NOTICE
ANSM - Updated: 04/05/2017
Name of the drug
VITAMIN B12 GERDA 1000 μg / 4 ml solution for injection (IM) and oral
cyanocobalamin
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse.
What does this booklet contain ?
1. What is Vitamin B12 GERDA 1000 μg / 4 ml solution for injection (IM) and drinkable and in what cases is it used?
2. What information do you need to know before using VITAMIN B12 GERDA 1000 μg / 4 ml solution for injection (IM) and oral?
3. How to use VITAMIN B12 GERDA 1000 μg / 4 ml solution for injection (IM) and drinkable?
4. What are the possible side effects?
5. How to store VITAMIN B12 GERDA 1000 μg / 4 ml solution for injection (IM) and drinkable?
6. Contents of the package and other information.
1. WHAT IS VITAMIN B12 GERDA 1000 μg / 4 ml solution for injection (IM) and drinkable AND WHAT IT IS USED FOR?
Pharmacotherapeutic class - ATC code: B03BA01.
This medicine contains vitamin B 12 . It is recommended in two separate indications.
· It is indicated in the treatment of vitamin B 12 deficiency due to a lack of absorption: Biermer's disease, removal of the stomach or part of the intestine, Imerslund's disease, and in this case it will have to be administered intramuscularly.
· It is indicated in the treatment of anemia due to lack of food intake of vitamin B 12 in vegans strict for more than 4 years (diet without meat, dairy products, eggs or fish) and in this case it will be administered orally ( drinkable light bulb) .
2. BEFORE YOU USE VITAMIN B12 GERDA 1000 μg / 4 ml solution for injection (IM) and drinkable?
Never use VITAMIN B12 GERDA 1000 μg / 4 ml solution for injection (IM) and drinkable:
· if you are allergic (hypersensitive) to cyanocobalamin or any of the other ingredients of this medicine, listed in section 6.
· in case of malignant tumor.
Warnings and precautions
Talk to your doctor or pharmacist before using VITAMIN B12 GERDA 1000 μg / 4 ml solution for injection (IM) and drinkable .
· This medication will be given only when the vitamin B 12 deficiency is established.
· During treatment, blood tests and neurological examinations must be performed.
· In case of megaloblastic anemia, the level of potassium in the blood (serum potassium) should be carefully monitored during the first two days of treatment.
children
Not applicable.
Other medicines and VITAMIN B12 GERDA 1000 μg / 4 ml solution for injection (IM) and oral
Tell your doctor or pharmacist if you use, have recently used, or may use any other medicines.
VITAMIN B12 GERDA 1000 μg / 4 ml solution for injection (IM) and drinkable with food and drink
Not applicable.
Pregnancy and breast feeding
This medicine, under normal conditions of use, can be used during pregnancy and lactation.
In general, consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Not applicable.
VITAMIN B12 GERDA 1000 μg / 4 ml solution for injection (IM) and oral contains
Not applicable.
3. HOW TO USE VITAMIN B12 GERDA 1000 μg / 4 ml solution for injection (IM) and drinkable?
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Dosage
In all cases strictly abide by your doctor's prescription.
· Injectable intramuscular injection for the treatment of vitamin B 12 deficiency :
o In treatment of attack : one ampoule per day or three times a week, intramuscular injection, 10 ampoules in total.
o In maintenance treatment : one ampoule in intramuscular injection per month.
· Oral in the treatment of anemia due to insufficient dietary intake of vitamin B 12 in strict vegans : pour the contents of the ampoule into a glass of water.
o In attack treatment : 1 ampoule per day for 15 days to 1 month.
o In maintenance treatment : 1 ampoule every 10 days.
Method and route of administration
Intramuscular and oral injectable routes.
Duration of treatment
Comply with your doctor's prescription.
If you have used more VITAMIN B12 GERDA 1000 μg / 4 ml solution for injection (IM) and drinkable than you should
Immediately consult your doctor or pharmacist.
If you forget to use VITAMIN B12 GERDA 1000 μg / 4 ml, solution for injection (IM) and drinkable
Not applicable.
If you stop using VITAMINE B12 GERDA 1000 μg / 4 ml solution for injection (IM) and drinkable
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
· Allergic reactions include: itching, eczema, urticaria, redness of the skin, edema can be severe, generalized malaise.
In case of allergic manifestations, stop your treatment and consult your doctor immediately.
· Risk of acne.
· Possibility of pain at the point of injection.
· Possible staining in red urine.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE VITAMIN B12 GERDA 1000 μg / 4 ml solution for injection (IM) and drinkable?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package.
Store at a temperature below 25 ° C and protected from light.
After opening and / or dilution and / or reconstitution: the product should be used immediately.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What VITAMINE B12 GERDA contains 1000 μg / 4 ml solution for injection (IM) and drinkable
· The active substance is:
Cyanocobalamin ................................................. .................................................. ....... 1000 μg
For a 4 ml ampoule.
· The other components are:
Concentrated hydrochloric acid, sodium chloride, water for injections.
What VITAMINE B12 GERDA 1000 μg / 4 ml solution for injection (IM) and drinkable and contents of pack
This medicine is in the form of injectable solution IM and drinkable in ampoule. Box of 6 ampoules of 4 ml.
Marketing Authorization Holder
GERDA LABORATORIES
24 RUE ERLANGER
75016 PARIS
Operator of the marketing authorization
GERDA LABORATORIES
24 RUE ERLANGER
75016 PARIS
Maker
DELPHARM TOURS
LA BARAUDIERE
37170 CHAMBRAY LES TOURS
or
HAUPT PHARMA LIVRON
1 STREET COUNTY SINARD
26250 LIVRON-SUR-DROME
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).