Solivito N powder for concentrate for solution for infusion

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Thiamine nitrate; Riboflavin sodium phosphate; Nicotinamide; Pyridoxine hydrochloride ; Sodium pantothenate; Sodium ascorbate; Biotin; Folic acid; Cyanocobalamin

Disponible des:

Fresenius Kabi Deutschland GmbH

Codi ATC:

B05XC

Designació comuna internacional (DCI):

Thiamine nitrate; Riboflavin sodium phosphate; Nicotinamide; Pyridoxine hydrochloride ; Sodium pantothenate; Sodium ascorbate; Biotin; Folic acid; Cyanocobalamin

Dosis:

10 millilitre(s)

formulario farmacéutico:

Powder for concentrate for solution for infusion

Área terapéutica:

Vitamins

Estat d'Autorització:

Marketed

Data d'autorització:

1999-12-10

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 leafl See section 4.
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-parahydroxy-
benzoate (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
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.
®
What is in this leaflet:
without a prescription.
If you use more Solivito
N than you should
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
Inform your doctor if:
•
you are taking phenytoin (medicine for epilepsy)
•
you are taking any medicine for Parkinson’s
It is very unlikely that you will re

Fitxa tècnica

Health Products Regulatory Authority
17 October 2019
CRN0092DR
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solivito N Powder for Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One 10 ml vial contains:
Thiamine Nitrate
3.1 mg
Riboflavine Sodium Phosphate
4.9 mg
Nicotinamide
40 mg
Pyridoxine Hydrochloride
4.9 mg
Sodium Pantothenate
16.5 mg
Biotin
60 micrograms
Folic Acid
0.4 mg
Cyanocobalamin
5.0 micrograms
Sodium Ascorbate
113 mg
One vial of Solivito N contains the following quantities of
water-soluble vitamins.
Vitamin B
1
2.5 mg
Vitamin B
2
3.6 mg
Nicotinamide
40 mg
Vitamin B
6
4.0 mg
Pantothenic acid
15.0 mg
Biotin
60 micrograms
Folic acid
0.4 mg
Vitamin B
12
5.0 micrograms
Vitamin C
100 mg
Excipients – contains methyl parahydroxybenzoate (E218) 0.5mg per
vial.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Sterile, freeze dried yellow cake.
Osmolality in 10 ml of water: approx. 490 mosm/kg water
pH in 10 ml of water: 5.8
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Solivito N is intended for use as a supplement in intravenous
nutrition providing the daily requirements of water soluble
vitamins in adults and children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Intravenous infusion after dilution, see
section 6.6.
Health Products Regulatory Authority
17 October 2019
CRN0092DR
Page 2 of 5
One vial of Solivito N should be infused over a minimum period of two
to three hours in patients with normal renal function so
as to minimise renal losses.
RECOMMENDED DOSAGE FOR ADULTS AND CHILDREN WEIGHING 10KG OR MORE
For adult patients and children weighing 10kg or more the recommended
daily dosage is the contents of one vial.
RECOMMENDED DOSAGE FOR INFANTS AND CHILDREN UNDER 10KG
Children weighing less than 10kg should be given 1/10 of the contents
of one vial per kg body weight per day.
RECOMMENDED DOSAGE FOR THE ELDERLY
No adjustment of the adult dosa