic safety - 10 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze - Syringe, 1 mL Type 1 glass with chlorobutyl rubber stopper, with automatic safety - 30 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze - Syringe, 0.8 mL Type 1 glass with chlorobutyl rubber stopper, with automatic safety - 30 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze - Syringe, 1 mL Type 1 glass with chlorobutyl rubber stopper, without automatic safety - 30 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze - Syringe, 0.8 mL Type 1 glass with chlorobutyl rubber stopper, without automatic safety - 30 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze

Authorization date:

2016-02-29

Patient Information leaflet

Page 1
NEW ZEALAND CONSUMER MEDICINE INFORMATION
CRUSIA-AFT
® AND CRUSIA-AFT
® FORTE*
_ENOXAPARIN SODIUM 100 MG/ML AND 150 MG/ML SOLUTION FOR INJECTION _
_* Subsequent references to "Crusia-AFT" refer to both Crusia-AFT and
Crusia-AFT Forte. _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Crusia-AFT. It does
not contain all the
available information. It does not take the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using Crusia-
AFT against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT CRUSIA-AFT IS USED FOR
Crusia-AFT is used in a number of medical conditions. It is used to:

treat blood clots

treat certain types of heart disease (e.g. angina and heart attacks),
when used with
aspirin

prevent blood clots forming after an operation, during hospitalisation
or extended bed
rest or during purification of the blood by an artificial kidney
(haemodialysis).
Crusia-AFT is one of a group of medicines called low molecular weight
heparins (LMWHs).
These medicines work by reducing blood clotting activity.
Your doctor may have prescribed Crusia-AFT for another reason.
Ask your doctor if you have any questions about why Crusia-AFT has
been prescribed for
you.
There is no evidence that Crusia-AFT is addictive.
This medicine is only available with a doctor's prescription.
Page 2
BEFORE YOU ARE GIVEN CRUSIA-AFT
_ _
_WHEN YOU MUST NOT USE IT _
_ _
DO NOT USE CRUSIA-AFT IF YOU HAVE AN ALLERGY TO CRUSIA-AFT, HEPARIN OR
ITS DERIVATIVES
INCLUDING OTHER LMWHS. SOME SIGNS AND SYMPTOMS OF AN ALLERGIC REACTION
CAN INCLUDE
SWELLING OF THE FACE, LIPS OR TONGUE, WHEEZING OR TROUBLED BREATHING,
SKIN RASH, ITCHING
HIVES, BLISTERS OR PEELING SKIN.
DO NOT USE CRUSIA-AFT IF YOU HAVE, OR HAVE EVER HAD ANY OF THE
FOLLOWING MEDICAL
CONDITIONS:

major blood disorders

c

Summary of Product characteristics

Page 1 of 24
NEW ZEALAND DATA SHEET
1.
CRUSIA-AFT AND CRUSIA-AFT FORTE
Crusia-AFT 100 mg/mL solution for injection
Crusia-AFT Forte 150 mg/mL solution for injection.
Crusia-AFT and Crusia-AFT Forte are biosimilar medicines.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Crusia-AFT 100 mg/mL solution for injection:
Each 0.2 mL prefilled syringe contains 20 mg (anti-Xa: 2,000 IU)
enoxaparin sodium.
Each 0.4 mL prefilled syringe contains 40 mg (anti-Xa: 4,000 IU)
enoxaparin sodium.
Each 0.6 mL prefilled syringe contains 60 mg (anti-Xa: 6,000 IU)
enoxaparin sodium.
Each 0.8 mL prefilled syringe contains 80 mg (anti-Xa: 8,000 IU)
enoxaparin sodium.
Each 1 mL prefilled syringe contains 100 mg (anti-Xa: 10,000 IU)
enoxaparin sodium.
Crusia-AFT Forte 150 mg/mL solution for injection:
Each 0.8 mL prefilled syringe contains 120 mg (anti-Xa: 12,000 IU)
enoxaparin sodium.
Each 1 mL prefilled syringe contains 150 mg (anti-Xa: 15,000 IU)
enoxaparin sodium.
Enoxaparin sodium is a biological substance obtained by alkaline
depolymerization of heparin benzyl
ester derived from porcine intestinal mucosa.
For the full list of excipients, see section 6.1.
Crusia-AFT* is a biosimilar medicine. The prescribing physician should
be involved in any decision
regarding interchangeability with other products. Additional
information is available on the following
website (http://www.medsafe.govt.nz/profs/RIss/Biosimilars.asp). Data
comparing Crusia-AFT to
Clexane can be found in section 5.1 of this datasheet.
*Any subsequent reference to Crusia-AFT refers to both Crusia-AFT and
Crusia-AFT Forte.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
Page 2 of 24
4.1
THERAPEUTIC INDICATIONS
Crusia-AFT is indicated in adults for:

Prophylaxis of venous thromboembolic disease, in particular those
which may be associated with
orthopaedic, general, major colorectal or cancer surgery.

Prophylaxis of venous thromboembolism in general medical patients
bedridden due to acute
illnesses inclu