Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - arsenic

Document Subject

Generated Narrative: MedicinalProductDefinition mp0765874a313ce115023e01847b82b59e

identifier: http://ema.europa.eu/identifier/EU/1/20/1427/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Arsenic trioxide Mylan 1 mg/ml 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-0765874a313ce115023e01847b82b59e

identifier: http://ema.europa.eu/identifier/EU/1/20/1427/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - arsenic

Attesters

What is in this leaflet

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

Arsenic trioxide Mylan is used in adult patients with newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL), and in adult patients, whose disease has not responded to other therapies. APL is a unique type of myeloid leukaemia, a disease in which abnormal white blood cells and abnormal bleeding and bruising occur.

Arsenic trioxide Mylan must be given under the supervision of a physician experienced in the treatment of acute leukaemias.

You must not receive Arsenic trioxide Mylan If you are allergic to arsenic trioxide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
You must talk to your doctor or nurse before you are given Arsenic trioxide Mylan, if

• you have impaired kidney function.
• you have any liver problems.

Your doctor will take the following precautions:

• Tests will be performed to check the amount of potassium, magnesium, calcium and creatinine in your blood before your first dose of Arsenic trioxide Mylan.

• You should have an electrical recording of the heart (electrocardiogram ECG) performed before your first dose.

• Blood tests (potassium, magnesium, calcium, liver function) should be repeated during your treatment with Arsenic trioxide Mylan.

• In addition, you will receive electrocardiograms twice weekly.

• If you are at risk for a certain type of abnormal heart rhythm (e.g. torsade de pointes or QTc prolongation), your heart will be monitored continuously.

• Your doctor may monitor your health during and after treatment, since arsenic trioxide, the active substance in Arsenic trioxide Mylan, may cause other cancers. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.

• Follow-up of your cognitive and mobility functions if you are at risk for vitamin B1 deficiency.

Children and adolescents
Arsenic trioxide Mylan is not recommended in children and adolescents below 18 years of age.

Other medicines and Arsenic trioxide Mylan Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

In particular tell your doctor

• if you are taking any of various types of medicines which could cause a change in the rhythm of your heartbeat. These include:

• some types of antiarrhythmics (medicines used to correct irregular heart beats, e.g. quinidine, amiodarone, sotalol, dofetilide)
• medicines to treat psychosis (loss of contact with reality, e.g. thioridazine)
• medicines for depression (e.g. amitriptyline)
• some types of medicines to treat bacterial infections (e.g. erythromycin and sparfloxacin)
• some medicines to treat allergies such as hayfever, called antihistamines (e.g. terfenadine and astemizole)
• any medicines that cause a decrease in magnesium or potassium in your blood (e.g. amphotericin B)
• cisapride (a medicine used to relieve certain stomach problems).
  The effect of these medicines on your heartbeat can be made worse by Arsenic trioxide Mylan. You must be sure to tell your doctor about all medicines you are taking.

• if you are taking or have recently taken any medicine which may affect your liver. If you are not sure, show the bottle or pack to your doctor.

Arsenic trioxide Mylan with food and drink
There are no restrictions on your food or drink while you are receiving Arsenic trioxide Mylan.

Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
Arsenic trioxide Mylan may cause harm to the foetus when used by pregnant women.
If you are able to become pregnant, you must use effective birth control during treatment with Arsenic trioxide Mylan and for 6 months following completion of treatment.
If you are pregnant or you become pregnant during the treatment with Arsenic trioxide Mylan, you must ask your doctor for advice.
Men should also use effective contraception and be advised to not father a child while receiving Arsenic trioxide Mylan and for 3 months following completion of treatment.

Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
The arsenic in Arsenic trioxide Mylan passes into breast milk.
Because Arsenic trioxide Mylan can harm nursing infants, do not breast-feed while on and until two weeks after the last dose of Arsenic trioxide Mylan.

Driving and using machines
Arsenic trioxide Mylan is expected to have no or negligible influence on your ability to drive and use machines.
If you experience discomfort or if you feel unwell after a Arsenic trioxide Mylan injection, you should wait until the symptoms go away before driving or using machines.

Arsenic trioxide Mylan contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially sodium-free .

Duration and frequency of treatment

Patients with newly diagnosed acute promyelocytic leukaemia
Your doctor will give you Arsenic trioxide Mylan once every day as an infusion. In your first treatment cycle, you may be treated every day up to 60 days at most or until your doctor determines that your disease is better. If your disease responds to Arsenic trioxide Mylan, you will be given 4 additional treatment cycles. Each cycle consists of 20 doses given 5 days per week (followed by 2 days interruption) for 4 weeks followed by 4 weeks interruption. Your doctor will decide exactly how long you must continue on therapy with Arsenic trioxide Mylan.

Patients with acute promyelocytic leukaemia, whose disease has not responded to other therapies
Your doctor will give you Arsenic trioxide Mylan once every day as an infusion. In your first treatment cycle, you may be treated every day up to 50 days at most or until your doctor determines that your disease is better. If your disease responds to Arsenic trioxide Mylan, you will be given a second treatment cycle of 25 doses given 5 days per week (followed by 2 days interruption) for 5 weeks. Your doctor will decide exactly how long you must continue on therapy with Arsenic trioxide Mylan.

Method and route of administration

Arsenic trioxide Mylan must be diluted with a solution containing glucose or a solution containing sodium chloride.

Arsenic trioxide Mylan is normally given by a doctor or a nurse. It is given as a drip (infusion) into a vein over 1-2 hours, but the infusion may last longer if side effects like flushing and dizziness occur.

Arsenic trioxide Mylan must not be mixed with or infused through the same tube with other medicines.

If your doctor or nurse gives you more Arsenic trioxide Mylan than he/she should
You may experience convulsions, muscle weakness and confusion. If this happens, treatment with Arsenic trioxide Mylan must be stopped immediately and your doctor will treat the arsenic overdose.

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

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

Tell your doctor or nurse straight away if you notice the following side effects, as these may be signs of a severe condition called differentiation syndrome , which might be fatal:

• difficulty in breathing
• coughing
• chest pain
• fever

Tell your doctor or nurse straight away if you notice one or more of the following side effects, as these may be signs of allergic reaction:

• difficulty in breathing
• fever
• sudden weight gain
• water retention
• fainting
• palpitations (strong heartbeat you can feel in your chest)

While on treatment with Arsenic trioxide Mylan, you may experience some of the following reactions:

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

• fatigue (weariness), pain, fever, headache
• nausea, vomiting, diarrhoea
• dizziness, muscle pain, numbness or tingling
• rash or itching, increased blood sugar, oedema (swelling due to excess fluid)
• shortness of breath, fast heart beat, abnormal ECG heart tracing
• reduced potassium or magnesium in the blood, liver function tests abnormal including presence of excess bilirubin or gamma-glutamyltransferase in the blood

Common (may affect up to 1 in 10 people):

• reduction in blood cell counts (platelets, red and/or white blood cells), increased white blood cells
• chills, increased weight
• a fever due to an infection and low levels of white blood cells, herpes zoster infection
• chest pain, bleeding in the lung, hypoxia (low oxygen level), collection of fluid around the heart or the lung, low blood pressure, abnormal heart rhythm
• fit, joint or bone pain, inflammation of the blood vessels
• increased sodium or magnesium, ketones in the blood and urine (ketoacidosis), renal function tests abnormal, kidney failure
• stomach (abdominal) ache
• redness of the skin, swollen face, blurred vision

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

• lung infection, infection in the blood
• inflammation of the lungs which causes chest pain and breathlessness, cardiac failure
• dehydration, confusion
• Cerebral disease (Encephalopathy, Wernicke encephalopathy) with various manifestations including difficulties to use arms and legs, speech disorders and confusion

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 vial label and the carton.

Do not freeze.

After dilution, if not used immediately, storage times and conditions before use are the responsibility of your doctor and would normally not be longer than 24 hours at 2 C 8 C, unless dilution has taken place in a sterile environment.

This medicine must not be used if you notice foreign particulate matter or if the solution is discoloured.

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 to protect the environment.

What Arsenic trioxide Mylan contains

• The active substance is arsenic trioxide. Each ml of concentrate contains 1 mg of arsenic trioxide. Each vial of 10 ml contains 10 mg of arsenic trioxide.
• The other ingredients are sodium hydroxide, hydrochloric acid and water for injections. See section 2 Arsenic trioxide Mylan contains sodium .

What Arsenic trioxide Mylan looks like and contents of the pack Arsenic trioxide Mylan is a concentrate for solution for infusion (sterile concentrate). It is supplied in glass vials as a concentrated, clear, colourless, aqueous solution. Each carton contains 1 or single-use glass vials.

Marketing Authorisation Holder
Mylan Ireland Limited Unit 35/36 grange Parade Baldoyle Industrial Estate Dublin Ireland

Manufacturer Haupt Pharma Wolfratshausen GmbH Pfaffenrieder Stra e 5 82515 Wolfratshausen Germany

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

Belgi /Belgique/Belgien Mylan bvba/sprl T l/Tel: + 32 (0)2 658 61 Lietuva Mylan Healthcare UAB
Tel: +370 5 205 1

: +359 2 44 55 Luxembourg/Luxemburg Mylan bvba/sprl T l/Tel: + 32 (0)2 658 61 (Belgique/Belgien)

esk republika Viatris CZ s.r.o. Tel: + 420 222 004 Magyarorsz g Mylan EPD Kft. Tel: + 36 1 465 2Danmark Viatris ApS Tlf: +45 28 11 69 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 Deutschland Viatris Healthcare GmbH Tel: + 49- 800 0700 Nederland Mylan BV Tel: +31 (0)20 426 3Eesti BGP Products Switzerland GmbH Eesti filiaal
Tel: + 372 6363 Norge Viatris AS Tlf: + 47 66 75 33
Generics Pharma Hellas
: +30 210 993 6 sterreich Arcana Arzneimittel GmbH Tel: +43 1 416 2Espa a Viatris Pharmaceuticals, S.L.U. Tel: + 34 900 102 Polska Mylan Healthcare Sp. z o.o. Tel: + 48 22 546 64 France Viatris Sant
T l: +33 4 37 25 75 Portugal Mylan, Lda. Tel: + 351 214 127 Hrvatska Viatris Hrvatska d.o.o. Tel: +385 1 23 50 Rom nia BGP Products SRL Tel: +40 372 579 Ireland Mylan Ireland Limited Tel: +353 1 8711Slovenija Viatris d.o.o. Tel: + 386 1 23 63 sland Icepharma hf. S mi: +354 540 8Slovensk republika Viatris Slovakia s.r.o.
Tel: +421 2 32 199 Italia Mylan Italia S.r.l. Tel: + 39 02 612 46Suomi/Finland Viatris Oy Puh/Tel: +358 20 720 9
Varnavas Hadjipanayis Ltd : +357 2220 7Sverige Viatris AB
Tel: +46 (0) 8 630 19 Latvija Mylan Healthcare SIA
Tel: +371 676 055 United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711This leaflet was last revised in

Other sources of information

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