Hyaluronidase For Injection USP 1500 IU Taj Pharma
- Name of the medicinal product
Hyaluronidase for Injection USP 1500 IU Taj Pharma
- Qualitative and quantitative composition
Each ampoule contains
Hyaluronidase 1,500 international units.
For excipients, see section 6.1.
- Pharmaceutical form
Powder for solution for injection / infusion.
A white, sterile freeze-dried powder for solution for injection or infusion.
- Clinical particulars
4.1 Therapeutic indications
Hyaluronidase can be used to enhance permeation of subcutaneous or intramuscular injections, local anaesthetics and subcutaneous infusions and to promote resorption of excess fluids and blood in the tissues.
4.2 Posology and method of administration
Adults, children and the elderly:
With subcutaneous infusion (hypodermoclysis): 1500IU of Hyaluronidase dissolved in 1ml of water for injections or normal saline injected into the site, before the infusion is set up, or injected into the tubing of the infusion set, about 2cm back from the needle, at the start of the infusion. 1500IU is sufficient for administration of 500-1000ml of most fluids. Refer to Section 4.4 for information on solutions for hypodermoclysis. Care should be taken in young children and the elderly to control the speed and total volume of fluid administered and to avoid over-hydration, especially in renal impairment.
With subcutaneous or intramuscular injections: 1500IU of Hyaluronidase dissolved directly in the solution to be injected.
With local anaesthetics: 1500IU Hyaluronidase is mixed with the quantity of local anaesthetic solution to be used. In ophthalmology, 15IU of Hyaluronidase per ml is recommended.
Extravasation: Where dispersal rather than localisation is indicated, 1500IU of Hyaluronidase in 1ml water for injections or normal saline infiltrated into the affected area as soon as possible after the extravasation is noted.
Haematoma: 1500IU of Hyaluronidase dissolved in 1ml water for injections or normal saline infiltrated into the affected area.
Immediately before use dissolve the freeze-dried powder in approximately 1ml of water for injections or directly in the solution with which Hyaluronidase is to be combined.
4.3 Contraindications
Hypersensitivity to hyaluronidase.
Not to be used for intravenous injections.
Not to be used to reduce the swelling of bites or stings or at sites where infection or malignancy is present.
Not to be used for anaesthetic procedures in cases of unexplained premature labour.
4.4 Special warnings and precautions for use
Do not apply directly to the cornea.
Hyaluronidase should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs.
Solutions for subcutaneous administration should be isotonic with extracellular fluid. Hyaluronidase is physically compatible with the commonly used infusion fluids. Use in hypodermoclysis has been reported with 0.9% sodIUm chloride, 0.18% sodIUm chloride with 4% glucose, 0.45% sodIUm chloride with 2.5% glucose and 5% glucose.
PotassIUm 34mmol/litre has been administered by hypodermoclysis in isotonic glucose or saline with 1500 I.U/litre hyaluronidase.
Electrolyte-free fluids are less preferable than those containing electrolytes and should not be given too rapidly. Hyaluronidase has also been mixed with morphine, diamorphine, hydromorphone, chlorpromazine, metoclopramide, promazine, dexamethasone, local anaesthetics and adrenaline (see 6.2. Incompatibilities).
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Pregnancy and lactation
It is not known whether the drug enters breast milk although it is unlikely to harm the breast-fed infant. Caution should be exercised in administering it to nursing mothers.
There is no evidence on the drug’s safety in human pregnancy nor is there evidence from animal work that it is free from hazard. Avoid use in pregnancy unless there is no safer alternative.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Oedema has been reported in association with hypodermoclysis. Allergic reactions have included rare reports of periorbital oedema occurring with the use of hyaluronidase in conjunction with local anaesthetics in ophthalmology.
Severe allergic reactions including anaphylaxis have been reported rarely. Local irritation, infection, bleeding and bruising occur rarely.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
4.9 Overdose
No cases of overdose appear to have been reported.
- Pharmacological properties
5.1 Pharmacodynamic properties
Hyaluronidase is an enzyme that has a temporary and reversible depolymerising effect on the polysaccharide hyaluronic acid, which is present in the intercellular matrix of connective tissue.
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
There are no additional pre-clinical data of relevance to the prescriber.
- Pharmaceutical particulars
6.1 List of excipients
None.
6.2 Incompatibilities
Physical incompatibility has been reported with heparin and adrenaline, although in clinical practice very low concentrations of adrenaline are combined with hyaluronidase without problems. Furosemide, the benzodiazepines and phenytoin have been found to be incompatible with hyaluronidase.
6.3 Shelf life
Unopened: 3 years.
Once opened use immediately and discard any unused contents.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
1ml neutral glass ampoule containing a plug of white freeze-dried powder.
Each ampoule contains
Hyaluronidase 1,500 international units.
For excipients, see section 6.1.
Pack size: 10 ampoules.
6.6 Special precautions for disposal and other handling
The solution should be used immediately after preparation. The appearance of the solution is clear and not more than faintly yellow.
For detailed instructions on preparation and administration, see section 4.2.
For single use only. Discard any unused contents.
7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine.
– Keep this leaflet. You may need to read it again while you are receiving your treatment
– If you have any further questions, please ask your doctor or nurse
– This medicine has been prescribed for you. The contents of your ampoule of Hyaluronidase should not be shared with other patients.
In this leaflet:
- WHAT HYALURONIDASE IS AND WHAT IT IS USED FOR
- BEFORE YOU ARE GIVEN HYALURONIDASE
- HOW HYALURONIDASE SHOULD BE GIVEN
- POSSIBLE SIDE-EFFECTS
- HOW TO STORE HYALURONIDASE
- FURTHER INFORMATION
1.WHAT HYALURONIDASE IS AND WHAT IT IS USED FOR
The name of your medicine is Hyaluronidase 1500 I.U. Powder for Solution for Injection or Infusion. The active ingredient in Hyaluronidase 1500 I.U. Powder for Solution for Injection or Infusion is hyaluronidase.
Hyaluronidase is an enzyme, a natural substance that activates processes in the body. It is used to temporarily break down the natural barriers in the body tissues so that injections or fluids injected under the skin or into muscle are more easily spread and absorbed.
Hyaluronidase is also used to enable excess fluids and blood in the tissues to be more easily reabsorbed.
- BEFORE YOU ARE GIVEN HYALURONIDASE
You should not be given Hyaluronidase:
- if you are known to be allergic to hyaluronidase
- to reduce the swelling of bites or stings
- at sites where infection or malignancy (cancerous growth) is present
- directly onto the front of the eye
- if you are in premature labour for which there is no
Hyaluronidase should not be administered by Intravenous Injection.
Hyaluronidase should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs. If you are taking dopamine or clonidine, or any other alpha agonist drug, please tell your doctor or nurse before you are given this medicine.
If you have any doubts about whether this medicine should be administered then talk to your doctor or nurse before it is given to you.
Pregnancy and breast-feeding
You should let your doctor know if you are pregnant, wish to become pregnant, or are breast-feeding before Hyaluronidase is administered.
Driving and using machines
Hyaluronidase has not been reported to affect ability to drive or operate machines.
- HOW HYALURONIDASE SHOULD BE GIVEN
- The usual dose for Hyaluronidase is 1500 International Units (iu)
- Hyaluronidase for injection is dissolved in water for injections, normal saline or the solution to be injected
- Your doctor or nurse will give the injection either into a muscle (intramuscular) or under the skin (subcutaneous)
- For an injection given continuously under the skin (subcutaneous infusion), the injection is injected into the infusion
Your doctor will decide the dose and route of administration that is best for you. If you do not understand what you are being given, or are in any doubt, ask your doctor or nurse.
If you think you have been given too much Hyaluronidase
Your doctor will decide which dose is best for you. If you think too much medicine has been given to you contact your doctor or nurse.
If you think you have missed a dose
If you think that an injection has been missed, speak to you doctor or nurse.
- POSSIBLE SIDE-EFFECTS
Like all medicines, Hyaluronidase may cause side-effects in some patients.
Very rarely, severe allergic reactions to Hyaluronidase may occur, with difficulty breathing,
rapid pulse and profuse sweating. If you develop any of these symptoms, contact your doctor or nurse immediately
- Hyaluronidase has on rare occasions caused allergic reactions (rash, itching, swelling around the eyes) or soreness, bleeding or bruising at the injection site
- Local swelling may occur when Hyaluronidase is used with subcutaneous
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
- HOW TO STORE HYALURONIDASE
Keep out of the sight and reach of children
- Hyaluronidase should not be stored above 25°C. Store the ampoules in the package container in which they were dispensed
- The injection must be used immediately after Any portion of the contents not used at once should be discarded
- Hyaluronidase should not be given if the powder shows signs of discolouration (it should be white)
- Hyaluronidase should not be used after the expiry date on the The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
- FURTHER INFORMATION
What Hyaluronidase looks like and contents of the pack
Hyaluronidase is a sterile, freeze-dried powder in 1 ml neutral glass ampoule, containing 1500 international units of the active ingredient (hyaluronidase).
The registered pack size is 10 x 1ml glass ampoules.
7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com
