Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - dynastat

Document Subject

Generated Narrative: MedicinalProductDefinition mp741439ba6d0ec3fbe3a33d580ea9911d

identifier: http://ema.europa.eu/identifier/EU/1/02/209/005

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Dynastat 40 mg powder for solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-741439ba6d0ec3fbe3a33d580ea9911d

identifier: http://ema.europa.eu/identifier/EU/1/02/209/005

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - dynastat

Attesters

What is in this leaflet

1. What Dynastat is and what it is used for
2. What you need to know before you use Dynastat
3. How to use Dynastat
4. Possible side effects
5. How to store Dynastat
6. Contents of the pack and other information

Dynastat contains the active substance parecoxib.

Dynastat is used for the short-term treatment of pain in adults after an operation. It is one of a family of medicines called COX-2 inhibitors (this is short for cyclo-oxygenase-2 inhibitors). Pain and swelling are sometimes caused by substances in the body called prostaglandins. Dynastat works by lowering the amount of these prostaglandins.

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 serious allergic reaction (especially a serious skin reaction) to any medicines
• 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 gastric or intestinal ulcer or bleeding in the stomach or gut
• if you have had an allergic reaction to acetylsalicylic acid (aspirin) or to other NSAIDs (e.g. ibuprofen) or to COX-2 inhibitors. Reactions might include wheezing (bronchospasm), badly blocked nose, itchy skin, rash or swelling of the face, lips or tongue, other allergic reactions or nasal polyps after taking these medicines
• if you are more than 6 months pregnant
• if you are breast-feeding
• if you have severe liver disease
• if you have inflammation of the intestines (ulcerative colitis or Crohn s disease)
• if you have heart failure
• if you are about to have heart surgery or surgery on your arteries (including any coronary artery procedure)
• if you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages
• if you have or have had problems with your blood circulation (peripheral arterial disease)

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

Warnings and precautions

Do not use Dynastat if you currently have a gastric or intestinal ulcer or gastrointestinal bleeding

Do not use Dynastat if you have severe liver disease

Talk to your doctor or nurse before using Dynastat:

• If you have previously had an ulcer, bleeding, or perforation of the gastrointestinal tract.
• 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 raised cholesterol
• If you are taking antiplatelet therapies
• If you have fluid retention (oedema)
• If you have liver or kidney disease.
• If you are dehydrated this may happen if you have had diarrhoea or have been vomiting (being sick) or unable to drink fluids
• If you have an infection as it may hide a fever (which is a sign of infection)
• If you use medicines to reduce blood clotting (e.g. warfarin/warfarin like anticoagulants or novel oral anti-clotting medicines, e.g. apixaban, dabigatran, and rivaroxaban)
• If you use medicines called corticosteroids (e.g. prednisone)
• If you use a class of medicines used to treat depression called selective serotonin re-uptake inhibitors (e.g. sertraline)

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

Children and adolescents 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. Medicines can sometimes interfere with each other. Your doctor may reduce the dose of Dynastat or other medicines, or you may need to take a different medicine. It s 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 conditions
• Ciclosporin or Tacrolimus used after transplants
• Warfarin or other warfarin like medicines used to prevent blood clots including newer medicines like apixaban, dabigatran, and rivaroxaban
• Lithium used to treat depression
• Rifampicin used for bacterial infections
• Antiarrhythmics used to treat an irregular heartbeat
• Phenytoin or Carbamazepine used for epilepsy
• Methotrexate used for rheumatoid arthritis and cancer
• Diazepam used for sedation and anxiety
• Omeprazole used for treating ulcers

Pregnancy, breast-feeding and fertility

• Dynastat must not be used if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby s tendency to bleed and cause labour to be later or longer than expected. Dynastat should not be used during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If used for more than a few days from 20 weeks of pregnancy onward, Dynastat can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.
• If you are breast-feeding, you must not receive Dynastat, as a small amount of Dynastat will be transferred to your breast milk.
• NSAIDs, including Dynastat, may make it more difficult to become pregnant. You should tell your doctor if you are planning to become pregnant or if you have problems becoming 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 the injection makes you feel dizzy or tired, do not drive or use machines until you feel better again.

Dynastat contains sodium This medicine contains less than 1 mmol sodium (23 mg) per ml that is to say essentially sodium-free .

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

The usual dose to start with is 40 mg. You may be given another dose either 20 mg or 40 mg 6 to 12 hours after the first one.

You will 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
• Patients over 65 who weigh less than 50 kg
• People taking fluconazole.

If Dynastat is used with strong pain killers (called opioid analgesics) such as morphine the dose of Dynastat will be the same as explained above.

If you are given more Dynastat than you should you may experience side effects that have been reported with recommended doses.

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

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 in any part of 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 which may cause wheezing, difficulty breathing, or swallowing this occurs rarely
• if you have blistering or peeling of the skin - this occurs rarely
• the onset of skin reactions can occur at any time but most often occur in the first month of treatment; the reported rate of these events appears to be greater for valdecoxib, a medicine related to parecoxib, as compared to other COX-2 inhibitors
• if you have jaundice (your skin or the whites of your eyes appear yellow)
• if you have any signs of bleeding in the stomach or intestine, such as passing a black or blood-stained bowel movement 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 your blood pressure (up or down)
• You may get back pain
• Ankles, legs and feet may swell (fluid retention)
• You may feel numb your skin may lose sensitivity to pain and touch
• You may get vomiting, stomach ache, indigestion, constipation, bloating and wind
• Tests may show abnormal kidney function
• You may feel agitated or find it hard to sleep
• Dizziness
• There is a risk of anaemia - changes in red blood cells after an operation that may cause fatigue and breathlessness
• You may get a sore throat or difficulty breathing (shortness of breath)
• Your skin may be itchy
• You may pass less urine than usual.
• Dry socket (inflammation and pain after a tooth extraction)
• Increased sweating
• Low levels of potassium in blood test results

Uncommon: may affect up to 1 in 100 people

• Heart attack
• There is a risk of cerebrovascular disease e.g. stroke, or transient ischaemic attack (transient reduced blood flow to the brain)/mini-stroke or angina, or blockages to blood vessels to the heart or brain
• Blood clot in the lungs
• Worsening of high blood pressure
• Ulcers in the digestive system, chronic stomach acid reflux
• The heart may beat more slowly
• Low blood pressure on standing
• Blood tests may show abnormal liver function
• You may bruise easily due to a low blood platelet count
• Surgical wounds may become infected, abnormal discharge from surgical wounds
• Skin discolouration or bruising
• Complications with skin healing after operations
• High sugar levels in blood tests
• Injection site pain or injection site reaction
• Rash, or raised itchy rash (hives)
• Anorexia (loss of appetite)
• Joint pain
• High levels of blood enzymes in blood tests that indicate injury or stress to the heart, the brain, or muscle tissue.
• Dry mouth
• Muscle weakness
• Ear ache
• Unusual abdominal sounds

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

• Rash or ulceration in any part of your body (e.g. skin, mouth, eyes, face, lips or tongue), or any other signs of allergic reactions such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing (potentially fatal)
• Swelling, blistering or peeling of the skin
• Acute kidney failure
• Hepatitis (inflamed liver)
• Inflammation of the gullet (oesophagus)
• Inflammation of the pancreas (can lead to stomach pain)

Not known: frequency cannot be estimated from the available data

• Collapse due to severe low blood pressure
• Heart failure
• Kidney failure
• Racing or irregularity of the heartbeat
• Breathlessness

Reporting of side effects If you get 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 vial label after Exp. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions prior to reconstitution.

It is recommended that Dynastat is used as soon as possible after it is mixed with solvent, although it may be stored if the instructions at the end of the leaflet are strictly followed.

The injection solution should be a clear colourless liquid. If there are particles in the injection solution or if either the powder or solution is discoloured, the solution will not be used.

What Dynastat contains

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

• The other ingredients are:

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

What Dynastat looks like and contents of the pack Dynastat is available as a white to off-white powder. The powder is contained in colourless glass vials (5 ml) with a stopper, sealed with a purple flip-off cap on the aluminium overseal.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium Manufacturer: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs-Sint-Amands, Belgium

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Belgi /Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA T l/Tel: +32 (0)2 554 62 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje. Tel: +370 5 251 4
,
.: +359 2 970 4Magyarorsz g Pfizer Kft. Tel: +36 1 488 37 esk republika Pfizer, spol. s r.o. Tel: +420 283 004 Malta Vivian Corporation Ltd. Tel: +356 21344Danmark Pfizer ApS Tlf: +45 44 20 11 Nederland Pfizer bv Tel: +31 (0)800 63 34 Deutschland Pfizer Pharma GmbH Tel: +49 (0)30 550055-51Norge Pfizer AS Tlf: +47 67 52 61 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7 sterreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0

PFIZER A.E. : +30 210 6785Polska Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 Espa a Pfizer, S.L. Tel: +34 91 490 99 Portugal Laborat rios Pfizer, Lda. Tel: +351 21 423 5France Pfizer T l: +33 (0)1 58 07 34 Rom nia Pfizer Romania S.R.L. Tel: +40 (0)21 207 28 Hrvatska Pfizer Croatia d.o.o. Tel: +385 1 3908 Slovenija Pfizer Luxembourg SARL Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana Tel: +386 (0)152 11 Ireland Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free)

• 44 (0)1304 616Slovensk republika Pfizer Luxembourg SARL, organiza n zlo ka Tel: +421 2 3355 5 sland Icepharma hf. S mi: +354 540 8Suomi/Finland Pfizer Oy Puh/Tel: +358(0)9 43 00 Italia Pfizer S.r.l. Tel: +39 06 33 18 Sverige
  Pfizer AB Tel: +46 (0)8 550 520
  PFIZER . . (Cyprus Branch)
  : +357 22817United Kingdom (Northern Ireland) Pfizer Limited Tel: +44 (0)1304 616Latvija Pfizer Luxembourg SARL fili le Latvij
  Tel: +371 670 35 This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.

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Detailed information on this medicine is available on the European Medicines Agency web site: