Clasificación de Braunwald de la Angina Inestable.
RESPIRATORIO Asma Bronquial:
1. No cede contratamiento habitual
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ampoule
Self-sealed container made of tubular glass in three standardized ISO types (B, C and D). Pharmaceutical ampoules feature different opening systems, including one point cut (OPC), color break and score ring.
autoinjector
Medical device for administering a single dose (injection) of a liquid drug. Autoinjectors were mainly developed for self-administration by the patient. The devices use prefilled syringes.
› pen system Backstop
The backstop is an ingenious addition to the Gerresheimer syringe range. The plastic system component is clipped onto the finger flange of a glass syringe. It narrows the top opening and stops the plunger head from being pulled out of the syringe. The ergonomically shaped wings also enlarge the finger flange for improved ease of use.
Biopharmaceutics
Drugs produced in genetically modified organisms by means of biotechnol- ogy. Biopharmaceutics is one of the fastest-growing product categories in the pharma and biotech industry.
Borosilicate glass
Glass with very high hydrolytic resistance thanks to its chemical makeup. Its low alkali composition makes borosilicate glass well suited as a packaging material for injectables.
› hydrolytic resistance
Bulk syringes
Syringe barrels supplied to the customer in an unsterilized state. Washing, siliconization and mounting of the closure cap/needle shield before filling is carried out by the pharma company.
Camera inspection systems
The quality of Gerresheimer products is monitored during and after manu- facture using in-process controls. Advanced inspection systems help pick out defective items at an early stage with the aid of dedicated computer technology and digital image processing.
Cartridge
Tubular glass cylinder closed at the front end by an aluminum cap with a membrane that is penetrated by a pen needle to draw up the injection solution.
Child-resistant closure
Closure that protects children from harm by making pharmaceutical pack- aging hard for them to open. These special closures require actions that (without instruction) are generally beyond the dexterity of a child. They typically call for non-intuitive opening actions or a combination of move- ments simultaneously or in sequence (e.g. press-and-turn caps).
GLOSSARY
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diagnostic systems
Systems for the analysis of organic liquids and materials outside the body (in vitro). Such systems can analyze patient samples for specific parameters – in many cases fully automatically.
dropper bottle system
Special glass or plastic bottle system consisting of bottle, dropper and closure for administering medication in drop form.
drug delivery system
System to transport a drug’s active substance in various ways (by pulmonary or nasal inhalation, through the skin, via the mucous membranes or orally) to exactly where it is needed in the body. Examples: inhalers for the treatment of respiratory disease and prefillable syringes for injection drugs. drug master file (dmf)
Document recording the (pharmaceutical) manufacturing process and drug quality assurance system used for regulatory agencies (such as the FDA in the USA or Health Canada in Canada). Drug master files enable producers who are not the final distributor of a drug (such as the producer of the active agent or primary packaging) to provide drug regulators with all necessary information without passing on trade secrets to their business partners. Clean room
Room in which special air handling processes and systems are used to control particulate and microbial air quality. An integral feature of pharmaceutical production technology, this is essential to the manufacture of numerous drug delivery and primary packaging solutions.
ClearJect™ taspack™ (Cop syringe)
A brand of sterile prefillable plastic syringes from our Japanese partner company Taisei Kako Co. Ltd. The syringes are made of cyclic olefin poly- mer (COP), a special plastic with glass-like transparency. COP syringes are especially well suited for demanding applications in cytostatics and biopharmaceutics. Like RTF® syringes, they are packaged sterile in nested
tub format (TasPack™ Taisei Kako Sterile Packaging). Cop syringe (ClearJect™ taspack™)
› ClearJect™ taspack™ Cytostatics
Cytostatics are natural or synthetic substances that inhibit cell growth. They are used for the most part in cancer treatment (chemotherapy) and in some treatments for autoimmune disease.
diabetes care
Medical specialism covering diabetes diagnosis and therapy. In this business field, Gerresheimer concentrates on development and production of highly innovative lancets, skin-prick aids and insulin pen systems.
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furnace
Used for the melting process in glass production. The raw materials are mixed in batches and melted in the furnace at about 1,600°C. Gerresheimer’s furnaces run 24 hours a day, 365 days a year.
gx Baked-on rtf®
Gx Baked-On RTF® optimizes RTF® syringes for silicone oil-sensitive biotech
drugs. This Gerresheimer process is patented in Europe and the USA. Baked- on siliconization permanently fixes the silicone oil to the glass surface and significantly reduces the number of free oil droplets.
gx® g3 inspection system
The Gx® G3 inspection system is the latest (third) generation inspection
system for tubular glass products. In syringe production, the system allows all parts of the glass body to be cosmetically inspected in extremely high resolution. The system also offers highly accurate inspection of product geometry.
gx multishell® plastic vials
These primary packaging vials are made from cyclic olefin polymer (COP) and polyamide (PA). Gx MultiShell® plastic vials are glass-clear, break-resistant
and biocompatible, making them especially well suited to long-term storage of sensitive parenteral medicines. A new development, Gerresheimer’s MultiShell® combines two COP outer layers with a middle layer of polyamide
for improved barrier properties against gas permeation compared with vials made of COP alone.
gx rtf® syringe systems
The letters RTF in Gerresheimer’s Gx RTF® syringe brand stand for “ready-
to-fill”. Gx RTF® syringe systems are delivered to the customer washed,
siliconized, assembled with the closure cap, packed in nests and tubs, and sterilized – completely ready-to-fill, as the name suggests. This cuts out a whole chain of elaborate process steps for pharma manufacturers. Customers can therefore start filling product straightaway, saving a lot of time and money in the process.
gx® tekion™
Gx® Tekion™ is a system developed by Gerresheimer for cleaning glass
tubes with ionized air.
hydrolytic resistance
The resistance of glass to the leaching of alkali ions from the glass surface, and the parameter used to grade glass into hydrolytic classes.
inhaler
Device used in the treatment of asthma, bronchitis and other chronic respira- tory ailments. It transports aerosol and powder-based medications into the upper and lower respiratory tracts.
injection vial › vial inner surface treatment
Special surfacing process for the inside of a pharmaceutical container, e.g. to ensure compatibility with the medication.
insulin pen system
An insulin pen is a special injection system for safe and near-painless delivery of insulin from a cartridge.
integrated moisture absorber
A moisture absorber protects medication from the effects of moisture during storage and absorbs atmospheric humidity that enters the container as a result of it being repeatedly opened. Gerresheimer integrates the desiccant in a capsule affixed to the inside of the Duma® Twist-Off cap.
Joint venture
Gerresheimer uses the term joint venture for entities where it is majority owner and exercises control but where minority interests exceed 20%. lancet
Plastic-coated blood-sampling needle for insertion into a skin-prick aid for diabetic patients.
lancet magazine
Magazine with integrated lancets in a drum housing. laser coding
In the new laser coding process for syringes, a tiny data matrix code uniquely identifying the respective packaging container’s type and origin is indelibly laser-etched onto the finger flange. In this way, Gerresheimer offers an innovative track-and-trace solution for pharma containers and helps combat drug counterfeiting.
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life sciences
Life sciences are the field in which research institutes work primarily on the application of scientific findings in modern biology, chemistry and medicine as well as related areas, with a highly interdisciplinary and also market-driven orientation.
molecular diagnostics
Molecular diagnostics refers to analysis methods based on examination of genetic material (DNA or RNA). These allow more precise information to be obtained than with traditional diagnostic procedures so that illnesses can be detected faster.
moulded glass
Moulded glass packaging is produced in a single operation directly after the melting process.
multifunctional closure system
Gerresheimer closures feature secure, air-tight opening and closure systems to meet varied requirements. All caps conform to ISO standards and can be combined with our glass and plastic packaging containers for liquids and solids. The multifunctional closures are tamper-evident, child-resistant, senior-citizen-friendly and moisture-absorbing.
needle shield
Syringe part made of a pharmaceutical rubber compound that is placed over the taper to protect the needle and stopper the front end of the syringe. needle trap
Label with integrated needle shield to avoid needleprick injuries from syringes.
ophthalmology
The medical field of ophthalmology deals with eye and sight diseases as well as malfunctions and their medical treatment.
paste mould technology
Glass-forming (blowing) process using a rotating mould to produce a round and seamless piece of glassware.
pen system
A pen system is used to administer medication in multiple doses. Unlike autoinjectors (which are non-reusable), pen systems are mostly used multiple times. A pen system contains a prefilled cartridge as the primary packaging. › insulin pen system
pharmaplus
PharmaPlus is a range of high-caliber technical solutions in glass form- ing for unprecedented levels of precision. This includes the production of borosilicate glass tubes, which Gerresheimer itself manufactures as an intermediary product. The subsequent forming processes likewise produce an excellent new standard of quality in primary packaging, for syringes, cartridges, vials and ampoules alike.
plastic systems
Complex and technically sophisticated assemblies made of multiple plastic components.
plunger (head)/rubber stopper
Syringe part made of a pharmaceutical rubber compound that closes the syringe end after filling.
plunger rod
Syringe part that is threaded or clipped onto the plunger head. For an injection, the user’s thumb pushes down on the plunger rod to move the plunger and empty the syringe.
prefillable syringe systems
Prefillable syringe systems in the form of Gx RTF® syringes are supplied sterile
to customers in the pharma and biotech industry. Gx RTF® syringes are ready
to be filled with liquid medication and sealed on accredited production lines. › gx rtf® syringe systems
primary packaging
Packaging that is in direct physical contact with medication. siliconization
Silicone oil is used as a glide agent in the inner surface treatment of pharma- ceutical containers. This makes it easier for the plunger to slide along the syringe barrel – an essential feature in a properly functioning syringe system. › gx Baked-on rtf®
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skin-prick aid
Device for diabetics allowing a lancet to be inserted near-painlessly into the skin. Some models allow for different penetration depths to cater for variations in skin thickness.
tamper-evident closure
A tamper-evident closure reliably signals that a pharmaceutical container has been previously opened. This means physicians, nurses and patients know if a drug has been tampered with. Gerresheimer’s Duma® Twist-Off
tamper-evident screw caps for tablet bottles have a ring on the cap that is detached by the twisting action when the container is first opened. The pieces of plastic connecting the ring to the cap are torn off in the process, clearly indicating that the product has been opened before. The Tamper Evident Luerlock Closure (TELC®) for Gerresheimer syringe systems is likewise
activated by twisting. The twist action causes the tabs on the twist-off closure to spread out, showing that the syringe has been previously opened. tCC
Technical Competence Center, where products and systems are developed and made ready for series production in collaboration with the customer. telC® (tamper evident luerlock Closure)
Tamper-evident closure system developed by Gerresheimer for prefilled syringes. The system combines a Luerlock adapter with a tamper-evident closure.
terns (thermoplastic elastomer rigid needle shield)
TERNS is a shield developed by Gerresheimer for needle tips, with a soft seal- ing element made of thermoplastic elastomer (TPE) and a firm plastic shell.
tip cap
Syringe part made of a pharmaceutical rubber compound that is placed over the taper to stopper the front end of the syringe.
tpe (thermoplastic elastomer)
Plastic with thermoplastic properties, behaving like a classical elastomer at room temperatures but allowing its shape to be modified when heated. tubular glass
Tubular glass relates to two separate processes: First, the production of glass tubes and, second, the manufacture from those tubes of primary packaging such as syringes, cartridges, ampoules and vials.