HEPARIN SODIUM 25000UNITS IN 5% DEXTROSE INJ SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

HEPARIN SODIUM; DEXTROSE

Διαθέσιμο από:

B. BRAUN MEDICAL INC

Φαρμακολογική κατηγορία (ATC):

B01AB51

INN (Διεθνής Όνομα):

HEPARIN, COMBINATIONS

Δοσολογία:

10000UNIT; 5G

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

HEPARIN SODIUM 10000UNIT; DEXTROSE 5G

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

250ML

Τρόπος διάθεσης:

Ethical

Θεραπευτική περιοχή:

HEPARINS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0220064003; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

1998-06-16

Φύλλο οδηγιών χρήσης

Heparin Sodium B. Braun
INJECTABLE DRUGS
Heparin has been used as an anticoagulant in clinical
medicine for more than 80 years.
1
In fact, it still
remains one of the most commonly used parenteral
anticoagulants to treat or prevent thromboembolism
until today.
2
Its importance in clinical medicine is also
reflected by being listed in the 21
st
WHO Model List of
Essential Medicines.
3
USER BENEFITS WITH HEPARIN SODIUM
·
Effective and safe in prevention and treatment of thrombosis
when appropriate dosing is given
4
·
Safe profile due to its short half-life and reversibility with
protamine
2
·
Preferred option for patients with renal dysfunction since it
is not excreted through the kidney
2
HEPARIN SODIUM B. BRAUN IS USED IN ADULTS AND PEDIATRICS
FOR THE FOLLOWING INDICATIONS
·
Therapy of acute venous and arterial thromboembolism in-
cluding early treatment of myocardial infarction and unstable
angina pectoris (i.v. or s.c.)
·
Prophylaxis of thromboembolism (s.c.)
·
Prevention of blood clotting during use of extracorporeal
circulation (e.g. cardiopulmonary bypass, hemodialysis)
METHOD OF ADMINISTRATION
·
Continuous intravenous infusion *
·
Intravenous bolus injection
·
Subcutaneous injection
PRODUCT
CONTAINER TYPE
TOTAL VOLUME
SALES UNIT
HEPARIN SODIUM B. BRAUN 5000 I.U / ML
Glass Vial
5 ml
10 x 5 ml
* For continuous intravenous infusion Heparin Sodium B. Braun may be
diluted
with Sodium chloride 9 mg / ml solution for infusion, Glucose 50 mg /
ml or
100 mg / ml solution for infusion or Ringer‘s solution for infusion.
FIG. 1 | Glass Vial – Heparin Sodium B. Braun 5000 I.U / ml
LITERATURE
1. Oduah EI et al.; Pharmaceuticals 2016, 9 (3), 38.
2. Malloy RJ et al.; Unfractionated Heparin and Low-Molecular-Weight
Heparin.
In: Lau J, Barnes G, Streiff M (eds) Anticoagulation Therapy.
Springer, Cham.
3. World Health Organization Model List of Essential Medicines, 21st
List, 2019.
Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO.
4. Hirsh J et al., Circulation 2001;103:2994-3018.
B. Braun Me

Αρχείο Π.Χ.Π.

1d1d0d1d0d1d1d0d1d1
126/12606671/0210
COMPOSITION
1 ml of solution contains
Heparin Sodium (mucosa)
5000
I.U.
_Excipients:_
Benzyl alcohol (antimicrobial preservative), sodium chloride, water
for injections
PHARMACEUTICAL FORM
Solution for injection in glass vials of 5 ml
PHARMACO-THERAPEUTIC GROUP
Anticoagulant
INDICATIONS
- Prophylaxis of thrombo-embolism in surgical and non-surgical
medicine;
- Use as anticoagulant in the therapy of acute venous and arterial
thrombo-
embolism;
- Therapy of consumption coagulopathy in the hypercoagulative phase,
- Prevention of blood clotting during use of extracorporal circulation
(heart-lung
machine).
CONTRAINDICATIONS
_Heparin Sodium Injection 5000 I.U./ml must not be used in the
following conditions:_
- Hypersensitivity to heparin;
- Diseases associated with an increased tendency to bleeding, such as:
haemorrhagic diathesis,
deficiency of coagulation factors with the exception of consumption
coagulopathy in
the hypercoagulative phase,
severe diseases of liver, kidneys, and pancreas,
severe thrombocytopenia;
- Diseases where there is a suspicion of vascular damage, e.g.
ulcers in the gastro-intestinal tract,
hypertension with a diastolic blood pressure higher than 105 mm Hg,
brain haemorrhage,
injuries or surgical procedures on the central nervous system,
cerebral arterial aneurysm,
retinopathias, bleeding into the vitreum,
ophthalmic surgical procedures,
subacute bacterial endocarditis;
- Imminent abortion;
- Spinal or epidural anaesthesia, lumbar puncture;
- Case history or acute cases of thrombocytopenia (type II) caused by
an allergic
reaction to heparin;
Because Heparin Sodium Injection 5000 I.U./ml contains benzyl alcohol,
it must not
be administered to new-borns, esp. to immature pre-term infants.
_Administration of Heparin Sodium Injection 5000 I.U./ml should also
be avoided in the_
_following conditions:_
- Suspected malignant tumour with risk of bleeding;
- Nephro- and ureterolithiasis;
- Chronic alcohol abuse.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
During therap