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How to use DYNASTAT 40 mg POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Dynastat 40 mg powder for solution for injection

parecoxib

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet, you may need to read it again.
If you have any further questions, ask your doctor or nurse.
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

What is Dynastat and what is it used for
What you need to know before you use Dynastat
How to use Dynastat
Possible side effects
Storage of Dynastat
Contents of the pack and other information

1. What is Dynastat and what is it used for

Dynastat contains the active substance parecoxib.

Dynastat is used for the short-term treatment of pain in adults after an operation. It belongs to a group of medicines called COX-2 inhibitors (short for cyclo-oxygenase-2). Sometimes pain and inflammation are caused by substances in the body called prostaglandins. Dynastat works by reducing the amount of these prostaglandins.

2. What you need to know before you use Dynastat

Do not use Dynastat

if you are allergic to parecoxib or any of the other ingredients of this medicine (listed in section 6)
if you have had a severe allergic reaction (especially a severe skin reaction) to any medicine
if you have had an allergic reaction to a group of medicines called “sulfonamides” (e.g. some antibiotics used to treat infections)
if you currently have a stomach or intestinal ulcer or bleeding
if you have had an allergic reaction to acetylsalicylic acid (aspirin), or other non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. ibuprofen) or COX-2 inhibitors. Reactions can include wheezing (bronchospasm), nasal congestion, skin itching, rash, or swelling of the face, lips or tongue, or other allergic reactions or nasal polyps after taking any of these medicines
if you are more than 6 months pregnant
if you are breast-feeding
if you have severe liver disease
if you have inflammatory bowel disease (ulcerative colitis or Crohn's disease)
if you have heart failure
if you are going to have heart surgery (bypass) or surgery on your arteries (including any coronary artery procedure)
if you have had heart or cerebrovascular disease diagnosed, e.g. if you have had a heart attack, or a stroke, or a transient ischaemic attack, or any blockage of the blood vessels that has prevented circulation to the heart or brain, or have had an operation to unblock your arteries or to perform a bypass
if you have had problems with blood circulation (peripheral arterial disease).

If any of these apply to you, you will not be given the injection. Tell your doctor or nurse immediately.

Warnings and precautions

Do not use Dynastatif you currently have a stomach or intestinal ulcer or gastrointestinal bleeding

Do not use Dynastatif you have severe liver disease

Tell your doctor or nurse before you start using Dynastat:

if you have had a previous ulcer, bleeding, or perforation in the gastrointestinal tract
if you have had a skin reaction (e.g. rash, itching, hives) with any medicine
if you are taking acetylsalicylic acid (aspirin) or other NSAIDs (e.g. ibuprofen)
if you smoke or drink alcohol
if you have diabetes
if you have angina, blood clots, high blood pressure, or high cholesterol
if you are on anti-coagulant treatment
if you have fluid retention (oedema)
if you have kidney or liver disease
if you are dehydrated, this can happen if you have had diarrhoea or have been vomiting or have not been able to drink fluids
if you have an infection, as this may mask a fever (which is a sign of infection)
if you are taking medicines to prevent blood clotting (e.g. warfarin/other medicines similar to warfarin or new oral anti-coagulants, e.g. apixaban, dabigatran, and rivaroxaban)
if you are taking corticosteroid medicines (e.g. prednisone)
if you are taking a class of medicines used to treat depression called selective serotonin reuptake inhibitors (e.g. sertraline)

Dynastat may lead to an increase in blood pressure or worsening of already high blood pressure, which can result in an increase in side effects associated with heart disease. Your doctor may want to monitor your blood pressure during treatment with Dynastat.

Potentially life-threatening skin rashes can occur with the use of Dynastat and treatment should be discontinued at the first appearance of a skin rash, blisters, or peeling of the skin, mucosal lesions, or any other sign of hypersensitivity. If you develop a skin rash or other signs and symptoms on the skin or mucous membranes (such as the inside of the cheeks or lips), seek urgent medical attention and inform your doctor that you are taking this medicine.

Children and adolescents

Dynastat should not be given to children and adolescents under 18 years.

Other medicines and Dynastat

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. Sometimes medicines can interfere with each other. Your doctor may reduce the dose of Dynastat or of other medicines, or may need to prescribe a different medicine. It is especially important to mention:

Acetylsalicylic acid (aspirin) or other anti-inflammatory medicines
Fluconazole - used for fungal infections
ACE inhibitors, angiotensin II inhibitors, beta blockers, and diuretics - used for high blood pressure and heart problems
Ciclosporin or tacrolimus - used after transplants
Warfarin - or other medicines similar to warfarin used to prevent blood clots, including new medicines such as apixaban, dabigatran, and rivaroxaban
Lithium - used to treat depression
Rifampicin - used for bacterial infections
Anti-arrhythmics - used to treat irregular heartbeats
Phenytoin or carbamazepine - used for epilepsy
Methotrexate - used for rheumatoid arthritis and cancer
Diazepam - used for sedation and anxiety
Omeprazole - used for the treatment of ulcers

Pregnancy, breast-feeding, and fertility

Dynastat should not be used if you are in the last 3 months of pregnancy, as it may harm the baby or cause problems during delivery. Dynastat may cause kidney or heart problems in the baby. Dynastat may affect your tendency and your baby's tendency to bleed and may cause prolonged delivery. Dynastat should not be used during the first 6 months of pregnancy unless absolutely necessary and under the guidance of your doctor. If you need treatment during this period or while trying to become pregnant, the lowest dose should be used for the shortest possible time. If used for more than a few days from 20 weeks of pregnancy, Dynastat may cause kidney problems in the baby that can lead to low levels of the fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductal constriction) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.
If you are breast-feeding,you should not be given Dynastat, as a small amount of Dynastat is transferred into breast milk.
NSAIDs, including Dynastat, may make it more difficult to become pregnant. Tell your doctor if you are planning to become pregnant or if you are having problems conceiving.

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

Driving and using machines

If you feel dizzy or drowsy after the injection, do not drive or use machines until you feel better.

Dynastat contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml; this is essentially “sodium-free”.

3. How to use Dynastat

Dynastat will be given to you by a doctor or nurse. They will dissolve the powder beforehand and then inject the solution into a vein or into a muscle. The injection can be given quickly and directly into a vein or into an existing intravenous line (a thin tube inserted into a vein), or it can be given slowly and deeply into the muscle. You will only be given Dynastat for a short period and only for pain relief.

The usual starting dose is 40 mg.

You may be given another dose - of 20 mg or 40 mg - 6 to 12 hours after the first dose.

You should not be given more than 80 mg in 24 hours.

Some people may be given lower doses:

People with liver problems
People with severe kidney problems
Patient over 65 years with a weight below 50 kg
People taking fluconazole

If Dynastat is used with strong pain-relieving medicines (called opioid analgesics) such as morphine, the dose of Dynastat will be the same as described above.

If you are given too much Dynastat, you may experience side effects that have been reported with the recommended doses.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

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

Stop taking Dynastat and tell your doctor immediately:

if you develop a rash or ulceration that can appear anywhere on your body (e.g. skin, mouth, eyes, face, lips, or tongue), or develop any other signs of an allergic reaction such as skin rash, swelling of the face, lips, or tongue, wheezing, difficulty breathing, or swallowing - this happens rarely
if you get blisters or peeling of the skin - this happens rarely
the appearance of these skin reactions can occur at any time, although they usually appear during the first month of treatment; the frequency of reporting of these events seems to be higher with valdecoxib, a medicine related to parecoxib, compared to other COX-2 inhibitors
if you get jaundice (your skin or the whites of your eyes turn yellow)
if you have any signs of stomach or intestinal bleeding, such as black or bloody stools, or vomiting blood

Very common: may affect more than 1 in 10 people

Nausea (feeling sick)

Common: may affect up to 1 in 10 people

Change in blood pressure (increase or decrease)
You may get back pain
Your legs, ankles, and feet may swell (fluid retention)
You may feel numbness - you may lose feeling in your skin to pain and touch
You may be sick, have stomach pain, indigestion, constipation, bloating, and gas
Kidney function tests may show changes
You may feel agitated or have difficulty sleeping
Dizziness
There is a risk of anaemia - changes in red blood cells after an operation that can cause tiredness and difficulty breathing
You may have a sore throat or difficulty breathing (shortness of breath)
You may have itching of the skin
You may urinate less than usual
Dry socket (inflammation and pain after a tooth extraction)
Increased sweating
Decrease in potassium levels in blood tests

Uncommon: may affect up to 1 in 100 people

Heart attack
There is a risk of stroke, e.g. stroke, or transient ischaemic attack (temporary reduction in blood flow to the brain) / mini-stroke or angina, or blockage of the blood vessels that go to the heart or brain
Blood clots in the lungs
Worsening of high blood pressure
Stomach ulcers, chronic acid reflux
Your heart may beat more slowly
Decrease in blood pressure when standing up

Blood tests may show changes in liver function
You may bruise easily due to a low platelet count in the blood
Surgical wounds may become infected, may have abnormal discharge
Discoloration of the skin (bruising)
Complications in wound healing after an operation
Blood tests may show high levels of sugar
Pain or reaction at the injection site
Rash, or increased rash with itching (urticarial rash)
Anorexia (loss of appetite)
Pain in the joints
High levels of enzymes in the blood in blood tests that indicate damage or stress to the heart, brain, or muscle tissue
Dry mouth
Muscle weakness
Ear pain
Abnormal bowel sounds

Rare: may affect up to 1 in 1,000 people

Rash or ulceration that can appear anywhere on your body (e.g. skin, mouth, eyes, face, lips, or tongue), or other signs of allergic reactions such as skin rash, swelling of the face, lips, and tongue, wheezing, difficulty breathing, or swallowing (which can be life-threatening)
Swelling, blisters, or peeling of the skin
Acute kidney failure
Hepatitis (inflammation of the liver)
Inflammation of the throat (oesophagus)
Inflammation of the pancreas (which can cause stomach pain)

Not known: frequency cannot be estimated from the available data

Collapse due to a severe drop in blood pressure
Heart failure
Kidney failure
Fast or irregular heartbeats
Difficulty breathing

Reporting of side effects

If you experience 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 Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dynastat

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 on the label of the vial after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions before reconstitution.

It is recommended that Dynastat should be used as soon as possible after mixing with the solvent, although it can be stored if the instructions at the end of the leaflet are strictly followed. The injectable solution should be a clear and colourless liquid. The solution should not be used if there are particlesin the injectable solution or if the powder or solution is discoloured.

6. Container Content and Additional Information

Dynastat Composition

The active ingredient is parecoxib (as parecoxib sodium). Each vial contains 40 mg of parecoxib as parecoxib sodium 42.36 mg. When reconstituted with 2 ml of solvent, 20 mg/ml of parecoxib is obtained. When reconstituted in a 9 mg/ml (0.9%) sodium chloride solution, Dynastat contains approximately 0.44 mEq of sodium per vial.

The other components are:

Disodium hydrogen phosphate

Phosphoric acid and/or sodium hydroxide (for pH adjustment).

Product Appearance and Container Content

Dynastat is available as a white to off-white powder.

The powder is contained in 5 ml colorless glass vials with a stopper, sealed with a purple flip-off cap, over the aluminum closure.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium.

Manufacturer: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs-Sint-Amands, Belgium.

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Spain

Pfizer, S.L.

Tel: +34 91 490 99 00

Date of the Last Revision of this Leaflet: 01/2024.

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

This information is intended only for healthcare professionals.

Dose.The recommended dose is 40 mg administered intravenously (IV) or intramuscularly (IM), followed by another dose of 20 mg or 40 mg every 6-12 hours, as needed, not exceeding 80 mg/day. The IV bolus injection can be administered rapidly and directly into a vein or into an existing IV line. The IM injection should be administered slowly and deeply into the muscle.

There is limited clinical experience with Dynastat in treatments exceeding 3 days.

Since the cardiovascular risk of selective cyclooxygenase-2 (COX-2) inhibitors may be increased with dose and duration of exposure, they should be used for the shortest duration possible and at the lowest effective daily dose.

During the post-marketing period, cases of severe hypotension have been reported shortly after the administration of parecoxib. Some of these cases have occurred without other signs of anaphylaxis. The physician should be prepared to treat severe hypotension.

Administration is by intramuscular (IM) or intravenous (IV) route.The IM injection should be performed slowly and deeply into the muscle, and the IV bolus injection can be performed rapidly and directly into a vein or into an existing IV line.

Administration Routes Other than IV or IM

Other administration routes, such as intra-articular or intrathecal, have not been studied and should not be used.

Reconstitution Solvents

This product should not be mixedwith other medicinal products. It should be reconstituted only with one of the following:

sodium chloride 9 mg/ml (0.9%) injection/infusion solution
glucose 50 mg/ml (5%) infusion solution; or
sodium chloride 4.5 mg/ml (0.45%) and glucose 50 mg/ml (5%) injection/infusion solution

The following solutions should not be usedfor reconstitution:

Do notuse Ringer's Lactate injection solution or glucose 50 mg/ml (5%) in Ringer's Lactate injection solution for reconstitution, as it causes precipitation of parecoxib in the solution.
Do notuse sterile water for injectable preparations for reconstitution, as the resulting solution is not isotonic.

Reconstitution Process

Use aseptic technique to reconstitute the parecoxib (as parecoxib sodium) lyophilized powder.

40 mg vial: Remove the purple flip-off cap to expose the central part of the rubber stopper of the 40 mg parecoxib vial. Remove, with a sterile needle and syringe, 2 ml of a suitable solvent and insert the needle into the central part of the rubber stopper, introducing the solvent into the 40 mg parecoxib vial.

Dissolve the powder completelyby gently shaking and inspect the reconstituted solution before use.

The reconstituted solution should not be usedif it is discolored or cloudy or if particles are observed in suspension.

The entire contents of the vial should be used for a single administration. If a dose less than 40 mg is required, the excess volume of reconstituted solution remaining in the vial should be discarded.

Compatibility of the Solution for IV Use

Dynastat may precipitate when combined in solution with other medicinal products, and therefore, Dynastat should not be mixed with any other medicinal product, either during reconstitution or during injection. In those patients where the same IV line is used to inject another medicinal product, the line should be flushed adequately before and after the administration of Dynastat, with a solution of known compatibility.

After Reconstitutionwith the suitable solvents, Dynastat can be injected only by the IV or IM route, or in IV lines that perfuse the following:

sodium chloride 9 mg/ml (0.9%) injection/infusion solution;
glucose 50 mg/ml (5%) infusion solution;
sodium chloride 4.5 mg/ml (0.45%) and glucose 50 mg/ml (5%) injection/infusion solution; or
Ringer's Lactate injection solution.

Do notinject into an IV line that perfuses glucose 50 mg/ml (5%) in Ringer's Lactate injection solution, or other IV solutions that have not been listed in this section, as it may cause precipitation of the solution.

The solution is for single use and should not be stored in the refrigerator or frozen.

Physical and chemical stability of the reconstituted solution has been demonstrated for up to 24 hours at 25°C. Therefore, 24 hours should be considered the maximum validity period of the reconstituted product. However, due to the risk of microbiological infection in injectable products, the reconstituted solution should be used immediately, unless the reconstitution has been performed in controlled and validated aseptic conditions. Unless such requirements are met, the storage times and conditions prior to use are the responsibility of the user and should not normally exceed 12 hours at 25°C.

DYNASTAT 40 mg POWDER FOR INJECTABLE SOLUTION