Heparin Solution Ampoule 10iu/ml 5ml (10)
Misc (Generics)
Prescription only medicine (POM)Heparin sodium 10 IU/ml flushing solution for maintenance of patency of intravenous devices
Certifications
- Licensed in the UK as a prescription Only medicine under Marketing Authorisation number PL 29831/0112 (Wockhardt UK Ltd).
- Product information (SmPC and PIL) published on the electronic Medicines Compendium (emc) and subject to MHRA oversight.
- Teleta Pharma operates as an MHRA Accredited, WDA Certified and GDP Compliant pharmaceutical wholesaler and pharmacy for prescription Only medicines.
- Licensed in the UK as a prescription Only medicine under Marketing Authorisation number PL 29831/0112 (Wockhardt UK Ltd).
- Product information (SmPC and PIL) published on the electronic Medicines Compendium (emc) and subject to MHRA oversight.
- Teleta Pharma operates as an MHRA Accredited, WDA Certified and GDP Compliant pharmaceutical wholesaler and pharmacy for prescription Only medicines.
Heparin sodium 10 IU/ml flushing solution for maintenance of patency of intravenous devices
Description
Heparin Solution Ampoule 10iu/ml 5ml (10) is a sterile, heparinised saline flush solution containing heparin sodium 10 international units per millilitre (50 IU per 5 ml ampoule) in sodium chloride solution. It is indicated for flushing and maintaining the patency of indwelling intravenous catheters, cannulas, attendant lines and heparin locks by healthcare professionals. The solution is intended for use as a device flush only and must not be used for systemic anticoagulation or injected directly into the body for therapeutic purposes.
Bnefits
- Maintains patency of indwelling intravenous catheters, cannulas, lines and heparin locks
- Reduces the risk of catheter occlusion and blockage during use when used as directed
- Provides low-dose heparin sodium (10 IU/ml) in saline, minimising systemic anticoagulant effect when used correctly for flushing
- Supplied as ready-to-use sterile ampoules for single use by healthcare professionals
- Colourless or straw-coloured solution allowing visual inspection for particulate matter
- Pack of 10 x 5 ml glass ampoules facilitates stock management in clinical settings
- Authorised prescription-only medicine with established safety and quality profile under MHRA regulation
Indications
- Maintenance of patency of indwelling intravenous catheters and cannulae
- Flushing of intravenous lines and attendant tubing to prevent or clear minor occlusion during use
- Maintenance of patency of heparin locks and similar vascular access devices where a heparinised saline flush is required
- Use in any clinical situation where a low-dose heparin sodium flush is considered necessary to maintain device patency, under the supervision of a qualified prescriber
Composition
- Active ingredient: Heparin sodium 10 I.U./ml (50 I.U. in each 5 ml ampoule)
- Excipients: Sodium chloride
- Water for injections
- Hydrochloric acid 3M (for pH adjustment)
- Sodium hydroxide 3M (for pH adjustment)
Formulation
- Pharmaceutical form: Flushing solution for maintenance of patency of intravenous devices
- Sterile heparinised saline solution containing 10 IU/ml heparin sodium
- Colourless or straw-coloured liquid, free from turbidity and from matter that deposits on standing
- Supplied in clear 5 ml glass ampoules for single use
Packaging
- 5 ml clear glass ampoules
- Carton containing 10 ampoules (10 x 5 ml per pack)
- Authorised pack size: 10 ampoules for hospital and clinic use
Usage
- For flushing of indwelling intravenous devices only; not for systemic anticoagulation or direct therapeutic injection.
- Use by healthcare professionals in accordance with local protocols and the Summary of Product Characteristics.
- Typical use as described in the SmPC: material to be used as a cannula flush (5 ml; 50 units) every four hours or as required to maintain patency, as assessed clinically.
- Employ rigorous aseptic technique when drawing up and administering the flush solution.
- Before drawing blood samples from an indwelling device that has been flushed with heparin, aspirate and discard a volume of fluid equivalent to the device’s internal volume to avoid interference with laboratory tests.
- Single-use ampoules: once opened, use immediately and discard any unused solution safely in accordance with local sharps and pharmaceutical waste policy.
Contraindications
- Established hypersensitivity or allergy to heparin sodium.
- History of immune-mediated heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia with thrombosis (HITT).
- Concomitant use of intravenous diclofenac with heparin (including low-dose heparin) is contraindicated.
- Do not use for systemic treatment of thromboembolic disease; this product is not formulated or licensed for systemic anticoagulation.
- Should not be injected directly into the body for therapeutic anticoagulant purposes.
Adverse Effects
- When used as directed for flushing, clinically significant systemic effects are unlikely; however, repeated flushing can, in some cases, lead to measurable systemic exposure.
- Rare immune-mediated heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia with thrombosis (HITT), which may be associated with serious thromboembolic complications including pulmonary embolism.
- Rare hypersensitivity reactions to heparin, including urticaria, conjunctivitis, rhinitis, asthma, cyanosis, tachypnoea, chest tightness or feeling of oppression, fever, chills, angioneurotic oedema and anaphylactic shock.
- With prolonged or repeated use, especially beyond 5 days, there is a risk of HIT; platelet counts should be monitored by healthcare professionals in patients receiving regular heparin flushes.
- Local irritation at the injection site or along the catheter track may occur, although this is uncommon when correct technique is used.
Storage Conditions
- Do not store above 25°C.
- Store in the original outer carton to protect from light.
- Shelf life of unopened ampoules is typically 3 years from the date of manufacture (refer to pack expiry date).
- From a microbiological point of view, the product should be used immediately after opening an ampoule; any unused solution must be discarded.
- Keep out of the sight and reach of children.
Duration
Used intermittently or regularly for as long as an indwelling intravenous catheter, cannula, line or heparin lock remains in place and requires patency maintenance, according to clinical judgement and local protocols. Long-term, repeated use should be supervised by a healthcare professional with appropriate monitoring for heparin-related adverse effects.
Onset
Flushing effect on maintenance of catheter or device patency is immediate upon proper administration. Systemic anticoagulant effect is not intended and, at the low dose used for flushing (50 IU per 5 ml), clinically significant systemic anticoagulation is unlikely when used as directed.
