Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - artesunate

Document Subject

Generated Narrative: MedicinalProductDefinition mpe3808b9785653fa349cd23efa0847a72

identifier: http://ema.europa.eu/identifier/EU/1/21/1582/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Artesunate Amivas 110 mg powder and solvent for solution for injection

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-e3808b9785653fa349cd23efa0847a72

identifier: http://ema.europa.eu/identifier/EU/1/21/1582/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - artesunate

Attesters

What is in this leaflet

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

Artesunate Amivas contains the active substance artesunate. Artesunate Amivas is used to treat severe malaria in adults and children.

After treatment with Artesunate Amivas your doctor will complete your treatment for malaria with a course of anti-malarial medication that can be taken by mouth.

Do not use Artesunate Amivas

• if you are allergic to artesunate, to any other antimalarial treatment that contains an artemisinin (e.g. artemether or dihydroartemisinin) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
You may develop anaemia, a reduced number of red blood cells, or other blood changes after treatment with this medicine. Some changes to numbers of blood cells can occur while you are being treated and usually recover after stopping treatment for malaria. However, some individuals develop severe anaemia that can occur up to several weeks after completing treatment for malaria. In most cases, the anaemia recovers without any specific treatment. In a small number of cases the anaemia may be severe and require blood transfusion. Your doctor will carry out regular blood tests that can include a direct antiglobulin test to determine if treatment, e.g. with corticosteroids, is necessary and monitor your recovery for 4 weeks after you have completed your treatment for malaria. It is important you attend appointments for these check-ups. Talk to your doctor for more information.

Other medicines and Artesunate Amivas Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines not on prescription.

Some medicines should not be taken with artesunate because they could reduce its effect on malaria. Some examples include:

• rifampicin (to treat bacterial infections)
• ritonavir, nevirapine (anti-HIV medication)
• carbamazepine, phenytoin (to treat epilepsy)

Some medicines may increase blood levels of artesunate and may increase the risk of side effects. Some examples include:

• diclofenac (to treat pain or inflammation)
• axitinib, vandetanib and imatinib (used in the treatment of certain cancers)

Artesunate may increase or decrease the blood levels of some other medicines. Your doctor will advise you on taking any medicines during artesunate treatment.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you should talk to your doctor before being given this medicine.

Your doctor will discuss with you the potential risk of taking Artesunate Amivas during pregnancy. Use in the first trimester of pregnancy is not recommended unless your doctor decides that the benefit of treatment for you outweighs the risk to your unborn child. In the later stages of pregnancy, you should only take Artesunate Amivas if your doctor feels that there are no suitable alternative medicines.

If you are or become pregnant during treatment with this medicine, the doctor will report your pregnancy to the manufacturer, who is keeping a record in order to understand any effects that the treatment may have on the pregnancy and the baby.

Traces of this medicine may be present in your breast milk. It is not known if these could have any effect on a breastfed baby. If you are planning to breastfeed, discuss with your doctor whether the benefits of breastfeeding to you and your baby outweigh the potential risk.

Driving and using machines You should not drive or use machines if you feel tired or dizzy.

Artesunate Amivas contains sodium This medicine contains 193 mg sodium (main component of cooking/table salt) in each single dose. This is equivalent to just under 10 % of the recommended maximum daily dietary intake of sodium for an adult.
As the first and second doses are recommended 12 hours apart, this would supply 386 mg sodium (nearly 20 %of your maximum daily intake).

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

This medicine will be given to you by a slow injection directly into a vein. Your doctor or nurse will inject this medicine for you.

The dose of the medicine you are given is based on your weight and your doctor or nurse will work out the right amount to give you. The recommended dose is 2.4 mg for each kg of body weight. The dose per kg is the same for adults and children of all ages.

You will be given at least three doses of Artesunate Amivas, each dose given 12 hours apart. After three doses, if you still cannot take medicines by mouth, you will be given one dose of Artesunate Amivas every 24 hours (once a day) until you are able to take a different malaria treatment by mouth.

It is very important that you complete a full course of antimalarial treatment taken by mouth after you have had at least three doses of Artesunate Amivas by injection.

If you are given more Artesunate Amivas than you should As this medicine will be given to you in a hospital, it is unlikely that you will be given too much. Tell your doctor if you have any concerns. Signs of an overdose include seizures, dark coloured stools, a blood test showing low blood cell counts, weakness, fatigue, fever and nausea. Your doctor will help to treat these symptoms if you are given too much of this medicine.

If a dose of Artesunate Amivas is forgotten
As this medicine will be given to you in a hospital, your doctor or nurse will manage your treatment and it is unlikley a dose will be forgotten. Should a dose be delayed, your doctor or nurse will give the required dose at the earliest opportunity and continue to give future doses 12 or 24 hours apart.

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

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

If you experience any of the following side effects seek medical help immediately:

• difficulty breathing or swallowing, swelling of your face, mouth or throat. These are signs you may be having a severe allergic reaction. The frequency of very severe allergic reactions leading to loss of consciousness is unknown.

Very common side effects (may affect more than 1 in 10 people) a lack of healthy red blood cells, which can make you feel tired and weak (anaemia); this can develop at least 7 days or sometimes several weeks after treatment has finished.

Common side effects (may affect up to 1 in 10 people)

• inflammation of a vein
• altered sense of taste
• raised body temperature or fever
• very dark yellow or reddish brown coloured urine
• reduced kidney function, including low urine output
• bruising easily or slow clotting of any cuts or wounds.
• abnormal levels of liver enzyme levels detected in blood tests
• yellowing of the skin (jaundice)
• diarrhoea
• abdominal pain
• vomiting
• slow heart rate
• low blood pressure
• cough
• rhinitis (blocked and/or runny nose)
• feeling dizzy or weak
• headache

Uncommon (affecting less than 1 in 100 patients)

tiredness

feeling sick

• constipation

pain at injection site

painful widespread rash with blisters especially near mouth, nose, eyes and genitals, flu-like symptoms for several days (Stevens-Johnson syndrome or SJS)

loss of appetite

• rash
• itching
• swelling and reddening of the face
• flushing

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

• a lack of healthy red blood cells caused by your immune system (immune haemolytic anaemia)
• abnormal electrical activity of the heart that affects its rhythm (Prolonged electrocardiogram QT)

Reporting of side effects If you get any side effects, talk to your 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 label on the carton after EXP.

This medicine does not require any special storage conditions.

The reconstituted solution must be used within 1.5 hours of preparation.

What Artesunate Amivas contains

• The active substance is artesunate.
• Each vial of powder contains 110 mg of artesunate.
• Each vial of solvent for reconstitution contains 12 mL of 0.3 M sodium phosphate buffer.
• The other ingredients in the 0.3 M sodium phosphate buffer solvent are monosodium phosphate monohydrate, disodium phosphate dihydrate (see section 2 Artesunate Amivas contains sodium ) and phosphoric acid, concentrated (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.

After reconstitution with 11 mL of the solvent provided, the solution for injection contains 10 mg of artesunate per mL.

What Artesunate Amivas looks like and contents of the pack Artesunate Amivas 110 mg powder and solvent for solution for injection.
The powder is white or almost white, fine crystalline powder in a glass vial. The solvent is a clear, colourless liquid in a glass vial.

Each pack contains 2 or 4 vials of Artesunate Amivas powder and 2 or 4 vials of sodium phosphate buffer solvent.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Amivas Ireland Ltd, Suite 5, Second Floor, Station House, Railway Square, Waterford, Ireland

Manufacturer
MIAS Pharma Limited, Suite 1, 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: