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respiratory function, emphysema, pulmonary fibrosis, chronic obstructive Acetylsalicylic acid / paracetamol / codeine phosphate hemihydrate
pulmonary disease, bronchorrhea, severe tuberculosis, chest trauma (codeine depresses respiration and interferes with the compensatory mechanisms Read all this leaflet carefully because it contains information important to
triggered by ventilation deficit lung). In asthma it may worsen obstructive This medicine is available without prescription. However, it is necessary to take Due to the codeine content, precautions are required in the follwing cases: the NEOLIN carefully, to get the best results.
elderly or physically frail (risks of respiratory depression), brain lesions (risk of - Keep this leaflet. You might need to read it again.
respiratory depression), intracranial hypertension (risk of worsening intracranial - Ask your pharmacist if you need more information or advice.
hypertension), adrenocortical insufficiency, myasthenia gravis, acute abdomen - You should see your doctor if your symptoms worsen or do not improve after (may mask clinical symptoms) hypothyroidism (hazard respiratory depression and central nervous depression), prostatic hypertrophy or urethral stricture - If any of the side effects gets serious, or if you notice any side effects not listed (retention of urine), chronic constipation.
in this leaflet, please tell your doctor or pharmacist.
Codeine use is not recommended in patients with ulcerative colitis (mayproduces toxic dilatation of the colon). Use should be avoided in patients with In this leaflet:
pancreatitis. Hypovolaemia, chronic pulmonary heart, myocardial infarction, 1. What is NEOLIN and what it is used for hypotensive shock favors accidents. The risk of seizure may be increased when codeine is administered to patients with cerebral edema and epilepsy. States of Upon abrupt discontinuation of treatment after prolonged use of high doses of analgesics, which do not meet recommendations, headache, fatigue, muscle pain, nervousness and autonomic signs may occur. These signs disappear after several days of interruption. Treatment should not resume until doctor's 1. WHAT IS NEOLIN AND WHAT IT IS USED FOR
NEOLIN is indicated for the symptomatic short-term treatment of mild to As codeine is metabolized in the liver and eliminated through the kidneys, close moderate pain, irrespective of its place of occurence: headache, migraine, monitoring of patients with hepatic and kidney impairment is recommended; toothache, sore muscles or joints, period pain as well as for the treatment of dosage is adjusted according to severity of impairment.
Related to NEOLIN
2. BEFORE YOU TAKE NEOLIN
Patients should be advised not to take other medicines based on paracetamol Do not take NEOLIN
and codeine at the same time. Athletes must be aware that this product contains - If you are allergic (hypersensitive) to acetylsalicylic acid, paracetamol, codeine an active principle that can induce positive values in anti-doping tests.
or any of the other components of NEOLIN, - Children and adolescents under 15 years, Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
- If you have active peptic ulceration,- If you have gastro-intestinal bleeding, Related to acetylsalicylic acid
- If you have bleeding diseases or other illnesses at risk of bleeding Other NSAIDs: increased bleeding and nephrotoxic risk.
- If you have had past asthma induced by administration of salicylates or Acetylsalicylic acid may increase the risk of gastrointestinal bleeding in substances with similar action, in particular NSAIDs, concurrent administration of corticosteroids or alcohol.
- If you have asthma attack, increased tracheobronchitis secretions or severe Anticoagulants: increased risk of bleeding.
breathingproblems (due to the presence of codeine) Concomitant administration of thrombolytics or other antiaggregants platelet - In case of head injury and high intracranial pressure (such as following a drugs e.g. ticlopidine: increased risk of bleeding.
Coadministration of digoxin, concentrations increase digoxin plasma levels due - If you suffer from paralytic ileus (a situation where the bowel muscles do not Acetylsalicylic acid enhances the effects of lithium, triiodothyronine, allow movement of food through them, resulting in intestinal blockage) sulfonilureics, anticoagulants, barbiturates. Effects of the following drugs are - If you have recently had surgery on the liver, bladder, biliary or bile duct (biliary reduced by acetylsalicylic acid: aldosterone antagonists and loop diuretics, antihypertensive, alpha interferon, uricosurics (even at low doses, acetylsalicylic - If you are taking medicines to treat depression called MAOIs (monoamine acid reduces the excretion of uric acid and can trigger gout in patients with a oxidase inhibitors - drugs to treat depression) or have taken such drugs in the tendency to low excretion of uric acid).
A 1-3 hour interval between administration of acetylsalicylic acid and - In case of acute alcoholism (the presence of codeine) tetracycline is recommended (concomitant administration may cause - If the patient is in a coma (no opioid analgesics administered, such as codeine) - If you at the same time take over 15 mg of methotrexate weekly (due to the Caution in concomitant acetylsalicylic acid and methotrexate in doses <15 mg per week. Administration is contraindicated concomitant with use of - If you know you lack the enzyme glucose-6-phosphate dehydrogenase acetylsalicylic acid with methotrexate in doses ≥ 15 mg per week, due to - In case of pregnancy and breastfeeding.
increased haematological toxicity of methotrexate (in general, anti-inflammatory medicine lowers renalclearance of methotrexate, and salicylates move the Take special care with NEOLIN
methotrexate from plasma protein binding sites).
Related to acetylsalicylic acid
Valproic acid: acetylsalicylic acid increases the toxicity of valproic acid Crisis of asthma and other anaphylactoid allergic reactions may be triggered in due to its displacement from plasma protein binding sites.
patients with asthma and other allergic respiratory disorders, and those with Antidiabetic sulfonamides: increased effect of sulphonamides, with the possibility of hypoglycaemic accidents.
Caution should be exercised in case of a history of ulcers or gastrointestinal Probenecid or other uricosurics: acetylsalicylic acid prevents increased urate bleeding, in renal mild to moderate impairment.
Not recommended in gout, because of high therapeutic doses lower the Spironolactone: reduced effectiveness as acetylsalicylic acid promotes sodium Caution should be exercised in patients undergoing surgery, even minor (eg tooth extraction), as acetylsalicylic acid has antiplatelet effect, which persists Related to paracetamol
several days, with the risk of bleeding accidents.
Potentiation of the sedative effect and depression of respiratory function have Medicine can be used in uncompensated heart failure only after careful been reported in concomitant use with other drugs and substances that cause consideration of the potential risk / benefit.
depression of the central nervous system activity (eg, sedatives or hypnotics, Medicines containing acetylsalicylic acid should be used on teenagers with antihistamines with sedative, neuroleptic, antidepressant effect sedatives, fever, chicken pox or viral diseases (including influenza) only after careful consideration of the potential risk / benefit due possibility of Reye syndrome, In case of concomitant use with drugs that induce liver enzymes, such as certain hypnotics, antiepileptics (including glutetimide, phenobarbital, phenytoin, carbamazepine), rifampicin, therapeutic doses of acetaminophen can cause liver Related to paracetamol
disorders. The same is true of alcohol abuse.
Doses should be reduced or the intervals between doses extended in the Paracetamol increases the elimination half-life of chloramphenicol.
If concomitant chronic administration of warfarin or coumarin derivatives - Liver function disorders (eg chronic liver diseases, long-term alcohol with paracetamol in high doses (over 2 g / day) increased anticoagulant effect with haemorrhagic manifestations was reported. It is therefore In patients with Gilbert's syndrome in some cases paracetamol metabolism may preferable to monitor the prothrombin time more frequently in the case of appear low. In such cases, doses should be reduced.
- Impairment of renal function in patients on dialysis. When long-term treatment The concomitant use of drugs that lead to slow gastric evacuation, for example is necessary, liver enzymes should be monitored.
propantelin, absorption can be slowed and the onset of paracetamol effect may In animal studies, high doses of paracetamol resulted in testicular atrophy and inhibition of spermatogenesis. Therefore benefits of NEOLIN therapy in men The concomitant administration of paracetamol with lamotrigine reduced undergoing low fertility treatment remain to be studied.
lamotrigine efficacy has been reported due to increase of its hepatic clearance.
In case of long term use of high doses of acetaminophen, which does not comply Oral contraceptives may increase the clearance of paracetamol.
with recommendations, headaches were reported, which should not be treated Rate of absorption of paracetamol may be increased by metoclopramide or by increasing the drug dose. In such cases, treatment must be stopped.
domperidone and cholestyramine may be reduced.
In concomitant use of paracetamol and zidovudine an increased tendency of Related to codeine
developing neutropenia and hepatotoxicity were reported. Therefore, this drug Codeine administered in high doses for a long time may cause addiction.
should be used concurrently with zidovudine only after a careful risk / benefit In patients with cholecystectomy, codeine can cause a painful biliary or pancreatic acute abdomen syndrome, usually associated with biological Long-term coadministration of paracetamol and NSAIDs (mainly changes, indicating sphincter Oddi spasm.
acetylsalicylic acid) in high doses increases the risk of analgesics nephropathy Codeine may prevent elimination of tracheo-bronchial secretions in patients with productive cough. Caution should be exercised in patients with limited The paracetamol - salicylates combination should be administered short-term; diflunisal increases the concentration of paracetamol by 50% and thus Renal and urinary disorders: prolonged treatment can cause interstitial nephritis The following may apper: false low glucose values, determined by the methodoxidase / peroxidase or a false serum uric acid increase, determined by Related to paracetamol
Hypersensitivity reactions (transient skin rash, paraesthesia, itching) Increases in prothrombin time and serum bilirubin, lactatdehydrogenase thrombocytopenia (usually asymptomatic, rarely bleeding or hematoma, soft and serum transaminases show liver toxicity.
black stools, blood in urine and faeces, red skin stains), agranulocytosis (pharyngitis and fever, unexpected), dermatitis, liver damage (jaundice, conjunc- Related to codeine
tival or skin) renal colic (strong back pain appearing suddenly), renal insufficien- Morphine agonist-antagonist (nalbufine, buprenorphine, pentazocine) decrease analgesic effect by competitively blocking the μ receptor, with the risk of At high doses and prolonged treatment, paracetamol can damage renal function by chronic renal failure (analgesics-specific nephropathy), especially in people Alcohol: association with alcoholic beverages or medicines containing alcohol increase the risk of psychomotor depression phenomena.
Cases of abnormal decrease in the number white blood cells (leukopenia) and Naltrexone: risk of analgesic effect mitigation.
abnormal deficiency of all blood cells (red cells, white cells and blood platelets - Hypnotics, sedatives, tranquilizers, general anesthetics, antihistamines pancytopenia) have been reported, exceptionally.
sedatives, other morphine derivatives act additively with codeine with regard to the sedative and breathing depressing effect. Codeine must not be associated Related to codeine
with MAO (monoamine oxidase) due to high toxic risk.
At therapeutic doses, side effects of codeine are moderated. The following may In combination with antihypertensive medications, codeine increases the risk of occur: constipation, nausea, vomiting, drowsiness, subjective impression of body or environment rotating accompanied by balance disorder (vertigo), allergic In combination with expectorant medication codeine promotes tracheobronchitis skin reactions, airway narrowing due to muscle spasm (bronchospasm), respira- torydepression. Rarely occurring: sleep disorders, ringing in the ears (tinnitus), dry NEOLIN use with food and drink
mouth, difficulty breathing (dyspnoea).
Since the product contains paracetamol and codeine, ingestion of alcoholic At doses higher than therapeutic ones, there is the risk of dependency, with beverages is not recommended during treatment.
withdrawal syndrome on abrupt discontinuation of treatment, both in adults and newborns of mothers dependent on codeine.
Pregnancy and lactation
High doses can cause euphoria, blurred vision, intestinal and biliary smooth Ask your doctor or pharmacist for advice before taking any medicine.
muscle spasms, hypotension, temporary loss of consciousness (syncope), respiratory depression, pulmonary edema, increased tone of bladder smooth Administration of usual therapeutic doses of acetylsalicylic acid was not associated with an increased incidence of congenital malformations.
Administration of salicylates in high doses (> 300 mg / day) in the last three Attention
months of pregnancy may cause prolongation of gestation, premature closure of Patients should be warned to discontinue the drug upon first signs of skin
ductus arteriosus and inhibition of uterine contractions. Also favors bleeding in hypersensitivity or adverse liver reactions and to report immediately to the
Administration of acetylsalicylic acid in high doses (> 300 mg / day) shortlybefore birth can cause intracranial hemorrhage, especially in premature babies.
If any of the side effects gets serious, or if you notice any side effects not
Paracetamol can be given short-term during pregnancy, in therapeutic doses, listed in this leaflet, please tell your doctor or pharmacist.
after mother benefit vs. fetus risk assessment.
Preclinical studies have demonstrated teratogenic effect of codeine, therefore 5. HOW TO STORE NEOLIN
the drug is contraindicated during pregnancy.
Keep out of reach and sight of children.
Store at temperatures below 25 °C in original package.
Salicylates and their metabolites are excreted in breast milk in small quantities.
Don’t use NEOLIN after the expiry date stated on the pack after EXP. Expiry date Paracetamol crosses the placenta and is excreted in breast milk in proportion of refers to the last day of that month.
Medicines should not be disposed of via water waste or household waste. Ask Codeine is excreted in breast milk; cases of hypotonia, apnea or respiratory your pharmacist how to dispose of medicines no longer required. These depression in children after ingestion of large doses of codeine by mothers have measures will help protect the environment.
been described.
Therefore, administration of this drug is contraindicated during breastfeeding.
6. FURTHER
INFORMATION
What NEOLIN contains
Driving and using machines
- Active substances are acetylsalicylic acid, paracetamol and codeine. Each NEOLIN has a major influence on ability to drive or machinery. It is therefore tablet contains 300 mg of acetylsalicylic acid, paracetamol 250 mg and contraindicated in people driving or use machines.
codeine phosphate hemihydrate 12 mg.
- Other ingredients are maize starch, talc, stearic acid, povidone K 30, pre-gela- 3. HOW TO TAKE NEOLIN
Always take NEOLIN tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
What NEOLIN looks like and contents of pack
NEOLIN is presented in the form of white tablets, lenticular, marked by punching
The medicine is given only for adults and adolescents aged 15 years or more.
Adults and adolescents over 15 years: The recommended dose is one NEOLIN Package size:
tablet taken orally, as needed; if necessary, the dose may repeat every 4-6 Carton box with 2 PVC / Al blisters of 10 tablets each.
hours, not exceeding four NEOLIN tablets per day.
The elderly: initially receiving half of the recommended adult dose; possibly Marketing Authorisation Holder
increasing the dose based on tolerance and needs.
HEALTH ADVISORS S.R.L.
10 Ghica Tei Blvd.
Renal failure: recommended doses lower than common in adults.
Tablets should be swallowed whole with sufficient fluid.
Treatment should be short (5 days).
Manufacturer
BIOEEL S.R.L.
If you use more NEOLIN than you should
If you use more NEOLIN than should, you should contact your doctor
immediately or go to the emergency room of the nearest hospital.

This leaflet was approved in December 2009 If you forget to take NEOLIN
Take the dose as soon as you remember. Do not take a double dose to
compensate for the forgotten dose.

If you have any further questions on this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, NEOLIN can cause side effects, although not everybody gets
them.
Related to acetylsalicylic acid
Gastrointestinal disorders: nausea, vomiting, burning sensation in the
stomach and esophagus, abdominal pain, serious acute or occult bleeding in the
stomach and gastrointestinal ulcers (if prolonged oral administration).
Blood and lymphatic disorders: bleeding nose and gums, spontaneous bleeding
in the skin, increased risk of intraoperative and postoperative bleeding,
abnormally low number of blood platelets (cells promoting blood clotting)
(thrombocytopenia).
Hepatobiliary disorders: hepatotoxicity, increased serum transaminases and
alkaline phosphatase.
Immune system disorders: anaphylactoid manifested by skin rash, especially
urticaria, inflammation and ulceration of the skin, swelling of face, larynx, hands,
feet and breathing problems, asthma crises.
Nervous system: administration of high doses causes headaches, dizziness,
feeling of ringing in the ears, drowsiness or excitation, confusion.

Source: http://www.healthadvisors.ro/wp-content/uploads/2012/10/Neolin-Leaflet.pdf

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