Ketoprofen for Injecton 100mg/10ml, GMP Medicine

• Application: Internal Medicine
• Usage Mode: For external use
• Suitable for: Elderly, Adult
• State: Powder
• Shape: Powder
• Pack: 100mg/10ml, 25′s/Box
• Model NO.: AMC13028
• Cap: Al or Al with Plastic
• Transport Package: 25′s / Box
• Specification: 100mg/10ml
• Trademark: MEDIPHARM/OEM
• Origin: China
• HS Code: 3004909099
• Production Capacity: 10000ctns Per Month

Product Description

KETOPROFEN FOR INJECTION 100mg

COMPOSITION:
Each vial contains:
Ketoprofen ................................. 100mg
Excipients .................................... C.S.

INDICATIONS:
The ketoprofen is indicated in the mild pain and inflammation in rheumatic diseases and other disorders
Musculoskeletal post-surgical, acute gout; dysmenorrhea.

Pharmacological action
The drug is not steroid anti-inflammatory (NSAID) inhibit the activity of the enzyme cyclo-oxygenase, leading to a decrease in the formation of precursors of prostaglandins and thromboxane from arachidonic acid. Although the decrease resulting from the synthesis and activity of prostaglandins that are produced in various tissues may be responsible for many of the therapeutic effects (and side) of NSAIDs, other actions may also contribute significantly to the therapeutic effects of these drugs .

PRECAUTIONS:
Cross sensitivity and other issues:
The patients sensitive to NSAIDs, including aspirin and other NSAIDs ketorolac not commercially available, can also be sensitive to other NSAIDs.
NSAIDs can cause anaphylaxis or bronchoconstriction in asthmatics sensitive to aspirin, especially those in which aspirin induces nasal polyps, asthma and other allergic reactions.
Carcinogenicity. We found no evidence of carcinogenicity studies in mice that received up to 32mg/kg (96mg/m2) per day.
Tumorgenicidad. Tumorgenicidad has not been shown in studies in rats that received 6mg/m2 (36mg/m2) per day for 81 weeks or the lowest dose for 104 weeks.
Mutagenicity. It was not shown any mutagenic activity in the Ames test.
Pregnancy / Play:
Fertility. There was no evidence of ningúndeterioro fertility studies of reproduction in male rats that received up 9mg/kg (54mg/m2) per day. However, and showed a decrease in the number of site of implantation in female rats that received 6 or 9mg/kg (36 or 54mg/m2) per day. In other studies, high doses of ketoprofen caused abnormal spermatogenesis or inhibition of spermatogenesis in rats and dogs, and a decrease in testicular dogs and cores.

Pregnancy:

First quarter: adequate and well controlled studies in humans have not been implemented.
Studies in animals have shown no evidence of embryotoxicity or teratogenicity in mice that received up to 12mg/kg (36 or 54mg/m2) per day or in rats that received 9mg/kg (54mg/m2) per day.
Second and third quarter: Although there have been no studies in humans with NSAIDs, their use during the second half of pregnancy is not recommended because of possible adverse effects on the fetus, such as the premature closure of the ductus arteriosus which can lead persistent pulmonary hypertension of the newborn.
In animal studies have also shown that it can cause prolonged gestation, dystocia, and delayed childbirth, possibly due to the decline in contractibilidad uterus, which is the result of inhibition of uterine prostaglandins.
Breastfeeding: It is not known whether the ketoprofen is distributed in human breast milk.
Geriatrics: Studies have shown that they can reduce the binding of proteins and the separation of ketoprofen, increasing and prolonging the serum concentration and elimination.
Dentistry: The NSAIDs can cause pain, irritation or ulceration of the oral mucosa.

Surgery: Caution is recommended in patients who need surgery. Most of the NSAIDs inhibit platelet aggregation and may prolong bleeding time which can increase the intra-and postoperative bleeding.

CONTRAINDICATIONS:
Except under special circumstances, this drug should not be used when there is the following medical problems:
Background or severe allergic reactions such as anaphylaxis or angioedema induced by aspirin or other NSAIDs. Nasal polyps associated with aspirin-induced bronchospasm.
Should assess the risk-benefit ratio when there are the following medical problems:
Background to moderate allergic reactions such as allergic rhinitis, hives or skin rash induced by aspirin and other NSAIDs. Anemia or asthma.
Predisposing conditions and / or exacerbated by fluid retention, such as cardiac function compromised, congestive heart disease, edema pre-existing hypertension, kidney dysfunction or failure.
Predisposing conditions such as gastrointestinal toxicity: Alcoholism, active gastrointestinal bleeding,
A history of ulcerative or inflammatory disease of the lower or upper gastrointestinal tract, including the enferrnedad Crohn's, diverticulitis, peptic ulcer or ulcerative colitis.
Background: Recent consumption of snuff.

Congestive heart failure or diabetes mellitus or preexisting edema or decrease the volume extracellular or sepsis. Hemophilia or other problems, including blood clotting disorders or platelet function. Liver cirrhosis or liver dysfunction. Renal dysfunction. Stomatitis. Systemic Lupus Erythematosus (SLE).
It's also wise to be cautious in geriatric patients who are more likely to develop liver or kidney side effects with these medications, and in which ulceration or gastrointestinal bleeding are more likely to cause serious, even fatal.

ADVERSE REACTIONS:
Those who require medical attention:
Incidents unknown:
Cardiovascular effects: Angina pectoris or exacerbations (chest pain). Pericarditis pulmonary edema. Convulsions. Sense of depersonalization or confusion. Intense headache. Aseptic meningitis. Changes in mood or mental including disorientation. Sense of depersonalization or confusion. Psychotic reaction. Syncope.
Dermatological effects: Eczema. Flaking. Erythema multiforme. Erythema nodosum. Photosensitive reaction. Stevens Johnson Syndrome. Toxic epidermal necrolysis.
Effects of the digestive system: abdominal distension, colitis or exacerbation. Enterocolitis or regional enteritis or exacerbation. Dysphagia. Esophagitis. Gastroenteritis.
Genitourinary effects: Pain of the bladder. Crystalluria, kidney stones or ureter obstruction. Urethritis. Urinary tract infection: Dysuria. Frequent urinary momentum. Incontinence. Proteinuria. Strong smell of urine.
Haematological effects: Aplastic anemia (pancytopenia). Bone marrow depression. Disseminated intravascular coagulation. Ecchymosis. Eosinophilia. Leukopenia. Petechiae.

Hepatic effects: Hepatitis or cholestatic jaundice. Angiitis. Angioedema. With or without fever, chills. Loeffler's syndrome. Reaction similar to the serum sickness. Syndrome similar to systemic lupus erythematosus. Lymphadenopathy.
Eye effects: Amblyopia toxic. Opacity of the cornea. Macular or retinal unrest. Corneal deposit. Eyelid edema. Escotomata.
Effects oral / peri: gingival ulceration. Glossitis. Swelling of lips and tongue.
Renal effects: Glomerulitis or glomerulonephritis. Hyperkalaemia. Nephrosis. Oliguria, anuria. Polyuria. Or papillary renal tubular necrosis.
Those that require medical attention only if they persist or are annoying:
Cardiovascular effects: flushing or hot flashes.
Effects of Central Nervous System: Anxiety. Tremor. Epigastric pain or discomfort. Ardor of the stomach. Muscle weakness. Photophobia.
More frequent incidences:
Digestive systemic effects: Rectal bleeding.
Renal effects: Fluid retention, edema.
Effects of Central Nervous System: Headache mild to moderate. Nervousness or irritability.

Gastrointestinal effects: abdominal cramps, pain or discomfort regular moderate. Bloating or gas. Constipation. Diarrhea. Indigestion. Nausea. Rectal irritation.
Less frequent occurrences:
Effects of Central Nervous System: mental depression.
Dermatological effects: skin rash.
Genitourinary effects: Cystitis.
Eye effects: Blurred vision or other changes in vision.
Effects of oral / peri: Stomatitis, canker.
Effects Oticos: Buzz ears.
Cardiovascular Effects: Sweating increased.
Effects of Central Nervous System: Dizziness. Dizziness. Discomfort sleeping.
Gastrointestinal effects: loss or decreased appetite. Vomiting. General feeling of malaise.
Rare occurrences:
Cardiovascular effects: Hemoptysis. Unexplained nosebleeds. Congestive heart failure or exacerbation of it. Increased blood pressure.
Effects of Central Nervous System: Confusion, Lack of memory. Migraine. Peripheral neuropathy.

Dermatological effects: Allergic Dermatitis: blisters, hives, itching. Exfoliative dermatitis. Erythema or skin discoloration.
Digestive systemic effects: gastritis. Bleeding or gastrointestinal bleeding. Gastrointestinal perforation. Gastrointestinal ulceration.
Genitourinary effects: Blood in urine.
Haematological effects: Agranulocytosis. Anemia. Hemolytic anemia. Hipocoagulability.
Hepatic effects: toxic hepatitis or jaundice.
Dermatological effects: Anaphylaxis or erythropoietin. Broncoespástica allergic reaction. Laryngeal edema. Allergic rhinitis. Lifting or exfoliation of the nails. Pain or muscle cramps.
Effects Eye: Conjunctivitis. Dryness, irritation or swelling of eyes. Sore eyes. Retinal hemorrhage.
Óticos effects: Hearing loss or other change in the hearing.
Renal effects: interstitial nephritis. Nephrotic syndrome. Or renal dysfunction. Breathing problems. Continuous thirst.
Cardiovascular effects: rapid heartbeat. Palpitations.
Effects of Central Nervous System: Dizziness, vertigo. Dermatological reaction fotosensitiva or photoallergic. Gastrointestinal effects: bitter taste or other changes in taste. Irritation, dryness or sores in the mouth. Unexplained weight loss.

DOSAGE AND PREPARATION OF THE FORM OF DOSAGE:
50 to 100mg every 4 hours (max. 200 mg in 24 hours) for up to 3 days. Not recommended for children.
5ml reconstituted with water for injections.
 
STORAGE: 
Store at temperatures not exceeding 30ºC .Protected from light.