Document: leaflet MAH BRAND_PL 08828-0118 change

• leaflet MAH BRAND_PL 08828-0118
• leaflet MAH BRAND_PL 08828-0119

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Vamin® 14 Solution for Infusion

Read all of this leaflet carefully before you start taking this medicine.

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

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

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

In this leaflet:

1.    What is V amin® 14 and what it is used for

2.    Before you receive Vamin® 14

3.    How you are given Vamin® 14

4.    Possible side effects

5.    How Vamin® 14 is stored

6.    Further information

1.    WHAT IS VAMIN® 14 AND WHAT IT IS USED FOR

Vamin® 14 provides nourishment into your blood stream when you cannot eat normally. It provides amino acids, which your body will use to make proteins (to build and repair muscles, organs, and other body structures).

Vamin® 14 is typically mixed with salts, fats, carbohydrates and vitamins, which together provide complete nutritional needs.

In this leaflet this solution will be referred to as Vamin® 14.

2.    BEFORE YOU RECEIVE VAMIN® 14

You should not receive Vamin® 14 if you are suffering from, or have suffered from:

• a known allergy (hypersensitivity) to Vamin® 14 or any of the ingredients of Vamin® 14 mentioned in section 6 (for symptoms of an allergic reaction please refer to section 4)

•    seriously reduced liver function

•    reduced kidney function (ureamia) and are not on dialysis or another form of blood filtration treatment

Inform your doctor if any of the above conditions apply to you before treatment with Vamin® 14.

Care should be taken when administering Vamin^® 14

Before giving you this medicine your doctor should know if you suffer from:

•    cardiac insufficiency- the heart can’t pump enough blood throughout the body or any other heart problems

•    a condition where your body has problems using proteins or amino acids

•    high potassium levels (hyperkalaemia)

•    high sodium levels (hypernatraemia)

•    acidosis - higher than normal blood pH levels

•    any liver and kidney problems

Your doctor may want to do regular blood tests to check your condition.

The doctor or nurse will check that the solution is particle free before it is administered to you.

Taking other medications

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Inform your doctor if you are taking any heart drugs such as digitalis.

Pregnancy and breast-feeding

You should tell your doctor if you are pregnant, if you think you are pregnant or if you are breast-feeding. The doctor will decide if you should receive Vamin® 14.

Driving and using machines

Vamin® 14 has no effect on driving or using machines.

3.    HOW YOU ARE GIVEN VAMIN® 14

You will receive your medicine by infusion (IV drip) into a vein.

The amount and rate at which the infusion is given depends on your requirements.

Your doctor will decide on the correct dose for you to receive.

Dosage

Adults and Elderly

The usual dose of Vamin® 14 for adults is up to 1 litre (1000ml) every 24 hours and may need to be lowered if you have heart, liver or kidney problems or are frail or elderly.

Each litre should be given over a period of at least 8 hours.

Infants and Children

If it is considered appropriate by doctors, this medicine can be given to infants and children. The dose given to the child will depend on their particular condition and will be decided by the doctor. Doctors may feel that another medicine is more appropriate in infants.

If you receive too much Vamin® 14

It is very unlikely that you will receive more infusion than you should as your doctor or nurse will monitor you during the treatment. However if you think that you have received too much Vamin^® 14, inform your doctor or nurse immediately.

The effects of an overdose may include nausea, vomiting, flushing and sweating.

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

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Vamin® 14 can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms after receiving this medicine, you should contact your doctor immediately:

-    skin rash

-    swelling (particularly of the lips, face, eyelids, tongue, and throat).

-    breathlessness

-    collapse

The following side effects have been observed when infusion was administered too quickly:

•    being sick

•    sweating

•    flushing

Other side effects include:

•    folate deficiency- shortage of a vitamin known as folic acid

•    abnormal liver test results- these will get back to normal after the treatment with Vamin® 14 is finished

•    cholestasis- a condition in which bile is not flowing properly from the liver to the intestines

•    soreness and tenderness of the vein.

•    thrombosis (the formation of a clot) in the vein where the injection is given

The symptoms of thrombosis include:

-    pain, swelling and redness at the blood clot site

-    an itchy rash at the clot site

-    warm skin around the clot

-    a mild fever

-    major veins that stand out from your skin

If any of the side effects gets serious or if you notice any side effects notlisted in this leaflet, please tell your doctor or pharmacist.

4.    HOW VAMIN® 14 IS STORED

Keep out of the reach and sight of children.

Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Vamin^® 14. The solution must not be used after the expiry date shown on the label. The expiry date refers to the last day of that month.

The solution should not be used if it is not clear of particles.

Any solution remaining after treatment should be disposed of using the approved hospital procedures.

6. FURTHER INFORMATION What Vamin® 14 Infusions contain

Each 1000 ml of Vamin® 14 contains the following active ingredients:

Potassium

Magnesium

Acetate

Sodium

Calcium

Sulphate

Chloride

Vamin® 14 also contains glacial acetic acid and water for injections.

What Vamin® 14 looks like and contents of pack

Vamin® 14 is a clear, colourless to slightly yellow solution of amino acids and salts. It is available in glass bottles with a rubber closure that contain 500 ml or 1000 ml of solution.

Not all pack sizes may be marketed

Marketing authorisation holder

Fresenius Kabi Limited Cestrian Court Eastgate Way Manor Park Runcorn Cheshire WA7 1NT UK

Manufacturer

Fresenius Kabi Austria GmbH HafnerstraBe 36 8055 Graz Austria

This leaflet was last approved in December 2009

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