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TINZAPARIN SODIUM is a brand name for Tinzaparin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of venous thrombosis and thromboembolic disease including deep vein thrombosis and pulmonary embolus in adults. Extended treatment of venous thromboembolism and prevention of recurrences in adult patients with active cancer. For some patients with pulmonary embolism (e.g. those with severe haemodynamic…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Treatment in adults 175 anti-Xa IU/kg body weight given subcutaneously once daily for at least 6 days and until adequate oral anticoagulation is established. Extended treatment in adult patients with active cancer 175 anti-Xa IU/kg body weight given subcutaneously once daily for a recommended treatment period of 6 months.
The benefit of continued anticoagulation treatment beyond 6 months should be evaluated. Neuraxial anaesthesia Treatment doses of tinzaparin sodium (175 IU/kg) are contraindicated in patients who receive neuraxial anaesthesia, see section
The most frequently reported undesirable effects are haemorrhage events, anaemia secondary to haemorrhage and injection site reactions. Haemorrhage may present in any organ and have different degrees of severity. Complications may occur particularly when high doses are administered.
Although major haemorrhages are uncommon, death or permanent disability has been reported in some cases. Immune-mediated heparin-induced thrombocytopenia (type II) largely manifests within 5 to 14 days of receiving the first dose. Furthermore, a rapid-onset form has been described in patients previously exposed to heparin.
Immune-mediated heparin- induced thrombocytopenia (type II) may be associated with arterial and venous thrombosis. 4). In rare cases, tinzaparin sodium may cause hyperkalaemia due to hypoaldosteronism. 4). Serious allergic reactions may sometimes occur.
g. Stevens-Johnson syndrome), angioedema and anaphylaxis. Treatment should be promptly discontinued at the slightest suspicion of such severe reactions. The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical studies and from spontaneous reporting.
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common ≥1/10 Common ≥1/100 to < 1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Very rare <1/10,000 Not known (cannot be estimated from the available data) Blood and lymphatic system disorders Common Anaemia (incl.
haemoglobin decreased) Uncommon Thrombocytopenia (type I) (incl. platelet count decreased) Rare Heparin-induced thrombocytopenia (type II) Thrombocytosis Immune system disorders Uncommon Hypersensitivity Rare Anaphylactic reaction Metabolism and nutrition disorders Rare Hyperkalaemia Vascular disorders Common Haemorrhage Haematoma Uncommon Bruising, ecchymosis and purpura Hepatobiliary disorders Uncommon Hepatic enzyme increased (incl.
4. Paediatric population The safety and efficacy of tinzaparin sodium in children below 18 years have not yet been established. 2, but no recommendation on a posology can be made. Renal impairment If renal impairment is suspected, renal function should be assessed using a formula based on serum creatinine to estimate creatinine clearance level.
Use in patients with a creatinine clearance level < 30 ml/minute is not recommended, as dosage in this population has not been established. Available evidence demonstrates no accumulation in patients with creatinine clearance levels down to 20 ml/min.
4: Renal impairment). In this situation, the dose of tinzaparin sodium should be adjusted, if necessary, based on anti-factor Xa activity. If the anti-factor Xa level is below or above the desired range, the dose of tinzaparin sodium should be increased or reduced respectively, and the anti-factor Xa measurement should be repeated after 3-4 new doses.
This dose adjustment should be repeated until the desired anti-factor Xa level is achieved. 5 IU/anti-factor Xa IU/ml. Anti-factor Xa activity determinations were by a chromogenic assay. Elderly Tinzaparin sodium should be used in the elderly in standard doses.
Precaution is recommended in the treatment of elderly patients with renal impairment. 4: Renal impairment. Method of administration Parenteral products should be inspected visually prior to administration. Do not use if cloudiness or precipitate is observed.
The liquid may turn yellow by storage but is still suitable. Administration is by subcutaneous injection. This can be done in abdominal skin, the outer side of the thigh, lower back, upper leg or upper arm. Do not inject in the area around the navel, near scars or in wounds.
For abdominal injections, the patient should be in supine position, alternating the injections between left and right side. The air-bubble within the syringe should not be removed. During the injection, the skin should be held in a fold.
3. If neuraxial anaesthesia is planned, tinzaparin sodium should be discontinued at least 24 hours before the procedure is performed. Tinzaparin sodium should not be resumed until at least 4-6 hours after the use of spinal anaesthesia or after the catheter has been removed.
Interchangeability For interchangeability with other LMWHs, see section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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increased transaminases, ALT, AST and GGT) Skin and subcutaneous tissue disorders Uncommon Dermatitis (incl. dermatitis allergic and bullous) Rash Pruritus Rare Toxic skin eruption (including Stevens-Johnson syndrome) Skin necrosis Angioedema Urticaria Musculoskeletal and connective tissue disorders Rare Osteoporosis (in connection with long-term treatment) Reproductive system and breast disorders Rare Priapism General disorders and administration site conditions Common Injection site reaction (incl.
injection site haematoma, haemorrhage, pain, pruritus, nodule, erythema and extravasation) Patients with cancer on extended treatment In a trial of patients with cancer on extended (6 months) treatment with tinzaparin sodium, the overall frequency of adverse reactions was comparable to that seen in other patients treated with tinzaparin sodium.
Patients with cancer generally have an increased risk of haemorrhage, which is further influenced by older age, comorbidities, surgical interventions and concomitant medications. Thus, as expected, the incidence of haemorrhagic events was higher than previously observed in short- term use, and similar to the rates seen with extended use of anticoagulants in patients with cancer.
Paediatric population Limited information derived from one study and postmarketing data indicates that the pattern of adverse reactions in children and adolescents is comparable to that in adults. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
1. 4). • Active major haemorrhage or conditions predisposing to major haemorrhage. g. 24 mmol/L) or more, or c) leads to transfusion of 2 or more units of whole blood or red blood cells. • Septic endocarditis. • The multidose vial formulations of tinzaparin sodium contain 10 mg/ml of the preservative benzyl alcohol.
These formulations must not be given to premature babies and neonates due to the risk of gasping syndrome. • Treatment doses of tinzaparin sodium (175 IU/kg) are contraindicated in patients who receive neuraxial anaesthesia. If neuraxial anaesthesia is planned, tinzaparin sodium should be discontinued at least 24 hours before the procedure is performed.
Tinzaparin sodium should not be resumed until at least 4-6 hours after the use of spinal anaesthesia or after the catheter has been removed. Patients should be closely monitored for signs and symptoms of neurological injury. 4 Special warnings and precautions for use Haemorrhage Caution is advised when administering tinzaparin sodium to patients at risk of haemorrhage.
3. 5). Intramuscular injections Tinzaparin sodium should not be administered by intramuscular injection due to the risk of haematoma. Due to the risk of haematoma, concomitant intramuscular injections should also be avoided. Heparin-induced thrombocytopenia Platelet count should be measured before the start of treatment and periodically thereafter because of the risk of immune-mediated heparin-induced thrombocytopenia (type II).
8). Platelet counts will usually normalise within 2 to 4 weeks after withdrawal. Regular monitoring of platelet count also applies to extended treatment for cancer-associated thrombosis, especially during the first month, considering that cancer and its treatments such as chemotherapy may also cause thrombocytopenia.
Hyperkalaemia Heparin products can suppress adrenal secretion of aldosterone, leading to hyperkalaemia. Risk factors include diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, raised plasma potassium at pre-treatment, concomitant therapy with drugs that may elevate plasma potassium, and long-term use of tinzaparin sodium.
In patients at risk, potassium levels should be measured before starting tinzaparin sodium and monitored regularly thereafter. g. decreasing potassium intake, discontinuing other drugs that may affect potassium balance). Prosthetic heart valves There have been no adequate studies to assess the safe and effective use of tinzaparin sodium in preventing valve thrombosis in patients with […]