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VAMIN 14

Active substance(s): ALANINE / ARGININE / ASPARTIC ACID / CALCIUM GLUCONATE MONOHYDRATE / GLUTAMIC ACID / GLYCINE / ISOLEUCINE / LEUCINE / MAGNESIUM SULPHATE HEPTAHYDRATE / PHENYLALANINE / POTASSIUM CHLORIDE / PROLINE / SERINE / SODIUM ACETATE TRIHYDRATE / VALINE / ALANINE / ARGININE / ASPART

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Product Name:
Vamin 14 EF
Type of Packaging:
Leaflet
Material number:
M095760/04 GB
Pharma-Code (Laetus)
Dimension:
180 x 294 mm

Territory:

GB
Dosage:
500ml
2-D-Matrix Code
M095760/04 GB
EAN Code:
Font:
Antique Olive
Smallest Size: 8

Colour:

1. Draft

24.02.2017, 10:30

Variable Data:

Schwarz

Operator: Peter Schaffer +43(0) 664-9116508

V002
PACKAGE LEAFLET: INFORMATION FOR THE USER

Vamin® 14 Electrolyte - Free solution for infusion
Read all of this leaflet carefully before you are given this medicine, because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What is Vamin® 14 EF and what it is used for
2. What you need to know before you receive Vamin® 14 EF
3. How you are given Vamin® 14 EF
4. Possible side effects
5. How to store Vamin® 14 EF
6. Contents of the pack and other information

1. What Vamin® 14 EF is 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. What you need to know before you are given Vamin® 14 EF
Do not use Vamin® 14 EF if:
• 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.
Warnings and precautions
Talk to your doctor or pharmacist before using 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. Vamin 14 EF should be given with caution to
patients with electrolyte retention e.g. impaired renal function and to those with cardiac disease requiring electrolyte
restriction or drug therapy e.g. digitalis.
Potassium replacement should be carefully controlled, as plasma potassium levels may not be directly related to tissue levels.
The doctor or nurse will check that the solution is particle free before it is administered to you.
Other medicines and Vamin® 14 EF
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Amino acid solutions may precipitate acute folate deficiency and folic acid should be given daily.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine. 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 intravenous 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 recommended 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.
Children and adolescents
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.
M095760/04 GB

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
• 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
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
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Vamin® 14 EF
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Vamin® 14 EF.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that
month. This solution should be free of particles before use. Do not throw away medicines via wastewater. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Vamin® 14 EF solution for infusion contains
Each 1000 ml of Vamin® 14 EF contains the following active ingredients:
Amino Acids
Alanine
Arginine
Aspartic acid
Cysteine/cystine
Glutamic acid
Glycine
Histidine
Isoleucine
Leucine
Lysine
Methionine
Phenylalanine
Proline
Serine
Threonine
Tryptophan
Tyrosine
Valine

Amount
12 grams
8.4 grams
2.5 grams
420 milligrams
4.2 grams
5.9 grams
5.1 grams
4.2 grams
5.9 grams
6.8 grams
4.2 grams
5.9 grams
5.1 grams
3.4 grams
4.2 grams
1.4 grams
170 milligrams
5.5 grams

Vamin® 14 EF 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 revised in February 2017

Expand Transcript

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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