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

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

tenoxicam

Dostopno od:

Anfarm Hellas S.A.

Koda artikla:

M01AC02

INN (mednarodno ime):

tenoxicam

Odmerek:

20mg

Farmacevtska oblika:

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

Enote v paketu:

glass vial and solvent in ampoule 2ml

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2021-09-16

Navodilo za uporabo

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

Lastnosti izdelka

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 /tenoxicam/ 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.
ADULTS
Katarel 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 of NSAID thera