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CARNITOR 1G SOLUTION FOR INJECTION

Active substance(s): LEVOCARNITINE

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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 your doctor or pharmacist.
Taking other medicines
Tell your doctor if you are taking anticoagulant medicine, such as warfarin, or any other
drug to reduce blood clotting. Your doctor may need to change how often you are
tested to see how fast your blood clots.
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those obtained without a prescription.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you may be pregnant or if you become
pregnant while having Carnitor injection. Your doctor will decide whether or not you
should continue to have your medicine.
If you wish to breastfeed, ask your doctor for advice.

3. How you will be given Carnitor injection
How much Carnitor injection will you be given
Your doctor will carefully calculate the amount of Carnitor injection that you should be
given and may vary it depending on your response to the treatment. The doctor may
take blood and urine samples to check the amount of the drug in your body.
Method of administration
Your doctor will give the injection slowly into your vein (intravenous injection) over a
period of 2-3 minutes.

20024214

Driving and using machines
You can drive or use machines whilst taking Carnitor injection.

Primary carnitine deficiency
The usual recommended dose is 100 mg per kg of your body weight per day. This will
be given in 3-4 doses.
Secondary carnitine deficiency in haemodialysis patients (dialysis of the blood)
A dose of 20 mg per kg of your bodyweight should be given in the same way as above
at the end of each dialysis session (assuming three sessions per week). The treatment
should last at least three months, which is the time required to restore normal muscle
levels of free carnitine. If significant benefit is seen following this first course of
treatment ongoing therapy using 1g per day of Carnitor Oral Solution may be used. On
the day of dialysis Carnitor Oral Solution should be taken at the end of the dialysis
session.
If you are given more Carnitor injection than you should
If you think you have been given too much Carnitor injection tell your doctor.
If you have any further questions about taking this medicine, please ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, Carnitor injection can cause side effects, although not everybody
gets them.
Side effects are:
- Drug-related body odour. Your doctor may reduce your dose to help lessen or stop
the odour.
- For people also taking anticoagulant medicine, such as warfarin, tests may show
your blood is taking longer than usual to clot.
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. You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Carnitor injection
Keep out of the reach and the sight of children.
Do not use Carnitor injection after the expiry date stated on the sealed glass ampoule.
The expiry date refers to the last day of that month.
Store below 25ºC and protect from light.
Medicines should not be disposed of via wastewater or in household waste. Return
any medicine you no longer need to the pharmacist.
6. Further information
What Carnitor injection contains
- The active substance is levocarnitine inner salt. Each Carnitor injection contains 1 g
levocarnitine inner salt in each 5 ml sealed glass container (ampoule).
- The other ingredients are hydrochloric acid 10% and water for injection.
What Carnitor injection looks like and contents of the pack
Carnitor injection is a clear, colourless or light straw-coloured liquid. It comes in 5 ml
clear sealed glass containers (ampoules). There are 5 ampoules in each pack of
Carnitor injection.
Marketing Authorisation Holder:
sigma-tau Industrie Farmaceutiche Riunite S.p.A.
Viale Shakespeare, 47 - 00144 Rome, Italy
Manufacturer:
sigma-tau Industrie Farmaceutiche Riunite S.p.A.
Pomezia, Italy

industrie farmaceutiche riunite s.p.a.
viale shakespeare, 47 - roma (italy)

20024214

This leaflet was last revised in January 2014

s. p. a.

Carnitor 1 g - fia
Uso mano

II

19:02:14 26:02

III

13:03

TESA

1 4 0 ,0

TESO
stiff

CARATTERI UTILIZZATI fonts type
PIEGATA
folded

Helvetica - Times

IV

14:04

BOZZA n.
proof

V

BOZZA n.
proof

VI

BOZZA n.
proof

VII

20024214

BOZZA n.
proof

4 5,5
n. IX
VIII BOZZA
proof

2 9 0 ,0
4 5,5
X

BOZZA n.
proof

06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06

TACCA di taglio mm

PURPLE color NOT to
be printed.
It shows text and varnish
no-print area.

Codice DE.CA.
DE.CA. code

20
FACCIA TA A - TEST O, AL TO
FACE A - TEXT , UP
5

PACKAGE LEAFLET: INFORMATION FOR THE USER

Carnitor 1 g Solution for Injection
(levocarnitine)

30

Codici DE.CA.
DE.CA. codes

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.

280

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 your doctor or pharmacist.
Taking other medicines
Tell your doctor if you are taking anticoagulant medicine, such as warfarin, or any other
drug to reduce blood clotting. Your doctor may need to change how often you are
tested to see how fast your blood clots.
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those obtained without a prescription.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you may be pregnant or if you become
pregnant while having Carnitor injection. Your doctor will decide whether or not you
should continue to have your medicine.
If you wish to breastfeed, ask your doctor for advice.

Codici DE.CA.
DE.CA. codes

Driving and using machines
You can drive or use machines whilst taking Carnitor injection.
3. How you will be given Carnitor injection
How much Carnitor injection will you be given
Your doctor will carefully calculate the amount of Carnitor injection that you should be
given and may vary it depending on your response to the treatment. The doctor may
take blood and urine samples to check the amount of the drug in your body.
Method of administration
Your doctor will give the injection slowly into your vein (intravenous injection) over a
period of 2-3 minutes.

30

20024214

I

BOZZA n.
proof

DIMENSIONI mm size

N.B.
Il colore PURPLE NON
deve essere
stampato,serve come
indicazione.
Zone retinate libere da
testo e/o vernice.

Codici DE.CA.
DE.CA. codes

IIXXXXXX

PANTONE NERO
COLORI
colours
BOZZA n.
BOZZA n.
proof
proof

Realizzato

CODICE COMPONENTE material code

20015172

TIPO PIEGA fold type

50 g/m

CODICE A BARRE bar code
BOZZA n.
proof

I

GRAMMATURA weigth
2 ±10%

FOGLIO ILLUSTRATIVO
leaflet

SOSTITUISCE it replaces

PRODUZIONE manifacturing

NOME PRODOTTO product description
CARTA paper

(GB)

SCHEDA MATERIALE DI CONFEZIONAMENTO
Packaging material data sheet

5

2,5

2,5
10
15

15
110
140

290

FACCIATA B - TESTO, ALTO
FA C E B - T E X T, U P

Primary carnitine deficiency
The usual recommended dose is 100 mg per kg of your body weight per day. This will
be given in 3-4 doses.

Codici DE.CA.
DE.CA. codes

Secondary carnitine deficiency in haemodialysis patients (dialysis of the blood)
A dose of 20 mg per kg of your bodyweight should be given in the same way as above
at the end of each dialysis session (assuming three sessions per week). The treatment
should last at least three months, which is the time required to restore normal muscle
levels of free carnitine. If significant benefit is seen following this first course of
treatment ongoing therapy using 1g per day of Carnitor Oral Solution may be used. On
the day of dialysis Carnitor Oral Solution should be taken at the end of the dialysis
session.
If you are given more Carnitor injection than you should
If you think you have been given too much Carnitor injection tell your doctor.
If you have any further questions about taking this medicine, please ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, Carnitor injection can cause side effects, although not everybody
gets them.
Side effects are:
- Drug-related body odour. Your doctor may reduce your dose to help lessen or stop
the odour.
- For people also taking anticoagulant medicine, such as warfarin, tests may show
your blood is taking longer than usual to clot.
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. You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Carnitor injection
Keep out of the reach and the sight of children.
Do not use Carnitor injection after the expiry date stated on the sealed glass ampoule.
The expiry date refers to the last day of that month.
Store below 25ºC and protect from light.
Medicines should not be disposed of via wastewater or in household waste. Return
any medicine you no longer need to the pharmacist.
6. Further information
What Carnitor injection contains
- The active substance is levocarnitine inner salt. Each Carnitor injection contains 1 g
levocarnitine inner salt in each 5 ml sealed glass container (ampoule).
- The other ingredients are hydrochloric acid 10% and water for injection.
What Carnitor injection looks like and contents of the pack
Carnitor injection is a clear, colourless or light straw-coloured liquid. It comes in 5 ml
clear sealed glass containers (ampoules). There are 5 ampoules in each pack of
Carnitor injection.
Marketing Authorisation Holder:
sigma-tau Industrie Farmaceutiche Riunite S.p.A.
Viale Shakespeare, 47 - 00144 Rome, Italy

This leaflet was last revised in January 2014

industrie farmaceutiche riunite s.p.a.
viale shakespeare, 47 - roma (italy)

20024214

Codici DE.CA.
DE.CA. codes

Manufacturer:
sigma-tau Industrie Farmaceutiche Riunite S.p.A.
Pomezia, Italy

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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