Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - tenkasi

Document Subject

Generated Narrative: MedicinalProductDefinition mp426fcc87e6dced0e7ea770b4b6114e7d

identifier: http://ema.europa.eu/identifier/EU/1/15/989/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Tenkasi 400 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-426fcc87e6dced0e7ea770b4b6114e7d

identifier: http://ema.europa.eu/identifier/EU/1/15/989/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - tenkasi

Attesters

What is in this leaflet

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

Tenkasi is an antibiotic that contains the active substance oritavancin. Oritavancin is a type of antibiotic (a lipoglycopeptide antibiotic) that can kill or stop the growth of certain bacteria. Tenkasi is used to treat infections of the skin and underlying tissues.
It is for use in adults and paediatric patients aged 3 months and older.

Tenkasi can only be used to treat infections caused by bacteria known as Gram-positive bacteria. In mixed infections where other types of bacteria are suspected, your doctor will give you other appropriate antibiotics together with Tenkasi.

You must not be given Tenkasi

• if you are allergic to oritavancin or any of the other ingredients of this medicine (listed in section 6).
• if it is expected that you may need to be given a blood thinning medicine (unfractionated heparin sodium) within 5 days (120 hours) of the dose of Tenkasi.

Warnings and precautions
Talk to your doctor or nurse before receiving Tenkasi if you:

• have ever had an allergic reaction to another glycopeptide antibiotic (such as vancomycin and telavancin)
• have developed severe diarrhoea during or following antibiotic treatment in the past
• have or are suspected to have a bone infection caused by bacteria (osteomyelitis). Your doctor will treat you as necessary
• have or are suspected to have a painful collection of pus on your skin (abscess). Your doctor will treat you as necessary

Intravenous infusions of Tenkasi can cause flushing of the upper body, hives, itching and/or rashes. Infusion-associated reactions characterized by chest pain, chest discomfort, chills, tremor, back pain, neck pain, shortness of breath, abdominal pain, fever and headache, fatigue, somnolence that might be symptoms of hypoxia, have also been observed. If you experience these types of reactions, your doctor may decide to stop or slow the infusion.

Tenkasi may interfere with laboratory tests that measure how well your blood is clotting and may cause a false reading.

While antibiotics, including Tenkasi, fight certain bacteria, they may not be active against other bacteria or fungi, which may, therefore, continue to grow. This is called overgrowth. Your doctor will monitor you in case this happens and treat you if necessary.

After being given Tenkasi, you may get a new infection at another site on your skin. Your doctor should monitor you in case this happens and treat you as necessary.

Children and adolescents Tenkasi should not be used in children below the age of 3 months. The use of Tenkasi has not yet been studied in this age group.

Other medicines and Tenkasi Tell your doctor if you are using, have recently used or might use any other medicines.

If you are going to be given a blood thinner called unfractionated heparin, then tell your doctor if you have received Tenkasi within the last 5 days (120 hours).

It is particularly important to tell your doctor if you are using medicines that prevent blood from clotting (oral anticoagulants, e.g.coumarin anticoagulants ). Tenkasi may interfere with laboratory tests or self-test that measure how well your blood is clotting (INR) and may cause a false reading up to hours after the infusion.

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

You should not be given this medicine during pregnancy unless the benefit is considered to be greater than the risk to the baby.

Driving and using machines Tenkasi make you feel dizzy, which can influence your ability to drive or operate machines.

Tenkasi is available as Tenkasi 400 mg and Tenkasi 1 200 mg. The two products differ in oritavancin quantity per vial, duration of infusion and preparation instructions for the administration.

Your doctor or nurse will carefully give you Tenkasi 400 mg by infusion (drip) into a vein.

In adults, the recommended dose for Tenkasi is one single infusion of 1 200 mg (equivalent to 3 vials of 400 mg) administered into a vein over 3 hours.

For paediatric patients aged 3 months and over the recommended dose for Tenkasi will be calculated based on the weight and age: one single infusion of 15 mg for each kg of body weight administered into a vein over 3 hours (maximum 1 200 mg). Please refer to section 6 for further details.

If you are given more Tenkasi than you should Your doctor will decide how to treat you, including stopping the treatment and monitoring for signs of ill effects.

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

Tell your doctor or nurse immediately if you experience a reaction to the infusion including any of the following symptoms:

• Flushing of the face and upper body, hives, itching and/or rashes
• Wheezing;
• Shortness of breath;
• Swelling around throat or under the skin that develops over a short period of time;
• Shivering or trembling;
• Rapid or weak pulse;
• Chest pain or tightness;
• Decrease in blood pressure (which could make you feel faint or dizzy).

Such reactions may be life-threatening.

Other side effects occur with the following frequencies:

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

• Fewer red blood cells or less haemoglobin than normal;
• Feeling dizzy;
• Headache;
• Feeling sick (nausea) or being sick (vomiting);
• Diarrhoea;
• Constipation;
• Pain or irritation where the injection was given;
• Itching, skin rash;
• Muscle pain;
• More enzymes produced by your liver (as shown in blood tests);
• Heart racing or beating fast;
• Infection getting worse or new infection at another site on your skin;
• Swollen, red area of skin or underneath skin that feels hot and tender;
• Accumulation of pus underneath the skin.

Uncommon side effects (may affect up to 1 in 100 patients)

• Higher than normal levels of eosinophils, a type of white blood cell (eosinophilia);
• Low blood sugar;
• High uric acid levels in the blood;
• Increased blood bilirubin levels;
• Severe rash;
• Flushing;
• Inflammation surrounding a tendon (known as tenosynovitis);
• Bone infection caused by bacteria (known as osteomyelitis);
• Reduced blood platelet count below the normal lower limit (known as thrombocytopenia);
• Abdominal pain;
• Chest pain;
• Fever;
• Shortness of breath.

Rare side effects (may affect up to 1 in 1000 patients)

• Headache, fatigue, somnolence that might be symptoms of low levels of oxygen in your body tissues (hypoxia);
• Back pain;
• Neck pain;
• Chills;
• Tremor.

Additional side effects in children and adolescents

Side effects in paediatric patients are similar to those seen in adults. The side effects seen only in paediatric patients are: irritability, changes in ECG heart tracing (transitory, asymptomatic and not associated to other changes in heart tracing), infection of the bowel (Clostridioides difficile colitis).

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 carton and vial label after EXP. The expiry date refers to the last day of that month. Do not store above 25 C.

The diluted solution should be used immediately.

From a microbiological point of view, the product should be used immediately. If not used immediately storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at 25 C and 24 hours at 2 C -8 C for Tenkasi diluted in glucose 5% intravenous infusion bag.

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

What Tenkasi contains

• The active substance is oritavancin. Each vial contains oritavancin diphosphate equivalent to 400 mg oritavancin.
• The other ingredients are mannitol and phosphoric acid (for pH-adjustment).

What Tenkasi looks like and contents of the pack

• Tenkasi is a powder for concentrate for solution for infusion.
• Tenkasi is a white to off white powder, supplied in a 50 ml glass vial.
• Tenkasi is available in cartons containing 3 vials.

Marketing Authorisation Holder Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
L-1611, Luxembourg
Luxembourg

Manufacturer Biologici Italia Laboratories S.r.l Via Filippo Serpero 2 20060 Masate (MI) Italy

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

Belgi /Belgique/Belgien Menarini Benelux NV/SA T l/Tel: + 32 (0)2 721 4Lietuva UAB BERLIN CHEMIE MENARINI BALTIC
Tel: +370 52 691

• / . E
  .: +359 24540Luxembourg/Luxemburg Menarini Benelux NV/SA T l/Tel: + 32 (0)2 721 4 esk republika Berlin-Chemie/A.Menarini Ceska republika s.r.o. Tel: +420 267 199 Magyarorsz g Berlin-Chemie/A. Menarini Kft. Tel.: +36 1799 7Danmark Menarini International Operations Luxembourg S.A. Tlf: +352 264Malta Menarini International Operations Luxembourg S.A. Tel: +352 264Deutschland Berlin-Chemie AG Tel: +49 (0) 30 67Nederland Menarini Benelux NV/SA Tel: +32 (0)2 721 4Eesti O Berlin-Chemie Menarini Eesti Tel: +372 667 5Norge Menarini International Operations Luxembourg S.A. Tlf: +352 264
  MENARINI HELLAS AE : +30 210 8316111- sterreich A. Menarini Pharma GmbH Tel: +43 1 879 95 85-0

Espa a Laboratorios Menarini S.A. Tel: +34-93 462 88 Polska Berlin-Chemie/Menarini Polska Sp. z o.o. Tel.: +48 22 566 21 France MENARINI France T l: +33 (0)1 45 60 77 Portugal A. Menarini Portugal Farmac utica, S.A. Tel: +351 210 935 Hrvatska Berlin-Chemie Menarini Hrvatska d.o.o. Tel: + 385 1 4821 Rom nia Berlin-Chemie A.Menarini S.R.L. Tel: +40 21 232 34 Ireland A. Menarini Pharmaceuticals Ireland Ltd Tel: +353 1 284 6Slovenija Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o.
Tel: +386 01 300 2 sland Menarini International Operations Luxembourg S.A. S mi: +352 264Slovensk republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o
Tel: +421 2 544 30 Italia A. Menarini - Industrie Farmaceutiche Riunite - s.r.l. Tel: +39-055 56Suomi/Finland Berlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000
MENARINI HELLAS AE : +30 210 8316111-Sverige Menarini International Operations Luxembourg S.A. Tel: +352 264Latvija SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103United Kingdom (Northern Ireland) A. Menarini Farmaceutica Internazionale S.R.L. Tel: +44 (0)1628 856This leaflet was last revised in:

Other sources of information

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