ALGIKEY

     (PHARMINISIO S.L. SPAIN)

Each ampoule contains 30 mg of  Ketorolac tromethamine as active ingredient.

The rest of the components (excipients) are: ethanol 100 mg, sodium chloride 4.35 mg and waqter for injection, s.q. 1 ml.

WHAT IS ALGIKEY injectable AND WHAT IS IT USED FOR

ALGIKEY injectable is presented in ampoules of 1 ml in packages of 6 ampoules.
ALGIKEY injectable is an analgesic belonging to non-steroidal anti-inflammatory group. 
ALGIKEY injectable is indicated in the Short-time treatment of moderate or severe pain.

BEFORE TAKING ALGIKEY injectable

Do not take ALGIKEY injectable if:

  • If you have ever experienced allergia to acetyl salicic acid or other non-steroidal anti-inflammatories, you should not take Ketorolac;
  • Angiodema, bronchospasm or nasal polyps;
  • Peptic ulcer;
  • Asthma;
  • Moderate or severe renal dysfunction;
  • Coagulation alterations, hemorrhagic diathesis, cerebral hemorrhage or any other blood disorder which can cause hemorrhagia;
  • Concomitant administration of other NSAIDs;
  • If you are following an anticoagulant therapy at complete doses;
  • Concomitant treatment with probeneid, lithium salts and pentoxifillin;
  • Pregnancy, labor and lactation;
  • Children under 16 years old.

HOW TO TAKE ALGIKEY injectable

ALGIKEY Injectable treatment must be followed under control and because of doctor recommendation. 
Recommended initial dose intramuscularly or intravenously is 10 mg followed by 10-30 mg dose every 4-6 h, according to needs for controlling pain. If intense pain or very intense pain, recommended initial dose is 30 mg of Ketorolac. Daily maximum dose will not exceed  90 mg in adults and 60 mg in elderly people. Maximum treatment length will be no longer than two days. 
Do not take at higher doses. Maximum treatment two days.
When the response is appropriate, the doctor can order to follow the treatment using tablets, taking into account that the total daily combined dose should not be more than 90 mg in adults and 60 mg in elderly people the day the change from injectable to tablets is done.
The administration of the medicine depends on the presence of  painful symptoms, as soon as they disappear, medication should be stopped.

Use in children

The treatment in children is not recommended. The safety and effectiveness in children under 16 have not been established.

Use in elderly people

Consult your doctor if you are over 65 years old.

If you take more ALGIKEY injectable than you should:

Immediately telephone your doctor or Poisons Information Centre. You may need urgent medical attention.

If you take too much Algikey, you may have pain or tenderness in the stomach, stomach upset including nausea (feeling sick), vomiting, heartburn, indigestion or cramps.
If you are not sure what to do, contact your doctor or pharmacist.

If you forgot to take ALGIKEY injectable

Do not take a double dose to compensate the forgotten doses.

POSSIBLE ADVERSE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ALGIKEY .
ALGIKEY helps most people with pain after surgery but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
* stomach upset including nausea (feeling sick), heartburn, indigestion
* pain in the stomach, wind,
* diarrhoea
* dizziness
* headache
* sweating
* aching muscles, muscle tenderness or weakness, not caused by exercise
* pain at site of injection
* dry mouth
* feeling extremely thirsty
These side effects of ALGIKEY  are usually mild.
Tell your doctor immediately if you notice any of the following:
* severe pain or tenderness in any part of the stomach or back
* severe dizziness, spinning sensation
* severe or persistent headache
* bleeding or bruising more easily than normal, reddish or purplish blotches under the skin
* unusual weight gain, swelling of ankles or legs
These are serious side effects. You may need urgent medical attention. Serious side effects are rare.
If any of the following happen, tell your doctor immediately or go to casualty at your nearest hospital:
* vomiting blood or material that looks like coffee grounds
* bleeding from the back passage (rectum), black sticky bowel motions (stools) or bloody diarrhoea
* swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
* asthma, wheezing, shortness of breath
* sudden or severe itching, skin rash, hives
* fainting, seizures or fits
* pain or tightness in the chest
These are very serious side effects.You may need urgent medical attention or hospitalisation. These side effects are rare.

Other side effects not listed above may also occur in some patients.

Tell your doctor if you notice anything else that is making you
feel unwell.
Ask your doctor or pharmacist if you do not understand anything in this list.
Do not be alarmed by this list of possible side effects. You may no experience any of them.

ALGIKEY injectable preservation

Keep ALGIKEY injectable out of  children’s reach and sight. Special preserving conditions are not necessary.

Expiry

Do not use ALGIKEY injectable after the expiry date stated in the packaging.

Licence holder

PHARMINICIO, S.L. (İspaniya)

C/Aribau 168-170

08036 Barcelona (Spain)

Manufacture

Laboratorio GENERFARMA, S.L. (İspaniya)

Isaac Peral, 6, Parque Tecnologico, Paterna, 46980 Valencia (İspaniya)