Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The following undesirable effects can occur during treatment with Heparin Sodium Panpharma 5,000 IU/ml.
The following frequency data are used for the assessment of undesirable effects:  very common         ≥10%
 common              ≥1.0% to <10% uncommon            ≥0.1% to <1.0%
 rare                ≥0.01% to <0.1%
 very rare           <0.01%, including isolated cases

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 thromboses or emboli, consumption coagulopathy, possibly skin necrosis at the injection site, petechiae, purpura and melaena. In non- sensitised individuals, the platelet count generally starts to fall 6-14 days after the start of treatment, while in sensitised individuals this can in some circumstances occur within hours. The anticoagulant effect of heparin may be reduced (heparin tolerance).

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 generalized hypersensitivity, including angioedema, reversible alopecia, skin necrosis.
Rare:        Hypersensitivity reactions due to the benzyl alcohol content.
Very rare:   Occurrence of anaphylactic shock, especially in sensitised patients who have previously received heparin. Calcinosis at the site of injection occurs very rarely, mainly in patients with severe renal failure.

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

Nervous system disorders
Spinal and epidural haematomas have been reported in rare cases with the use of heparin sodium in the context of spinal or epidural anaesthesia or postoperative indwelling catheters. These events have resulted in neurological complications of varying severity, such as persistent or permanent paralysis (see also 4.4).

Vascular disorders
Very rare:    Vasospasm.

Hepatobiliary disorders
Very common: Elevation of serum transaminases (AST, ALT), gamma-glutamyl transpeptidase (gamma-GT), LDH and lipase, which is not clinically relevant and generally reversible.
Reproductive system disorders
Very rare:    Priapism.

Musculoskeletal and connective tissue disorders
Osteoporosis may develop after prolonged use (months), mostly when higher doses are used and especially in patients with a predisposition to it.

Administration site conditions
Local tissue reactions (induration, redness, discoloration and small haematomas) at the injection site are common.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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/