What it is and what it is used for

for Heparin Sodium 100 I.U./ml Flushing Solution is heparinised saline which is heparin dissolved in a salt water solution. Heparin is an anti-clotting agent and is produced naturally in the body. Heparin Sodium 100 I.U./ml Flushing Solution is used to wash and rinse the inside of intravenous catheters and cannulas (surgical forms of tubing) to ensure they do not become blocked while they are in use.

What you need to know before you take it

e Heparin Sodium 100 I.U./ml Flushing Solution Do not use Heparin Sodium 100 I.U./ml Flushing Solution:

• if you are allergic to heparin or any of the other ingredients of this medicine (listed in section 6).
• if you are about to be treated for pain and inflammation with intravenous diclofenac Take special care with Heparin flush Before you have Heparin flush, tell your doctor:
• If you are allergic (hypersensitive) to low molecular weight heparins, such as tinzaparin, enoxaparin or dalteparin. If you have Heparin flush regularly for more than five days, your doctor may take regular blood tests. This is to check the level of platelets (a type of cell) in your blood while you have your medicine. Depending on the result the doctor may tell you to stop having this medicine straight away. Also your doctor may take a blood test up to several weeks after the end of your heparin treatment. Again, this is so the doctor can check the level of the platelets in your blood. Pregnancy, breast-feeding and fertility Do not use Heparin Sodium 100 I.U./ml Flushing Solution if you are pregnant or trying to become pregnant without talking to your doctor first Do not use Heparin Sodium 100 I.U./ml Flushing Solution if you are breast-feeding without talking to your doctor. If you have any doubts about whether Heparin Sodium 100 I.U./ml Flushing Solution should be used for you then discuss things more fully with your doctor or nurse.

1

NAME OF THE MEDICINAL PRODUCT

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Heparin Sodium 100 I.U./ml Flushing Solution for maintenance of patency of intravenous devices Heparin sodium 100 I.U./ml (200 I.U. in 2ml) For the full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM

Flushing solution for maintenance of patency of intravenous devices A colourless or straw coloured liquid, free from turbidity and from matter that deposits on standing.

4 CLINICAL PARTICULARS 4.1 Therapeutic indications

Heparin is an anticoagulant and acts by potentiating the naturally occurring inhibitors of thrombin and factor X (Xa). Heparin Sodium 100 I.U./ml Flushing Solution is indicated in any clinical circumstances in which it is desired to flush an intravenous catheter or cannula with a low concentration of heparin to ensure patency prior to administration of an intravenous injection.

4.2 Posology and method of administration

Not recommended for systemic use. For cleaning indwelling cannulae. Material to be used as an intravascular cannula or catheter flush in doses of 200 units every 4 hours or as required. Hypersensitivity to the active substance or to any of the other excipients listed in section 6.1. Concomitant use of intravenous diclofenac with heparin (including low dose heparin) is contraindicated.

4.4 Special warnings and precautions for use

When an indwelling device is used for repeated withdrawal of blood samples for laboratory analyses and the presence of heparin or saline is likely to interfere with or alter results of the desired blood tests, the in situ heparin flush solution should be cleared from the device by aspirating and discarding a volume of solution equivalent to that of the indwelling venipuncture device before the desired blood sample is taken. The safety of Heparin Sodium 100 I.U./ml Flushing Solution in pregnancy is not established, but the dose of heparin involved would not be expected to constitute a hazard. Heparin does not appear in breast milk.

4.7 Effects on ability to drive and use machines None stated.

4.8 Undesirable effects

Caution should be exercised in patients with known hypersensitivity to low molecular weight heparins. Rigorous aseptic technique should be observed at all times in its use.

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4.5 Interaction with other medicinal products and other forms of interactions

4.6 Fertility, pregnancy and lactation

4.3 Contraindications

Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client's brief, the final responsibility must be taken by our client.

As there is a risk of antibody-mediated heparininduced thrombocytopenia, platelet counts should be measured in patients receiving regular and repeated use of heparin flush solutions for longer than 5 days or earlier in patients with previous exposure to heparin. In patients who develop thrombocytopenia or paradoxical thrombosis, heparin treatment should be stopped immediately and heparin eliminated from all flushes and ports. Heparin induced thrombocytopenia (HIT) and heparin induced thrombocytopenia with thrombosis (HITT) can occur up to several weeks after discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT or HITT. Repeated flushing of a catheter device with heparin may result in a systemic anticoagulant effect.

Used as directed, it is extremely unlikely that the low levels of heparin reaching the blood will have any systemic effect, however, there have been rare reports

Customer

Wockhardt UK Limited

Colours Used

Description

Heparin Sodium UK LFT 0111

Black

Item Code

106932/4

Keyline (Non-Printing)

Profile

As per uploaded pdf

Text Free Area (Non-Printing)

Size

148 x 375mm

Min. Point Size

Other

Market

UK

Language

English

Standard 432

Actual Min Point Size 8.5 pt

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Date

10/06/2018

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How to take it

Heparin Sodium 100 I.U./ml Flushing Solution

• Heparin Sodium 100 I.U./ml Flushing Solution should not be injected directly into the body.
• Heparin Sodium 100 I.U./ml Flushing Solution is used for cleaning catheters and cannulas (surgical forms of tubing) by flushing with 2ml (200 units) every four hours or as required.
• The doctor will decide which dose is best to be used.
• If blood for tests are to be taken from the tubing which has been rinsed with this product, the heparin in the tubing should first be withdrawn and discarded.
• Aseptic techniques should be used at all times during its use to avoid contamination.
• Your doctor will check your blood if you use Heparin Sodium 100 I.U./ml Flushing Solution for longer than five days.

4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them, particularly when treatment is first started.

• It can cause bleeding and occasionally a serious blood disorder (thrombocytopenia)
• Thrombocytopenia may result in the formation of dangerous blood clots causing chest pains, shortness of breath, coughing, feeling faint, dizziness or loss of consciousness. If thrombocytopenia develops, Heparin treatment should be stopped immediately.
• Rarely, allergic reactions can occur. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

Possible side effects

not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

Heparin Sodium 100 I.U./ml Flushing Solution Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the ampoule. The expiry date refers to the last day of that month.
• Do not use if the contents of the ampoule show signs of deterioration such as discolouration.
• Do not store above 25oC.
• Store in the original package in order to protect from light.
• Any portion of the contents not used at once should be discarded. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Heparin Sodium 100 I.U./ml Flushing Solution contains Heparin Sodium 100 I.U./ml Flushing Solution is heparinised saline which is heparin dissolved in a salt water solution. It is available as a sterile heparinised saline flush solution in one strength of 100 international units per ml. Each 2ml ampoule contains 200 international units of heparin sodium. The active substance is heparin sodium. The other ingredients are sodium chloride, water for injections, hydrochloric acid and sodium hydroxide. What Heparin Sodium 100 I.U./ml Flushing Solution looks like and contents of the pack Heparin Sodium 100 I.U./ml Flushing Solution is a colourless or straw-coloured liquid. The registered pack size is 10 glass ampoules. Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only) Please be ready to give the following information: Product Name Reference Number Heparin Sodium 100 I.U./ml Flushing Solution 29831/0111 This is a service provided by the Royal National Institute of Blind People. Marketing Authorisation holder and Manufacturer Marketing Authorisation holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK. 106932/4 This leaflet was last revised in 06/2018

of immune-mediated thrombocytopenia and thrombosis in patients receiving heparin flushes. Pulmonary embolism has been reported as thromboembolic complications of heparin-induced thrombocytopenia. Heparin should be discontinued immediately in patients who develop thrombocytopenia. Hypersensitivity reactions to heparin are rare. They include urticaria, conjunctivitis, rhinitis, asthma, cyanosis, tachypnoea, feeling of oppression, fever, chills, angioneurotic oedema and anaphylactic shock. 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/ yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

6.2 Incompatibilities

4.9 Overdose Not applicable

Do not store above 25°C Store in the original package

5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties

6.5 Nature and contents of container

Heparin Sodium 100 I.U./ml Flushing Solution, containing only 200 I.U. of sodium heparin per ampoule (2ml), is used for flushing indwelling cannulae. This is unlikely to produce blood levels of heparin having any systemic effect.

5.2 Pharmacokinetic properties None stated

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections.

Unopened – 36 months From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

6.4 Special precautions for storage

2ml clear glass ampoules

6.6 Special precautions for disposal Not applicable

7

MARKETING AUTHORISATION HOLDER

8

MARKETING AUTHORISATION NUMBER(S)

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Wockhardt UK Ltd Ash Road North Wrexham LL13 9UF UK.

Date of first authorisation: 11 September 2007

Sodium chloride Water for injections Hydrochloric acid 3M Sodium hydroxide 3M

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6.3 Shelf life

PL 29831/0111

6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients

Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client's brief, the final responsibility must be taken by our client.

Heparin and reteplase are incompatible when combined in solution. Amikacin sulfate, gentamicin sulfate, netilmicin sulfate, pethidine hydrochloride, promethazine hydrochloride and tobramycin sulfate. If reteplase and heparin are to be given through the same line this, together with any Y-lines, must be thoroughly flushed with a 0.9% saline or a 5% glucose solution prior to and following the reteplase injection.

10 DATE OF REVISION OF THE TEXT June 2018

106932/4

Customer

Wockhardt UK Limited

Colours Used

Description

Heparin Sodium UK LFT 0111

Black

Item Code

106932/4

Keyline (Non-Printing)

Profile

As per uploaded pdf

Text Free Area (Non-Printing)

Size

148 x 375mm

Min. Point Size

Other

Market

UK

Language

English

Standard 432

Actual Min Point Size 8.5 pt

Barcode Proof By

MPI

Date

10/06/2018

Body Text Fonts:

Helvetica LT, Helvetica LT Condensed, Helvetica Neue LT, Helvetica Neue LT Condensed

Body Text Fonts Ctd

Myriad Pro

Proof No.

1