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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

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Product Name:
Vamin 14
Type of Packaging:
Leaflet
Material number:
M095820/04 GB
Pharma-Code (Laetus)
10040
Dimension:
180 x 294 mm

Territory:

GB
Dosage:
2-D-Matrix Code
EAN Code:
Font:
Antique Olive
Smallest Size: 6

Colour:
Schwarz

1. Draft
1. Corr

30.05.2016, 11:30
22.08.2016, 20:30

Variable Data:

Operator: Roberto Grill +43(0) 69917181288

V002

M095820/04 GB

PACKAGE LEAFLET: INFORMATION FOR THE USER

Vamin® 14 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 and what it is used for
2. What you need to know before you receive Vamin 14
3. How you are given Vamin 14
4. Possible side effects
5. How to store Vamin 14
6. Contents of the pack and other information

1. What Vamin 14 is 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. What you need to know before you are given Vamin 14
Do not use Vamin 14 if:
• 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.
Warnings and precautions
Talk to your doctor or pharmacist before using 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. Vamin 14 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
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.
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 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 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
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
- 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 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
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.
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. The solution should not be used if it is not clear of particles. 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 solution for infusion contains
Each 1000 ml of Vamin 14 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
Salts
Potassium 50 mmol
Magnesium 8 mmol
Acetate 135 mmol
Sodium 100 mmol
Calcium 5 mmol
Sulphate 8 mmol
Chloride 100 mmol
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
Manufacturer
Fresenius Kabi Limited
Fresenius Kabi Austria Gmb
Cestrian Court
Hafnerstraße 36
Eastgate Way
8055 Graz
Manor Park
Austria
Runcorn
Cheshire
WA7 1NT
UK
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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