25 mg/ml concentrate for infusion solution,
bezlotoxumab
What ZINPLAVA is and what it is used for
ZINPLAVA contains the active substance bezlotoxumab.
ZINPLAVA is given together with an antibiotic to prevent infection with the bacterium Clostridium difficile (CDI) from coming back in patients aged 18 and over who are at high risk of CDI coming back.
How ZINPLAVA works
- When you get CDI, you are usually given antibiotics to get rid of the infection, but in many cases, CDI can come back within weeks or months.
- The bacterium that causes CDI produces a harmful substance ( toxin ) that can inflame and damage the large intestine, causing stomach pain and severe diarrhea. ZINPLAVA works by binding to the toxin and blocking it. This prevents the symptoms of CDI from returning.
What you need to know before you receive ZINPLAVA
Do not use ZINPLAVA
Talk to your doctor before receiving ZINPLAVA.
You should not receive ZINPLAVA:
- if you are allergic to bezlotoxumab or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
ZINPLAVA is not a treatment for CDI. ZINPLAVA has no effect on the CDI you have now.
ZINPLAVA is given along with the antibiotic treatment you are taking for CDI.
Children and young people
ZINPLAVA should not be used in children and adolescents under the age of 18.
Other medicines and ZINPLAVA
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
- Tell the doctor if you are pregnant or trying to become pregnant.
- It is not known whether ZINPLAVA can harm the fetus during pregnancy.
- If you are breastfeeding or plan to breastfeed, consult your doctor first.
- It is not known whether ZINPLAVA can pass into breast milk and pass on to the baby.
- You and your doctor must decide together whether or not to take ZINPLAVA.
Driving ability and use of machinery
ZINPLAVA has no or very little effect on the ability to drive and use machines.
ZINPLAVA contains sodium
This medicine contains 182.8 mg of sodium (the main ingredient in common/table salt) per vial. This corresponds to 9.1% of the maximum recommended daily intake of sodium for adults.
How to get ZINPLAVA
- You will receive ZINPLAVA as an infusion (drip) into a vein.
- You receive ZINPLAVA as a single dose. It takes about 1 hour. The dose is calculated based on your body weight.
- You should continue to take your CDI antibiotic as directed by your doctor.
If you miss a visit when you should have received ZINPLAVA
- Contact a doctor or healthcare professional immediately to get a new appointment.
- You mustn’t miss your dose of this medicine.
If you have any further questions about this medicine, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported in clinical studies:
Common (may affect up to 1 in 10 users)
- diarrhea
- dizziness
- nausea
- fever
- headache
- high blood pressure
- shortness of breath
- fatigue
Tell your doctor or healthcare professional if you get any of the side effects above.
How to store ZINPLAVA
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and vial after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2°C–8°C). Do not freeze. Store the vial in the outer carton. Light sensitive.
The reconstituted ZINPLAVA solution can be stored either at room temperature for up to 16 hours or in a refrigerator at 2°C–8°C for up to 24 hours. If stored in a refrigerator, the infusion bag should be allowed to reach room temperature before use.
Do not save any remaining infusion fluid for later use. Unused medicines and waste must be disposed of according to current instructions.
Contents of the packaging and other information
Contents declaration
- The active substance is bezlotoxumab. Each ml of the concentrate contains 25 mg of bezlotoxumab.
- The other ingredients are citric acid monohydrate (E330), diethylenetriaminepentaacetic acid, polysorbate 80 (E433), sodium chloride, sodium citrate dihydrate (E331), water for injections, and sodium hydroxide (E524) (for pH adjustment).
Appearance and package sizes of the medicine
The concentrate for the infusion solution is clear to moderately opalescent (pearlescent), colorless to pale yellow liquid.
It is packaged in cartons containing a glass vial.
Marketing Authorisation Holder
Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
Netherlands
Manufacturer
SP Labo NV
Industriepark 30
B-2220 Heist-op-den-Berg
Belgium
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