5 mg / mL concentrate for infusion solution
fomepizole (as sulphate)
1. What Fomepizole SERB is and what it is used for
Fomepizole SERB is an antidote. It is used in emergency care for oral ethylene glycol poisoning.
Your doctor has prescribed this medicine because you have swallowed a toxic substance called ethylene glycol (a clear, colorless, and odorless liquid that tastes sweet and is widely used as an antifreeze in cars).
Fomepizole SERB stops the progression of ethylene glycol poisoning and removes ethylene glycol from the blood.
2. What you need to know before using Fomepizole SERB
Do not use Fomepizole SERB:
- if you are allergic to fomepizole or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to any other medicine of the same group (pyrazoles). In that case, you may also be allergic to fomepizole.
Warnings and cautions
Take special care with Fomepizole SERB:
- if you experience:
- sudden swelling of the throat, face, lips, or mouth,
- redness, rash, or itching.
It’s an allergic reaction. In this case, your doctor will monitor your symptoms.
If your allergic reaction becomes more severe or worsens, stop treatment immediately unless there is another obvious cause for the reaction.
- if you have liver problems (impaired liver function). In this case, your doctor will take blood samples to monitor your liver function.
Talk to your doctor before using Fomepizole SERB.
Other medicines and Fomepizole SERB
You should not combine alcohol-containing medicines with Fomepizole SERB. It can reduce their degradation.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
You should not take Fomepizole SERB if you are pregnant or breast-feeding unless necessary.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Do not drive or use any tools or machines for the first few days after stopping treatment.
Dizziness and dizziness may occur after treatment. If you experience any of these symptoms, do not drive or use any tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Fomepizole SERB contains sodium
This medicine contains 55 mg of sodium (the main ingredient in table salt/table salt) per ampoule. This corresponds to 2.8% of the maximum recommended daily sodium intake for adults.
3. How to use Fomepizole SERB
Dosage
You will receive this medicine from a doctor. You will get it in the form of a slow injection into one of your veins.
Dosage one of Fomepizole SERB varies depending on the patient. Your doctor will decide which dose is the right one.
Dose one depends on:
- your age and weight
- how your liver and kidneys work
- if you need to undergo a medical procedure to remove ethylene glycol from the blood (also called hemodialysis ).
If you take more Fomepizole SERB then you should
If you take more Fomepizole SERB than you should, the following symptoms may occur:
- dizziness
- inebriation
- nausea
- dizziness
- headache
- dimsyn
- slurred speech.
If you experience any of these symptoms, contact your doctor immediately.
In such circumstances, your doctor may decide to perform a medical procedure called hemodialysis that removes the excess drugs from the blood.
If you forget to use Fomepizole SERB
Take the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are:
- dizziness
- headache.
The following side effects are common:
Allergic reactions:
- At the site of administration: injection site reaction, injection site inflammation.
- Skin: sudden swelling of the throat, face, lips, or mouth, reddening of the skin, rash, or itching. If you experience any of these symptoms, talk to your doctor. He or she will monitor your symptoms. If your allergic reaction becomes more extensive or worsens, in the absence of any other obvious cause, discontinue treatment immediately.
Other side effects that may occur with Fomepizole SERB:
Heart and blood circulation:
- abnormal pulse
- severe heartbeat.
Nervous system:
- dizziness
- anxiety, agitation
- blurred vision, visual disturbances
- seizures (convulsions)
- slurred speech.
Stomach and intestine:
- nausea, vomiting
- diarrhea, digestive problems ( dyspepsia )
- hiccup.
Blood changes:
- temporarily elevated levels of liver enzymes (tests are performed to check liver function)
- high blood pressure
- elevated CK (creatine kinase) (tests performed to check muscle function)
- elevated levels of certain white blood cells ( eosinophils )
- lower levels of red blood cells ( anemia ).
5. How to store Fomepizole SERB
Keep this medicine out of the sight and reach of children.
Do not freeze.
The product should be diluted immediately after opening and any unused product should be discarded.
The chemical and physical properties of the diluted solution are stable for 24 hours at 25 ° C.
From a microbiological point of view, the product must be used immediately. If not used immediately, in-use storage times and conditions before use is the responsibility of the user. The storage time should not normally exceed 24 hours at 2-8 ° C unless dilution has been performed under controlled and validated aseptic conditions.
Do not use this medicine after the expiry date which is stated on the carton and the label after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is fomepizole (5 mg per 1 ml concentrate for solution for infusion ).
- The other ingredients are sodium chloride and water for injections.
One ampoule of 20 ml contains 160 mg of fomepizole sulfate, equivalent to 100 mg of fomepizole.
What the medicine looks like and the contents of the pack
Fomepizole SERB is a concentrate for solution for infusion. It is a clear and colorless solution. Each pack contains 5 ampoules of 20 ml.
Marketing Authorisation Holder:
SERB SA
Avenue Louise, 480
1050 Brussels
Belgium
Manufacturer
AP-HP Pharmaceutical Establishment
(Assistance Public-Hospitals of Paris)
7, rue du Fer à Moulin – BP 09
75221 Paris Cedex 05 – France
This medicinal product is authorized under the European Economic Area under the names:
| Austria | Fomepizole SERB | Zul No: 1-24520 |
| Belgium | FOMEPIZOLE SERB | BE233326 |
| France | FOMEPIZOLE SERB | 34009 562 842 4 5 |
| Finland | FOMEPIZOLE SERB | 16705 |
| Germany | FOMEPIZOLE SERB | 52 450.00.00 |
| Iceland | FOMEPIZOLE SERB | IS / 1/01/044/01 |
| Ireland | FOMEPIZOLE SERB | PA 20595/001/001 |
| Luxembourg | FOMEPIZOLE SERB | 2001120031 |
| Norway | FOMEPIZOLE SERB | Mr. 2001-06270 |
| Netherlands | FOMEPIZOLE SERB | RVG 26970 |