Katarel powder lyophilized and solvent for solution for i/m/i/v injection

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

tenoxicam

Commercializzato da:

Anfarm Hellas S.A.

Codice ATC:

M01AC02

INN (Nome Internazionale):

tenoxicam

Dosaggio:

20mg

Forma farmaceutica:

powder lyophilized and solvent for solution for i/m/i/v injection

Confezione:

(1) glass vial and solvent in ampoule 2ml

Tipo di ricetta:

Prescription

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2016-09-15

Foglio illustrativo

PATIENT INFORMATION LEAFLET
KATAREL 20 MG/VIAL
Tenoxicam
Lyophilized powder and solvent for solution for IM or IV injection
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them even if their symptoms are the same as yours.

If any of the side effects become serious or troublesome, or if you
notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What Katarel is and what it is used for
2. Before you take Katarel
3. How to take Katarel
4. Possible side effects
5. How to store Katarel
6. Further information
1.
WHAT KATAREL IS AND WHAT IT IS USED FOR
Katarel contains a medicine called tenoxicam. This is a ‘Non
Steroidal Anti Inflammatory
Drug’ or NSAID.
Katarel can lessen pain, swelling, redness and heat (inflammation) in:

Problems with your muscles, joints and tendons, like strains, sprains
or injuries.

Arthritis.
2.
BEFORE YOU TAKE KATAREL
DO NOT TAKE KATAREL IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO:

Tenoxicam or any of the other ingredients of Katarel (see Section 6).

Aspirin, or any other NSAIDs (such as ibuprofen or diclofenac).
DO NOT TAKE KATAREL IF:

You now have or have ever had any problems with your stomach or gut
(intestine)
like an ulcer or bleeding.

You have previously experienced bleeding or perforation in your
stomach while
taking NSAIDs.

You have SEVERE problems with your kidneys, liver or heart.

You are in the last three months of pregnancy.
Do not take Katarel if any of the above apply to you. If you are not
sure, talk to your doctor or
pharmacist before taking Katarel.
TAKE SPECIAL CARE WITH KATAREL
If you have heart problems, previous stroke or think that you might be
at risk of these
conditions (for example if you have high blood pressure, diabetes or
high cholesterol or

Scheda tecnica

1
SUMMARY PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
KATAREL 20MG/ML
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 20mg tenoxicam as lyophilised sterile powder for
reconstitution. Each
ampoule contains 2ml sterile Water for Injections Ph. Eur.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Lyophilised sterile powder and solvent for solution for injection
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Katarel is indicated for the relief of pain and inflammation in
osteoarthritis and rheumatoid
arthritis. It is also indicated for the short term management of acute
musculoskeletal disorders
including strains, sprains and other soft-tissue injuries.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for the shortest
duration necessary to control symptoms (see section 4.4).
ADULTS
Katarel Vials should be given IV or IM. A single daily dose of 20mg
for one to two days
initially to be continued with the oral form, with administration at
the same time each day.
The lyophilisate should be dissolved in 2 ml of the solvent provided
(2ml sterile water for
injections). This reconstituted solution should be used immediately.
Higher
doses
should
be
avoided
as
they
do
not
usually
achieve
significantly
greater
therapeutic effect but may be associated with a higher risk of adverse
events.
In acute musculoskeletal disorders treatment should not normally be
required for more than 7
days, but in severe cases it may be continued up to a maximum of 14
days.
ELDERLY_ _
As with other non-steroidal anti-inflammatory drugs, Katarel should be
used with special
caution in elderly patients since they may be less able to tolerate
side-effects than younger
patients. They are also more likely to be receiving concomitant
medication or to have
impaired hepatic, renal or cardiovascular function. The lowest dose
should be used in elderly
patients and the patient should be monitored for GI bleeding for 4
weeks following initiation