40 mg of powder and solvent for injection, solution
, parecoxib
1. What Dynastat is and what it is used for
Dynastat contains the active substance parecoxib.
Dynastat belongs to a group of medicines called COX-2 inhibitors (short for cyclooxygenase -2 inhibitors ). Pain and swelling are sometimes caused by substances in the body called prostaglandins. Dynastat works by reducing the amount of these prostaglandins.
2. What you need to know before using 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 sulphonamides(eg some antibiotics used to treat infections )
- if you currently have stomach ulcers, intestinal ulcers, or bleeding in the stomach or intestines
- if you have had an allergic reaction to acetylsalicylic acid (aspirin) or other so-called NSAIDs (eg ibuprofen ) or COX-2 inhibitors. These reactions may include wheezing (bronchial spasm), severe nasal congestion, itchy skin, rash or swelling of the face, lips, or tongue, other allergic reactions, or nasal polyps after using these medicines
- if you are pregnant and have passed the 6th month
- if you are breast-feeding
- if you have severe liver disease
- if you have an inflammatory bowel disease ( ulcerative colitis or Crohn’s disease )
- if you have heart failure
- if you are going to have heart surgery or arterial surgery (blood vessels), including coronary artery surgery
- if you have a diagnosed heart disease and/or disease of the blood vessels of the brain, such as a heart attack, stroke (stroke) including TIA (mini-stroke ), narrowing of blood vessels to the heart or brain, or have had surgery to clear or bypass the narrowing of these blood vessels
- if you have or have had problems with blood circulation ( peripheral vascular disease).
If any of these apply to you, you should not be treated with Dynastat. Tell your doctor or nurse immediately.
Warnings and cautions
Do not use Dynastat if you currently have stomach ulcers, intestinal ulcers, or bleeding in the gastrointestinal tract
Do not use Dynastat if you have severe liver disease.
Talk to your doctor or nurse before using Dynastat:
- if you have a history of ulcers, bleeding, or perforation of the gastrointestinal tract
- if you use acetylsalicylic acid (aspirin) or other so-called NSAIDs (eg ibuprofen )
- if you smoke or drink alcohol
- if you have diabetes
- if you have angina, blood clots, high blood pressure, or high cholesterol levels
- if you are taking medicines that reduce the ability of the platelets to clot
- if you have fluid retention in your body ( edema )
- if you have liver or kidney disease
- if you are dehydrated – for example, if you have had diarrhea or vomited or have not been able to drink fluids
- if you have an infection, as Dynastat may mask a fever (which is a sign of infection)
- if you are taking “blood-thinning” medicines that reduce the blood’s ability to coagulate (eg warfarin / warfarin-like anticoagulants or new oral anticoagulants, eg apixaban, dabigatran, and rivaroxaban)
- if you are taking medicines called corticosteroids (eg prednisone)
- if you are taking a class of medicines called selective serotonin reuptake inhibitors (eg sertraline) to treat depression
Dynastat may lead to an increase in blood pressure or worsening of already established high blood pressure which may lead to an increase in side effects associated with heart problems. Your doctor may want to check your blood pressure during treatment with Dynastat.
Children and young people
Children and adolescents under the age of 18 should not be given Dynastat.
Other medicines and Dynastat
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. Drugs can sometimes affect each other’s effects. Your doctor may need to reduce the dose of one of Dynastat or other medicines, or you may need to take another medicine. It is especially important to tell if you are using:
- Acetylsalicylic acid (aspirin) or other anti-inflammatory drugs
- Fluconazole – used to treat 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 warfarin-like blood thinners, including newer medicines like apixaban, dabigatran, and rivaroxaban
- Lithium – used to treat depression
- Rifampicin – used against bacterial infections
- Antiarrhythmics – used to treat irregular heartbeat
- Phenytoin or carbamazepine – used for epilepsy
- Methotrexate – used for rheumatism and cancer
- Diazepam – used as a sedative and for anxiety
- Omeprazole – used to treat stomach ulcers
Pregnancy, breastfeeding, and fertility
- Tell your doctor if you are pregnant or trying to become pregnant. Dynastat is not recommended during the first 6 months of pregnancy and you must not be given Dynastat during the last three months of pregnancy.
- If you are breast-feeding, you should not be given Dynastat, as a small amount of Dynastat will be transferred to your breast milk.
- NSAIDs, including Dynastat, may make it harder to get pregnant. Tell your doctor if you are trying to get pregnant or if you are having difficulty getting pregnant.
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 tired after the injection, do not drive or use machines until you feel better again.
Dynastat contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per ml, ie essentially ‘sodium-free’.
3. How to use Dynastat
Dynastat is given by a doctor or nurse, who dissolves the powder before injecting one. The solution is injected into a vein or muscle. The injection can be given quickly and directly into a vein or into an existing intravenous port (a thin tube that goes into a vein), or it can be given slowly and deep into a muscle. You will only be treated with Dynastat for a short time, and only as pain relief.
The usual dose to start with is 40 mg.
You can receive another dose, 20 mg or 40 mg, 6 to 12 hours after the first.
You will not receive more than 80 mg in one day.
Some people may receive a lower dose :
- People with liver problems
- People with severe kidney problems
- Patients over 65 years weighing less than 50 kg
- People using fluconazole .
If Dynastat is used in combination with strong painkillers such as morphine (so-called opioid painkillers), one dose of Dynastat should be the same as described above.
If you are given too much Dynastat, you may experience side effects that have been reported at recommended doses.
If you have any further questions on the use of this product, 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 get a rash or ulceration anywhere on the body (eg on the skin, mouth, eyes, face, lips, or tongue) or if you get any other signs of an allergic reaction, such as a rash, swelling of the face, lips or tongue such as can cause wheezing, breathing problems or difficulty swallowing – this rarely happens
- if your skin gets blisters or scales – this rarely happens
- Skin reactions can occur at any time but usually occur during the first month of treatment. The frequency of these reactions appears to be higher for valdecoxib, a drug-related to parecoxib, compared to other COX-2 inhibitors
- if you get jaundice (your skin or the whites of your eyes look yellowish)
- if you get any signs of bleeding in the stomach or intestines, such as black or blood-stained stools or vomiting with blood in
Very common: affects more than 1 user in 10
- Nausea (feeling sick)
Common: affects more than 1 user in 100
- Changing your blood pressure (up or down)
- You may get back pain
- Ankles, legs, and feet may swell (fluid retention)
- You can get numbness – lose the feeling in the skin of pain and touch
- You may experience vomiting, stomach pain, indigestion, constipation, flatulence, and gas
- Tests may indicate abnormal renal function values
- You may feel anxious and have difficulty sleeping
- Dizziness
- There is a risk of anemia – altered red blood cell count after surgery, which can cause fatigue and shortness of breath
- You may have a sore throat or difficulty breathing (shortness of breath)
- You may get itching
- The amount of urine may be less than usual
- Inflammation and pain after tooth extraction
- Increased sweating
- Low levels of potassium in the blood
Uncommon: affects less than 1 user in 100
- Heart attack
- There is a risk of cardiovascular diseases, such as stroke or transient ischemic attack (decreased blood flow to the brain, which passes) / mini-stroke or angina, or narrowing of the blood vessels to the heart or brain
- Blood clots in the lungs
- Elevation of already high blood pressure
- Gastric ulcer, chronic regurgitation of gastric acid
- Slower heart rate
- Low blood pressure when you stand up
- Blood tests may show abnormal liver function values
- You can get bruises more easily due to low platelet counts
- Surgical wounds can become infected, abnormal secretion from surgical wounds
- Discolored skin or bruises
- Complications of skin healing after surgery
- High blood sugar levels
- Injection site pain or injection site reaction
- Rash or worsening itchy rash (hives)
- Anorexia (loss of appetite)
- Joint pain
- High levels of enzymes in the blood during blood tests, which indicates damage or stress in the heart, brain, or muscle tissue
- Dry mouth
- Muscle weakness
- Earache
- Unusual sounds from the abdomen
Rare: affects less than 1 user in 1,000
- Rash or ulceration anywhere on the body (eg on the skin, mouth, eyes, face, lips, or tongue) or other signs of an allergic reaction, such as skin rash, swelling of the face, lips, or tongue, wheezing, difficulty breathing or swallowing (possibly with death as a result)
- Swelling, blistering, or flaking of the skin
- Acute renal failure
- Hepatitis ( inflammation of the liver)
- Inflammation of the esophagus (esophagus)
- Inflammation of the pancreas (may cause stomach pain)
Has been reported: occurs an unknown number of users
- Collapse due to very low blood pressure
- Heart failure
- Kidney failure
- Palpitations or irregular heartbeats
- Shortness of breath
5. How to store 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 label after Exp. The expiration date is the last day of the specified month.
No special storage instructions before preparation.
It is recommended to use Dynastat as soon as possible after mixing the powder with the diluent, but it can be stored if the instructions at the end of the package leaflet are strictly followed. The injection solution should be a clear, colorless liquid. If there are particles in the solution for injection or if the powder or solution is discolored, do not use the solution.
6. Contents of the packaging and other information
Content declaration
- The active substance is parecoxib (as parecoxib sodium). Each vial contains 40 mg of parecoxib, in the form of 42.36 mg of parecoxib sodium. When reconstituted with 2 ml of diluent, the concentration of parecoxib is 20 mg/ml. When reconstituted with sodium chloride 9 mg / ml (0.9%) solution, Dynastat contains approximately 0.44 mEq of sodium per vial .
- Other ingredients are: Powder
Disodium hydrogen phosphate
Phosphoric acid and/or sodium hydroxide (for pH adjustment).
Diluent
Sodium chloride
Hydrochloric acid or sodium hydroxide (for pH adjustment)
Water for injections.
What the medicine looks like and the contents of the pack
Dynastat is supplied as a white to off-white powder.
The powder is packaged in a vial (5 ml) in stained glass with a stopper, fitted with a purple detachable cap over the aluminum seal.
The diluent is packaged in a neutral glass ampoule (2 ml) in stained glass.
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, Belgium
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienPfizer SA / NVTel: +32 (0) 2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in Lithuania.Tel. +3705 2514000 |
| BulgariaPfizer Luxembourg SAARЛ, Clone of BulgariaTel: +359 2 970 4333 | Luxembourg / LuxemburgPfizer SATel: +32 (0) 2 554 62 11 |
| Czech RepublicPfizer, spol. s roTel: + 420-283-004-111 | HungaryPfizer Kft.Tel .: + 36 1 488 37 00 |
| DenmarkPfizer ApSTel: +45 44 20 11 00 | Malta Vivian Corporation Ltd.Tel: +356 21344610 |
| GermanyPfizer Pharma GmbHTel: +49 (0) 30 550055 51000 | The NetherlandsPfizer bvTel: +31 (0) 10 406 43 01 |
| EestiPfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500 | NorwayPfizer ASTel: +47 67 52 61 00 |
| GreecePFIZER ΕΛΛΑΣ AE,:Ηλ: +30 210 6785800 | AustriaPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0 |
| SpainPfizer, SLTel: +34 91 490 99 00 | PolandPfizer Polska Sp. z oo,Tel .: +48 22 335 61 00 |
| FrancePfizerTel: +33 (0) 1 58 07 34 40 | PortugalPfizer Laboratories, Lda.Tel: +351 21 423 5500 |
| CroatiaPfizer Croatia dooTel: + 385 1 3908 777 | RomaniaPfizer România SRLTel: +40 (0) 21 207 28 00 |
| IrelandPfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161 | SloveniaPfizer Luxembourg SARLPfizer, a company in the field of pharmaceuticals, LjubljanaTel: + 386 (0) 152 11 400 |
| Ice landIcepharma hf.Tel: + 354 540 8000 | Slovak RepublicPfizer Luxembourg SARL, organizer el: + 421–2–3355 5500 |
| ItalyPfizer SrlTel: +39 06 33 18 21 | Finland / FinlandPfizer OyPuh / Tel: +358 (0) 9 43 00 40 |
| LatviaPfizer Luxembourg SARL affiliate Latvia Tel: +371 670 35 775 | United KingdomPfizer LimitedTel: +44 (0) 1304 616161 |