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 Levocarnitine Injection USP 1g/5ml Injection will be called Levocarnitine Injection USP 1g/5ml injection.
IN THIS LEAFLET:
- What Levocarnitine Injection USP 1g/5ml injection is and what it is used for
- Before you are given Levocarnitine Injection USP 1g/5ml injection
- How you will be given Levocarnitine Injection USP 1g/5ml injection
- Possible side effects
- How to store Levocarnitine Injection USP 1g/5ml injection
- Further information
1. WHAT LEVOCARNITINE INJECTION USP 1G/5ML INJECTION IS AND WHAT IT IS USED FOR
Levocarnitine Injection USP 1g/5ml 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. Levocarnitine Injection USP 1g/5ml injection makes up for your bodies lack of levocarnitine and helps give your body more energy.
2. BEFORE YOU ARE GIVEN LEVOCARNITINE INJECTION USP 1G/5ML INJECTION
Do not take Levocarnitine Injection USP 1g/5ml injection:
-if you are allergic to levocarnitine or any other ingredients in Levocarnitine Injection USP 1g/5ml injection. These ingredients are listed in section 6 of this leaflet. If this applies to you, do not take Levocarnitine Injection USP 1g/5ml injection.
Tell your doctor before you are given Levocarnitine Injection USP 1g/5ml 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 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 Levocarnitine Injection USP 1g/5ml 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.
Driving and using machines
You can drive or use machines whilst taking Levocarnitine Injection USP 1g/5ml injection.
3. HOW YOU WILL BE GIVEN LEVOCARNITINE INJECTION USP 1G/5ML
How much Levocarnitine Injection USP 1g/5ml injection will you be given
Your doctor will carefully calculate the amount of Levocarnitine Injection USP 1g/5ml 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 the body.
Method of administration
Your doctor will give the injection slowly into your vein (intravenous injection) over a period of 2-3 minutes.
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 body weight 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 a significant benefit is seen following this first course of treatment ongoing therapy using 1 g per day of Levocarnitine Injection USP 1g/5ml Oral Solution may be used. On the day of dialysis Levocarnitine Injection USP 1g/5ml, Oral Solution should be taken at the end of the dialysis session.
If you are given more Levocarnitine Injection USP 1g/5ml injection than you should
If you think you have been given too much Levocarnitine Injection USP 1g/5ml 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, Levocarnitine Injection USP 1g/5ml 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 side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE LEVOCARNITINE INJECTION USP 1G/5ML INJECTION
Keep out of the reach and sight of children.
Do not use Levocarnitine Injection USP 1g/5ml injection after the expiry date stated on the sealed glass ampoule. The expiry date refers to the last day of that month.
Store below 25?C 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 Levocarnitine Injection USP 1g/5ml injection contains
-The active substance is levocarnitine inner salt. Each Levocarnitine Injection USP 1g/5ml injection contains 1 g levocarnitine in every 5 ml sealed glass container (ampoule).
-The other ingredients are hydrochloric acid 10% and water for injection.
What Levocarnitine Injection USP 1g/5ml injection looks like and contents of the pack
Levocarnitine Injection USP 1g/5ml 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 Levocarnitine Injection USP 1g/5ml injection.
7. MANUFACTURED IN INDIA BY:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)