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SOLIVITO N POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): BIOTIN / CYANOCOBALAMIN / FOLIC ACID / NICOTINAMIDE / PYRIDOXINE HYDROCHLORIDE / RIBOFLAVINE SODIUM PHOSPHATE / SODIUM ASCORBATE / SODIUM PANTOTHENATE / THIAMINE MONONITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Solivito® N

Powder for Concentrate for
Solution for Infusion

Read all of this leaflet carefully before you
start taking 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, pharmacist or nurse.
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Solivito® N is and what it is used for
2. What you need to know before you receive
Solivito® N
3. How you are given Solivito® N
4. Possible side effects
5. How to store Solivito® N
6. Contents of the pack and other information
1. What Solivito N is and what it is used for
Solivito® N provides water-soluble vitamins into
your bloodstream when you cannot eat normally.
Vitamins are chemicals required in small amounts
for the body to work normally.
®

Solivito® N is usually used as part of a balanced
intravenous diet, together with proteins, fat,
carbohydrates, other salts and other vitamins.
2. What you need to know before you use
Solivito® N
Do not use Solivito® N:
• if you (or your child) are allergic (hypersensitive)
to Solivito® N or any of the ingredients of this
medicine listed in section 6. If you develop a
rash or other allergic reactions (like itching,

swollen lips or face or shortness of breath
or bronchospasm), please inform your
doctor.
Warnings and Precautions
Your doctor may want to do regular blood tests
to check your condition.
This medicine may affect the result of other tests
you may have. It is important to tell any doctor
doing tests that you are using Solivito® N.
This medicine contains Methyl-parahydroxybenzoate (E218) which may cause allergic reactions
(possibly delayed), and exceptionally bronchospasm.
Other medicines and Solivito® N
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines obtained
without a prescription.
Inform your doctor if:
• you are taking phenytoin (medicine for epilepsy)
• you are taking any medicine for Parkinson’s
disease - levodopa
• you are having injections of a drug called
hydroxo-cobalamin (used in the treatment of
deficiency of vitamin B12 and used in the
treatment of some types of eye conditions)
Pregnancy, breast-feeding and fertility
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
Solivito® N has no effect on driving or using
machines.

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Your doctor will decide on the correct dose for
you to receive.
Other solutions containing carbohydrates, lipids,
amino acids, electrolytes and trace elements may
be added to this product by the doctor.
Recommended dosage
Adults and children weighing more than
10 kilograms
The usual daily dose for adults and children
weighing more than 10 kg is one vial (dissolved
to give 10 ml of solution).
Children weighing less than 10 kilograms
For children weighing less than 10 kg, the usual
daily dose is one tenth of a vial for each kg of
body weight.
If you use more Solivito® N 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
Solivito® N, inform your doctor, pharmacist or
nurse as soon as possible.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Allergic reactions may occur in patients
hypersensitive to any of the ingredients of
Solivito® N, see section 6 for the full list.
No known side effects have been reported with
Solivito® N.

3. How you are given Solivito® N
The dissolved and diluted Solivito® N will be given
to you by infusion (IV drip).
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For UK - You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.gov.
uk/yellowcard
For Ireland - Via;

Pyridoxine hydrochloride (B6)
Sodium pantothenate
Biotin
Folic acid
Cyanocobalamin (B12)
Sodium Ascorbate (Vitamin C)

4.9 mg
16.5 mg
60 micrograms
0.4 mg
5.0 micrograms
113 mg

Solivito® N also contains glycine (aminoacetic acid),
disodium edetate and methyl parahydroxybenzoate (E218).

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

What Solivito® N looks like and contents of
the pack
Solivito® N is a yellow powder containing water
soluble vitamins.

By reporting side effects you can help provide
more information on the safety of this medicine.

Solivito® N is supplied in cartons containing
10 glass vials with a rubber stopper.

5. How to store Solivito® N
Keep out of the sight and reach of children
Your doctor and hospital pharmacist are
responsible for the correct storage, use and
disposal of Solivito® N
infusion. Keep the container in the outer carton
to protect from light. Do not store above 25°C.

Marketing authorisation holder
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 INT
UK

Do not use this medicine after the expiry date
shown on the label. The expiry date refers to the
last day of that month.
Any solution remaining after treatment should
be disposed via approved hospital procedures.
6.
Contents of the pack and further
information
What Solivito® N contains
Each vial of Solivito® N contains the following
active ingredients:
Thiamine Nitrate (B1)
3.1 mg
Sodium Riboflavin Phosphate (B2) 4.9 mg
Nicotinamide
40 mg

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When the powder is dissolved, each vial contains
10 millilitres of solution.

Manufacturer:
Fresenius Kabi AB,
S-751 74 Uppsala,
Sweden
This leaflet was last revised in February 2016

V002

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.

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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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