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VAMIN 18 ELECTROLYTE FREE

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

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Product Name:
Vamin 18 EF
Type of Packaging:
Leaflet
Material number:
M095710/04 GB
Pharma-Code (Laetus)
Dimension:
180 x 294 mm

Territory:

GB
Dosage:
2-D-Matrix Code
M095710/04 GB
EAN Code:
Font:
Antique Olive
Smallest Size: 8

Colour:
Schwarz

1. Draft
1. Corr
2. Corr
3. Corr
4. Corr

30.11.2015, 19:15
02.12.2015, 13:15
15.12.2015, 17:00
17.10.2016, 10:30
27.10.2016, 09:30

Variable Data:

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

V002

M095710/04 GB

PACKAGE LEAFLET: INFORMATION FOR THE USER

Vamin® 18 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 18 EF and what it is used for
2. What you need to know before you receive Vamin 18 EF
3. How you are given Vamin 18 EF
4. Possible side effects
5. How to store Vamin 18 EF
6. Contents of the pack and other information

1. What Vamin 18 EF is and what it is used for
Vamin 18 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 18 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 18 EF.

2. What you need to know before you are given Vamin 18 EF
Do not use Vamin 18 EF if:
• a known allergy (hypersensitivity) to Vamin 18 EF or any of the ingredients of Vamin 18 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
Warnings and precautions
Talk to your doctor or pharmacist before using Vamin 18EF







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.
Other medicines and Vamin 18 EF
Amino acid solutions may precipitate acute folate deficiency and folic acid should be given daily.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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.
Driving and using machines
Vamin 18 EF has no effect on driving or using machines.

3. How you are given Vamin 18 EF
You will receive your medicine by intravenous 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 recommended dose of Vamin 18 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.
Use in 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 more Vamin 18 EF than you should
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 18 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.

M095710/04 GB

4. Possible side effects
Like all medicines, Vamin 18 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
• Signs of 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 18 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.
In the UK you can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
In Malta you can report side effects directly via the ADR reporting website: www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Vamin 18 EF
Keep this medicine out of the sight and reach of children.
Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Vamin 18 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 18 EF solution for infusion contains
Each 1000 ml of Vamin 18 EF contains the following active ingredients:
Amino Acids
Amount
Alanine
16 grams
Arginine
11.3 grams
Aspartic acid
3.4 grams
Cysteine/cystine
560 milligrams
Glutamic acid
5.6 grams
Glycine
7.9 grams
Histidine
6.8 grams
Isoleucine
5.6 grams
Leucine
7.9 grams
Lysine
9 grams
Methionine
5.6 grams
Phenylalanine
7.9 grams
Proline
6.8 grams
Serine
4.5 grams
Threonine
5.6 grams
Tryptophan
1.9 grams
Tyrosine
230 milligrams
Valine
7.3 grams
Vamin 18 EF also contains glacial acetic acid and water for injections.
What Vamin 18 EF looks like and contents of pack
Vamin 18 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 October 2016

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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