Cyperguard may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Cypermethrin is reported as an ingredient of Cyperguard in the following countries:
International Drug Name Search
Generic Name: denosumab (Xgeva) (den OH sue mab)
Brand Names: Xgeva
Denosumab is a monoclonal antibody. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.
The Xgeva brand of denosumab is used to prevent bone fractures and other skeletal conditions in people with tumors that have spread to the bone. Xgeva is not for use in people with multiple myeloma (bone marrow cancer).
This medication guide provides information about the Xgeva brand of denosumab. Prolia is another brand of denosumab used to treat osteoporosis in postmenopausal women who have high risk of bone fracture.
Denosumab may also be used for purposes not listed in this medication guide.
This medication guide provides information about the Xgeva brand of denosumab. Prolia is another brand of denosumab used to treat osteoporosis in postmenopausal women who have high risk of bone fracture.
Before you receive this medication, tell your doctor if you have kidney disease or if you are on dialysis.
Some people using denosumab have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.
To make sure you can safely use Xgeva, tell your doctor if you have kidney disease or if you are on dialysis.
Some people using denosumab have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.
Denosumab is injected under the skin of your stomach, upper thigh, or upper arm. A healthcare provider will give you this injection.
Xgeva is usually given once every 4 weeks. Follow your doctor's instructions.
Your doctor may have you take extra calcium and vitamin D while you are being treated with denosumab. Take only the amount of calcium and vitamin D that your doctor has prescribed.
Pay special attention to your dental hygiene. Brush and floss your teeth regularly while receiving this medication. You may need to have a dental exam before you begin treatment with Xgeva. Follow your doctor's instructions.
You may take the medicine out of the refrigerator and allow it to reach room temperature before giving the injection. Do not heat the medicine before using.
Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
Call your doctor for instructions if you miss an appointment for your Xgeva injection.
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
numbness or tingly feeling around your mouth or in your fingers or toes, fast or slow heart rate, muscle cramps or contraction, overactive reflexes; or
trouble breathing.
Less serious side effects may include:
feeling weak or tired;
diarrhea, nausea; or
headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Osteoporosis:
For the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy, treatment to increase bone mass in women at high risk for fracture
receiving adjuvant aromatase inhibitor therapy for breast cancer, and treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer:
60 mg administered as a single subcutaneous injection in the upper arm, the upper thigh, or the abdomen once every 6 months. All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily
Usual Adult Dose for Hypercalcemia of Malignancy:
For the prevention of skeletal related events in patients with bone metastases from solid tumors:
120 mg as a subcutaneous injection in the upper arm, upper thigh, or abdomen every 4 weeks.
Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia.
There may be other drugs that can interact with Xgeva. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: denosumab side effects (in more detail)
Alaceril may be available in the countries listed below.
Alacepril is reported as an ingredient of Alaceril in the following countries:
International Drug Name Search
Didanosine Delayed-Release Enteric-Coated Capsules may cause serious and sometimes fatal inflammation of the pancreas (pancreatitis). This has occurred in patients who have just started taking Didanosine Delayed-Release Enteric-Coated Capsules and in patients who have already been taking it. Contact your doctor right away if you experience sudden stomach or back pain, swelling of the stomach, fever or chills, nausea or vomiting, or fast heartbeat.
Didanosine Delayed-Release Enteric-Coated Capsules may cause severe and sometimes fatal lactic acidosis and liver problems. Fatal lactic acidosis has also occurred in pregnant women who have used Didanosine Delayed-Release Enteric-Coated Capsules along with certain other medicines for HIV (eg, stavudine). Tell your doctor if you are taking stavudine and you are pregnant or planning to become pregnant.
Treating HIV infection when used in combination with other medicines.
Didanosine Delayed-Release Enteric-Coated Capsules are a nucleoside analogue reverse transcriptase inhibitor. It works by stopping the growth of HIV-1, the virus that causes AIDS.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Didanosine Delayed-Release Enteric-Coated Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Didanosine Delayed-Release Enteric-Coated Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Didanosine Delayed-Release Enteric-Coated Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Didanosine Delayed-Release Enteric-Coated Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Didanosine Delayed-Release Enteric-Coated Capsules.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Breast enlargement; changes in body fat; darkened complexion with purple markings; diarrhea; dry mouth; headache; itching; muscle pain; skin and facial wasting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the vomit or vomit that looks like coffee grounds; blurred vision or other vision changes; chest pain or discomfort, numbness of an arm or leg, or shortness of breath; confusion; dark urine; dizziness; fainting; fast, shallow breathing; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; lightheadedness; low body temperature; nausea or vomiting; numbness, tingling, or pain in the hands or feet; pale stools; seizures; severe muscle pain or cramping; stomach pain or swelling; tiredness; unusual bruising or bleeding; weakness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Didanosine side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dark urine; diarrhea; pale stools; severe stomach pain with nausea and vomiting; tingling, burning, or numbness in the hands or feet; unusual fatigue; yellowing of the skin or eyes.
Store Didanosine Delayed-Release Enteric-Coated Capsules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C), in a tightly closed container. Brief storage at temperatures of up to 86 degrees F (30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Didanosine Delayed-Release Enteric-Coated Capsules out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Didanosine Delayed-Release Enteric-Coated Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Cabergolin Teva may be available in the countries listed below.
Cabergoline is reported as an ingredient of Cabergolin Teva in the following countries:
International Drug Name Search
Deprozol may be available in the countries listed below.
Secnidazole is reported as an ingredient of Deprozol in the following countries:
International Drug Name Search
Opipram may be available in the countries listed below.
Opipramol dihydrochloride (a derivative of Opipramol) is reported as an ingredient of Opipram in the following countries:
International Drug Name Search
Julab may be available in the countries listed below.
Selegiline hydrochloride (a derivative of Selegiline) is reported as an ingredient of Julab in the following countries:
International Drug Name Search
Eryrox may be available in the countries listed below.
Erythromycin is reported as an ingredient of Eryrox in the following countries:
International Drug Name Search
Note: This “Introduction and Test Instructions” contains information for:
| Test Collection Kit | Breath Test Instrument |
| BreathTek™ UBT for H. pylori | 1. UBiT®-IR 300 Infrared Spectrophotometer |
| 2. POCone™ Infrared Spectrophotometer |
The BreathTek™ UBT Collection Kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four (4) weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples.
For administration by health care professionals. To be administered under a physician’s supervision.
Since the isolation of the spiral urease-producing Helicobacter pylori bacteria (H. pylori) in 1983 by Drs. Marshall and Warren1, a significant body of evidence has accumulated indicating that the bacteria is an important pathogen in the upper GI tract of humans.2.3 The causal relationship between H. pylori and chronic active gastritis, duodenal ulcer, and gastric ulcer is well documented.4.5 Methods available for detecting current infection of the human stomach by H. pylori are generally divided into two (2) general types: Invasive and Non-invasive.
Invasive methods are so named because they include, as a first step, an esophagogastroduodenoscopy (“EGD”) with collection of gastric biopsies. These biopsies are then examined by one or more detection methods: histological examination of stained tissue, microbiological culture of the organism, or direct detection of urease activity in the tissue (for example, the CLOtest®). Biopsy based methods are expensive, entail some patient risk and discomfort and may give false negative results due to sampling errors when colonization of the gastric mucosa is patchy.6
The non-invasive, non-radioactive method for detecting current H. pylori infection is based on the BreathTek™ UBT which is described in the next section. Several serological tests that detect serum antibodies to H. pylori are commercially available. A positive result with these tests cannot distinguish between current infection and past exposure to infection and, therefore, is not a conclusive indicator of current gastrointestinal colonization by H. pylori.
| (NH2)213CO + H2O + 2H+ | HP Urease | 13CO2 + 2NH4+13C-urea |
| → |
The BreathTek™ UBT Collection Kit should be stored at 15°-30°C (59°-86°F). Pranactin®-Citric has an expiration date. Do not use beyond the expiration date stated on the label.
Note: An Infrared Spectrophotometer (UBiT®-IR3000 or POCone™, Otsuka Pharmaceutical Co., Ltd.) is required for analysis of breath samples.
Complete operating information, including self-diagnostic instrument routines and user maintenance procedures, is provided in the Instruction Manuals for the UBiT®-IR300 Spectrophotometer, the UBiT®-AS10 Autosampler and the POCone™ Spectrophotometer, respectively. Additionally, each office laboratory or test facility should follow its own internal procedures for quality control.
Delta Over Baseline values for the BreathTek™ UBT were determined in a controlled clinical study of twenty-six (26) infected and twenty-three (23) uninfected adult volunteers. The Meretek UBT® Breath Test was used as the reference method in the diagnosis of infection. The range of BreathTek™ UBT Delta Over Baseline values for the uninfected group was determined to be 0.0 to 1.0. A histogram for the distribution of Delta Over Baseline values from the uninfected subjects is shown in Figure 2a.
Values for the Meretek UBT® Breath Test were determined in a controlled clinical study of sixty-six (66) infected and fifty-three (53) uninfected asymptomatic, apparently healthy volunteers. Histological examination of biopsy tissue was used as the reference method in the determination of infection in this study. The range of Meretek UBT® Delta Over Baseline values for the uninfected group was determined to be 0.0 to 2.2. A histogram for the distribution of Delta Over Baseline values from the uninfected subjects is shown in Figure 2b.
| BreathTek™ UBT Results | |||
| Meretek UBT® | Positive | Negative | Total |
| Positive | 105 | 1 | 106 |
| Negative | 1 | 145 | 146 |
| Total | 106 | 146 | 252 |
| GIRMS Results | |||
| UBiT®-IR 300 Results | Positive | Negative | Total |
| Positive | 115 | 1 | 116 |
| Negative | 2 | 202 | 204 |
| Total | 117 | 203 | 320 |
| UBiT ® -IR 300 Results | |||
| POCone™Results | Positive | Negative | Total |
| Positive | 86 | 1 | 87 |
| Negative | 0 | 133 | 133 |
| Total | 86 | 134 | 220 |
| Meretek™ UBT Results | |||
| CLOtest® Results | Positive | Negative | Total |
| Positive | 397 | 31 | 428 |
| Negative | 1 | 16 | 17 |
| Total | 398 | 47 | 445 |
| Meretek™ UBT Results | |||
| Histology | Positive | Negative | Total |
| Positive | 394 | 20 | 414 |
| Negative | 3 | 27 | 30 |
| Total | 397 | 47 | 444 |
| Combined endoscopic methods used were CLOtest®, histology, and culture per DAIDP guidelines8 for pre-treatment diagnosis. | |||
| Meretek™ UBT Results | |||
| Endoscopy | Positive | Negative | Total |
| Positive | 395 | 20 | 414 |
| Negative | 3 | 26 | 29 |
| Total | 398 | 46 | 444 |
| Meretek UBT® Breath Test Results | ||||||||
| 1 Month EOT | 3 Months EOT | 6 Months EOT | 1-6 Months ComBined | |||||
| Endoscopy | Pos | Neg | Pos | Neg | Pos | Neg | Pos | Neg |
| Positive | 187 | 6 | 123 | 8 | 91 | 5 | 401 | 19 |
| Negative | 5 | 97 | 4 | 87 | 2 | 80 | 11 | 264 |
| Sensitivity (95% CI) | 96.9 (93, 99) | 93.9 (88, 97) | 94.8 (88, 98) | 95.5 (93, 97) | ||||
| Specificity (95% CI) | 95.1 (89, 98) | 95.6 (89, 99) | 97.6 (92, 100) | 96.0 (93, 98) | ||||
| *Combined endoscopic methods used were histology and culture per DAIDP guidelines8 for post-treatment monitoring. | ||||||||
The BreathTek™ UBT for H. pylori Collection Kit is manufactured for Meretek Diagnostics Group of Otsuka America Pharmaceutical, Inc., 2440 Research Boulevard, Rockville, MD 20850.
Revision: September 2008
Print Code: 0508L-0177
Part Number: 002215AC
| PRANACTIN-CITRIC urea c-13 powder, for solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA020586 | 05/10/2001 | |
| Labeler - Otsuka America Pharmaceutical (008314390) |
| Registrant - Otsuka America Pharmaceutical (008314390) |
Dercome may be available in the countries listed below.
Benzoyl Peroxide is reported as an ingredient of Dercome in the following countries:
International Drug Name Search
Treating symptoms of allergies, such as runny nose, sneezing, nose or throat itching, or itchy, watery eyes. It may also be used for other conditions as determined by your doctor.
Doxytex Liquid is an antihistamine. It works by blocking the action of histamine, which reduces the symptoms of an allergic reaction. It also depresses the central nervous system (brain) to produce drowsiness.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Doxytex Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Doxytex Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Doxytex Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Doxytex Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Doxytex Liquid.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Dizziness; drowsiness; dry mouth, throat, and nose.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); convulsions; decreased alertness; decreased urination; excitability; fast heartbeat; hallucinations; seizures; severe drowsiness; tightness or pounding in the chest; tremor; wheezing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Doxytex side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; excitement; hallucinations; loss of consciousness; muscle twitching; seizures; tremor; weakness.
Store Doxytex Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), or according to the directions on the package label. Store in the original package or container away from heat, moisture, and light. Do not store in the bathroom. Keep Doxytex Liquid out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Doxytex Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
In some countries, this medicine may only be approved for veterinary use.
In the US, Vexol (rimexolone ophthalmic) is a member of the drug class ophthalmic steroids and is used to treat Postoperative Ocular Inflammation and Uveitis.
US matches:
UK matches:
Rimexolone is reported as an ingredient of Vexol in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Algoremin may be available in the countries listed below.
Metamizole sodium anhydrous (a derivative of Metamizole) is reported as an ingredient of Algoremin in the following countries:
International Drug Name Search
Covonia Vapour Drops
Covonia Vapour Drops contains the following active ingredients:
Menthol BP natural or Menthol BP synthetic 17.5% w/v
Peppermint Oil BP 0.2% v/v
For excipients, see 6.1
Inhalation vapour, solution.
A clear yellow liquid.
For the symptomatic relief of catarrh, hay fever and nasal congestion.
Adults, the elderly and children over 3 months:
Sprinkle a few drops on a handkerchief and inhale the vapour.
Children under 3 months:
Not recommended for children under 3 months.
Hypersensitivity to any of the ingredients.
Not recommended for children under 3 months.
In young children, menthol can cause spasm of the glottis and cases of collapse have been reported in children following local application.
The label states:
1 If symptoms persist, consult your doctor.
2 Avoid contact with the eyes.
3 Not to be taken internally.
4 Keep all medicines out of the sight and reach of children.
None stated.
The safety of Covonia Vapour Drops in pregnancy and lactation has not been established, but is not thought to constitute a hazard.
No or negligible influence.
Occasional hypersensitivity reactions are a possibility.
Following oral ingestion, the following symptoms may be expected: insomnia, unsteady gait, tremor of hands, nausea and vomiting, delirium, epileptiform convulsions, depression and coma. Treatment should consist of gastric lavage and aspiration. A saline purgative such as 30g of sodium sulphate in 250ml of water may be given and any convulsions controlled by intravenous diazepam.
R01A X – Other nasal preparations, combinations
Menthol, a frequent constituent of inhalation preparations, produces a sensation of decreased nasal congestion, possibly by virtue of its local anaesthetic action on the nasal mucosal surface. Peppermint Oil possesses the physiological actions and therapeutic uses of menthol.
Not applicable.
No data of relevance to the prescriber, which is additional to that included in other sections of the SPC.
Eucalyptus Oil Ph. Eur
Cajuput Oil BPC 1973
Spike Lavender Fragrance Oil HSE
Industrial Methylated Spirit BP
None stated.
10ml: 36 months
15ml: 36 months
30ml: 36 months
Do not store above 25°C
10ml, 15ml & 30ml pack - amber glass bottle with polyethylene screw cap with integral polyethylene dropper.
Not applicable.
Thornton & Ross Limited
Linthwaite
Huddersfield
West Yorkshire
HD7 5QH
United Kingdom
PL 00240/0073
19 June 2002
19/09/03
Not Applicable
Not Applicable
Polyethylene Glycol 3350, 17 grams (cap filled to line)
Laxative
Allergy alert: Do not use if you are allergic to polyethylene glycol
if you have kidney disease, except under the advice
and supervision of a doctor
taking a prescription drug
you may have loose, watery, more frequent stools
abdominal pain gets worse. These may be signs of a serious
condition.
ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
none
1-800-477-7877
Distributed by
Kremers Urban, LLC
Princeton, NJ 08540 USA
Rev. 1E
Original Prescription Strength
4.1 oz Label. Drug Facts on ECL.
8.9 oz Label. Drug Facts on ECL.
18.5 oz Label. Drug Facts on ECL.
| POLYETHYLENE GLYCOL 3350 polyethylene glycol 3350 powder, for solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA090600 | 10/06/2009 | |
| Labeler - Kremers Urban (015411751) |
