50 mg/ml and 125 mg/ml solution
for injection
thiamine hydrochloride
What Thiamine Sterop is and what it is used for
Thiamine Sterop contains the active substance thiamine ( vitamin B1) as thiamine hydrochloride. Thiamine is a water-soluble vitamin that belongs to a group of drugs called “B vitamins”.
Sometimes your body needs supplements of vitamin B1, because your diet does not contain enough thiamine or because you cannot absorb thiamine in your diet. You may also have an extra need for thiamine if you excrete the substance in a shorter time than normal (for example via the urine).
Thiamine Sterop is used to cure or prevent thiamine deficiency (when there is too little thiamine in your body), such as in Beri-Beri disease, chronic alcoholism, or Wernicke-Korsakoff syndrome.
The thiamine contained in Thiamine Sterop may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Thiamine Sterop
Do not use Thiamine Sterop
- if you are allergic to thiamine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Thiamine Sterop.
- The solution should only be injected when it is necessary to start treatment with thiamine quickly (eg Wernicke-Korsakoff syndrome) or when drugs taken orally (by mouth) do not give effective results (eg in case of vomiting or problems with absorption of drugs ).
- When injected intramuscularly, 50 mg/ml solution for injection is less painful compared to 125 mg/ml solution for injection, due to the latter being less hypertonic (that is, the concentration of salt in the solution is more similar to the concentration of salt in blood). Intravenous injection (after dilution) is recommended for 125 mg/ml solution for injection, especially in long-term treatment.
- Be careful if you have previously had a mild allergic reaction (sneezing or mild asthma ) when taking or injecting thiamine/vitamin B1. This may mean that you may have become hypersensitive and may have a more serious allergic reaction if you receive Thiamine Sterop. This risk increases with repeated doses. Your doctor must ensure before administering the solution that you are not allergic to thiamine. A skin test should be performed when in doubt. Emergency medical equipment should be in place to treat a possible anaphylactic shock when the solution is injected.
- The solution should be injected slowly intravenously (over 30 minutes). This is to reduce the risk of anaphylactic shock and reactions at the injection site.
- The medicine must be injected into a vein before or at the same time as the glucose solution is given.
- If you have problems with your kidneys, your doctor will monitor you closely.
If you use other medicines, also read the following section “Other medicines and Thiamine Sterop”.
Blood tests or other medical tests
High concentrations of thiamine in the blood can affect certain medical tests. If you have a blood test, an X-ray, or are asked to do another medical test (such as a urine test), tell your doctor that you are using Thiamin Sterop.
Other medicines and Thiamine Sterop
Tell your doctor or pharmacist if you are using, have recently used, or maybe thinking about using other medicines, including non-prescription medicines and natural medicines.
Tell your doctor if you are using the following medicines as he/she may need to adjust your treatment:
- Fluorouracil, other fluoropyrimidines (such as capecitabine), and ifosfamide (a medicine used to treat certain cancers).
- Diuretics (for example furosemide ), are medicines used to treat high blood pressure and excess fluid that collects in the body’s cavities and tissues ( edema ).
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
This medicine can if deemed necessary, be given during pregnancy and breastfeeding.
Your doctor will decide whether to discontinue breastfeeding or to discontinue/abstain from thiamine treatment, taking into account the benefit of breastfeeding for your baby or the benefit of treatment for you.
Driving ability and use of machinery
Thiamine Sterop is not expected to affect your ability to drive or use machines.
If you feel that you may be affected, do not drive or use machines and talk to your doctor.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Thiamine Sterop contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per ampoule (2 ml), i.e. it is almost sodium-free.
How to use Thiamine Sterop
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The doctor decides which dose of the medicine is to be used and how often and for how long you are to be treated.
The medicine is given by trained healthcare professionals, by injection into a muscle ( intramuscular ) or as a slow drip into a vein ( slow intravenous infusion ) as decided by your doctor.
The doctor decides which dose you are given.
For additional instructions for use, see information intended for healthcare professionals at the end of the package leaflet.
If you used too much Thiamine Sterop
This product will be given to you under medical supervision. It is therefore unlikely that you will get too much.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Thiamine Sterop
If you miss a dose, use the medicine as soon as you remember. If it is close to the time for the next dose, skip the missed dose and continue with your usual dosing schedule. Missing a dose should not pose a risk to your health. Do not take a double dose to make up for a missed dose.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following side effects:
Side effects with an unknown frequency (the frequency cannot be estimated from the available data):
- Allergic reactions such as breathing difficulties, hives ( itching ), shock, or stomach pain. These reactions were often preceded by sneezing or temporary itching. If you experience these symptoms after your injection, talk to your doctor immediately. This may be an indication that you are sensitive to Thiamin Sterop and should not be given a repeated dose.
- Pain at the injection site. A slow intravenous administration can reduce the risk of a burning sensation in the arm.
- Skin inflammation at the injection site ( contact dermatitis ). This may occur after injection in hypersensitive patients.
How to store Thiamine Sterop
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25 °C. Do not freeze.
Store the ampoules in the outer carton. Light sensitive.
For single use only. Any unused medicine must be discarded after use.
The solution must be used immediately after opening the ampoule.
Thiamine Sterop can be diluted in the following infusion solutions:
- Glucose 50 mg/ml (5%).
- Sodium chloride 9 mg/ml (0.9%).
Chemical and physical in-use stability has been demonstrated for up to 8 hours when stored between 15-25°C (without protection from light) for products diluted with 50 ml and 250 ml respectively 9 mg/ml (0.9% ) sodium chloride or 50 mg/ml (5%) glucose solution.
From a microbiological point of view, the product after dilution should be used immediately and storage should not normally be longer than 24 hours at 2-8°C unless opening and dilution have taken place under controlled and validated aseptic conditions. If the product is not used immediately, storage times and conditions before use is the responsibility of the user.
This medicine must not be mixed with other medicines except those mentioned in the text above.
Use before the expiry date which is stated on the carton after EXP.
Only clear solutions free of visible particles should be used.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is thiamine hydrochloride ( vitamin B1). Each ampoule (2 ml) contains 100 mg or 250 mg thiamine hydrochloride. Each ml of solution contains 50 mg or 125 mg of thiamine hydrochloride.
- Other ingredients are sodium hydroxide and water for injection.
Appearance and package sizes of the medicine
Thiamine Sterop is a solution for injection.
The solution is a clear, colorless to the pale yellow sterile aqueous solution, free of visible particles.
Thiamine Sterop is available in transparent glass ampoules (2 ml), packed in boxes of 5, 10 or 100 ampoules. Not all pack sizes may be marketed.
LABORATOIRES STEROP NV
Scheutlaan 46-50
1070 Brussels
Belgium