Additrace, concentrate for solution for infusion

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Ferric chloride hexahydrate; Zinc chloride; Manganese chloride tetrahydrate; Copper chloride dihydrate; Chromium trichloride hexahydrate; Sodium selenite anhydrous; Sodium molybdate dihydrate; Sodium fluoride; Potassium iodide

Beschikbaar vanaf:

Fresenius Kabi Deutschland GmbH

ATC-code:

B05XA; B05XA31

INN (Algemene Internationale Benaming):

Ferric chloride hexahydrate; Zinc chloride; Manganese chloride tetrahydrate; Copper chloride dihydrate; Chromium trichloride hexahydrate; Sodium selenite anhydrous; Sodium molybdate dihydrate; Sodium fluoride; Potassium iodide

Dosering:

10 millilitre(s)

farmaceutische vorm:

Concentrate for solution for infusion

Therapeutisch gebied:

Electrolyte solutions; electrolytes in combination with other drugs

Autorisatie-status:

Not marketed

Autorisatie datum:

1988-05-16

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ADDITRACE®
CONCENTRATE FOR SOLUTION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Additrace is and what it is used for
2.
What you need to know before you use Additrace
3.
How to use Additrace
4.
Possible side effects
5.
How to store Additrace
6.
Contents of the pack and other information
1. WHAT ADDITRACE IS AND WHAT IT IS USED FOR
Additrace provides trace elements into your blood stream when you
cannot eat normally. Trace
elements are tiny amounts of chemicals that your body needs to work
normally. Additrace is usually
used as part of a balanced intravenous diet, together with proteins,
fat, carbohydrates, salts and
vitamins.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ADDITRACE
DO NOT USE ADDITRACE:
•
if you are allergic to any of the ingredients of Additrace mentioned
in section 6.
IF YOU DEVELOP A RASH OR OTHER ALLERGIC REACTIONS (LIKE ITCHING,
SWOLLEN LIPS OR FACE OR SHORTNESS OF
BREATH), PLEASE INFORM YOUR DOCTOR.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Additrace if you
suffer from:
- impaired liver and/or kidney function
Your doctor may want to do regular blood tests to check your
condition.
Additrace
MUST BE DILUTED BEFORE USE.
It will be added to another solution before it is given to you.
Your doctor, pharmacist or nurse will make sure it is prepared
correctly before you receive Additrace.
Additrace should not be used if the solution is cloudy or contains
particles. The doctor, pharmacist or
nurse will check that the solution is particle free before it is
administered to you.
OTHER MEDICINES AND ADDITRACE
Talk to you

Productkenmerken

Health Products Regulatory Authority
26 June 2020
CRN009TTG
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Additrace, concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 10ml of concentrate.
Each 1 ml of concentrate contains:
Ferric chloride, 6H2O Ph. Eur.
540
microgram
Zinc chloride Ph. Eur
1.36
mg
Manganese chloride 4H
2
O USP
99.0
microgram
Copper chloride 2H
2
O USP
340
microgram
Chromic chloride 6H
2
O USP
5.33
microgram
Sodium Selenite anhydrous
6.9
microgram
Sodium molybdate, 2H
2
O Ph. Eur.
4.85
microgram
Sodium fluoride BP
210
microgram
Potassium iodide Ph. Eur
16.6
microgram
One 10ml ampoule of Additrace contains:
Fe
3+
20
micromol
Zn
2+
100
micromol
Mn
2+
5
micromol
Cu
2+
20
micromol
Cr
3+
0.2
micromol
Se
4+
0.4
micromol
Mo
6+
0.2
micromol
F
-
50
micromol
I
-
1
micromol
Less than 1 mmol of both potassium and sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Sterile, clear, almost colourless solution for addition to amino acid
solutions
• Osmolality: approx. 3100 mosm/kg water
• pH: 2.3 – 2.8
Health Products Regulatory Authority
26 June 2020
CRN009TTG
Page 2 of 5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A source of electrolytes and trace elements as an integral part of a
complete intravenous nutritional regimen, for adults and
children over 40 kg.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
One 10ml ampoule of Additraceis added to one of the following Vamin
solutions:
Vamin 9 Glucose, Vamin 14, Vamin 14 Electrolyte-Free, Vamin 18
Electrolyte-Free, Glucose Intravenous Infusion 5-50%
The mixture should be infused at an appropriate rate for the amino
acid solution.
_Paediatric Population_
Additrace is contradindicated in infants and children under 40kg body
weight.
The electrolyte solution Pedictraceshould be used.
Method of administration
Intravenous infusion after dilution.
Additracemust not be given undiluted. For instruction