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VAMINOLACT

Active substance(s): GLYCINE

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Product Name:
Vaminolact
Type of Packaging:
Leaflet
Material number:
M087436/01 UK
Pharma-Code (Laetus)
Dimension:
180 x 294 mm

Territory:

UK
Dosage:
2-D-Matrix Code
M087436/01 UK
EAN
Code: –
Font:

Colour:




Black
Fold lines

Arial

Smallest Size: 8

1. Draft
1. Corr

01.12.2015, 16:30
03.12.2015, 15:30

Variable Data:

Operator: Roberto Grill +43(0) 699-17181288

PACKAGE LEAFLET: INFORMATION FOR THE USER

Vaminolact® 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 Vaminolact® is and what it is used for
2. What you need to know before your child receives Vaminolact®
3. How your child will be given Vaminolact®
4. Possible side effects
5. How to store Vaminolact®
6. Contents of the pack and other information

1. What Vaminolact® is and what it is used for
Vaminolact® is especially designed for new born babies and infants.
It provides nourishment into your child’s blood stream when they cannot eat normally. It provides amino acids, which the body
will use to make proteins (to build and repair muscles, organs, and other body structures).
Vaminolact® is typically mixed with glucose, salts, fats, carbohydrates and vitamins, which together provide complete nutritional
needs.
In this leaflet this solution will be referred to as Vaminolact®.

2. What you need to know before your child is given Vaminolact®
Your child should not use Vaminolact® if:
• a known allergy (hypersensitivity) to Vaminolact® or any of the ingredients of Vaminolact® mentioned in section 6 (for
symptoms of an allergic reaction please refer to section 4).
• seriously reduced liver function
• reduced kidney function (ureamia) and is not on dialysis or another form of blood filtration treatment
Inform your doctor if any of the above conditions apply to your child before treatment with Vaminolact®.
Warnings and precautions
Talk to your doctor or pharmacist before using Vaminolact®
Before giving this medicine to your child your doctor should know if he/she suffers from:
• cardiac insufficiency - where the heart can’t pump enough blood throughout the body or any other heart problems
• a condition where the 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 will carry out regular blood tests to check the condition of your child.
The doctor or nurse will check that the solution is particle free before it is administered to your child.
Other medicines and Vaminolact®
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
This medicine may cause your child to become deficient in a vitamin known as folic acid, but he /she will usually be given extra
vitamins to prevent this.

3. How your child will be given Vaminolact®
Your child will receive this medicine by intravenous infusion (IV drip).
The dose given to the child will depend on his/her particular condition and will be decided by the doctor.
Dosage
The dose of Vaminolact® for new born babies and infants is between 8ml and 35ml for every kg of body weight every
24 hrs. The dose is usually increased gradually during the first week.
The dose for children varies between 14.5ml and 24ml for every kg of body weight every 24 hours. The dose should be given
slowly over 24 hours.
If your child receives too much Vaminolact®
It is very unlikely that the child will receive more infusion than it should as a doctor or nurse will monitor your child during the
treatment. However, if you think that your child has received too much Vaminolact® look for the symptoms described below and
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, Vaminolact® can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare. If your child does 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

100 ml

V002

M087436/01 UK

The following side effects have been observed when infusion was administered too quickly:
• feeling 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 Vaminolact® 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

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 Ireland you can report side effects directly to HPRA Pharmacovigilance, Earlsfort Terrace, IRL- Dublin 2.
Or by email to medsafety@hpre.ie
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Vaminolact®
Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not freeze.
Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Vaminolact®.
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 Vaminolact® solution for infusion contains
Each 1000 ml of Vaminolact® contains the following active ingredients:
Amino Acids
Amount
Alanine 6.3 grams
Arginine 4.1 grams
Aspartic acid
4.1 grams
Cysteine/Cystine
1.0 grams
Glutamic acid
7.1 grams
Glycine 2.1 grams
Histidine 2.1 grams
Isoleucine
3.1 grams
Leucine 7.0 grams
Lysine 5.6 grams
Methionine
1.3 grams
Phenylalanine
2.7 grams
Proline

5.6 grams
Serine 3.8 grams
Taurine 0.3 grams
Threonine
3.6 grams
Tryptophan
1.4 grams
Tyrosine 0.5 grams
Valine 3.6 grams
Vaminolact® also contains water for injections.
What Vaminolact® looks like and contents of pack
Vaminolact® 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 100 ml or 500 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 November 2015

Product Name:
Vaminolact
Type of Packaging:
Leaflet
Material number:
M093400/04 UK
Pharma-Code (Laetus)
9652
Dimension:
180 x 294 mm

Territory:

UK
Dosage:
2-D-Matrix Code
EAN
Code: –
Font:

Colour:




Black
Fold lines

Arial

Smallest Size: 8

1. Draft
1. Corr

02.12.2015, 13:45
03.12.2015, 15:30

Variable Data:

Operator: Roberto Grill +43(0) 699-17181288

PACKAGE LEAFLET: INFORMATION FOR THE USER

Vaminolact solution for infusion
®

M093400/04 UK

V002

500 ml

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 Vaminolact® is and what it is used for
2. What you need to know before your child receives Vaminolact®
3. How your child will be given Vaminolact®
4. Possible side effects
5. How to store Vaminolact®
6. Contents of the pack and other information

1. What Vaminolact® is and what it is used for
Vaminolact® is especially designed for new born babies and infants.
It provides nourishment into your child’s blood stream when they cannot eat normally. It provides amino acids, which the body
will use to make proteins (to build and repair muscles, organs, and other body structures).
Vaminolact® is typically mixed with glucose, salts, fats, carbohydrates and vitamins, which together provide complete nutritional
needs.
In this leaflet this solution will be referred to as Vaminolact®.

2. What you need to know before your child is given Vaminolact®
Your child should not use Vaminolact® if:
• a known allergy (hypersensitivity) to Vaminolact® or any of the ingredients of Vaminolact® mentioned in section 6 (for
symptoms of an allergic reaction please refer to section 4).
• seriously reduced liver function
• reduced kidney function (ureamia) and is not on dialysis or another form of blood filtration treatment
Inform your doctor if any of the above conditions apply to your child before treatment with Vaminolact®.
Warnings and precautions
Talk to your doctor or pharmacist before using Vaminolact®
Before giving this medicine to your child your doctor should know if he/she suffers from:
• cardiac insufficiency - where the heart can’t pump enough blood throughout the body or any other heart problems
• a condition where the 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 will carry out regular blood tests to check the condition of your child.
The doctor or nurse will check that the solution is particle free before it is administered to your child.
Other medicines and Vaminolact®
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
This medicine may cause your child to become deficient in a vitamin known as folic acid, but he /she will usually be given extra
vitamins to prevent this.

3. How your child will be given Vaminolact®
Your child will receive this medicine by intravenous infusion (IV drip).
The dose given to the child will depend on his/her particular condition and will be decided by the doctor.
Dosage
The dose of Vaminolact® for new born babies and infants is between 8ml and 35ml for every kg of body weight every
24 hrs. The dose is usually increased gradually during the first week.
The dose for children varies between 14.5ml and 24ml for every kg of body weight every 24 hours. The dose should be given
slowly over 24 hours.
If your child receives too much Vaminolact®
It is very unlikely that the child will receive more infusion than it should as a doctor or nurse will monitor your child during the
treatment. However, if you think that your child has received too much Vaminolact® look for the symptoms described below and
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, Vaminolact® can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare. If your child does 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:
• feeling 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 Vaminolact® 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

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 Ireland you can report side effects directly to HPRA Pharmacovigilance, Earlsfort Terrace, IRL- Dublin 2.
Or by email to medsafety@hpre.ie
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Vaminolact®
Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not freeze.
Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Vaminolact®.
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 Vaminolact® solution for infusion contains
Each 1000 ml of Vaminolact® contains the following active ingredients:
Amino Acids
Amount
Alanine 6.3 grams
Arginine 4.1 grams
Aspartic acid
4.1 grams
Cysteine/Cystine
1.0 grams
Glutamic acid
7.1 grams
Glycine 2.1 grams
Histidine 2.1 grams
Isoleucine
3.1 grams
Leucine 7.0 grams
Lysine 5.6 grams
Methionine
1.3 grams
Phenylalanine
2.7 grams
Proline

5.6 grams
Serine 3.8 grams
Taurine 0.3 grams
Threonine
3.6 grams
Tryptophan
1.4 grams
Tyrosine 0.5 grams
Valine 3.6 grams
Vaminolact® also contains water for injections.
What Vaminolact® looks like and contents of pack
Vaminolact® 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 100 ml or 500 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 November 2015

Expand view ⇕

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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