Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - pedmarqsi

Document Subject

Generated Narrative: MedicinalProductDefinition mpb61e3b7d3b2a48a0ce57af4f9ff7b307

identifier: http://ema.europa.eu/identifier/EU/1/23/1734/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Pedmarqsi 80 mg/mL solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-b61e3b7d3b2a48a0ce57af4f9ff7b307

identifier: http://ema.europa.eu/identifier/EU/1/23/1734/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - pedmarqsi

Attesters

What is in this leaflet

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

Pedmarqsi contains the active substance sodium thiosulfate.

Pedmarqsi is used to reduce the risk of hearing loss from the cancer medicine cisplatin. It is given to children and adolescents aged 1 month to 18 years who are being treated with cisplatin for solid tumours that have not spread to other areas of the body.

Do not give Pedmarqsi if the child is:

• allergic to sodium thiosulfate or any of the other ingredients of this medicine (listed in section 6)

a baby under the age of 1 month

Warnings and precautions
Talk to a doctor or nurse before you or your child receives Pedmarqsi if the child:

• has had an allergic reaction like a rash, hives or difficulty breathing after a previous dose of sodium thiosulfate
• has a known allergy to chemicals called sulfites this may mean you or the child is more likely to have an allergic reaction to this medicine
• has poor kidney function or serious kidney disease
• needs a low salt diet because of another medical condition

Other medicines and Pedmarqsi Tell the doctor or nurse if you or your child is taking, has recently taken or might take any other medicines.

Pregnancy and breast-feeding
This medicine should not be given if you or your child is pregnant (or could be pregnant), or is breast- feeding. This medicine is only given after cisplatin chemotherapy and cisplatin can harm your baby. Discuss with your doctor whether there is a need for contraception both during treatment and for 6 months after treatment.

Pedmarqsi contains boric acid This medicine contains boric acid which may impair fertility when given chronically.

Pedmarqsi contains sodium This medicine contains 23 mg sodium (main component of cooking/table salt) in each mL. This is equivalent to 1-2% of the safe dietary intake of sodium for children aged 1 to 17 years and 12% in babies aged 7 to 11 months.

Before you or your child will receive this medicine, he/she will be given anti-sickness medicines to help prevent vomiting.

This medicine is a solution that is given as an infusion (drip) into a vein by a doctor or nurse. This is usually done via a tube inserted into a vein in the chest, known as a central line. The infusion is given over 15 minutes. Treatment is started 6 hours after the dose of cisplatin has finished.

The dose of this medicine is worked out based on your size (body surface area) in m2, which is calculated from height and weight. The recommended dose for those weighing 10 kg or more is 12.8 g per m2; lower doses are given to those weighing less than 10 kg. Your doctor will work out the dose that is right for you or your child.

If you or your child receives more Pedmarqsi than he/she should Because the dose is worked out and checked by healthcare professionals, it is unlikely that you or your child will be given the wrong amount. In case of overdose, you or your child may experience nausea, vomiting, changes to levels of sodium, phosphate or potassium in the blood, changes to blood pressure, or acidic blood (metabolic acidosis) which can cause nausea, vomiting, drowsiness and breathlessness. Your doctor may give you or your child symptomatic treatment for these side effects.

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

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

Serious side effects

If you or your child has a severe allergic reaction to this medicine with symptoms such as a skin rash, tight chest, wheezing, shortness of breath or feeling cold you or they should tell a doctor or nurse immediately.

Other side effects

The other side effects seen with this medicine are usually mild. The side effects you or your child may experience are:

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

• Feeling sick (nausea)
• Vomiting
• Reduced level of phosphate or potassium seen in blood tests
• Increased level of sodium seen in blood tests

Common (may affect more than 1 in 100 people)

• Increased or reduced blood pressure
• Reduced level of calcium seen in blood tests
• Acidic blood (metabolic acidosis) which can cause nausea, vomiting, drowsiness and breathlessness

Reporting of side effects If you or your child get any side effects, talk to the doctor 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 vial after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Pedmarqsi contains

• The active substance is sodium thiosulfate, in anhydrous form.

• The other ingredients are:

• boric acid (0.25 mg/mL)

• water for injections

• hydrochloric acid and sodium hydroxide for pH adjustment (see section 2; Pedmarqsi contains sodium).

What Pedmarqsi looks like and contents of the pack This medicine is a solution for infusion. This medicine is a clear and colourless sterile solution supplied in clear glass vials sealed with a rubber stopper and an aluminium flip-off overseal. Each carton contains one vial.

Marketing Authorisation Holder
Fennec Pharmaceuticals (EU) Limited Regus House, Harcourt Centre Block 4 Harcourt Rd, Saint Kevin's Dublin D02 HWIreland

Manufacturer MIAS Pharma Limited Suite 2, Stafford House Strand Road Portmarnock Co. Dublin Ireland

This leaflet was last revised in.

Other sources of information

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