Adverse reactions : תופעות לוואי

4.8   Undesirable effects
The following adverse reactions can occur during treatment with Heparin Sodium B.Braun 5000 IU/ML.
The frequency data on adverse reactions are based on the following categories: 
Very common                  ≥1/10
Common                       1/100 to <1/10
Uncommon
≥1/1000 to <1/100
Rare
≥1/10,000 to <1/1000
Very rare                    <1/10,000
Not known                   Cannot be estimated from the available data

Blood and lymphatic system disorders
Very common: Depending on the heparin dosage, increased incidence of bleeding, especially from skin, mucous membranes, wounds, gastrointestinal and urogenital tract.
Common:         At the start of treatment, type 1 heparin-induced thrombocytopenia not mediated by antibodies (platelet count: 100,000-150,000/μl), without thrombosis.
Rare:           Type 2 heparin-induced, antibody-mediated thrombocytopenia (platelet count: <100,000/μl or a rapid fall in the platelet count to <50% of the initial count), with arterial and venous thrombosis or emboli, consumption coagulopathy, skin necrosis at the, petechiae, melaena. The anticoagulant effect of heparin may be reduced.
Inpatients without heparin hypersensitivity, the fall in platelet count usually occurs 6-14 days after the start of heparin treatment. In patients with pre- existing heparin hypersensitivity, the fall in platelet count can occur after just a few hours.
Very rare:      Type 2 thrombocytopenia can occur after a delay of several weeks after the end of heparin treatment (Spinler S A: New concepts in heparin-induced thrombocytopenia: Diagnosis and management, J Thromb Thrombolysis
21(1), 17-21, 2006: FDA MedWatch Safety Alert. Heparin Sodium
Injection. December 8, 2006).
If type 2 thrombocytopenia occurs, heparin should be stopped immediately.
Other treatment measures depend on the nature and severity of symptoms.
Further parenteral heparin administration is absolutely contraindicated.


Immune system disorders
Uncommon:       Allergic reactions with symptoms such as nausea, headache, rise in temperature, limb pain, urticaria, vomiting, pruritus, dyspnoea,
bronchospasm and a fall in blood pressure. Local and generalised hypersensitivity, including angioedema.
Rare:           Hypersensitivity reactions due to the benzyl alcohol content.
Very rare:      Occurrence of anaphylactic shock, especially in sensitised patients who have previously received heparin.

Endocrine disorders
Rare:           Hypoaldosteronism, associated with hyperkalaemia and metabolic acidosis, especially in patients with renal impairment and diabetes.
Vascular disorders
Very rare:      Vasospasm

Hepatobiliary disorders
Very common: Elevation of serum transaminases (AST, ALT), gamma-glutamyl transpeptidase (gamma-GT), LDH and lipase/ -
Reproductive system disorders
Very rare:       Priapism

Skin and subcutaneous tissue disorders
Uncommon:       Transient alopecia, skin necrosis.

Musculoskeletal and connective tissue disorders
Not known:      Osteoporosis may develop after prolonged use (months), mostly when higher doses are used and especially in patients with a predisposition to it.


Reproductive system disorders
Very rare:       Priapism


General disorders and administration site conditions
Common:          Local tissue reactions at the injection site (induration, redness, discoloration and small haematomas).
Very rare:       Calcinosis at the injection site, mainly in patients with severe kidney failure.
Benzyl alcohol can cause allergic reactions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il