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PATIENT INFORMATION LEAFLET
PF LACTATED RINGER SOLUTION FOR IV INFUSION
Used intravenously Sterile
Active ingredients: Each liter of solution included 3 grams of sodium lactate, 6 gram sodium chloride, 0,4 gram potassium chloride and 0,3 gram calcium chloride dihydrate. Excipients: Sterile water for injection
The following headlines are included in this PATIENT INFORMATION LEAFLET :
1. **What is PF LACTATED RINGER and what is it used for****_?
- Before you are given_** PF LACTATED RINGER 3. How you will be given **PF LACTATED RINGER****_?
- Possible side effects
- How to store_** PF LACTATED RINGER
Please read this PATIENT INFORMATION LEAFLET carefully before starting to use the drug; because important information is included here.
_- Keep these PATIENT INFORMATION LEAFLET. You may need to re-read it later.
- In case you have additional questions, please consult your doctor or pharmacist.
- This drug is prescribed personally for you, do not give to others.
- During the use of this drug, please tell your doctor that you are using this drug when you visit your doctor or a hospital.
- Please follow these instructions strictly. Do not use dosages_ higher or lower than the dosage recommended to you.
1. What is PF LACTATED RINGER and what is it used for****?
PF LACTATED RINGER is a solution administered intravenously and that contains the electrolytes, which are the building blocks of the body.
PF LACTATED RINGER is available in glass bottles with volumes 500 and 1000 ml with or without sets.
PF LACTATED RINGER is used in the treatment of water and chemical loss in the body (for example, excessive sweating, kidney disorders), low blood volume in the blood vessels (hypovolemia) or low blood pressure (hypotension) and metabolic acidosis (very acidic blood).
2. Before you are given PF LACTATED RINGER
PF LACTATED RINGER is a safe drug in many patients. However, if you have problems in your heart, kidneys, liver or lungs, if you are diabetic or if you have swelling (edema) in your body related to excessive salt accumulation in your body, your doctor can decide not to administer this drug to you.
DO NOT USE PF LACTATED RINGER under following conditions: In case you have had allergic reaction when you took drugs containing the same active substances or excipients with PF LACTATED RINGER, that is, if you have experienced sudden stopping of breath, wheezing, skin rashes, itching or swelling in your body, DO NOT USE this drug.
If you are not sure if you are allergic, consult your doctor.
If, -you are a newborn (less than 28 days old) using ceftriaxone (an antibiotic), -you are allergic to sodium lactate or any other substance in the PF LACTATED RINGER, -there is too much fluid in the spaces around the body cells (extracellular hyperhydration), -the blood volume in the blood vessels is higher than it should be (hypervolemia), -severe kidney failure (when your kidneys are not working well and dialysis is needed), -uncompensated heart failure. This heart failure has not been adequately treated and causes the following symptoms: -Shortness of breath -Swelling in the ankles -potassium levels in the blood are higher than normal (hyperkalaemia), -calcium levels in the blood are higher than normal (hypercalcemia), -very basic blood disturbance (metabolic alkalosis), -liver discomfort (acidic cirrhosis) that causes increased fluid in the abdomen, -your blood is as acidic as life threatening (severe metabolic acidosis), -a type of metabolic acidosis (lactic acidosis),
Calcium chloride can be harmful if injected into body tissues. Therefore, PF LACTATED RINGER should not be injected into the muscles (intramuscular injection). Your doctor will also make an effort to avoid leaking the solution into the tissues around the vein. PF LACTATED RINGER should not be given through the same needle used in blood transfusion. This can damage red blood cells or cause them to clump. PF LACTATED RINGER contains lactate, making your blood very alkaline (metabolic alkalosis). PF LACTATED RINGER should be given to babies younger than 6 months carefully. Your doctor will take this into account if you are receiving parenteral nutrition (infusion administered by intravenous infusion). If the PF LACTATED RINGER has been applied to you for a long time, you should be given an extra food source.
Please consult your doctor if these warnings are valid for you, even at any time in the past.
Use of PF LACTATED RINGER with foods or drinks
PF LACTATED RINGER does not interact with foods and drinks in relation with the route of its administration.
Pregnancy Consult your doctor or pharmacist before using this drug.
Your doctor will monitor the levels of chemicals in your blood and the amount of fluid in your body. Do not use the PF LACTATED RINGER during pregnancy, unless it is deemed particularly appropriate by your doctor. Calcium can pass to your unborn baby through the placenta and through breast milk after birth. In addition, if any other device will be added to your infusion solution during your pregnancy or lactation period, you must:
- Consult your doctor
- Read the Instructions for Use of the device to be added.
In case you become aware that you are pregnant during treatment, immediately consult your doctor or pharmacist.
Lactation Consult your doctor or pharmacist before using this drug.
If you are breastfeeding your baby, please declare it to your doctor. Unless otherwise considered appropriate by your doctor, do not use PF LACTATED RINGER during lactation period.
Driving vehicle and using machine PF LACTATED RINGER does not have any effect on driving or using machines.
Some important information about some ingredients of PF LACTATED RINGER
No adverse effects are expected related to the excipients included in the contents of PF LACTATED RINGER unless you are hypersensitive against such substances.
Taking other medicines Please inform your doctor if you plan, are taking, or have recently taken any other medicines, including over-the-counter medicines, vaccines, and herbal medicines.
It is important to inform your doctor if you use the following:
- Ceftriaxone (an antibiotic) should not be given through the same infusion unless it is thoroughly washed.
- Cardiac glycosides (heart enhancers) such as digitalis or digoxin should not be used in conjunction with the PF LACTATED RINGER (see also "DO NOT USE PF LACTATED RINGER"). The effects of these drugs may increase with calcium. This can be life-threatening by changing the heart rhythm.
- Corticosteroids (anti-inflammatory drugs).
- These drugs can cause sodium and water to accumulate in the body. This situation; -Tissue swelling due to water accumulation under the skin (edema) -High blood pressure (hypertension)
The following medicines can increase potassium concentrations in the blood. This effect can be life threatening. Increased potassium levels in the blood may occur if you have kidney problems.
- Potassium-sparing diuretics (certain water tablets, such as amiloride, spironolactone, triamterene) (it should be noted that these drugs may be combined with medicinal products)
- Angiotensin converting enzyme (ACE) inhibitors (used to treat high blood pressure)
- Angiotensin II receptors antagonists (used to treat high blood pressure)
- Tachromilus (used to prevent the body from rejecting organ transplants and in the treatment of skin conditions)
- Cyclosporine (used to prevent the body from rejecting organ transplants)
Other drugs affected or likely to be affected by PF LACTATED RINGER
- Thiazide productions such as hydrochlorothiazide or chlortalidone
- Vitamin D
- Bisphosphonates (used to treat bone disorders such as osteoporosis)
- Fluoride (for teeth and bones)
- Fluoroquinolones (a type of antibiotic such as ciprofloxacin, norfloxacin, ofloxacin)
- Tetracyclines (a type of antibiotic containing tetracycline)
- Acidic drugs, -Salicylates (aspirin) used to treat inflammations -Barbiturates (sleeping pills) -Lithium (used to treat psychiatric diseases),
- Alkali drugs, -Sympathomimetics (stimulant drugs such as ephedrine and pseudoephedrine are used in cough and cold) -Other stimulant drugs (eg dexamphetamine, fenfluramine)
Consult a doctor or a pharmacist if you had used PF LACTATED RINGER in an amount more than you should.
If you have used PF LACTATED RINGER in an amount more than you should, or if the solution has been administered to you very rapidly, the following signs can be seen:
- Water and/or sodium (salt) that can cause fluid accumulation (edema) and swelling in your tissues
- Hyperkalemia (higher-than-normal potassium levels in your blood) that can cause pins and needles or numbness in limbs that is more frequent particularly in those with renal failure
- Muscular weakness
- Inability to move/ paralysis
- Irregular heartbeats (cardiac arrhythmia)
- Cardiac blockade (very slow heartbeats)
- Cardiac arrest (a life-threatening condition that heart had stopped)
- Confusion
- Hypercalcemia (blood calcium level being higher than normal) that will result in the following: Anorexia nausea vomiting constipation abdominal pain mental status disorders including easy excitability or depression drinking excessive amounts of water (polydipsia) urination in amounts higher than normal (polyuria) renal disease related to calcium accumulation in kidneys (nephrocalcinosis) renal stones coma (loss of conscious) chalk-like taste in mouth flushing in face and neck dilation of the blood vessels in the skin.
- Hypokalemia (lowering of the potassium level in your blood to levels below normal) and metabolic alkalosis (your blood being more alkaline than normal) so as to cause the following signs, which are more frequent particularly in those with renal insufficiency: Mood changes Fatigue Stopping of breathing Muscular hardening Muscular fasciculation Muscular contractions.
Urgently notify your doctor if any of these signs are seen in you. The drug being administered to you will be stopped and treatment will be started based on your signs.
In case you forget to take PF LACTATED RINGER: Do not take double dosage to balance the skipped dosage.
Possible effects related to the termination of the treatment with PF LACTATED RINGER: None
4. Possible side effects Like all drugs, PF LACTATED RINGER can cause adverse effects in individuals who are sensitive to the contents.
Side effects are listed as shown in the following categories: Very common: It can be seen in at least one of 10 patients. Common: Less than one in 10 patients, but more than one in 100 patients. Uncommon: Less than one in 100 patients, but more than one in 1,000 patients. Rare: Less than one in 1,000 patients, but more than one in 10,000 patients. Very rare: Less than one in 10,000 patients can be seen. Unknown: It cannot be estimated from the available data.
If you notice any of the following, stop the PF LACTATED RINGER and report it to your doctor IMMEDIATELY or contact the emergency department of the nearest hospital:
- Common hives (urticaria)
- Rash on the skin
- Skin flushing (erythema)
- Itching (pruritus)
- Skin swelling (angioedema)
- Cough
- Difficulty breathing as a result of narrowing of the airways (bronchospasm)
- Rapid heartbeat (tachycardia)
- Slow heart rate (bradycardia)
- Decreased blood pressure
- Discomfort or pain in the chest
- Anxiety state (anxiety)
- Chest tightness (making breathing difficult)
- Shortness of breath (dyspnea)
- Al flushes
- Irritation in the throat
- Tingling (paresthesia)
- Reduced sensation in the mouth (decreased mouth sensation)
The expiry date is indicated on the label of each bottle. This drug will not be administered to you if this date has expired.
Use this drug according to the expiry date. Do not use PF LACTATED RINGER after the expiry date indicated on the packaging.
Do not dispose of expired or unused drugs! Give to the collection system determined by the Ministry of Environment and Urbanization.
Marketing Authorisation Holder and Manufacturer: POLİFARMA İLAÇ SAN. VE TİC. A.Ş. Vakıflar OSB Mahallesi, Sanayi Caddesi, No:22/ Ergene/TEKİRDAĞ/TURKEY Tel: +90 282 675 14 04 Fax: +90 282 675 14 05
This patient information leaflet has been approved on 29/01/2020.
THE FOLLOWING INFORMATION IS FOR THE HEALTHCARE PERSONNEL
WHO WILL ADMINISTER THIS DRUG
The solution must be checked before administration. Administration must be made intravenously using sterile/non-pyrogen sets.
Use only clear products not containing particles within intact packaging.
Administration must be started within the shortest time possible after the application set is attached to the product.
To prevent any air embolism related to the residual air in the bottle, no serial connection must be established with other infusion fluids.
The solution must be administered through a sterile application set using the aseptic technique.
Fluid must be passed through the application set before administration to prevent entry of air into the system.
Additional drugs can be mixed from the injection end with the help of a needle under aseptic conditions before or during the infusion.
Isotonicity of the end product must be determined before the parenteral administration.
The added drug must be completely mixed before being administered to the patient. Solutions containing additional drugs must be used immediately after mixing, and must not be maintained to be used later.
Adding drugs to the solution or wrong application technique can cause fever reaction related to contamination of the drug with pyrogens. Infusion must be stopped immediately in case of any adverse effects.
Mixing additional drugs: Caution: Like all the parenteral solutions, all the substances to be added to the product must be compatible with the product. If any drug will be added to the solution, compatibility in the final mixture must be checked before administration to the final mixture.
Addition of drugs before administration
- The bottle stopper will be disinfected.
- The drug to be added will be added into the bottle using an injector with a 19-22 gauge tip.
- The solution with the added drug will be mixed thoroughly. Caution: Bottles with added drugs must not be stored.
Mixing drugs during administration
- The clamp of the set will be closed.
- The bottle stopper will be disinfected.
- The drug to be added will be added into the bottle using an injector with a 19-22 gauge tip.
