Carnitor 1g/5ml solution for injection ampoules

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

L-Carnitine

זמין מ:

Logixx Pharma Solutions Ltd

קוד ATC:

A16AA01

INN (שם בינלאומי):

L-Carnitine

כמות:

200mg/1ml

טופס פרצבטיות:

Solution for injection

מסלול נתינה (של תרופות):

Intravenous

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 09080100

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
CARNITOR 1 G SOLUTION FOR INJECTION
(Levocarnitine)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
- Keep this leaflet. You may need to read it again
- If you have any further questions, ask your doctor or pharmacist
- This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours
- If any of the side effects get serious, or you notice any side
effects not listed in this leaflet
please tell your doctor or pharmacist.
- In this leaflet Carnitor 1 g Solution for Injection will be called
Carnitor injection.
IN THIS LEAFLET:
1. What Carnitor injection is and what it is used for
2. Before you are given Carnitor injection
3. How you will be given Carnitor injection
4. Possible side effects
5. How to store Carnitor injection
6. Further information
1.
WHAT CARNITOR INJECTION IS AND WHAT IT IS USED FOR
Carnitor injection contains levocarnitine which is a type of protein.
It is used to treat primary
and secondary carnitine deficiency in adults, children, infants and
newborn children. It can
also be used to treat secondary carnitine deficiency in haemodialysis
patients.
Carnitine deficiency occurs when the body has a shortage of
levocarnitine. Carnitor injection
makes up for your bodies lack of levocarnitine and helps give your
body more energy._ _
_ _
2.
BEFORE YOU ARE GIVEN CARNITOR INJECTION
DO NOT TAKE CARNITOR INJECTION:
-if you are allergic to levocarnitine or any other ingredients in
Carnitor injection. These
ingredients are listed in section 6 of this leaflet.
If this applies to you, do not take Carnitor injection._ _
TELL YOUR DOCTOR BEFORE YOU ARE GIVEN CARNITOR INJECTION IF:
- you have severe kidney problems or kidney disease and are having
dialysis
- you are diabetic and taking insulin, or any other drug to treat your
diabetes
- you are taking anticoagulant medicine, such as warfarin, or any
other drug to reduce blood
clotting.
If any of the above applies to you, talk to yo

מאפייני מוצר

OBJECT 1
CARNITOR 1 G SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 22-Jan-2018 | Logixx Pharma
Solutions Ltd
1. Name of the medicinal product
Carnitor 1 g Solution for Injection
2. Qualitative and quantitative composition
Levocarnitine 1 g
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
A clear, colourless or light straw- coloured solution
4. Clinical particulars
4.1 Therapeutic indications
Indicated for the treatment of primary and secondary carnitine
deficiency in adults, children, infants and
neonates.
Secondary carnitine deficiency in haemodialysis patients.
Secondary carnitine deficiency should be suspected in long-term
haemodialysis patients who have the
following conditions:
1. Severe and persistent muscle cramps and/or hypotensive episodes
during dialysis.
2. Lack of energy causing a significant negative effect on the quality
of life.
3. Skeletal muscle weakness and/or myopathy.
4. Cardiomyopathy.
5. Anaemia of uraemia unresponsive to or requiring large doses of
erythropoietin.
6. Muscle mass loss caused by malnutrition.
4.2 Posology and method of administration
For slow intravenous administration over 2-3 minutes
ADULTS, CHILDREN, INFANTS AND NEONATES:
It is advisable to monitor therapy by measuring free and acyl
carnitine levels in both plasma and urine.
THE MANAGEMENT OF INBORN ERRORS OF METABOLISM:
The dosage required depends upon the specific inborn error of
metabolism concerned and the severity of
presentation at the time of treatment. However, the following can be
considered as a general guide.
In acute decompensation, dosages of up to 100 mg/kg/day in 3-4 divided
doses are recommended. Higher
doses have been used although an increase in adverse events, primarily
diarrhoea, may occur.
SECONDARY CARNITINE DEFICIENCY IN HAEMODIALYSIS PATIENTS:
It is strongly recommended that, before initiating therapy with
Carnitor, plasma carnitine is measured.
Secondary carnitine deficiency is suggested by a plasma ratio of acyl
to free carnitine of greater than 0.4
and/o