NOTICE
ANSM - Updated on : 14/02/2023
Product name
VITAMIN B12 DELAGRANGE 1000 micrograms/2 ml, solution for injection (IM) and drinking
Cyanocobalamin
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information provided in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is VITAMIN B12 DELAGRANGE 1000 micrograms/2 ml, solution for injection (IM) and drinking and what is it used for?
2. What do I need to know before taking VITAMIN B12 DELAGRANGE 1000 micrograms/2 ml, solution for injection (IM) and for drinking?
3. How to use VITAMIN B12 DELAGRANGE 1000 micrograms/2 ml, injectable (IM) and drinkable solution?
4. What are the possible side effects?
5. How to store VITAMIN B12 DELAGRANGE 1000 micrograms/2 ml, solution for injection (IM) and oral use?
6. Package contents and other information.
1. WHAT IS VITAMIN B12 DELAGRANGE 1000 micrograms/2 ml, injectable (IM) and drinkable solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: ANTIANEMIC - VITAMIN B12 ATC code: B03BA01
This medicine contains vitamin B12.
It is used :
- by intramuscular injection to make up for vitamin B12 deficiencies that the body no longer absorbs, in people suffering from Biermer's disease or Imerslund's disease, or who have had their stomach or part of their intestine removed.
- orally (drinkable ampoule) to treat anemia (reduced number of red blood cells in the blood) caused by a diet low in vitamin B12, in people following a diet without meat, dairy products, egg or fish for more than 4 years (strict vegans).
2. WHAT DO I HAVE TO KNOW BEFORE USING VITAMIN B12 DELAGRANGE 1000 micrograms/2 ml, solution for injection (IM) and for drinking?
Never use VITAMIN B12 DELAGRANGE 1000 micrograms/2 ml, solution for injection (IM) and for drinking:
- if you are allergic to vitamin B12 and related substances (cobalamins), or to any of the other components of this medicine listed in section 6.
- if you have Leber's hereditary optic neuropathy (see "Warnings and Precautions" below).
Warnings and precautions
Talk to your doctor or pharmacist before using VITAMIN B12 DELAGRANGE 1000 micrograms/2 ml, solution for injection (IM) and for drinking.
This medicine should not be used if you have a hereditary disease of optic nerve malfunction manifested by a sudden drop in vision, called Leber's hereditary optic neuropathy, as there is an increased risk of potentially rapid and severe optic neuropathy (destruction of optic nerve fibers).
Other medicinal products and VITAMIN B12 DELAGRANGE 1000 micrograms/2 ml, solution for injection (IM) and drinking
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, especially those used to reduce stomach acidity (gastric antisecretory drugs).
In the event of prolonged treatment, the reduction of stomach acidity by these drugs may reduce the digestive absorption of vitamin B12.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Use of this drug should be avoided during pregnancy. If you discover that you are pregnant during treatment, consult your doctor immediately, as only he or she can decide whether to continue treatment.
This drug passes into breast milk. Its use during breast-feeding is not recommended. If its use is necessary, breast-feeding must be stopped.
VITAMIN B12 DELAGRANGE 1000 micrograms/2 ml, solution for injection (IM) and drinking contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, i.e. it is essentially "sodium-free".
3. HOW TO USE VITAMIN B12 DELAGRANGE 1000 micrograms/2 ml, solution for injection (IM) and for drinking?
Always use this medicine exactly as prescribed by your doctor. Check with your doctor or pharmacist if in doubt.
- Treatment of vitamin B12 deficiency (intramuscular injection):
o To start treatment: 1 ampoule a day for 10 days or 1 ampoule 3 times a week for just over 3 weeks, i.e. 10 ampoules in all.
o Then, as a maintenance treatment: one ampoule per month.
- Treatment of anemia caused by low vitamin B12 intake in strict vegans (oral) :
o To begin treatment: 1 ampoule per day for 15 days to 1 month.
o Then, as a maintenance treatment: 1 ampoule every 10 days.
Method and route of administration
The way you use this drug depends on the disease being treated (see paragraph 1):
- or by intramuscular injection: it is injected into a muscle;
- orally: in this case, pour the contents of the vial into a glass of water and drink.
To open the vial :
Hold lampoule firmly. Grasp the lampoule head between thumb and index finger, then press backwards.
Duration of treatment
Follow your doctor's instructions.
If you have used more VITAMIN B12 DELAGRANGE 1000 micrograms/2 ml, solution for injection (IM) and for drinking than you should have :
Consult your doctor or pharmacist.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Discontinue your treatment and consult your doctor immediately if you experience an allergic reaction. It may manifest itself as itching, eczema, urticaria, reddening of the skin, or even localized skin lesions which may progress to destruction of the skin cells (necrosis), swelling (angioedema), or allergic shock (intense generalized malaise).
The following adverse reactions may occur with undetermined frequency (frequency cannot be estimated on the basis of available data):
- Allergic reaction
- Acne
- Pain at the injection site
- Red coloration of urine (due to elimination of vitamin B12 in the urine).
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE VITAMIN B12 DELAGRANGE 1000 micrograms/2 ml, solution for injection (IM) and drinking?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C and protect from light.
Do not dispose of any medicine in the sewer or with the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What VITAMIN B12 DELAGRANGE 1000 micrograms/2 ml, injectable (IM) and drinkable solution contains
- The active substance is :
Cyanocobalamin.......................................................................................................... 1000 µg
For one 2-ml ampoule.
- The other components are :
Dilute hydrochloric acid, sodium chloride (see section 2), water for injection.
What VITAMIN B12 DELAGRANGE 1000 micrograms/2 ml, solution for injection (IM) and drinking is and what it contains
This medicine is available as an injectable (IM) and drinkable solution in 2 ml ampoules. Boxes of 6 and 48 ampoules.
Not all presentations may be marketed.
Marketing authorization holder
ZENTIVA FRANCE
35 RUE DU VAL DE MARNE
75013 PARIS
Marketing authorization holder
ZENTIVA FRANCE
35 RUE DU VAL DE MARNE
75013 PARIS
Manufacturer
DELPHARM DIJON
6 BOULEVARD DE LEUROPE
21800 QUETIGNY
Or
FAMAR HEALTH CARE SERVICES MADRID S.A.U
AVDA DE LEGANES N° 62
ALCORCON
28925 MADRID
Spain
Product names in member states of the European Economic Area
Not applicable.
This leaflet was last revised on :
To be completed subsequently by the holder
Other
Detailed information on this drug is available on the ANSM (France) website.