50 mg / 20 mg coated granules in dose
capsules glekaprevir / pibrentasvir

What Maviret is and what it is used for

Maviret is an antiviral drug used to treat children from 3 years of age with long-term (“chronic”) hepatitis C. It is an infectious disease that affects the liver and is caused by the hepatitis C virus. Mavirate contains the active substances glekaprevir and pibrentasvir.

Mavir works by preventing the hepatitis C virus from multiplying and infecting new cells. This causes infection in the body to heal.

What you need to know before you use Maviret

Do not give Maviret if:

  • your child is allergic to glekaprevir, pibrentasvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
  • the child has severe liver problems in addition to hepatitis C.
  • the child is taking the following medicines:
    • atazanavir (against HIV – infection )
    • atorvastatin or simvastatin (to lower cholesterol in the blood)
    • carbamazepine, phenobarbitalphenytoin , primidone (commonly used for epilepsy )
    • dabigatran etexilate (to prevent blood clots)
    • medicines containing ethinyl estradiol (such as contraceptives, including vaginal rings and birth control pills )
    • rifampicin (against infection )
    • St. John’s wort ( Hypericum perforatum ) ((traditional) herbal and herbal remedies used for mild depression and mild anxiety).

Do not give the child Maviret if any of the above apply. If you are not sure, talk to your child’s doctor or pharmacist before giving Maviret.

Warnings and cautions

Talk to your child’s doctor if he or she has any of the following as the child may need to be checked more often:

  • liver problems in addition to hepatitis C
  • have or have previously had a hepatitis B virus infection
  • diabetes . The child’s blood sugar levels may need to be monitored more closely and / or adjustment of the child’s diabetes medication may be needed after starting Maviret. In some diabetic patients, blood sugar levels have dropped ( hypoglycaemia ) after starting treatment with medicines such as Maviret.

Blood tests

Your child’s doctor will take blood samples before, during, and after treatment with Maviret. This is so that the doctor can decide if:

  • the child can take Maviret and for how long
  • the treatment has worked and the child no longer carries the hepatitis C virus .

Children under 3 years

Do not give this medicine to children younger than 3 years or weighing less than 12 kg. The use of Maviret in children younger than 3 years or weighing less than 12 kg has not yet been studied.

Other medicines and Maviret

Tell your child’s doctor or pharmacist if he or she is taking, has recently taken, or might take any other medicines.

Tell your child’s doctor or pharmacist before giving Maviret if your child is taking any of the medicines in the table below. Your doctor may need to change the dose of one of these medicines.

Medicines you must tell your doctor before taking Maviret
Drug Purpose of the drug
cyclosporine, tacrolimus to inhibit the immune system
darunavir, efavirenz, lopinavir, ritonavir against HIV – infection
digoxin against heart problems
fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin to lower cholesterol in the blood
warfarin and other similar drugs * to prevent blood clots

* The child’s doctor may need to take blood samples more often to check how well the blood is clotting (coagulating).

If any of the above apply to your child (or you are not sure), talk to your child’s doctor or pharmacist before giving Maviret.

Mavirate contains lactose

If you have been told by a doctor that your child does not tolerate certain sugars, talk to a doctor before giving this medicine.

Maviret contains propylene glycol

Maviret contains 4 mg of propylene glycol in each sachet.

Mavirate contains sodium

Maviret contains less than 1 mmol (23 mg) sodium per sachet, ie essentially ‘sodium-free ‘.

How your child takes Maviret

Always give this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your child’s doctor or pharmacist. Mavir coated granules are intended for children aged from 3 years to under 12 years and weigh 12 kg to less than 45 kg. Maviret tablets are intended for adults, children from 12 years of age, or children weighing 45 kg or more.

Your child’s doctor will tell you how long your child needs to take Maviret.

How much the child should take

The recommended dose for children from 3 years to under 12 years is based on the child’s body weight according to the table below.

Child’s weight (kg) Number of sachets once a day
From 12 to less than 20 kg 3 sachets
From 20 to less than 30 kg 4 sachets
From 30 to less than 45 kg 5 sachets

If your child weighs 45 kg or more, talk to his or her doctor about giving Maviret tablets.

How your child takes Maviret

  • Give Maviret once a day just before or after a snack or meal.
  • Mix all granules in the sachet with a small amount of recommended food and let the child swallow mixture one (see Instructions for use for a list of recommended foods).
  • Do not give Maviret granules via a tube feed tube .

If the child vomits after taking Maviret, it may affect the amount of Maviret in the blood. This may make Maviret work worse.

  • If the child vomits less than 3 hours after taking Maviret, give another dose .
  • If the child vomits more than 3 hours after taking Maviret, you do not need to give another dose until it is time for the next dose .

If the child has taken too much Maviret

If the child accidentally takes more than the recommended dose, contact a doctor immediately or go to the nearest hospital. Bring the medicine pack so that you can show the doctor what the child has taken.

If you forget to give Maviret

The child mustn’t miss a dose of this medicine.

If your child misses a dose, find out how long it has been since the child last took Maviret:

  • If you notice that you have forgotten to give a dose within 18 hours after you would normally give Maviret, you should give that dose as soon as possible. Then give the next dose at the usual time.
  • If you notice that you have forgotten to give a dose 18 hours or more after you would normally give Maviret, wait and give the next dose at the usual time. Do not give a double dose (two doses too close together).

If you have any further questions on the use of this product, ask your child’s doctor or pharmacist.

Possible side effects

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

Tell your child’s doctor or pharmacist if you notice any of the following side effects:

Very common: may affect more than 1 user in 10

Common: may affect up to 1 in 10 users

  • nausea
  • diarrhea
  • feeling of weakness or weakness ( asthenia )

Uncommon: may affect up to 1 in 100 people

  • swelling of the face, lips, tongue, neck, abdomen, arms or legs

No known frequency (can not be calculated from the available data)

How to store Maviret

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 sachet after “EXP”.

This medicine does not require any special storage.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

  • The active substances are glekaprevir and pibrentasvir. One sachet contains 50 mg glekaprevir and 20 mg pibrentasvir.
  • The other ingredients are: copovidone, tocopherol, propylene glycol monocaprylate, colloidal silica, croscarmellose sodium (only in the glacaprevir granules), sodium stearyl fumarate, hypromellose (E464), lactose monohydrate , titanium dioxide, macrolide (E17] iron2 oxide).

What the medicine looks like and contents of the pack

Mavir coated granules are supplied in polyester/aluminum / polyethylene sachets

which is in a carton. Each carton contains 28 sachets. Each sachet contains pink and yellow granules.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Manufacturer

AbbVie Srl

SR 148 Pontina km 52 SNC

04011 Campoverde di Aprilia (LT)

Italy

Muhammad Nadeem

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