Zinplava - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

ZINPLAVA 25 mg/mL concentrate for solution for infusion bezlotoxumab

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor.

• – If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What ZINPLAVA is and what it is used for

• 2. What you need to know before you are given ZINPLAVA

• 3. How you are given ZINPLAVA

• 4. Possible side effects

• 5. How to store ZINPLAVA

• 6. Contents of the pack and other information

1. What ZINPLAVA is and what it is used for

ZINPLAVA contains the active substance bezlotoxumab.

ZINPLAVA is a medicine that is given together with an antibiotic to prevent Clostridium difficile infection (CDI) from coming back in patients 18 years of age or older who have a high risk of CDI coming back.

How ZINPLAVA works

• When people get CDI, they are usually given an antibiotic to get rid of the infection, but CDI can often come back within weeks or months.
• The bacteria responsible for CDI produce a toxin that can inflame and damage your colon, causing stomach pain and severe diarrhoea. ZINPLAVA acts by attaching to the toxin and blocking it, thereby preventing the symptoms of CDI from coming back.

2. What you need to know before you are given ZINPLAVA

Talk to your doctor before you are given ZINPLAVA.

You should not be given 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 with the antibiotic therapy you are taking for CDI.

Children and adolescents

ZINPLAVA should not be used in children and adolescents below 18 years of age.

Other medicines and ZINPLAVA

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

• If you are pregnant or trying to get pregnant, tell your doctor.
• We don’t know if ZINPLAVA will harm your baby while you are pregnant.
• If you are breast-feeding or are planning to breast-feed, check with your doctor first.
• We don’t know if ZINPLAVA gets in your breast milk and is passed to your baby.
• You and your doctor should decide together if you will use ZINPLAVA.

Driving and using machines

ZINPLAVA has no or very little effect on the ability to drive and use machines.

ZINPLAVA contains sodium

This medicine contains 182.8 mg sodium (main component of cooking / table salt) in each vial. This is equivalent to 9.1 % of the recommended maximum daily dietary intake of sodium for an adult.

• 3. How you are given ZINPLAVA

• You will get ZINPLAVA as an infusion (drip) into a vein.
• You will get ZINPLAVA in one dose and it will take about 1 hour. Your dose will be calculated

using your body weight.

• You should keep taking your antibiotic for CDI as directed by your doctor.

If you miss an appointment to get ZINPLAVA

• Call your doctor or healthcare professional right away to reschedule your appointment.
• It is very important that you do not miss the dose of this medicine.

If you have any further questions on the use of this medicine, ask your doctor.

4. 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 trials:

Common (may affect up to 1 in 10 people)

• diarrhoea
• dizziness
• feeling sick (nausea)
• fever
• headache
• high blood pressure
• shortness of breath
• tiredness

Tell your doctor or health care professional if you notice any of the side effects above.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ZINPLAVA

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 carton and vial label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator 2 °C to 8 °C. Do not freeze. Keep vial in the outer carton in order to protect from light.

The diluted solution of ZINPLAVA may be stored either at room temperature for up to 16 hours or under refrigeration at 2 °C to 8 °C for up to 24 hours. If refrigerated, allow the IV bag to come to room temperature prior to use.

Do not store any unused portion of the infusion solution for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements.

6. Contents of the pack and other information

What ZINPLAVA contains

• – The active substance is bezlotoxumab. Each mL of 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).

What ZINPLAVA looks like and contents of the pack

The concentrate for solution for infusion is a clear to moderately opalescent, colourless to pale yellow liquid.

It is available in cartons containing one glass vial.

Marketing Authorisation Holder

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

Manufacturer

SP Labo NV

Industriepark 30

B-2220 Heist-op-den-Berg

Belgium

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgiqu­e/Belgien MSD Belgium Tél/Tel: +32(0)27766211	Lietuva UAB Merck Sharp & Dohme Tel. + 370 5 278 02 47
Et^rapus	Luxembourg/Lu­xemburg
MepK Oapn u ^oyM EMrapua EOO^	MSD Belgium
Te^.: +359 2 819 3737	Tél/Tel: +32(0)27766211

Česká republika Merck Sharp & Dohme s.r.o. Tel: +420 233 010 111	Magyarország MSD Pharma Hungary Kft. Tel.: +36 1 888 5300
Danmark MSD Danmark ApS Tlf: + 45 4482 4000	Malta Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558)
Deutschland MSD Sharp & Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0)	Nederland Merck Sharp & Dohme B.V. Tel: 0800 9999000 (+31 23 5153153)
Eesti Merck Sharp & Dohme OÜ Tel.: +372 6144 200	Norge MSD (Norge) AS Tlf: +47 32 20 73 00
EZZárta MSD A.O.B.E.E. TnX: +30 210 98 97 300	Österreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044
España Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00	Polska MSD Polska Sp. z o.o. Tel: +48 22 549 51 00
France MSD France Tél: + 33 (0) 1 80 46 40 40	Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465700
Hrvatska Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333	România Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 00
Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700	Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386 1 5204 201
Ísland Vistor hf. Sími: + 354 535 7000	Slovenská republika Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010
Italia MSD Italia S.r.l. Tel: +39 06 361911	Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 650

Sverige

Merck Sharp & Dohme (Sweden) AB

Tel: +46 77 5700488

United Kingdom (Northern Ireland)

Merck Sharp & Dohme Ireland (Human Health)

Limited

Tel: +353 (0)1 2998700

This leaflet was last revised in {month YYYY }.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

The following information is intended for healthcare professionals only:

Preparation of diluted solution

• Prepare the diluted solution immediately after removal of the vial(s) from refrigerated storage,

or the vial(s) may be stored at room temperature protected from light for up to 24 hours prior to preparation of the diluted solution.

• Inspect vial contents for discoloration and particulate matter prior to dilution. ZINPLAVA is a clear to moderately opalescent, colourless to pale yellow liquid. Do not use the vial if the solution is discoloured or contains visible particles.
• Do not shake the vial.
• Withdraw the required volume from the vial(s) based on the patient’s weight (in kg) and transfer into an IV bag containing either 0.9 % Sodium Chloride Injection, or 5 % Dextrose Injection, to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL. Mix diluted solution by gentle inversion.
• Discard vial(s) and all unused contents.
• If the diluted solution is refrigerated, allow the IV bag to come to room temperature prior to use.
• Do not freeze the diluted solution.

Method of administration

• Administer the diluted solution for infusion intravenously over 60 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter. ZINPLAVA should not be administered as an intravenous push or bolus.
• The diluted solution can be infused via a central line or peripheral catheter.
• ZINPLAVA must not be co-administered with other medicinal products simultaneously through