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VAMIN 14 ELECTROLYTE FREE

Active substance(s): ALANINE / ARGININE / ASPARTIC ACID / GLUTAMIC ACID / GLYCINE / ISOLEUCINE / LEUCINE / PHENYLALANINE / PROLINE / SERINE / VALINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Vamin® 14 Electrolyte - Free 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 Vamin® 14 EF and what it is used for
2. Before you receive Vamin® 14 EF
3. How you are given Vamin® 14 EF
4. Possible side effects
5. How Vamin® 14 EF is stored
6. Further information

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

2. BEFORE YOU RECEIVE VAMIN® 14 EF
You should not receive Vamin® 14 EF if you are suffering from, or if you have suffered from:
• a known allergy (hypersensitivity) to Vamin® 14 EF or any of the ingredients of Vamin® 14 EF 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 EF.
Care should be taken when administering Vamin® 14 EF
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.
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 EF.
Driving and using machines
Vamin® 14 EF has no effect on driving or using machines.

3. HOW YOU ARE GIVEN VAMIN® 14 EF
You will receive your medicine by infusion (IV drip).
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 EF 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 EF
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 EF, 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 EF 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 EF 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 not listed in this leaflet, please tell your
doctor or pharmacist.

5. HOW VAMIN® 14 EF 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 EF.
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.
This solution should be free of particles before use.
Any solution remaining after treatment should be disposed of using the approved hospital procedures.

6. FURTHER INFORMATION
What Vamin® 14 EF infusions contain
Each 1000 ml of Vamin® 14 EF contains the following active ingredients:
Amino Acids

Amount
Alanine

12 grams
Arginine

8.4 grams
Aspartic acid

2.5 grams
Cysteine/cystine
420 milligrams
Glutamic acid

4.2 grams
Glycine

5.9 grams
Histidine

5.1 grams
Isoleucine

4.2 grams
Leucine

5.9 grams
Lysine

6.8 grams
Methionine

4.2 grams
Phenylalanine

5.9 grams
Proline

5.1 grams
Serine

3.4 grams
Threonine

4.2 grams
Tryptophan

1.4 grams
Tyrosine

170 milligrams
Valine

5.5 grams
Vamin® 14 also contains glacial acetic acid and water for injections.
What Vamin® 14 EF looks like and contents of pack
Vamin® 14 EF 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
Hafnerstraße 36
8055 Graz
Austria
This leaflet was last approved in December 2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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