ARIXTRA 7.5 MG0.6 ML

Ország: Izrael

Nyelv: angol

Forrás: Ministry of Health

Aktív összetevők:

FONDAPARINUX SODIUM

Beszerezhető a:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC-kód:

B01AX05

Gyógyszerészeti forma:

SOLUTION FOR INJECTION

Összetétel:

FONDAPARINUX SODIUM 12.5 MG/ML

Az alkalmazás módja:

S.C

Recept típusa:

Required

Gyártó:

ASPEN NOTRE DAME DE BONDEVILLE, FRANCE

Terápiás csoport:

FONDAPARINUX

Terápiás terület:

FONDAPARINUX

Terápiás javallatok:

Treatment of adults with acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

Engedély dátuma:

2023-09-30

Betegtájékoztató

PATIENT LEAFLET IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed according to a physician’s
prescription only
ARIXTRA 7.5 MG/0.6 ML
Solution for injection
THE ACTIVE INGREDIENT AND ITS CONCENTRATION:
12.5 MG FONDAPARINUX SODIUM IN 1 ML SOLUTION FOR INJECTION
Inactive ingredients and allergens in the medicine – see section 2
“Important information about some of the ingredients of this
medicine” and section 6 “Additional information” in this
leaflet.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE, AS IT CONTAINS IMPORTANT INFORMATION FOR YOU. This
leaflet contains concise information about the medicine. Keep
the leaflet; you may need to read it again. If you have any other
questions, refer to the physician or the pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them even if it seems to you that their
ailment is similar.
If side effects occur, including side effects not mentioned in
section 4 of this leaflet, inform the physician or pharmacist.
1. WHAT IS THE MEDICINE INTENDED FOR?
ARIXTRA IS A MEDICINE THAT TREATS OR HELPS TO PREVENT BLOOD
CLOTS FROM FORMING IN THE BLOOD VESSELS )an antithrombotic
agent(.
Arixtra contains a synthetic substance called fondaparinux
sodium that stops a clotting factor Xa )“ten-A”( from working in
the blood, and so prevents unwanted blood clots )thromboses(
from forming in the blood vessels.
ARIXTRA IS USED TO TREAT ADULTS WITH A BLOOD CLOT IN THE BLOOD
VESSELS OF THEIR LEGS )deep vein thrombosis( AND/OR LUNGS
)pulmonary embolism(.
THERAPEUTIC GROUP:
Anticoagulant.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• YOU ARE SENSITIVE )ALLERGIC( to the active ingredient
fondaparinux sodium or to any of the other ingredients
contained in the medicine as listed in section 6
• YOU ARE BLEEDING EXCESSIVELY
• YOU HAVE A BACTERIAL HEART INFECTION
• YOU HAVE SEVERE KIDNEY DISEASE
TELL YOUR PHYSICIAN if you think any of these apply to you. If
the

Termékjellemzők

1.
NAME OF THE MEDICINAL PRODUCT
Arixtra 7.5 mg/0.6 ml solution for injection, pre-filled syringe.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 7.5 mg of fondaparinux sodium in 0.6
ml solution for injection.
Excipient(s) with known effect: Contains less than 1 mmol of sodium
(23 mg) per dose, and therefore
is essentially sodium free.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
_._
The solution is a clear and colourless to slightly yellow liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of adults with acute Deep Vein Thrombosis (DVT) and
treatment of acute Pulmonary
Embolism (PE), except in haemodynamically unstable patients or
patients who require thrombolysis or
pulmonary embolectomy
_. _
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of fondaparinux is 7.5 mg (patients with body
weight

50,

100kg) once
daily administered by subcutaneous injection. For patients with body
weight < 50 kg, the
recommended dose is 5 mg. For patients with body weight > 100 kg, the
recommended dose is 10 mg.
Treatment should be continued for at least 5 days and until adequate
oral anticoagulation is established
(International Normalised Ratio 2 to 3). Concomitant oral
anticoagulation treatment should be initiated
as soon as possible and usually within 72 hours. The average duration
of administration in clinical
trials was 7 days and the clinical experience from treatment beyond 10
days is limited.
_ _
_ _
_Special populations _
_Elderly patients_
- No dosing adjustment is necessary.
_ _
In patients

75 years, fondaparinux should be
used with care, as renal function decreases with age (see section
4.4).
_ _
_Renal impairment - _
Fondaparinux should be used with caution in patients with moderate
renal
impairment (see section 4.4).
There is no experience in the subgroup of patients with
_both_
high body weight (>100 kg) and moderate
renal impairment (creatinine clearance 30-50 ml/min). In this
su