Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - rezzayo

Document Subject

Generated Narrative: MedicinalProductDefinition mp92e6fb3296c549e1fee744233084617c

identifier: http://ema.europa.eu/identifier/EU/1/23/1775/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: REZZAYO 200 mg powder for concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-92e6fb3296c549e1fee744233084617c

identifier: http://ema.europa.eu/identifier/EU/1/23/1775/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - rezzayo

Attesters

What is in this leaflet

1. What REZZAYO is and what it is used for
2. What you need to know before you are given REZZAYO
3. How REZZAYO is given
4. Possible side effects
5. How to store REZZAYO
6. Contents of the pack and other information

What REZZAYO is REZZAYO contains the active substance rezafungin, which is an antifungal. Rezafungin belongs to a group of medicines called echinocandins.

What REZZAYO is used for This medicine is given to adults to treat invasive candidiasis, a serious fungal infection in your tissues or organs that is caused by a type of yeast called Candida.

How REZZAYO works This medicine blocks the action of an enzyme (a type of protein) that is needed by fungal cells to make a molecule that strengthens their cell walls. This makes the fungal cells fragile and stops the fungus from growing. This stops the infection from spreading and gives the body s natural defences a chance to remove the infection.

REZZAYO must not be given

• if you are allergic to rezafungin, other echinocandins (such as caspofungin, anidulafungin), or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given REZZAYO.

Effects on the liver Your doctor may decide to monitor you for liver function more closely if you develop liver problems during your treatment.

Infusion-related reactions REZZAYO may cause infusion-related reactions, which could include reddening of the skin (flushing), sensation of warmth, nausea (feeling sick) and chest tightness. Your doctor may decide to monitor you during the infusion for signs of an infusion-related reaction. Your doctor may decide to slow down your infusion (drip) if an infusion-related reaction occurs.

Light sensitivity REZZAYO may increase your risk of phototoxicity (condition in which the skin or eyes become very sensitive to sunlight or other forms of light). During your treatment, and for 7 days after you have been given the last dose of this medicine, you should avoid being out in the sun or using artificial sun tanning lights without protection (like sunscreen).

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

Pregnancy, breast-feeding and fertility You should not use this medicine unless specifically told by your doctor. If you are pregnant or breast-feeding, or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine. If you are a woman of childbearing potential, you may be advised by your doctor to use contraception during your therapy with REZZAYO. The effect of REZZAYO in pregnant or breast-feeding women is not known.

Driving and using machines This medicine is unlikely to have an effect on driving or using machines.

REZZAYO contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free .

This medicine will be prepared and given to you by a doctor or a healthcare professional.

Recommended dose Your treatment will start with a loading dose' (an initial dose of a medicine which is higher than the maintenance dose) of 400 mg on the first day. This will be followed by a maintenance dose of 200 mg on day 8 of your treatment and once weekly thereafter.

REZZAYO should be given to you once a week, by infusion (a drip) into your vein. This will take at least 1 hour. Your doctor will determine how long the infusion time will be and may increase it to up to 3 hours to avoid infusion-related reactions.

Your doctor will determine how long you need to receive treatment based on your response to the medicine and your condition.

In general, your treatment will continue for at least 14 days after the last day Candida was found in your blood.

If symptoms of invasive candidiasis come back, tell your doctor or another healthcare professional immediately.

If you have been given more REZZAYO than you should You should not receive this medicine more than once a week. If you are concerned that you may have been given too much REZZAYO, tell your doctor or another healthcare professional immediately.

If you miss a dose of REZZAYO As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. However, if you miss an appointment to receive this medicine, contact your doctor or another healthcare professional as soon as possible to schedule a new appointment.

If you stop using REZZAYO Your doctor will monitor your response and condition to determine when to stop your treatment with this medicine. You should not experience any side effects after this.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects - tell your doctor or another healthcare professional immediately should you experience any of the following side effects:

• reddening of the skin, sensation of warmth, nausea (feeling sick), chest tightness these may be signs you are having an infusion-related reaction (common may affect up to 1 in 10 people).

Other side effects

Very common (may affect more than 1 in 10 people)

• low blood potassium level (hypokalaemia)
• diarrhoea
• fever (pyrexia)

Common (may affect up to 1 in 10 people)

• decreased red blood cells (anaemia)
• low blood magnesium level (hypomagnesaemia)
• low blood phosphate level (hypophosphataemia)
• low blood pressure (hypotension)
• wheezing
• vomiting
• feeling sick (nausea)
• stomach (abdominal) pain
• constipation
• redness of the skin (erythema)
• rash
• increased blood levels of alkaline phosphatase, an enzyme (protein) made in the liver, bones, kidney and gut
• increased levels of liver enzymes (including alanine aminotransferase and aspartate aminotransferase)
• increased blood levels of bilirubin, a breakdown product of red blood cells

Uncommon (may affect up to 1 in 100 people)

• high blood phosphate levels (hyperphosphataemia)
• low blood sodium level (hyponatraemia)
• skin or eyes become very sensitive to sunlight or other forms of light (phototoxicity)
• shaking (tremor)
• high blood levels of eosinophils (a type of white blood cell)

Not known (frequency cannot be estimated from the available data)

• Hives (urticaria)

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

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.

Do not store above 25 C.

Keep the vial in the outer carton in order to protect from light.

Only a trained healthcare professional who has read the complete directions can prepare this medicine for use. Once REZZAYO has been prepared, it should normally be used immediately. However, the reconstituted and diluted infusion solution may be stored up to 24 hours in a refrigerator.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What REZZAYO contains

• The active substance is rezafungin. Each vial contains 200 mg rezafungin (as acetate).
• The other ingredients are mannitol, histidine, polysorbate 80, hydrochloric acid, sodium hydroxide (see section 2 REZZAYO contains sodium ).

What REZZAYO looks like and contents of the pack

REZZAYO is a powder for concentrate for solution for infusion in a glass vial with a rubber stopper and an aluminium seal with plastic flip-off cap. It is a white to pale yellow cake or powder. Each pack contains 1 vial.

Marketing Authorisation Holder Mundipharma GmbH, De-Saint-Exupery-Strasse 10, Frankfurt Am Main, 60Germany Tel: +49 69506029-Email: info@mundipharma.de

Manufacturer Fareva Mirabel Route de Marsat Riom Clermont-Ferrand 63France

OR

Mundipharma DC B.V. Leusderend Leusden
Utrecht 3832 RC Netherlands

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: