FRAGMIN INJECTION 5000 iu0.2 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DALTEPARIN SODIUM

Available from:

PFIZER PRIVATE LIMITED

ATC code:

B01AB04

Dosage:

5000 iu/0.2 ml

Pharmaceutical form:

INJECTION

Composition:

DALTEPARIN SODIUM 5000 iu/0.2 ml

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Vetter Pharma-Fertigung GmbH & Co. KG

Authorization status:

ACTIVE

Authorization date:

1990-12-03

Patient Information leaflet

LPD Reference: FRA-SIN-0213/1 
Date of Last Revision: 07 Feb 2013 
Country: Singapore 
Reference document: CDS version 6 & 7, 
effective 22 Jan 2013 
Reason for change: Consolidate changes in 
Version 6 & 7 
FRAGMIN
®
Dalteparin Sodium 
Solution for Injection 
1. NAME OF THE MEDICINAL PRODUCT
FRAGMIN 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: dalteparin sodium 
3. PHARMACEUTICAL FORM
Solution for Injection 
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS 
Treatment of acute deep-vein thrombosis. 
Prevention
of clotting in the extra corporeal system during hemodialysis and
hemofiltration in 
patients with acute renal failure or chronic
renal insufficiency.  
Thromboprophylaxis in conjunction with surgery. 
The prophylaxis of proximal deep venous thrombosis in
patients bedridden due to a medical 
condition, including, but not limited to: congestive cardiac
failure, acute respiratory failure or 
acute infection, who also have a predisposing risk
factor for venous thromboembolism such as 
age over 75 years,
obesity, cancer or previous history of VTE. 
Unstable coronary artery disease
(unstable angina and non-ST-elevation myocardial infarction, 
also known as non-Q-wave myocardial infarction). 
Dalteparin should not be used in patients who have suffered
a recent (within 3 months) stroke 
unless due to systemic emboli. 
4.2. POSOLOGY AND METHOD OF ADMINISTRATION 
See _SECTION 4.4_ SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
PFIZER CONFIDENTIAL 
Page 1 
LPD Reference: FRA-SIN-0213/1 

Date of Last Revision: 07 Feb 2013 

Country: Singapore 

Reference document: CDS version 6 & 7, 
effective 22 Jan 2013 
Reason for change: Consolidate changes in 
Version 6 & 7 

GENERAL - DO
NOT ADMINISTER DALTEPARIN BY THE INTRAMUSCULAR ROUTE 
COMPATIBILITY WITH IV SOLUTIONS - Dalteparin is compatible with isotonic s

Summary of Product characteristics

FRAGMIN
®
Dalteparin Sodium
Solution for Injection
1.
NAME OF THE MEDICINAL PRODUCT
FRAGMIN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: dalteparin sodium
3.
PHARMACEUTICAL FORM
Solution for injection
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
1.
Treatment of acute deep vein thrombosis (DVT)
2.
Prevention of clotting in the extra corporeal system during
hemodialysis and
hemofiltration in patients with acute renal failure or chronic renal
insufficiency
3.
Thromboprophylaxis in conjunction with surgery
4.
The prophylaxis of proximal DVT in patients bedridden due to a medical
condition,
including, but not limited to: congestive cardiac failure, acute
respiratory failure or
acute infection, who also have a predisposing risk factor for venous
thromboembolism
such as age over 75 years, obesity, cancer or previous history of VTE
5.
Unstable coronary artery disease (unstable angina and non-ST-elevation
myocardial
infarction, also known as non-Q-wave myocardial infarction)
Dalteparin should not be used in patients who have suffered a recent
(within 3 months) stroke
unless due to systemic emboli.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
See
_SECTION 4.4._ SPECIAL WARNINGS AND PRECAUTIONS FOR USE
.
GENERAL
Do not administer dalteparin by the intramuscular route.
COMPATIBILITY WITH INTRAVENOUS (IV) SOLUTIONS
Dalteparin is compatible with isotonic sodium chloride (9 mg/mL) or
isotonic glucose
(50 mg/mL) infusion solution in glass bottles and plastic containers.
The solution should be used within 12 hours.
1. TREATMENT OF ACUTE DVT
Administer dalteparin subcutaneously (SC) either as a single daily
injection or as two daily
injections. Simultaneous anticoagulation with oral vitamin K
antagonists can be started
immediately. Continue combined treatment until the prothrombin complex
tests have reached
therapeutic levels (usually at least 5 days). Outpatient treatment is
feasible using the same
doses recommended for treatment in a medical institution.
•
ONCE-DAILY ADMINISTRATION -
200 IU/kg total bo