INTRODUCING (ENOXAPARIN SODIUM)▼Inhixa® Product
Inhixa 2,000 IU (20 mg) in 0.2 mL solution for injection in pre-filled syringe
Inhixa 4,000 IU (40 mg) in 0.4 mL solution for injection in pre-filled syringe
Inhixa 6,000 IU (60 mg) in 0.6 mL solution for injection in pre-filled syringe
Inhixa 8,000 IU (80 mg) in 0.8 mL solution for injection in pre-filled syringe
Inhixa 10,000 IU (100 mg) in 1.0 mL solution for injection in pre-filled syringe
Pip Code
4052502 4052528 4052510 4052494 4052536
To place your order contact Movianto: TEL: 01234 248 632 FAX: 01234 248 705
E mail:
Orders.UK@
movianto.com Also available from AAH, Alliance Unichem and Phoenix
ABBREVIATED PRESCRIBING INFORMATION ▼Inhixa (enoxaparin sodium) solution for injection in
pre-filled syringe 2000IU (20mg) in 0.2mL; 4000IU (40mg) in 0.4mL; 6,000IU (60mg) in 0.6mL; 8000IU (80mg) in 0.8mL; 10000IU (100mg) in 1.0mL Please refer to the Summary of Product Characteristics (SmPC) before prescribing Inhixa. Presentation: Inhixa comes in prefilled syringes of: 0.2mL contains 2000IU (20mg) enoxaparin sodium; 0.4mL contains 4000IU (40mg) enoxaparin sodium; 0.6mL contains 6000IU (60mg) enoxaparin sodium; 0.8mL contains 8000IU (80mg) enoxaparin sodium; 1.0mL contains 10000IU (100mg) enoxaparin sodium. Indication: Prophylaxis of venous thromboembolism, particularly in orthopaedic, general or oncological surgery. Prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses (40 mg/0.4mL). DVT treatment, with or without pulmonary embolism. Treatment of unstable angina and non-Q-wave myocardial infarction, in combination with acetylsalicylic acid (ASA). Acute STEMI treatment, including conservatively treated patients and percutaneous coronary angioplasty patients (60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL). Blood clot prevention in extracorporeal circulation during haemodialysis. Dosage and administration: For adult use. Venous thromboembolism (surgery): s.c. injection, 20 mg daily for 7-10 days, given 2 hours before surgery. In high-risk patients, give 40mg daily, 12 hours before surgery. Venous thromboembolism (bedridden): s.c. injection, 40 mg daily for 6-14 days. DVT: s.c. injection at either 1.5mg/kg body weight once daily for 5 days, or 1 mg/kg body weight twice daily for 5 days. In cases of thromboembolic complication, give 1 mg/kg body weight twice daily for 5 days. Oral anticoagulants should be started when appropriate. Unstable angina & non-Q-wave myocardial infarction (combined with oral ASA): s.c. injection, 1 mg/kg bw every 12 hours with oral ASA at 100mg- 325mg once daily, for 2-8 days. Acute STEMI: 30 mg i.v. injection, plus 1mg/kg s.c. injection, followed by
1mg/kg s.c. injection every 12 hours, for up to 8 days. In cases of PCI, if last s.c. injection was >8 hours before balloon inflation, administer 0.3 mg/kg body weight via i.v. bolus. Bolus dosing should not be used in the elderly. Prevention of extracorporeal thrombus: 1 mg/kg body weight introduced in the intra-arterial line at start of dialysis is usually sufficient for a 4-hour session. If fibrin rings become visible, a further dose of 0.5-1 mg/kg bw may be given. In case of high risk of haemorrhage, reduce dose to 0.5 mg/kg bw for double vascular access or 0.75 mg/kg for single vascular access.
Dose adjustment is necessary in the elderly (>75 years) and in severe renal impairment (creatinine clearance < 30 ml/min): refer to SmPC. Contraindications: Hypersensitivity to the active substance, heparin or its derivatives. Acute bacterial endocarditis, severe blood coagulation disorders, major bleeding, thrombocytopenia in patients with a positive in- vitro aggregation test in the presence of enoxaparin, active gastric and/or duodenal ulceration, stroke (excluding apoplexy after the blockage of the arteries), increased risk of bleeding. Warnings and Precautions: Use caution in case of increased risk of bleeding. Exercise extreme caution in cases of heparin-induced thrombocytopenia; risk may persist for several years. Monitor platelet count. If platelets decrease by 30% or more, immediately discontinue treatment and switch to another therapy. Monitor plasma potassium in patients at risk of hyperkalaemia, particularly if treatment is >7 days. Simultaneous enoxaparin sodium and spinal/epidural anaesthesia can cause intramedullary haematoma leading to long-term or permanent paralysis. Exercise extreme caution and remove subarachnoid or epidural catheters when effect of enoxaparin is low. Monitor regularly for signs of neurological impairment. If spinal haematoma is suspected, urgent diagnosis and treatment is required. In case of PCI, minimise the risk of bleeding by adhering precisely to enoxaparin sodium dose intervals. It is important to achieve homeostasis at the puncture site after PCI. The site of the procedure
laboratories
should be observed for signs of bleeding or haematoma formation. Enoxaparin is not recommended in patients with prosthetic heart valves. Carefully monitor the elderly and patients with renal impairment due to a possible increased risk of bleeding complications. Carefully monitor patients with low body weight. Observe obese patients carefully for signs of thromboembolism. Measurements of APTT and ACT are unsuitable for monitoring enoxaparin activity. Risk assessment and clinical monitoring are the best indicators. Anti-Xa activity monitoring should be considered in patients with increased bleeding risk. Interactions: agents affecting haemostasis should be discontinued prior to enoxaparin therapy unless their use is essential. If the combination cannot be avoided, monitor carefully for blood clotting. Pregnancy and lactation: Pregnancy: There are no data in pregnant women. Do not prescribe in pregnancy unless clearly necessary. Breastfeeding: Not recommended. Undesirable effects: Haemorrhage, thrombocytosis, thrombocytopenia, allergic reaction, hepatic enzyme increases, urticaria, pruritis, erythema, injection site reactions including pain and haematoma have been commonly reported. Refer to the SmPC for a full list of adverse events. Legal Category: POM
Pack size and price: Supplied in 10 packs, priced at: £16.69 (2000IU); £24.22 (4000IU); £31.41 (6000IU); £44.10 (8000IU); £57.84 (10000IU). MA Numbers: EU/1/16/1132/012; EU/1/16/1132/014; EU/1/16/1132/016; EU/1/16/1132/018; EU/1/16/1132/020. MA Holder: Techdow Europe AB, Banégatan 36, 75237 Uppsala, Sweden Full SmPC available from Techdow Europe AB or from
www.medicines.org.uk. Date of preparation: September 2017 ID Code: 005 Adverse events should be reported. Reporting forms and information can be found at
https://yellowcard.mhra.gov.uk/ Adverse events should also be reported to Techdow on 01271 334 609 or
PVUK@eu.techdow.com
GUARANTEED FULL SUPPLY
VTE Prophylaxis and DVT Treatment
Product EAN Code
7350094030029 7350094030043 7350094030067 7350094030081 7350094030104
Movianto SKU Codes
INHIXA2KIU0.2PFS10 INHIXA4KIU0.4PFS10 INHIXA6KIU0.6PFS10 INHIXA8KIU0.8PFS10 INHIXA10KIU1PFS10
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