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INNOHEP is a brand name for Tinzaparin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Prophylaxis of venous thromboembolism in adult patients undergoing surgery, particularly orthopaedic, general or oncological surgery. Prophylaxis of venous thromboembolism in non-surgical adult patients immobilised due to acute medical illness including: acute heart failure, acute respiratory failure, severe…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Prophylaxis of thromboembolic events in adults:
Administration is by subcutaneous injection. Surgical patients at moderate risk of thromboembolic events: 3,500 anti-Xa IU given SC 2 hours before surgery and then once daily for as long as the patient is considered to be at risk of VTE.
g. undergoing orthopaedic or cancer surgery: 4,500 anti-Xa IU given SC 12 hours before surgery and then once daily for as long as the patient is considered to be at risk of VTE. Non-surgical patients immobilised due to acute medical illness: 3,500 anti-Xa IU given SC once daily in patients at moderate risk of VTE, or 4,500 anti-Xa IU given SC once daily in patients at high risk of VTE.
Administration should continue for as long as the patient is considered to be at risk of VTE. 4: Neuraxial anaesthesia. If neuraxial anaesthesia is planned, a minimum delay of 12 hours should be allowed between the last prophylactic dose and the needle or catheter placement.
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. Thus, the 2 hours preoperative initiation of thromboprophylaxis with tinzaparin sodium is not compatible with neuraxial anaesthesia.
Haemodialysis and haemofiltration in adults:
Duration of 4 hours or less: A bolus injection of 2,000 to 2,500 anti-Xa IU at the start of dialysis.
Duration of more than 4 hours:
A bolus injection of 2,500 anti-Xa IU at the start of dialysis/filtration, followed by 750 anti-Xa IU/hour as a continuous infusion.
Dose adjustment:
If necessary, the bolus dose may be increased or decreased gradually in increments of 500 anti-Xa IU until a satisfactory response is obtained. The usual dose is within 2,000–4,500 anti-Xa IU. In case of concomitant transfusion of blood or concentrated red corpuscles, an extra bolus injection of 500–1,000 anti-Xa IU can be administered.
Dose monitoring:
Determination of plasma anti-Xa activity can be used to monitor the tinzaparin sodium dose during haemodialysis/haemofiltration. 5 anti-Xa IU/ml one hour after administration. Interchangeability For interchangeability with other LMWHs, 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. Special populations 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). 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. Weight For patients with very low or very high body weight, 50 anti-Xa IU per kg body weight once daily may be considered as an alternative to fixed dosing.
For surgical patients, the first dose is given SC 2 hours before surgery. The administration should continue once daily for as long as the patient is considered to be at risk of VTE. 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 during storage but is still useable. Administration is by subcutaneous injection when given as prophylaxis of thromboembolic events in adults. 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 a supine position, alternating the injections between the 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. For haemodialysis, the dose of tinzaparin sodium should be given into the arterial side of the dialyser or intravenously. The dialyser can be primed by flushing with 500- 1,000 ml isotonic sodium chloride (9 mg/ml) containing 5,000 anti-Xa IU tinzaparin sodium per litre.
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 or neonates due to the risk of gasping syndrome.
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) 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 or neonates due to the risk of gasping syndrome. 4 Special warnings and precautions for use Neuraxial anaesthesia Caution is advised when performing neuraxial anaesthesia or lumbar puncture in patients receiving prophylactic doses of tinzaparin sodium due to the risk of spinal haematomas resulting in prolonged or permanent paralysis.
A minimum delay of 12 hours should be allowed between the last prophylactic dose of tinzaparin sodium and the needle or catheter placement. For continuous techniques, a similar delay should be observed before removing the catheter. Moreover, 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. 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. 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 Therapeutic failures have been reported in patients with prosthetic […]