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Argipressin 20iu/Ml Solution For Injection

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MercuryPharma

PATIENT INFORMATION LEAFLET

Argipressin 20 International Units/ml Solution for Injection


READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or nurse.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet please tell your doctor or nurse.


This product is known by the above name but will be referred to as Argipressin Injection throughout the rest of this leaflet.

In this leaflet:

1.    What Argipressin Injection is and what it is used for

2.    Before you are given Argipressin Injection

3.    How Argipressin Injection is given to you

4.    Possible side effects

5.    How to store Argipressin Injection

6.    Further information


1. WHAT ARGIPRESSIN INJECTION IS AND WHAT IT IS USED FOR


Argipressin Injection contains argipressin which is similar to a naturally occurring hormone in your body. It is an 'antidiuretic' which helps to prevent excess loss of water in your urine and also narrows some blood vessels in the body.

Argipressin is used to treat:

•    diabetes insipidus. This is a rare form of diabetes causing production of large quantities of urine. Argipressin increases the amount of water absorbed back into your kidneys

•    bleeding from enlarged veins in the oesophagus (food pipe).


2. BEFORE YOU ARE GIVEN ARGIPRESSIN INJECTION


YOU SHOULD NOT BE GIVEN Argipressin Injection if:

•    you know that you are allergic to argipressin or any of the other ingredients (see section 6 of this leaflet)

•    you suffer from a certain type of kidney disease called chronic nephritis with nitrogen retention (your doctor will advise you)

•    you suffer from any diseases or conditions associated with your arteries and veins, especially the artery of your heart

•    you are intended to receive halogenated anaesthetic agents during surgical procedures.

Speak to your doctor if one of these applies to you before you are given this medicine.

Before you are given Argipressin Injection, your doctor will take special care if any of the following situations apply to you. Make sure your doctor is aware of these situations:

•    you suffer from asthma or other allergic conditions

•    you suffer from migraine

•    you suffer from epilepsy (fits)

•    you suffer from high blood pressure, heart or kidney disease

•    you suffer from obstruction of the blood vessels of the heart (e.g. coronary artery)

•    you have undergone removal of pituitary gland (dosage will depend on urine concentration).

Speak to your doctor if one of these applies to you before you are given this medicine.

Taking other medicines

Tell your doctor before you are given this medicine if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is extremely important because some medicines can strengthen or weaken the effects of others.

In particular, tell your doctor if you are taking any of the following:

•    medicines which control seizures (carbamezepine)

•    other medicines to treat diabetes (chloropropamine)

•    medicines used in corticosteroid replacement therapy (fludrocortisone)

•    medicines to treat depression (e.g. amitriptyline, imipramine etc.)

•    antibiotics (demeclocycline)

•    medicines which prevent blood clotting (heparin)

•    medicines used to treat mania (lithium)

•    medicines used for severe low blood pressure or cardiac arrest (noradrenaline)

•    medicines containing urea (in some skin and ear preparations)

•    lipid lowering agent (clofibrate)

Taking Argipressin Injection with food and drink

•    Do not drink alcohol "before you are given Argipressin Injection.


Cf

MercuryPharma

Date of Approval:

N/A

To be implemented by: N/A

PROOF

1

11/09/2014

Product Description:

Originated by Date:

Tech Approved

Date:

Argipressin 20 lU/ml Injection

PAT 11/09/2014

N/A

N/A

Component:

Revised by

Version:

Leaflet

N/A

101901/LF/1

Manufacturer:

File Name:

CRF No.:

Haupt-Wulfing GmbH

101901LF Argipressin Inj V1_1

QA.CRF041.2013 |

Market:

Software Package:

Barcode:

UK

Quark Xpress 10

N/A

Minimum Font Size & Typeface:

Dimensions:

Pharma Code:

8pt Swiss 721 BT

125 X 250 mm

N/A

Colours: Hglack

Key Line:


Pregnancy and breast-feeding

Tell your doctor before you are given this medicine if you are or think you may be pregnant or are planning to'"become pregnant, or are breast-feeding.

As with all drugs, Argipressin should only be given in pregnancy and when breast feeding if absolutely necessary. Your doctor will guide you.

Driving and using machines

Argipressin can affect your ability to drive and use machinery safely, as you may feel dizzy after receiving your injection. Speak to your doctor for further advice.


3. HOW ARGIPRESSIN INJECTION IS GIVEN TO YOU


It is most likely that you will be in hospital when you are given Argipressin. For the treatment of diabetes insipidus: the dose is usually 0.25ml to 1ml injected under the skin or into a muscle every two hours.

For the treatment of bleeding in the oesophagus: the dose is usually 1ml diluted in a sugar solution and slowly dripped through a needle into a vein. This will usually take about 15 minutes.

Your doctor will decide on the most suitable dose and way to give it to you depending on your symptoms.

If you have any further questions on the use of this product, ask your doctor


or nurse


If you think you have been given more Argipressin Injection than you should have

As the Injection will be administered by a doctor, it is unlikely that you will be given more than is necessary. However, if you think that you nave been given too much, tell your doctor immediately.


4. POSSIBLE SIDE EFFECTS


Like all medicines, Argipressin can sometimes cause side-effects, although not everyone gets them.

All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

Argipressin can cause 'water intoxication'. Signs of this are drowsiness, being uninterested in anything (listless) and headaches. If you notice any of these signs, tell the nurse or your doctor straightaway. If it is not corrected, water intoxication can lead to fits or even coma.

Other side effects sometimes seen are:


Pounding in the head Stomach ache Abnormal collection of fluid in the body or 'bloating’ Paleness of the lips Wheezing Sweating Shakiness


•    Dizziness

•    Feeling sick or being sick

•    Repeated desire to pass stools

•    Wind

•    'Nettle rash’ or hives - Itchy red bumps on the skin

•    Gangrene which causes dead black areas of skin like fingers or toes (very rare).

In patients with disease of the heart or circulation, Argipressin may give rise to angina (chest pain).

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet please tell your doctor or nurse.


5. HOW TO STORE ARGIPRESSIN INJECTION


Keep out of the sight and reach of children.

The storage of Argipressin Injection will not be your responsibility.

Store between 2°C and 8°C. Keep the ampoules in the outer carton in order to protect from light. Do not freeze.

For single use only.

If only part used, discard the remaining solution.

Do not use after the last day of the month shown in the expiry date.


6. FURTHER INFORMATION


The active substance is argipressin.

The other ingredients are glacial acetic acid and sufficient water for injections is used to make the final volume of 1ml.

What Argipressin Injection looks like and contents of pack

Argipressin Injection is a clear, sterile solution. It is a solution for injection which comes in a small glass bottle (ampoule), containing 20 international units of the active ingredient, argipressin. It is available in packs of ten 1ml ampoules.

Marketing Authorisation Holder

Mercury Pharmaceutical Ltd, Capital House, 85 King William Street,

London EC4N 7BL, UK.

Manufacturer

Haupt Pharma Wulfing GmbH, Bethelner LandstraGe 18, D-31028 Gronau, Germany

This leaflet was last revised in September 2014.

101901/LF/1


MercuryPharma

Date of Approval:

N/A

To be implemented by: N/A

PROOF

1

11/09/2014

Product Description:

Originated by Date:

Tech Approved

Date:

Argipressin 20 lU/ml Injection

PAT 11/09/2014

N/A

N/A

Component:

Revised by

Version:

Leaflet

N/A

101901/LF/1

Manufacturer:

File Name:

CRF No.:

Haupt-Wulfing GmbH

101901LF Argipressin Inj V1_1

QA.CRF041.2013 |

Market:

Software Package:

Barcode:

UK

Quark Xpress 10

N/A

Minimum Font Size & Typeface:

Dimensions:

Pharma Code:

8pt Swiss 721 BT

125 X 250 mm

N/A

Colours: Hglack

Key Line: