FRAGMIN 2500 I.UML

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

DALTEPARIN SODIUM

Beschikbaar vanaf:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC-code:

B01AB04

farmaceutische vorm:

SOLUTION FOR INJECTION

Samenstelling:

DALTEPARIN SODIUM 2500 IU/ML

Toedieningsweg:

S.C

Prescription-type:

Required

Geproduceerd door:

PFIZER MANUFACTURING BELGIUM NV, BELGIUM

Therapeutische categorie:

DALTEPARIN

Therapeutisch gebied:

DALTEPARIN

therapeutische indicaties:

Prevention of clotting during haemodialysis and haemofiltration in connection with acute renal failure or chronic renal insufficiency. Treatment of acute deep venous thrombosis and/or pulmonary embolism. Unstable coronary artery disease. Thromboprophylaxis in conjunction with surgery. Prophylaxis in patients with substantially increased risk for venous thromboembolism and that are temporarily immobilized due to acute illness such as cardiac insufficiency respiratory insufficiency and severe infections. Cancer patients : Treatment and secondary prevention of deep-vein thrombosis and/or pulmonary embolism.

Autorisatie datum:

2021-08-31

Productkenmerken

Fragmin LPD CC 27 October 2020
2015-0009954, 2016-0015333, 2016-0021600, 2019-0053629, 2019-0056880
1
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FULL PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
FRAGMIN
®
2500 IU /0.2 ML
FRAGMIN
®
2500 IU/ML
FRAGMIN
®
10000 IU/ML
FRAGMIN
®
25000 IU/ML
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Dalteparin sodium
Potency is described in International anti-Factor Xa units (IU) of the
1st International Standard for Low Molecular Weight
Heparin.
Each single dose syringe contains either: 2,500 IU (anti-Factor Xa)/
0.2 ml; 5000 IU (anti-Factor Xa)/ 0.2 ml 7,500 IU (anti-
Factor Xa)/ 0.3 mL,10,000 IU(anti-Factor Xa)/ 0.4mL, 12,500
IU(anti-Factor Xa)/ 0.5 mL, 15,000 IU(anti-Factor Xa)/ 0.6
mL or 18,000 IU(anti-Factor Xa)/ 0.72 mL
Each ampoule contains either: 2,500 IU (anti- Factor Xa)/ml (4ml) or
10,000 IU (anti-Xa)/ml (1ml)
For the full list of excipients,
_see_
_Description (11)_
in this leaflet.
PHARMACEUTICAL FORM
Solution for injection for subcutaneous or intravenous administration.
WARNING: SPINAL/EPIDURAL HEMATOMAS
EPIDURAL OR SPINAL HEMATOMAS MAY OCCUR IN PATIENTS WHO ARE
ANTICOAGULATED WITH LOW MOLECULAR WEIGHT HEPARINS
(LMWH) OR HEPARINOIDS AND ARE RECEIVING NEURAXIAL ANESTHESIA OR
UNDERGOING SPINAL PUNCTURE. THESE
HEMATOMAS MAY RESULT IN LONG-TERM OR PERMANENT PARALYSIS. CONSIDER
THESE RISKS WHEN SCHEDULING PATIENTS FOR
SPINAL PROCEDURES. FACTORS THAT CAN INCREASE THE RISK OF DEVELOPING
EPIDURAL OR SPINAL HEMATOMAS IN THESE PATIENTS
INCLUDE:
● USE OF INDWELLING EPIDURAL CATHETERS
● CONCOMITANT USE OF OTHER DRUGS THAT AFFECT HEMOSTASIS, SUCH AS
NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
(NSAIDS), PLATELET INHIBITORS, OTHER ANTICOAGULANTS.
● A HISTORY OF TRAUMATIC OR REPEATED EPIDURAL OR SPINAL PUNCTURES
● A HISTORY OF SPINAL DEFORMITY OR SPINAL SURGERY
● OPTIMAL TIMING BETWEEN THE ADMINISTRATION OF FRAGMIN AND NEURAXIAL
PROCEDURES IS NOT KNOWN
MONITOR PATIENTS FREQUENTLY FOR SIGNS AND SYMPTOMS OF NEUROLOGICAL
IMPAIRMENT. IF NEUROLOGICAL COMPROMISE IS
NOTED, URGENT TREATMENT IS NECE